2016 Chemical Data Reporting (CDR): Don’t Despair; Get ...TSCA Section 5 civil actions; TSCA...
Transcript of 2016 Chemical Data Reporting (CDR): Don’t Despair; Get ...TSCA Section 5 civil actions; TSCA...
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2016 Chemical Data Reporting (CDR):
Don’t Despair; Get Prepared!
Webinar
May 3, 2016 1:00 p.m. – 2:00 p.m. (EDT)
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Richard E. Engler, Ph.D. Kathleen M. Roberts Bergeson & Campbell, P.C. Washington, D.C. www.lawbc.com
© 2016 Bergeson & Campbell, P.C. All Rights Reserved.
2016 Chemical Data Report ing (CDR) Don’t Despair; Get Prepared! May 3, 2016
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SPEAKERS:
Richard E. Engler, Ph.D. Senior Chemist Bergeson & Campbell, P.C. [email protected]
Kathleen M. Roberts Senior Regulatory Consultant Bergeson & Campbell, P.C. [email protected]
Lynn L. Bergeson Managing Partner Bergeson & Campbell, P.C. [email protected]
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What We Will Cover
Overview of CDR Reporting Elements
Changes in 2016 Reporting Cycle
Helpful Hints
CDR and Next Generation Compliance
Q&A
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Who Is Subject to CDR? Companies that manufacture or import a chemical substance in 2012-2015 (inclusive) that: Is subject to the Toxic Substances Control Act
(TSCA) AND Is listed on the TSCA Inventory AND Is not otherwise exempt from CDR reporting AND Meets or exceeds the CDR reporting threshold
Threshold depends on substance and company size
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Chemicals Subject to TSCA Used in applications not otherwise regulated
under another federal statute, such as: Pesticides
Tobacco
Nuclear materials
Food additives
Drugs
Cosmetics
Medical devices
Chemicals on the TSCA Inventory = self-explanatory
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Chemicals Exempt from CDR
Water or naturally occurring substances
Polymers
Microorganisms
Certain forms of natural gases
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WATCH OUT! Exclusions to Chemical Exemption No exemption if substances subject to:
TSCA Section 4, 5(a)(2), 5(b)(4), or 6 rule (proposed or promulgated)
Enforceable consent agreement (ECA)
TSCA Section 5(e) or 5(f) order
TSCA Section 5 or 7 civil action
In force as of June 1, 2016
Actions do NOT affect naturally occurring chemical exemption
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CDR Reporting Thresholds
■ 2,500 pounds per year per facility for chemicals subject to: TSCA Section 5(a)(2)
Significant New Use Rules (SNUR) (proposed or promulgated);
TSCA Section 5(b)(4) rules (proposed or promulgated);
TSCA Section 5(e) orders;
TSCA Section 5(f) orders;
TSCA Section 5 civil actions;
TSCA Section 6 rules (proposed or promulgated); and
TSCA Section 7 civil actions
As of June 1, 2016
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25,000 pounds per year per facility for all other chemicals subject to CDR
NEW for 2016
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CDR Reporting Thresholds (cont’d)
Reporting required on chemicals that meet annual reporting threshold in any year since the last principal reporting year
For 2016, reporting on chemicals that meet threshold in:
2012;
2013;
2014; OR
2015
NEW for 2016
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Small Business Exemption Full reporting exemption available for companies
with all sales combined (including parent company and subsidiaries) Less than $40 million in principle reporting year (i.e.,
2015) • As long as given chemical substance production or import
does not exceed 100,000 pounds
Full reporting exemption available for companies with all sales combined with parent company Less than $4 million in principle reporting year (i.e., 2015)
• Regardless of annual production volume
May be eligible for the small business exemption for one chemical and not others
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WATCH OUT! Exclusion to Small Business Exemption Small business exemption voided if chemical is
subject to: TSCA Section 4, 5(b)(4), or 6 rule (proposed or
promulgated)
TSCA Section 5(e) order
TSCA Section 5 or 7 civil action
As of June 1, 2016
AND
Produced or imported at 25,000 pounds or more per facility per year
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CDR Reporting Elements -- Form U, Part I Parent Company
Site Information
For imports, reporting facility = U.S. site of the operating unit within the person’s organization that is directly responsible for importing the chemical substance
• May be the organization’s headquarters
• If no U.S. unit, use address of agent authorized to accept service of process for the importer
