TIC, TAC, TSCA:WHAT YOU NEED TO KNOWTO PREPARE ...€¦ · PRIORITIZATION PROCESS RULE Procedural...

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TIC, TAC, TSCA: WHAT YOU NEED TO KNOW TO PREPARE

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TIC, TAC, TSCA: WHAT YOU NEED TO KNOW TO PREPARE FOR IMPLEMENTATION IN 2017

Ian CohenProduct Manager, Medgate

February 23, 2017

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ABOUT MEEDUCATION

• MS Environmental Science, 2011• BS Biology, 2008

EXPERIENCE• Environmental Suite Product Manager

• Medgate, 2016‐present

• Environmental Specialist• Florida Power & Light, 2012‐2016

• Intern/Environmental Technician• Tennessee Valley Authority, 2010‐2012


AGENDA

01 Legislative history

02 Legal requirements

03 Immediate Actions & Framework Actions

04 Early Mandatory Actions

05 Later Mandatory Actions

06 Recent developments

07 Near‐term & long‐term issues


LEGISLATIVE HISTORY

06/22/2016 Became Public Law No: 114‐182. (TXT | PDF)

06/22/2016 Signed by President.

06/14/2016 Presented to President.

06/07/2016Resolving differences ‐‐ Senate actions: Senate agreed to the House amendment to the Senate amendment by Voice Vote.(consideration: CR S3523)

05/24/2016Resolving differences ‐‐ House actions: On motion that the House agree with an amendment to the Senate amendment Agreed to by the Yeas and Nays: 403 ‐ 12 (Roll no. 238).(text as House agreed with an amendment to the Senate amendment: CR H3007‐3025)

12/17/2015 Passed/agreed to in Senate: Passed Senate with an amendment by Voice Vote.

06/23/2015Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 398 ‐ 1 (Roll no. 378).(text: CR H4551‐4556)

06/23/2015 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114‐176.

05/26/2015 Introduced in House

This is the first substantive changes to TSCA since it’s passage in 1976.


Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines

New risk‐based safety standard for new chemicals

Increased public transparency for chemical information – real‐time inventory

Consistent source of funding for EPA to carry out the responsibilities under the new law

LEGAL REQUIREMENTSTSCA covers everyone ‐manufacturers, users, processors, importers, exporter and those who sell products containing chemicals.


When the list is published in the Federal Register:• Triggers a statutory deadline to complete risk evaluations for these chemicals

within three years • Evaluation will determine whether the chemicals present an unreasonable

risk to humans and the environment• If it is determined that a chemical presents an unreasonable risk, EPA must

mitigate that risk within two years

LEGAL REQUIREMENTS


EPA must release a scoping document within six months for each chemical that includes:

• Hazard(s), exposure(s), conditions of use, and the potentially exposed or susceptible subpopulation(s) the agency plans to consider for the evaluation

LEGAL REQUIREMENTS


• For each risk evaluation that EPA completes, TSCA requires that EPA begin another

• By the end of 2019, EPA must have at least 20 chemical risk valuations ongoing at any given time

• The new law provides a consistent source of funding for EPA to carry out its statutory responsibilities

LEGAL REQUIREMENTS


POLL QUESTION #1What impact will the revised TSCA law have on your company? Select all that apply.

A. Increased regulatory burdensB. Shift to production/purchase of “green” chemicals C. Delays in manufacturing D. Changes to chemical formulations E. Changes in procurement processF. Increased disposal costs


REQUIREMENTS• Review and make an affirmative

determinations for pre‐manufacture notices (PMNs) and significant new use notices (SNUNs)

GOALS• Meet applicable deadlines• PMNs submitted prior to

enactment and are currently undergoing review

IMMEDIATE ACTIONSNEW CHEMICALS


REQUIREMENTS• Confidentiality claims: Review all

new chemicals that have been offered for commercial distribution within 90 days

• Approved chemicals: Apply a unique identifier to the chemical and any associated information

