The Chemical Prioritization Rule and Its Implications 30_30 Feb 8, 2017.pdfand regulation programs,...

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

The Chemical Prioritization Rule

and Its Implications

February 8, 2017


Please Don’t Forget to Dial-In:

Conferencing Number: (800) 768-2983

Access Code: 4344318(View the slides via webinar, and the sound via phone)


Adrienne Timmel, Esq.

Adrienne Timmel specializes in regulatory compliance

and enforcement matters under the Toxic Substances

Control Act (TSCA) and the Federal Insecticide,

Fungicide and Rodenticide Act (FIFRA). Ms. Timmel

assists clients in obtaining pre-manufacture approval

of chemicals under TSCA and pesticide registrations

under FIFRA in the U.S. and under comparable

statutes in international markets. She also advises

clients on compliance with the EPA fuels registration

and regulation programs, product labeling, and hazard

communication. Her work has included audits under

EPA’s “Audit Policy” and EPA settlement negotiations.

Ms. Timmel represents individual companies as well

as trade associations and has also counseled trade

association clients on antitrust matters.

[email protected] • 202.434.4164


Rachel Novick, Ph.D., DABT

Dr. Rachel Novick is a board-certified

toxicologist and Supervising Health

Scientist with Cardno ChemRisk. She has a

wide range of experience in regulatory

toxicology, consumer product safety,

Proposition 65 exposure assessment, and

toxicology research. Dr. Novick has co-

authored about 8 peer-reviewed journal

articles and more than 10 conference

abstracts on the topics of toxicology and

exposure.

[email protected] • 415-618-3202


Agenda

Prioritization process and timeline

EPA’s use of Work Plan Chemicals

Program evaluation criteria

A Work Plan Chemical case study

Predicting future chemicals for

prioritization

Implications of EPA’s proposal

Preemption

What manufacturers should do


Overarching Timeline and Process

By December 2019:

• 20 High Priority Chemicals Risk Evaluations

• 20 Low Priority Chemical Designations

Designations and Risk Evaluations to

Continue

• One In/One Out

Over time, all substances on the TSCA

Inventory will be prioritized


High versus Low Priority

High Priority – EPA concludes, without consideration

of costs or other non-risk factors, that substance MAY

present an unreasonable risk of injury to health or

the environment because of a potential hazard and a

potential route of exposure under the conditions of

use, including an unreasonable risk to a potentially

exposed or susceptible subpopulation

Low Priority – EPA concludes, based on information

sufficient to establish, without consideration of costs

or other non-risk factors, that substance does not

meet the standard for High Priority designation


Proposed Prioritization Rule 82 Fed. Reg. 4,825 (January 17, 2017)

• https://www.gpo.gov/fdsys/pkg/FR-2017-01-17/pdf/2017-00051.pdf

TSCA § 6(b)(1)(A) – Must be finalized by June 22,

2017

4-step process of 9-12 months:

1.“Pre-Prioritization” – Screening

2.“Initiation” – Decision to prioritize; 90-day comment

period

3.“Proposed Designation” – Formal designation

proposal; 90-day comment period

4.“Final Designation”

https://www.gpo.gov/fdsys/pkg/FR-2017-01-17/pdf/2017-00051.pdf


Prioritization of Chemicals in TSCA Work Plan

EPA will use the 2012 Work

Plan method document to

identify potential candidate

substances for near term

review

An updated list of work plan

chemicals was released in

2014

2012 Work Plan is a 2-step

process


Candidate Identification- Step 1

Meets any one of the criteria below, based on

their presence on defined lists:

• Chemicals identified as potentially of concern for children’s

health (e.g., chemicals with reproductive or developmental

effects)

• Chemicals identified as persistent, bioaccumulative, and

toxic (PBT)

• Chemicals identified as probable or known carcinogens

• Chemicals used in children’s products

• Chemicals used in consumer products

• Chemicals detected in biomonitoring programs

Applied exclusion criteria


Candidate Identification- Step 2


Example Chemical Prioritization

Chemical Hazard ExposurePersistence and

Bioaccumulation

DecaBDE Developmental

and aquatic

toxicity

3 Flame retardant

in consumer

goods

3 High

persistence,

high

bioaccumulation

3

DecaBDE- Persistent, bioaccumulative,

and toxic


Predicting Chemicals for Prioritization

Reference the 2014 Work Plan list and the

chemical’s score

Use the 2012 Work Plan Methods to score a

chemical

• Hazard

• Exposure

• PBT

Reference international prioritization plans:

European Union, Canada, Australia, Japan


Preferred High Priority Chemicals

Section 6(b)(2)(D)

• EPA must give these 2014 Work Plan

chemicals preference when selecting High

Priority Chemicals

–Score high (i.e., 3) for persistence and

bioaccumulation

–Are known human carcinogens with high acute

and chronic toxicity


“Preferred” High Priority Candidates

Work Plan Chemicals meeting § 6(b)(2)(D) criteria:• Antimony & Antimony Compounds

• Pigment Yellow 83 (Butanamide, 2,2'-[(3,3'-dichloro[1,1'- biphenyl]-4,4'-

diyl)bis(azo)]bis[N(4-chloro-2,5 -dimethoxyphenyl)-3-oxo-)

• Cobalt & Cobalt Compounds

• Hexabromocyclododecane (HBCD)

• Lead & Lead Compounds

• Long-chain chlorinated paraffins (C18-20)

• Medium-chain chlorinated paraffins (C14-17)

• Molybdenum and Molybdenum Compounds

• Octamethylcyclotetrasiloxane (D4)

• Arsenic and arsenic compounds

• Asbestos and asbestos like fibers

• Cadmium and cadmium compounds

• Chromium and chromium compounds

• Nickel & Nickel Compounds


Implications of EPA’s Proposal

Low Bar for High Priority Designations

• Default to High

Usual Suspects First – Existing data

Scope

• All conditions of use

Lacking Clear Definitions

• Discrepancies Anticipated


Preemption

States generally can regulate chemicals

identified for High and Low Prioritization

“Pause Preemption”

• Begins when EPA defines scope of risk

evaluation

• Only applies to uses within risk evaluation

States can avoid pause preemption by acting

when a chemical is identified for prioritization

• 1 year window


What Companies Can Do

Comment on the proposal!

• Comments due March 20, 2017

Begin evaluating substances to anticipate EPA

prioritization

Provide EPA all information on uses, exposure, and

toxicology as early as possible to facilitate a Low

Priority designation

Provide EPA information on any substitutes of equal

or greater risks

• EPA aims to avoid pushing market to higher-risk

substitutes


The Next TSCA 30/30:

Wednesday, March 8th

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

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