The Challenge of Protecting CBI Under the New TSCA 30.30 slides April 2019.pdf · the negotiation and development of various international environmental instruments governing persistent

Copyright © 2019 | www.khlaw.com Keller and Heckman LLP 1

The Challenge of Protecting CBI

Under the New TSCA

April 17, 2019


Please Don’t Forget to Dial-In:

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


[email protected] • 202.434.4334

Herbert Estreicher, Ph.D.

Herbert Estreicher, Ph.D. has a broad practice in international environmental regulatory

law.

Dr. Estreicher has an interdisciplinary approach combining law and science. He

represents leading manufacturers of chemicals, pesticides, insect repellents, food

additives, and consumer products before Federal and State regulatory agencies.

Dr. Estreicher provides advice on product liability risk control and assists clients with

crisis management for embattled products, including chlorinated pesticides, wood

preservatives, dioxins, and persistent, bioaccumulative, and toxic (PBT) chemicals. He

helps clients secure and maintain chemical approvals and pesticide registrations in

Canada and Europe, advises clients on responding to the CEPA challenge program,

and provides advice on European chemical directives and initiatives, such as the EU

Biocidal Products Directive, the Classification, Labelling and Packaging Regulation, the

EU Registration, Evaluation and Authorization of Chemicals (REACH) regulation, and

the Prior Informed Consent (PIC) Regulation. Dr. Estreicher also represents clients in

the negotiation and development of various international environmental instruments

governing persistent organic pollutants (POPs), has been actively involved in the Great

Lakes Binational Toxics Strategy, and has participated in the Canadian Strategic

Options Process (SOP). He is actively engaged in the areas of TSCA Reform and the

California Green Chemistry Initiative. His extensive background in organic chemistry,

risk assessment and bioengineering is valued highly by clients in the chemical,

nanotechnology, and biotechnology industries.


[email protected] • 202.434.4176

Javaneh NekoomaramJavaneh Nekoomaram is an associate in the environmental and workplace safety and

health (OSHA) practice groups at Keller and Heckman.

Ms. Nekoomaram practices in all areas of environmental law as well as occupational

health and safety law, and chemical control law. She routinely advises clients on a

broad range of environmental health and safety compliance issues.

Prior to joining Keller and Heckman, Ms. Nekoomaram served for three years as

Counsel for the American Coatings Association where she was responsible for the

association’s Occupational Health and Safety, Product Stewardship, and

Environmental Management Committees. She provided regulatory compliance and

advocacy on a number of issues on behalf of the coatings industry including TSCA,

Prop 65, hazard communication and labeling, state chemical regulation, hazardous

waste, air and water quality, occupational health and safety, and chemical safety

regulations. She also served as Advocacy Counsel for the Graffiti Resource Council,

an organization supported by the aerosol coatings industry that provides anti-graffiti

strategies for cities across the country.

While in law school, Ms. Nekoomaram was a member of the Dean’s Tutorial Society

and the Order of the Barristers, and participated in the National Health Law Moot

Court Competition and the Wagner National Labor and Employment Law Moot Court

Competition.


Agenda

▪ EPA release of Health and Safety studies

voluntarily submitted during Prioritization

and Risk Evaluation

▪ EPA’s proposed plan to review CBI claims

for substances on the Confidential TSCA

Inventory

▪ Expansion of CBI claim justification

needed for the 2020 CDR


Introduction

▪ Congress amended Section 14 of TSCA to

require substantiation of CBI claims

▪ One of the most valuable trade secrets is

the specific chemical identity

▪ Small variations in chemical structure may

account for a chemical’s novel properties

and technological edge

▪ NGOs are systematically insisting on more

and more disclosure


Release of Full Study Reports

Submitted in Connection with

Prioritization and Risk Evaluation


Low Priority Designations

▪ On March 21, 2019, EPA issued a Federal

Register notice, 84 FR 10491-98, that

proposes to evaluate whether it can make

a low priority designation for 20

substances.

▪ Comments are due by June 19, 2019.

▪ Substances proposed for low priority

designation are supported by HPV and

SIDS data, but will that be enough?


