Biological Safety Manual - UMass Amherst Amherst... · 2016. 6. 6. · 3.2 IBC membership conforms...

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University of Massachusetts at Amherst Environmental Health and Safety

117 Draper Hall 40 Campus Center Way

Amherst, MA 01003-9243 Phone: 413-545-2862

Fax: 413-545-2600 Website: www.ehs.umass.edu

Biological Safety Manual

December 2010

Contact:

Judith A. LaDuc, RBP

Biological Safety Services Manager Voice: 413-545-7293 Cell: 413-687-5476

Email: [email protected]

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University of Massachusetts at Amherst


Table of Contents

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University of Massachusetts/Amherst

Biological Safety

Section A. Oversight Mission Statement Institutional Biosafety Committee Use of Biohazardous Materials in Research and Instruction Biological Safety Program Responsibilities BMBL Laboratory Biosafety Criteria for BSL 1,2,3 & ABSL 1,2,3 B. Procedural Biosafety Disinfection Personal Protective Equipment Biological Safety Training Shipping Biological Material Biological Safety Cabinet Management Program Accidental Biohazardous Material Spill Procedure Body Fluid Spill Clean-up Procedure Emergency Eyewash and Drench Shower Program Accidental Exposure Procedure Serum Banking Guidelines Lab Occupational Health Program for Human Source Material Lab Occupational Health Program for Pathogenic Agents Lab Occupational Health Program for Handling Non-human Primates Animal Handler Occupational Health Program C. Waste Management Autoclave Management Program for Bio-waste Decontamination Bio-materials & Biohazardous/Medical Waste Disposal Program Sharps Policy D. Appendix Fact Sheet: Autoclave Safety Fact Sheet: Autoclaved Waste Fact Sheet: Biological Exposure Fact Sheet: Biological Spill Clean-up Fact Sheet: Biological Safety Cabinets vs. Laminar Flow Hoods Fact Sheet: Biological Waste Fact Sheet: Blood Borne Pathogens Fact Sheet: Centrifuge Safety

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Fact Sheet: Chemical Disinfectants Table of Contents (cont.) Section Appendix (cont.) Fact Sheet: Ethidium Bromide Waste Disposal Fact Sheet: Secondary Containment Devices Fact Sheet: Sharps Fact Sheet: UV Lights are Not Recommended in Biosafety Cabinets Fact Sheet: Protection of Vacuum Systems used in Tissue Culture Work Sign: No Gloves Beyond This Point Sign: Biohazardous Waste Packaging Guide Sign: Biohazardous Waste Packaging Guidelines Sign: Biohazard Emergency Procedures Sign: Autoclave Verification Flowchart Sign: Reprocessing Methods for Equipment Used in Research Setting Form: Laboratory Accident Form: Recombinant DNA Research Protocol

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A. Oversight

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University of Massachusetts/Amherst Biological Safety Mission Statement

The University of Massachusetts-Amherst Biosafety Program’s primary mission is to support science in assuring the safety of the research, the scientist, the public and the environment by providing biosafety and research compliance guidance. We provide a wide range of services that include training on handling biohazardous agents & materials, laboratory assessments, protocol/SOP reviews, risk assessments for labs and vivariums, regulatory oversight & guidance for recombinant DNA research, registration reviews for rDNA, animal models, human source materials and infectious agents etc. In addition we are responsible for the organization and are voting members of the following safety related committees on campus: the laboratory safety coordinator group, the occupational health committee, Institutional Biosafety Committee, Institutional Animal Care and Use Committee, Infection Control Committee, Institutional Chemical Safety Committee, Health Council, etc. and also manage various safety equipment on campus including biological safety cabinets, fume hoods, autoclaves, etc.

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THE UNIVERSITY OF MASSACHUSETTS AMHERST ADMINISTRATIVE POLICIES AND PROCEDURES

Office of Primary Responsibility: Subject: Vice Chancellor for Research and Engagement Institutional Biosafety Committee 1.0 Purpose The University of Massachusetts Amherst (the University) has an Institutional Biosafety Committee (IBC) in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines, 2002) and in accordance with Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, 2007. The following sections describes the University’s policy and procedures for the IBC 2.0 Policy

The IBC follows NIH Guidelines for practices for reviewing projects that require constructing and handling: (i) rDNA molecules, and (ii) organisms and viruses containing rDNA molecules. The IBC also reviews activities involving use of Select Agents and Toxins and other biohazardous agents that must be handled at BSL3 and 4. The IBC will assist the Biosafety Officer (BSO) in the Department of Environmental Health & Safety (EH&S) in formulating policies and procedures related to the use of biohazards. The IBC is also charged with reviewing the biological and medical waste management program annually according to The Department of Public Health’s regulation on the minimum requirements for the management of medical and biological waste CMR 480.000 The IBC may advise the institution and the Principal Investigator (PI) concerning management of research that is classified as “dual use”.

3.0 Procedure

3.1 IBC members are appointed by the Vice Chancellor for Research and Engagement for 3-year terms. At the end of a member’s term he/she may be reappointed for a further term.

3.2 IBC membership conforms to NIH Guideline IV-B-2-a-(3).

3.3 The IBC meets no less than four times a year for review of projects using rDNA that require review at NIH review level IIIE and higher, or for any other matter within the scope of the committee. A meeting is conducted in person or via conference call. A quorum is a majority of the membership. When possible, and consistent with the protection of privacy and proprietary interests, IBC meetings are open to the public.

3.4 The Research Compliance Coordinator serves as Executive Secretary to the IBC including preparation of IBC minutes and filing reports with OBA. Annual Reports to OBA are filed on or before the anniversary of the previous Annual Report. Reports of significant problems or violations are reported to OBA within 30 days of the incident

3.5 An IBC member may not be involved in the review of any project in which he/she or a close relative or spouse has a personal or financial interest.

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3.6 The IBC may approve a registration for a period of up to 5 years.

3.7 The PI is notified in writing that a registration has been approved by the IBC. The approval letter includes the registration number, expiration date, and any other pertinent information and special approval conditions. Approval letters for reviews conducted at NIH review level IIIE may be signed by the Executive Secretary. All other approval letters are signed by the IBC Chair.

3.8 The IBC has been granted authority to investigate potential violations or compliance problems related to its area of oversight

3.9 Requests from members of the public for documents relating to IBC activities are handled in accordance with provisions of the Massachusetts Open Records Law (M.G.L. c. 66, § 10) and University policy for handling requests for documents related to research. The University policy documents a process for review and redaction of research records before they are sent to a requestor. The institution’s response to a request for records is handled in consultation with Legal Counsel. The Vice Chancellor for Research and Engagement responds to the request.

Approved by Vice Chancellor for Research and Engagement Michael Malone

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University of Massachusetts/Amherst Institutional Biosafety Committee

The Institutional Biosafety Committee (IBC) is a University-wide review body appointed by the Vice Provost for Research to review and approve potentially biohazardous research (see: http://www.umass.edu/research/primary/biological-safety-and-ibc ). When it is unclear as to whether a material constitutes a potential biohazard, questions should be directed to the BSO in the Office of Environmental Health and Safety (EHS) (545-2682). Note: In the past the University had two standing committees to oversee rDNA, and pathogens, oncogenes, carcinogens and toxins. These activities are now combined, as reflected by the IBC’s charge which encompasses:

Review of policies, programs and directives regarding biological hazards in academic, research, clinical and animal care activities.

Review and approval of research that involves potentially biohazardous materials (plant and animal pathogens, oncogenes, carcinogens, toxins and recombinant DNA), as required by University, State and Federal directives. Review includes: (i) an independent assessment of the containment levels required by the NIH guidelines for the proposed research, (ii) assessment of the facilities, procedures, practices and training and expertise of the personnel involved in rDNA research, and (iii) ensuring compliance with all reporting and adverse event reporting required by the NIH guidelines. The committee may approve, disapprove, or request revisions which would lead to approval.

Advising the Administration regarding problems of a biologically hazardous nature and recommending actions. Recommendations include: denial of proposed activities where adequate facilities, equipment or personnel are not available; sanctions against individuals who are non-cooperative in biosafety matters; suspension of any biohazardous activity judged to pose a significant risk to health of safety.

Review of emergency plans covering spills and personnel contamination resulting from rDNA research and research using biohazards.

The IBC currently has eleven members appointed for three-year terms to provide oversight over University operations and activities of a potentially biologically hazardous nature. Membership of the IBC is consistent with NIH guidelines (sections IV-B-2-a and IV-B-2-b) on the review of projects involving the use of recombinant DNA and its make-up has been reviewed and approved by the NIH/Office of Biotechnology Activities. The BSO is a member of the committee and the other members work closely with the BSO to recommend actions necessary to maintain and/or improve biosafety on the campus. The IBC meets at least four times a year. A quorum consists of a simple majority. A passing

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vote is a simple majority of members present. Minority views are recorded in the minutes. The CC attends the meetings and takes the minutes. Procedures PIs conducting research with biohazardous materials must register with the IBC. Grant-funded research: PIs proposing research that uses biohazardous materials must indicate the category on the Internal Processing Form (IPF). When one or more of the following items are checked

biohazardous substances carcinogenic substances recombinant DNA Select Agents

A copy of the proposal is forwarded from the Office of Grants and Contracts to the Office of Research Affairs for action. When the research involves biohazardous or carcinogenic substances a copy of the proposal is forwarded to the BSO for review. The BSO contacts the PI and requests that he/she submit the appropriate form (EH&S Research Registration Form) to register the work with the IBC and to ensure that the procedures are in compliance with all relevant regulations. The BSO will forward registrations for biohazardous work at BSL2, 3, and 4 to the IBC for review. Non-funded research and teaching activities: If there is no grant proposal the registration must also include an outline of the parts of the experimental procedure that involve the use of rDNA or Select Agents. When the research involves work with rDNA and/or Select Agents the ORA assistant contacts the PI and requests that he/she submit the appropriate form (rDNA registration or Select Agent registration) to register the work with the IBC (see Appendix 1 for copies of the forms). For rDNA registrations the PI must indicate the Biohazard level according to the NIH Recombinant DNA/Infectious Agent registration Guidelines http://www4.od.nih.gov/oba/ and should clearly identify projects that involve more than one biohazardous material. The completed rDNA or Select Agent registration is returned to the Office of Research Affairs (Bev Strakose, Office of Research Affairs, Goodell Building) where the information is entered into a database then forwarded to the BSO together with a copy of the proposal. For rDNA registrations the BSO reviews the registration and, depending on the biohazard level, either approves the registration (Level III-F, E, BSL1) and determines the appropriate biosafety requirements for the PI, or submits the project for consideration by the full IBC (levels III-A, B, C,D; BSL>1). For work registered at Levels III-F and III-E the PI may begin the project without receipt of formal approval from the BSO and/or IBC. For work registered at Levels III-D through III-A formal written approval by the BSO, the IBC and appropriate federal agencies must be received before the project can be started. For Select Agents registration the BSO follows up with the PI to ensure that all aspects of Homeland Security and the Patriot Act and other regulations are complied with including:

whether or not the Select Agents are exempt from registration with the CDC

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justification of the type of Biological Agent, Toxin or Delivery system to be used assurance that “Restricted Persons” and/or unauthorized persons will not have

access to the Select Agents how the Select Agents will be secured and be controlled when not in storage the locations where the Select Agents will be stored and used disinfection and disposal methods

If the project is to be conducted in a University laboratory, the BSO contacts the PI and schedules an inspection of the site(s) where the research will be conducted. If the research also needs review and approval by the IACUC or IRB, approval by these committees is withheld pending approval of the project by the BSO/IBC and an assurance from the BSO that procedures are in place to ensure the safety of any personnel that will come in contact with the biohazardous materials, including laboratory staff and students, and animal care or greenhouse technicians. Note: When contacted by the BSO the PI should discuss the need for a written Safety Protocol. A written Safety Protocol is required for projects where the biohazardous material comes in contact with animals and animal care staff. Upon receiving a positive recommendation from the BSO (and the IBC chair if the protocol received full committee review), the IBC Chair informs the principal investigator. Approvals are for the life of the project or for a maximum of five years. Records for the IBC and a database of BSO-approved protocols are maintained in the ORA in accordance with federal standards. Laboratory inspection records, training records, and the inventory are maintained by EHS in accordance with applicable federal regulations.

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University of Massachusetts/Amherst Use of Biohazardous Materials in Research and Instruction

PURPOSE The University of Massachusetts Amherst (the University) is committed to ensuring the safe handling, storage, and disposal of potentially biohazardous materials, as defined below, used in University research or instructional projects. This policy is designed to ensure that employees, students and visitors follow safe practices when working with or near potentially biologically hazardous materials or recombinant DNA. The University will pursue biological safety through ensuring prudent practices to protect people and the environment from biological hazards and will conform to state and federal biosafety directives and guidelines. Implementation of this policy by the University is intended to provide a safe working atmosphere and a well-controlled research environment. The University’s concern is for all biosafety issues but in particular it is concerned with activities involving

Infectious agents Recombinant DNA research Agents on the list of Select Agents Potentially biologically hazardous materials

This policy statement describes the role of the University and the Research Compliance Coordinator (CC) in the Office of Research Affairs (ORA), the Environmental Health and Safety Director (who is the Responsible Official with oversight over biosafety issues) and the Institutional Biological Safety Officer (BSO) in EHS, the Institutional Biosafety Committee (IBC), and the IBC’s structure and function. The Biological Safety Officer and IBC are charged with reviewing and approving projects that need to comply with federal regulations on the use of recombinant DNA and Select Agents. The review process is described below. DEFINITION Biosafety promotes safe laboratory practices, procedures and proper use of containment equipment and facilities among University staff and visitors. Biohazardous Material - The following categories represent the areas of primary concern with respect to biosafety. Projects involving material(s) included in any of these categories should be submitted to the BSO for initial review and may require IBC approval.

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1. Chemical Carcinogens used in conjunction with animals. 2. Toxic/Infectious agents used in conjunction with animals and plants. 3. Oncogenic viruses used in conjunction with animals. 4. Infectious agents requiring handling conditions above Biosafety Level-1.

(Biosafety Level determinations are based on the recommendations outlined by the CDC-NIH publication Biosafety in Microbiological and Biomedical Laboratories.

5. Recombinant DNA 6. Human blood and blood products, human body fluids, human tissue, and/or

human cells. 7. Biological toxins. 8. Agents regulated by CDC or USDA (e.g. on the list of Select Agents) 9. Whenever a contractual agreement or grant proposal requires Institutional

Biosafety Committee approval for the safe handling of a biological or chemical product.

10. Any research that requires a permit from USDA Animal and Plant Health Inspection Service (APHIS).

11. Wild Poliovirus or materials that may contain wild poliovirus [contact Environmental Health and Safety (413) 545-2682 for additional information on this subject].

POLICY This policy applies to all research and instructional activities, sponsored and unsponsored, conducted under the auspices of the University. This policy is applicable to all University locations. University projects involving the use of biohazardous materials at other institutions should receive Institutional Biosafety Committee (IBC) approval from the cooperating institution. Copies of approvals from cooperating institutions should be forwarded to the Office of Grant and Contract Administration (OGCA) and the Office of Research Affairs (ORA). All University research and instructional activities involving biohazardous materials must be reviewed and approved by the Biological Safety Officer and, as required, the Institutional Biosafety Committee (IBC). Projects submitted for sponsorship by external agencies will be submitted for review prior to acceptance of funding. The review process is coordinated by the Research Compliance Coordinator in the Office of Research Affairs (ORA) in Research Administration Building (545-5283). RESPONSIBILITY Administrative heads of departments and other units have responsibility for the biosafety of people, animals and the environment within their jurisdiction. Appropriate planning, provision of appropriate space and equipment, and training of personnel are essential in potentially biohazardous activities. Principal investigators (PIs), instructors, supervisors and other personnel in charge of potentially hazardous activities are key to the biosafety effort. PIs must set an example by their own actions to ensure compliance with the regulations and the University’s

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biosafety policy, directives and guidelines regarding the work they supervise. They must report biologically hazardous incidents to the Biological Safety Officer (BSO) promptly and assist in any resulting decontamination; investigation and/or reporting that may be required. They are responsible for posting biohazard warning signs at the entrance to the laboratory. They are responsible for notifying the Office of Research Affairs of any proposed activity using biohazards by indicating so on the Internal Processing Form IPF form that accompanies a grant proposal submitted to the Office of Grants and Contracts (OGCA). They are responsible for making the initial determination of the required level of physical and biological containment in accordance with National Institute of Health (NIH) and Center for Disease Control (CDC) Guidelines. Once the project starts they are responsible for reporting any significant problems to the appropriate authorities (BSO, and/or Greenhouse or Animal Care Director as appropriate). It is the responsibility of the PI to ensure that copies of approval letters are properly directed to any funding agency or sponsor. It is also the PI’s responsibility to renew approved projects with the ORA and provide a current listing of personnel involved in approved projects to the ORA. All personnel involved in potentially biologically hazardous activity share biosafety responsibility and must follow specified procedures, take appropriate training, act responsibly, and report incidents and hazardous circumstances. They should inform their supervisor of any personal condition such as illness, medications, pregnancy, or reduced immunity which could make their work more hazardous to themselves and others. The Biological Safety Officer (BSO) is appointed by the University and is a member of the EHS staff. The BSO reports to the Director of Environmental Health and Safety who is charged with oversight of research and other activities involving the use of biohazardous materials. The EHS Director is the Responsible Official for biosafety issues and the BSO is his/her Alternate as required by the Homeland Security Act. The Director of EHS and the BSO set containment levels in accordance with the National Institute of Health Guidelines and the Center for Disease Control Prevention. The BSO reports any violations of the NIH Guidelines to the Responsible Official and the Institutional Biosafety Committee. The BSO and other EHS personnel maintain an inventory of all potentially biologically hazardous materials, including Select Agents. EHS records include a biohazard’s nature, location, and the Principal Investigator(s) involved. The BSO is responsible for:

advising and training the Institutional Biosafety Committee members, faculty and staff concerning biologically hazardous materials and their control

reviewing (or pre-reviewing for the IBC) registrations of rDNA and Select Agents inspecting facilities reviewing and inspecting biologically hazardous activities in coordination with

other EHS personnel and activities, the Animal Care Director, Greenhouse Managers, and the Compliance Coordinator in the Office of Research Affairs

providing technical advice to investigators on laboratory containment facilities, safety equipment, security and research safety procedures

developing emergency plans for containment and handling spills and personnel contamination

investigating accidents involving biologically hazardous materials.

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The Research Compliance Coordinator (CC) is a professional staff member in the Office of Research Affairs (ORA). The CC works closely with the BSO and EHS Director to ensure that research with biologically hazardous materials and organisms at the University is conducted in accordance with all applicable local, state and federal regulations. The CC and staff in the Office of Research Affairs have responsibility for:

managing the rDNA and Select Agent registrations database managing the registration review process and interfacing with the BSO and the

IBC for registration review taking IBC meeting minutes recording registrations submitted and actions taken providing administrative support to the IBC and BSO notifying the principal investigator of the outcome of a registration review filing the IBC Annual Report for the University of Massachusetts Amherst with

the NIH/Office of Biotechnology Activities reporting oversight activity to the IBC when, according to State and Federal

Regulations, the activity does not require the committee’s direct oversight interfacing between the BSO and the IBC and other University oversight

committees like the Institutional Animal Care and Use Committee (IACUC) and the Institutional Review Board (IRB). The CC attends meetings of all three committees.

The University is responsible for

establishing an IBC and appointing the IBC Chair ensuring that the IBC members, the BSO, the CC, PIs and laboratory staff have

appropriate expertise and training ensuring that an Annual Report is filed with the NIH Office of Biotechnology

Activities and that the report includes (1) a roster of IBC members indicating their expertise; and (2) biosketches of the members. [The Institution has an Approval on file with the NIH/Office of Biotechnology Activities. The Approval must be renewed annually.]

establishing procedures for the IBC making available to the public, on request, IBC meeting minutes and any

documents submitted to, or received from, funding agencies that those agencies must make available to the public.

THE INSTITUTIONAL BIOSAFETY COMMITTEE The Institutional Biosafety Committee (IBC) is a University-wide review body appointed by the Vice Provost for Research to review and approve potentially biohazardous research. When it is unclear as to whether a material constitutes a potential biohazard, questions should be directed to the BSO in the Office of Environmental Health and Safety (EHS) (545-2682). Note: In the past the University had two standing committees to oversee rDNA, and pathogens, oncogenes, carcinogens and toxins. These activities are now combined. When the research involves work with rDNA and/or Select Agents the ORA assistant contacts the PI and requests that he/she submit the appropriate form (rDNA registration

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or Select Agent registration) to register the work with the IBC. For rDNA registrations the PI must indicate the Biohazard level according to the NIH Recombinant DNA/Infectious Agent registration Guidelines and should clearly identify projects that involve more than one biohazardous material. The completed rDNA or Select Agent registration is returned to the Office of Research Affairs (Melinda LeLacheur, Office of Research Affairs, Research Affairs Building) where the information is entered into a database then forwarded to the BSO together with a copy of the proposal. For work registered at Levels III-D through III-A formal written approval by the BSO, the IBC and appropriate federal agencies must be received before the project can be started. For Select Agents registration the BSO follows up with the PI to ensure that all aspects of Homeland Security and the Patriot Act and other regulations are complied with. DISPOSAL OF BIOHAZARDOUS WASTE All biohazardous waste must be disposed of in accordance with local, state and federal regulations. Biohazardous waste must be collected in a bag with the biohazard symbol marked on the bag. Bags must be kept in a sturdy, covered, leak-proof container. Biohazardous waste must be decontaminated by autoclaving, disinfection, or incineration. Waste that cannot be decontaminated by laboratory personnel will be removed from the area by EHS personnel for disposal, shipment, or destruction in accordance with applicable regulations. Sharps waste must be collected in “sharps” containers and removed by EH&S personnel in accordance with applicable regulations. Refer to the EH&S Biohazardous Waste treatment, packaging, and disposal guidelines at http://www.ehs.umass.edu

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University of Massachusetts/Amherst

Biological Safety Program Responsibilities

Biosafety Program Responsibilities Biosafety The Chancellor is the institutional official for Biosafety. The Vice Chancellor for Administration and Finance has the primary delegated role in the Biological safety program. Those with contributing responsibilities at this level are: Vice Provost of Research Affairs, Director of Environmental Health and Safety, Director of Research Affairs, Deans and Department Heads, Biosafety Officer, Institutional Biological Safety Committee and the Compliance Coordinator. The primary role for overall compliance of biological research falls to the Vice Provost of Research Affairs, with the primary delegated role belonging to the Compliance Coordinator. Those with contributing responsibilities at this level are: Director of Research Affairs, Deans and Department Heads, Biological Safety Officer, IACUC and Institutional Biosafety Committee. The applied health and safety practices are primarily seen to by the Principle Investigators. Deans and Department Heads may support the PI’s with oversight and training. USDA, CDC and NIH audits for bio-research are the primary responsibility of the Chancellor with the Vice Chancellor in the primary delegated role. Those with contributing responsibilities at this level are: Director of Research Affairs, Biological Safety Officer, Director of Animal Care and the Compliance Coordinator. The Development of Policy and Protocols related to Biological safety are the responsibility of the Vice Chancellor for Administration and Finance with the primary delegate being the Director of Environmental Health & Safety. Those with contributing responsibilities at this level are: Biological Safety Officer, Institutional Biosafety Committee and the Compliance Coordinator. The approval of policy and protocols related to biological safety is the responsibility of the Vice Provost of Research Affairs with the IBC as the primary delegate for this duty. Those with contributing responsibilities at this level are: Director of Research Affairs, Biological Safety Officer and the Compliance Coordinator. Institutional Biosafety Committee oversight is the responsibility of the Vice Provost of Research Affairs with the Compliance Officer as the primary delegate for this duty.

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Those with contributing responsibilities at this level are: Director of Research Affairs, Biological Safety Officer and the Institute Biosafety Committee. Research registration of pathogenic organisms and toxins is the responsibility of Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities at this level are: Biological Safety Officer, Institute Biosafety Committee and the Compliance Coordinator. The rDNA research oversight is the responsibility of the Vice Provost of Research Affairs with the Compliance Officer as the primary delegate for this duty. Those with contributing responsibilities at this level are: Director of Research Affairs, Biological Safety Officer and the Institute Biosafety Committee. University biosafety inspections are the responsibility of the Vice Provost of Research Affairs with the Biological Safety Officer having contributing responsibilities. Review and approval of research involving biosafety/biohazard issues; BSL-2 level research, pathogenic microorganisms and toxins are the responsibility of Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities at this level are: Biological Safety Officer, Institute Biosafety Committee and the Compliance Coordinator. Review and approval of research involving biosafety/biohazard issues with rDNA is the responsibility of the Vice Provost of Research Affairs with the IBC as the primary delegate for this duty. Those with contributing responsibilities at this level are: Director of Research Affairs, Biological Safety Officer and the Compliance Coordinator. The Compliance Coordinator is responsible for reporting to NIH as well as responding to queries regarding rDNA/IBC. The Compliance Coordinator is the primary delegate for these duties and the Biological Safety Officer has contributing responsibilities as well. The Select Agent program is the responsibility of the Environmental Health and Safety Program Director, with the primary delegate being the biological safety officer. Those with contributing responsibilities at this level are: PI’s and the Compliance Coordinator. Inventory of biologicals on campus is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities at this level are: Biological Safety Officer and the Institutional Biosafety Committee. Biosafety cabinet inspections/certifications are the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities at this level are: Deans and Department Heads, Biological Safety Officer and PI’s.

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Safety and health of laboratory staff, researchers and students are the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities at this level are: Deans and Department Heads, Biological Safety Officer, Institutional Biosafety Committee, Compliance Coordinator and PI’s. Bloodborne pathogen training is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. The Biological Safety Officer has contributing responsibilities in this area. Biosafety training of students, staff and PI’s is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities at this level are: Deans and Department Heads, Biological Safety Officer, Director of Animal Care, Institutional Biosafety Committee and PI’s. Biohazard waste disposal policies and procedures are the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. The Biological Safety Officer has contributing responsibilities in this area. Hazwoper biosafety training is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. The Biological Safety Officer has contributing responsibilities in this area. Development of biosafety level-2 and 3 protocols and emergency procedures for researchers and staff is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities at this level are: The Biological Safety Officer and the PI’s. Maintenance of the facilities is the responsibility of the Vice Chancellor for Administration and Finance with the Associate Vice Chancellor of Facilities and Campus Services. Those with contributing responsibilities at this level are: The Director of Facilities and Campus Planning and the Director of the Physical Plant. Decontamination of facilities is the responsibility of the Vice Chancellor for Administration and Finance with the Associate Vice Chancellor of Facilities and Campus Services. Those with contributing responsibilities at this level are: The Director of Facilities and Campus Planning, the Biological Safety Officer, Director of Animal Care and the Director of the Physical Plant. Development of emergency procedures (“SOP’s”) for emergency personnel is the responsibility of the Vice Chancellor for Administration and Finance with the Director of

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Environmental Health and Safety as the primary delegate for this duty. The Biological Safety Officer has contributing responsibilities in this area. Infection control oversight is the responsibility of the University Health Services. Those with contributing responsibilities at this level are: The Vice Chancellor of Research Affairs, the Director of Environmental Health and Safety and the Biological Safety Officer. Human Subjects The Provost is the institutional official for Biosafety. Those with contributing responsibilities at this level are: the Vice Provost for Research Affairs, Deans and Department Heads and the Institutional Review Board Administrator. Overall compliance of human subjects’ research is the responsibility of the Provost and Senior Vice Chancellor for Academic Affairs with the Institutional Review Board Administrator as the primary delegate for this duty. Those with contributing responsibilities at this level are: The Director of Research Affairs, Deans and Department Heads and the Institutional Review Board. Applied health and safety practices are the responsibility of the PI’s with contributing responsibilities delegated to deans and department heads. NIH audits for human-subject research are the responsibility of the Provost and Senior Vice Chancellor for Academic Affairs. Those with contributing responsibilities at this level are: the Vice Provost of Research Affairs, Director of Research Affairs, Institutional Review Board and the Institutional Review Board Administrator. NIH reporting is the responsibility of the Provost and Senior Vice Chancellor for Academic Affairs with the Institutional Review Board Administrator as the primary delegate for this duty. Development of policies and protocols related to human subjects’ research is the responsibility of the Institutional Review Board with contributing responsibilities falling to the IRB Administrator. Approval of policies and protocols related to human subjects’ research is the responsibility of the Provost and Senior Vice Chancellor for Academic Affairs. Those with contributing responsibilities at this level are: The Director of Research Affairs, Deans and Department Heads, the Institutional Review Board, and Institutional Review Board Administrator. IRB oversight is the responsibility of the Provost and Senior Vice Chancellor for Academic Affairs with the Institutional Review Board Administrator as the primary delegate for this duty. The Director of Research Affairs has contributing responsibilities as well.

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Research registration of human subjects’ research is the responsibility of the Institutional Review Board Administrator with the PI’s as the primary delegates for this duty. The Institutional Review Board has contributing responsibilities. Human studies research registration oversight is the responsibility of the Institutional Review Board Administrator. Those with contributing responsibilities at this level are: the Director of Research Affairs and the Institutional Review Board. Review and approval of research involving human subjects is the responsibility of the Institutional Review Board. Those with contributing responsibilities at this level are: the Biological Safety Officer, Institutional Review Board and the Compliance Coordinator. Safety and health of laboratory staff, students and researchers is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities at this level are: the Biological Safety Officer, Deans and Department Heads and PI’s. Bloodborne pathogen training is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. The Biological Safety Officer has contributing responsibilities in this area. Biosafety training of students, staff and PI’s is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities at this level are: Deans and Department Heads, Biological Safety Officer, Institutional Review Board and PI’s. Biohazard waste disposal policies and procedures are the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. The Biological Safety Officer has contributing responsibilities in this area. Hazwoper biosafety training is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. The Biological Safety Officer has contributing responsibilities in this area. Development of biosafety level-2 and 3 protocols and emergency procedures for researchers and staff is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities at this level are: The Biological Safety Officer and the PI’s.

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Maintenance of the facilities is the responsibility of the Vice Chancellor for Administration and Finance with the Associate Vice Chancellor of Facilities and Campus Services. Decontamination of facilities is the responsibility of the Vice Chancellor for Administration and Finance with the Associate Vice Chancellor of Facilities and Campus Services. Those with contributing responsibilities at this level are: The Biological Safety Officer. Development of emergency procedures (“SOP’s”) for emergency personnel is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. The Biological Safety Officer and PI’s have contributing responsibilities in this area. Infection control oversight is the responsibility of the University Health Services. Those with contributing responsibilities in this area are: The Vice Chancellor of Administration and Finance, the Director of Environmental Health and Safety and the Biological Safety Officer. Animal Use The institutional official for animal use is the Chancellor. The primary delegated official is the Vice Provost of Research Affairs. Those with contributing responsibilities in this area are: The Director of Research Affairs, Deans and Department Heads, the Director of animal Care, and the Compliance Coordinator. Overall compliance for research using animals is the responsibility of the Chancellor with the Vice Provost of Research Affairs as the primary delegate for this duty. Those with contributing responsibilities in this area are: The Director of Research Affairs, Deans and Department Heads, IACUC, the Director of animal Care, PI’s and the Compliance Coordinator. USDA reports and inspections are the responsibility of the Chancellor with the Director of Animal Care as the primary delegate for this duty. Those with contributing responsibilities in this area are: the Director of Research Affairs, IACUC and the Compliance Coordinator. OLAW Assurance reports are the responsibility of the Chancellor with the Compliance Coordinator as the primary delegate for this duty. Those with contributing responsibilities in this area are: the Director of Research Affairs, the Director of Animal Care and IACUC. The development of policies and protocols related to animal use is the responsibility of IACUC with the Compliance Coordinator as the primary delegate for this duty. The Director of Animal Care has contributing responsibilities in this area as well.

23

IACUC oversight is the responsibility of the Chancellor with the Vice Provost of Research as the primary delegate for this duty. The Compliance Coordinator has contributing responsibilities in this area as well. The applied health and safety practices are primarily seen to by the Principle Investigators. Deans and Department Heads may support the PI’s with oversight and training. Research registration of animal use protocols is the responsibility of the PI’s. Those with contributing responsibilities in this area are: The Director of Research Affairs, Director of Animal Care, IACUC and the Compliance Coordinator. Registration oversight is the responsibility of the Compliance Coordinator. Those with contributing responsibilities in this area are: Director of Animal Care, IACUC and the attending veterinarian. Facilities inspections (ACS) are the responsibility of IACUC with the Director of Animal Care as the primary delegate for this duty. Those with contributing responsibilities in this area are: the Compliance Coordinator. Facilities inspections (research) are the responsibility of IACUC with the Compliance Coordinator as the primary delegate for this duty. Those with contributing responsibilities in this area are: the Director of Animal Care. The semi-annual review of the animal use program is the responsibility of IACUC with the Compliance Coordinator as the primary delegate for this duty. Those with contributing responsibilities in this area are: the Director of Animal Care and the attending veterinarian. The review and approval of research using animals is the responsibility of IACUC. Those with contributing responsibilities in this area are: Biological Safety Officer, Director of Animal Care, Compliance Officer and the attending veterinarian. Animal welfare (husbandry) is the responsibility of the Chancellor with the Director of Animal Care as the primary delegate for this duty. Animal welfare oversight (medical) is the responsibility of the Chancellor with the Director of Animal Care as the primary delegate for this duty. Those with contributing responsibilities in this area are: the attending veterinarian. The occupational health and safety of the animal care staff is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities in this area are: the Biological Safety Officer, Director of Animal Care and the University Health Service.

24

The occupational health and safety of the researchers and students is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities in this area are: Deans and Department Heads, Biological Safety Officer, IACUC, Compliance Coordinator, PI’s and UHS. Biosafety training related to animal use (ACS staff) is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities in this area are: the Biological Safety Officer and the Director of Animal Care. Biosafety training related to animal use (researchers and students) is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities in this area are: the Biological Safety Officer, PI’s and the Deans and Department Heads. Hazwwoper – animal use is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. The Biological Safety Officer, Pi’s Deans and Department Heads and the Director of Animal Care have contributing responsibilities in this area. Maintenance of the facilities is the responsibility of the Vice Chancellor for Administration and Finance with the Associate Vice Chancellor of Facilities and Campus Services. Decontamination of facilities is the responsibility of the Vice Chancellor for Administration and Finance with the Associate Vice Chancellor of Facilities and Campus Services. Those with contributing responsibilities at this level are: The Director of Animal Care, Director of Facilities and Campus Planning and Director of the Physical Plant. Development of emergency procedures (“SOP’s”) for emergency personnel is the responsibility of the Vice Chancellor for Administration and Finance with the Director of Animal Care as the primary delegate for this duty. The Director of Environmental Health and Safety, Biological Safety Officer, PI’s Director of Facilities and Campus Planning and Director of the Physical Plant have contributing responsibilities in this area. Infection control oversight (animals) is the responsibility of the Director of Animal Care. Those with contributing responsibilities in this area are: the attending veterinarian. Infection control oversight (Zoonoses) is the responsibility of the Vice Chancellor of Administration and Finance with the Director of Environmental Health and Safety as the primary delegate for this duty. Those with contributing responsibilities in this area are: Director of Animal Care, the Biological Safety Officer, Compliance Coordinator, PI’s and University Health Services.

25

Select agents in animals are the responsibility of the Director of Environmental Health and Safety with the Biological Safety Officer as the primary delegate for this duty. Those with contributing responsibilities in this area are: Director of Animal Care, Compliance Coordinator and PI’s.

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Biosafety in Microbiological and Biomedical Laboratories*

U.S. Department of Health and Human Services

Public Health Service

Centers for Disease Control and Prevention and

National Institutes of Health

Fifth Edition 2007

U. S. Government Printing Office Washington: 2007

27

Section IV Laboratory Biosafety Level Criteria The essential elements of the four biosafety levels for activities involving infectious microorganisms and laboratory animals are summarized in Table 1 of this section and discussed in Section 2. The levels are designated in ascending order, by degree of protection provided to personnel, the environment, and the community. Standard microbiological practices are common to all laboratories. Special microbiological practices enhance worker safety, environmental protection, and address the risk of handling agents requiring increasing levels of containment.

Biosafety Level 1 Biosafety Level 1 is suitable for work involving well-characterized agents not known to consistently cause disease in immunocompetent adult humans, and present minimal potential hazard to laboratory personnel and the environment. BSL-1 laboratories are not necessarily separated from the general traffic patterns in the building. Work is typically conducted on open bench tops using standard microbiological practices. Special containment equipment or facility design is not required, but may be used as determined by appropriate risk assessment. Laboratory personnel must have specific training in the procedures conducted in the laboratory and must be supervised by a scientist with training in microbiology or a related science. The following standard practices, safety equipment, and facility requirements apply to BSL-1: A. Standard Microbiological Practices

1. The laboratory supervisor must enforce the institutional policies that access to the laboratory.

2. Persons must wash their hands after working with potentially hazardous materials

and before leaving the laboratory.

3. Eating, drinking, smoking, handling contact lenses, applying cosmetics, and storing food for human consumption must not be permitted in laboratory areas. Food must be stored outside the laboratory area in cabinets or refrigerators designated and used for this purpose.

4. Mouth pipetting is prohibited; mechanical pipetting devices must be used.

5. Policies for the safe handling of sharps, such as needles, scalpels, pipettes, and

broken glassware must be developed and implemented. Whenever practical, laboratory supervisors should adopt improved engineering and work practice controls that reduce risk of sharps injuries.

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Laboratory Biosafety Level Criteria – Biosafety Level 1

Precautions, including those listed below, must always be taken with sharp items. These include:

a. Careful management of needles and other sharps are of primary

importance. Needles must not be bent, sheared, broken, recapped, removed from disposable syringes, or otherwise manipulated by hand before disposal.

b. Used disposable needles and syringes must be carefully placed in

conveniently located puncture-resistant containers used for sharps disposal.

c. Non disposable sharps must be placed in a hard walled container for

transport to a processing area for decontamination, preferably by autoclaving.

d. Broken glassware must not be handled directly. Instead, it must be

removed using a brush and dustpan, tongs, or forceps. Plasticware should be substituted for glassware whenever possible.

6. Perform all procedures to minimize the creation of splashes and/or aerosols.

7. Decontaminate work surfaces after completion of work and after any spill or

splash of potentially infectious material with appropriate disinfectant.

8. Decontaminate all cultures, stocks, and other potentially infectious materials before disposal using an effective method. Depending on where the decontamination will be performed, the following methods should be used prior to transport:

a. Materials to be decontaminated outside of the immediate laboratory must

be placed in a durable, leak proof container and secured for transport.

b. Materials to be removed from the facility for decontamination must be packed in accordance with applicable local, state, and federal regulations.

