2016 Chemical Data Reporting (CDR): Don’t Despair; Get ...TSCA Section 5 civil actions; TSCA...

© 2014 Bergeson & Campbell, P.C. All Rights Reserved.

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 Chemical Data Report ing (CDR) Don’t Despair; Get Prepared! May 3, 2016

© 2014 Bergeson & Campbell, P.C. All Rights Reserved. © 2014 Bergeson & Campbell, P.C. All Rights Reserved.

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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© 2016 Bergeson & Campbell, PC. All Rights Reserved.

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

© 2016 Bergeson & Campbell, PC. All Rights Reserved. 10

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


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


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


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


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


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

Import site is address of importer, not shipping destination 26


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


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


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 2012, 2013, 2014, or 2015

Reporting threshold for process and use (Form U, Part III)



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


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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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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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


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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http://www.epa.gov/cdr


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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mailto:[email protected]

mailto:[email protected]

http://www.bc-cm.com/

2016 Chemical Data Reporting (CDR): Don’t Despair; Get ...TSCA Section 5 civil actions; TSCA...

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