• If two or more parties are involved in import transaction and each meets definition of “importer,” they may determine among themselves who will submit
– If no one reports, all who qualify as importer are liable
Technical Contact
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CDR Reporting Elements -- Form U, Part II Chemical Identification Manufacturing Information
For 2012, 2013, 2014, and 2015 production and/or import volumes
For 2015 (principal reporting year): Number of workers, maximum concentration, physical form, volumes manufactured, volume imported, activity (manufacture, import, or both), indication if chemical is physically at site, indication if chemical is recycled, volumes used on site, volumes exported
Include export volume in production volume total Report per chemical per site
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NEW for 2016
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CDR Reporting Elements -- Form U, Part III: Processing and Use Information
No separate reporting threshold for Part III
Same as reporting threshold for CDR
• 25,000 pounds or
• 2,500 pounds if subject to certain TSCA actions
Processing and use information based on principal reporting year data (i.e., 2015)
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NEW for 2016
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Process and Use Information
Industrial Uses Top ten combinations of
industrial process, industrial sector, and industrial functions;
Production or importation volumes associated with each combination;
Number of industrial sites using the chemical within each combination; and
Number of workers potentially exposed within each combination
Commercial/Consumer Uses Top ten
consumer/commercial downstream applications;
Indication of whether in products intended for children;
Production or importation volumes associated with each reported category;
Maximum concentration within each reported category; and
Number of workers potentially exposed with each reported commercial category
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CDR Reporting Elements -- Form U, Part III: Partial Reporting Exemption List of chemicals exempt from process and use
information reporting
Partial reporting exemption unavailable if subject to: TSCA Section 4, 5(a)(2), 5(b)(4), or 6 rule (proposed
or promulgated)
ECA developed under 40 C.F.R. Part 790
TSCA Section 5(e) or 5(f) order
TSCA Section 5 or 7 civil action
As of June 1, 2016
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CDR Reporting Standard
Report information “known to or reasonably ascertainable by” Means all information in a person’s possession or
control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know
No requirements to conduct new customer surveys • If surveys conducted in the past, that information should
be used • Other information viewed as “known to or reasonably
ascertainable by” includes marketing studies, sales reports, and safety data sheets (SDS)
If unknown, report “NKRA” -- not known or reasonably ascertainable
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Preparing for 2016 CDR -- Manufactured Chemicals ■ Identify chemicals subject to TSCA manufactured in
2012, 2013, 2014, and 2015 If blending or processing of materials occurs onsite, verify
that no new chemical reactions are occurring as part of that blending or processing
• If reaction occurs, identify chemical component(s) – Could be discrete substance(s) or UVCB substance
(Unknown or Variable composition, Complex reaction products and Biological material)
• If no reaction occurs, the material is a mixture not subject to CDR reporting
Calculate volumes of each reportable chemical in 2012, 2013, 2014, and 2015
Note that for “toll manufacturing,” parties are jointly responsible
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WATCH OUT! Byproducts Byproduct = chemical substance produced
without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance or mixture “(2) Manufacture for commercial purposes also applies to
chemical substances that are produced coincidentally during the manufacture, processing, use, or disposal of another chemical substance or mixture, including both byproducts that are separated from that other substance or mixture and impurities that remain in that chemical substance or mixture. Such byproducts and impurities may, or may not, in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose (40 CFR 704.3)”
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WATCH OUT! Exempted Byproducts Byproducts exempted from CDR reporting IF the
only commercial purpose(s) consists of the following: 1. Burned as a fuel; 2. Disposed of as a waste, including in a landfill or for
enriching soil; or 3. Used to extract component chemical substances from it
for commercial purposes To qualify for exemption point 3, the U.S.