9. A sign incorporating the universal biohazard symbol must be posted at the

entrance to the laboratory when infectious agents are present. The sign may include the name of the agent(s) in use, and the name and phone number of the laboratory supervisor or other responsible personnel. Agent information should be posted in accordance with the institutional policy.

10. An effective integrated pest management program is required. See Appendix G.

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11. The laboratory supervisor must ensure that laboratory personnel receive appropriate training regarding their duties, the necessary precautions to prevent exposures, and exposure evaluation procedures. Personnel must receive annual updates or additional training when procedural or policy changes occur. Personal health status may impact an individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions. Therefore, all laboratory personnel and particularly women of child-bearing age should be provided with information regarding immune competence and conditions that may predispose them to infection. Individuals having these conditions should be encouraged to self-identify to the institution’s healthcare provider for appropriate counseling and guidance.

B. Special Practices None required. C. Safety Equipment (Primary Barriers and Personal Protective Equipment)

1. Special containment devices or equipment, such as BSCs, are not generally required.

2. Protective laboratory coats, gowns, or uniforms are recommended to prevent

contamination of personal clothing.

3. Wear protective eyewear when conducting procedures that have the potential to create splashes of microorganisms or other hazardous materials. Persons who wear contact lenses in laboratories should also wear eye protection.

4. Gloves must be worn to protect hands from exposure to hazardous materials.

Glove selection should be based on an appropriate risk assessment. Alternatives to latex gloves should be available. Wash hands prior to leaving the laboratory. In addition, BSL-1 workers should:

a. Change gloves when contaminated, integrity has been compromised, or

when otherwise necessary.

b. Remove gloves and wash hands when work with hazardous materials has been completed and before leaving the laboratory.

c. Do not wash or reuse disposable gloves. Dispose of used gloves with other

contaminated laboratory waste. Hand washing protocols must be rigorously followed.

D. Laboratory Facilities (Secondary Barriers)

1. Laboratories should have doors for access control.

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2. Laboratories must have a sink for hand washing.

3. The laboratory should be designed so that it can be easily cleaned. Carpets and rugs in laboratories are not appropriate.

4. Laboratory furniture must be capable of supporting anticipated loads and uses.

Spaces between benches, cabinets, and equipment should be accessible for cleaning.

a. Bench tops must be impervious to water and resistant to heat, organic

solvents, acids, alkalis, and other chemicals. b. Chairs used in laboratory work must be covered with a non-porous

material that can be easily cleaned and decontaminated with appropriate disinfectant.

5. Laboratories windows that open to the exterior should be fitted with screens.

Biosafety Level 2 Biosafety Level 2 builds upon BSL-1. BSL-2 is suitable for work involving agents that pose moderate hazards to personnel and the environment. It differs from BSL-1 in that 1) laboratory personnel have specific training in handling pathogenic agents and are supervised by scientists competent in handling infectious agents and associated procedures; 2) access to the laboratory is restricted when work is being conducted; and 3) all procedures in which infectious aerosols or splashes may be created are conducted in BSCs or other physical containment equipment. The following standard and special practices, safety equipment, and facility requirements apply to BSL-2: A. Standard Microbiological Practices

1. The laboratory supervisor must enforce the institutional policies that control access to the laboratory.

2. Persons must wash their hands after working with potentially hazardous materials

and before leaving the laboratory.

3. Eating, drinking, smoking, handling contact lenses, applying cosmetics, and storing food for human consumption must not be permitted in laboratory areas. Food must be stored outside the laboratory area in cabinets or refrigerators designated and used for this purpose.



broken glassware must be developed and implemented. Whenever practical,

31

laboratory supervisors should adopt improved engineering and work practice controls that reduce risk of sharps injuries.


a. Careful management of needles and other sharps are of primary importance. Needles must not be bent, sheared, broken, recapped, removed from disposable syringes, or otherwise manipulated by hand before disposal.



c. Non-disposable sharps must be placed in a hard walled container for transport to a processing area for decontamination, preferably by autoclaving.

d. Broken glassware must not be handled directly. Instead, it must be removed

using a brush and dustpan, tongs, or forceps. Plasticware should be substituted for glassware whenever possible.




8. Decontaminate all cultures, stocks, and other potentially infectious materials before disposal using an effective method. Depending on where the decontamination will be performed, the following methods should be used prior to transport:

a. Materials to be decontaminated outside of the immediate laboratory must be

placed in a durable, leak proof container and secured for transport.



entrance to the laboratory when infectious agents are present. Posted information must include: the laboratory’s biosafety level, the supervisor’s name (or other responsible personnel), telephone number, and required procedures for entering and exiting the laboratory. Agent information should be posted in accordance with the institutional policy.


11. The laboratory supervisor must ensure that laboratory personnel receive

appropriate training regarding their duties, the necessary precautions to prevent

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Laboratory Biosafety Level Criteria – Biosafety Level 2 exposures, and exposure evaluation procedures. Personnel must receive annual updates or additional training when procedural or policy changes occur. Personal health status may impact an individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions. Therefore, all laboratory personnel and particularly women of child-bearing age should be provided with information regarding immune competence and conditions that may predispose them to infection. Individuals having these conditions should be encouraged to self-identify to the institution’s healthcare provider for appropriate counseling and guidance.

B. Special Practices

1. All persons entering the laboratory must be advised of the potential hazards and meet specific entry/exit requirements.

2. Laboratory personnel must be provided medical surveillance and offered

appropriate immunizations for agents handled or potentially present in the laboratory.

3. When appropriate, a baseline serum sample should be stored.

4. A laboratory-specific biosafety manual must be prepared and adopted as policy.

The biosafety manual must be available and accessible.

5. The laboratory supervisor must ensure that laboratory personnel demonstrate proficiency in standard and special microbiological practices before working with BSL-2 agents.

6. Potentially infectious materials must be placed in a durable, leak proof container

during collection, handling, processing, storage, or transport within a facility.

7. Laboratory equipment should be routinely decontaminated, as well as, after spills, splashes, or other potential contamination.

a. Spills involving infectious materials must be contained, decontaminated,

and cleaned up by staff properly trained and equipped to work with infectious material.

b. Equipment must be decontaminated before repair, maintenance, or removal

from the laboratory.

8. Incidents that may result in exposure to infectious materials must be immediately evaluated and treated according to procedures described in the laboratory biosafety safety manual. All such incidents must be reported to the laboratory

33

Laboratory Biosafety Level Criteria – Biosafety Level 2 supervisor. Medical evaluation, surveillance, and treatment should be provided and appropriate records maintained.

9. Animals and plants not associated with the work being performed must not be

permitted in the laboratory.

10. All procedures involving the manipulation of infectious materials that may generate an aerosol should be conducted within a BSC or other physical containment devices.

C. Safety Equipment (Primary Barriers and Personal Protective Equipment)

1. Properly maintained BSCs (preferably Class II), other appropriate personal protective equipment, or other physical containment devices must be used whenever:

a. Procedures with a potential for creating infectious aerosols or splashes are

conducted. These may include pipetting, centrifuging, grinding, blending, shaking, mixing, sonicating, opening containers of infectious materials, inoculating animals intranasally, and harvesting infected tissues from animals or eggs.

b. High concentrations or large volumes of infectious agents are used. Such

materials may be centrifuged in the open laboratory using sealed rotor heads or centrifuge safety cups.

2. Protective laboratory coats, gowns, smocks, or uniforms designated for laboratory

use must be worn while working with hazardous materials. Remove protective clothing before leaving for non-laboratory areas (e.g., cafeteria, library, administrative offices). Dispose of protective clothing appropriately, or deposit it for laundering by the institution. It is recommended that laboratory clothing not be taken home.

3. Eye and face protection (goggles, mask, face shield or other splatter guard) is

used for anticipated splashes or sprays of infectious or other hazardous materials when the microorganisms must be handled outside the BSC or containment device. Eye and face protection must be disposed of with other contaminated laboratory waste or decontaminated before reuse. Persons who wear contact lenses in laboratories should also wear eye protection.


Glove selection should be based on an appropriate risk assessment. Alternatives to latex gloves should be available. Gloves must not be worn outside the laboratory. In addition, BSL-2 laboratory workers should:

34


a. Change gloves when contaminated, integrity has been compromised, or when otherwise necessary. Wear two pairs of gloves when appropriate.

b. Remove gloves and wash hands when work with hazardous materials has

been completed and before leaving the laboratory.

c. Do not wash or reuse disposable gloves. Dispose of used gloves with other contaminated laboratory waste. Hand washing protocols must be rigorously followed.

5. Eye, face and respiratory protection should be used in rooms containing infected

animals as determined by the risk assessment. D. Laboratory Facilities (Secondary Barriers)

1. Laboratory doors should be self-closing and have locks in accordance with the institutional policies.

2. Laboratories must have a sink for hand washing. The sink may be manually,

hands-free, or automatically operated. It should be located near the exit door.

3. The laboratory should be designed so that it can be easily cleaned and decontaminated. Carpets and rugs in laboratories are not permitted.


Spaces between benches, cabinets, and equipment should be accessible for cleaning.


solvents, acids, alkalis, and other chemicals.

b. Chairs used in laboratory work must be covered with a non-porous material that can be easily cleaned and decontaminated with appropriate disinfectant.

6. Laboratory windows that open to the exterior are not recommended. However, if a

laboratory does have windows that open to the exterior, they must be fitted with screens.

7. BSCs must be installed so that fluctuations of the room air supply and exhaust do

not interfere with proper operations. BSCs should be located away from doors,

35


windows that can be opened, heavily traveled laboratory areas, and other possible airflow disruptions.

8. Vacuum lines should be protected with High Efficiency Particulate Air (HEPA) filters, or their equivalent. Filters must be replaced as needed. Liquid disinfectant traps may be required.

9. An eyewash station must be readily available.

10. There are no specific requirements on ventilation systems. However, planning of

new facilities should consider mechanical ventilation systems that provide an inward flow of air without recirculation to spaces outside of the laboratory.

11. HEPA filtered exhaust air from a Class II BSC can be safely re-circulated back

into the laboratory environment if the cabinet is tested and certified at least annually and operated according to manufacturer’s recommendations. BSCs can also be connected to the laboratory exhaust system by either a thimble (canopy) connection or a direct (hard) connection. Provisions to assure proper safety cabinet performance and air system operation must be verified.

12. A method for decontaminating all laboratory wastes should be available in the

facility (e.g., autoclave, chemical disinfection, incineration, or other validated decontamination method).

Biosafety Level 3 Biosafety Level 3 is applicable to clinical, diagnostic, teaching, research, or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through inhalation route exposure. Laboratory personnel must receive specific training in handling pathogenic and potentially lethal agents, and must be supervised by scientists competent in handling infectious agents and associated procedures. All procedures involving the manipulation of infectious materials must be conducted within BSCs, other physical containment devices, or by personnel wearing appropriate personal protective equipment. A BSL-3 laboratory has special engineering and design features. The following standard and special safety practices, equipment, and facility requirements apply to BSL-3:

A. Standard Microbiological Practices

36


1. The laboratory supervisor must enforce the institutional policies that control access to the laboratory.

2. Persons must wash their hands after working with potentially hazardous materials and before leaving the laboratory.

3. Eating, drinking, smoking, handling contact lenses, applying cosmetics, and

storing food for human consumption must not be permitted in laboratory areas. Food must be stored outside the laboratory area in cabinets or refrigerators designated and used for this purpose.



broken glassware must be developed and implemented. Whenever practical, laboratory supervisors should adopt improved engineering and work practice controls that reduce risk of sharps injuries.


a. Careful management of needles and other sharps are of primary

importance. Needles must not be bent, sheared, broken, recapped, removed from disposable syringes, or otherwise manipulated by hand before disposal.



c. Non-disposable sharps must be placed in a hard walled container for







8. Decontaminate all cultures, stocks, and other potentially infectious materials before disposal using an effective method. A method for decontaminating all

37


laboratory wastes should be available in the facility, preferably within the laboratory (e.g., autoclave, chemical disinfection, incineration, or other validated decontamination method). Depending on where the decontamination will be performed, the following methods should be used prior to transport:

a. Materials to be decontaminated outside of the immediate laboratory must

be placed in a durable, leak proof container and secured for transport.



entrance to the laboratory when infectious agents are present. Posted information must include the laboratory’s biosafety level, the supervisor’s name (or other responsible personnel), telephone number, and required procedures for entering and exiting the laboratory. Agent information should be posted in accordance with the institutional policy.


11. The laboratory supervisor must ensure that laboratory personnel receive

appropriate training regarding their duties, the necessary precautions to prevent exposures, and exposure evaluation procedures. Personnel must receive annual updates or additional training when procedural or policy changes occur. Personal health status may impact an individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions. Therefore, all laboratory personnel and particularly women of child-bearing age should be provided with information regarding immune competence and conditions that may predispose them to infection. Individuals having these conditions should be encouraged to self-identify to the institution’s healthcare provider for appropriate counseling and guidance.


1. All persons entering the laboratory must be advised of the potential hazards and meet specific entry/exit requirements.

2. Laboratory personnel must be provided medical surveillance and offered

appropriate immunizations for agents handled or potentially present in the laboratory.

3. Each institution should consider the need for collection and storage of serum

samples from at-risk personnel.

38


4. A laboratory-specific biosafety manual must be prepared and adopted as policy. The biosafety manual must be available and accessible.

5. The laboratory supervisor must ensure that laboratory personnel demonstrate

proficiency in standard and special microbiological practices before working with BSL-3 agents.

6. Potentially infectious materials must be placed in a durable, leak proof container

during collection, handling, processing, storage, or transport within a facility.

7. Laboratory equipment should be routinely decontaminated, as well as, after spills, splashes, or other potential contamination.

a. Spills involving infectious materials must be contained, decontaminated,

and cleaned up by staff properly trained and equipped to work with infectious material.

b. Equipment must be decontaminated before repair, maintenance, or

removal from the laboratory.

8. Incidents that may result in exposure to infectious materials must be immediately evaluated and treated according to procedures described in the laboratory biosafety safety manual. All such incidents must be reported to the laboratory supervisor. Medical evaluation, surveillance, and treatment should be provided and appropriate records maintained.


permitted in the laboratory.

10. All procedures involving the manipulation of infectious materials must be conducted within a BSC, or other physical containment devices. No work with open vessels is conducted on the bench. When a procedure cannot be performed within a BSC, a combination of personal protective equipment and other containment devices, such as a centrifuge safety cup or sealed rotor, must be used.


1. All procedures involving the manipulation of infectious materials must be conducted within a BSC (preferably Class II or Class III), or other physical containment devices.

2. Protective laboratory clothing with a solid-front such as tie-back or wraparound

gowns, scrub suits, or coveralls are worn by workers when in the laboratory.

39

Protective clothing is not worn outside of the laboratory. Reusable clothing is decontaminated with appropriate disinfectant before being laundered. Clothing is changed when contaminated.

3. Eye and face protection (goggles, mask, face shield or other splatter guard) is

used for anticipated splashes or sprays of infectious or other hazardous materials. Eye and face protection must be disposed of with other contaminated laboratory waste or decontaminated before reuse. Persons who wear contact lenses in laboratories must also wear eye protection.


Glove selection should be based on an appropriate risk assessment. Alternatives to latex gloves should be available. Gloves must not be worn outside the laboratory. In addition, BSL-3 laboratory workers should:

a. Change gloves when contaminated, integrity has been compromised, or

when otherwise necessary. Wear two pairs of gloves when appropriate.

b. Remove gloves and wash hands when work with hazardous materials has been completed and before leaving the laboratory.

c. Do not wash or reuse disposable gloves. Dispose of used gloves with other

contaminated laboratory waste. Hand washing protocols must be rigorously followed.

5. Eye, face, and respiratory protection must be used in rooms containing infected

animals. D. Laboratory Facilities (Secondary Barriers)

1. Laboratory doors must be self closing and have locks in accordance with the institutional policies.

The laboratory must be separated from areas that are open to unrestricted traffic flow within the building.

Access to the laboratory is restricted to entry by a series of two self-closing doors.

A clothing change room (anteroom) may be included in the passageway between the two self-closing doors.

2. Laboratories must have a sink for hand washing. The sink must be hands-free or automatically operated. It should be located near the exit door.

If the laboratory is segregated into different laboratories, a sink must also be available for hand washing in each zone.

Additional sinks may be required as determined by the risk assessment.

40

3. The laboratory must be designed so that it can be easily cleaned and

decontaminated. Carpets and rugs are not permitted. Seams, floors, walls, and ceiling surfaces should be sealed. Spaces around doors and ventilation openings should be capable of being sealed to facilitate space decontamination.

a. Floors must be slip resistant, impervious to liquids, and resistant to

chemicals. Consideration should be given to the installation of seamless, sealed, resilient or poured floors, with integral cove bases.

b. Walls should be constructed to produce a sealed smooth finish that can be

easily cleaned and decontaminated.

c. Ceilings should be constructed, sealed, and finished in the same general manner as walls.

Decontamination of the entire laboratory should be considered when there has been gross decontamination of the space, significant changes in laboratory usage, for major renovations, or maintenance shut downs. Selection of the appropriate materials and methods used to decontaminate the laboratory must be based on the risk assessment of the biological agents in use.


Spaces between benches, cabinets, and equipment must be accessible for cleaning.


solvents, acids, alkalis, and other chemicals.

b. Chairs used in laboratory work must be covered with a non-porous material that can be easily cleaned and decontaminated with appropriate disinfectant.

5. All windows in the laboratory must be sealed.

6. BSCs must be installed so that fluctuations of the room air supply and exhaust do

not interfere with proper operations. BSCs should be located away from doors, heavily traveled laboratory areas, and other possible airflow disruptions.

7. Vacuum lines must be protected with HEPA filters, or their equivalent. Filters

must be replaced as needed. Liquid disinfectant traps may be required.

8. An eyewash station must be readily available in the laboratory.

9. A ducted air ventilation system is required. This system must provide sustained directional airflow by drawing air into the laboratory from “clean” areas toward “potentially contaminated” areas. The laboratory shall be designed such that under failure conditions the airflow will not be reversed.

41

a. Laboratory personnel must be able to verify directional air flow. A visual

monitoring device which confirms directional air flow must be provided at the laboratory entry. Audible alarms should be considered to notify personnel of air flow disruption.

b. The laboratory exhaust air must not re-circulate to any other area of the

building.

c. The laboratory building exhaust air should be dispersed away from occupied areas and from building air intake locations or the exhaust air must be HEPA filtered.

10. HEPA filtered exhaust air from a Class II BSC can be safely re-circulated into the

laboratory environment if the cabinet is tested and certified at least annually and operated according to manufacturer’s recommendations. BSCs can also be connected to the laboratory exhaust system by either a thimble (canopy) connection or a direct (hard) connection. Provisions to assure proper safety cabinet performance and air system operation must be verified. BSCs should be certified at least annually to assure correct performance. Class III BSCs must be directly (hard) connected up through the second exhaust HEPA filter of the cabinet. Supply air must be provided in such a manner that prevents positive pressurization of the cabinet.

11. A method for decontaminating all laboratory wastes should be available in the

facility, preferably within the laboratory (e.g., autoclave, chemical disinfection, incineration, or other validated decontamination method).

12. Equipment that may produce infectious aerosols must be contained in devices that

exhaust air through HEPA filtration or other equivalent technology before being discharged into the laboratory. These HEPA filters should be tested and/or replaced at least annually.

13. Facility design consideration should be given to means of decontaminating large

pieces of equipment before removal from the laboratory.

14. Enhanced environmental and personal protection may be required by the agent summary statement, risk assessment, or applicable local, state, or federal regulations. These laboratory enhancements may include, for example, one or more of the following; an anteroom for clean storage of equipment and supplies with dress-in, shower-out capabilities; gas tight dampers to facilitate laboratory isolation; final HEPA filtration of the laboratory exhaust air; laboratory effluent decontamination; and advanced access control devices such as biometrics. HEPA filter housings should have gas-tight isolation dampers; decontamination ports; and/or bag-in/bag-out (with appropriate decontamination procedures) capability. The HEPA filter housing should allow for leak testing of each filter and assembly. The filters and the housing should be certified at least annually.

42

15. The BSL-3 facility design, operational parameters, and procedures must be verified and documented prior to operation. Facilities must be re-verified and documented at least annually.

Section V Vertebrate Animal Biosafety Level Criteria for Vivarium Research Facilities This guidance is provided for the use of experimentally infected animals housed in indoor research facilities (e.g., vivaria), and is also useful in the maintenance of laboratory animals that may naturally harbor zoonotic infectious agents. In both instances, the institutional management must provide facilities, staff, and established practices that reasonably ensure appropriate levels of environmental quality, safety, security and care for laboratory animal. Laboratory animal facilities are a special type of laboratory. As a general principle, the biosafety level (facilities, practices, and operational requirements) recommended for working with infectious agents in vivo and in vitro are comparable. The animal room can present unique problems. In the animal room, the activities of the animals themselves can present unique hazards not found in standard microbiological laboratories. Animals may generate aerosols, they may bite and scratch, and they may be infected with a zoonotic agent. The co-application of Biosafety Levels and the Animal Biosafety Levels are determined by a protocol driven risk assessment. These recommendations presuppose that laboratory animal facilities, operational practices, and quality of animal care meet applicable standards and regulations (e.g., Guide for the Care and Use of Laboratory Animals1 and Laboratory Animal Welfare Regulations2) and that appropriate species have been selected for animal experiments. In addition, the organization must have an occupational health and safety program that addresses potential hazards associated with the conduct of laboratory animal research. The following publication by the Institute for Laboratory Animal Research (ILAR), Occupational Health and Safety in the Care of Research Animals3 is most helpful in this regard. Additional safety guidance on working with non-human primates is available in the ILAR publication, Occupational Health and Safety in the Care and Use of Nonhuman Primates.4

Facilities for laboratory animals used in studies of infectious or non-infectious disease should be physically separate from other activities such as animal production and quarantine, clinical laboratories, and especially from facilities providing patient care. Traffic flow that will minimize the risk of cross contamination should be incorporated into the facility design. The recommendations detailed below describe four combinations of practices, safety equipment, and facilities for experiments with animals involved in infectious disease

43

Vertebrate Animal Biosafety Level Criteria – Animal Biosafety Level 1 research and other studies that may require containment. These four combinations, designated Animal Biosafety Levels (ABSL) 1-4, provide increasing levels of protection to personnel and to the environment, and are recommended as minimal standards for activities involving infected laboratory animals. The four ABSLs describe animal facilities and practices applicable to work with animals infected with agents assigned to Biosafety Levels 1-4, respectively. Investigators that are inexperienced in conducting these types of experiments should seek help in designing their experiments from individuals who are experienced in this special work. In addition to the animal biosafety levels described in this section the USDA has developed facility parameters and work practices for handling agents of agriculture significance. Appendix D includes a discussion on Animal Biosafety Level-3 Agriculture (ABSL-3-Ag). USDA requirements are unique to agriculture because of the necessity to protect the environment from pathogens of economic or environmental impact. Appendix D also describes some of the enhancements beyond BSL/ABSL-3 that may be required by USDA-APHIS when working in the laboratory or vivarium with certain veterinary agents of concern. Facility standards and practices for invertebrate vectors and hosts are not specifically addressed in this section. The reader is referred to Appendix E for more information on the Arthropod Containment Guidelines.

Animal Biosafety Level 1 Animal Biosafety Level 1 is suitable for work involving well characterized agents that are not known to cause disease in immunocompetent adult humans, and present minimal potential hazard to personnel and the environment. ABSL-1 facilities should be separated from the general traffic patterns of the building and restricted as appropriate. Special containment equipment or facility design may be required as determined by appropriate risk assessment (See Section 2). Personnel must have specific training in animal facility procedures and must be supervised by an individual with adequate knowledge of potential hazards and experimental animal procedures. The following standard practices, safety equipment, and facility requirements apply to ABSL-1: A. Standard Microbiological Practices

44

Vertebrate Animal Biosafety Level Criteria – Animal Biosafety Level 1

1. The animal facility director establishes and enforces policies, procedures, and protocols for institutional policies and emergency situations.

Each institute must assure that worker safety and health concerns are addressed as part of the animal protocol review.

Prior to beginning a study animal protocols must also be reviewed and approved by the Institutional Animal Care and Use Committee (IACUC) and the Institutional Biosafety Committee.

2. A safety manual specific to the animal facility is prepared or adopted in

consultation with the animal facility director and appropriate safety professionals.

The safety manual must be available and accessible. Personnel are advised of potential hazards and are required to read and follow instructions on practices and procedures.

3. Supervisor must ensure that animal care, laboratory and support personnel receive appropriate training regarding their duties, animal husbandry procedure, potential hazards, manipulations of infectious agents, necessary precautions to prevent hazard or exposures, and hazard/exposure evaluation procedures (physical hazards, splashes, aerosolization, etc.). Personnel must receive annual updates or additional training when procedures or policies change. Records are maintained for all hazard evaluations, employee training sessions and staff attendance.

4. Appropriate medical surveillance program is in place, as determined by risk

assessment. The need for an animal allergy prevention program should be considered.

Facility supervisors should ensure that medical staff is informed of potential occupational hazards within the animal facility, to include those associated with research, animal husbandry duties, animal care and manipulations. Personal health status may impact an individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions. Therefore, all personnel and particularly women of child-bearing age should be provided information regarding immune competence and conditions that may predispose them to infection. Individuals having these conditions should be encouraged to self-identify to the institution’s healthcare provider for appropriate counseling and guidance. Personnel using respirators must be enrolled in an appropriately constituted respiratory protection program.

45

5. A sign incorporating safety information must be posted at the entrance to the areas where infectious materials and/or animals are housed or are manipulated. The sign must include the animal biosafety level, general occupational health requirements, personal protective equipment requirements, the supervisor’s name (or other responsible personnel), telephone number, and required procedures for entering and exiting the animal areas. Identification of specific infectious agents is recommended when more than one agent is being used within an animal room. Security-sensitive agent information should be posted in accordance with the institutional policy.

Advance consideration should be given to emergency and disaster recovery plans, as a contingency for man-made or natural disasters.1,3,4

6. Access to the animal room is limited. Only those persons required for program or

support purposes are authorized to enter the facility.

All persons including facility personnel, service workers, and visitors are advised of the potential hazards (natural or research pathogens, allergens, etc) and are instructed on the appropriate safeguards.



Gloves are worn to prevent skin contact with contaminated, infectious and hazardous materials, and when handling animals. Gloves and personal protective equipment should be removed in a manner that minimizes transfer of infectious materials outside of the areas where infectious materials and/or animals are housed or are manipulated. Persons must wash their hands after removing gloves, and before leaving the areas where infectious materials and/or animals are housed or are manipulated. Eye and face and respiratory protection should be used in rooms containing infected animals, as dictated by the risk assessment.


storing food for human use should only be done in designated areas and are not permitted in animal or procedure rooms.

9. All procedures are carefully performed to minimize the creation of aerosols or

splatters of infectious materials and waste. 10. Mouth pipetting is prohibited. Mechanical pipetting devices must be used. 11. Policies for the safe handling of sharps, such as needles, scalpels, pipettes, and

broken glassware must be developed and implemented.

46

When applicable, laboratory supervisors should adopt improved engineering and work practice controls that reduce the risk of sharps injuries. Precautions, including those listed below, must always be taken with sharp items. These include:

a. Needles and syringes or other sharp instruments are limited to use in the

animal facility when there is no alternative for such procedures as parenteral injection, blood collection, or aspiration of fluids from laboratory animals and diaphragm bottles.

b. Disposable needles must not be bent, sheared, broken, recapped, removed from disposable syringes, or otherwise manipulated by hand before disposal. Used disposable needles must be carefully placed in puncture-resistant containers used for sharps disposal. Sharps containers should be located as close to the work site as possible.

c. Non-disposable sharps must be placed in a hard-walled container for




e. Equipment containing sharp edges and corners should be avoided.

12. Equipment and work surfaces are routinely decontaminated with an appropriate

disinfectant after work with an infectious agent, and after any spills, splashes, or other overt contamination.


permitted in the areas where infectious materials and/or animals are housed or are manipulated.

14. An effective integrated pest management program is required. See Appendix G. 15. All wastes from the animal room (including animal tissues, carcasses, and

bedding) are transported from the animal room in leak-proof, covered containers for appropriate disposal in compliance with applicable institutional, local and state requirements.

Decontaminate all potentially infectious materials before disposal using an effective method.


None required.

47


1. A risk assessment should determine the appropriate type of personal protective equipment to be utilized.

2. Special containment devices or equipment may be required as determined by appropriate risk assessment.

Protective laboratory coats, gowns, or uniforms may be required to prevent contamination of personal clothing. Protective outer clothing is not worn outside areas where infectious materials and/or animals are housed or manipulated. Gowns and uniforms are not worn outside the facility.

3. Protective eyewear is worn when conducting procedures that have the potential to

create splashes of microorganisms or other hazardous materials. Persons who wear contact lenses should also wear eye protection when entering areas with potentially high concentrations or airborne particulates.

Persons having contact with the NHP should assess risk of mucous membrane exposure and wear appropriate protective equipment (e.g., masks, goggles, face shields, etc.) as needed.

4. Gloves are worn to protect hands from exposure to hazardous materials.

A risk assessment should be performed to identify the appropriate glove for the task and alternatives to latex gloves should be available.

Change gloves when contaminated, integrity has been compromised, or when otherwise necessary. Gloves must not be worn outside the animal rooms. Gloves and personal protective equipment should be removed in a manner that prohibits transfer of infectious materials. Do not wash or reuse disposable gloves. Dispose of used gloves with other contaminated waste. Persons must wash their hands after handling animals and before leaving the areas where infectious materials and/or animals are housed or are manipulated. Hand washing should occur after the removal of gloves.


48

1. The animal facility is separated from areas that are open to unrestricted personnel

traffic within the building. External facility doors are self-closing and self-locking.

Access to the animal facility is restricted. Doors to areas where infectious materials and/or animals are housed, open inward, are self-closing, are kept closed when experimental animals are present, and should never be propped open. Doors to cubicles inside an animal room may open outward or slide horizontally or vertically.

2. The animal facility must have a sink for hand washing.

Sink traps are filled with water, and/or appropriate liquid to prevent the migration of vermin and gases.

3. The animal facility is designed, constructed, and maintained to facilitate cleaning

and housekeeping. The interior surfaces (walls, floors and ceilings) are water resistant.

It is recommended that penetrations in floors, walls and ceiling surfaces are sealed, to include openings around ducts, doors and door frames, to facilitate pest control and proper cleaning. Floors must be slip resistant, impervious to liquids, and resistant to chemicals.

4. Cabinets and bench tops must be impervious to water and resistant to heat,

organic solvents, acids, alkalis, and other chemicals. Spaces between benches, cabinets, and equipment should be accessible for cleaning.

Chairs used in animal area must be covered with a non-porous material that can be easily cleaned and decontaminated. Furniture must be capable of supporting anticipated loads and uses. Sharp edges and corners should be avoided.

5. External windows are not recommended; if present windows must be resistant to

breakage. Where possible, windows should be sealed. If the animal facility has windows that open, they are fitted with fly screens. The presence of windows may impact facility security and therefore should be assessed by security personnel.

6. Ventilation should be provided in accordance with the Guide for Care and Use of

Laboratory Animals.1 No recirculation of exhaust air should occur. It is recommended that animal rooms have inward directional airflow.

Ventilation system design should consider the heat and high moisture load produced during the cleaning of animal rooms and the cage wash process.

49

7. Internal facility appurtenances, such as light fixtures, air ducts, and utility pipes, are arranged to minimize horizontal surface areas to facilitate cleaning and minimize the accumulation of debris or fomites.

8. If floor drains are provided, the traps are filled with water, and/or appropriate

disinfectant to prevent the migration of vermin and gases.

9. Cages are washed manually or preferably in a mechanical cage washer. The mechanical cage washer should have a final rinse temperature of at least 180°F.

10. Illumination is adequate for all activities, avoiding reflections and glare that could

impede vision.

11. Emergency eyewash and shower are readily available; location is determined by risk assessment.

Animal Biosafety Level 2 Animal Biosafety Level 2 builds upon the practices, procedures, containment equipment, and facility requirements of ABSL-1. ABSL-2 is suitable for work involving laboratory animals infected with agents associated with human disease and pose moderate hazards to personnel and the environment. It also addresses hazards from ingestion as well as from percutaneous and mucous membrane exposure. ABSL-2 requires that 1) access to the animal facility is restricted; 2) personnel must have specific training in animal facility procedures, the handling of infected animals and the manipulation of pathogenic agents; 3) personnel must be supervised by individuals with adequate knowledge of potential hazards, microbiological agents, animal manipulations and husbandry procedures; and 4) procedures involving the manipulation of infectious materials, or where aerosols or splashes may be created, should be conducted in BSCs or by use of other physical containment equipment. Appropriate personal protective equipment must be utilized to reduce exposure to infectious agents, animals, and contaminated equipment. Implementation of employee occupational health programs should be considered. The following standard and special practices, safety equipment, and facility requirements apply to ABSL-2: A. Standard Microbiological Practices


Each institute must assure that worker safety and health concerns are addressed as part of the animal protocol review.

50

Prior to beginning a study animal protocols must also be reviewed and approved by the IACUC5 and the Institutional Biosafety Committee.



The safety manual must be available and accessible. Personnel are advised of potential hazards, and are required to read and follow instructions on practices and procedures. Consideration should be given to specific biohazards unique to the animal species and protocol in use.

3. Supervisor must ensure that animal care, laboratory and support personnel receive

appropriate training regarding their duties, animal husbandry procedure, potential hazards, manipulations of infectious agents, necessary precautions to prevent hazard or exposures, and hazard/exposure evaluation procedures (physical hazards, splashes, aerosolization, etc.). Personnel must receive annual updates or additional training when procedures or policies change. Records are maintained for all hazard evaluations, employee training sessions and staff attendance.



Facility supervisors should ensure that medical staff is informed of potential occupational hazards within the animal facility, to include those associated with research, animal husbandry duties, animal care and manipulations. Personal health status may impact an individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions. Therefore, all personnel and particularly women of child-bearing age should be provided information regarding immune competence and conditions that may predispose them to infection. Individuals having these conditions should be encouraged to self-identify to the institution’s healthcare provider for appropriate counseling and guidance. Personnel using respirators must be enrolled in an appropriately constituted respiratory protection program.


entrance to areas where infectious materials and/or animals are housed or are manipulated when infectious agents are present. The sign must include the animal biosafety level, general occupational health requirements, personal protective equipment requirements, the supervisor’s name (or other responsible personnel), telephone number, and required procedures for entering and exiting the animal

51

areas. Identification of specific infectious agents is recommended when more than one agent is being used within an animal room.

Security-sensitive agent information and occupational health requirements should be posted in accordance with the institutional policy. Advance consideration should be given to emergency and disaster recovery plans, as a contingency for man-made or natural disasters.1,3,4

6. Access to the animal room is limited. Only those persons required for program or

support purposes are authorized to enter the animal facility and the areas where infectious materials and/or animals are housed or are manipulated.

All persons including facility personnel, service workers, and visitors are advised of the potential hazards (natural or research pathogens, allergens, etc.) and are instructed on the appropriate safeguards.



Gloves are worn to prevent skin contact with contaminated, infectious and hazardous materials and when handling animals. Gloves and personal protective equipment should be removed in a manner that minimizes transfer of infectious materials outside of the areas where infectious materials and/or animals are housed or are manipulated. Persons must wash their hands after removing gloves, and before leaving the areas where infectious materials and/or animals are housed or are manipulated. Eye and face and respiratory protection should be used in rooms containing infected animals, as dictated by the risk assessment.




splatters of infectious materials and waste.

10. Mouth pipetting is prohibited. Mechanical pipetting devices must be used.

11. Policies for the safe handling of sharps, such as needles, scalpels, pipettes, and broken glassware must be developed and implemented. When applicable, laboratory supervisors should adopt improved engineering and work practice controls that reduce the risk of sharps injuries.

52




b. Disposable needles must not be bent, sheared, broken, recapped, removed

from disposable syringes, or otherwise manipulated by hand before disposal. Used disposable needles must be carefully placed in puncture-resistant containers used for sharps disposal. Sharps containers should be located as close to the work site as possible.



d. Broken glassware must not be handled directly; it should be removed



12. Equipment and work surfaces are routinely decontaminated with an appropriate

disinfectant after work with an infectious agent, and after any spills, splashes, or other overt contamination.



14. An effective integrated pest management program is required See Appendix G.

15. All wastes from the animal room (including animal tissues, carcasses, and

bedding) are transported from the animal room in leak-proof containers for appropriate disposal in compliance with applicable institutional, local and state requirements.

Decontaminate of all potentially infectious materials before disposal using an effective method.


1. Animal care staff, laboratory and routine support personnel must be provided a medical surveillance program as dictated by the risk assessment, and administered

53

appropriate immunizations for agents handled or potentially present, before entry into animal rooms.

When appropriate, a baseline serum sample should be stored.

2. Procedures involving a high potential for generating aerosols should be conducted

within a biosafety cabinet or other physical containment device. When a procedure cannot be performed within a biosafety cabinet, a combination of personal protective equipment and other containment devices must be used.

Consideration should be given to the use of restraint devices and practices that reduce the risk of exposure during animal manipulations (e.g., physical restraint devices, chemical restraint medications, etc).

3. Decontamination is recommended for all potentially infectious materials and

animal waste before movement outside the areas where infectious materials and/or animals are housed or are manipulated by an appropriate method (e.g. autoclave, chemical disinfection, or other approved decontamination methods). This includes potentially infectious animal tissues, carcasses, contaminated bedding, unused feed, sharps, and other refuse.

Consideration should be given to means for decontaminating routine husbandry equipment, sensitive electronic and medical equipment. Materials to be decontaminated outside of the immediate areas where infectious materials and/or animals are housed or are manipulated must be placed in a durable, leak proof, covered container and secured for transport. The outer surface of the container is disinfected prior to moving materials. The transport container must contain a universal biohazard label. Develop and implement an appropriate waste disposal program in compliance with applicable institutional, local and state requirements. Autoclaving of content prior to incineration is recommended.

4. Equipment, cages, and racks should be handled in manner that minimizes

contamination of other areas.

Equipment must be decontaminated before repair, maintenance, or removal from the areas where infectious materials and/or animals are housed or are manipulated. Spills involving infectious materials must be contained, decontaminated, and cleaned up by staff properly trained and equipped to work with infectious material.

5. Incidents that may result in exposure to infectious materials must be immediately

evaluated and treated according to procedures described in the safety manual. All such incidents must be reported to the animal facility supervisor or personnel

54

designated by the institution. Medical evaluation, surveillance, and treatment should be provided as appropriate and records maintained.


