the tsca inventory “reset” tsca 3030...tom berger has a chemical engineering background and is a...

Copyright © 2017 | www.khlaw.com Keller and Heckman LLP 1

The TSCA Inventory “Reset”

November 8, 2017


Please Don’t Forget to Dial-In:

Conferencing Number: (800) 768-2983

Access Code: 434 4318(View the slides via webinar, and the sound via phone)


Thomas C. “Tom” Berger

Tom Berger has a chemical engineering background and is a partner at Keller and Heckman. His practice focuses on the regulation and approval of new and existing chemicals under the Toxic Substances Control Act (TSCA) and its international counterparts in Australia, Canada, China, the European Union, Japan, Malaysia, New Zealand, the Philippines, South Korea, and Taiwan. Mr. Berger also counsels trade association clients on various matters, including environmental, and product disparagement and defense issues. Mr. Berger has been heavily involved in “reformed” TSCA, EPA's Chemical Data Reporting (CDR) rule, TSCA “Work Plan Chemicals,” and the TSCA Inventory “reset.”

[email protected] • 202.434.4285


Agenda

Basic reset requirements and deadlines

Scope and exemptions

Multi-party and importer situations

Polymers

CBI Issues

Practical tips


As of January 2017: ~86,000 Chemicals

New Chemicals Added (~24,000): notified via the PMN/NOC process

Initial Inventory (~62,000): Substances in U.S. commerce between 01/01/75 and 06/01/79

Public (70%)

Confidential (3%)

Public (10%)

Confidential (17%)

The TSCA Inventory…


LCSA §§ 8(b)(4)–(5)

Statutory requirement to “reset” Inventory

LCSA requires EPA to issue rule within one year of enactment requiring manufacturers and importers to notify EPA within 180 days of each TSCA Inventory listed non-exempt substance produced within 10 years prior to June 21, 2016

• EPA “may” require processor reporting


Inventory Reset Rulemaking

August 11, 2017 EPA publishes final “reset” rule• 82 Fed. Reg. 37,520

Companies must report via CDX all non-exempt substances that they manufactured or imported for non-exempt purpose in 10-year period (“lookback period”, LBP)

• LBP = June 21, 2006 to June 21, 2016

• Voluntary for processors

This is called “retrospective” reset reporting


Retrospective Reset Reporting

Based on “retrospective” reports, EPA to subdivide Inventory into separate lists of “active”, “inactive” substances• Reported substances = “active”

• Non-reported substances = “inactive”

February 7, 2018 = deadline for mandatory reporting by manufacturers and importers

October 5, 2018 = deadline for voluntary reporting by processors


Forward-Looking Reporting

Once designated as “inactive,” substance prohibited from being manufactured, imported, or processed unless EPA notified in advance (“forward-looking reporting”)

• Substance not formally designated as “inactive” until 90-days after EPA identifies substance as such

– Addresses “resumption” issue

• EPA cannot delist inactive or require PMN for inactive upon change to active


Reset Forms (CDX)

NOA “Form A” = used by manufacturers, importers, processors for retrospective reporting

• Must contain: company, technical contact, CASRN, CA Index name, Accession No., required certifications

• Date range requirement eliminated

NOA “Form B” = used by manufacturers, importers, and processors for forward-looking reporting

• Must contain same information as Form A and “anticipated” date by which substance to be manufactured or processed in the U.S.


Exemptions From Reset

Non-“chemical substances”• e.g., food additives, pesticides

R&D / test marketing substances Substances in processed/imported

“articles” • e.g., most films

720.30(g) and (h) exempt substances• Byproducts, impurities, end-use, non-isolated

intermediates, etc.

Export-only substances (unless §12(a)(2) finding made) (new)


“Exemptions”, cont.

No exemption for polymers, low volume substances, low concentration substances• Very different from CDR

LVE, LoREX, and 1995 “polymer exempt” substances = not exempt• Although not required to be on Inventory, they may be

– However, “EPA anticipates that the presence of a substance on the confidential portion of the Inventory may be information that is not ‘known to or reasonably ascertainable by’ a person who is operating under a PMN exemption and who did not submit the confidentiality claim for the specific chemical identity of that substance.”


“Interim Active” (IA) Substances

Reported for TSCA §8(a) CDR (by anyone) as being produced in 2010, 2011, 2012, 2013, 2014, or 2015

• i.e., reported for 2012 or 2016 CDR

• Even if on confidential Inventory (NEW)

Deemed “active” - do not need to report IA substances for reset

• But must report if you wish to maintain chemical identity as CBI


Other Substances Deemed “Active”

Any “naturally occurring” substance

• Unless produced “synthetically”

Any substance added to Inventory on/after June 21, 2006 due to NOC received by EPA on/after that date

Also, no need to submit Form A if have CDX receipt documenting Agency receipt of Form A from another person for same substance


Multi-Party Issues

Co-manufacturers and co-processors• May determine among themselves who may

report• If no notice submitted, EPA will hold both parties

liable

If importer lacks information because claimed confidential by supplier, importer must ask supplier to provide information directly to EPA in “joint” submission• Similar procedure if reporter manufactured,

imported, processed chemical using proprietary reactant


Polymers

Treated the same as non-polymers• CDR, OECD definitions/provisions irrelevant

Pre-1995 polymer exemption polymers (i.e., “Y” flag) = subject to reset• Because on Inventory if commenced

Same for post-1995 polymer exempt polymers but only if another company added the polymer to the Inventory• But recall that presence of substance on

confidential Inventory may be not ‘known to or reasonably ascertainable by’ person who did not submit confidentiality claim for substance


Confidential Business Information (CBI)

Chemical identity information• Can claim CBI but only if substance listed on

confidential Inventory when notice submitted – CBI claim must be made at time information is submitted

• Claim can be made even if reporter not original claimant

– If no person requests that claim be maintained, EPA will move substance to public Inventory

• May substantiate CBI claim by providing responses to CBI questions with NOA Form A

– Otherwise fall within separate EPA CBI plan

Form B – must substantiate w/i 30 days of notice Information other than chemical identity

• Must make and substantiate when information submitted


Tips and Tricks

Basic approach: Ascertain all substances m/I during LBP, exclude IA, report remainder• Standard: “known to or reasonably ascertainable by”

Report any CBI IAs that you wish to maintain as CBI

Work with foreign suppliers – start NOW• May be unwilling (or even be out of business)

• May not have language capability

• May not wish to assist multiple U.S. importers

Nomenclature, polymer 2% rule

Compliance efforts may uncover other TSCA issues• EPA “Audit Policy”


The Next TSCA 30/30:Wednesday, December 13th

For more information on past and future TSCA 30/30 programs, please visit www.khlaw.com/tsca3030 and

www.TSCAReformCenter.com for the most up-to-date TSCA news

the tsca inventory “reset” tsca 3030...tom berger has a chemical engineering background and is a...

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