TSCA Reform for EU Stakeholders - Keller Heckman Webinar Slides (2).pdf · • Require reporting of...

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TSCA Reform for EU Stakeholders22 September 2016

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Introduction

Marcus Navin-JonesPartner

[email protected]

mailto:[email protected]


Preliminary Word

This presentation provides information about the law. Legal

information is not the same as legal advice, which involves

the application of law to an individual’s specific

circumstances. The interpretation and application of the

law to an individual’s specific circumstance depend on

many factors. This presentation is not intended to provide

legal advice.

The information provided in this presentation is drawn

entirely from public information. The views expressed in

this presentation are the author’s alone and not those of

the author’s clients.


Your Moderator and Speakers Today

Herbert Estreicher, Ph.D.Partner

[email protected]

Martha E. MarrapesePartner

[email protected]


[email protected]





Acronyms FRL21 – The Frank R. Lautenberg Chemical Safety for the 21st Century Act amending TSCA

TSCA – US Toxic Substances Control Act

EPA – US Environmental Protection Agency

CDR – Chemical Data Reporting

CBI – Confidential Business Information

PMN – Premanufacture Notice

SNUR – Significant New Use Rules

SNUN – Significant New Use Notice (NB SNAc – Signif New Activity(Canada))

HPV – High Production Volume Challenge Program

SAR – Structure-Activity Relationships

CDX – Central Data Exchange https://cdx.epa.gov/

PBTs – Persistent Bioaccumulative Toxic (PBT) Chemicals (NB Toxics Release Inventory

(TRI) Program: https://www.epa.gov/toxics-release-inventory-tri-program/persistent-

bioaccumulative-toxic-pbt-chemicals-rules-under-tri) – Section 6(h)

Work Plan Chemicals – TSCA Chemicals Work Plan for Chemical Risk Assessment

Priority Chemicals – High Priority Chemicals for Risk Evaluation

TSCA New Chemicals Review Program – NB Section 5 TSCA

Rule-making – Procedural rules establishing EPA process for, for example, evaluating the

risks regarding high priority chemicals

https://cdx.epa.gov/

https://www.epa.gov/toxics-release-inventory-tri-program/persistent-bioaccumulative-toxic-pbt-chemicals-rules-under-tri


http://uscode.house.gov/view.xhtml?path=/prelim@title15/chapter53&edition=prelim

http://uscode.house.gov/view.xhtml?path=/prelim@title15/chapter53&edition=prelim


Overview

The New TSCA in comparison to the REACH Regulation

Use of alternatives to animal testing to meet information needs

Opportunities for Data Sharing of REACH dossiers with U.S. companies

Tips for EU companies doing business in the U.S.



How Does TSCA Stack Up in

Comparison to REACH?


[email protected]



U.S. Has Struggled with the Legacy of the Past

TSCA enacted in 1976.

Some 80,000 Substances Grandfathered onto the TSCA Inventory as Compared to Some 100,000 Substances on EINECS.

Difficult for U.S. EPA to Take Regulatory Action to Control Existing Chemicals.

1990s-2000s High Production Volume (HPV) Chemical Challenge Program Similar to EU Existing Substance Regulation (793/93) but Voluntary Program (similar to OECD SIDS)


Efforts to Reform TSCA

U.S. Congress was well aware of REACH.

Major drivers for TSCA reform were patchwork of State Regulation and Bans (Common Market Problem) and No Direct Mandate Under Old TSCA to Review Existing Chemicals.

Early Proposed Legislation (2005-2011) by Democratic Party Considered Too Ambitious.

Republican Party Majority in 2012 Allowed the Legislation to Progress.


Frank R. Lautenberg Act

Changes effective as of June 22, 2016.

Nearly every major section of the law is affected, with

the most significant change being a new program to

notify existing chemical substances in the coming

year that are actively manufactured or imported in

U.S. commerce.

These substances are to be screened and prioritized

for more in-depth risk evaluation and risk

management.

Federal Administering Agency - Environmental

Protection Agency, Office of Chemical Safety and

Pollution Prevention (OCSPP) within the Office of

Pollution Prevention and Toxics (OPPT).


EPA – OPPT Organization

Chemical Control Division*

Chemistry, Economics and Sustainable Strategies Division*

Environmental Assistance Division

Information Management Division

National Program Chemicals Division

Risk Assessment Division*

Toxics Release Inventory Program Division

TSCA Interagency Testing Committee

*Key Implementation Divisions


Main Elements of the New TSCA

Identification of Substances Actively in Commerce.