GOALS• Meet the 90 day deadline and

create a plan to link associated information within 30 days

IMMEDIATE ACTIONSCONFIDENTIAL BUSINESS INFORMATION (CBI)


REQUIREMENTS• Routine review of and

determination for at least 25% of new confidentiality claims for other types of information (Within 90 days)

• Claimants to submit required statement and certification for all CBI claims

GOALS• Develop approach for routine

review in 30 days • Provide stakeholders with

additional information on statement and certification

IMMEDIATE ACTIONSCONFIDENTIAL BUSINESS INFORMATION (CBI)


IMMEDIATE ACTIONSONGOING SECTION 6 RULEMAKINGS

ADDRESS IDENTIFIED RISKS FROM:

Trichloroethylene (TCE), methylene chloride (MC) and N‐methylpyrrolidone (NMP)

• TCE: Final rule anticipated October 2017 for use in spot cleaning and aerosol degreasing and for use in vapor degreasing anticipated December 2017• The comment period to ban aerosol degreaser and spot

cleaning in dry cleaning facilities was extended to March 16, 2017 and commercial vapor degreaser has been extended to April 19, 2017.

• MC and NMP: Final rule anticipated December 2017 for use in paint removers


Deadline180 days after enactment (Completed November 2016)

Publish scope of each assessment within 6 months (June 2017)

FRAMEWORK ACTIONSINITIAL RISK EVALUATIONSPublish list of 10 Work Plan chemicals and initiate risk evaluations


FRAMEWORK ACTIONSPRIORITIZATION PROCESS RULEProcedural rule to establish process and criteria for identifying high and low priority chemicals for evaluation

Deadline Final rule one year after enactment (June 2017)

Interim MilestonePublished proposed rule (December 2016)


FRAMEWORK ACTIONSRISK EVALUATION PROCESS RULEProcedural rule to establish the process for evaluating the risk of high priority chemicals

DeadlineFinal rule one year after enactment (June 2017)

Interim MilestonePublished proposed rule (December 2016)


FRAMEWORK ACTIONSFEES RULEDevelop a rule to require fees:• Help defray the cost of

implementing certain provisions

• Fully defray the cost of industry‐requested risk evaluations

There is no deadline in the bill for establishing a fee schedule.Goal: Final rule one year after enactment (June 2017)

Interim MilestoneConsulted with parties potentially subject to the fees and published proposed rule(December 2016)


FRAMEWORK ACTIONSINVENTORY RULECreate a rule to require industry reporting of chemicals manufactured/processed in the previous 10 years. Results will be used to designate active and inactive chemicals on the TSCA Inventory list.

DeadlineFinal rule one year after enactment (June 2017)

Interim MilestonePublished proposed rule(December 2016)


DeadlineCommittee established one year after enactment

GoalCommittee established 6 months after enactment(mid‐December 2016)

Interim MilestonesFederal Register Notice published early (September 2016)Public comment period ended early (November 2016)

FRAMEWORK ACTIONSSCIENCE ADVISORY COMMITTEE ON CHEMICALSEstablish a committee to provide independent advice and expert consultation


EARLY MANDATORY ACTIONSSCOPE OF INITIAL RISK EVALUATIONSPublication of the scope of the evaluation for the first 10 chemicals

Deadline: publish 6 months after initiation (June 2017)

ANNUAL PLAN FOR RISK EVALUATIONSIdentify chemicals that evaluations are expected to be initiated or completed that year, resources needed, status of other chemicals under evaluation, updated schedules

Deadline: the beginning of each calendar year after enactmentFirst plan due early January 2017


ADDITIONS TO MERCURY EXPORT BANAll mercury compounds are now banned from export

• Elemental mercury already banned under MEBA

Deadline: Publish initial list of mercury compounds prohibited from export 90 days after enactment (September 2016)

MERCURY INVENTORYPublish an inventory of mercury supply, use, and trade in the U.S. and update it every three years