1. Properly maintained BSCs, personal protective equipment (e.g., gloves, lab coats, face shields, respirators, etc.) and/or other physical containment devices or equipment, are used whenever conducting procedures with a potential for creating aerosols or splashes. These include necropsy of infected animals, harvesting of tissues or fluids from infected animals or eggs, and intranasal inoculation of animals.

When indicated by risk assessment, animals are housed in primary biosafety containment equipment appropriate for the animal species, such as solid wall and bottom cages covered with filter bonnets for rodents, or larger cages placed in inward flow ventilated enclosures or other equivalent primary containment systems for larger animal cages.

2. A risk assessment should determine the appropriate type of personal protective

equipment to be utilized.

Scrub suits and uniforms are removed before leaving the animal facility. Reusable clothing is appropriately contained and decontaminated before being laundered. Laboratory and protective clothing should never be taken home. Gowns, uniforms, laboratory coats and personal protective equipment are worn while in the areas where infectious materials and/or animals are housed or manipulated and removed prior to exiting. Disposable personal protective equipment and other contaminated waste are appropriately contained and decontaminated prior to disposal.

3. Eye and face protection (mask, goggles, face shield or other splatter guard) are

used for anticipated splashes/ sprays from infectious or other hazardous materials and when the animal or microorganisms must be handled outside the BSC or containment device. Eye and face protection must be disposed of with other contaminated laboratory waste or decontaminated before reuse.

Persons who wear contact lenses should also wear eye protection when entering areas with potentially high concentrations or airborne particulates. Persons having contact with the NHP should assess risk of mucous membrane exposure and wear appropriate protective equipment (e.g., masks, goggles, faceshields, etc.) as needed. Respiratory protection is worn based upon risk assessment.

4. Gloves are worn to protect hands from exposure to hazardous materials. A risk

assessment should be performed to identify the appropriate glove for the task and alternatives to latex gloves should be available.

55

Gloves are changed when contaminated, integrity has been compromised, or when otherwise necessary. Gloves must not be worn outside the animal rooms. Gloves and personal protective equipment should be removed in a manner that prohibits transfer of infectious materials. Do not wash or reuse disposable gloves. Dispose of used gloves with other contaminated waste.

Persons must wash their hands after handling animals and before leaving the areas where infectious materials and/or animals are housed or are manipulated. Hand washing should occur after the removal of gloves.


1. The animal facility is separated from areas that are open to unrestricted personnel traffic within the building. External facility doors are self-closing and self-locking.

Access to the animal facility is restricted.

Doors to areas where infectious materials and/or animals are housed, open inward, are self-closing, are kept closed when experimental animals are present, and should never be propped open. Doors to cubicles inside an animal room may open outward or slide horizontally or vertically.

2. A hand washing sink is located at the exit of the areas where infectious materials

and/or animals are housed or are manipulated. Additional sinks for hand washing should be located in other appropriate locations within the facility.

If the animal facility has segregated areas where infectious materials and/or animals are housed or manipulated, a sink must also be available for hand washing at the exit from each segregated area. Sink traps are filled with water, and/or appropriate liquid to prevent the migration of vermin and gases.

3. The animal facility is designed, constructed, and maintained to facilitate cleaning

and housekeeping. The interior surfaces (walls, floors and ceilings) are water resistant.

Penetrations in floors, walls and ceiling surfaces are sealed, to include openings around ducts, doors and door frames, to facilitate pest control and proper cleaning.

56

Floors must be slip resistant, impervious to liquids, and resistant to chemicals.

4. Cabinets and bench tops must be impervious to water and resistant to heat, organic solvents, acids, alkalis, and other chemicals. Spaces between benches, cabinets, and equipment should be accessible for cleaning.

Furniture should be minimized. Chairs used in animal area must be covered with a non-porous material that can be easily cleaned and decontaminated.

Furniture must be capable of supporting anticipated loads and uses. Sharp edges and corners should be avoided.

5. External windows are not recommended; if present, windows should be sealed

and must be resistant to breakage. The presence of windows may impact facility security and therefore should be assessed by security personnel.

6. Ventilation should be provided in accordance with the Guide for Care and Use of

Laboratory Animals.1 The direction of airflow into the animal facility is inward; animal rooms should maintain inward directional airflow compared to adjoining hallways. A ducted exhaust air ventilation system is provided. Exhaust air is discharged to the outside without being recirculated to other rooms.

Ventilation system design should consider the heat and high moisture load produced during the cleaning of animal rooms and the cage wash process.

7. Internal facility appurtenances, such as light fixtures, air ducts, and utility pipes,

are arranged to minimize horizontal surface areas, to facilitate cleaning and minimize the accumulation of debris or fomites.

8. Floor drains must be maintained and filled with water, and/or appropriate


9. Cages should be autoclaved or otherwise decontaminated prior to washing Mechanical cage washer should have a final rinse temperature of at least 180°F. The cage wash area should be designed to accommodate the use of high pressure spray systems, humidity, strong chemical disinfectants and 180°F water temperatures, during the cage/equipment cleaning process.

10. Illumination is adequate for all activities, avoiding reflections and glare that

could impede vision.

11. If BSCs are present, they must be installed so that fluctuations of the room air supply and exhaust do not interfere with proper operations. BSCs should be located away from doors, heavily traveled laboratory areas, and other possible airflow disruptions.

57

Vertebrate Animal Biosafety Level Criteria – Animal Biosafety Level 3 HEPA filtered exhaust air from a Class II BSC can be safely re-circulated back into the laboratory environment if the cabinet is tested and certified at least annually and operated according to manufacturer’s recommendations. BSCs can also be connected to the laboratory exhaust system by either a thimble (canopy) connection or a direct (hard) connection. Provisions to assure proper safety cabinet performance and air system operation must be verified. Correct performance of the BSCs should be recertified at least once a year.

All BSCs should be used according to manufacturer’s recommendation, to protect the worker and avoid creating a hazardous environment from volatile chemical and gases.

12. If vacuum service (i.e., central or local) is provided, each service connection should be fitted with liquid disinfectant traps and an in-line HEPA filter, placed as near as practicable to each use point or service cock. Filters are installed to permit in-place decontamination and replacement.

13. An autoclave should be considered in the animal facility to facilitate

decontamination of infectious materials and waste.


Animal Biosafety Level 3 Animal Biosafety Level 3 involves practices suitable for work with laboratory animals infected with indigenous or exotic agents, agents that present a potential for aerosol transmission and agents causing serious or potentially lethal disease. ABSL-3 builds upon the standard practices, procedures, containment equipment, and facility requirements of ABSL-2. ABSL-3 laboratory has special engineering and design features. ABSL-3 requires that 1) access to the animal facility is restricted; 2) personnel must have specific training in animal facility procedures, the handling of infected animals and the manipulation of potentially lethal agents; 3) personnel must be supervised by individuals with adequate knowledge of potential hazards, microbiological agents, animal manipulations and husbandry procedures; and 4) procedures involving the manipulation of infectious materials, or where aerosols or splashes may be created, must be conducted in BSCs or by use of other physical containment equipment.

58

Appropriate personal protective equipment must be utilized to reduce exposure to infectious agents, animals, and contaminated equipment. Employee occupational health programs must be implemented. The following standard and special safety practices, safety equipment, and facility requirements apply to ABSL-3 A. Standard Microbiological Practices


Each institute must assure that worker safety and health concerns are addressed as part of the animal protocol review. Prior to beginning a study animal protocols must also be reviewed and approved by the IACUC5 and the Institutional Biosafety Committee.



The safety manual must be available and accessible. Personnel are advised of potential and special hazards, and are required to read and follow instructions on practices and procedures. Consideration should be given to specific biohazards unique to the animal species and protocol in use.

3. Supervisor must ensure that animal care, laboratory and support personnel receive

appropriate training regarding their duties, animal husbandry procedure, potential hazards, manipulations of infectious agents, necessary precautions to prevent hazard or exposures, and hazard/exposure evaluation procedures (physical hazards, splashes, aerosolization, etc.). Personnel must receive annual updates or additional training when procedures or policies change. Records are maintained for all hazard evaluations, employee training sessions and staff attendance.



Facility supervisors should ensure that medical staff is informed of potential occupational hazards within the animal facility, to include those associated with research, animal husbandry duties, animal care and manipulations. Personal health status may impact an individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions. Therefore, all personnel and particularly women of child-bearing age should be provided

59

Vertebrate Animal Biosafety Level Criteria – Animal Biosafety Level 3 information regarding immune competence and conditions that may predispose them to infection. Individuals having these conditions should be encouraged to self-identify to the institution’s healthcare provider for appropriate counseling and guidance. Personnel using respirators must be enrolled in an appropriately constituted respiratory protection program.


entrance to areas where infectious materials and/or animals are housed or are manipulated. The sign must include the animal biosafety level, general occupational health requirements, personal protective equipment requirements, the supervisor’s name (or other responsible personnel), telephone number, and required procedures for entering and exiting the animal areas. Identification of specific infectious agents is recommended when more than one agent is being used within an animal room. Security-sensitive agent information and occupational health requirements should be posted in accordance with the institutional policy. Advance consideration should be given to emergency and disaster recovery plans, as a contingency for man-made or natural disasters.1,3,4

6. Access to the animal room is limited to the fewest number of individuals possible.

Only those persons required for program or support purposes are authorized to enter the animal facility and the areas where infectious materials and/or animals are housed or are manipulated.

All persons including facility personnel, service workers, and visitors are advised of the potential hazards (natural or research pathogens, allergens, etc) and are instructed on the appropriate safeguards.


contamination of personal clothing. Gloves are worn to prevent skin contact with contaminated, infectious/ and hazardous materials and when handling animals. Double-glove practices should be used when dictated by risk assessment. Gloves and personal protective equipment should be removed in a manner that minimizes transfer of infectious materials outside of the areas where infectious materials and/or animals are housed or are manipulated.

60

Vertebrate Animal Biosafety Level Criteria – Animal Biosafety Level 3 Persons must wash their hands after removing gloves, and before leaving the areas where infectious materials and/or animals are housed or are manipulated. Eye and face and respiratory protection should be used in rooms containing infected animals, as dictated by the risk assessment.




splatters of infectious materials and waste.

10. Mouth pipetting is prohibited. Mechanical pipetting devices must be used.

11. Policies for the safe handling of sharps, such as needles, scalpels, pipettes, and broken glassware must be developed and implemented.

When applicable, laboratory supervisors should adopt improved engineering and work practice controls that reduce the risk of sharps injuries. Precautions, including those listed below, must always be taken with sharp items. These include:



b. Disposable needles must not be bent, sheared, broken, recapped, removed

from disposable syringes, or otherwise manipulated by hand before disposal. Used disposable needles must be carefully placed in puncture-resistant containers used for sharps disposal. Sharps containers should be located as close to the work site as possible.



d. Broken glassware must not be handled directly; it should be removed



61

12. Equipment and work surfaces are routinely decontaminated with an appropriate disinfectant after work with an infectious agent, and after any spills, splashes, or other overt contamination.




15. All wastes from the animal room (including animal tissues, carcasses, and

bedding) are transported from the animal room in leak-proof containers for appropriate disposal in compliance with applicable institutional, local and state requirements.

Decontaminate all potentially infectious materials before disposal using an effective method.


1. Animal care staff, laboratory and routine support personnel must be provided a medical surveillance program as dictated by the risk assessment, and administered appropriate immunizations for agents handled or potentially present, before entry into animal rooms.

Each institution should consider the need for collection and storage of serum samples from at-risk personnel.

2. All procedures involving the manipulation of infectious materials, handling

infected animals or the generations of aerosols must be conducted within BSCs or other physical containment devices when practical.

When a procedure cannot be performed within a biosafety cabinet, a combination of personal protective equipment and other containment devices must be used. Consideration should be given to the use of restraint devices and practices that reduce the risk of exposure during animal manipulations (e.g., physical restraint devices, chemical restraint medications, etc).

3. The risk of infectious aerosols from infected animals or their bedding also can be

reduced if animals are housed in containment caging systems (such as solid wall and bottom cages covered with filter bonnets, open cages placed in inward flow ventilated enclosures, HEPA-filter isolators and caging systems, or other equivalent primary containment systems).

4. Actively ventilated caging systems must be designed to prevent the escape of

microorganisms from the cage. Exhaust plenums for these systems should be

62

sealed to prevent escape of microorganisms if the ventilation system becomes static, and the exhaust must be HEPA filtered. Safety mechanisms should be in place that prevent the cages and exhaust plenums from becoming positive to the surrounding area should the exhaust fan fail. The system should also be alarmed to indicate when operational malfunctions occur.

5. A method for decontaminating all infectious materials must be available within

the facility, preferably within the areas where infectious materials and/or animals are housed or are manipulated (e.g. autoclave, chemical disinfection, or other approved decontamination methods).

Consideration should be given to means for decontaminating routine husbandry equipment, sensitive electronic and medical equipment. Decontaminate all potential infectious materials (including animal tissues, carcasses, contaminated bedding, unused feed, sharps, and other refuse) before removal from the areas where infectious materials and/or animals are housed or are manipulated by an appropriate method. It is recommended that animal bedding and waste be decontaminated prior to manipulation and before removal from the areas where infectious materials and/or animals are housed or are manipulated, preferably within the caging system. Develop and implement an appropriate waste disposal program in compliance with applicable institutional, local and state requirements. Autoclaving of content prior to incineration is recommended.

6. Equipment, cages, and racks should be handled in manner that minimizes

contamination of other areas.

Equipment must be decontaminated before repair, maintenance, or removal from the areas where infectious materials and/or animals are housed or are manipulated. Spills involving infectious materials must be contained, decontaminated, and cleaned up by staff properly trained and equipped to work with infectious material.

7. Incidents that may result in exposure to infectious materials must be immediately

evaluated and treated according to procedures described in the safety manual. All such incidents must be reported to the animal facility supervisor or personnel designated by the institution. Medical evaluation, surveillance, and treatment should be provided as appropriate and records maintained.


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1. Properly maintained BSCs, and other physical containment devices or equipment, should be used for all manipulations for infectious materials and when possible, animals. These manipulations include necropsy, harvesting of tissues or fluids from infected animals or eggs, and intranasal inoculation of animals.

The risk of infectious aerosols from infected animals or bedding can be reduced through the use of primary barrier systems. These systems may include solid wall and bottom cages covered with filter bonnets; ventilated cage rack systems; or for larger cages placed in inward flow ventilated enclosures or other equivalent systems or devices.

2. A risk assessment should determine the appropriate type of personal protective

equipment to be utilized.

Protective clothing such as uniforms or scrub suits is worn by personnel within the animal facility. Reusable clothing is appropriately contained and decontaminated before being laundered. Laboratory and protective clothing should never be taken home. Disposable personal protective equipment such as non-woven olefin cover-all suits, wrap-around or solid-front gowns should be worn over this clothing, before entering the areas where infectious materials and/or animals are housed or manipulated. Front-button laboratory coats are unsuitable.

Disposable personal protective equipment must be removed when leaving the areas where infectious materials and/or animals are housed or are manipulated. Scrub suits and uniforms are removed before leaving the animal facility. Disposable personal protective equipment and other contaminated waste are appropriately contained and decontaminated prior to disposal.

3. Appropriate eye, face and respiratory protection are worn by all personnel

entering areas where infectious materials and/or animals are housed or are manipulated. To prevent cross contamination boots, shoe covers, or other protective footwear, are used where indicated.

Eye and face protection must be disposed of with other contaminated laboratory waste or decontaminated before reuse. Persons who wear contact lenses should also wear eye protection when entering areas with potentially high concentrations or airborne particulates.

4. Gloves are worn to protect hands from exposure to hazardous materials.

A risk assessment should be performed to identify the appropriate glove for the task and alternatives to latex gloves should be available. Procedures may require the use of wearing two pairs of gloves (double-glove).

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Gloves are changed when contaminated, integrity has been compromised, or when otherwise necessary. Gloves must not be worn outside the animal rooms. Gloves and personal protective equipment should be removed in a manner that prohibits transfer of infectious materials. Do not wash or reuse disposable gloves. Dispose of used gloves with other contaminated waste. Persons must wash their hands after handling animals and before leaving the areas where infectious materials and/or animals are housed or are manipulated. Hand washing should occur after the removal of gloves.


1. The animal facility is separated from areas that are open to unrestricted personnel

traffic within the building. External facility doors are self-closing and self-locking.

Access to the animal facility is restricted.

Doors to areas where infectious materials and/or animals are housed, open inward, are self-closing, are kept closed when experimental animals are present, and should never be propped open. Doors to cubicles inside an animal room may open outward or slide horizontally or vertically. Entry into the containment area is via a double-door entry which constitutes an anteroom/airlock and a change room. Showers may be considered based on risk assessment. An additional double-door access anteroom or double-doored autoclave may be provided for movement of supplies and wastes into and out of the facility.

2. A hand washing sink is located at the exit of the areas where infectious materials

and/or animals are housed or are manipulated. Additional sinks for hand washing should be located in other appropriate locations within the facility. The sink should be hands-free or automatically operated.

If the animal facility has multiple segregated areas where infectious materials and/or animals are housed or are manipulated, a sink must also be available for hand washing at the exit from each segregated area. Sink traps are filled with water, and/or appropriate liquid to prevent the migration of vermin and gases.

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3. The animal facility is designed, constructed, and maintained to facilitate cleaning, decontamination and housekeeping. The interior surfaces (walls, floors and ceilings) are water resistant.

Penetrations in floors, walls and ceiling surfaces are sealed, to include openings around ducts, doors and door frames, to facilitate pest control, proper cleaning and decontamination. Walls, floors and ceilings should form a sealed and sanitizable surface. Floors must be slip resistant, impervious to liquids, and resistant to chemicals. Flooring is seamless, sealed resilient or poured floors, with integral cove bases. Decontamination of an entire animal room should be considered when there has been gross contamination of the space, significant changes in usage, for major renovations, or maintenance shut downs. Selection of the appropriate materials and methods used to decontaminate the animal room must be based on the risk assessment.

4. Cabinets and bench tops must be impervious to water and resistant to heat,

organic solvents, acids, alkalis, and other chemicals. Spaces between benches, cabinets, and equipment should be accessible for cleaning.

Furniture should be minimized. Chairs used in animal area must be covered with a non-porous material that can be easily cleaned and decontaminated. Furniture must be capable of supporting anticipated loads and uses. Sharp edges and corners should be avoided.

5. External windows are not recommended; if present, all windows must be sealed

and must be resistant to breakage. The presence of windows may impact facility security and therefore should be assessed by security personnel.

6. Ventilation to the facility should be provided in accordance with the Guide for

Care and Use of Laboratory Animals.1 The direction of airflow into the animal facility is inward; animal rooms should maintain inward directional airflow compared to adjoining hallways. A ducted exhaust air ventilation system is provided. Exhaust air is discharged to the outside without being recirculated to other rooms.

This system creates directional airflow which draws air into the animal room from "clean" areas and toward "contaminated" areas. Ventilation system design should consider the heat and high moisture load produced during the cleaning of animal rooms and the cage wash process. Filtration and other treatments of the exhaust air may not be required, but should be considered based on site requirements, specific agent manipulations and use

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Vertebrate Animal Biosafety Level Criteria – Animal Biosafety Level 3 conditions. The exhaust must be dispersed away from occupied areas and air intakes, or the exhaust must be HEPA-filtered. Personnel must verify that the direction of the airflow (into the animal areas) is proper. It is recommended that a visual monitoring device that indicates directional inward airflow be provided at the animal room entry. The ABSL-3 animal facility shall be designed such that under failure conditions the airflow will not be reversed. Audible alarms should be considered to notify personnel of ventilation and HVAC system failure.

7. Internal facility appurtenances, such as light fixtures, air ducts, and utility pipes,

are arranged to minimize horizontal surface areas, to facilitate cleaning and minimize the accumulation of debris or fomites.

8. Floor drains must be maintained and filled with water, and/or appropriate


9. Cages are washed in a mechanical cage washer. The mechanical cage washer has a final rinse temperature of at least 180°F. Cages should be autoclaved or otherwise decontaminated prior to removal from ABSL-3 space. The cage wash facility should be designed and constructed to accommodate high pressure spray systems, humidity, strong chemical disinfectants and 180°F water temperatures, during the cage cleaning process.

10. Illumination is adequate for all activities, avoiding reflections and glare that could

impede vision.

11. BSCs (Class II, Class III) must be installed so that fluctuations of the room air supply and exhaust do not interfere with its proper operations. Class II BSCs should be located away from doors, heavily traveled laboratory areas, and other possible airflow disruptions.

HEPA filtered exhaust air from a Class II BSC can be safely re-circulated back into the laboratory environment if the cabinet is tested and certified at least annually and operated according to manufacturer’s recommendations. BSCs can also be connected to the laboratory exhaust system by either a thimble (canopy) connection or a direct (hard) connection. Provisions to assure proper safety cabinet performance and air system operation must be verified. BSCs should be certified at least annually to assure correct performance. Class III BSCs must supply air in such a manner that prevents positive pressurization of the cabinet or the laboratory room.

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All BSCs should be used according to manufacturers’ recommendations. When applicable, equipment that may produce infectious aerosols must be contained in devices that exhaust air through HEPA filtration or other equivalent technology before being discharged into the animal facility. These HEPA filters should be tested and/or replaced at least annually.

12. An autoclave is available which is convenient to the animal rooms where the

biohazard is contained. The autoclave is utilized to decontaminate infectious materials and waste before moving it to the other areas of the facility. If not convenient to areas where infectious materials and/or animals are housed or are manipulated, special practices should be developed for transport of infectious materials designated alternate location/s within the facility.

13. Vacuum lines must be protected with HEPA filters, or their equivalent. Filters

must be replaced as needed. Liquid disinfectant traps may be required.


15. The ABSL-3 facility design and operational procedures must be documented. The

facility must be tested to verify that the design and operational parameters have been met prior to use. Facilities should be re-verified at least annually against these procedures as modified by operational experience.

16. Additional environmental protection (e.g., personnel showers, HEPA filtration of

exhaust air, containment of other piped services, and the provision or effluent decontamination) should be considered if recommended by the agent summary statement, as determined by risk assessment of the site conditions, or other applicable federal, state or local regulations.

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B: Procedural Biosafety

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University of Massachusetts/Amherst Disinfection

Disinfection is generally a less lethal process than sterilization. It eliminates nearly all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores) on inanimate objects. Disinfection does not ensure “overkill” and therefore lacks the margin of safety achieved by sterilization procedures. The effectiveness of a disinfection procedure is controlled significantly by a number of factors, each one of which may have a pronounced effect on the end result. Among these are:

• Nature and number of contaminating microorganisms (especially the presence of bacterial spores) • Amount of organic matter present (e.g., soil, feces, and blood) • Type and condition of instruments, devices, and materials to be disinfected • Temperature.

Disinfection is a procedure that reduces the level of microbial contamination, but there is a broad range of activity that extends from sterility at one extreme to a minimal reduction in the number of microbial contaminants at the other. By definition, chemical disinfection and in particular, high-level disinfection differs from chemical sterilization by its lack of sporicidal power. This is an over simplification of the actual situation because a few chemical germicides used as disinfectants do, in fact, kill large numbers of spores even though high concentrations and several hours of exposure may be required. Non-sporicidal disinfectants may differ in their capacity to accomplish disinfection or decontamination. Some germicides rapidly kill only the ordinary vegetative forms of bacteria such as staphylococci and streptococci, some forms of fungi, and lipid containing viruses, whereas others are effective against such relatively resistant organisms as Mycobacterium tuberculosis var. bovis, non-lipid viruses, and most forms of fungi. High-Level Disinfection This procedure kills vegetative microorganisms and inactivates viruses, but not necessarily high numbers of bacterial spores. Such disinfectants are capable of sterilization when the contact time is relatively long (e.g., 6 to 10 hours). As high-level disinfectants, they are used for relatively short periods of time (e.g., 10 to 30 minutes). These chemical germicides are potent sporicides and, in the United States, are classified by the FDA as sterilant/disinfectants. They are formulated for use on medical devices, but not on environmental surfaces such as laboratory benches or floors.

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Intermediate-Level Disinfection This procedure kills vegetative microorganisms, including Mycobacterium tuberculosis, all fungi, and inactivates most viruses. Chemical germicides used in this procedure often correspond to Environmental Protection Agency (EPA)-approved "hospital disinfectants" that are also "tuberculocidal." They are used commonly in laboratories for disinfection of laboratory benches and as part of detergent germicides used for housekeeping purposes. Low-Level Disinfection This procedure kills most vegetative bacteria except M. tuberculosis, some fungi, and inactivates some viruses. The EPA approves chemical germicides used in this procedure in the US as "hospital disinfectants" or "sanitizers." DECONTAMINATION IN THE MICROBIOLOGY LABORATORY Decontamination in the microbiology laboratory must be carried out with great care. In this arena, decontamination may entail disinfection of work surfaces, decontamination of equipment so it is safe to handle, or may require sterilization. Regardless of the method, the purpose of decontamination is to protect the laboratory worker, the environment, and anyone who enters the laboratory or handles laboratory products away from the laboratory. Reduction of cross-contamination in the laboratory is an added benefit. Decontamination and Cleaning Decontamination renders an area, device, item, or material safe to handle (i.e. safe in the context of being reasonably free from a risk of disease transmission). The primary objective is to reduce the level of microbial contamination so that infection transmission is eliminated. The decontamination process may be ordinary soap and water cleaning of an instrument, device, or area. In laboratory settings, decontamination of items, spent laboratory materials, and regulated laboratory wastes is often accomplished by a sterilization procedure such as steam autoclaving, perhaps the most cost-effective way of decontaminating a device or an item. The presence of any organic matter necessitates longer contact time with a decontamination method if the item or area is not precleaned. For example, a steam cycle used to sterilize precleaned items is 20 minutes at 121°C. When steam sterilization is used to decontaminate items that have a high bioburden and there is no pre-cleaning (i.e., infectious waste) the cycle is longer. Decontamination in laboratory settings often requires longer exposure times because pathogenic microorganisms may be protected from contact with the decontaminating agents. Chemical germicides used for decontamination range in activity from high-level disinfectants (i.e., high concentrations of sodium hypochlorite [chlorine bleach]), which might be used to decontaminate spills of cultured or concentrated infectious agents in research or clinical laboratories, to low-level disinfectants or sanitizers for general housekeeping purposes or spot decontamination of environmental surfaces in healthcare settings. Resistance of selected organisms to decontamination is presented in descending order in Table 1. If dangerous and highly infectious agents are present in a laboratory, the

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methods for decontamination of spills, laboratory equipment, BSC, or infectious waste are very significant and may include prolonged autoclave cycles, incineration or gaseous treatment of surfaces (see following Table 1).

TABLE 1

DESCENDING ORDER OF RESISTANCE TO GERMICIDAL CHEMICALS BACTERIAL SPORES Bacillus subtilis, Clostridium sporogenes

⇓ MYCOBACTERIA Mycobacterium tuberculosis var. bovis, Nontuberculous mycobacteria

⇓ NONLIPID OR SMALL VIRUSES Poliovirus, Coxackievirus, Rhinovirus

⇓ FUNGI Trichophyton spp., Cryptococcus spp., Candida spp.

⇓ VEGETATIVE BACTERIA Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella choleraesuis, Enterococci

⇓ LIPID OR MEDIUM-SIZE VIRUSES Herpes simplex virus, Cytomegalovirus, Respiratory syncytial virus, HBV, HCV, HIV, Hantavirus, Ebola virus Note: There are exceptions to this list. Pseudomonas spp are sensitive to high level disinfectants, but if they grow in water and form biofilms on surfaces, the protected cells can approach the resistance of bacterial spores to the same disinfectant. The same is true for the resistance to glutaraldehyde by some nontuberculous mycobacteria, some fungal ascospores of Microascus cinereus and Cheatomium globosum, and the pink pigmented Methylobacteria. Prions are also resistant to most liquid chemical germicides and are discussed in the last part of this chapter. Decontamination of Surfaces Liquid chemical germicides formulated as disinfectants may be used for decontamination of large areas. The usual procedure is to flood the area with a disinfectant for periods up to several hours. This approach is messy and with some of the disinfectants used represents a toxic hazard to laboratory staff. For example, most of the “high-level” disinfectants on the United States market are formulated to use on instruments and medical devices and not on environmental surfaces. Intermediate and low-level

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disinfectants are formulated to use on fomites and environmental surfaces but lack the potency of a high-level disinfectant. For the most part intermediate and low level disinfectants can be safely used and, as with all disinfectants, the manufacturer’s instructions should be closely followed. Disinfectants that have been used for decontamination include sodium hypochlorite solutions at concentrations of 500 to 6000 parts per million (ppm), oxidative disinfectants such as hydrogen peroxide and peracetic acid, phenols, and iodophors. Concentrations and exposure times vary depending on the formulation and the manufacturer’s instructions for use. A spill control plan should be available in the laboratory. This plan should include the rationale for selection of the disinfecting agent, the approach to its application, contact time and other parameters. Agents requiring BSL-3 and BSL-4 containment pose a high risk to workers and possibly to the environment and should be managed by well-informed professional staff trained and equipped to work with concentrated material. Because of the ongoing controversy of the role of formaldehyde as a potential occupational carcinogen, the use of formaldehyde is limited to certain specific circumstances under carefully controlled conditions, e.g., for the disinfection of certain equipment. There are no FDA cleared liquid chemical sterilant/disinfectants that contain formaldehyde. Generic disinfectants containing chlorine are available in liquid or solid form (e.g., sodium or calcium hypochlorite). Although the indicated concentrations are rapid acting and broad-spectrum (tuberculocidal, bactericidal, fungicidal, and virucidal), no proprietary hypochlorite formulations are formally registered with EPA or cleared by FDA. Common household bleach is an excellent and inexpensive source of sodium hypochlorite. Concentrations between 500 and 1000 mg/L chlorine are appropriate for the vast majority of uses requiring an intermediate level of germicidal activity; higher concentrations are extremely corrosive as well as irritating to personnel, and their use should be limited to situations where there is an excessive amount of organic material or unusually high concentrations of microorganisms (e.g., spills of cultured material in the laboratory). The effectiveness of alcohols as intermediate level germicides is limited because they evaporate rapidly, resulting in short contact times, and also lack the ability to penetrate residual organic material. They are rapidly tuberculocidal, bactericidal and fungicidal, but may vary in spectrum of virucidal activity (see text). Items to be disinfected with alcohols should be carefully pre-cleaned then totally submerged for an appropriate exposure time (e.g., 10 minutes). Only those iodophors registered with EPA as hard-surface disinfectants should be used, closely following the manufacturer's instructions regarding proper dilution and product stability. Antiseptic iodophors are not suitable to disinfect devices, environmental surfaces, or medical instruments. SPECIAL INFECTIOUS AGENT ISSUES Transmissible Spongiform Encephalopathy Agents (Prions)

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The major exception to the rule in the previous discussion of microbial inactivation and decontamination is the causative agent of CJD or other prion agents responsible for transmissible spongiform encephalopathies of the central nervous system in humans or animals. Studies show that prions are resistant to conventional uses of heat and/or chemical germicides for the sterilization of instruments and devices. REFERENCES 1. Vesley D, Lauer J, Hawley R. Decontamination, sterilization, disinfection, and antisepsis. In: Fleming DO, Hunt DL, editors. Laboratory safety: principles and practices. 3rd ed. Washington, DC: ASM Press; 2001. p. 383-402. 2. Rhame FS. The inanimate environment. In: Bennett JV, Brachmann PS, editors. Hospital infections. 4th ed. Philadelphia: Lippincott-Raven; 1998. p. 299-324. 3. Favero M. Developing indicators for sterilization. In: Rutala W, editor. Disinfection, sterilization and antisepsis in health care. Washington, DC: Association for Professionals in Infection Control and Epidemiology, Inc.; 1998. p. 119-132. 4. Favero M. Sterility assurance: concepts for patient safety. In: Rutala W, editor. Disinfection, sterilization and antisepsis: principles and practices in healthcare facilities. Washington, DC: Association for Professionals in Infection Control and Epidemiology, Inc.; 2001. p. 110-9. 5. Spaulding EH. Chemical disinfection and antisepsis in the hospital. J Hosp Res. 1972:9;5-31. 6. Favero M, Bond W. Chemical disinfection of medical surgical material. In: Block S, editor. Disinfection, sterilization, and preservation. 5th edition. Philadelphia: Lippencott, Williams and Wilkens; 2001. p. 881-917. 7. Centers for Disease Control and Prevention [www.cdc.gov]. Atlanta: The Centers for Disease Control and Prevention; [updated 2006 Sept 21]. Guidelines for Environmental Infection Control in Health-Care Facilities, 2003; [about 2 screens]. Available from: http://www.cdc.gov/ncidod/hip/enviro/guide.htm 8. Tearle P. Decontamination by fumigation. Commun Dis Public Health. 2003;6:166-8. 9. Fink R, Liberman DF, Murphy K, et al. Biological safety cabinets, decontamination or sterilization with paraformaldehyde. Am Ind Hyg Assoc J. 1988;49:277-9. 10. Klapes NA, Vesley D. Vapor-phase hydrogen peroxide as a surface decontaminant and sterilant. Appl Environ Microbiol. 1990;56:503-6. 11. Graham GS, Rickloff JR. Development of VHP sterilization technology. J Healthc Mater Manage. 1992;54:56-8. 12. Johnson JW, Arnold JF, Nail SL, et al. Vaporized hydrogen peroxide sterilization of freeze dryers. J Parenter Sci Techl. 1992;46:215-25. 13. Heckert RA, Best M, Jordan LT, et al. Efficacy of vaporized hydrogen peroxide against exotic animal viruses. Appl Environ Microbiol. 1997;63:3916-8. 14. Krause J, McDonnell G, Riedesel H. Biodecontamination of animal rooms and heat-sensitive equipment with vaporized hydrogen peroxide. Contemp Top Lab Anim Sci. 2001;40:18-21.

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15. Knapp JE, Battisti DL. Chlorine Dioxide. In: Block S, editor. Disinfection, sterilization, and preservation. 5th ed. Philadelphia: Lippencott, Williams and Wilkens; 2001. p. 215-27. 16. Weber DJ, Rutala WA. Occupational risks associated with the use of selected disinfectants and sterilants. In: Rutala WA, editor. Disinfection, sterilization and antisepsis in health care. Champlain (NY): Polyscience Publications: 1998 p. 211

Chemical Disinfectants

Chemical Disinfectants and Their Use in Laboratories

Disinfectant Concentration

(active ingredients)

Contact Time

(min)

Effective Against*

B F LV TB HV S

Quaternary Ammonium

0.1 - 0.2% 10 - 30 ++ ++ ++ - - -

Phenolic compounds 0.2 - 3.0% 10 - 30 ++ ++ ++ ++ + -

Chlorine Compounds ** (available chlorine)

0.01 - 5.0% 10 - 30 ++ ++ ++ ++ ++ +

Iodophor Compounds) 0.5% 10 - 30 ++ ++ ++ ++ + -

Alcohol (ethyl or isopropyl)

70 - 85% 10 - 30 ++ ++ ++ - + -

Formaldehyde 4 - 8% 10 - 30 ++ ++ ++ ++ ++ +

Glutaraldehyde 2% 10 - 600 ++ ++ ++ ++ ++ ++

* B = Vegetable bacteria; F = fungi and asexual spores but not necessarily chlamydospores or sexual spores; LV = lipophilic viruses; TB = tubercle bacillus; HV = hydrophilic viruses; S = spores. + = positive response; ++ = very positive response; - = negative response.

** Household bleach contains 5% available chlorine.

*** References: "Decontamination, Sterilization, Disinfection, and Antisepsis in the Microbiology Laboratory," in Laboratory Safety: Principles and Practices and "Sterilization, Disinfection, and Antisepsis in the Hospital," in Manual of Clinical Microbiology.

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University of Massachusetts/Amherst PPE: Personal Protective Equipment

The following personal protective equipment must be available for laboratory personnel who are working with hazardous materials. It is also appropriate for laboratories to provide safety glasses for visitors and a sign indicting that eye protection is required where hazardous materials are in use. Personal protective equipment is not supplied by EH&S. However, EH&S will assist with recommendations on specific types and uses of protective equipment. Eye and face protection must be worn in the laboratory when there is a potential for contact with hazardous chemicals or other agents (e.g., non ionizing radiation, biohazardous materials, flying objects.) Please note that all protective eye and face wear should meet American National Standards Institute ANSI Z 87.1, 1989 standards. Visitors' safety glasses are not acceptable for any laboratory procedures. (Contact EH&S for standards). The type of protection needed depends on the hazard (e.g. chemical, UV, laser, impact). For instance, when laboratory chemicals are used, approved eye protection is mandatory and chemical splash goggles are recommended. Goggles should be worn over eyeglasses or prescription safety glasses with side shields should be worn. Ordinary prescription glasses do not meet these standards. The University has an agreement with a local optician to provide low-cost regular or prescription safety glasses. Be sure to specify side shields. For authorization forms, contact EH&S. When working with severely corrosive or strongly reactive chemicals, with glass wear under reduced and elevated pressures, in combustion and other high temperature operations, and whenever there is a possibility of an explosion or implosion both eye and skin protection are needed and face shields are necessary in addition to approved safety glasses. Special safety glasses and face shields may also be required for work with UV light, lasers, and other types of radiation which is absorbed by the eyes or skin (chemical splash goggles are not adequate for these types of work). Please consult with the Radiation Safety group at EH&S.

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Laboratory coats and shoes (not open sandals) should be worn when performing laboratory work. Depending on the type of work, additional personal protective equipment, such as gloves and aprons may be necessary. Coats, aprons and gloves should be removed when leaving the laboratory. Gloves should be replaced immediately if they are contaminated or torn. In situations involving extremely hazardous chemicals and/or biologicals, double gloves are recommended. Gloves should be carefully selected for their degradation and permeation characteristics to provide proper protection. The thin, latex, vinyl, or nitrile gloves, popular for their dexterity are not appropriate for highly toxic chemicals or solvents. When using chemicals, consult chemical compatibility information that is provided in manufacturer's catalogs to help you in selecting the proper gloves and other protective clothing. More information on specific types and uses of personal protective apparel is available from EH&S. The use of air-purifying respirators for routine laboratory work is not recommended. Respirators are discouraged because they protect only the wearer and require periodic medical monitoring, specific training and fit testing before they can be worn effectively. Properly operating laboratory chemical hoods provide the best overall protection from chemical hazards, and biological safety cabinets provide the best overall biological protection in the laboratory. That being said, there is a respiratory protection program which addresses the needs of those individuals that do require air-purifying respirators.