Environmental Protection Agency (EPA) states: “‘[T]he component to be extracted must be already
existing as a distinct chemical substance in the waste stream.’ When the chemical substance present in the byproduct and the chemical substance extracted from the byproduct are distinct chemical substances, neither the manufacture of the byproduct nor the manufacture of the extracted chemical substance qualify for the 40 CFR 720.30(g)(3) [byproduct] exemption.”
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Preparing for 2016 CDR -- Imported Chemicals Identify chemicals subject to TSCA imported in 2012,
2013, 2014, and 2015 If imported material is a mixture, identify each individual
chemical component and percentage of each component in mixture
There is no de minimis threshold for components that are intentionally present
For each substance, gather Chemical Abstracts Registry Numbers (CAS RN) or Accession Numbers and names
Calculate volumes of each reportable chemical component imported in 2012, 2013, 2014, and 2015
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Preparing for 2016 CDR -- Identify Threshold Determine if any substances manufactured
(including byproducts) or imported in 2012, 2013, 2014, and 2015 are subject to TSCA actions that impact reporting thresholds or reporting exemptions as of June 1, 2016
Compare volumes manufactured and imported in 2012, 2013, 2014, and 2015 against applicable reporting threshold to identify substances requiring 2016 CDR reporting Reporting thresholds = sum of manufacture and import
volumes
Maintain documentation for chemicals that do not meet thresholds and therefore are not reported
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Use Substance Registry System (SRS) to Identify Chemicals Subject to TSCA Actions ■ Search by chemical
Type in chemical name
Select “Program and Regulatory Information”
View listed regulations
■ Search for lists Click on “Search by
List” in green box
Add “2016 CDR” in filter box
Click on list of interest
Export list for review
EPA to post guidance document,
Searching SRS for Chemicals That Are Subject to Certain TSCA Actions
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Summary -- List of Reportable Chemicals
For years 2012, 2013, 2014, and 2015:
1. Identify manufactured chemicals subject to TSCA
2. Identify imported chemicals subject to TSCA
3. Determine annual volumes (manufacture and import) for all chemicals subject to TSCA
4. Determine if any chemical(s) subject to lower reporting thresholds due to certain TSCA actions
5. Compare annual volumes against reporting thresholds (including small business criteria) to identify chemicals subject to CDR reporting
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Preparing for CDR -- Information Elements For each chemical to be reported, identify:
Production volumes per year for 2012, 2013, 2014, and 2015
Import volumes per year for 2012, 2013, 2014, and 2015
For 2015, identify: • Number of workers potentially exposed at facility
• Maximum concentration as it leaves site
• Physical forms
• Whether chemical is physically at site
• Whether chemical is recycled
• Volumes used on site
• Volumes exported
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Preparing for CDR -- Information Elements (cont’d) Identify chemicals eligible for partial reporting
exemption For all remaining chemicals, review sales/marketing
files and other relevant information sources to identify: Top ten combinations of industrial process, industrial
sector. and industrial functions in 2015; with associated production/importation volumes, number of industrial sites, and number of workers for each combination
Top ten consumer/commercial downstream applications in 2015; with indications of whether in products intended for children, associated production/importation volumes, maximum concentrations, and number of workers
Gather location information for all sites (best to find EPA Facility Registry System Identification number, FRS ID)
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Preparing for CDR -- Claiming CBI
Determine if any reported information element is considered Confidential Business Information (CBI) Upfront substantiation required for:
• Processing and use information
• Site
• Chemical identity
Cannot claim responses of “NKRA” -- not known or reasonably ascertainable -- as CBI
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Certain TSCA Actions -- Summary
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TSCA Action
Limitation on Reporting Exemption
2,500 lbs Reporting Threshold
No Small Businesses
Exemption*
Section 4 test rule
Section 5(a)(2) SNUR
Section 6
ECA
Section 5(e) or 5(f) order
Section 5(b)(4)
Section 7
* If production volume at any site, in any year, exceeds 25,000 pounds
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Inventory Update Rule (IUR)/CDR Reporting Elements for 2006, 2012, and 2016
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2006 2012 2016