Deadline: First inventory will be published April 1, 2017

EARLY MANDATORY

ACTIONS


EARLY MANDATORY ACTIONSSMALL BUSINESS DEFINITIONSReview standards for identifying small manufacturers and processors, and revise as warranted

DeadlineDetermine whether revision is warranted within 180 days of enactment

GoalPlan and schedule for revisions published with the determination


EARLY MANDATORY ACTIONSREPORT TO CONGRESSReport must provide the following:

• Capacity to conduct industry‐requested risk evaluations• The likely demand for such requests• The anticipated schedule for accommodating the demand

DeadlineFirst report must be submitted 180 days after enactment (December 2016) and every 5 years thereafter


Mercury Use/Product Reporting RuleDeadline: Final rule 2 years after enactment (June 2018)

CBI Review/Substantiation RuleDeadline: Final rule 1 year after publication of active list of chemicals

Generic Names for CBI ChemicalsDeadline: Guidance 2 years after enactment (June 2018)

Negotiated Rulemaking on Byproducts Reporting for CDR

Deadline: Proposed rule 3 years from enactment (June 2019)

Alternative Testing Methods StrategyDeadline: Publish strategy 2 years after enactment (June 2018)

LATER MANDATORY

ACTIONS


ON NOVEMBER 29, 2016, EPA RELEASED THE FIRST 10 CHEMICALS IT WOULD REVIEW

FROM THE 2014 TSCA WORK PLAN.

Methylene ChlorideN‐methylpyrrolidonePigment Violet 29Tetrachloroethylene (perchloroethylene)Trichloroethylene

1,4‐Dioxane1‐BromopropaneAsbestosCarbon TetrachlorideCyclic Aliphatic Bromide Cluster


RECENT DEVELOPMENTSEPA is doing/has done the following:

• Held Public meeting on February 14, 2017 on collecting chemical use information for 10 chemicals being evaluated

• Establishing a Negotiated Rulemaking Committee on CDR byproduct chemical substances

• Requesting comment on standards for small manufacturers and processors• Identified the first chemicals for review• Provided Q&A on PBT chemicals (June 2019) • Established the Science Advisory Committee on Chemicals• Identified five mercury compounds for export restrictions


POLL QUESTION #2

What risk does this regulations present to your company?

A. HighB. MediumC. LowD. None identifiedE. Unsure at this time


NEAR‐TERM ISSUES • Scott Pruitt, new head of the EPA • Republicans control both chambers

of Congress and the presidency• H.R.861 ‐ To terminate the

Environmental Protection Agency • Presidential Executive Order on

Reducing Regulation and Controlling Regulatory Costs


• Decentralization of environmental protection• 50 States, 50 regulations?

• Lawsuits between States due to environmental degradation?

• The desire by many conservatives to eliminate the EPA altogether will likely result in each state developing their own environmental protection laws

LONG‐TERM ISSUES


POLL QUESTION #3

Do you think the elimination of the EPA would be a positive benefit to your company?

A. YesB. No


CONCLUDING REMARKS

• Amended TSCA law provides EPA with more authority when it comes to reviewing new and existing chemicals

• EPA has identified the first 10 chemicals it will risk review

• EPA has an aggressive timeline that is statutorily governed

• Changes in D.C. remain unclear but could result in further or complete decentralization of environmental protection at the State and local level


THANK YOU!

Ian CohenProduct Manager

Medgate


Disclaimers

*This webinar is designed to provide accurate and authoritative information about the subject matter covered. It is sold with the understanding that the publisher is not engaged in rendering legal, accounting, or other professional services. *This webinar provides general information only and does not constitute legal advice. No attorney-client relationship has been created. If legal advice or other expert assistance is required, the services of a competent professional should be sought. We recommend that you consult with qualified local counsel familiar with your specific situation before taking any action.

TIC, TAC, TSCA:WHAT YOU NEED TO KNOWTO PREPARE ...€¦ · PRIORITIZATION PROCESS RULE Procedural...

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