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University of Massachusetts/Amherst Biological Safety Training

EH&S provides an introductory course on Biosafety that covers definitions of biological and biohazardous materials, risk groups, biosafety containment levels and controls, biosafety policy and the role of the Institutional Biosafety Committee, biological waste management and other general biosafety principles and requirements. Biosafety training is required for all personnel who work with potentially viable biological materials, including for example: microorganisms (of any risk level); cells or cell lines; tissue cultures; recombinant DNA, organisms, or viruses; animal blood, body fluids, or tissues; or animals. Annual biological safety training is required for all individuals that work with human source material and/or work at biosafety level 2 or higher. Annual review may be accomplished in a classroom training or with EH&S’s OWL (On-line Web-based Learning). The OSHA Blood Borne Pathogen Standard is addressed as well and the NIH’s Guidelines for Use of Recombinant DNA in Research Laboratories.

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University of Massachusetts/Amherst Shipping Biological Material

HazMat SHIPPING PROGRAM Introduction: The Univer sity ha s in stituted a c ampus-wide program for shipp ing all h azardous materials, which can include biological sam ples. This progr am is intende d to be in f ull compliance with all app licable federal regulations. Only tra ined and c ertified personnel are pe rmitted to pack age and sh ip the regu lated m aterials cove red by the f ederal mandates. Hazardous m aterials can include com pressed gases, flammable liquids and solids, oxidizers, poisons, corrosive materials, radioactive and biological materials and even dry ice. For shipm ents of biological and radioactive m aterials, transport or export perm its and/or authorization may be required prior to shipment. EH&S personnel will prepare the paperwork and packag e hazardous m aterials for all campus departments [see shipping instructions below]. Regulations and Penalties: Federal regulations have outlined specific shipping requirements for hazardous materials. The Office of Hazardous Materials Safety , which is within the United States Depar tment of Transportation' s Research and Special Programs Administration, is responsible for coordinating a nation al safety program for th e transportation of hazard ous materials by air, rail, highway and water. Depending on m ode of trans port and destination, these shipments are regu lated by Hazard ous Materials Regulatio ns (Title 49 CFR parts 100-185) and/or International Air Transport Association (IATA) . When materials are shipped out of the c ountry, items that may not be consid ered hazardous in the United States m ay be classified as hazard ous in other count ries. To com ply with ship ping regulations, hazardous materials must be properly classified, documented, packaged, and handled. Federal law also requires that anyone who is involved in or responsible for preparing or transporting a hazardous material must have DOT and/or IATA training and certification. No one offering hazardous materials is exempt from federal transportation requirements. Failure to meet regulatory requirements when shipping hazardous materials may result in citations, fines and/or imprisonment. Fines to the University can range from $250 to $500,000 per violation. In addition, individual researchers and shippers may be subject to criminal penalties of up to $500,000 and five years imprisonment.

http://hazmat.dot.gov/

http://www.iata.org/about/Pages/mission.aspx

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Hazardous Materials Classification and Applicability Hazardous m aterial reg ulations m ay apply to comm ercial products, chemical m ixtures, and newly synthesized com pounds. Various types of batteri es, fuel containers and cleaning pro ducts are ex amples of m aterials that are regulated fo r shipm ent. There are nine classes of hazardous materials:

Class or Division No.

Name of Class or Division [for DOT definition click on Name below]

Class or Division No.

Name of Class or Division[for DOT definition click on Name below]

1.1 to 1.6 Explosives 6.1 Poisonous Materials

2.1 to 2.3 Gases 6.2 Infectious Substances / Biological Materials

3 Flammable Liquids 7 Radioactive

4.1 to 4.3 Flammable Solids 8 Corrosives

5.1 and 5.2

Oxidizers and Organic Peroxides 9

Miscellaneous Hazard ous Materials (asbestos, dry ice, PCBs)

Forbidden Forbidden Materials

Dry Ice: Shipments with dry ice also re quire proper packaging and labeling. Complete and submit the On-Line Intent to Ship Hazardous Materials Form .

Hazardous material is g enerally defined as a ny substance that could adversely affect the safety of the public, handlers or carriers dur ing transportation. Haza rdous m aterial, as defined by the DOT, is any substance that appears in the Title 49 CFR Hazardous Materials Table. (The link is found on the upper left hand side of the page Hazmat Table) Shipping Instructions: EH&S personnel have been trained and certified to ship hazardous materials. To ensure compliance with federal law, departments are required to ship their hazardous materials using the following procedure:

Complete the On-Line Intent to Ship Hazardous Materials Form o Important: If CAS number field on the On-Line Intent to Ship Hazardous

Materials Form is left blank you will be autom atically sent to an On-Line TSCA Form

EH&S will contact the requesto r to schedule a convenient tim e to pre pare the shipment and coordinate the required paperwork.

Domestic packages require 24 hours (one business day) for processing. International packages require 48 hours (two business days) for processing. Emergency shipments can be arranged on a case-by-case basis. Special hazards and radioactive materials may take extra time to process For more info: http://www.ehs.umass.edu/prog_hazmat2-new.html

http://beloki.admin.umass.edu/ehs/hazmat.php

http://beloki.admin.umass.edu/ehs/hazmat.php

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Biological Safety Cabinet Management Program

Document Number: EHS.BSC.08.01 Effective Date: 05/28/2008 Revision Date: 06/10/11

1.0 Purpose and Applicability 1.1 The following document describes the proper procedures for working in a biosafety cabinet as well as the annual certification requirements. These procedures must be followed properly by all who own and work in a biosafety cabinet. 1.2 This document covers the types of cabinets and the proper techniques for in working in them. 1.3 The following document also offers guidance in selecting new cabinets and decommissioning old biological safety cabinet equipment as well as several important safety topics specific to this equipment. 2.0 Definitions 2.1 A biological safety cabinet (BSC) is the primary barrier protection for individuals working with biohazardous materials. Laboratory procedures that could create airborne biohazards should always be performed in a BSC as it protects the laboratory workers and the environment from aerosols or droplets that could spread biohazardous material. The common element to all classes of biological safety cabinets is the high efficiency particulate air (HEPA) filter. This filter removes particles with aerodynamic diameters of 0.3 microns (the ‘most penetrating particle size’) with an efficiency of 99.97 percent. Particles with aerodynamic diameters both larger and smaller than 0.3 microns – which includes the majority of bacteria and viruses – are removed with virtually 100 percent efficiency. It is important to note, however, that HEPA filters are ‘particle filters’ that do not remove vapors or gases. 2.2 Laminar flow/clean benches are devices that look similar to a biosafety cabinet, but only protect the product from contamination. These devices direct air towards the operator and should never be used for handling biological, hazardous, toxic or sensitizing materials. 2.3. Chemical (Fume) hoods are designed for working with chemicals. 2.4 Certification involves performance and safety tests that are conducted annually by an NSF-49 certified outside contractor to ensure that the cabinet is working according to the NSF-49 Safety Standard. These tests include measurement and/or correction of air velocities, patterns, balance, leakage and filtration system efficiency. 2.5 Environmental Protection – Means that any aerosol generated within the unit is removed from the air by HEPA filters before the air from the cabinet is discharged either inside or outside the facility. 2.6 Personnel Protection - Means that any aerosol generated within the cabinet is contained within the cabinet and away from the person doing the work. 2.7 Product Protection – Means that the air at the work surface of the cabinet has been filtered so that it is free of airborne particles and organisms that could contaminate the work. 2.8 Air Curtain (Barrier) – The unidirectional movement of air past and parallel to the plane of an opening and at a velocity greater than that on either side, thereby creating an impedance to transverse movement of airborne particulates through the opening.

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3.0 Roles and Responsibilities 3.1 Principal Investigator – Individual responsible for ensuring that biosafety cabinets are certified annually

and that all researchers working in the laboratories are informed on biosafety cabinet use procedures. 3.2 Biosafety Officer at EH&S – Is the staff member responsible for advising researchers on biosafety cabinet

purchasing, certifications, locations, and procedures for use. 3.3 Institutional Biosafety Committee (IBC) – This committee reviews, sets policy and provides oversight of

recombinant DNA work and biohazardous materials used on campus. 3.4 Facilities & Campus Planning –Responsible for notifying EH&S before purchasing or moving BSC’s. If

any BSC’s are being moved, they must be taken out of service until recertified. 4.0 Procedures for Use 4.1 Biosafety Cabinet Operational Procedures:

1. Ready the work area. Operate cabinet blowers for five minutes before beginning work to allow the cabinet to purge or remove particulates from the cabinet.

2. Disinfect the work area. Wipe the work surface, interior walls and surface of the window with a suitable disinfectant such as 70% ethanol, 10% bleach solution, an iodophor, or quaternary ammonium compound.

3. Assemble material. Introduce only those items that are required to perform the procedures and arrange in a logical order. Each item should be wiped with a disinfectant prior to placing it into the cabinet in order to reduce the introduction of contaminants. The flow of work should proceed across the work surface from clean to contaminated areas. Similarly, pipette tip discard trays containing disinfectant, biohazard bags, sharps containers, etc., should be placed to one side inside the BSC.

4. Wear protective clothing. Laboratory coats or solid front gowns should be worn over street clothing and long-cuffed latex or other appropriate gloves (e.g., nitrile, vinyl) should be worn for hand protection. The cuffs of the gloves should be pulled up and over the cuffs of the coat sleeves.

5. Perform procedures slowly by moving items in and out of the cabinet using a straight in and out motion and avoiding side to side motions. Avoid rapid movements. After placing arms/hands inside the BSC, manipulations should be delayed to permit the cabinet to stabilize and allow the flow of air to remove surface contaminants from your arms/hands.

6. Do not block the front grille with papers, equipment, etc., as this may cause air to enter the work space area instead of being drawn through the front grille and into the HEPA filter. Arms should be raised slightly and operations should be performed on the work surface at least four inches from the front grille. The middle third area is ideal. Likewise, no operations or equipment should block the rear exhaust grille. Any equipment generating aerosols such as a microcentrifuge, vortex or blender should be placed near the rear of the cabinet. A disinfectant-soaked towel can be placed on the work surface to contain any spills or splatters that may occur.

7. Open flames inside the cabinet create turbulence that can disrupt the pattern of air and compromise the safety of the operator and affect product protection (i.e., cause contamination). Flames can also damage the interior of the cabinet as well as the HEPA filters. If a burner is necessary to sterilize tools such as a loop or needle, consider the use of a touch plate burner that provides a flame on demand, and place it to the rear of the cabinet. Alternatively, electric furnaces or disposable, sterile tools can be used. (See Section 4.8)

8. If culture media or other fluids need to be aspirated, suction or aspirator flasks should be connected to an overflow collection flask containing disinfectant (the aspirated materials can then be discarded as noninfectious waste). (See section 4.9)

9. When work is completed all items within the cabinet should be wiped down with disinfectant and removed from the cabinet. Do not use the interior of the BSC as a storage area since stray organisms may become "trapped" and contaminate future experiments. The interior surfaces of the cabinet should

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be cleaned with a disinfectant. Let the blowers operate for five minutes with no activity inside the cabinet to purge the cabinet of contaminants.

10. Investigators should remove their gowns and gloves and thoroughly wash their hands before exiting the laboratory.

4.2 Registration of Biosafety Cabinets Please notify us of new equipment. The form in Appendix B can be faxed to EH&S Biosafety at 413-545-2600. 4.3 Biosafety Cabinet Annual Certification All biosafety cabinets at the University must be certified annually by an authorized contractor. The Biosafety Department of EH&S coordinates this testing annually. Currently, the biosafety cabinets on campus are certified by B&V Testing (800) 851-9081. The certifications follow the NSF-49 Safety Standard for biosafety cabinets. The contractor will test down flow and inflow velocities, air flow patterns, the HEPA filter and perform a cabinet leak test to ensure that the BSC is working properly. The Biosafety Office at EH&S maintains a complete inventory of safety cabinets which records the historical certification and repair of each cabinet, so it is important to ensure all biological safety cabinets are registered. Should you have any questions, please call us. 545-7293. Guidelines for when a Biosafety Cabinet certification must be performed:

1. Before initial use to verify the cabinet is effective 2. After moving a BSC from one location to another, even if it is just a few inches, as it is very easy

to compromise a containment system 3. After replacement of high efficiency particulate air (HEPA) filter(s) 4. At least annually to assure that filters are not plugged, damaged or leaking 5. After possible contamination 6. Following a large spill or accident inside the BSC 7. When requested by the Biosafety Officer

Guidelines for when a Biosafety Cabinet Testing Results in a Failure:

1. The BSC must be placed out of service and have appropriate signage on it 2. The Biosafety Department of EH&S will obtain a quote for repairs/remediation ASAP 3. The cabinet owner will obtain a purchase order for the repairs ASAP (verbal is usually ok) 4. Biosafety will give the PO to the repair company and schedule the repair visit ASAP 5. Repairs/remediation will be done and testing 6. If equipment is to be removed from service indefinitely, it will be gas decontaminated and

removed from the laboratory. 7. Records of these actions are to be made in the EH&S database

4.4 Training – Use of Biological Safety Cabinets Since biological safety cabinets are one of the most critical pieces of equipment to protect the user, as well as

the product and the environment, it is important to understand how BSC's function and their limitations. The effectiveness of the cabinet depends heavily on proper use, appropriate work practices, continued maintenance and annual certification. To support the BSC training provided by your supervisor, the Biosafety Office at EH&S also provides information during their biosafety training sessions. In addition, the following DVD is available for your viewing: “Safe Use of Biological Safety Cabinets” by the Eagleston Institute, Sanford, Maine.

4.5 Helpful Tips for Biological Safety Cabinet Use

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DO: Do place containment trays or absorbent drapes under experiments to catch spills and to ease clean-

up. Do operate the BSC sash at the manufacturers design criteria. Do operate the BSC for approximately 5 minutes prior to use. Do wipe down unit work surfaces with appropriate disinfectant prior to using BSC for sterility

purposes, and after the completion of work, but before unit has been turned off. Do monitor alarms, pressure gauges or flow indicators for any major fluctuation or changes possibly

indicating a problem with the unit.

DON’T: Don’t use a BSC unless there is a current certification label attached. Don’t overload the containment area or block front, side or rear air grills which will reduce or restrict

air flow and compromise product protection and /or personnel protection. Don’t use the BSC for storage. Don’t change baffle, damper, speed control settings. Don’t lean into the BSC so that the user’s head is inside the plane of the BSC face. Don’t operate an ultraviolet light while working in the BSC. Don’t operate an ultraviolet light when occupants are in the laboratory unless the sash is closed

completely and it is known to block UV light. Don’t use gas in cabinets. Don’t use open flame in cabinets. 4.6 Classification – Biological safety Cabinets There are three main classes of biological safety cabinets (I, II & III). Each type of cabinet provides protection through different configurations of HEPA filtered laminar air flow into and within the cabinets as well as HEPA filtered exhaust air. Class I BSC’s are not used very often but tend to be used to enclose equipment or procedures which have the potential to generate aerosols. They provide an inward flow of unfiltered air, similar to a chemical fume hood, which protects the worker from the material in the cabinet. The environment is protected by HEPA filtration of the exhaust air before it is discharged into the laboratory or to the outside via the building exhaust. Class II BSC’s are the most common type of BSC and can be used with biosafety level 1, 2 and 3 agents. Class II (Types A, B1, B2, and B3) biological safety cabinets provide personnel, environment, and product protection. Air is drawn around the operator into the front grille of the cabinet, which provides personnel protection. In addition, the downward laminar flow of HEPA-filtered air provides product protection by minimizing the chance of cross-contamination along the work surface of the cabinet. Because cabinet air has passed through the exhaust HEPA filter, it is contaminant-free (environment protection), and may be recirculated back into the laboratory (Type A) or ducted out of the building (Type B). Class III BSC’s are designed for work with level 4 agents and provide maximum protection. The cabinet is gas-tight with a non-opening view window, and has rubber gloves attached to ports in the cabinet that allow for manipulation of materials in the cabinet. Air is filtered through one HEPA filter as it enters the cabinet, and through 2 HEPA filters before it is exhausted to the outdoors. This type of cabinet provides the highest level of product, environmental, and personnel protection. Horizontal laminar flow "clean air benches" are not BSCs. They discharge HEPA-filtered air across the work surface and toward the user, providing only product protection. They can be used for certain clean activities,

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such as pouring media, plant tissue culture, and dust-free assembly of sterile equipment or electronic devices. However, they should not be used when handling human cell culture materials or potentially infectious materials, or as a substitute for a biological safety cabinet in research laboratories.

Comparison of Biological Safety Cabinets (from NIH, BMBL) Type Face Velocity

(1fpm) Airflow Pattern Radionuclides

/Toxic chemical

Biosafety Levels

Product Protection

Class I open front 75 In at front; rear and top through HEPA filter

No 2,3 No

Class II, Type A 75 70% recirculated through HEPA; exhaust through HEPA

No 2,3 Yes

Class II, Type B1 100 30% recirculated through HEPA; exhaust via HEPA and hard ducted

Yes (low levels, volatility)

2,3 Yes

Class II, Type B2 100 No recirculation; total exhaust via HEPA and hard ducted

Yes 2,3 Yes

Class II, Type B3 100 Same as IIA, but plena under negative pressure to room and exhaust air is ducted

Yes 2,3 Yes

Class III NA Supply air inlets and exhaust through 2 HEPA filters

Yes 3,4 Yes

Airflow Diagrams:

Class II, Type A BSC: Horizontal Flow “Clean Bench”

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4.7 Biosafety Purchasing Guidelines All biosafety cabinets purchased at the University must meet the NSF-49 Safety Standard. The most common BSC on campus is Class II/A2. There are a wide variety of biosafety cabinets on the market that are suitable for all types of research involving biohazardous materials (see table on page 5). Before purchasing a biosafety cabinet, you will need to assess and evaluate the type of cabinet that would be suitable for the work conducted in your laboratory. Please contact the Biosafety Officer at EH&S for biosafety cabinet purchase recommendations at: 545-2682. 4.8 Location of Biological Safety Cabinets within the Laboratory The ideal location for the biological safety cabinet is remote from the entry (i.e., the rear of the laboratory away from traffic), since people walking parallel to the face of a BSC can disrupt the air curtain. The air curtain created at the front of the cabinet is quite fragile, amounting to a nominal inward and downward velocity of 1 mph. Open windows, air supply registers, portable fans or laboratory equipment that creates air movement (e.g., centrifuges, vacuum pumps) should not be located near the BSC. Similarly, chemical fume hoods must not be located close to BSCs. 4.9 Dangers of natural gas use in a BSC: Biological safety cabinets (BSC’s) are designed to protect workers, their products, and their environment.

Certain biological safety cabinets (BSC’s) recirculate air within the cabinet. Most BSC’s at UMass Amherst are recirculating. Open flames are not required in the near microbe-free environment of a biological safety cabinet. On an open bench, flaming the neck of a culture vessel will create an upward air current which prevents microorganisms from falling into the tube or flask. An open flame in a BSC, however, creates turbulence which disrupts the pattern of HEPA-filtered air supplied to the work surface. The use of natural gas or other flammable gases within these BSC’s may allow flammable gases to concentrate, potentially leading to an explosive atmosphere.

The use of open flames within a BSC may alter the airflow pattern used to protect product and personnel. This

communication outlines which BSC’s recirculate air and the procedures to increase safety and prevent flammable gas explosions within BSC’s.

BSC Type Former Name(s) % Recirculated Air Class II Type A1 Class II Type A 70 Class II Type A2 Class II Type A/B3 70 Class II Type B1 N/A 30 Class II Type B2 N/A 0

BSCs that recirculate air are commonly found at UMass Amherst. To determine the type of cabinet, locate the unique serial number on the cabinet. This area should also contain the BSC type. If unable to locate this information, contact EHS for further assistance (545-2682).

4.9.1 Use of gas in BSC’s has led to fires, compromised HEPA filters, destroyed cabinets and injured workers.

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4.9.2 Certain types of BSCs are designed to contain, not exhaust, most of the air within a cabinet. This makes them prone to the buildup of materials within the cabinet. 4.9.3 If a gas leak occurs (e.g. valve left on or tube leak) inside a recirculating biological safety cabinet, over time the gas would become more concentrated and could reach explosive levels. Since it is within a BSC, the user may not detect the leak and, upon ignition, it could explode. Therefore, natural gas or other flammable gases should not be used within recirculating biological safety cabinets. 4.9.4 The high efficiency particulate air (HEPA) filters, responsible for providing a sterile environment in the cabinet, can act as a dense mass of combustible material during an uncontrolled fire inside the cabinet. 4.9.5 The heat convection currents generated by the open flame compromise the carefully controlled airflow pattern responsible for protecting product and personnel. 4.9.6 Heat generated by an open flame can damage the HEPA filter and/or the filter’s adhesive. This can produce leaks in the filter, adverse flow patterns in the cabinet, and potential user exposure. 4.9.7 Use of an open flame within the BSC inactivates manufacturers’ warranties on the cabinet: cabinet manufacturers will assume no liability in the event of fire, explosion or worker exposure due to the use of a flammable gas in the cabinet. Additionally, the UL™ (Underwriters Laboratories) approval will automatically be voided. 4.9.8 Cited Regulations or Quotes from Manufacturers: NIH/CDC: National Institutes of Health and the Centers for Disease Control and Prevention: “Open flames are not required in the near microbe-free environment of a biological safety cabinet. On an open bench, flaming the neck of a culture vessel will create an upward air current which prevents microorganisms from falling into the tube or flask. An open flame in a BSC, however, creates turbulence which disrupts the pattern of HEPA-filtered air supplied to the work surface.” WHO: World Health Organization’s Laboratory Biosafety Manual: Open flames should be avoided in the near microbe-free environment created inside the BSC. They disrupt the airflow patterns and can be dangerous when volatile, flammable substances are also used. To sterilize bacteriological loops, micro-burners or electric “furnaces” are available and are preferable to open flames. Public Health Agency of Canada; The Laboratory Biosafety Guidelines: The provision of natural gas to BSC’s is not recommended. Open flames in the BSC create turbulence, disrupt airflow patterns and can damage the HEPA filter. When suitable alternatives (e.g., disposable sterile loops, micro-incinerators) are not possible, touch-plate micro-burners that have a pilot light to provide a flame on demand may be used. NSF/ANSI Standard 49 – 2009 published by NSF International, Annex G; Section G.3.3.1: Service valves allow inert gases, air, or vacuum lines to be plumbed into the BSC. Although many users connect gas to a service valve in the cabinet, this practice should be avoided because open flames in a Class II BSC disrupts the airflow, and there is the possibility of a buildup of flammable gas in BSC’s that recirculate their air. The Baker Company (BSC manufacturer): The Baker Company does not endorse the use of flammable gasses within BSC’s under any conditions. There are alternatives to open flames such as small electrical incinerators, use of disposables, and proper aseptic technique. NuAire (BSC manufacturer): NuAire doesn’t recommend the use of natural gas within the BSC and assumes no liability for its use. USE AT YOUR OWN RISK. The Bunsen burner flame within the BSC not only contributes

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to heat build-up; it also disrupts the laminar air stream, which must be maintained for maximum efficiency. If the procedure demands use of a flame, a Bunsen burner with on demand ignition is strongly recommended. Do not use constant flame gas burners. During use, the Bunsen burner should be placed to the rear of the workspace where the resulting air turbulence will have a minimal effect. 4.9.9 Policy for gas and flame in BSC’s: The University of Massachusetts at Amherst concurs with the national and international agencies mentioned above, and does not support natural gas being plumbed to biological safety cabinets unless the cabinet is fitted with 100% exhaust air. BSC’s that currently do not meet the 100% exhaust requirement, and are fitted for natural gas use, are discouraged from continuing to use natural gas and are encouraged to switch to safer alternative methods. However, should a situation arise where an investigator feels that natural gas is a necessity for their process the investigator may contact EH&S for a risk assessment and possible approval for future use. 4.9.10 Alternatives to Gas Use and Alcohol Burners:

a. Touch-plate burners that require a hand or foot switch for the flame to be engaged and gas cartridges vs. gas lines

b. Electrical incinerators c. Glass bead sterilizers d. Electric Bunsen burners e. Mini propane torches f. Use sterile disposable plastic ware instead of glassware that must be flamed g. Rely upon good chemical disinfection (such as bleach) to clean equipment and surfaces h. Appendix A lists some suggestions for equipment above

5.0 Protection of Vacuum Systems Used in Tissue Culture Work When laboratory vacuum is used to manipulate biohazardous materials, a suitable trap should be employed to insure that building vacuum lines do not become contaminated. When house vacuum is used, the system should include in-line HEPA filter as near as practical to each point of use or service cock. An approved reservoir and filtration apparatus for vacuum systems is described below: Vacuum filtration or aspirating supernatants into collection flasks are common laboratory procedures. During vacuum filtration or aspiration procedures building and/or laboratory vacuum systems should be protected. A simple bench-top aerosol/fluid trap can protect building/laboratory vacuum systems. The basic vacuum trap consists of a disposable cartridge-type filter or equivalent installed in-line with a collection/overflow vacuum flask system. The aerosol/fluid trap consists of two vacuum flasks, preferably plastic, (size dependent on amount of fluid that may accidentally be aspirated out of the collection flask), thick walled plastic tubing (to prevent tubing collapse), rubber stoppers, a filter (prevents unwanted potentially biohazardous fluid and aerosols from entering vacuum systems), and a ceramic sparger (ceramic fish tank bubbler) immersed in disinfectant. The sparger disperses aerosols passing out of the collection flask into small bubbles so that adequate contact is made with a disinfectant solution. Use an appropriate disinfectant solution shown to be effective on the biohazardous material under study. When the filter or overflow flask require routine changing, they can be safely removed by clamping the line between the filter and the vacuum source before disconnecting the tubing from the source. The filter and vacuum flask should be decontaminated by autoclaving if they have been in contact with potentially biohazardous material. This is one method to protect a house vacuum system during aspiration of infectious fluids. The left suction flask (A) is used to collect the contaminated fluids into a suitable decontamination solution; the right flask serves as a fluid overflow collection vessel. A glass splarger in flask B minimizes splatter. An in-line HEPA filter (C) is used to protect the vacuum system (D) from aerosolized microorganisms. See diagram:

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CDC: Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets 2nd ed.

Suggested Product: Whatman HEPA-Vent Filter Assure sterile air for mixing, filling, storing, fermenting and transporting with this Whatman filter. Glass fiber filter is treated to be mildly hydrophobic; repels moisture, prevents bacterial growth; 0.3 μm particle retention unaffected by autoclaving. Bidirectional flow. 16 cm2 filter area.

Inlet/Outlet Whatman # Fisher Cat. # Pack of 10 1/4-3/8” tapered hose barb 6723-5000 09-744-79 $96.48 (Jan 2010) 5.1 Use of UV Light in a Biosafety Cabinet We recommend that biosafety cabinets be disinfected with the appropriate disinfectant (i.e., 10% bleach or 70% ethanol), instead of using a UV light. Ultraviolet (UV) lamps in Biological Safety Cabinets (BSCs) are intended to destroy microorganisms in the air or on exposed surfaces. However, relying on UV lamps may give personnel working in BSCs a false sense of security.

The UV lamps attract dust and debris and thus reduce the transmission of the germicidal effect. UV lights have limited penetrating power and are only effective when the lamps are properly cleaned, maintained, and checked to ensure that the appropriate intensity is being emitted. If UV lights are used, they must be tested yearly to ensure that the appropriate wavelength for decontamination is emitted (254nm). NSF, the certifying agency for BSC’s stopped requiring the testing of UV lights in 2003 as they do not consider them an effective decontamination source. If you want your UV light tested, you need to make arrangements with B&V Testing at the time of your cabinet’s certification testing. In addition, many people allow the lamps to surpass their effective life span. When the terminal ends are blackened even slightly, they have lost their effectiveness even though they still glow blue-violet.

If not used properly, UV light can also cause serious eye and skin injury. If UV lamps are used it must be remembered that UV light can be harmful to the eyes and skin and should therefore be turned off when occupying the room. UV light can bounce off the reflective surfaces inside the cabinet and affect people and materials around the outside of the cabinet. 5.2 Biosafety Cabinet Decontamination and Decommissioning BSCs shall be decontaminated before the cabinet is: 1. relocated; 2. repaired; or 3. taken out of service. Decontamination is recommended as a prudent practice (1) after a gross spill of infectious material or (2) before the cabinet activity is changed from work with moderate-risk or high-risk infectious materials to work with noninfectious materials. All biological safety cabinets must be decontaminated prior to disposal. EH&S should be contacted to determine whether B&V Testing needs to be called to do a chemical gas-decontamination of the HEPA filter and cabinet. If this is the case, the BSC will need to be placed in a room with a fume hood so that the gas can be vented out

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through it. The room will also need to be vacant (no personnel access) while the gas decontamination is underway (allow 24 hours). Once the decontamination is complete the cabinet is evaluated by EH&S staff for the presence of hazardous materials (i.e.: mercury, oil, asbestos, etc.). Once the cabinet is cleared for disposal a sticker will be placed on it, it will be removed from inventory, and you may call Building Services for disposal. 5.3 Biological Safety Contact Information Judy LaDuc, Biological Safety Services Manager, Department of Environmental Health & Safety, 117 Draper

Hall, University of Massachusetts/Amherst, (413) 545-7293/Fax: (413)545-2600. B and V Testing, 222 Calvary Street, Waltham, MA 02453 Phone: 800.851.9081 5.4 Key References Institute of Environmental Sciences and Technology, Arlington Place One, 2340 S. Arlington Heights Rd.,

Suite 100, Arlington Heights, IL 60005-4516 Phone (847) 981-0100 University of Ottawa, Biological Safety Cabinets & Laminar Flow Cabinets, EH&S Website, Ottawa, Ontario,

Canada U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and

Prevention and National Institutes of Health. 2nd Edition Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets. Washington: US Government Printing Office, 2000.

University of Maryland, College Park, MD. Environmental Health and Safety Website: Biological Safety Cabinets Manual; http://www.des.umd.edu/biosafety/rest/manual.pdf#page=31

CDC-NIH Guidelines, 2nd Edition of Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets: http://www.cdc.gov/od/ohs/pdffiles/BSC-3.pdf

World Health Organization’s Laboratory Biosafety Manual Public Health Agency of Canada; The Laboratory Biosafety Guidelines: 3rd Edition 2004; Chapter 9,

Biological Safety Cabinets NSF/ANSI Standard 49 – 2009, Biohazard Cabinetry; published by NSF International, P.O. Box 130140, Ann

Arbor, Michigan 48113-0140, USA Stanford University, Environmental Health and Safety; Memo: Use of open flames in Biosafety

Cabinets/Tissue Culture Hoods, May 29, 2003 From: Ellyn Segal, Ph.D., Biosafety Manager NFPA 54, National Fuel Gas Code NFPA 45, Standard on Fire Protection for Laboratories using Chemicals

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Appendix A: Suggested Gas/Flame Alternatives FIREBOY Bunsen burner by Integra Biosciences A mobile Bunsen burner with non-touch sensor ignition. Has flame monitoring, over-temperature and burning time limitation Operates in three modes: - Foot switch: Flame stays as long as the foot switch is pressed - Continuous: Manually switch On/Off - Sensor: The sensor registers your hand movement and ignites the flame automatically Timer: 10 to 60 minutes Bacti-Cinerator IV Sterilizes platinum loops and needles safely and conveniently Prevents infectious spatter and cross contamination The Bacti-Cinerator IV utilizes infrared heat to incinerate organic material deep within the ceramic

funnel. Sterilization takes only 5 to 7 seconds at optimum sterilizing temperature of 1500°F. Unit can be used in anaerobic chambers Glass Bead Sterilizer Ideal for sterilizing surgical instruments. To use, simply insert the cleaned surgical instrument, leave for 5 seconds, and remove. Within 30 seconds, the surgical instruments are cool enough to use. The chassis stays cool, even at the end of a full day of operations. The air above the unit is cool enough to insert an instrument into the well without discomfort. Sterilization of the inserted parts by dry heat (250° C) takes 3-5 seconds. The working end is sterile before the handles get hot. The sterilizer's small size fits conveniently into the back corner of a hood or surgical table. Electric Bunsen burner Combines gas efficiency with precision electric control Radiant heat is concentrated directly at top where required Combines gas efficiency with precision electric control Radiant heat is concentrated directly at top where required Burner concentrates heat at top making it ideal for heating test tubes, crucibles, small flasks and beakers, or for sterilizing inoculating needles for microbiological work. 400-w. element produces temperatures of 800-1000°C. Specially formed, replaceable element is mounted in the top of a cylindrical housing which has

ventilation holes at the bottom for cooling. The unit may be handheld at the base for direct heating. Removable cowl deflects heat away from hand. Corrosion-resistant metal housing. CSA certified. 7-in. high, 4.5-in. diam. at base.

FLAMEBOY Portable flame sterilizer The FLAMEBOY is a handy, portable flame sterilizer with piezo-electric ignition for safe flame sterilization. Compatible to a wide range of common gas cartridges including, Camping Gaz CP250, CV270, CV360 and CV470 or other butane cylinders, the FLAMEBOY is independent of any gas distribution system. The gas cartridge adapters are very easily mounted by means of an intelligent ‘click and go’ mechanism. Features and benefits: - Piezo-electric triggered ignition for immediate use - Pistol grip for convenient holding. - Various gas cartridge adapters for independent and portable use.

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Appendix A: Suggested Gas/Flame Alternatives (continued)

Shandon Mini Hot Plate Used in histology for removing stubborn wrinkles from sections and for reorientating embedded

tissue. Can be used to heat-fix bacterial smears while avoiding cell damage through overheating in

microbiology applications. Manufactured to operate over a fixed temperature range of 70-80° C. Lower casing is made from stainless steel; top is matte-black epoxy-coated aluminum. Dimensions (H x W x D): 2.36” x 5.78” x 5.78” Heated surface area: 5.5” x 5.5”

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Appendix B

Biological Safety Cabinet Registration

Biological safety Cabinet or Laminar Flow Cabinet Mr. Ms. Dr. Status: _____________________ First Name: _____________________________________________ Last Name: ______________________________________________ Faculty/Service: __________________________________________ Department: ______________________________________________ Cabinet Manufacturer: ______________________________________ Cabinet Model Number: ____________________________________ Cabinet Serial Number: _____________________________________ Cabinet Class: ____________________________________________ Cabinet Type: ____________________________________________ UMass Number: UMA______________________________________ Facilities Tracker Number: __________________________________ Telephone Number: _______________________________________ Email: __________________________________________________ Comments/Questions:

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University of Massachusetts/Amherst Accidental Biohazardous Material Spill Procedure

In The Event of a Spill:

1. Alert all persons nearby. 2. If you have spilled a small amount, know that the biological agent is

of minimal hazard, and can clean it up, do so. Label and package according to the biohazardous waste guidelines. Otherwise,

3. Evacuate the area and close the door to the laboratory facility. If

flammables are spilled and your safety is assured, turn off any ignition devices.

4. Contact EH&S at 5-2682 (on weekends, and after 5pm, contact

UMass Police at 911 and state you are at UMass-Amherst Campus) for advice and assistance. Be prepared to provide the identity, amount, and location of the spill, as well as your location and a phone number where you can be reached (not your lab phone, since you should not remain in the lab after the spill).

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Body Fluid Spill Clean-up Procedure

Document Number: EHS.SPILL.06.01 Effective Date: 2/13/2006 Revision Date:

1.0 Purpose and Applicability 1.1. This document spells out proper procedures for clean-up, decontamination and disposal of a

body fluid spill. 1.2. This procedure must be followed by all involved in the clean-up, disinfection and disposal of

a body fluid spill. 2.0 Definitions Body fluids are defined as blood, feces, urine, vomit, saliva, semen, vaginal secretions and any other fluids that originate from a human body. All body fluids can potentially carry infectious agents. 3.0 Roles and Responsibilities 3.1 Supervisors - responsible for ensuring that all personnel involved in a body spill clean-up

are supplied with the appropriate personal protective equipment (PPE) and that it is worn during the clean-up, disinfection and disposal procedure. It is recommended that this procedure be posted or provided to all staff that could potentially be involved in a body fluid spill clean up.

3.2 EH&S – responsible for advising of potential risks and providing PPE and disinfectant

recommendations for incidents involving a large body fluid spill. 3.3 Staff – responsible for wearing appropriate PPE and following procedures for body spill

clean-up, disinfection and disposal. 4.0 Procedures 4.1 Determination of PPE requirements based on size and characterization of spill: Large spill of body fluids such as a raw sewage leak that has a high risk of splash potential: PPE requirements include water proof gloves (rubber, nitrile, etc.), rubber boots, waterproof Tyvek coveralls or suit and mucous membrane protection that includes goggles and a dust mask. Small spill of body fluids such as a small pool of blood that has a risk of splashing: PPE requirements at a minimum include waterproof gloves (rubber, nitrile, etc.) and mucous membrane protection with goggles and dusk mask. Protective clothing such as boots and coveralls may be worn depending on the size and potential for splashing during clean-up. Dried body fluids or a very small spill of body fluids such as dried blood or blood from a mild nose bleed, that have a low risk of splashing: Wearing water-proof gloves (rubber, nitrile, etc.) at

98

a minimum would be required for PPE in this type of spill clean up. Other PPE may be worn depending on the situation. 4.2 Clean up Procedures: Large or small spill with splash potential: first use absorbent material to soak up and contain spill with absorbent powder/ paper towels. Pour disinfectant directly onto material to disinfect. A broad spectrum disinfectant such as a 10% bleach solution poured on and left on the material 10-30 minutes before clean-up is sufficient in most instances to disinfect. Other disinfectants may be used as long as the label lists that it kills a broad spectrum of human infectious agents. After the body fluid material is collected and placed into a trash bag, pour disinfection on the area of spill to complete disinfection and wipe up with paper towels. Dried body fluids or small spill with low splash potential: Use absorbent material to soak up and contain spill with absorbent powder/ paper towels if necessary. Pour a broad spectrum disinfectant such as a 10% bleach solution onto the body spill and leave on for 10-30 minutes before clean-up. Other disinfectants may be used as long as the label lists that it kills a broad spectrum of human infectious agents. It is important to read these labels and be familiar with the directions for use and expiration dates of the disinfectant. After the body fluid material is collected and placed in a trash bag, pour disinfection on the area of spill to complete disinfection and wipe up with paper towels. 4.3 Basic Hygiene & Accidental Exposures ►Employees should wash their hands with soap and warm water immediately after removal of gloves and other protective equipment. ►Disinfect all reusable equipment ►Upon accidental skin contaminations wash the area with copious amounts of soap and water ►If the eyes or mucous membranes are accidentally contaminated flush with copious amounts of water ►Report all accidental exposures to your supervisor 4.4 Disposal Procedures Most body fluids and clean-up materials can be placed into dark garbage bags and thrown into a dumpster. The only exception would be if the body fluid spill was large quantities of blood (i.e. pooled blood). If clean up materials are soaked or dripping with blood, please call EH&S for biohazard bags & boxes to package material for off-site medical waste incineration. 5.0 Key References 5.1 Please contact Judy LaDuc, Biological Safety Services, at EH&S if you have any questions

545-7293 5.2 Physical Plant EH&S Officer 545-6043 5.3 Supervisor

Emergency Eyewash and Drench Shower Program

Document Number: Effective Date: Revision Date: 3-10-2010

1.0 Purpose and Applicability 1.1 The purpose of this program is to ensure that all safety eyewashes and showers supply clean, potable water and are in proper working order. This program describes procedures for emergency use; selection, installation and placement; guidelines for activation, inspection, testing and maintenance of emergency eyewash and shower equipment. This program applies to all emergency eyewash and shower units in university buildings. Annual flow rate testing will be conducted by EH&S personnel or others and monthly sanitation testing may be performed by the workplace personnel. The Occupational Safety and Health Administration (OSHA) regulation that applies to emergency eyewashes and safety showers is applicable to all facilities that require this equipment as a form of first aid. This regulation (29 CFR 1910.151 (c), Medical Services and First Aid) states that: "Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use." This regulation specifies where and when emergency eye wash and shower equipment must be available. These regulations do not specify minimum operating requirements, installation requirements, or maintenance requirements. The American National Standards Institute (ANSI) standard Z358.1-1990 (revised in 2004), "Emergency Eye Wash and Shower Equipment" provides guidance for selecting, installation, operation and maintenance of this equipment to meet OSHA requirements. 1.2 The Emergency Eyewash and Shower Program at the University of Massachusetts at Amherst (UMA) was developed to render guidance on the proper installation, inspection and repair of eyewashes and drench showers. As stated in the campus policy, all reasonable efforts shall be made to meet the requirements specified in the most recent edition of the American National Standard for Emergency Eyewash and Shower Equipment (ANSI, Z358.1) which is the widely accepted guideline for the design, performance, installation, use, and maintenance of emergency eyewashes and showers. 1.3 All new construction and remodeling shall meet the requirements of the UMA Facilities Standards, which may go above the minimum requirements described in this Program document. This document includes information on equipment specifications, location and installation requirements, equipment inspection and testing, and areas where emergency eyewashes and showers are required. 1.4 Architects, building designers, Facilities and Planning staff and Plant Operations staff must all be aware of the policy for floor drains in laboratories.