Preservation of Existing Class II Nomenclature• Including Statutory Mixtures and Soap and Detergent

Association (SDA) Nomenclature.

No Lock-step Information Requirements. • QSAR and Alternative Testing to Play a Central Role.

Risk-based Safety Standard Evaluated Under Conditions of Use Not Taking into Account Costs or Other Non-risk Factors but Requiring Consideration of Potentially Exposed or Susceptible Populations.

Prioritization of Active Substances into High and Low Priority for Risk Evaluation.

Data Sharing Based on Market Share.


Agency-driven Process.

Science-based Risk Assessment.

Broad Authority to Regulate But Bans and Phase-Outs Must Offer Alternatives.

No Authorization-type Scheme but PBTs/vPvBs are Given Priority for Assessment.

Regulatory Pace is Measured.

Preservation of CBI But More Liberal Disclosure Similar to Art. 119 REACH.

Industry Pays a Portion of the Cost or Roughly 25%. Downstream users likely to play a role in gathering

exposure and use information.

Main Elements of the New TSCA (con’t)


Schedule – Some Key RulemakingsDeadline EPA Must -

Within 1 year by June 22,

2017

Proposed rules to issue

by December 2016

• Promulgate a rule setting risk based screening

process for prioritization of existing substances in

commerce as high or low priority for risk evaluation

• Promulgate a rule establishing risk evaluation

process

• Require reporting of active chemicals in US

Commerce

Within 3 years • Propose risk management rules for select group of

PBT substances that are scored moderate to high.

Risk is assumed.

Within 3.5 years • Be in the process of publishing risk evaluation

decisions and risk management measures for

approximately 40 chemicals.


Schedule, cont.

50 percent of chemicals in risk evaluation

in the first 3.5 years have to be ones EPA

identified as high priority in 2014 Work

Plan.

At least 25 percent of the risk evaluations

must consist of voluntary requests.

These cannot comprise > 50 percent of

the ongoing evaluations at any one time.


Stewardship (Risk Management)

By rule (or in certain cases by order) EPA can require

testing and impose limits on process and use conditions.

By rule, EPA can impose bans/phase outs, and regulate

articles. To do so, EPA must consider:

• Effects on human health, environment and magnitude of

exposure

• The benefits of the substance/mixture for various uses

• Reasonably ascertainable economic consequences on

national economy, small business, innovation, environment,

public health, costs/benefits, and cost effectiveness of the

proposed rule and alternative

• Availability of alternatives

Agency may request and defer to action under another

statute unless the contacted agency/office declines to act.


What the New TSCA Does Not Do

No Statutorily Mandated Producer Responsibility.

• This is Left to the Tort Liability System.

No Concept of No Data-No Market for Existing Chemicals

• Uses of unsafe chemicals ultimately to be withdrawn from the

market unless appropriate controls can be implemented.

EPA has authority to assess and protect worker health

• However, safety data sheets remain the purview of the US

Occupational Safety and Health Administration (OSHA).

New chemicals must have sufficient data to establish

safety

• 3 Rs will play a central role in determining data needs.

No Candidate List of SVHCs or other purely hazard

based provisions with the exception of PBTs.


Comparison

Identification of Substances Actively in Commerce -

Similar to EU REACH pre-registration.

Preservation of Existing Class II Nomenclature - A

sharp and positive effort to coordinate with EU

REACH.

Absence of Lock Step Data Requirements - More

aligned with Canadian and Australian approaches.

More Limited Scope – TSCA does NOT include

cosmetic ingredients, food contact substances.

Different Approach to Polymers – Reporting

necessary for monomers and their polymers.


Comparison, cont.

Agency-driven Process Follows the Approach

in Other Countries although the EU has a

Bifurcated Scheme.

Measured Pace and Science-based Risk

Assessment and Decision-making may

become the Major Contribution of the New

TSCA to the Global Debate.

More Modest Cost and Burden on Industry

Relative to the EU.


Some Statistics

EU: Registration of 13,441 unique substances from 51,920 Dossiers

to-date with the largest number of substances still to be registered by

mid-2018; 1130 compliance checks; 270 substances on the

Community Rolling Action Plan (CoRAP) list; 168 substances on the

Candidate List of Substances of Very High Concern (SVHCs); 31

substances on the Annex XIV authorization list with 11 additional

substances recommended for authorization; and 105 Restrictions.

400+ ECHA staff and 200 MM € budget plus 28 member states plus

EU Commission.

CANADA: 2,740 screening assessments under its Chemical

Management Plan (CMP 1 and 2); 276 final risk management

instruments covering 325 substances or groups of substances have

been developed; and 363 substances (or groups) have been

assessed as toxic.

