The New TSCA: Key Issues and Implementation Mark N. Duvallmedia.mycrowdwisdom.com.s3.amazonaws.com/asc/2016 Fall Conv... · 9 chemicals identified based on 2014 TSCA Work Plan ratings

The Adhesive and Sealant Council 2016 Fall Convention

The New TSCA: Key Issues and Implementation

Mark N. Duvall

October 18, 2016

Overview

Major changes to TSCA

TSCA implementation timeline

Implementation activities so far

Adhesive and Sealant Council 2016 Fall Convention October 18, 2016 2

TSCA History – In a Nutshell

October 11, 1976 – TSCA, Public Law 94-469, signed into Law

• Corrosion Proof Fittings v. EPA (5th Cir., Oct. 18, 1991)

~ 40 years later …

June 22, 2016 – The Frank R. Lautenberg Chemical Safety for the 21st Century Act, Public Law 114-182, signed into law

• ~25 years after Corrosion Proof Fittings

• Effective immediately, started clock on implementation

• What to call it?


Major Changes to TSCA

Major Changes

• Assessed on the basis of conditions of use, but without regard to cost or other non-risk factors

Unreasonable risk

• Test orders

Section 4

• Affirmative EPA findings for PMNs and SNUNs

Section 5


Section 5

PMN or

SNUN

“presents” unreasonable

risk of injury to health or

environment

“may present” unreasonable

risk of injury to health or

environment or substantial …

“not likely to present”

unreasonable risk of injury to

health or environment

Manufacture or use may commence

EPA order restricting substance (pending further

information)

EPA rule restricting substance


Section 6

Prioritization; risk

evaluation; risk

management

Criteria, quotas,

deadlines

Certain PBTs get exposure evaluation + restrictions


Section 6 Process(Except Certain PBT Substances)

EPA conducts risk evaluation

EPA promulgates rule regulating chemical

EPA designates chemical as high-

priority

Manufacturer requests risk

evaluation and EPA grants

request

10 chemicals to be drawn from

2014 TSCA Work Plan list by EPA within 180 days of enactment

No regulation


Other Major Changes

• Inventory resetSection 8

• CBI substantiation, 10-year limitSection 14

• PreemptionSection 18

• Fees

• Science standardsSection 26


TSCA Implementation Timeline

1st Three Months

Immediately upon enactment – June 2016

• New “unreasonable risk” standard

• New PMN and SNUR provisions

• New science provisions

• CBI provisions

3 months after enactment – September 2016

• Deadline to request risk evaluation for certain PBTs

• First Year Implementation Plan, FAQs

• Public meetings in August 2016 on prioritization, risk evaluation, fees + comment periods

• Initial PMN reviews


1st Six Months

6 months after enactment – December 2016

• Publish list of 10 risk evaluations underway

• Determination re 1988 definition of “small business”

• Proposed rules

• Prioritization process

• Risk evaluation process

• Inventory reset

• Fees

• Methylene chloride, NMP, trichloroethylene


Year 1

1 year after enactment – June 2017

• Final rules

• Prioritization process

• Risk evaluation process

• Inventory reset

• Fees

•Guidance on submitting draft risk evaluations

• Establish Science Advisory Committee


Year 2

1½ years after enactment – December 2017

• Reports due for Inventory reset (rule + 6 months)

• Proposed CBI substantiation rules

• Final rules for methylene chloride, NMP, trichloroethylene

2 years after enactment – June 2018

• Final CBI substantiation rules

• Develop any policies, procedures, or guidance

• Strategic plan to promote alternative testing methods

• Proposed rule for review of confidential chemicals on active substances list

• Generic names guidance


Year 3

2½ years after enactment (1 year after list) – December 2018

• Final rule for review of confidential chemicals on active substances list

3 years after enactment – June 2019

• Propose rules on certain PBTs

• Begin negotiated rulemaking on inorganic byproducts reporting

3½ years after enactment – December 2019

• Ensure that risk evaluations are underway for 20 high-priority substances

• Ensure that 20 low-priority substances are designated

• Final inorganic byproducts negotiated rule


Later Years

3½ years after enactment (+ extensions)

• Complete risk evaluations on the 1st 10 chemicals


• Complete PBT rulemakings

• Propose risk management rules for 1st 10 chemicals found to present an unreasonable risk


• Final risk management rules for 1st 10 chemicals found to present an unreasonable risk


• Complete risk evaluations on 20 high-priority chemicals

• Complete review of confidential chemicals on active list


EPA Implementation So Far

Resources

• https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act

EPA implementation

webpage

• https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemicals

TSCA Work Plan webpage

• 81 Fed. Reg. 58925 (Aug. 23, 2016)

Science Advisory Committee on

Chemicals

• 81 Fed. Reg. 65636 (Sept. 23, 2016)PMNs reviewed in

first 90 days


https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act

https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemicals

Section 5 – PMNs

“The new law effectively resets the 90-day review period.”