Default to High Priority

▪ 40 C.F.R. 702.9(e) provides: Insufficient information. If

information remains insufficient to enable the

proposed designation of the chemical substance as a

Low-Priority Substance after any extension of the initial

public comment period pursuant to § 702.7(e), EPA will

propose to designate the chemical substance as a

High-Priority Substance.

▪ Low priority candidates with insufficient data move up

the queue for risk evaluation.

▪ EPA-initiated risk evaluation fee of $1,350,000.

▪ Will REACH data be needed to ensure EPA has

sufficient information on Low Priority candidates?


The case of Pigment Violet 29

▪ EPA relied on REACH data, but initially

refused to release the full study reports.

▪ NGOs complained.

▪ EPA has now released lightly redacted

versions of the full study reports, but

NGOs are still not satisfied. See Docket

ID: EPA-HQ-OPPT-2018-0604


Procedures for Review of CBI Claims for the

Identity of Chemicals on the TSCA Inventory


Substantiation and EPA Review of CBI Claims Asserted in

Form A Notice of Activity (NOA)

▪ Pre-publication proposed rule issued April 10, 2019.

▪ 60-day comment period from date of publication in the Federal

Register.

▪ TSCA section 8(b)(4)(C) requires EPA to issue a rule explaining

how it plans to review CBI claims for the specific chemical

identities of substances on the confidential portion of the TSCA

Inventory that were asserted in an NOA Form A pursuant to the

Active-Inactive rule.

▪ Companies that asserted such claims as part of the NOA Form A

submission, but did not provide (voluntary) upfront substantiation at

that time are subject to the rule.

▪ Companies who identify a previous claim substantiation made

during the 5-year period ending on the substantiation deadline

specified by EPA would be exempt from this requirement.


CBI Substantiation▪ CDX to be used for substantiating CBI claims.

▪ Substantiations to be filed no later than 90 days after the effective

date of the final rule.

▪ The same filing deadline is proposed for submissions identifying a

previously submitted substantiation for purposes of establishing

eligibility for an exemption.

▪ In that case must report submission date; submission type; and case

number, transaction ID, or equivalent identifier.

▪ If you miss the 90-day deadline the specific chemical identity may be

made public without further notice.

▪ If a CBI claim is rejected, EPA will notify the submitter.

▪ EPA will not disclose the specific chemical identity until 30 days after the

date the submitter receives the denial notice.

▪ Submitters can challenge a denial of a CBI claim in court.

▪ Records relevant to compliance with this rule must be retained for 5 years.


10-Year Period of CBI Protection

▪ The filing date of the NOA Form A is the date that

determines the period of protection from disclosure.

▪ However, in cases where the same specific chemical

identity was claimed CBI in a prior submission filed on or

after June 22, 2016, EPA will consider the date of that

prior submission as the CBI claim assertion date.

▪ Companies will be notified of the date from which the

10-year period of protection will be calculated.


How This Will Work in Practice▪ If on July 1, 2016, Company A claims the specific chemical identity as

CBI in a CDR report, and EPA approves the claim, then the 10-year

time period of CBI protection begins on July 1, 2016.

▪ If Company A subsequently filed an NOA Form A on January 1, 2018

claiming specific chemical identity as CBI, and EPA approves the claim,

the 10-year period of protection from disclosure would still be

July 1, 2016.

▪ If Company B filed an NOA Form A on February 1, 2018 seeking to

maintain a CBI claim for the same specific chemical identity, and the

second company’s claim were approved, the 10-year period of

protection from disclosure would still run from July 1, 2016.

▪ In cases where an NOA Form A was the first submission to assert the

CBI claim after June 22, 2016, the 10-year period of protection for an

approved claim would begin on the date of that NOA filing.


EDF CBI Lawsuit

▪ The Environmental Defense Fund (EDF) sued EPA over

its inventory notification rule in 2017 (Case No. 17-1201

DC Circuit) alleging that the rule inappropriately allowed

any person to maintain an existing confidentiality claim,

regardless of whether they were the original claimant.

▪ The suit also took issue with EPA’s alleged failure to

include a reasonable basis to believe that the

information is not readily discoverable through reverse

engineering as one of the substantiation questions.

▪ Oral argument was held on October 12, 2018 and a

decision is expected this year.