2.0 Definitions Combination unit – A unit that has any combination of the following equipment: emergency shower, eyewash, eye/face wash or drench hose. Drench hose – A supplemental device consisting of a flexible hose connected to a flushing fluid supply and used to irrigate and flush face and body areas. Areas that require eyewashes can only utilize drench hoses, if a plumbed or self-contained eyewash is also available in that area, or if the drench hose is designed to meet the definition of a plumbed or self-contained eyewash. Emergency shower – A device specifically designed and intended to deliver flushing fluid in sufficient volume to cause that fluid to cascade over the entire body. Flushing fluid – Fluid that is either water or else a sterile buffer solution designed specifically for eyewash and shower units. Personal eyewash – A supplemental device to plumbed or self-contained eyewashes, which can deliver immediate flushing fluid to the eyes or body. Areas that require eyewashes can only use personal eyewashes, if plumbed or self-contained eyewashes are also available in that area. Plumbed eyewash – An eyewash unit permanently connected to an uninterruptible water supply that is capable of delivering a minimum of 0.4 gallons per minute (GPM) for 15 minutes. Remodel – Any large scale alterations to an area that will change the location of walls, doors, counter space or cabinets; or a project that replaces most existing furnishings/fixtures (cabinets, chemical fume hoods, light figures, wiring, plumbing, etc.) with new furnishings/fixtures in one area. Note: the implementation of numerous “small projects” for the same area in order to avoid being labeled as a remodel project may be subject to the requirements of this document as a remodel, based on the judgment of the Associate Director for Campus Code Compliance and Fire Safety. Self-contained eyewash – A stand-alone eyewash device containing flushing fluid that is capable of delivering a minimum of 0.4 GPM for 15 minutes. Emergency eyewashes and showers are not a substitute for the use of personal protective equipment (glasses, goggles, gloves, aprons, etc.). Contact Environmental Health and Safety (EH&S) at: 545-2682, for additional information or assistance in determining areas where emergency eyewashes and showers are required. 3.0 Roles and Responsibilities 3.1 Key Personnel

Department Heads:

1. Ensure that emergency eyewashes and showers are provided for laboratories and other areas as required by this program document.

2. Ensure that emergency eyewashes and showers located in all areas of the unit including laboratories, corridors or common areas are tested and inspected as specified in this program document. This includes weekly testing and inspection of eyewashes and showers.

Principal Investigators/Supervisors:

1. Work with department head to ensure that emergency eyewashes and showers are provided for laboratories and other areas as required by this program document.

2. Ensure that emergency eyewashes and showers installed in their areas are tested and inspected weekly as specified in this program document.

3. Are responsible for reporting problems with drench showers and eye washes to Environmental Health and Safety and Physical Plant, and insure that all eye washes are tested weekly.

4. Ensure that laboratory/unit personnel are familiar with the location and operation of the emergency eyewash and shower equipment.

Facilities and Campus Planning (F&CP):

1. Facilities and Campus Planning will be responsible for the proper installation of drench showers and eye washes.

2. Will assure that new laboratory facilities will NOT incorporate floor drains into their designs with exceptions (autoclaves, RO water, ice machines, animal care) as noted in EH&S Floor Drain Policy.

3. Will assure that future renovations of laboratory space disconnect and plug all applicable inlets to and outlets from (where possible) applicable sanitary sewer lines, leaching structures, oil/water separators, and/or septic systems.

4. Will also assure removal of all existing sludge in traps, oil/water separators, septic systems, and where accessible, leaching structures. Any sludge determined to be a hazardous waste shall be disposed of in accordance with State hazardous waste regulations (310 CMR 30.000). Remedial activity involving any excavation and/or soil or groundwater sampling must be performed in accordance with appropriate Mass DEP policies.

5. Assists campus personnel or units with the selection and installation of emergency eyewashes and showers that meet the requirements of the campus program.

6. Assists in the development and maintenance of the campus program for emergency eyewashes and showers.

Physical Plant (PP):

1. Physical Plant will be responsible for the proper installation and repair of existing drench showers and eye washes.

2. Physical Plant will notify Environmental Health and Safety once repairs are made.

Environmental Health and Safety (EH&S):

1. Assists in the development and maintenance of the campus program for emergency eyewashes and showers.

2. Assists campus personnel or units with the selection of emergency eyewashes and showers that meet the requirements of the campus program.

3. Verifies that emergency eyewashes and showers in a given area meet the requirements of this campus program during EH&S inspections.

4. Evaluates whether a given area qualifies for the emergency shower exception. 5. Environmental Health and Safety will be responsible for the testing of all drench showers and

eye washes on a semi-annual basis, submitting work orders to Physical Plant for drench showers and eye washes that need repair and for following up on all repairs.

Contractors:

1. Notify EH&S one week before the testing of new drench shower and eye wash installations. 2. Have a plumber test the drench shower and eyewash installation with EH&S.

3. Provide a 55-gallon drum with draining capacity, measuring tape, thermometer, and timer to test drench showers.

4. Record the following data for the plumbing inspector:

Acceptable Range: Your Results: Water Pressure >30 PSI but <55 PSI ___________ Water Flow Rate > 20 Gal per Min ___________ Time Water Ran > 15 Minutes ___________ Water Temperature 60-900F ___________

Serial Number of Unit: ______________________________________ Building: _________________________________________________ Room Number: ____________________________________________

4.0 Emergency Procedures 4.1 Eyewashes, Drench Hoses, and Eyewash/Facewash Units Assist the victim to get to the eyewash. Sight may be impaired. Activate the unit using the hands-free valve. Hold the eyelids open with the fingers if necessary. Place the eyes in the stream of water. Flush for 15 minutes. Get medical attention.

4.2 Emergency Showers and Drench Hoses Assist the victim to the shower. Do not let them slip and fall. Activate the unit using the hands-free valve. Put modesty aside. Remove contaminated clothing first if possible. (Rinsing contaminated

clothing will wash chemicals out of the clothing and onto the skin). If this is not possible, remove contaminated clothing during the flushing process.

Flush for 15 minutes. Get medical attention.

4.3 Notes

1. Assist the victim with procedures. Shield them using fire blankets if necessary. Provide alternative clothing (lab coats, hospital scrubs, fire blankets can be used as necessary).

2. The contaminated water from a deluge shower or eyewash is very dilute. Use standard housekeeping precautions when cleaning the area.

3. Drains are not installed under emergency showers intentionally. Sanitary sewer drains from any fixture (floor drains, sinks, etc.) have an S-trap that contains a small amount of water to prevent sewer gas from entering the buildings. Because of the infrequent use of an emergency shower, drains under emergency showers will go dry and allow sewer gas into the building. If one is present, pour some water down the drain at regular intervals.

5.0 Application and Installation

5.1 Emergency Eyewashes - A plumbed or self-contained eyewash shall be provided in all work areas where faculty, staff or students are exposed to a potential hazard of injury to the eye due to contact with a hazardous chemical or biological materials of BSL-2 or greater, and radioactive materials. Such work areas include, but are not limited to:

Laboratories, storerooms and other work areas where chemicals that are corrosive, irritating to mucous membranes, or toxic are stored and/or used including but not limited to: bleach, formaldehyde, phenol, liquids with pH equal to or less than 2 or greater than 12.5, biotoxins and organic solvents;

Laboratories or other areas where work with biological materials that are at BSL 2 or greater is occurring;

Laboratories using radioactive materials;

Pesticide storage or mixing facilities;

Battery repair areas;

Acid neutralization tank storage areas.

5.2 Emergency Showers - An emergency shower shall be provided in all work areas where faculty, staff or students are exposed to a potential hazard of injury to the skin due to contact with a corrosive, severely irritating or toxic chemical. Such work areas include, but are not limited to:

Research laboratories, storerooms and other work areas where corrosive, severely irritating or toxic chemicals are stored and/or used including but not limited to bleach, formaldehyde, phenol, liquids with pH equal to or less than 2 or greater than 12.5, and organic and flammable solvents;

Pesticide storage or mixing facilities;

Laboratories using radioactive materials;

Battery repair areas;

Acid neutralization tank storage areas.

5.3 Exception for existing facilities without an emergency shower. In lieu of installing an emergency shower, a facility can choose to use or install both a drench hose and eyewash unit, or a combination unit of those devices, if all of the following criteria are met:

1. The work area is not being remodeled;

2. All containers of corrosive, severely irritating and toxic chemicals that are stored or used in the work area are one liter or less in size;

3. The work area supervisor provides documentation of the chemical inventory including container sizes for that work area to Environmental Health and Safety to verify that the area qualifies for this exception.

5.4 Combination Units

A combination unit of an emergency shower and eyewash that complies with ANSI Z358.1, Section 7.1, and the UMA Facilities Standards may be used in work areas required to have both devices. A Combination Unit shall meet the following requirements at the time of installation:

1. The equipment must be certified by the manufacturer as meeting the most recent edition of ANSI Z358.1.

2. The equipment shall have a controlled flow of flushing fluid that is provided to both eyes simultaneously (for eyewashes) which is not injurious to the user. Massachusetts Plumbing Inspectors require a fluid pressure of >30 PSI but <55 PSI.

3. Valves on emergency eyewashes and showers shall be designed so that the flushing fluid remains on without requiring the use of the operator’s hands. The valve should be designed to remain activated until intentionally shut off.

4. Emergency eyewash nozzles shall be protected from airborne contamination. Whatever means is used to afford such protection, its removal should not require a separate motion by the operator when activating the unit.

5. The equipment shall be in unobstructed and accessible locations that require no more than 10 seconds for the injured person to reach along an unobstructed pathway from the source of the hazard. If the pathway includes a door, then the door shall have panic hardware for easy egress.

6. The equipment shall be located such that accessing the equipment should not require going up and down stairs or ramps.

7. The equipment location should be identified with a highly visible sign. See Attachment 1.

8. The equipment shall be connected to a system capable of supplying adequate flushing fluid (20 GPM for 15 minutes) to meet the requirements of each component as outlined in ANSI Z358.1.

9. Deliver tepid (60-90oF) flushing fluid. In circumstances where chemical reaction is accelerated by flushing fluid temperature, EHS should be consulted for the optimum temperature for each application

5.5 Installation

5.5.1 Specific Plumbed or Self-Contained Eyewash Requirements:

1. Plumbed eyewashes shall be installed so that they are capable of delivering to the eyes a minimum of 0.4 GPM of flushing fluid for 15 minutes (1.5 liters per minute).

2. Self-contained eyewashes shall be installed with the water nozzles 33-45 inches from the floor and 6 inches minimum from the wall or nearest obstruction. If they are installed mounted on a counter, they should be mounted within 6 inches of the front edge of the lab sink to allow the eyes to be placed in the path of water by simply standing near the unit. There should be minimal reaching, bending, stretching or contorting to reach the eyewash.

3. All plumbed eyewashes shall be plumbed to a waste line as per the latest ANSI Standard: Z358.1 and Massachusetts State Plumbing Code (most recent edition).

4. Eyewashes shall not be installed on a faucet spout.

5. Eyewashes shall be installed to meet ADA accommodations, if needed.

6. Environmental Health and Safety should be contacted whenever an eye wash/drench shower is to be installed to insure proper placement and testing of the unit.

5.5.2 Specific Emergency Shower Requirements:

1. Emergency shower heads shall be installed so that they are capable of delivering a minimum of 20 GPM of flushing fluid for 15 minutes.

2. Emergency shower heads shall be designed so that a flushing fluid column is provided not less than 82 inches and not more than 96 inches in height from the surface on which the user stands.

3. The shower head shall not be mounted flush or recessed with any constructed surfaces or partitions and the center of the spray pattern should be located at least 16 inches from any obstruction.

4. The spray pattern shall have a minimum diameter of 20 inches at 60 inches above the surface on which the user stands.

5. The manual actuator triangle pull shall not be located more than 69 inches above the surface on which the user stands. The manual actuator should be free from obstruction for 18 to 24 inches in most directions.

6. The perimeter of the area (e.g., 3 x 3.5 ft) directly under the shower head shall be demarcated.

7. Emergency showers shall be installed to meet ADA accommodations, if needed. 5.5.3 Activation and Test Procedures It is important to understand that “testing” and “activation or flushing” are different procedures that occur at different intervals. The ANSI standard recommends weekly activations and annual flow testing for both eyewash and safety showers. Because of the difficulty of activating some installations monthly activations are sufficient however more frequent activations are recommended to maintain clean water in the units. Daily activations of some units are easy to perform upon entering the workplace each day. Activations and inspections should be done by laboratory occupants or laboratory safety coordinator. The following procedures are established to facilitate testing of all campus emergency eyewashes and drench showers as required by Massachusetts Fire Prevention Regulations.

1. Emergency eyewashes should be activated weekly for a period long enough to verify operation and ensure that flushing fluid is available. This helps clean out any rust, scale deposits, or bacteria that may accumulate. At a minimum, the weekly inspections should include the following:

a. Ensure that access to the eyewash is unobstructed.

b. Visually inspect the eyewash to ensure that there are no broken parts or leakage.

c. Verify that protective eyewash covers are properly positioned, clean and intact.

d. Check that the spouts are clean and that the bowl and/or sink drains are free of trash.

e. Check that the flow is effective and continuous.

f. Allow the water to flow for at least 5 minutes or until the water is clear. Water pressure should be >30 PSI but <55 PSI.

g. Check that the unit remains activated without the use of the operator’s hands.

h. Fail the equipment if water pressure is weak or if the water color is a dirty, rusty color. Attach an “Out of Service” tag to the eyewash station.

i. Put in the work order requesting service/repair online at: www.umass.edu/services, or call Physical Plant at: 545-0600.

j. For two-headed eye wash stations place the test gauge on top of the stream of the eye wash. The flushing fluid should cover the areas between the interior and exterior lines when the gauge is lowered not more than 1.5 inches below the fluids peak. Adjust heads as necessary.

k. If the eyewash passes testing, mark the date on and initial the attached tag.

l. Maintain an inspection log for weekly testing. Affix it to the column of the drench shower or somewhere near the equipment. Checklists are available from EH&S (545-2682), or are posted right near the eyewashes.

m. Ensure that problems identified during the testing are resolved.

2. Emergency showers should be activated weekly for a period long enough to verify operation and ensure that flushing fluid is available. This helps clean out any rust, scale deposits, or bacteria that may accumulate. At a minimum, the inspections should include the following:

a. Ensure that access to the shower is unobstructed;

b. Visually inspect the shower to ensure that there are no broken parts, leakage, etc.;

c. Check that the flow is effective and continuous;

d. Check that the unit remains activated without the use of the operator’s hands;

e. Maintain an inspection log for this testing. Tags are available free of charge from EH&S (545-2682);

f. Plumbed shower equipment shall be activated semi-annually for a period long enough to verify operation and ensure that flushing fluid is available. The intent is to ensure that there is a flushing fluid supply at the head of the device and to clear the supply line of any sediment build-up that could prevent fluid from being delivered to the head of the device and minimize microbial contamination due to standing water;

g. Ensure that problems identified during the testing are resolved. Call Physical Plant at: 545-0600, to report a problem testing drench showers and eyewashes (for EH&S testing team and contractors).

5.5.4 Equipment and Supplies

A listing of emergency drench showers is available from the Industrial Hygiene Program at EH&S. The following is a list of equipment and supplies that should be available for the emergency drench showers:

Lab coats and protective eyewear 55 gallon drum/cart with spray curtain 30 gallon plastic drum Small pipe wrench Ladder Pole for shut off valve Portable radio Eye wash gauge Testing record tags

Out of Service cards Flashlight Transport vehicle Emergency shower drip buckets Sponge mop Paper towels

5.5.5 Procedures for Testing Drench Showers and Eyewashes

A testing team will be designated by the Laboratory Safety inspectors and Industrial Hygiene Services staff. All members of the team shall undergo hands-on training by experienced EH&S personnel.

a. Prior to activation of emergency shower, the shut off valve to the shower must be located and turned closed several times, then opened completely to insure that it is working properly. In most cases ladder access will be necessary. Place the 55 gallon drum beneath the drench shower and extend the spray control sleeve over the shower head.

b. While one team member is located at the shut-off valve, the other activates the emergency

shower for 5-10 seconds directing water to the 55 gallon drum. The shut off valve should stay open at least 10 seconds.

c. All person(s) locating shut off valves located in ceiling areas must have undergone asbestos

awareness training. d. The emergency shower should be delivering a continuous stream of at least 20GPM.

e. Mark the drum level for the amount of water for 1 or 2 minutes. f. Take the temperature of the potable water in the drum; it should be between 65-900F. g. If the shower functions well, the “Drench Shower Testing Record Tag” attached to the shower

must be punched or signed by the team indicating the current month/year. h. If there is a problem with the drench shower, and it needs to be placed “Out of Service” attach

the “WARNING DO NOT USE” card and call the Physical Plant Service Desk at: 545-0600 immediately. Ask them for the work request # and note it on the drench shower tag along with the date of the call.

i. “Out of Service” problems would include, but are not limited to: leaks, pipe breaks, showers they

will not shut off, shut off valve not operable. A Service Request can be submitted on–line at: www.umass.edu/services. A work order (WO) will be generated by Physical Plant for the reapair.

j. Note: If the drench shower is not able to be tested at the request of the occupants, it should be

tagged as “Out of Service” and the reason given.

k. Promptly clean up any water that is spilled on the floor as a result of this process.

l. Once full, the 55 gallon drum shall be emptied at the most convenient location such as a custodial floor sink or a floor drain which goes to the sanitary sewer. Note: It is NOT acceptable to dump the drums of water into any storm drains outside of University buildings.

m. Upon completion of an emergency shower test, the corresponding shower on the emergency

showers list shall be checked off as having been completed. n. Data Entry - Use the Drench Showers database in Excel. Select “fcomment/Drench Shower

Testing” then select the appropriate year. Enter the room number, drench shower number, the reason it failed (if applicable), and the date the WO was initiated (if applicable).

o. Once a drench shower is repaired, Physical Plant will notify EH&S for a retest.

5.6 Testing Eyewash Stations

a. Use a bucket to capture the water. Let the water flow for at least 5 minutes. The water pressure should be at least 30 PSI but below 55 PSI.

b. Use the eyewash testing gauge. The flushing fluid should cover both inside and outside line when the gauge is lowered no more than 1.5 inches below the fluid peak.

c. If the water pressure is weak or the color of the water is dirty (rusty), the equipment has “failed.” Note the failure on the checklist. Attach an “Out of Service” tag to the eyewash station. Submit a WO using the same method as drench showers. (See above.)

d. If the eyewash passes the test, note the date and initial the form (See Attachment 3) and affix it to the wall near the equipment. Notify lab personnel to test the eyewash station weekly and mark dates and initials on the list.

e. Enter all data for the eyewash station in the Drench Shower database in Excel. Select “fcomment/Drenchshower testing” then select the appropriate year.

5.7 Purchasing Emergency Shower and Plumbed or Self-Contained Eyewash Equipment In order to initiate the installation of a required emergency eyewash/safety shower unit, the Department Head, Laboratory Supervisor, or Principal Investigator should first contact the Facilities and Campus Planning Office at: 545-1383, to request an estimate for the purchase and installation of emergency eyewashes and showers.

If the laboratory has received approval from EH&S for the use of a counter-mounted drench hose/eyewash station, the Facilities Manager must specify that the estimate request is for this specific device. If the laboratory is required to install an emergency eyewash/safety shower unit, the Facilities Manager must request an estimate for the complete installation including a mixing valve. Once F&CP has provided the estimate, the Department has identified a funding source and provided F&CP with a charge number and proper authorization, the installation can be scheduled. 5.8 Test Failures, Malfunctions, and Deficiencies 5.8.1 Corrective actions must be performed when deficiencies are noted by any personnel at any time. 5.8.2 Malfunctions or deficiencies noted during monthly activations, inspections, or normal daily activities must be reported immediately. Inform the supervisor. They will notify the Physical Plant by initiating a repair work request (Phone: 545-6401 or Fax: 545-0729). On-line request form: http://facil6.facil.umass.edu/custinfo/request.html 5.8.3 If use of the equipment is not possible tag the unit “DO NOT USE”. The supervisor must notify the Physical Plant for repair or replacement. 5.8.4 Annual test failures must be corrected immediately. Malfunctions will be reported to supervisors and EH&S will submit a work order for repair. 5.9 Training 5.9.1 Employees receive training during laboratory and chemical safety training on the proper procedure for eyewash and shower use during an emergency. 5.9.2Training to perform monthly activations and maintain minimum performance requirements for eyewash and shower equipment is provided during annual testing or safety inspections in the lab or workplace. 6.0 Key References American Chemical Society; Safety in Academic Laboratories, Vol. 2. Accident Prevention for Faculty and Administrators. 7th edition. American National Standards Institute (ANSI) Z358.1 (current edition). Emergency Eyewash and Shower Equipment. Center for Disease Control and Prevention/National Institutes of Health. Biosafety in Microbiological and Biomedical Laboratories (current edition). National Research Council. Prudent Practices in the Laboratory. National Academy Press, 1995. Regulations, Consensus Standards and References. Massachusetts State Plumbing Code 248 CMR

1.00-10.00. General Provisions Governing the Conduct of Plumbing and Gas Work Performed in the Commonwealth. Introduction and Massachusetts Modifications.

University of Illinois at Urbana-Champaign: Emergency Eyewashes and Drench Showers Program.

Indiana University, Office of Environmental, Health, and Safety Management: Emergency Eyewash and Safety Showers: Bloomington, IL United States Environmental Protection Agency: EPA Small Business Office: http://www.epa.gov/smallbusiness/help.htm or call (800) 368-5888. EPA Compliance Assistance Center: http://es.epa.gov/oeca/main/compasst/ compcenters.html Massachusetts Department of Environmental Protection:http://www.mass.gov/dep/ Regulations, Massachusetts Board of Fire Prevention: 527 CMR 10.02; Fire Extinguishers: http://www.lawlib.state.ma.us/source/mass/cmr/cmrtext/527CMR10.pdf

Attachment 1

Attachment 2

Attachment 3

EMERGENCY SHOWER & EYE WASH TEST RECORD

INSPECT THIS UNIT CAREFULLY BEFORE SIGNING INSPECTION RECORD

DATE: BY: DATE: BY:

Attachment 4 Eyewash and Drench Shower Equipment

Serum Banking Guidelines

Document Number: EHS.SERBANK.07.01 Effective Date: Revision Date:

1.0 Purpose and Applicability 1.3.Typically, the purpose of serum banking is to give the University the ability to compare serum

obtained after an acute illness or exposure with serum obtained before the illness or exposure began. Serum banking should be conducted only when there is a clear reason for obtaining the specimens and there is a plan to analyze the data as part of a risk assessment strategy. The CDC and NIH (CDC-NIH 1999) recommend serum banking and serological surveillance when a substantial risk of occupational illness is associated with an agent under study and methods are available to measure immunological response to the agent. All biohazardous research conducted at or sponsored by the University of Massachusetts is conducted in accordance with NIH/CDC Guidelines in Biosafety in Microbiological and Biomedical Laboratories “BMBL”.

1.4.Many important issues would need to be implemented in advance of instituting a serum banking

program, including chain of custody, confidentiality, identification and handling of samples, retention, potential deterioration of sample quality over time, and cost. The program should include informed consent of employees and should allow them to decline to participate.

2.0 Definitions 2.1 Serum banking is the collection and frozen storage of serum samples obtained from employees who

may be at risk for occupationally acquired infection. 3.0 Roles and Responsibilities 3.4 Key Personnel – The Occupational Health Committee is the principal campus committee charged

with advising on matters that relate to the exposure to biological hazards at the University of Massachusetts.

4.0 Procedure 4.1 The Occupational Safety Committee has recommended that serum banking is not necessary at this

time. 4.2 The Occupational Health Committee may institute programs and procedures, such as requirements

for limiting access, collection and storage of serum samples, immunization, screening tests, medical surveillance, and post-exposure counseling and prophylaxis.

4.3 The Biosafety Officer provides consultation and training at the individual lab and department level regarding the safe use of biologically hazardous agents and appropriate action to take upon exposure.

4.4 The Occupational Health Committee reviews reports related to its area of concern to

determine appropriate action. 5.0 Key References 5.1 Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, Centers for

Disease Control, Atlanta, Georgia; 2006

University of Massachusetts/Amherst Laboratory Occupational Health Program

For Human Source Material (Exposure Control Plan)

PURPOSE

The U.S. Occupational Safety and Health Administration’s (OSHA) final standard for occupational exposure to bloodborne infectious diseases (aka, the Bloodborne Pathogens Standard) became effective July 15, 1993. It was designed to eliminate or minimize occupational exposure to Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), and other bloodborne pathogens.

The Bloodborne Pathogens Standard requires employers to implement a combination of engineering and work practice controls, personal protective clothing and equipment, informational training, Hepatitis B vaccination, post exposure evaluation and follow-up, sign and label programs, and other provisions for employees who may be reasonably anticipated to come into contact with blood or other potentially infectious materials (OPIM) during the performance of their job duties.

Human Blood And Body Fluids Working safely with human blood and certain/body fluids requires that Universal Precautions be followed. Laboratory personnel should assume that all human blood, body fluid, and tissues are infectious. The Centers for Disease Control and National Institutes for Health recommend that Biosafety Level 2 (BSL 2) standards, containment, and facilities be used for activities involving clinical specimens, body fluids and tissues from humans or from laboratory animals infected or inoculated with human material (see Biosafety in Microbiological and Biomedical Laboratories 5th Ed., U.S. Dept. of Health and Human Services). These standards should also be applied to work with human cells in culture, human serum-derived reagents which may be used as controls, and any blood obtained from the Red Cross. PERSONS INCLUDED IN THE PLAN AND UNIVERSITY RESPONSIBILITIES

1. Any UMass laboratory staff person, who, by the nature of their job required tasks, has occupational exposure to blood or other potentially infectious materials shall be included in this plan.

2. All newly hired employees covered by this regulation and employees who through transfer or change of job description become covered by this standard shall also be reported to EH&S for inclusion under the plan.

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3. All required training, personal protective equipment; engineering controls, record keeping, other supplies and testing necessary for compliance with the standard shall be supplied at no cost to the employee.

4. All covered employees shall be offered immunization against Hepatitis B Virus (HBV) and/or any other job appropriate immunizations.

DEFINITIONS

1. Occupational Exposure means reasonably anticipated skin, eye, mucous membrane or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties.

2. Blood means human blood, human blood components and products made from human blood.

3. Other Potentially Infectious Materials (OPIM) means: The following human body fluids: semen, vaginal secretions, cerebrospinal fluid,

synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids,

Any unfixed tissue or organ (other than intact skin) from a human (living or dead), and

HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.

4. Parenteral means piercing mucous membranes or the skin barrier through such events as needle sticks, human bites, cuts, and abrasions.

5. Bloodborne Pathogens means pathogenic microorganisms that are or may be present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV), Hepatitis C virus (HCV), and human immunodeficiency virus (HIV).

6. Engineering Controls means controls that isolates or removes the bloodborne pathogens hazard from the workplace (e.g., sharps disposal containers and self-sheathing needles).

7. Personal Protective Equipment is specialized clothing or equipment worn by an employee for protection against a hazard (e.g., gloves face protection, respirators, gowns, etc.). General work clothes (uniforms) not intended to function as protection against a hazard are not considered to be personal protective equipment. Other definitions may be found in the text of the regulation.

EXPOSURE CONTROL

Employees incur risk each time they are exposed to blood or OPIM. Any exposure incident may result in infection and subsequent illness; therefore exposures must be prevented whenever possible. The goal of the OSHA Bloodborne Pathogen Standard is to reduce the significant risk of infection by:

Eliminating or limiting occupational exposure to blood and OPIM Providing the hepatitis B vaccine Providing post exposure medical evaluation and follow-up

All employees who hold positions that have been determined to have occupational exposure are entitled to the protection afforded by the Standard.

EXPOSURE CONTROL PLAN

The Exposure Control Plan (ECP) is the key provision of the OSHA Bloodborne Pathogen Standard and of the University of Massachusetts/Amherst Laboratory Occupational Health Program for human source material. The Plan identifies individuals who are potentially exposed to human blood or OPIM and requires that they be provided with appropriate training and protective clothing and equipment, and that they also be offered the Hepatitis B vaccination.

Based on the requirements established by the Standard, the ECP has been developed and designed to minimize the risk of employee occupational exposure to bloodborne pathogens during the performance of their duties.

The following elements are contained in the Plan:

1. Exposure determination 2. Universal Precautions 3. Engineering and work practice controls 4. Personal protective equipment 5. Housekeeping 6. Regulated Medical Waste 7. Laundry 8. Hepatitis B vaccination of declination form; post-exposure evaluation and follow up 9. Communication of hazards to employees 10. Summary of training program 11. Recordkeeping

The ECP will be reviewed and updated annually and as when necessary.

Each department in which there is a potential for occupational exposure shall develop and implement task-specific standard operating procedures (SOPs) that address each of the following areas:

1. Employee recognition of reasonably anticipated exposure to blood and OPIM 2. Appropriate selection, use, maintenance, and disposal of PPE 3. Contingency plans for foreseeable circumstances that require deviating from recommended

SOPs.

Exposure Determination A review of employee positions has been conducted to determine which employees have occupational exposure to blood or other potentially infectious materials during the performance of their duties. Job classifications were divided into two categories:

Category A: Consists of occupations that involve exposure or reasonably anticipated exposure to blood or OPIM.

Category B: Consists of occupations that do not require tasks that involve exposure to blood or OPIM on a routine or non-routine basis as a condition of employment.

Category A Job Classifications: (not all inclusive)

1. Students working in laboratories 2. Environmental Health and Safety personnel 3. Lab Animal Technicians 4. Laboratory Managers 5. Facilities Maintenance 6. Public Safety Officers 7. Research Associates 8. Research Assistants 9. Research Scientists 10. Research Specialists 11. Research Technicians

Universal Precautions

Universal Precautions will be observed by all employees to prevent contact with blood and OPIM, which includes:

1. Human body fluids such as blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids.

2. Any unfixed tissue or organ (other than intact skin) from a human (living or dead). 3. HIV-containing cell or tissue cultures, organ cultures, and HIV or HBV-containing culture

medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.

The underlying concept of Universal Precautions is that all blood and certain body fluids are considered to be infectious for bloodborne pathogens. Employees must treat all blood and potentially infectious materials as though they are known to be infected. This can be accomplished through a variety of measures including, but not necessarily limited to:

Engineering controls Work practice controls Personal protective equipment Housekeeping

The only exception to the use of Universal Precautions is in unexpected, extraordinary circumstances involving the provision of health care or public safety services. An example of this would be a medical emergency where an employee is unable to put on gloves, don a gown, or tie on a surgical mask or respirator immediately. This does not mean that an employee can decide not to use PPE because he / she consider this use to be impractical. It is an option only in rare situations where the employee decides that such equipment will prevent the proper delivery of health care or public safety services, or it will create a greater hazard to their personal safety if such equipment is used.

Engineering and Work Practice Controls

Engineering and work practice controls are the primary means of reducing employee exposure in the workplace, by either removing the hazard or isolating the worker from the hazard.

1. Engineering controls eliminate or reduce employee exposure by acting on the source of the hazard, and not relying on the employee to take self protective action. Engineering controls may include process or equipment redesign (e.g. use of self-sheathing needles), process or equipment enclosure, (e.g. biosafety cabinets), and employee isolation.

2. Work practice controls reduce the likelihood of exposure by altering the manner in which a task is performed. The protection they provide is based more upon the behavior of the employer and employee. Engineering and work practice controls should be used together to ensure maximum protection for employees.

Where the risk of occupational exposure still remains after the implementation of engineering and work practice controls, departments must provide and assure that employees use PPE to further protect themselves.

Listed below are engineering and work practice controls that should be in place in all UMass facilities where there is a potential for BBP exposure:

1. Hand Washing Facilities

In all facilities where employees are reasonably anticipated to come into contact with blood or OPIM, hand washing facilities must be readily accessible. Where hand-washing facilities are not feasible, departments will provide other means (antiseptic hand cleanser with clean cloth/paper towels or antiseptic towelettes) by which employees can clean their hands. When these other methods are used, employees will be instructed to wash their hands as soon as feasible with soap and warm running water. Employees are required to wash their hands or any other skin with soap and water, or flush mucous membranes with water immediately or as soon as feasible following exposure of those body areas to blood or OPIM. Employees are also required to wash their hands immediately or as soon as feasible after removal of gloves or other PPE. Reusable personal protective equipment, if contaminated, shall be decontaminated and inspected prior to reuse.

2. Sharps Use a. Consideration should be given to reduce or eliminate occupational exposure to needles.

b. Contaminated needles and other contaminated sharps should not be bent, recapped, or removed unless it can be demonstrated by the department that no alternative is feasible or that such action is required by a specific medical procedure. Under these circumstances, recapping or needle removal shall be accomplished through the use of a mechanical device or one-handed technique.

c. Broken glassware which may be contaminated with human body fluids shall not be picked up directly with the hands. It shall be handled using mechanical means, such as a brush and dustpan, tongs or forceps. The contaminated broken glassware shall be placed in a puncture resistant container and disposed as medical waste. Decontamination of the broken glassware by autoclave or chemical means may be necessary to protect subsequent handlers of the waste.

d. Immediately or as soon as feasible after use, contaminated sharps shall be placed in appropriate containers. These containers shall be:

* Puncture resistant

* Appropriately labeled or color-coded * Leak proof on the sides and bottom * Not handled in a manner that requires employees to reach by hand into the sharps

containers

3. Other Procedures

Eating, smoking, drinking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is reasonable likelihood of occupational exposure to blood or OPIM. Food and drink will not be stored in refrigerators, freezers, shelves, cabinets, or on cabinet tops or bench tops where blood or OPIM are present.

All procedures involving blood or OPIM shall be performed in a manner to minimize splashing, spraying, spattering, and generation of aerosols of these substances. Mouth pipetting / suctioning of blood or other potentially infectious materials is strictly prohibited.

Specimens of blood or OPIM shall be placed in a container, which prevents leakage during collection, handling, processing, storage, transport or shipping. The container for storage, transport, or shipping shall be labeled or appropriately color coded and closed prior to being stored, transported or shipped. When Standard / Universal Precautions are utilized in the handling of specimens, the labeling / color coding of specimens is not necessary provided that containers are recognizable as containing specimens. This exception only applies while such specimens / containers remain within the facility. Appropriate labeling/color coding is required when such specimens / containers leave the facility.

If the outside of the container becomes contaminated, the primary container will be placed inside a second container which prevents leakage during handling, processing, storage, transport, or shipping and will be appropriately labeled or color-coded. If the specimen could puncture the primary container, it will be placed inside a secondary container that is also puncture resistant.

Equipment that may become contaminated with blood or OPIM will be decontaminated prior to servicing or shipping, unless it can be demonstrated that decontamination of the equipment or portions of the equipment is not feasible. In this event, the equipment will be appropriately labeled in a readily observable area stating what area on the equipment is still contaminated. The department is responsible for ensuring that this information is conveyed to all affected employees, the servicing representative, and / or the manufacturer as appropriate, before handling, servicing, or shipping, so that appropriate precautions will be taken.

Personal Protective Equipment

Where there is occupational exposure, each department will provide, at no cost to the employee, appropriate PPE such as, but not limited to, gloves, gowns, laboratory coats, face shields, surgical masks, respirators, or other appropriate devices. Respirators are required in certain settings but all potential users must first be evaluated by the University Health Services Department. Use of respirators requires a Respiratory Protection Program and evaluation for the fit of the respirator and a medical evaluation of the individual wearing the respirator.

1. Respirators cannot be worn by lab personnel without following the above guidelines. PPE should not permit blood or OPIM to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth or other mucous membranes under normal conditions of use, and for the duration of time in which the protective equipment will be used.

2. Each user department will ensure that appropriate PPE in the appropriate sizes is readily accessible at the work site or is issued to employees. If an employee is allergic to the gloves provided, hypoallergenic gloves, powderless gloves, or other alternatives will be provided at no cost to the employee.

3. Each user department will ensure that the employee uses appropriate PPE unless it can be demonstrated that, under rare and extraordinary circumstances, it was the employee's judgment that its use would have prevented delivery of health care or public safety services or it would have posed an increased hazard to the safety of the worker or a co-worker.

4. User departments will repair or replace PPE whenever necessary, at no cost to the employee. Departments will also clean, launder, and dispose of PPE at no cost to the employee.

5. PPE will be removed prior to leaving the work area. If a piece of protective clothing is penetrated by blood or other potentially infectious materials, it will be removed immediately or as soon as feasible. As soon as personal protective clothing or equipment is removed, it will be placed in an appropriately designated area or container for storage, washing, decontamination, or disposal.