Reporting threshold for production volume (Form U, Parts I and II)
25,000 lbs per site in 2005
25,000 lbs per site in 2011
25,000 lbs per site in 2012, 2013, 2014, or 2015
Reporting threshold for process and use (Form U, Part III)
300,000 lbs per site in 2005
100,000 lbs per site in 2011
25,000 lbs per site in 2012, 2013, 2014, or 2015 (but only 2015 data reported on Form U, Part III)
Reporting threshold for chemicals subject to certain TSCA rules/orders
25,000 lbs per site
25,000 lbs per site
2,500 lbs per site
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Inventory Update Rule (IUR)/CDR Reporting Elements for 2006, 2012, and 2016 (cont’d)
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2006 2012 2016
Years of production and volume information to be reported
2005 2010 and 2011 2012, 2013, 2014, and 2015
Reporting period Original period 9/1/06 to 12/31/06; extended to 3/23/07
2/1/12 to 6/30/12; extended to
8/13/12
6/1/16 to 9/30/16
Report submission options Electronic submission urged but not required
e-CDR e-CDR
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Inventory Update Rule (IUR)/CDR Reporting Elements for 2006, 2012, and 2016 (cont’d)
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2006 2012 2016
Upfront substantiation on CBI required
For chemical identity and plant site only
For chemical identity, plant site, and process and use information
For chemical identity, plant site, and process and use information
Reporting standard for processing and use information
Readily obtainable
Known to or reasonably ascertainable by
Known to or reasonably ascertainable by
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Inventory Update Rule (IUR)/CDR Reporting Elements for 2006, 2012, and 2016 (cont’d)
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2006 2012 2016
Allowable chemical identifying number CAS, PMN, TSCA Accession numbers
Only CAS or TSCA Accession number
Only CAS or TSCA Accession number
Volume of substance used at site Not required
Required Required
Whether imported chemical is physically at the reporting site
Not required
Required Required
Volume of chemical directly exported Not required
Required Required
Whether substance is being recycled, remanufactured, reprocessed, or reused
Not required
Required Required
Reporting on number of commercial workers potentially exposed
Not required
Required Required
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Reminders and Helpful Hints Submission period = June 1 to September 30, 2016 CDR Report = Form U
Electronic reporting via Central Data Exchange (CDX): For each individual who will enter data: If not already registered with CDX, do so NOW
If already registered, verify passwords and security question responses and verify role as Primary Authorized Official in Chemical Safety and Pesticide Program (CSPP) workflow
Review compliance needs for company acquisitions/changes If new company acquired or formed in 2012, 2013, 2014, or
2015, repeat steps in “Preparing for CDR” for those entities
Document basis for reporting (or non-reporting) determinations
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More Information Guidance information, webinars, frequently asked
questions on EPA website -- www.epa.gov/cdr, including: Reporting Thresholds for 2016 Chemical Substances That Are the Subject of Certain
TSCA Actions Changes to Company Ownership or Legal Identity Importers Imported Articles Toll Manufacturing Byproducts Reporting for the Printed Circuit Board
Industry More
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Next Generation Compliance Design regulations and permits that are easier to
implement, with a goal of improved compliance and environmental outcomes
Use and promote advanced emissions/pollutant detection technology so that regulated entities, the government, and the public can more easily see pollutant discharges, environmental conditions, and noncompliance
Shift toward electronic reporting to help make environmental reporting more accurate, complete, and efficient while helping EPA and co-regulators better manage information and improve effectiveness and transparency
Expand transparency by making information more accessible to the public
Develop and use innovative enforcement approaches (e.g., data analytics and targeting) to achieve more widespread compliance
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Next Generation Compliance (cont’d)
If you filed a Notice of Commencement, be sure to file a Form U (or document CDR exemption)
Be sure that reporting for other EPA programs and permits (e.g., Toxics Release Inventory (TRI), air, and water permits) are consistent with CDR reporting
Be sure that CDR Form U data meet any restrictions (e.g., SNUR) for substance
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Thank You
Richard E. Engler, Ph.D. Kathleen M. Roberts
Bergeson & Campbell, P.C. 2200 Pennsylvania Avenue, N.W.
Suite 100W Washington, D.C. 20037
[email protected] [email protected]
www.lawbc.com
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