Korea: 510 substances subject to registration by 2018 with additional

500 by 2021, and 500-600 by 2024.


In Sum

New TSCA envisions a more hands on role for

EPA than EU REACH does, but process is most

similar to Substance Evaluation under REACH.

No Authorization type-process and therefore

different from EU and Korea REACH.

Decision-making based on risk rather than

hazard.

Use of alternatives to animal testing likely to

play a central role

Far lower through-put than in the other

countries.


Use of Alternatives to Animal

Testing to Meet Information

Needs


[email protected]



Greater Authority to Require Testing

EPA can proceed by rule, order or consent agreement.

If EPA decides to issue a testing order, it must justify

the use.

However, EPA must proceed in a tiered fashion unless

it can justify that more advanced testing is required.

EPA is given express authority to require exposure

information.

EPA can require development of new information to

implement a regulation of new and existing chemicals

including biomonitoring and environmental monitoring.

Other Federal Agencies or States acting under Federal

authority can request EPA to require toxicity/exposure

testing to support other Federal programs.


Authority to Require Testing Limited in Context

of Prioritization

EPA is expected to prioritize based on

existing data and screening techniques.

Can require development of new

information but only upon a showing of

need, the testing must be tailored to

prioritization, and must complete

prioritization decision within 90 days of

receiving the information.


Use of Alternatives to Animal Testing

Significant Focus on Three R’s (Replacement, Reduction and Refinement) in order to avoid unnecessary animal testing:

• Use Existing Info where available

• Use QSAR and Biometrics

• Use High-throughput Screening Methods

• Test with Reduced Animal Numbers

• Use Grouping and Read-across

• Encourage Joint Testing through Consortia


Within 2 Years of Enactment EPA is to

Develop a Strategic Plan for Alternative

Testing including a list of Scientifically

Sound Alternative Methods (to be updated)

Public to be given Notice and Opportunity to

Comment.

Report to Congress Every 5-years on

Progress.

Industry Encouraged to Use Alternative

Testing When Voluntarily Developing TSCA

Data.

More on Three R’s


Opportunities for Data

Sharing of REACH Dossiers


[email protected]



OVERVIEW

When Testing Will Be Required

Compensation Requirements

Possible Manifested Forms of Compensation

• Data Compensation Agreements

• Letters Of Access


When Testing Will Be Required

In the case of an order;

In the case of a rule, 30 days after

publication, manufacturers and importers

must submit:

• letter of intent to test; or

• request for exemption from test


Forum/Alternatives

Industry consortiums

Categories and testing of representative

substances

Use of alternative test methods


Compensation

• Manufacturers, importers bear test costs

• Can apply to processors (rare)

Must provide “fair and equitable

reimbursement” to those that test

EPA reimbursement orders rare


Data Compensation Under TSCA

No change from old TSCA

When persons subject to test rules (or orders) are unable to

reach an agreement on the amount or method of

reimbursement, either party may initiate arbitration before

the American Arbitration Association (AAA).

EPA publishes a notice in the Federal Register that a

request for an arbitration hearing has been made.

Any other person wishing to participate in the hearing must

notify EPA within 45 days of the Federal Register notice.

Opportunity for foreign data owners to participate?

The parties may mutually agree on the location where the

hearing is to be held. If parties cannot decide AAA sets the

locale.


Arbitration Procedure

EPA publishes a notice in the Federal Register advising those

subject to the test rule that a request for an arbitration hearing

has been made.

Any other person wishing to participate in the hearing must

notify EPA within 45 days of the Federal Register notice.

The parties may mutually agree on the locale where the

hearing is to be held. If the locale is not designated within 45

days from the time the complete list of parties is received, the

American Arbitration Association shall have power to

determine the locale.

Expedited procedure for claims of $5,000 or less.

The award is made promptly by the hearing officer and, unless

otherwise agreed by the parties, no later than 30 days from the

date of closing the hearings, or if oral hearings have been

waived, from the date of transmitting the final statements and

proofs to the hearing officer.


Oral Hearing

One arbitrator unless AAA decides more are needed.

If one of the parties is a foreign national, the arbitrator is appointed from a third country.

Any party may be represented by counsel.

Testimony given under oath.

The party seeking reimbursement must present a claim and proofs and witnesses, who shall submit to questions or other examination.

The party from whom reimbursement is sought then presents a defense and proofs and witnesses, who shall submit to questions or other examination.

Fees and expenses usually paid by the parties equally but arbitrator can order one party to pay more than an equal share.