CBI Aspects of Proposed Rule for TSCA

Chemical Data Reporting Revisions


CDR Proposed Rule

▪ On April 12, 2019, EPA released a pre-

publication proposed rule on “TSCA Chemical

Data Reporting Revisions and Small

Manufacturer Definition Update for Reporting

and Recordkeeping Requirements under TSCA

Section 8(a).”

▪ 60-day comment period from the date of

publication in the Federal Register.

▪ Proposed rule revises requirements for

confidentiality claims to align with LCSA

amendments.


CDR Proposed Rule: CBI Claims

▪ Persons submitting information under the CDR

may assert confidentiality claims for information

at the time it is submitted.

▪ Cannot make confidentiality claims for:

• Public contact information if voluntarily provided

• Chemical identities listed on the public portion of the

TSCA Inventory at the time of submission

• Certain processing and use data elements

• When a response is left blank or designated as “not

known” or “reasonably ascertainable”

▪ Information not asserted as confidential may be

made public without further notice to submitter


CDR Proposed Rule: CBI Substantiation

▪ Confidentiality claims must be substantiated at the time

of submission except:

• Production volume information

• Joint submission information from the primary submitter,

including trade name and supplier identification

• Joint submission information from the secondary submitter,

including the % formulation

▪ For each data element claimed confidential, must:

• Submit with report detailed written answers to 6 questions

– Substantial harm to business’ competitive position

– Precautions taken to protect information

– Availability of information in public documents

– Trade secrets

– Duration of claim

– Prior confidentiality determinations


CDR Proposed Rule: Chemical identity

▪ Specific chemical identity = CA Index name and

corresponding CASRN

▪ Generic chemical identities or TSCA Accession Number

cannot be claimed CBI

▪ Can assert a confidentiality claim for specific chemical

identity only if the identity of that chemical is treated as

confidential in the Master Inventory File as of the time

the report is submitted for that chemical substance

▪ For confidentiality claims for chemical identity, must

• Submit with report detailed written answers to same 6 questions

• Submit with report detailed written answers to 4 additional

questions


CDR Proposed Rule: Site info

▪ Can claim site, company, or technical contact

confidential only if the linkage of that information

to a reportable chemical substance is

confidential

▪ For confidentiality claims, must

• Submit with report detailed written answers to same 6

questions

• Submit with report detailed written answer to one

question– Has company, site, or technical contact identity information been

linked with a reportable chemical substance in any public document

or any other Federal, State, or local reporting scheme?


CDR Proposed Rule: Production and Use

▪ Can claim certain production and use

information confidential only if the linkage of that

information to a reportable chemical substance

is confidential

▪ For confidentiality claims, must

• Submit with report detailed written answers to same 6

questions

• Submit with report detailed written answers to two

questions

– Information publicly known?

– Ever provided information to any person and not

ask that it be treated confidential?


CDR Proposed Rule: Joint Submissions

▪ Joint Submissions. If a primary submitter asks a

secondary submitter to provide information directly to

EPA in a joint submission under §711.15(b)(3)(i)(A) and

(B), only the primary submitter may assert a

confidentiality claim for the data elements it directly

submits to EPA.

▪ The primary submitter must substantiate those claims

(unless exempt).

▪ The secondary submitter is responsible for asserting all

confidentiality claims for the data elements it submits

directly to EPA and substantiating those claims (unless

exempt).


FURTHER THOUGHTS


Please join us at 1:00 PM Eastern U.S.

Wednesday, May 15, 2019

www.khlaw.com/TSCA3030


Wednesday, April 24, 2019

www.khlaw.com/TSCA3030


Wednesday, May 15, 2019

www.khlaw.com/REACH-3030


The Next TSCA 30/30:

Wednesday, May 15th

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programs, please visit www.khlaw.com/tsca3030 and

www.TSCAReformCenter.com for the

most up-to-date TSCA news

Copyright © 2019 | www.khlaw.com Keller and Heckman LLP 28TSCA 30/30

THANK YOU

Herbert Estreicher, Ph.D.

[email protected]

202.434.4334

Javaneh Nekoomaram

[email protected]

202.434.4176

Documents

The Challenge of Protecting CBI Under the New TSCA 30.30 slides April 2019.pdf · the negotiation and development of various international environmental instruments governing persistent