6. Surgical masks or respirators and eye protection devices, such as goggles or glasses with solid side shields, or chin-length face shields, shall be worn whenever splashes, spray or aerosols of blood or OPIM may be generated and there is a potential for mucous membranes (eyes, nose, mouth) to be exposed to the material.

7. Appropriate protective clothing such as, but not limited to, gowns, aprons, lab coats, or similar outer garments, shall be worn in areas where there is a potential for occupational exposure. The type of clothing selected will depend upon the tasks being carried out and the degree of exposure anticipated. In situations where gross contamination can be reasonably anticipated, (e.g. during necropsies), surgical caps or hoods and shoe covers or boots will be worn.

8. Gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood or OPIM, when performing vascular access procedures, and when handling or touching contaminated items or surfaces.

9. Disposable (single use) gloves such as surgical or examination gloves shall be replaced as soon as practical when contaminated or as soon as feasible if they are torn, punctured, or when their ability to function as an effective barrier is compromised. Disposable gloves shall not be washed or decontaminated for reuse. Heavier utility gloves may be decontaminated for reuse if the integrity of the glove is not compromised. If the gloves are cracked, torn, punctured or deteriorated and can no longer function as an effective barrier, they must be discarded.

Housekeeping

Departments shall ensure that worksites are maintained in a clean and sanitary condition. Each department shall determine and implement an appropriate written schedule for cleaning and a method of decontamination based upon the location within the facility, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in the area.

1. All equipment, environmental surfaces, and working surfaces must be cleaned and decontaminated after contact with blood or OPIM. Contaminated work surfaces shall be decontaminated with an appropriate disinfectant, such as a 1:10 solution of sodium hypochlorite or an approved germicidal cleaner, after completion of procedures, immediately or as soon as feasible when surfaces are overtly contaminated, or after any spill of blood or OPIM, and at the end of the work shift if they have become contaminated since the last cleaning.

2. Protective coverings (e.g. plastic wrap, aluminum foil, or imperviously-backed absorbent paper), used to cover equipment and environmental surfaces, will be removed and replaced as soon as feasible when they become overtly contaminated or at the end of the work shift if they have become contaminated during the shift.

3. All bins, pails, cans, and similar receptacles intended for reuse which have a reasonable likelihood of becoming contaminated with blood or other potentially infectious materials will be inspected and decontaminated on a regularly scheduled basis and cleaned and decontaminated immediately or as soon as feasible upon visible contamination.

4. Broken glassware that may be contaminated must not be picked up directly with the hands. The spill and / or debris will be cleaned up using mechanical means such as a brush and dustpan, tongs, or forceps. Reusable sharps that are contaminated with blood or other potentially infectious materials shall not be stored or processed in a manner that requires employees to reach by hand into the containers where these sharps have been placed.

Regulated Medical Waste

In Massachusetts, potentially-infectious medical and biological waste is regulated by the Department of Public Health under 105 CMR 480.000, Minimum Requirements for the Management of Medical or Biological Waste (State Sanitary Code Chapter VIII). Per this regulation, there are six categories of ‘regulated medical and biological waste’:

1) Human blood, blood products, and other potentially infectious materials as defined by OSHA

2) Human pathological waste

3) Cultures and stocks of infectious agents and associated biological

4) Contaminated animal carcasses, body parts, body fluids, and bedding

5) Sharps

6) Biotechnology byproduct effluents.

Regulated medical waste must be placed in containers that are:

Closable Constructed to contain all contents and prevent leakage of fluids during handling, storage,

transport or shipping Appropriately labeled or color coded Closed prior to removal to prevent spillage or protrusion of contents during handling, storage,

transport, or shipping

If outside contamination of the regulated waste container occurs, it must be placed in a second container that meets the same requirements listed above for the primary container.

The collection of regulated waste for disposal is carried out by a Stericycle or other approved vendor/contractor.

Disposal of regulated waste will be in accordance with applicable federal, state, and local regulations.

Contaminated sharps will be discarded immediately or as soon as feasible in containers that are:

Closable Puncture resistant

Leak proof on sides and bottom Appropriately labeled or color-coded

During use, sharps containers shall be:

Easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonably anticipated to be found.

Maintained in an upright position throughout use Replaced routinely and not be allowed to overfill

When moving containers of contaminated sharps from the area of use, the containers must be:

Closed immediately prior to removal or replacement to prevent spillage or protrusion of contents during handling, storage, transport, or shipping

Placed in a secondary container if leakage is possible. The second container will be: Closable Constructed to contain all contents and prevent leakage during handling, storage, transport or

shipping Appropriately labeled or color-coded

Reusable containers will not be opened, emptied, or cleaned manually or in any manner that would expose employees to the risk of needle stick injuries.

Details about collecting and properly disposing of potentially infectious regulated medical and biological waste at the UMass is presented in Section C, Waste Management, of this Manual.

Laundry

1. Contaminated laundry will be handled as little as possible, with a minimum of agitation. It must be bagged or put into containers at the location where it was used. Prior to removal from the facility, all lab laundry will be appropriately disinfected. Whenever contaminated laundry is wet and may be reasonably expected to soak or leak through a normal container, the laundry will be placed and transported in bags or containers that prevent soak through and / or leakage of fluids to the exterior.

2. User departments will provide laboratorians who may have contact with contaminated laundry with appropriate PPE including gloves and protective clothing.

3. When a department ships contaminated laundry off site to a second facility which does not utilize standard / universal precautions in the handling of all laundry, the department generating the contaminated laundry must place such laundry in bags or containers which are appropriately labeled or color coded. The department shall ensure that all contaminated laundry is cleaned and laundered in such a way that any bloodborne pathogens present are inactivated or destroyed.

Hepatitis B Vaccination Program There is a safe and effective vaccine against Hepatitis B. Three injections are required for full protection. The second injection is given one month after the first, and the third is given five months later. Remember, this vaccination only provides protection against hepatitis B virus.

In over 90 percent of individuals who complete the vaccination series, long term protection against hepatitis B is provided.

All ‘Category A’ employees shall be offered immunization against Hepatitis B Virus (HBV) within at least 10 working days of initial assignment and after the employee has received biosafety training. The

HBV vaccination will be given in accordance with recommendations of the U.S. Public Health Service current at the time the vaccination takes place.

1. The prescreening, hepatitis B vaccinations, post screening and necessary boosters will be administered by the Student Health Service in compliance with current recommendations.

2. Employees who refuse to participate in a prescreening program will not be excluded from the program.

3. Employees who initially decline hepatitis B vaccination but at a later date, while still covered under the standard, decide to accept the vaccination shall be given such in a timely manner.

4. Covered employees who decline to accept hepatitis B vaccination when offered, shall sign the Hepatitis B Notification form. Notification form is given out during Initial Bloodborne Training.

5. If a routine booster dose(s) of hepatitis B vaccine is recommended by the U.S. Public Health Service at a future date, such booster dose(s) shall be made available to all covered employees.

Post-Exposure Evaluation and Follow up

The importance of immediate medical evaluation cannot be over emphasized. The reason for this is because if the initial medical evaluation determines that the risk for BBP exposure is high for HIV or Hepatitis B, post-exposure prophylactic (PEP) treatment should be started immediately to have its maximum protective effect.

1. An exposure incident shall be reported by the employee to the supervisor, manager or dean who shall complete an Incident Report.

2. The exposed worker shall then report to the University Health Service or Cooley Dickinson Hospital for a confidential medical evaluation and follow-up which shall include the following:

3. Exposed employees are encouraged to report illness symptoms consistent with HIV, HBV and HCV infection for the six-month period immediately following exposure.

The medical evaluation and follow-up will include at least the following elements:

1. Documentation of the route(s) of exposure, and the circumstances under which the exposure incident occurred.

2. Identification and documentation of the source individual, unless the employer can establish that identification is infeasible or prohibited by state or local laws.

a. The source individual's blood will be tested as soon as feasible after consent is obtained in order to determine HBV, HCV and HIV infectivity (written consent required for HIV; verbal consent for HBV and HCV is acceptable). If consent is not obtained, the department will establish that legally required consent cannot be obtained. When the source individual's consent is not required by law, the source individual's blood, if available will be tested and the results documented. A source individual who is deemed no awake, aware, or mentally competent to provide informed consent for BBP testing will not be tested, even if blood specimens are available, unless and until in the short term mental competency is regained.

b. When the source individual is already known to be infected with HBV, HIV, or HCV, testing for the source individual's known HBV, HCV or HIV status may not need to be repeated. Confirmation of prior infection and current health status will be requested with the source individual’s permission in the form of a letter or verbal communication from the source individual’s treating doctor, and when indicated, more current laboratory test

results. The reason for securing current health status information is that some source individuals who have been infected remotely with Hepatitis B or C, may have fully recovered and, if so, no longer pose a risk of transmission.

c. Results of the source individual's testing shall be made available to the exposed employee, and the employee shall be informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source individual.

d. Collection and testing of source individual’s blood for HBV, HCV and HIV serological status:

3. The exposed employee's blood will be collected as soon as feasible and tested after consent is obtained.

4. If the employee consents to baseline blood collection, but does not give consent at that time for HIV serologic testing, the sample will be preserved for at least 90 days. If, within 90 days of the exposure incident, the employee elects to have the baseline sample tested, such testing will be done as soon as feasible.

5. Post-exposure prophylaxis, when medically indicated, as recommended by the U.S. Public Health Service as soon as possible after the known exposure, preferably within two hours of the exposure and no longer than 72 hours.

6. Counseling of the exposed worker will cover the topics of symptomotology, risk of disease transmission and behavior modification recommended for at risk individuals.

7. All diagnostic laboratory tests will be conducted by an accredited laboratory at no cost to the employee.

Information Provided to the Healthcare Professional

UMass will provide the healthcare professional evaluating an employee after an exposure incident with the following information:

1. A description of the exposed employee's duties as they relate to the exposure incident. 2. Documentation of the route(s) of exposure and circumstances under which exposure occurred. 3. Results of the source individual's blood testing, if available, or health status with regard to BBP

infection, if known. 4. All medical records relevant to the appropriate treatment of the employee, including vaccination

status. 5. A description of any PPE used or to be used.

Healthcare Professional's Written Opinion

University Health Service healthcare professional’s written opinion shall be made available to the employee within 15 days of the completion of the evaluation. The healthcare professional's written opinion for Hepatitis B vaccination will be limited to whether Hepatitis B vaccination is indicated for an employee and if the employee has received the vaccination. The healthcare professional's written opinion for post-exposure initial evaluation and follow-up will be limited to the following information:

1. That the employee has been informed of the results of the evaluation. 2. That the employee has been told about any medical conditions resulting from exposure to blood

or OPIM which require further evaluation or treatment, and has been educated about what personal precautions to follow in order to prevent potential transmission of infection to others.

3. That the employee has been informed of the recommended use of personal protective clothing or equipment, and temporary or permanent work restrictions, if appropriate.

All other findings or diagnoses will remain confidential and will not be included in the written report.

Communication of Hazards to Employees

Labels and Signs

1. Warning labels shall be affixed to containers and bags of regulated, biological, and medical waste, refrigerators, and freezers containing blood or OPIM, and other containers used to store, transport or ship blood or OPIM.

2. Contaminated equipment scheduled for maintenance or repair will be labeled in accordance with the provisions in this section and the label will also state which portions of the equipment remain contaminated.

3. Labels will be affixed as close as feasible to the container by string, wire, adhesive, or other method that prevents their loss or unintentional removal.

4. The label will be fluorescent orange-red or predominantly so, with lettering and symbols in a contrasting color as follows:

Exemptions to the labeling requirement: * Containers of blood, blood components, or blood products that are labeled as to their contents

and have been released for transfusion or other clinical use do not need to be labeled in accordance with the provisions outlined in this section.

* Individual containers of blood or OPIM that are placed in a labeled container during storage, transport, shipment, or disposal do not need to be labeled in accordance with the provisions outlined in this section.

* Regulated, medical, and biological waste that has been decontaminated does not need to be labeled.

Signs will be posted at the entrance to research laboratories. These signs will be fluorescent orange-red or predominantly so, with lettering and symbols in a contrasting color. Signs will bear the following legend and information:

AUTHORIZED PERSONNEL ONLY Identification of Hazard: P.I. Responsible: Phone number: Special requirements for entering laboratory:

BIOHAZARD

Information and Training

All personnel who work with potentially viable biological materials, including microorganisms, cells or cell lines, tissue cultures, recombinant DNA, organisms or viruses, animal blood, body fluids, or animals, shall receive the available Biosafety Training. Annual Biosafety training is required for all individuals that work with human source material and/or work at biosafety level 2 or higher. Annual training may be accomplished in a classroom training or with EH&S’s OWL (On-line Web-based Learning).

The Biosafety Training covers the following general elements:

Biosafety levels Human source materials / infectious microbes / OSHA Bloodborne Pathogens Standard Routes of Transmission Disinfection Biosafety cabinets Accidental spill and exposure procedures Biological Waste Recombinant DNA and NIH Guidelines Universal Precautions Hepatitis B Vaccination Personnel protective equipment Medical surveillance

Employees working in HIV, HCV or HBV research laboratories will receive specialized initial training by Principal Investigators (PI), in addition to the established Biosafety Training Program. Additional elements of this training program will include:

Provisions to verify that employees demonstrate proficiency in standard microbiological practices and techniques and in the practices and operations specific to the facility before being allowed to work with HIV or HBV.

Provisions to verify that employees have prior experience in the handling of human pathogens or tissue cultures before working with HIV or HBV.

Provisions to provide a training program to employees who have no prior experience in handling human pathogens. Initial work activities shall not include the handling of infectious agents. A progression of work activities shall be assigned as techniques are learned and proficiency is developed. These provisions will ensure that employees participate in work activities involving infectious agents only after proficiency has been demonstrated.

Recordkeeping

Training Records

EH&S will maintain training records. All training records will be provided upon request for examination and copying as appropriate and legal.

Training records will include the following information:

Dates of the training sessions The contents or a summary of the training sessions

The names and qualifications of the persons conducting the training The names and job titles of all persons attending the training sessions

Medical Records

University Health Services will establish and maintain an accurate record for each UMD employee with occupational exposure. The record shall include:

A copy of the employee's Hepatitis B vaccination status including the dates of all the Hepatitis B vaccinations and any medical records relative to the employee's ability to receive vaccination

A copy of all results of examinations, medical testing, and follow-up procedures required The copy of the healthcare professional's written opinion as required A copy of the information provided to the healthcare professional as required

University of Massachusetts/Amherst Laboratory Occupational Health Program

For Pathogenic Agents

The Occupational Health Program is designed to inform individuals who work with animals about potential zoonoses (diseases of animals transmissible to humans), personal hygiene, and other potential hazards associated with animal exposure. This information is directed toward those involved in the care and use of laboratory animals. How to Protect Yourself

Wash your hands. The single most effective preventatives measure that can be taken is thorough, regular hand washing. Wash hands and arms after handling any animal. Never smoke, drink or eat in the animal rooms or before washing your hands.

Wear gloves. When working with animals wear appropriate gloves for the task and wash your hands after removing gloves.

Wear respiratory protection. Dust masks should be worn when there is a risk of aerosol transmission of a zoonotic agent or when there is a medical history of allergies. Fit testing of a respirator can be done at Environmental Health & Safety.

Wear other protective clothing. Lab coats should be available and worn when working with animals. Avoid wearing street clothes while working with animals. Lab coats should be laundered at work.

Seek Medical Attention Promptly. If you are injured on the job, promptly report the accident to your supervisor, even if it seems relatively minor. Minor cuts, abrasions and all bites should be immediately cleansed with antibacterial soap and then protected from exposure to animals. For more serious injuries or if there are any questions, contact Employee Health Services.

Tell your physician you work with animals. Whenever you are ill, even if you're not certain that the illness is work-related, always mention to your physician that you work with animals. Many zoonotic diseases have flu-like symptoms and would not normally be suspected. Your physician needs this information to make an accurate diagnosis. Questions regarding personal human health should be answered by your physician.

Vaccination may be available depending upon the animals you work with and the agents that may be used in the experiments.

Know what you are working with. Your supervisor or PI should tell you the specific hazards you are working with. Know the signs and symptoms of the disease and be aware of any changes in your health status.

University of Massachusetts/Amherst Occupational Health Program for Handling Non-Human Primates

There are some potential occupational hazards associated with the use of non-human primates and there is a need to take precautions to minimize the potential for animal-to-human zoonotic disease. Also of concern is possible disease transmission from human to animal. Gloves, masks and a laboratory coat (or other dedicated protective clothing such as arm protection and/or a scrub suit) should be worn when working with non-human primates. In some cases protective eye wear is also indicated. Do not eat, drink, or apply cosmetics while working in an animal use area, and always wash your hands after handling primates. Remember that unfixed tissues, blood, serum, urine, and other materials derived from primates may also pose a risk. Bedding and fur may exacerbate allergies. Contact Barbara Miller at 545-0668 with any concerns or questions you have about working with non-human primates or any vertebrate animal and occupational risks. Help with training personnel in specific work practices to minimize risk is also obtained by contacting Barbara. Non-human primates raised in “clean” facilities are relatively free of zoonotic diseases unless they have been experimentally or accidentally infected with a human pathogen. A broad variety of non-human primate diseases are transmissible to humans. Tuberculosis can be transmitted from primates to humans and vice versa. TB testing is performed regularly in primate colonies and in personnel working with these species. Humans and other primates share a broad range of gastrointestinal microorganisms and parasites. These include Campylobacter, Shigella, Salmonella, Giardia, or Trichuris which are commonly spread via the fecal/oral route. Rhesus and other macaques can carry Herpes B and the carriers may be asymptomatic. Bites and scratches involving non-human primates or injuries from objects contaminated with body fluids from non-human primates require immediate first aid and medical attention. If you feel sick or are injured and concerned it might be related you your work with primates, notify your supervisor! During the hours of 9:00 to 5:00 pm Monday through Friday you can call, or go to, University Health Services (413) 577-5000. For immediate life threatening injuries dial 911 or go to the nearest Emergency facility (e.g., Cooley Dickinson Hospital, phone (413) 582-2000). University Health Services is not an emergency facility.

University of Massachusetts/Amherst Animal Handler Occupational Health Program

Federal r egulations req uire tha t in stitutions where ver tebrate anim als are used in resear ch projec ts develop an Occupational Health and Safety Program (OHSP) for personnel working with research animals. The Guide for the Care and Use of Laboratory Animals (National Academy of Sciences, 1996) further defines the requirements for the establishment of an Occupational Health and Safety Program as part of the anim al care and use program at research institutions. At the University of Massachusetts Amherst this progr am follows th e r ecommendations se t by the National Comm ittee on Occupa tional Health and Safety in Research Anim al F acilities and summ arized in their publication Occupational Health and Safety in the Care and Use of Research Animals (NAS, 1997). The OHSP at UMass Amherst is base d on hazards identified in the wo rkplace, assessment of the risk associated with those hazards, an d elimination or m anagement of those assess ed risks. The OHSP is under the supervision of the Ins titutional Animal Care and Use Comm ittee (IACUC) and is coordinated by the Director of Anim al Care and the Attending Ve terinarian in conjunction with the Director of Environmental Health and Safety ( EHS), and the Bio logical/Chemical Saf ety an d Radiation Saf ety Officers in EHS. Operational and day-to-day res ponsibility for safety in the workplace, however, resides with the laboratory or facility supervisor (e.g. PI, facility director or veterinarian) and depends on performance of safe work practices of all employees. At the time the IACUC reviews an anim al use protocol the committee assigns a level of risk, identif ies the hazards of concern, and inform s the appropriate Safety Officer of th e hazards. It is im portant that researchers and the ir collaborators on the protocol identify their m anner of animal contact so th at their risks can be identified and they can be properly info rmed. For projects that pose a m oderate or high level of risk the Director of Ani mal Care m ay contact affected personnel with inform ation about their risks and recommend a ppropriate tests and medical procedures. All researchers and all animal handlers exposed to moderate or high risk ar e asked to fill out an Annual Health History Review to be submitted to the Director of Animal Care for evaluation. Routine testing base d on risk exposure is not usually performed but m ay oc cur when workers exposed to a specific ha zard repo rt s ymptoms. In these situations, if Workers Compensation is to b e claimed to cover the cost of these procedures an Accident Report Form must be filed for the employee to be eligible for Workers Compensation. Definitions : Animal contact is any contact with animals based on hazard identification and relative risk assessment. Animal contact may be direct or indi rect. Indirect contact is contact with animal products or item s that have been in contact with anim als. Animal products include: unpreserved tissues, blood, excreta, body fluids or discharges, hair, dander etc. Items that could be contaminated include sharps, pens and cages, bedding, clothing, gloves etc.

http://www.nap.edu/openbook.php?record_id=5140

http://books.nap.edu/openbook.php?isbn=0309052998

http://www.ehs.umass.edu/

http://www.umass.edu/research/iacuc

Health Hazard is any thing tha t ha s been s cientifically p roven to hav e an adv erse health effect in a person. Hazards associated with anim al use are identi fied by the nature of the procedure, the sp ecies of animal, the origin o r source of the anim al, the locat ion where the animal(s ) are ho used or used, or the existence of known zoonotic diseas es. Hazards are identified through protocol review, facility walk-throughs, animal disease and surveillance, review of personnel medical histories, during physical exams or through the evaluation of accident reports. Hazar ds can be che mical (e.g. disinfectants, bleach, formalin), physical agents (inc luding ionizing and non-ioni zing radiation), physical (e.g. bites, kicks, scratches, needle sticks, dust, noise , heavy lifting), or biological (z oonotic agents e.g. those that cause rabies, ring worm, TB). Procedu res for th e storag e, h andling and disposal of h azardous biological, chemical and physical agents are contained in the EHS Laboratory Safety Manual. Biohazards are infectious agents that are tran smissible to hum ans and capable of causing disease. Biohazardous agents may be used in animals as part of an experimental project, and thus may pose a risk to personnel working on those projects. Projects using such pathogens are revi ewed by the Institutional Biosafety C ommittee and the Biological Safety Offi cer who advises investig ators on th e m easures needed to minimize the risk to themselves and other workers. Chemical hazards are chemicals or substances for which the National Institute for Occupational Safety and Health (NIOSH) has recomm ended exposure lim its (R ELs) and those with perm issible exposure limits (PELs) as found in the Occupational Safety and Health Adm inistration (OSHA) General Industry Air Contaminants Standard (29 CFR 1910.1000). Projects using such chemical hazards are reviewed by the Chemical Safety Officer who advises investigator s on th e measures needed to minim ize the risk to themselves and other workers. Radiation is energy traveling thro ugh space. Collec tively, energy radiation beyond ultrav iolet is referred to as ionizing radiation. Ionizing radiation can cause dam age, particula rly to liv ing tissue . Projects us ing sources of ionizing radia tion ar e reviewed by the Radiation Safety Committee and the Radiation S afety Officer who advise s investigators on the m easures needed to m inimize the risk to themselves and other workers. Radioisotopes are 'unstable' or 'radioactive' atoms which are changing towards a more stable form (each element exists in th e f orm of atom s with severa l di fferent sized nuclei, called isotopes). Radiation is emitted by radioisotopes. Projects using radioisotopes are reviewed by the Radiation Safety Committee and the Radiation Safety Officer who advises investigators on the measures needed to minimize the risk to themselves and other workers. Allergies and asthma due to animal contact result from e xaggerated reactions of the body's immune system to a nimal proteins, also known as allergens. Sources of these allergens include anim al dander, scales, fur, body wastes, and saliva. Zoonoses are diseases in which the causativ e agents can be transmitted between anim als and hum ans. Most animals used in research pr ojects and their products are free from disease but there are exceptions in which inf ectious agents present in animals may produce d isease in hu mans even when the an imals show no symptoms. A potential risk of infection must be recognized in order to reduce or avoid it.

http://www.ehs.umass.edu/lhs.html

http://www.cdc.gov/niosh/

http://www.osha.gov

http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9992

Risk Management Risk assessment is based on dose response and exposure information once a hazard has been identified. Risk characterization is based on a norm al healthy adult. Risk assessm ent and m anagement of biohazards and chemical hazards are coordinated by the Biological Safety Officer an d Chemical Safety Officer in EHS, the Attend ing Ve terinarian, and the Director of Animal Care . Risk assessm ent considers the natural history of th e health problem , the m ode of disease transm ission, virulence and pathogenicity, and manner of animal contact. Risk assessment and management of hazards from sources of ionizing radiation are coordi nated by the Radiation S afety Co mmittee and the Radia tion Saf ety Officer. Estimated risk leve l is f or a norm al healthy ad ult. Risk levels can be divide d into four categories: negligible, low, m oderate and high. Risk charact erization is based on the sever ity of the health condition and on the probability th at an advers e health effect will occur in a giv en situation. Risks associated with the experimental use of animals must be reduced to acceptable levels. Risk management for researchers is based on the IAC UC's assessm ent of the leve l of risk af ter consulting with the appropriate Safety Officer. 1. Negligible risk hazard: no action taken. Personnel are informed of the OHSP and are advised that all accidents are to be reported and may require a visit to UHS depending on the severity of the accident. 2. Low risk hazard: personnel at this risk level are prov ided inform ational handouts regarding the specific low risk hazard. 3. Moderate and high risk hazards: the n ames of person nel in thes e catego ries are en tered into a database together with the haza rds they are exposed to. The infor mation is shared w ith the Biological/Chemical Safety Officer and/or the R adiation Safety Officer, the Attending Veterinarian and the Director of Animal Care. Personnel in these risk groups are provided with educational handouts and special training. They are asked to com plete an Annual Health History Revi ew and m ay be pr ovided with specific procedures based on their m edical histories and the partic ular hazards to which they are exposed. Risk management for animal care personnel is organized in a slightly different m anner. Anim al handlers are entered into the database at th e tim e they are hired. A pre-employm ent e valuation including health history is advise d to assess the potential risks for individual employees. The Ani mal Care Director informs the Attend ing Veterinarian and the IACUC when a new person join s the animal care staff so that their risks can be assessed and they can be appropriately trained. The extent and level of particip ation of personnel in th e OHSP is ba sed on the hazards posed, the exposure in tensity, duration, and frequency, an indivi dual's probable susceptibility, a nd on the history of occupational illness and injury in the workplace. For occupational health purposes animal handlers are separated into two groups: basic or high risk exposure. 1. Basic exposure animal handlers include the majority of UMass animal caretakers. They are exposed to no, or a few well-defined, hazards. They require: tetan us shots every ten years, pre-em ployment physical exams, informational handouts specific to their ta sks, a copy of the Gene ral Health Guidelines,

http://www.umass.edu/research/animal-care

information on special procedures to m anage or mon itor exposure to specific hazards, and an annual medical history review. 2. High exposure animal handlers are exposed to num erous hazards. They must receive all the basic information and training plus annu al physical exam inations that m ay include special procedures based on the hazards to which they are exposed. Standard Safe Work Practices and Procedures: It is strongly recomm ended that new e mployees should receive a pre-employm ent medical evaluation and histo ry which is f ree at University Hea lth Services (contact Wende Graves at UHS for an appointment). Health risks associated with wo rking with anim als are m inimized by following safe practices that include:

Pre-employment medical evaluations. Restricting access to the laboratory or animal care facility. Ensuring that tetanus shots are up to date. Providing training in anim al restraint and ha ndling, lab safety, and safe work practices

relating to animal work-related hazards. Posting appropriate safety procedures (e.g. bite and scratch procedures) Providing employees with “good p ractice” General Health Guidelines to m inimize the

likelihood of work-related health problems. Minimizing splashes and aerosols and providing protection from inhalation of aerosols. Isolating sick or infected animals where possible and caring for them last. Decontaminating equipment and work surfaces at least once a day and after spills. Using appropriate waste disposal (see Laboratory Safety Manual). Reviewing employees' medical health history as appropriate. Reporting accidents, illnesses and zoonotic diseases promptly.

Specific Guidelines: Safety Sheets for personnel working with specifi c categories of anim al are available online at http://www.umass.edu/research/occupational-health-and-safety, and hard copies can be obtained fro m the Animal Care Office. General Health, and health i ssues as sociated with working with the follo wing animals are covered:

General Health Non-human primates Wild mammals Birds Reptiles and Amphibians Farm animals, hooved mammals Fish Rabbits Laboratory Rodents Wild Rodents

The online Safety Sheets include links to information about Zoonoses. OH&S Training Training for personnel who work with animals in laboratories and the field.

http://www.umass.edu/research/animal-care

http://www.ehs.umass.edu/lhs.html

All personnel (faculty, staff, and students, graduates and undergradu ates, post-doctorates and visiting scholars) who work wi th anim als are required to take a one-hour classroom Anim al Users Training session. O HS-related topics covered include: what inform ation is included in a protocol; how the IACUC works with the Environm ental Hea lth a nd Saf ety ( EHS) Program on OH&S issue s; how the IACUC assigns an OH&S risk lev el; how the IACU C ove rsees projects; and contact inform ation for questions, advice, and reporting probl ems. Training participants ar e provided with General Health Guidelines and Safety Sheets specific to the animals they will be working with (see Specific Guidelines) and are told how to access the Safety Sheets on the web. There are online training modules that faculty, staff, students, post-doctorates and visiting scholars are required to take before they perform surgery or conduct wildlife studies. All personnel who wor k with anim als in laboratories or in the field are requi red to take the IA CUC's annual online refresher training for animal users. Additional training for personnel who work with animals in laboratories Laboratory and Fire Safety Training is required before initial assignment to a laboratory. This training is offered year round by instructors in Environm ental Health and Safety (EHS) Program . New e mployees attend a tw o-hour seminar or ENVH569, Laboratory Heal th and Safety Se minar, a one-credit course, offered in the fall semester. The two-hour seminar includes one hour of Laboratory Safety Training, one half hour of Hazardous Waste and one half hour of Fire Safety Training. Laboratory Safety Training includes:

The UMass Laboratory Health and Safety Plan The Massachusetts Right to Know Law, and how to read MSDSs Basic toxicology including routes of entry and occupational exposure limits (PELs, TLVs) Physical and health hazards of hazardous chemicals Information on safety equipment and personal protective equipment Location and availability of additional reference materials Proper use of laboratory fume hoods Laboratory inspections Emergency awareness

Hazardous Waste Training includes:

Federal and state Requirements for point of generation collection Management and disposal of hazardous waste

Fire Safety Training includes

Common fire hazards and causes and your role in preventing fires. What to do in case of a fire and what to do if trapped by a fire Fire protection systems How to choose and use the proper fire extinguisher

Annual on-line update training is required by EHS for all personnel wo rking in laboratories and/or animal care facilities.

http://ehs.umass.edu/train.html?UserType=Student&Server=owl-ehs

Training for animal care personnel New animal care em ployees take the EHS training un its described above, as well as the annual online update train ing. In add ition new anim al care em ployees receive the General Health Guid elines and individual instruction f rom the An imal Care Directo r on the u se of appropriate personal protective clothing and equipment before starting to work with animals. Throughout the year the Attending Ve terinarian organizes m onthly l unch tim e sem inars that address topics pertinent to the health and safety of animal care employees. Topics relating to OH&S include:

Ergonomics Zoonoses Hazardous agents

Training for personnel working with biohazardous agents and radioisotopes used with animals All personnel working with biologi cal or chem ical hazardous agents and/or radioisotopes m ust receive specific safety training before starting work with these hazardous m aterials. Personnel who will be working with, or exposed to, biological or chem ical hazards or radiation are iden tified via EHS records, PI repo rting on th e IPF subm itted with a gran t proposal , P I repo rting directly to a Safety Officer, o r through the submission of an animal use protocol for review by the IACUC. Any protocol submitted for IACUC review involving a biohazardous agent, infectious agent, material of non-human primate origin (blood, ti ssues, body fluids), toxic agent, carcinogens, mutagens, controlled substances, radioisotopes and/or irradiation devices, or an imals brought to cam pus from non-conventional sources requires review and approval by the Biological Sa fety Offic er and/or Chem ical Safety Officer (and as n eeded, the Institutional Biosafety Committee), and/or the University Radiatio n Safety Committee before the work can start. EHS Safety Officers ensure that all em ployees who work with hazard ous agents receive app ropriate formal training before joining a project. For new projects the appropriate Safety Officer at EHS contacts the investigator, the m embers of hi s/her research team, and affected animal care workers about specific hazards and safety issues that will b e encountered. The Safety Officers ensure that all personn el that require it receive formal classroom training in Radiation Safety and/or Biological and Chemical Safety. These officers also assist investigato rs in design ing appropriate project-specific safety protocols for the safe handling and disposal of anim als and other m aterials that are co ntaminated with hazard ous or radioactive m aterials. F or ongoing projects the Safety Officers ensu re that new pers onnel joining the research team or the anim al care staff receiv e a ppropriate training b efore they have contac t with hazardous materials.

http://ehs.umass.edu/train.html?UserType=Student&Server=owl-ehs

http://ehs.umass.edu/train.html



C: Waste Management

Autoclave Management Program for Biological Waste Decontamination

Document Number: EHS.AUTOVER.07.01 Effective Date:07/25/07 Revision Date:

1.0 Purpose 1.5. The purpose of the Autoclave Management Program for Biological Waste Decontamination is to

comply with state regulations (105 CMR 480.000) and protect the public health, safety, welfare, and environment. Implementation of this program by all research laboratories within the University of Massachusetts at Amherst will ensure that all biological waste generated in the laboratories will be decontaminated and/or deactivated prior to disposal as solid waste. Examples of biological waste are: Human and animal cell lines

Tissue cultures

Organisms with recombinant DNA

Cultures and stocks of infectious agents and non-infectious microbial agents

Bacteria, viruses, and fungi Blood and blood products

Labware that has come into contact with the aforementioned waste steams (e.g. contaminated plastic pipettes, pipette tips, Petri dishes, centrifuge tubes, Eppendorf tubes, disposable gloves, wipes, etc.)

1.6. For this protocol, decontamination is defined as a minimum of a 4 log10 reduction in infective

organisms, not sterilization. Sharps waste is not covered under this program because they are handled as medical waste and are shipped off-site for incineration.

2.0 Program Description 2.1 The Autoclave Management Program for Biological Waste Decontamination depends on four core

components: appropriate use of the autoclave to decontaminate biological waste record keeping performance verification annual calibration and maintenance

2.2 Individuals shall be designated within each department to ensure these components are met and the corresponding documentation is recorded. Proper documentation of this program is both essential and mandatory, and will be maintained by all users of the autoclaves. This documentation will be monitored by the Biological Safety Program.

2.3 Biological waste for decontamination and disposal should be stored in covered, leak-proof

containers lined with autoclavable RED biological hazard bags that meet OSHA and ASTM standards. Once this waste has been decontaminated, an adhesive label with “NON-INFECTIOUS

AUTOCLAVED BIOLOGICAL WASTE” with a notation of the building on the label is placed on them, and the waste is then placed in black bags for disposal in the landfill. Autoclave bag ordering information for Fisher Scientific: Bag Size Catalog # # in Box 8 x 12 in. (20 x 30cm) 01-828A Pack of 200 14 x 19 in. (36 x 48cm) 01-828B Pack of 200 19 x 23 in. (48 x 58cm) 01-828C Pack of 200 25 x 35 in. (64 x 89cm) 01-828D Pack of 200 37 x 48 in. (94 x 122cm) 01-828E Pack of 100

2.4 The requirements of 105 CMR 480.000 shall not apply to biological waste that is contained in a

mixture which, due to the presence of other materials, should not be autoclaved. These mixtures may include but are not limited to amalgam (mercury), lead foil, adjuvants and chemotherapeutics and are regulated by either hazardous or radioactive waste laws or regulations. Ethidium bromide gels are an example of biological waste that is NOT autoclaved as it has its own waste stream. Complete a hazardous waste pick-up request which can be found on the EH&S website at: http://www.umass.cems.sr.unh.edu/CEMS/RequestRemoval

2.5 All biological waste, except sharps, shall be contained in a primary container which is a strong red

plastic bag that is impervious to moisture and has sufficient strength to resist ripping, tearing, or bursting under normal conditions of use and handling. Sharps are placed in rigid, red plastic containers and are disposed of as medical waste and shipped offsite to a treatment facility for disposal. Complete a hazardous waste pick-up request for sharps pick up which can be found on the EH&S website at: http://www.umass.cems.sr.unh.edu/CEMS/RequestRemoval

2.6 Animal carcasses are stored frozen until they are removed for off-site incineration. 3.0 Roles and Responsibilities 3.5 Principal Investigator – Individual responsible for ensuring that autoclave logs are kept and that

autoclaves are properly used, maintained, and validated. 3.6 Biosafety Officer at EH&S – Staff member responsible for advising researchers on autoclave

validation, maintenance, record keeping, and procedures for use. 4.0 Autoclave Use and Training 4.1 Equipment manuals shall be made available to all autoclave users and stored in the departmental

office. In addition, a master copy of the equipment manual will be kept near the autoclave for reference.

4.2 Adherence to Autoclave Management Program will be monitored by the Biosafety program. 4.3 All new Students, Faculty and Staff must be trained according to this program and the use of the

autoclave.

5.0 Logs/Records

An Autoclave Waste Decontamination log (see attached) must be used for each autoclave and will be a crucial tool in ensuring proper use and care of the autoclave. These logs will have secured, consecutively numbered pages and shall be kept on file in the departmental office or by the designated responsible individual for a minimum of three years. These logs will include a description of the equipment, each event relative to a piece of equipment, manufacturer’s instructions, results of monthly verification tests, and contact information for the calibration contractor, as follows:

Name of the equipment, current location, manufacturer’s name, serial number, UMass inventory number, date placed in service, condition when received (e.g. new, used, reconditioned; if known), and name or initials of the person completing the results of monthly verification tests are listed on the log sheet.

A copy of the manufacturer’s instruction, dates and results of calibrations, date of next calibration, each event relative to the piece of equipment to include date, event, any corrective action taken, and name or initials of the person completing the tasks are maintained in a notebook near the autoclave.

6.0 Performance Verification 6.1 Performance of the autoclave must be verified for each run with indicator tape and monthly by a

biological indicator test (Prospores©). The frequency of biological indicator testing will vary with the hazard levels of the waste. These policies are based on the requirements for processing waste as described in Biosafety in Microbiological and Biomedical Laboratories, fifth edition, HHS Publication No. (CDC) 93-8395.

6.2 Each set of conditions (time, temperature, pressure) used to decontaminate biohazardous waste by

each autoclave must be verified monthly using a biological indicator such as Prospores©. Results are recorded on the Autoclave Log sheet, listing the conditions, date, and signature of person performing the test. All autoclaves that issue tapes with instrument operation parameters on them shall have the tapes stored in date order for a minimum of three years.