Basis for the Award

Based on share of total production volume of the test chemical.

However, arbitrator can use a different sharing basis that may take into account the effect of the reimbursement share on competitive position.

Production volume measured over a period that begins one calendar year before publication of the final test rule (or issuance of the order) and continues up to the time of the arbitration.

Production volume includes amounts of the test chemical imported in bulk form and mixtures, and the total domestic production of the chemical including amounts produced as a byproduct. Impurities not included unless the test rule/order specifically includes them.

Amounts of the test chemical manufactured for export generally not included unless covered by a finding under TSCA’s export provisions.

Chemicals excluded from the TSCA jurisdiction not included in the computation of production volume.


Testing Costs

All costs reasonable and necessary to comply with the test

rule/order, taking into account the practices of other

laboratories in conducting similar tests, are eligible for

reimbursement. Necessary costs include:

• Direct and indirect costs of planning, conducting, analyzing and

submitting the test results to EPA.

• A reasonable profit, and a reasonable rate of interest and

depreciation on the tester's initial capital investment.

• The cost of repeating or repairing tests where failure was

demonstrably due to some cause other than negligence of the

tester.

• EPA fees associated with the test rule/order.

• Costs attributable to tests beyond those specified by EPA shall

not be eligible for reimbursement under this rule.


Data Access

EPA must base decisions on sound science.

Likely to require peer reviewed published data and/or full study reports.

Robust summaries generated for REACH likely will not be sufficient.

Therefore only REACH data owners will have data in a form suitable for sharing.

EPA will make full study reports public and the effect of this on data compensation under EU REACH and Korea REACH will need to be considered.


Tips and Traps


[email protected]



Some Points to Consider

For purposes of notification requirements, there is no “only representative” option under TSCA - must work through US importers

It is anticipated that non-U.S. companies who seek to do so will be able to participate in industry testing consortia for existing, high priority chemical reviews

The timing of EU restrictions or authorization prohibitions may influence US risk management schedules


2017 - Attention on Inventory Reset and CBI

EPA will maintain public and confidential Inventories.

Must work with an importer to submit an active chemical notice.

Inventory “Reset” submitter must assert/substantiate CBI claims for confidential Inventory substances.

EPA will review all chemical identity CBI claims• Can approve, deny, approve in part, etc.

• If approved, EPA will protect for 10 years but submitter must renew or protection will expire.


Slated for Regulation

Preferred High Priority: § 6(b)(2)(D). (1) score 3 for persistence and bioaccumulation; (2) known human carcinogen; and (3) high acute and chronic toxicity.

• Cadmium and cadmium compounds

• Chromium and chromium compounds

For carcinogenic effects generally, non-linear approach may be proposed if supported by the science.

Mercury compounds: § 8(b)(10).

• Hg export ban beginning 1/1/2020 for:

• Hg(I) chloride, Hg(II) oxide, Hg(II) sulfate, Hg(II) nitrate, Cinnabar, or Hg sulphide

Endocrine disruption in the mix

• US evaluation lags behind EU and has yet to adopt a “no threshold? approach


PBT’s Also A Priority for Regulation

Initial candidates may include:

• Pigment Yellow 83 (CASRN 5567-15-7)

• DecaBDE (CASRN 1163-19-5)

• Ethanone, 1- (1,2,3,4,5,6,7,8- octahydro-2,3,5,5-

tetramethyl-2- naphthalenyl)- (CASRN 54464-59-4)

• Ethanone, 1- (1,2,3,4,5,6,7,8- octahydro-2,3,8,8-

tetramethyl-2- naphthalenyl)- (CASRN 54464-57-2)

• 4-tert-Octylphenol (4-(1,1,3,3- Tetramethylbutyl)- phenol)

(CASRN 140-66-9)

• Pentachlorothio-phenol (CASRN 133-49-3)

• Phenol, isopropylated, phosphate (3:1) (iPTPP) (CASRN

68937-41-7)

• 2,4,6-Tris(-tert- butyl)phenol (CASRN 732-26-3)


Penalties/Enforcement

Penalties

• Civil: Maximum penalty $25,000 $37,500

• Criminal: Maximum penalty $25,000 $50,000

• Imminent Endangerment: Persons that know that violation places individual in imminent danger of death or serious bodily injury subject to fine of $250,000, imprisonment not more than 15 years, or both

–Organizations subject to fine not more than $1MM


Questions?

Visit TSCAReformCenter.com to stay

updated on new and developing TSCA

Issues and Regulations


Washington, DC • Brussels • San Francisco • Shanghai • Paris

Keller and Heckman LLP

THANK YOU


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