6.3 Every BSL-3/ABSL-3 autoclave load must conduct a biological indicator test (Prospore©) for

validation and results are recorded on the Autoclave Log sheet. 6.4 Autoclaves that are not used for decontamination of biohazardous materials must be validated

quarterly to ensure proper autoclave performance. 6.5 Autoclaves must be inspected and certified annually by a professional. The following companies

have performed these services on campus:

Getinge Castle, 1777 E. Henrietta Rd., Rochester, NY 14623-3133, 1-800-950-9912 Ranger Engineering, P.O. Box 3111, Framingham, MA 01705, (508) 877-3166

7.0 Procedures for Use 7.1 Autoclave Validation / Spore Testing Procedures:

Exposure:

Prospore© Procedure:

To test autoclave performance with a biological indicator place a Prospore© ampoule in the most difficult location to sterilize, usually near the drain, between animal cages or suspended in a volume of liquid. Use as many ampoules as needed to get an accurate measurement of steam penetration throughout the load.

After the autoclave run place the processed ampoule in a vertical position in an incubator at 50-

60 C for 48 hours. Mark a control ampoule from the same package and incubate it along with the autoclaved ampoule to ensure spore viability. Leave the ampoules at 50-60C for 48 hours.

Interpretation:

Control ampoule should exhibit a color change to or toward yellow. If the control ampoule does not exhibit growth via a color change the test is considered invalid because the spores are not considered to be viable.

Autoclaved ampoule will exhibit no growth and retain the original purple color if the autoclave

is working properly meaning that both time and temperature were reached for decontamination. If the ampoule remains purple this indicates that the autoclave sterilization was successful. If the ampoule changes color towards a yellow or the liquid becomes turbid this indicates spore growth and failed autoclave sterilization.

Test Failure If the control ampoule or the autoclaved Prospore© ampoule tests fails, the load

must be re-autoclaved and retested with Prospores© again before disposal. The failure of a spore test may be the result of improper loading or incorrect parameter settings. If the autoclave spore test fails for a second time the autoclave needs to be serviced and use of the autoclave for decontamination suspended.

Prospore Storage and Disposal:

Store in a non-food refrigerator at 2-8C. Do not freeze. Prospores© have an expiration date stamped on the outside of the box. Do not use after

expiration.

Sterilize all positive and expired units prior to disposal. The deactivated glass ampoules must be disposed of in a sharps container.

Precautions:

Do not use damaged ampoules. Do not use Prospores© after the expiration date. Since Prospores© contain live cultures, ampoules should be handled with care. Do NOT freeze. If the Prospores© have frozen, discard them.

After sterilization handle the Prospore© ampoules with care. The contents of the ampoule are

hot and under pressure. Failure to allow sufficient cooling time (10-15 minutes) may result in bursting of the ampoule.

Hold all autoclaved waste until the biological indicator tests have been shown to be functioning

correctly/validated. If the tests are not satisfactory, the autoclave must be repaired, new biological indicators run and the waste is re-autoclaved before it is disposed of. The waste can NOT be disposed of until there is a valid indicator test.

7.2 Prospore©/Geobacillus sterothermophilus Purchasing

Prospores©/ Geobacillus sterothermophilus ampoules can be purchased through Thermo Fisher Scientific, Catalog# 12-001-1 (pack of 10) or 12-001-2 (pack of 50) or directly through Raven Labs. Raven Labs phone # 800-728-5702. Prospores© typically have a six month to one year expiration date so take care not to order too many at one time.

8.0 Annual Calibration 8.1 All autoclaves are considered “pressure vessels” and must be calibrated annually to meet

Massachusetts State regulations 105 CMR 480.000: Minimum Requirements for Medical or Biological Waste (State Sanitary Code Chapter VIII). Calibration consists of a preventative maintenance service which entails replacing valves and check valves that warrant it as well as door gaskets that may need replacing. Test cycles are run with chemical indicators to verify proper operation by the service representative(s). Documentation shall be kept in the departmental office and entered into the Maintenance Log. The following companies have performed these services on campus:

Getinge Castle, 1777 E. Henrietta Rd., Rochester, NY 14623-3133, 1-800-950-9912. A service

contract is available and that covers four visits a year as well as the annual maintenance/certification.

Ranger Engineering, P.O. Box 3111, Framingham, MA 01705, (508) 877-3166.

9.0 Documentation 9.1 All autoclave runs must be documented. The autoclave log must include date, time, load

characteristics, run time, and if there were spore test results. 9.2 Accurate and timely documentation is necessary to ensure proper decontamination of waste.

Documentation procedures are mandatory and are included in each component of the autoclave verification program.

9.3 Autoclave Log sheets, completed work orders and maintenance records should be stored in a

unique folder for each individual autoclave to facilitate review of these materials. Save any tapes from autoclaves in date order for at least three years.

10.0 Key References 10.1 10.2 Judy LaDuc, Biological Safety Services, Department of Environmental Health & Safety, 117 Draper

Hall, University of Massachusetts/Amherst, (413) 545-7293/Fax: (413) 545-2600. 10.3 Biosafety in Microbiological and Biomedical Laboratories. CDC/NIH. 5th edition, 2007 10.4 Getinge Castle, 1777 E. Henrietta Rd., Rochester, NY 14623-3133, 1-800-950-9912 10.5 Ranger Engineering, P.O. Box 3111, Framingham, MA 01705, (508) 877-3166 10.6 Thermo-Fisher Scientific, 9999 Veterans Memorial Drive, Houston, TX 77038 Telephone: 800-766-

7000 10.7 105 CMR 480.000 Minimum Requirements for the Management of Medical or Biological Waste

University at Massachusetts Amherst: Biological Waste Record for On-Site Treatment

Department: Building: Room: Manufacturer: Model #: Serial #: UMass Tag #: Date Placed in Service: Autoclave was: New/Used

Chart prepared in accordance with M.G.L.c. 111 §§ 3, 5 and 105 CMR 480.000, minimum requirements for medical or biological waste. Results should be reviewed, signed and dated by a laboratory supervisor, coordinator, principal investigator or EH&S Biosafety staff at regular intervals.

Date Quantity Type Treatment Method

Process Parameters Printed Name QC Results

Time Pressure Temp Signature Chemical or Spore + or -

Heat

Heat

Heat

Heat

Heat

Heat

Heat

Heat

Heat

Heat

Heat

Heat

Heat

1

Biological Materials and Biohazardous/Medical Waste Disposal Program

Document Number: EHS.BIOW.08.02 Effective Date: 7/18/08 Revision Date: 7/15/10

1.0 Purpose and Applicability 1.1. Biological waste is waste from the laboratory that contains or potentially contains

biohazardous agents or recombinant DNA material. Laws and regulations are in place to ensure the proper handling of these materials and to offer guidance to those who must do so. Generator requirements are listed in 105 Code of Massachusetts Regulations (CMR) 480.000: http://www.mass.gov/Eeohhs2/docs/dph/regs/105cmr480.pdf ; Special waste and facility: 310 CMR 19.000; New Source Performance Standards (NSPS) for hospital/medical/infectious waste generators (HMIWI): 40 CFR 60.50c to 60.58c. Additional regulatory agencies are the Massachusetts Department of Public Health (DPH) Division of Community Sanitation and the Massachusetts Department of Environmental Protection.

1.2. The purpose of this document is to establish the process through which biological waste,

rDNA materials, and medical waste is handled; whether it is deactivated on-site, or stored, packaged and shipped for off-site deactivation and/or incineration.

2.0 Definitions 2.1 Biohazardous Agent: refers to an agent that is biological in nature and has the capacity to

produce deleterious effects upon biological organisms. Biohazardous agents include, but are not limited to; bacteria, fungi, viruses, rickettsiae, Chlamydia, prion, parasites, recombinant products, allergens, cultured human and animal cells and the potentially biohazardous agents these cells may contain, infected clinical specimens, tissue from experimental animals, plant viruses, bacteria and fungi, toxins, and other biohazardous agents as defined by State and Federal regulations.

2.2 Experimental rDNA material: In the context of the NIH Guidelines, recombinant DNA

molecules are defined as either: (i) molecules that are constructed outside living cells by joining natural or synthetic

DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above. Synthetic DNA segments which are likely to yield a potentially harmful polynucleotide or

polypeptide (e.g., a toxin or a pharmacologically active agent) are considered as equivalent to their natural DNA counterpart.

All recombinant DNA waste must be deactivated prior to disposal. 2.3 Infectious medical waste: In Massachusetts this waste is defined as waste that, because of

its characteristics, may cause or significantly contribute to an increase in mortality or an increase in serious irreversible or incapacitating reversible illness or pose as a substantial present potential hazard to human health or to the environment when improperly treated, stored, transported, disposed of, or otherwise managed. The following are included in infectious medical wastes: blood and blood products; pathological waste; cultures and

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stocks of infectious agents; contaminated animal carcasses, body parts, and bedding; sharps (needles, scalpels, blades, etc.); and biotechnical by-product effluents.

2.4 Biohazardous and medical waste: is defined as human tissues, wastes from contact with

patients; waste contaminated with infectious agents, live vaccines, all contaminated sharps (syringes, needles, scalpel blades, etc.), and animal carcasses/tissues. These wastes must be disposed of by incineration. We currently have a contract with Stericycle to pick-up biohazardous and medical waste at University Health Services and dispose of it at approved treatment facilities.

2.5 Sharps: are items that are capable of puncturing, cutting or abrading the skin. Sharps

include, but are not limited to; glass and plastic pipettes, broken glass, test tubes, razor blades, syringes, and needles. Sharps shall be segregated from other wastes and aggregated immediately after use in red, fluorescent orange or orange-red leak proof, rigid, puncture-resistant, shatterproof containers that resist breaking under normal conditions of use and handling, meet ASTM standard F2132-01, and that are marked prominently with the universal biohazard warning symbol and the word “Biohazard” in a contrasting color. These containers may be obtained free of charge from the Thermo-Fisher Stockroom in the basement of the Lederle Research Tower. You must contact EH&S at: http://www.umass.cems.sr.unh.edu/CEMS/RequestRemoval for removal of your sharps containers once the contents have reached the fill line on the side of the container. UMass currently has a contract with Triumvirate, Inc. to pick-up biohazardous waste on campus and to deliver it to University Health Services where Stericycle will pick up and dispose of our biohazardous and medical waste off campus.

2.6 Incineration: is a waste treatment technology that involves the combustion of organic

materials and/or substances. Incineration and other high temperature waste treatment systems are described as thermal treatment. Incineration has particularly strong benefits for the treatment of certain waste types in niche areas such as clinical wastes and certain hazardous wastes where pathogens and toxins can be destroyed by high temperatures. The University of Massachusetts at Amherst chooses incineration for the treatment of the infectious waste generated by campus medical and research activities. We currently have a contract with Stericycle to pick-up and dispose of our biohazardous and medical waste.

2.7 Autoclaves: are pressurized vessels designed to heat aqueous solutions above their boiling

point at normal atmospheric pressure to achieve sterilization. There are chemical and biological indicators that can be used to ensure an autoclave reaches the correct temperature for the correct amount of time. Chemical indicators can be found on medical packaging and autoclave tape, and these change color once the correct conditions have been met. This color change indicates that the object inside the package, or under the tape, has been autoclaved sufficiently. Biological indicators include attest devices. These contain spores of a heat-resistant bacterium, Geobacillus stearothermophilus. If the autoclave does not reach a high enough temperature, the spores will germinate, and their metabolism will change the color of a pH-sensitive chemical. Parametric monitoring is automated equipment that records critical parameters appropriate for the treatment process of rendering medical or biological waste non-infectious including but not limited to time, temperature, pressure and pH.

2.8 Animals and Animal Bedding: All animal carcasses (or animal tissues) that have been used

for teaching and/or research purposes are to be disposed of by incineration. The carcasses must be packed in a leak-proof container, labeled appropriately, and frozen until disposal. If

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the animals or animal tissues have been placed in a formaldehyde solution, they must be separated from the solution before incineration.

Animal bedding must be bagged, placed in a dumpster and disposed of in a sanitary landfill. Bedding contaminated with biohazardous waste, (e.g., from animals shedding pathogens) must be decontaminated by autoclaving before disposal. All bedding should be placed in heavy-duty, leak proof bags, tied securely and placed in dumpsters. Loose bedding shall not be placed in dumpsters.

3.0 Roles and Responsibilities 3.1 Biological Safety Officer – (Environmental Health & Safety) advises the Environmental

Health & Safety Director on all matters relating to the use of biological agents within UMass. The BSO advises faculty, staff and students on waste disposal policies, disinfection policies, risk assessments, hazardous waste training, and autoclave management program, etc.

3.2 Laboratory Health and Safety Services Technicians – (EH&S) assist Environmental Health & Safety management teams as well as laboratory staff and PI’s with safety oversight of laboratories. The technicians are assigned to specific laboratories. These technicians also provide on-site inspections and offer advice to laboratory staff when needed.

3.3 Environmental Management Staff – (EH&S) assists the University with the proper characterization, removal and disposal of hazardous waste. This group monitors the website where waste requests are processed by a commercial hauler: http://www.umass.cems.sr.unh.edu/CEMS/RequestRemoval

3.4 Principle Investigator – Lead research scientist in the laboratory and responsible person for training on proper laboratory practices including waste decontamination and disposal as well as safety.

3.5 Laboratory Staff – scientists, assistants, technicians, students, clerical staff and any other persons that are working in the laboratory.

3.6 University Health Services Staff – UHS personnel that generate, handle or dispose of infectious waste.

3.7 Institutional Biosafety Committee: University personnel plus two community members who are responsible for the annual review of the biological and medical waste management program.

4.0 Procedures for Managing Biological/Infectious Waste 4.1 Storage and Handling of Biological/Infectious Waste Dedicated Storage Enclosure – Customer/Generator Site

1. All medical or biological waste, except sharps, shall be contained in a primary container which is a red, fluorescent-orange or orange-red plastic bag that is impervious to moisture and has sufficient strength to resist ripping, tearing, or bursting under normal conditions of use and handling, and which meets the American Society for Testing Materials (ASTM) standard D1922-06a and ASTM D1709-04.

2. “Working” containers of medical/biohazardous waste must be maintained in secondary containment and this containment must be covered and labeled with biohazard symbols. Step cans with hands-free operation are strongly recommended for this purpose.

3. Medical/biohazardous waste stored on site will be maintained by the generator within a time limit to prevent the development of offensive odors.

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4. Biological/Infectious waste is not placed on the floor while awaiting pick-up or autoclaving. This waste may temporarily reside in an appropriately labeled bin until the waste is treated.

5. Medical/biological waste to be treated shall be maintained in an enclosure or designated accumulation area, which is secured, to deny access to unauthorized persons, marked with the appropriate warning signs, and which provides protection from animals, rodents and natural elements.

6. The designated accumulation area may be a room at room temperature, a walk-in cooler, or a freezer (such as for animal carcasses).

7. Warning signs should be posted to prevent unauthorized access such as: “CAUTION, BIOHAZARDOUS WASTE STORAGE AREA – UNAUTHORIZED PERSONS KEEP OUT”.

4.2 Management of Liquid Biological Waste

1. Biological waste must be decontaminated with an appropriate disinfectant prior to disposal via the sanitary sewer.

2. Liquid waste is diluted 1:10 with bleach (or another EPA approved disinfectant) and is allowed to stand for the appropriate kill time (usually 30 minutes) before disposal down the sanitary sewer.

4.3 Program for Autoclave (Steam Sterilization) Treatment of Biohazardous Waste

1. Collection: Solid biological waste which includes discarded cultures and stocks of

infectious agents and their associated biologicals, including culture dishes and devices used to transfer, inoculate, and mix cultures, as well as live and attenuated vaccines, culture plates with rDNA, waste contaminated with potentially infectious agents, and other tissues and preparations from genetically altered living organisms should be collected in ASTM (American Society for Testing and Materials) approved red/orange autoclave bags. These bags must be maintained in secondary containment until they are placed into an autoclave. Bags should not be packed so tightly that steam can not penetrate the entire load. The top should not be tied so tightly so that steam cannot escape; otherwise the bag may burst while autoclaving. Autoclave tape or some other indicator must be on the bag to show that the bag has undergone a successful autoclave run once the process is complete.

2. Record Keeping Log: All workers should review the Autoclave Management Program

that is available from EH&S. a) Use the CMR 480.500 log sheets provided near the autoclaves. Massachusetts

mandates that these records be kept up to date by every user, for every run. b) These log sheets are maintained in a log book with secured, consecutively numbered

pages, for three years. c) Challenge testing with Geobacillus stearothermophilus biological indicators are run

once a month (or more often as needed) to verify that successful kill levels have been achieved. A successful run is quantified by at least a 1.0 x 104 reduction in heat resistant organisms and the type of bacterial indicator selected should contain this volume or more of Geobacillus stearothermophilus.

d) When a 4 log 10 bacterial spore reduction has not been demonstrated (results indicate bacterial growth), an operations and mechanical systems assessment shall be conducted by a qualified individual who has received training from the

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manufacturer in the operations and maintenance of the equipment. Appropriate corrective actions shall be implemented when warranted, including but not limited to mechanical adjustments and, when applicable, recalibration of all parametric monitoring devices followed by re-treatment of the waste and additional challenge testing to confirm the effectiveness of any implemented corrective action. (105 CMR 480.150)

e) The methods that rely on heat shall be evaluated for each load or cycle by using a recording thermometer, thermocouple, parametric monitoring device, thermal indicator strip, or by an equivalent method approved in writing by the Commonwealth.

f) All parametric monitoring equipment utilized in conjunction with autoclaves, shall be calibrated at a minimum annually by an individual who has received training from the manufacturer in the operations and maintenance of the equipment.

g) When implemented, corrective actions pursuant to 105 CMR 480.150(E)(4) shall be documented in detail including the date, name of the individual implementing the corrective actions and a description of the work performed, on the back of the applicable record-keeping log form for medical or biological waste treated on-site.

3. Packaging: Once the autoclave run is complete and your indicators are positive for a

successful run*, you will allow the waste to cool. Once the waste is cool, you will need to place a sticker on the AUTOCLAVE bag with the name of the building and room number of the facility that generated the waste.

*Chemical indicators can be found on medical packaging and autoclave tape, and these change color once the correct conditions have been met. This color change indicates that the object inside the package, or under the tape, has been autoclaved sufficiently. Biological indicators include attest devices. These contain spores of a heat-resistant bacterium, Geobacillus stearothermophilus. If the autoclave does not reach a high enough temperature, the spores will germinate, and their metabolism will change the color of a pH-sensitive chemical. Parametric monitoring is automated equipment that records critical parameters appropriate for the treatment process of rendering medical or biological waste non-infectious including but not limited to time, temperature, pressure and pH.

4. Disposal: Place the autoclaved bag(s) inside a black trash bag and dispose of them as

general solid waste trash (dumpster).

4.4 Procedure for Shipping Biohazardous Waste to Stericycle for Treatment This method is only for labs that generate:

a) Animal carcasses b) Sharps containers c) Small scale biohazardous waste that have no access to an autoclave

4.4.1 Packaging 1. Line all corrugated bio-boxes with two primary red biohazard bags provided by

Stericycle. 2. Animal carcasses should be frozen for at least two days prior to packaging and pick-up

by EH&S/contractor. 3. All non-sharp waste (blood soaked materials) may be placed directly into the red

biohazard bag, or individually bagged to help eliminate odor. 4. Sharps (syringes, scalpels, tubes of blood, razors, etc.) must be placed into a puncture-

resistant sharps container prior to being placed into the red biohazard bags.

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5. The primary red biohazard bag liner must be sealed or tied to avoid spillage. Securely seal the top of the corrugated boxes with tape.

6. Corrugated boxes should not exceed 40 pounds. The boxes will be rejected if the containers are; overweight, leaking, bulging or damaged.

7. Do not discard any chemical hazardous wastes, radioactive materials, flammable liquids, DEA-regulated waste, pharmaceutical waste or lead-foil in the bio-boxes. If there is an accidental cross-contamination of these waste streams, please notify EH&S (545-2682) so that we may handle these on a case by case basis.

4.4.2 Labeling

1. Label the primary red biohazard bag and sharps containers with a water resistant label with department name and building.

2. Label the outside of the corrugated bio-boxes with department, date, a bar-coded address label and a “PATH WASTE” sticker provided by Stericycle. “PATH WASTE” stickers are required on all bio-boxes containing carcasses and sharps.

4.4.3 Pick-Ups & Packaging Material Requests

1. You may place a pick-up request and request packaging supplies on the EH&S website at http://www.umass.cems.sr.unh.edu/CEMS/RequestRemoval

2. Pick-ups and packaging supply requests will be filled on Thursday afternoons by EH&S staff.

3. Stericycle provides bio-boxes, red biohazard bags and labeling materials. Please place an order with EH&S when your supplies are running low.

4.4.4 Special Waste Requests

Special waste requests will be handled on a case by case basis. If you have any questions concerning disposal of biological wastes or other wastes please contact Judy LaDuc at Environmental Health & Safety @ 545-7293 or [email protected] .

4.4.5 Storage of Biological/Infectious Waste 1. Medical waste to be collected by Stericycle shall be maintained in an enclosure or

designated accumulation area, which is secured, to deny access to unauthorized persons, marked with the appropriate warning signs, and provides protection from animals, rodents and natural elements.

2. Warning signs should be posted to prevent unauthorized access such as: “CAUTION, BIOHAZARDOUS WASTE STORAGE AREA – UNAUTHORIZED PERSONS KEEP OUT”.

3. Medical waste stored on site will be maintained by the generator for a limited time to prevent the development of offensive odors.

4. Waste is stored refrigerated or frozen until picked up by contractor.

Generator Name: Room 5 Location: Halfpenny Hall Date Packed: August 25, 2008

PATH WASTE

Stericycle

Generator

UMass Amherst Amherst, MA

Transporter Date: ________

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4.4.6 Treatment of Waste

1. Permitted Waste Treatment Facilities

All waste collected by Stericycle is transported to a permitted facility for proper treatment and subsequent disposal.

2. Waste treatment Methods/Parameters

a) Pathology waste (human tissue specimens, organs, limbs, and contaminated animal carcasses, parts and specimen(s) is incinerated.

b) Bio-hazardous waste, sharps and non-hazardous pharmaceutical waste is subjected to incineration, autoclaving, Stericycle’s Electro-Thermal-Deactivation (ETD) technology or other approved treatment technologies.

c) Small scale biohazardous waste (blood samples, etc.), from laboratories that have no access to an autoclave and DO NOT work with rDNA, is boxed for incineration and shipment off-site by Stericycle.

3. Stericycle waste treatment facilities operate in compliance with all applicable federal, state and local laws/regulations and maintain all required permits and licenses.

4. In accordance with M.G.L. c. 111 §§ 3, 5, and 127A and 105 CMR 480.000: Minimum Requirements for the Management of Medical or Biological Waste State Sanitary Code, Chapter VIII), generators of medical or biological waste, shipped off-site for treatment, shall maintain a current record-keeping log with the following information: the exact date of shipment; the total number of containers; the type of waste; the total combined weight or volume; the name of the transporter with transporter identification number (if applicable); the verification (via check box) of shipping papers generated with receipt of corresponding tracking forms for each shipment; and the printed name and signature of the person responsible for shipping the waste.

5. There is a Medical or Biological Waste Record-Keeping Log In the cold room in UHS where the waste is stored prior to pick up by Stericycle. This log (mandated by 105 CMR 480.000) is completed by a member of the UHS staff at the time of waste pick-up.

The record-keeping log for medical or biological waste shipped off-site for treatment shall specify: (a) The exact date of each shipment; (b) The total number of containers; (c) The type of waste; (d) The total combined weight or volume; (e) The name of the transporter with transporter identification number (f) The verification (via check box) of shipping papers generated with receipt of corresponding medical waste tracking forms for each shipment; and (g) The printed name and signature of the person responsible for shipping the waste.

The log remains in the waste area. A copy of the Medical Waste Tracking Form from Stericycle is obtained at the same time, and this form is forwarded to Biological Safety Services at UHS. These forms are redundant and are useful for auditing purposes. These records are maintained for 3 years.

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5.0 Key References

1. 105 CMR 480.000 Minimum Requirements for the Management of Medical or Biological Waste (Massachusetts State Sanitary Code Chapter VIII)

2. Bloodborne pathogen Standard 29 CFR 1910.1030, and OSHA Instruction CPL, 2-2, 44C,

Occupational Health and Safety Administration, 1999

3. HM 226, 49 CFR Part 171 ET. Al. Federal Register, 14 August 2002, Revisions to Standards for Infectious Substances, Final Rule.

4. Code of Federal Regulations, Hazardous Waste Criteria, 40 CFR 261, Subpart C and

Subpart D, 40 CFR 262.11, and 21 CFR 1200-1316.

5. Stericycle, Inc., Medical Waste Acceptance Protocol, Northeast Version; May 2004 6. National Institutes of Health for Research Involving Recombinant DNA Molecules,

April 2002.

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Quick Reference Guide

Biohazardous Waste Packaging Guidelines (All Bio Waste will be picked up on Thursday mornings 9-11 AM)

Definition: Waste contaminated with potentially infectious agents, animal carcasses and other tissues. Examples: Human tissues, blood, blood

products, other tissues Wastes from contact with

patients/subjects Laboratory cultures/waste

contaminated with infectious agents

Live Vaccines Syringes, hypodermic

needles, scalpel blades, and other sharps

Animal carcasses and tissues Contaminated bedding Other contaminated items Drug Enforcement Agency

(DEA) and other Controlled Substances

Preparations from genetically altered living organisms

If Discarding: Then: Autoclavable or chemically treatable wastes

1. Disinfect using steam sterilization or an appropriate chemical disinfectant that will kill the target organism.

2. Record data (date, name, type of waste, temperature, dwell time, etc.) for each load rendered non-infectious by steam sterilization.

3. Periodically test autoclave by using biological spore tests (Pro- spores) and record results.

4. Package all waste properly and dispose of as general solid waste trash (no BioHazard signs allowed outside bag)

Human blood, body fluids and tissues, medically generated wastes (patient contact), animal carcasses/tissues, and full sharps containers

1. Double bag in a rigid, leak-proof package (e.g. red plastic bag in a cardboard box) labeled with the “Biohazard symbol supplied by EH&S, and seal well with the translucent packing tape provided (no duct tape).

2. Limit weight to 40 pounds in EH&S box.

3. Fill out the label on the box with name, department, campus address, telephone, contents and date. Apply all appropriate stickers

4. All body fluids, tissue and animal carcasses must be frozen for a minimum of 48 hours.

Laboratory cultures and contaminated bedding

1. Treat using accepted lab procedures and autoclave using manufacturer’s instructions.

2. After treatment, handle as general waste

Biohazardous packaging and labeling supplies

1. Satellite supply stations in various buildings

2. For requests for packing materials or pickups go to: www.ehs.umass.edu Select Hazardous Waste Pickup Request

Other biohazardous materials Contact Judy LaDuc, Biological Safety Services, at Environmental Health & Safety @ 545-7293 jladuc@ ehs.umass.edu

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Quick Reference Guide

Sharps Container Disposal Information Distribution & Disposal For: Then: Examples: Syringes Scalpels Razor Blades Capillary Tubes Pasteur Pipettes

Sharps containers may be obtained by

1. Picking up the containers at the Chemical Stockroom located in the basement of the Lederle GRC Tower A

2. Picking up the containers at the EH&S main office in Draper Hall

3. Requesting a sharps container drop-off by EH&S staff when placing a waste pick up on line at: www.ehs.umass.edu

Sharps Container Disposal 1. All sharps must be disposed of as a biohazardous/ medical waste. Sharps containers must not exceed the fill-line and be taped shut when full.

2. You may place a waste sharps pick up request by emailing EH&S at www.ehs.umass.edu

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University at Massachusetts Amherst: Biological Waste Record for On-Site Treatment

Department: ___ ______ Building: ___________ Room: _______ Manufacturer: ________________ Model #: _____ Serial #: _________ UMass Tag #: __________ Date Placed in Service: __________________ Autoclave was: New /Used

Chart prepared in accordance with M.G.L.c. 111 §§ 3, 5 and 105 CMR 480.000, minimum requirements for medical or biological waste.

Results should be reviewed, signed and dated by a laboratory supervisor, coordinator, principal investigator or EH&S Biosafety staff at regular intervals.

MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

Date Quantity Type Treatment Method

Process Parameters Printed Name QC Results

Time Pressure pH Temp Signature Chemical or Spore + or -

Heat

Heat

Heat

Heat

Heat

Heat

Heat

Heat

Heat

Heat

Heat

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Medical or Biological Waste Record-Keeping Log OFF-SITE TREATMENT

Facility Name and Address: University of Massachusetts at Amherst, 150 Infirmary Way, Amherst,

MA 01003 In accordance with M.G.L. c. 111 §§ 3, 5, and 127A and 105 CMR 480.000: Minimum Requirements for the Management of Medical or Biological Waste State Sanitary Code, Chapter VIII), generators of medical or biological waste, which is shipped off-site for treatment, shall maintain a current record-keeping log with the following information: the exact date of shipment; the total number of containers; the type of waste; the total combined weight or volume; the name of the transporter with transporter identification number (if applicable); the verification (via check box) of shipping papers generated with receipt of corresponding tracking forms for each shipment; and the printed name and signature of the person responsible for shipping the waste.

Date #

Containers

Type VolumeCu Ft

Transporter

ID #

Please Check: Shipping Paper/Tracking Form

Printed Name Signature

Regulated

Med Waste NOS

6.2,UN 3291, PG II

Stericycle,

Inc.

860.632.0294

Regulated

Med Waste NOS

6.2,UN 3291, PG II

Stericycle,

Inc.

860.632.0294

Regulated

Med Waste NOS

6.2,UN 3291, PG II

Stericycle,

Inc.

860.632.0294

Regulated

Med Waste NOS

6.2,UN 3291, PG II

Stericycle,

Inc.

860.632.0294

Regulated

Med Waste NOS

6.2,UN 3291, PG II

Stericycle,

Inc.

860.632.0294

Regulated

Med Waste NOS

6.2,UN 3291, PG II

Stericycle,

Inc.

860.632.0294

Sharps Policy

Document Number: EHS.SHARPS.07.01 Effective Date: 06/05/2007 Revision Date: 03/12/09

1.0 Purpose and Applicability 1.1 The following document describes the proper precautionary procedures for handling of sharps and how they are managed in the waste stream. 1.2 These procedures must be followed properly by all who are likely to come in contact with needles or other “sharps” materials. 2.0 Definitions 2.1 Sharps are discarded articles that may cause punctures or cuts, including, but not limited to all used and discarded hypodermic needles and syringes, Pasteur pipettes, scalpels, capillary tubes, razor blades and suture needles. 2.2 Sharps may also be described as any material that may be rigid enough, that when cracked or broken, is able to pierce the skin. Examples would be: broken beaker, metal from a cage or a broken test tube. 3.0 Roles and Responsibilities 3.1 Principal Investigator – Individual responsible for ensuring that staff are trained annually regarding safe

sharps handling and that all researchers working in the laboratories are informed on biosafety procedures. 3.2 Biological Safety Services Manager at EH&S – Staff member responsible for advising researchers on

biosafety engineering controls, procedures for use and proper disposal. 3.3 Laboratory Supervisor - should adopt improved engineering and work practice controls that reduce risk of sharps injuries. 4.0 Procedures for Use 4.1 Sharps Precautions and Disposal Procedures: a) Sharps must not be handled directly, use gripping tools such as forceps or a broom and dust pan to collect

sharp objects such as broken glass or needles b) All sharps must be disposed of in puncture-proof/leak-proof containers, which indicate that they are “sharps”

biohazard waste and the container must be labeled with the international biohazard symbol: These are red/orange shatterproof containers that resist breaking under normal conditions of use and handling, meet ASTM standard F2132-01, and that are marked prominently with the universal biohazard warning symbol and the word “Biohazard” in a contrasting color.

c) Careful management of needles and other sharps are of primary importance. Needles must not be bent,

sheared, broken, recapped, removed from disposable syringes, or otherwise manipulated by hand before disposal.

d) Used disposable needles and syringes must be carefully placed in conveniently located puncture-resistant containers used for sharps disposal.

e) Plastic-ware should be substituted for glassware whenever possible.

f) Once the sharps containers are filled to the line marked on the container, they must be sealed and then disposed of by Environmental Health and Safety (EH&S) and not placed in the regular trash. Contact EHS at: http://www.ehs.umass.edu/

g) Care must be taken to follow these procedures to prevent serious injury and comply with the Massachusetts

Department of Public Health regulations, 105 CMR 480, Minimum Requirements for the Management of Medical or Biological Waste (State Sanitary Code Chapter VIII)

4.2 How to obtain sharps containers for medical care: a) On campus resident students who regularly use hypodermic needles for medical care and must dispose of

these needles can obtain sharps containers and proper procedures for handling sharps from the University Health Services (UHS) Pharmacy. When these containers are full, they must be returned to the UHS Pharmacy for proper disposal and new containers will be issued.

4.3 How to obtain sharps containers for laboratories: a) Employees and students who use sharps in their work can obtain sharps containers from the Thermo-Fisher

Stockroom in the Lederle Graduate Research Tower. These containers must be disposed of through EHS and NOT WITH REGULAR TRASH. Contact EH&S for pick-up at: http://www.umass.cems.sr.unh.edu/CEMS/RequestRemoval

4.4 What to do when hypodermic needles are found: a) When a hypodermic needle (improperly disposed of) is found on the campus, notify EHS or Custodial

Services. They will pick it up, dispose of it properly, and investigate the incident. 4.5 What to do if you are injured with a hypodermic needle: a) Immediately seek medical attention at the University Health Services - Urgent Care Department

b) Report the incident to your supervisor and the Biological Safety Services Manager at EH&S

c) File a Notice of Injury Report

Resources: http://www.osha.gov/OshDoc/data_BloodborneFacts/bbfact02.pdf http://www.osha.gov/SLTC/bloodbornepathogens/index.html/

http://www.bd.com/safety/edu/



Appendix

Biological Safety Services 117 Draper Hall

40 Campus Center Way Amherst, MA 01003-9244

Phone: 413-545-7293 Fax: 413-545-2600

E-mail: [email protected]

EN V I R O N M E N T A L HE A L T H & SA F E T Y FA C T SH E E T: AU T O C L A VE SA F E T Y

An autoclave is a commonly used piece of equipment in biomedical laboratories. Autoclaves pose many haz-ards including physical hazards (e.g. heat, steam and pressure) and biological hazards. Each autoclave has unique characteristics. Review and understand the owner’s manual before using any autoclave for the first time and as needed thereafter. Contact the manufacturer to request on-site training as needed. Ensure the owner’s man-ual is readily available in case questions arise during operation. Autoclave maintenance is an important aspect of a properly functioning autoclave. Follow the manufacturer’s recommendations for preventative maintenance and ensure all contractors are approved by the manufacturer. Maintenance should include periodic efficiency tests (e.g. Bacillus stearothermophilus spore testing) to en-sure the autoclave is functioning properly. Do not autoclave items containing corrosives (e.g. acids, bases, phenol), solvents or volatiles (e.g. ethanol, methanol, chloroform) or radioactive materials. Utilize the following autoclave safety practices: 1. Before using the autoclave, check inside the autoclave for any items left by the previous user that could pose a hazard (e.g. sharps). 2. Clean the drain strainer before loading the autoclave. 3. Load the autoclave properly as per the manufacturer’s recommendations. Do not overload; tie bags loosely; steam needs to penetrate the densest part of the load. 4. To prevent bottles from shattering during pressurization, the caps of containers with liquids must be loos-ened before loading. 5. Use a tray with a solid bottom and walls to contain the contents and catch spills. 6. Add water to the autoclave bags to facilitate steam generation. 7. Add 1/4 to 1/2 inch of water to the tray so the bottles will heat evenly. 8. Check plastic materials to ensure they are compatible with the autoclave. 9. Individual glassware pieces should be within a heat resistant plastic tray on a shelf or rack and never placed directly on the autoclave bottom or floor. 10. Make sure the door of the autoclave is fully closed (latched) and the correct cycle has been se-lected before starting the cycle. 11. Wear heat-resistant gloves when opening the autoclave door after a cycle. When there is a sharps haz-ard (e.g. biological waste), wear heat AND cut resistant gloves. 12. Before removing autoclaved items, wait 5 minutes for loads containing only dry glassware, and 20 min-utes for autoclaved liquid loads. 13. At a minimum, when removing items from an autoclave, safety glasses, a lab coat, sleeve protectors and heat-resistant gloves should be worn. 14. For non-liquid loads, let the glassware cool for 15 minutes before touching it with ungloved hands. For liquid loads, let liquids stand for a full hour before touching with ungloved hands. Be sure o t h -ers in the area know a heat hazard is present.



Phone: 413-545-7293 Fax: 413-545-2600


EN V IR O N M E N T A L HE A L T H & SA F E T Y FA C T SH E E T: AU T O C L A V E D W A S T E

What is an autoclave? An autoclave, or steam sterilizer, is an insulated pressure chamber in which saturated steam is used to elevate the temperature. Autoclaves are found in research, diagnostic and microbiology laboratories, health centers and other places that require high-level disinfection. How does an autoclave work? An autoclave uses pressurized steam to decontaminate infectious waste. Laboratory autoclaves normally operate at a temperature of 250° F (121° C), a pressure of 15 pounds per square inch (psi), and a mini-mum cycle time of 30 minutes. The effectiveness of an autoclave depends on the time, temperature and direct steam contact with infectious agents. Therefore, we recommend that bags are opened for best steam penetration during the autoclave run. Other factors that influence treatment efficiency include: waste destiny, physical state, size, and organic content. How do I use the autoclave? Autoclaves come in many different styles. Therefore, always follow the manufacturer’s instructions when using the autoclave. What can be autoclaved? In Massachusetts, all biological research material noninfectious and infectious, must be deactivated by autoclave or chemical treatment before being disposed as Municipal Solid Waste (MSW). Massachusetts currently prohibits medical sharps (needles, syringes, etc.) and research animal carcasses from entering the MSW stream. These items must be removed by an outside contractor according to their specifications. Waste law: http://www.mass.gov/Eeohhs2/docs/dph/regs/105cmr480.pdf The following biological waste products may be autoclaved and disposed of as MSW: • Cultures and stocks of noninfectious and infectious biological waste; • Human blood waste and human blood products; • Human, animal & plant cell lines; • Biological waste and discarded materials contaminated with excretions from humans or animals; • Preparations made from genetically altered living organisms and their products. What cannot be autoclaved? Types of waste that should not be autoclaved include: cancer drugs, toxic chemicals, radioisotopes, vola-tile chemicals or any other harmful material that can be vaporized and disseminated with heat. In general, do not autoclave flammable, reactive, corrosive, toxic or radioactive materials. Autoclave Maintenance & Record Keeping Autoclaves must be validated to ensure effective disinfection by spore testing quarterly and inspected yearly by a professional. Autoclave logs are required by the Massachusetts Department of Public Health and are available from EH&S. How should I collect and dispose the waste? Liquid infectious waste may be autoclaved and then disposed via the laboratory drainage system. (Do not pour melted agar into a sink. Allow it to cool and solidify for disposal as a solid waste.) Follow these disposal procedures for solid biological waste: 1. Collect the biological waste in red or orange ASTM approved autoclave bags (imprinted with process

indicator). 2. Autoclave and cool the waste. Place a completed Autoclaved Waste Label on the bag. 3. Place the autoclave bag into a black polypropylene trash bag. 4. Place the black-bagged waste into an approved location/dumpster.



Phone: 413-545-7293 Fax: 413-545-2600


EN V IR O N M E N T A L HE A L T H & SA F E T Y FA C T SH E E T: BIOLOGICAL EXPOSURE

Biological Exposure: Potential exposures include needle sticks, animal bites, aerosol exposures, and other incidents potentially resulting in disease from a biological agent. Biohazardous Agent: refers to an agent that is biological in nature and has the capacity to produce deleterious ef-fects upon biological organisms. Biohazardous agents include, but are not limited to; bacteria, fungi, viruses, rickettsiae, Chlamydia, prion, parasites, recombinant products, allergens, cultured human and animal cells and the potentially biohazardous agents these cells may contain, infected clinical specimens, tissue from experimental ani-mals, plant viruses, bacteria and fungi, toxins, and other biohazardous agents as defined by State and Federal regu-lations. Common Routes of Exposure: Sharps injuries: contaminated hypodermic needles, razor blades and contaminated glassware. Aerosols: dropped cultures, dropped animal cages, broken tubes in centrifuges, mixing procedures Non-intact Skin: skin with micro abrasions and gloves were not worn or poor hand washing, cuts not covered Mucous Membrane: Splashes to eyes, nose or mouth Ingestion: Eating or drinking in contaminated areas (example: labs), not washing hands after wearing gloves

and then handling food or tobacco products, applying lip balm or chewing gum in contaminated areas. Exposure Procedures: 1. Stop work and immediately begin washing injury/exposed area with warm soapy water for 15 minutes. 2. If exposure is to eyes, use eye wash to irrigate eyes for 15 minutes. If only one eye was exposed, take care not

to contaminate the other eye. 3. Seek medical attention at the University Health Services - Urgent Care Department as soon as possible (before

2 hours have elapsed). 577-5000. Tell them what you were exposed to and bring any information that you may have on the agent.

4. If injury is severe, call 911 from a land-line. This will connect you with UMPD. UMPD will call for an ambu-lance and will dispatch help to you until the ambulance arrives. If you use a cell phone, calling 911 puts you in contact with a State Police dispatcher at a Massachusetts relay center. You must tell them: UMass –Amherst, building and room number.

5. Report the incident to your supervisor and the Biological Safety Services Manager at EH&S (545-7293) 6. File a Notice of Injury Report



Phone: 413-545-7293 Fax: 413-545-2600


EN V IR O N M E N T A L HE A L T H & SA F E T Y FA C T SH E E T: BIOLOGICAL SPILL CLEAN UP

Biohazardous Agent: refers to an agent that is biological in nature and has the capacity to produce deleteri-ous effects upon biological organisms. Biohazardous agents include, but are not limited to; bacteria, fungi, viruses, rickettsiae, Chlamydia, prion, parasites, recombinant products, allergens, cultured human and ani-mal cells and the potentially biohazardous agents these cells may contain, infected clinical specimens, tissue from experimental animals, plant viruses, bacteria and fungi, toxins, and other biohazardous agents as de-fined by State and Federal regulations.

PPE (Personal Protective Equipment): Large spill such as a raw sewage leak that has a high risk of splash potential: PPE requirements include water proof gloves (rubber, nitrile, etc.), rubber boots, waterproof Tyvek™ coveralls or suit and mucous membrane protection that includes goggles and a dust mask. Small spill such as a small pool of blood that has a risk of splashing: PPE requirements at a minimum include water-proof gloves (rubber, nitrile, etc.) and mucous membrane protection with goggles and dusk mask. Protective clothing such as boots and coveralls may be worn depending on the size and potential for splashing during clean-up. Dried body fluids or a very small spill of biohazardous material such as dried blood or blood from a tube of blood, that have a low risk of splashing: Wearing water-proof gloves (rubber, nitrile, etc.) at a minimum would be required for PPE in this type of spill clean up. Other PPE may be worn depending on the situation. Clean Up Procedure: Large or small spill with splash potential: first use absorbent material to soak up and contain spill with absorbent pow-der/ paper towels. Pour disinfectant directly onto material to disinfect. A broad spectrum disinfectant such as a freshly made 10% bleach solution poured on and left on the material 10-30 minutes before clean-up is sufficient in most in-stances to disinfect. Other disinfectants may be used as long as the label lists that it kills a broad spectrum of human in-fectious agents. After the material is collected and placed into a trash bag, pour disinfection on the area of spill to com-plete disinfection and wipe up with paper towels. Dried body fluids or small spill with low splash potential: Use absorbent material to soak up and contain spill with ab-sorbent powder/ paper towels if necessary. Pour a broad spectrum disinfectant such as a freshly made 10% bleach solu-tion onto the spill and leave on for 10-30 minutes before clean-up. Other disinfectants may be used as long as the label lists that it kills a broad spectrum of infectious agents. It is important to read these labels and be familiar with the direc-tions for use and expiration dates of the disinfectant. After the material is collected and placed in a trash bag, pour disin-fection on the area of spill to complete disinfection and wipe up with paper towels.

Basic Hygiene & Accidental Exposures: Employees should wash their hands with soap and warm water immediately after removal of gloves and other protective equipment. ►Disinfect all reusable equipment ►Upon accidental skin contaminations wash the area with copious amounts of soap and water ►If the eyes or mucous membranes are accidentally contaminated flush with copious amounts of water ►Report all accidental exposures to your supervisor Disposal Procedures: For non-laboratory areas: Most body fluids and clean-up materials can be placed into dark garbage bags and thrown into a dumpster. The only exception would be if the body fluid spill was large quantities of blood (i.e. pooled blood). If clean up materials are soaked or dripping with blood, please call EH&S for biohazard bags & boxes to package material for off-site medical waste incineration. Laboratories: Dispose of as biohazardous waste.



Phone: 413-545-7293 Fax: 413-545-2600


EN V IR O N M E N T A L HE A L T H & SA F E T Y FA C T SH E E T: BI O L O G I C A L SA F E T Y CA B I N E T S V S. LA M I N A R FL O W HO O D S

It’s all about airflow and where it does and does not go. A lot of the cabinets that you are using currently are BSC’s (aka: biological safety cabinets). Yes, they still get called laminar flow hoods (LFH’S), but that’s like calling a pizza oven a microwave. At UMass Amherst we are steadily converting from the LFH’s to the BSC’s as the old equipment is replaced. Why are we doing this? The BSC is a better and more versatile piece of lab protection/equipment. A LFH protects only the product in the hood, such as sterile media. A BSC will protect the user and the product in the cabinet from bacterial contamination. BSC LFH (aka: Clean Bench)

The most essential piece of containment equipment is the biological safety cabinet in which manipulations of microorganisms are performed. BSC’s incorporate the use of HEPA filters in the exhaust or supply air system to trap airborne particulate ma-terial. Depending on the configuration of these filters and the direction of airflow, varying degrees of person-nel, environmental and product protection can be achieved. BSC’s will protect you from biological agents in the cabinet, with proper use. LFH’s don’t. BSC’s have a sash in the front and the air is drawn away from you through the grill-work along the edges. BSC’s should be used when working with potentially infectious agents such as human-source material and pathogenic microorganisms. BSC’s can be used for non-infectious work too. 70% of the air in most BSC’s is recycled through its HEPA filter. This purifies the air of particles but does not reduce chemicals or gases. Fumes can actually concentrate in a BSC! Heat build up in a BSC will damage your HEPA filter. LFH’s have an open face and air is blown towards you through the grill-work on the back wall and should only be used for work with non-infectious materials such as media preparation. LFH’s (clean benches) should never be used when handling cell culture materials or drug formulations, or when manipulating poten-tially infectious materials. The worker can be exposed to materials (including proteinaceous antigens) being manipulated on the clean bench, which may cause hypersensitivity.



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EN V IR O N M E N T A L HE A L T H & SA F E T Y FA C T SH E E T: BL O O D BO R N E PA T H O G E N S

What are bloodborne pathogens? Bloodborne pathogens are infectious materials in blood that can cause disease in humans, including but not limited to, hepatitis B and C and human immunodeficiency virus, or HIV. Workers exposed to these patho-gens risk serious illness or death. What protections does OSHA’s Bloodborne Pathogen standard provide? The full text of OSHA’s Bloodborne Pathogens standard, published in Title 29 of the Code of Federal Regula-tions 1910.1030, details what employers must do to protect workers whose jobs put them at a reasonable risk of coming into contact with blood and other potentially infectious materials. The standard requires employers to do the following: ■ Establish an exposure control plan. This is a written plan to eliminate or minimize employee exposures. Em-ployers must update the plan annually to reflect technological changes that will help eliminate or reduce expo-sure to bloodborne pathogens. In the plan, employers must document annually that they have considered and implemented safer medical devices, if feasible, and that they have solicited input from frontline workers in identifying, evaluating, and selecting engineering controls. ■ Use engineering controls. These are devices that isolate or remove the bloodborne pathogen hazard from the workplace. They include sharps disposal containers, self-sheathing needles, and safer medical devices such as sharps with engineered sharps-injury protection and needleless systems. ■ Enforce work practice controls. These are practices that reduce the likelihood of exposure by changing the way a task is performed. They include appropriate procedures for hand washing, sharps disposing, lab speci-men packaging, laundry handling, and contaminated material cleaning. ■ Provide personal protective equipment such as gloves, gowns, and masks. Employers must clean, repair, and replace this equipment as needed. ■ Make available Hepatitis B vaccinations to all employees with occupational exposure to bloodborne patho-gens within 10 days of assignment. ■ Provide post-exposure follow up to any worker who experiences an exposure incident, at no cost to the worker. This includes conducting laboratory tests; providing confidential medical evaluation, identifying, and testing the source individual, if feasible; testing the exposed employee’s blood, if the worker consents; per-forming post-exposure prophylaxis; offering counseling; and evaluating reported illnesses. All diagnoses must remain confidential. ■ Use labels and signs to communicate hazards. The standard requires warning labels affixed to containers of regulated waste, refrigerators and freezers, and other containers used to store or transplant blood or other potentially infectious materials. Facilities may use red bags or containers instead of labels. Em-ployers also must post signs to identify restricted areas. ■ Provide information and training to employees. Employers must ensure that their workers receive regular training that covers the dangers of bloodborne pathogens, preventive practices, and post-exposure proce-dures. Employers must offer this training on initial assignment, then at least annually. In addition, laboratory and production facility workers must receive specialized initial training. ■ Maintain employee medical and training records. The employer also must maintain a Sharps Injury Log unless classified as an exempt industry under OSHA’s standard on Recording and Reporting Occupational Injuries and Illnesses. How can I get more information? OSHA’s website provides more in depth information about bloodborne pathogens on the Bloodborne Patho-gens webpage at www.osha.gov/SLTC/bloodbornepathogens and U.S. Department of Labor Occupational Safety and Health Administration.

There are three general classes of centrifuges in use at the University of Massachusetts at Amherst. Low speed centrifuges which do not exceed 5000 rpm are commonly found on the bench top. High speed centrifuges which do not exceed 25000 rpm are generally floor models. Ultracentrifuges which may exceed 100,000 rpm are often found in core equipment areas and are the most expensive and most dangerous centrifuges on campus. Knowledgeable use, careful procedures, and preventative maintenance are important for all centrifuges but especially for ultracentrifuges.

Over time centrifuge rotors show signs of metal fatigue as a result of the powerful mechanical forces to which they are subjected. Manufacturer guidelines should be followed regarding when to derate (permanently lower the speed) and when to retire centrifuge rotors. Centrifuges are designed to contain the rotor in the event of a failure but there have been documented incidences of rotor failures that were not contained and caused injury to property and personnel. Preventive maintenance for centrifuges should include an inspection of the rotors by trained personnel. Keeping a use log for ultracentrifuges can assist in calculating hours of use which can then be used to determine when a rotor should be derated or retired.

Operators of centrifuges on campus should be trained by supervisors or colleagues in the proper use of centrifuges. User error is the biggest cause of centrifuge malfunction.

Common causes of centrifuge malfunctions include:

Failure to place the lid on the rotor. Failure to properly secure the rotor lid. Failure to properly secure the rotor to the drive. Overloading the rotor’s maximum mass. Running swinging bucket rotor with missing buckets. Buckets hooked incorrectly and unable to swing freely. Improper balancing of centrifuge tubes. Utilization of centrifuge tubes that are not rated for the correct speed.

If a centrifuge malfunctions:

Turn off the centrifuge and do not attempt to open the lid. Contact your supervisor or administrative assistant to determine who to call for

centrifuge repairs. If there is evidence of leakage or tube damage when centrifuging infectious materials,

close the lid immediately, allow aerosols to settle, and plan the disinfection procedure.

All centrifugation shall be done using centrifuge safety buckets or sealed centrifuge tubes in sealed rotors. If any spills or leakage are apparent in the centrifuge the rotor should be cleaned

ENVIRONMENTAL HEALTH & SAFETY FACT SHEET: CENTRIFUGE SAFETY

with a mild detergent, rinsed thoroughly with distilled water, and allowed to air dry completely. Do not use abrasive or corrosive materials to clean the rotor as this can cause damage to the rotor.

The following procedures for centrifugation are recommended:

Examine tubes and bottles for cracks or stress marks before using them. Fill and decant all centrifuge tubes and bottles within the biological safety cabinet. Wipe outside of tubes with disinfectant before placing in safety cups or rotors. Never overfill centrifuge tubes as leakage may occur when tubes are filled to capacity.

The maximum capacity for centrifuge tubes is 3/4 full. Always cap tubes before spinning. Use screw cap tubes. Place all tubes in safety buckets or sealed rotors when centrifuging infectious materials.

Inspect the "O" ring seal of the safety bucket and the inside of safety buckets or rotors. Open safety buckets or rotors in a biological safety cabinet.

Never exceed safe rotor speed. Ensure that the load is balanced. A difference of 0.5 grams at 500000 x g is equivalent

to a 250 kilogram difference. Stop the centrifuge immediately if an unusual condition (noise or vibration) begins.

Centrifuge Safety Online:

Beckman Coulter Centrifugation Laboratory Resources: http://www.beckman.com/resourcecenter/labresources/resource_centrif.asp

Sorvall Centrifuge Information: http://www.kendro.com

AIHA Laboratory Health and Safety Committee Centrifuge information: http://www2.umdnj.edu/eohssweb/aiha/accidents/explosion.htm#Centrifuge http://www2.umdnj.edu/eohssweb/aiha/technical/labequipment.htm#Centrifuge



Phone: 413-545-7293 Fax: 413-545-2600


EN V IR O N M E N T A L HE A L T H & SA F E T Y FA C T SH E E T: CH E M I C A L DI S I N F E C T A N T S

Chemical Disinfectants and Their Use in Laboratories

Disinfectant Concentration (active ingredients)

Contact Time (min)

Effective Against*

B F LV TB HV S

Quaternary Ammonium 0.1 - 0.2% 10 - 30 ++ ++ ++ - - -

Phenolic compounds 0.2 - 3.0% 10 - 30 ++ ++ ++ ++ + -

Chlorine Compounds ** (available chlorine)

0.01 - 5.0% 10 - 30 ++ ++ ++ ++ ++ +

Iodophor Compounds) 0.5% 10 - 30 ++ ++ ++ ++ + -

Alcohol (ethyl or isopropyl) 70 - 85% 10 - 30 ++ ++ ++ - + -

Formaldehyde 4 - 8% 10 - 30 ++ ++ ++ ++ ++ +

Glutaraldehyde 2% 10 - 600 ++ ++ ++ ++ ++ ++

* B = Vegetable bacteria; F = fungi and asexual spores but not necessarily chlamydospores or sexual spores; LV = lipophilic viruses; TB = tubercle bacillus; HV = hydrophilic viruses; S = spores. + = positive response; ++ = very positive response; - = negative response.

** Household bleach contains 5% available chlorine.

*** References: "Decontamination, Sterilization, Disinfection, and Antisepsis in the Microbiology Laboratory," in Laboratory Safety: Principles and Practices and "Sterilization, Disinfection, and Antisepsis in the Hospital," in Manual of Clinical Microbiology.

Environmental Health & Safety 117 Draper Hall


Phone: 413-545-7293 Fax: 413-545-2600

Website: www.ehs.umass.edu

EN V IR O N M E N T A L HE A L T H & SA F E T Y FA C T SH E E T: ET H I D I U M BR O M I D E WA S T E DI S P O S A L

EtBr wastes are not regulated by the State of Massachusetts or the EPA. The wastes are prudently managed by laboratory staff and EH&S to minimize human and environmental exposure. Please follow the instructions listed in the following table when handling EtBr:

Hazardous Waste Pick-up Request: http://www.umass.cems.sr.unh.edu/CEMS/RequestRemoval Do NOT dispose of Ethidium Bromide as Biohazardous waste. Keep waste streams separate.

Please note that studies have shown that treatment with hypochlorite does little to diminish the mutagenic properties of Ethidium Bromide.

Spills and Decontamination 1. Use soap and water mixture (detergent solution) or 70% ethanol to wipe clean laboratory work surfaces

contaminated with ethidium bromide. 2. Use a UV light to survey work surfaces in the laboratory to ensure that the ethidium bromide has been

removed. Wear UV protective glasses when using UV light.

Waste Stream Description Waste Disposal Procedure

Buffer

Typically contain very small concentrations of EtBr (<0.5 mg/L)

Dispose as hazardous waste. Con-tact EH&S for a waste pick-up.

Stock Solutions

Typically contain higher con-centrations of EtBr (1–10 mg/ml)

Dispose as hazardous waste in origi-nal container. Contact EH&S for a waste pick-up.

Gels

Typically contain lower con-centrations of EtBr (3–5 mg/L)

Allow gels to dry out then place in clear, labeled bags. Dried gels may be bagged with EtBr-contaminated debris. Contact EH&S for a waste pick-up.

Contaminated Debris

Gloves, spill cleanup materials, and other lab supplies contami-nated with EtBr

Broken glassware and sharps must be placed in puncture-resistant con-tainers. Other debris may be placed in clear, labeled bags. Contact EH&S for a waste pick-up.

Crystals and Powders

Typically pure or concentrated EtBr

Dispose of EtBr crystals and pow-ders through EH&S. Contact EH&S for a waste pick-up.

The Biological Safety Office has compiled a list of devices and vendors that are recommended for secondary containment when transporting biological agents outside of the laboratory. Feel free to contact one of our specialists for further consultation on appropriate containment for transporting biological agents. Email Judy LaDuc, Associate Biological Safety Officer at: [email protected]

Nalgene Biotransport Carrier Fisher Catalog # 15-251-2

Gene Mate Portable Cooler www.BioExpress.Com 1-800-999-2901 D-3500 Portable Cooler (0°C) $48.00 D-3501 Portable Cooler (-15°C) $51.00

Lock Top IGLOO Cooler (1 Gallon Capacity)

http://www.igloo-store.com/product_list

Item No: PM ELITE RED $29.00

Rubbermaid Storage Containers

http://www.rubbermaid.com Item #4006

ENVIRONMENTAL HEALTH & SAFETY FACT SHEET: SECONDARY CONTAINMENT DEVICES

Rubbermaid All-PurposeUtility Canister

http://www.rubbermaid.com Item #

Hinged, Snap-top Containers

ThermoFisher Scientific # varies with product size

Life Latch® Plastic Pails United States Plastic Corporation Phone: 1-800-809-4217 http://www.usplastic.com

Plano X-Lg Dry Storage (must have O-ring)

Dick’s Sporting Goods

Item # 1929180 $19.99

ShowOffs Storage Container http://www.sterilite.com/ Model #’s: 1890, 1892, 1894, 1896

NO GLOVES BEYOND THIS POINT By order of the University of Massachusetts,

Department of Environmental Health and Safety

As a routine safety precaution, gloves should be removed before exiting the lab. Do not wear gloves into public areas such as corridors, elevators, stairwells, etc. This is for both personal and public safety. Please be courteous to your colleagues. PLEASE USE Secondary Containment methods for transporting biological, chemical or radiological specimens.

http://www.ehs.umass.edu/

http://www.umass.cems.sr.unh.edu/CEMS/RequestRemoval

http://www.umass.cems.sr.unh.edu/CEMS/RequestRemoval

Biological Safety Services

117 Draper Hall

40 Campus Center Way

Amherst, MA 01003-9244

Phone: 413-545-7293

Fax: 413-545-2600


EN V IR ON M EN TA L HEA L TH & SA FE TY FA C T SH E ET :

UV L I G HT S A R E N O T REC OM M EN D ED I N B I O SA FE TY CA B I N E T S

Germicidal Effects of UV Light in Biological Safety Cabinets The Centers for Disease Control (CDC) and the National Institute of Health (NIH) agree that UV lamps are not recom-

mended nor required in biological safety cabinets 2.

The activity of UV lights for sterilization/decontamination purposes is limited by a number of factors including4:

Penetration - In a dynamic air stream (e.g. biological safety cabinet): UV light is not penetrating. Microorganisms be-

neath dust particles or beneath the work surface are not affected by the UV irradiation. UV irradiation can cause ery-

thema that may damage both the skin and eyes of laboratory. Eyes and skin are primarily involved because UV does not

penetrate deeply into tissue. These effects are generally not permanent but can be quite painful.

Relative Humidity - Humidity adversely affects the effectiveness of UV. Above 70% relatively humidity, the germi-

cidal effects drops off precipitously

Temperature and Air Movement - Optimum temperature for output is 77-80°F. Temperatures below this optimum tem-

perature result in reduced output of the germicidal wavelength. Moving air tends to cool the lamp below its optimum

operating temperature and therefore results in reduced output.

Cleanliness - UV lights should be cleaned weekly with an alcohol and water mixture as dust and dirt can block the ger-

micidal effectiveness of the ultraviolet lights.

Age – UV lamps should be checked periodically (approximately every six months) to ensure the appropriate intensity of

UV light is being emitted for germicidal activity (UV C). The amount of germicidal wavelength light emitted from these

bulbs decreases with age and bulb ratings (hours of use) may vary by manufacturer.

Performance Standards for UV Light in Biological Safety Cabinets The Center for Disease Control (CDC) and the National Institute of Health (NIH) agree that UV lamps are not recom-

mended nor required in Biological Safety Cabinets (BSC) 2. The National Sanitation Foundation (NSF) Standard 49 3,

the industry testing standard for all biohazard cabinetry, does not provide any performance criteria for UV lighting and

specifically states in section 4.24.2 that “UV lighting is not recommended in class II (laminar flow) biohazard cabi-

netry.” as it is possible to produce ozone levels from UV wavelengths below 250 nm sufficient to affect rubber or other

polymer made materials, low or no ozone UV light bulbs are commercially available.

Recommendations Due to the short time for UV overexposure to occur, it is recommended that neither laboratory nor maintenance person-

nel work in a room where UV lights are on 1. The CDC, NIH and NSF agree that UV lamps are neither recommended

nor required in Biological Safety Cabinets (BSC). Criteria is not even available from NSF to evaluate the perform-

ance of the UV lights within a biological safety cabinet. Numerous factors affect the activity of the germicidal effect

of UV light, which require regular cleaning, maintenance and monitoring to ensure germicidal activity.

1. Ultraviolet Radiation Exposures in Biomedical Research Laboratories, Mark L. Noll. Appl. Occup. Environ. Hyg. 10(12) December,

1995, pp. 969-972.

2. Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets, U.S. Department of Health and

Human Services, Public Health Services, CDC, and NIH, September 1995. US Government Printing Office Washington, 1995.

3. NSF International (NSF) Standard 49: Class II (Laminar Flow) Biohazard Cabinetry, The NSF Joint Committee on Biohazard Cabi-

netry, May 1992.

4. Keene, Jack; Certification and Use of Biosafety Cabinets (BSC’s) © 1999 Biohaztec Associates, Inc., Midlothian, VA.

Biological Safety Services

117 Draper Hall

40 Campus Center Way

Amherst, MA 01003-9244

Phone: 413-545-7293

Fax: 413-545-2600


EN V I R O N ME NT A L HE AL TH & S AF E TY FAC T SH E E T :

Protection of Vacuum Systems Used in Tissue Culture Work

When laboratory vacuum is used to manipulate biohazardous materials, a suitable trap should be em-ployed to insure that vacuum lines do not become contaminated. When vacuum is used, the system should in-clude an in-line HEPA filter as near as practical to each point of use or service cock. An approved reservoir and filtration apparatus for vacuum systems is described below: Vacuum filtration or aspirating supernatants into collection flasks are common laboratory procedures. Dur-ing vacuum filtration or aspiration procedures building and/or laboratory vacuum systems should be protected. A simple bench-top aerosol/fluid trap can protect building/laboratory vacuum systems. The basic vacuum trap consists of a disposable cartridge-type filter or equivalent installed in-line with a collection/overflow vacuum flask system. The aerosol/fluid trap consists of two vacuum flasks, preferably autoclavable plastic, (size dependent on amount of fluid that may accidentally be aspirated out of the collection flask), thick walled plastic tubing (to prevent tubing collapse), rubber stoppers, a filter (prevents unwanted potentially biohazardous fluid and aerosols from en-tering vacuum systems), and a ceramic splarger (ceramic fish tank bubbler) immersed in disinfectant. The splarger disperses aerosols passing out of the collection flask into small bubbles so that adequate contact is made with a disinfectant solution. Use an appropriate disinfectant solution (such as bleach) shown to be effective on the biohaz-ardous material under study. Add the chemical disinfectant to the collection flasks in full strength. Allow the aspi-rated fluids to complete the dilution. (For example: Start with 100ml bleach, aspirate 900ml fluids and discard). The two vacuum flasks (labeled with biohazard stickers) must be placed in secondary containment such as a plastic tub large enough to contain both vessels. The tubing to the vessels should be neat and not constitute a hazard in and of itself. When the filter or overflow flask require routine changing, they can be safely removed by clamping the line between the filter and the vacuum source before disconnecting the tubing from the source. The filter and vacuum flask should be decontaminated by autoclaving if they have been in contact with potentially biohazardous material. These flasks should be emptied before they are 2/3 full. Replace the vacuum filter when it is clogged or if liquid makes contact with the filter. Check that all connections or seals are tight to assure the vacuum is adequate. See below for a method to protect a vacuum system during aspiration of infectious fluids. The left suction flask (A) is used to collect the contaminated fluids into a suitable decontamination solution; the right flask serves as a fluid overflow collection vessel. A glass splarger in flask B minimizes splatter. An in-line HEPA filter (C) is used to pro-tect the vacuum system (D) from aerosolized microorganisms. See diagram:

CDC: Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets 2nd ed.

Suggested Product: Whatman HEPA-Vent Filter Assure sterile air for mixing, filling, storing, fermenting and transporting with this Whatman filter. Glass fiber filter is treated to be mildly hydrophobic; repels moisture, prevents bacterial growth; 0.3 μm particle retention unaffected by autoclaving. Bidirectional flow. 16 cm2 filter area.

Inlet/Outlet Whatman # Fisher Cat. # Pack of 10 1/4-3/8” tapered hose barb 6723-5000 09-744-79 $96.48 (Jan 2010)

NO GLOVES BEYOND THIS POINT By order of the University of Massachusetts,

Department of Environmental Health and Safety

As a routine safety precaution, gloves should be removed before exiting the lab. Do not wear gloves into public areas such as corridors, elevators, stairwells, etc. This is for both personal and public safety. Please be courteous to your colleagues. PLEASE USE Secondary Containment methods for transporting biological, chemical or radiological specimens.

Biohazardous Waste Packaging Guide: Biohazardous and medical waste is defined as human tissues, wastes from contact with patients, waste contaminated with infectious agents, live vaccines, all sharps (syringes, needles, scalpel blades, etc.), and animal carcasses/tissues. These wastes must be disposed of by incineration. We currently have a contract with Stericycle to pick-up and dispose of our biohazardous and medical waste. Packaging

1. Line the corrugated box with two red bags provided by Stericycle 2. Freeze animal carcasses prior to packaging and pick-up by EH&S 3. All non-sharp waste may be placed directly into the red bag, or individually bagged to help

eliminate odor. 4. Sharps must be in puncture resistant containers prior to going into red bags. 5. The red bag liners must be sealed or tied to prevent leakage. Securely seal the top of the boxes

with tape. 6. The boxes MUST NOT EXCEED 40 POUNDS. The boxes will be rejected if they are

overweight, leaking, bulging or damaged. 7. Do not place any chemical hazardous wastes, radioactive materials, flammable liquids, DEA-

regulated waste, pharmaceutical waste or lead-foil in the bio-boxes. Labeling

1. Before you close the flaps of the box, label the red bag with the name of the facility and building. 2. Label the outside of the corrugated bio-boxes with:

a. Stericycle bar code label b. “PATH WASTE” label if box contains carcasses or sharps c. Label with the name and facility that generated the waste and write the date packed on

this label Pick-Ups and Packaging Material Requests

1. You may place a pick-up request and request packaging supplies at any time on the EH&S website at: http://www.ehs.umass.edu/ and click on “Hazardous Waste Pick-Up Request” at this link: http://www.umass.cems.sr.unh.edu/CEMS/RequestRemoval

2. Pick-ups and packaging supply requests will be filled on Thursday afternoons by EH&S and they will coordinate pick-ups of all biohazardous packages, (especially frozen carcasses) on Thursday mornings.

3. Stericycle provides bio-boxes, red biohazard bags and labeling materials. Please make a note in “Comments” on the “Hazardous Waste Request” when your supplies are getting low. There is no charge for these supplies as used for biohazardous waste.

4. All waste should be left in a secure location until removed by EH&S. Please denote pick-up location when submitting pick-up request.

Special waste requests will be handled on a case by case basis. If you have any questions concerning disposal of biological wastes or other wastes please contact Judy LaDuc, Biological safety Services Manager at Environmental Health and Safety at 545-7293 or [email protected].

Biohazardous Waste Packaging Guidelines Definition: Human tissues and medical waste is defined as human tissues, wastes from contact with patients, waste contaminated with infectious agents, live vaccines, all sharps (syringes, needles, scalpel blades, etc.), and animal carcasses/tissues. Examples: Human tissues, blood, blood

products, other bodily fluids Wastes from contact with

patients/subjects Laboratory cultures/ waste

contaminated with infectious agents

Live vaccines Syringes, hypodermic needles,

scalpel blades and other sharps Animal carcasses and tissues Contaminated bedding Other contaminated items DEA and other controlled

substances Preparations from genetically

altered living organisms

If Discarding: Then: Autoclavable or chemically treatable wastes

1. Disinfect using steam sterilization or an appropriate chemical disinfectant that will kill the target organism(s).

2. Record each autoclave run on the log sheets provided. This is mandated by MA state code: 105 CMR 480.000

3. Test autoclave monthly using biological test spores to verify steam penetration

Human blood, body fluids, and tissues, wastes from contact with patients, laboratory cultures and biotechnology products

3. Label the primary red bag and the sharps containers with a label with the name of the facility and building.

4. The boxes MUST NOT EXCEED 40 POUNDS. The boxes will be rejected if they are overweight, leaking, bulging or damaged.

5. Label the outside of the corrugated bio-boxes with: Stericycle bar code label “Incinerate Only” label if

box contains carcasses or sharps

Label with the name and facility that generated the waste and write the date packed on this label

4. Refrigerate not more than three days or freeze

Animal carcasses/tissues and contaminated bedding

1. Place in leak-proof bag, seal well. No other items may be placed in bag.

2. See #1-4 above 3. Animal carcasses must be

completely frozen (at least 48 hours) before pick-up

For additional information: Biological Safety Services 117 Draper Hall 40 Campus Center Way Amherst, MA 01003-9244 Tel: 413-545-2682

Sharps

1. Place Syringes, hypodermic needles, scalpel blades and other sharps in a red, leak-proof, puncture resistant container labeled with the “Biohazard” symbol.

2. Close and secure the opening with tape if necessary

3. Package same as with blood instructions above.

Other biohazardous materials

Package in accordance with appropriate category listed above or call EH&S for information.

Disposal Information For: Then: Autoclavable and chemically disinfected wastes

1. Treat using accepted procedures and autoclave using manufacturer’s instructions

2. After treatment, handle as general waste (see “General Waste”) by placing in a black trash bag and disposing of in regular trash (dumpster).

Pick-Ups and Packaging Material Requests 5. You may place a pick-up request and request packaging supplies at

any time on the EH&S website at: http://www.ehs.umass.edu/ and click on “Hazardous Waste Pick-Up Request” at this link: http://www.umass.cems.sr.unh.edu/CEMS/RequestRemoval

6. Pick-ups and packaging supply requests will be filled on Thursday afternoons by EH&S and they will coordinate pick-ups of all biohazardous packages, (especially frozen carcasses) on Thursday mornings.

7. Stericycle provides bio-boxes, red biohazard bags and labeling materials. Please make a note in “Comments” on the “Hazardous Waste Request” when your supplies are getting low. EH&S also maintains some supplies in the Fisher Stockroom of LGRT. There is no charge for these supplies as used for biohazardous waste.

8. All waste should be left in a secure location until removed by EH&S. Please denote pick-up location when submitting pick-up request.

Biohazard Emergency Procedures

SPILLS – of Potentially Infectious Material (PIM), cultures or Recombinant DNA

1. For releases outside of containment that cannot be easily and quickly cleaned up by one person, leave room immediately to allow aerosols to dissipate with the room ventilation. Wait at least 15 minutes.

2. If you were splashed or believe you were exposed to aerosols, follow exposure procedures.

3. Limit access to areas where there is potential contamination. Make sure those in the area are not contaminated before they leave.

4. Don gloves, coat and eye protection. Cover the spill with absorbent material such as paper towels.

5. Carefully pour appropriate disinfectant on the spill working toward the center. Be careful not to splash and allow sufficient contact time (10-15 minutes). Fresh 10% bleach is generally appropriate.

6. If there is broken glass, use tongs or a dustpan and a piece of stiff cardboard to collect the glass and put into a sharps container.

7. Clean up gross contamination first without spreading it then work inward from cleaner areas to the dirtiest areas applying more disinfectant as needed.

8. If spill contains a hazardous chemical call EH&S, 5-2682. For radioactive contamination call EH&S, 5-2682.

EXPOSURES - to Potentially Infectious Material (PIM), cultures or Recombinant DNA

1. For splashes that contact mucus membranes or open skin, remove contaminated clothing and put in a red biohazard bag.

Note: if you believe you have inhaled an aerosol, this is an exposure and you should proceed to get medical attention (#4)

2. Immediately wash the exposed area in a sink, eyewash or shower for 15 minutes. Contaminated skin should be washed with soap or a mild disinfectant.

3. Those attending should be careful not to become contaminated as well.

4. As soon as possible the exposed individual should get medical treatment. For serious incidents go directly to the emergency room (call 911). For non-serious incidents go to University Health Services or see your personal physician.

5. Fill out an incident report, check recombinant DNA if applicable

6. Notify EH&S of all biological exposures, 5-7293.

7. Contaminated garments must be disinfected at no cost to the employee by using a laundering company that provides this service or by using a method such as autoclaving before returning them to the worker. Otherwise they must be discarded as biowaste.

Autoclave

Verification Flowchart

Used for Sterilization of

Supplies or Instruments

Used to Sterilize Media Only

Used to

Decontaminate General BSL-1

Lab Waste

Used to Decontaminate BSL-2 Waste

(Biohazardous) Blood, Cultures,

RNA, etc.

Used to

Decontaminate BSL-3/ABSL-3

Waste

All autoclave runs

must be documented on

the log sheet

Verify with Prospores Quarterly;

Use packaging

with sterilization indicators on

them

All autoclave runs must be

documented on the log sheet

Verify with Prospores Quarterly;

Use packaging

with sterilization indicators on

them

Inspected and Certified

Annually by a Professional



Verify with Prospores Quarterly

Inspected and

Certified Annually by a Professional



Inspected and

Certified Annually by a Professional

Verify with Prospores

Monthly



Verify with

Prospores on Every Autoclave

Run





Reprocessing Methods for Equipment Used in the Research Setting Sterilization Destroys: All forms of microbial life including high numbers of bacterial spores.

Methods: Steam under pressure (autoclave), gas (ethylene oxide), dry heat or immersion in an approved chemical “sterilant” (e.g., US Environmental Protection Agency – approved) for prolonged period of time, e.g., 6-10 hours or according to manufacturer’s instructions. Note: Liquid chemical “sterilants” should be used only on those instruments that are impossible to sterilize or disinfect with heat.

Use: For those instruments or devices that penetrate skin or contact normal sterile areas of the body, e.g., scalpels, needles, etc. Disposable invasive equipment eliminates the need to reprocess these types of items. When indicated, however, arrangements should be made with a facility for reprocessing of reusable invasive instruments.

High-Level Disinfection

Destroys: All forms of microbial life except high numbers of bacterial spores. Methods: Hot water pasteurization (80-1000C, 30 minutes) or an exposure to an approved (e.g., US EPA

– approved “sterilant” chemical as above, except for a short exposure time (10 – 45 minutes or as directed by manufacturer).

Use: For reusable instruments or devices that come into contact with mucous membranes Intermediate Level Disinfection

Destroys: Mycobacterium tuberculosis, vegetative bacteria, most viruses and most fungi, but does not kill bacterial spores

Methods: Approved (e.g., US EPA – approved) “hospital disinfectant” chemical germicides that have a label claim for tuberculocidal activity; commercially available hard-surface germicides or solutions containing at least 500 ppm free available chlorine (a 1:10 dilution of common household bleach – about ¼ cup bleach per gallon of tap water).

Use: For those surfaces that come into contact only with intact skin, and have been visibly contaminated with blood or bloody body fluids. Surfaces must be pre-cleaned of visible material before the germicidal chemical is applied for disinfection.

Low Level Disinfection Destroys: Most bacteria, some viruses, some fungi, but no Mycobacterium tuberculosis or bacterial spores.

Methods: Approved (e.g., US EPA – approved) “hospital disinfectants” (no label claim for tuberculocidal activity).

Use: Use these excellent cleaning agents for routine housekeeping or removal of soiling in the absence of visible blood contamination.

Environmental Disinfection

Environmental surfaces that have become soiled should be cleaned and disinfected using any cleaner or disinfectant that is intended for environmental use. Such surfaces include floors, woodwork, seats, countertops, etc.

Important: To assure effectiveness of any sterilization or disinfection process, equipment and instruments must first be thoroughly cleaned of all visible soil.

Biological Safety Manual - UMass Amherst Amherst... · 2016. 6. 6. · 3.2 IBC membership conforms...

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