• Reset period expired September 19, 2016

• Now “voluntary” suspensions (no refunds)

In 1st 90 days, EPA posted “not likely to present” findings for 14 PMNs (and 9 MCANs)

334 PMNs pending on June 22

• ~ 184 PMNs submitted in 90 days prior to June 22

• ~ 72 PMNs submitted June 22 – July 31

• 7 PMN findings in July, 0 in August, 7 in September

• 2 PMN findings < 90 days from original submission date

• 100 findings expected soon


Section 5 - PMNs

Section 5(e) order where EPA finds that:

• (i) the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of the relevant chemical substance or significant new use; or [not and]

• (ii) (I) in the absence of sufficient information to permit the Administrator to make such an evaluation, the manufacture, processing, distribution in commerce, use, or disposal of such substance, or any combination of such activities, may present an unreasonable risk …; or

• (II) such substance is or will be produced in substantial quantities ….


Section 5 - PMNs

• Searching review, more section 5(e) orders expected

• Section 5(e) orders likely even where PMN submitter does not raise a concern

• “The term ‘conditions of use’ means the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”

− Consider actions of third parties?


Section 5 - SNURs

SNURs remain an important tool for EPA

•6 SNUNs expected per year for > 2,800 SNURs

•81 Fed. Reg. 48788 (July 26, 2016)

•SNURs operate as substantive rules

•Avoid engaging in significant new use, or

•Avoid SNUR chemicals altogether

TSCA Implementation: Opportunities and Challenges October 6, 2016 22

Section 6 – Prioritization

• Public meeting and comment period in August

• 1st 10 chemicals to come from TSCA Work Plan− Had draft risk assessments for 1-bromopropane,

MCCPs/LCCPs

− Had begun risk assessment on octamethyltetracyclosiloxane

− Had problem formulations for 4 clusters of flame retardants, 1,4-dioxane

− Asbestos suggested

− Still time for advocacy

• 50% of subsequent high-priority chemicals to come from TSCA Work Plan

• Provide data, arguments


Section 6 – Risk Management

•Methylene chloride in commercial and consumer paint and varnish stripping uses

•Projected for October 2016

•N-Methylpyrrolidone (NMP) in commercial and consumer paint and varnish stripping uses

•Projected for October 2016

•Trichloroethylene as a spotting agent in dry cleaning and in commercial and consumer aerosol spray degreasers

•Projected for September 2016

Section 6 proposed rules expected:

OSHA letter


Section 6(h) - PBTs

9 chemicals identified based on 2014 TSCA Work Plan ratings

• No risk evaluation

• Exposure and use assessment before rulemaking

• Risk management rule to reduce exposure to the extent practicable

• 4 chemicals dropped through advocacy


Section 6(h) – Certain PBTs

Decabromodiphenyl ethers (DecaBDE) (CAS No. 1163-19-5)

Hexachlorobutadiene (CAS No. 87-68-3)

Pentachlorothio-phenol (CAS No. 133-49-3)

Phenol, isopropylated, phosphate (3:1) (iPTPP) (CAS No. 68937-41-7)

2,4,6-Tris(-tert-butyl)phenol (CAS No. 732-26-3)


CBI

New certification statement required

Substantiation required

• Existing substantiation requirements continue

Structurally-descriptive generic name

• Existing guidance continues

EPA review

• All claims for chemical identity

• 25% of other claims


Preemption

FAQs

• No pause preemption for 1st 10 TSCA Work Plan chemicals

• Not high-priority substances

• No pause or permanent preemption for chemicals subject to risk assessments completed by June 22, 2016

• Preemption to be consistent with scope of risk evaluation under § 6(b)(4)(D)


Fees

Implementation plan – final rule by June

2017

Public meeting and comment period in

August 2016

FAQs

• Manufacturers requesting risk evaluations for PBT chemicals must pay fee


Summary

It’s a new world

EPA has a LOT more authority

EPA plans to exercise that authority

There are multiple opportunities for stakeholder involvement – and potential rewards for involvement


Mark N. Duvall

(202) 789-6090

[email protected]


Questions?

Thank you!

mailto:[email protected]

Documents

The New TSCA: Key Issues and Implementation Mark N. Duvallmedia.mycrowdwisdom.com.s3.amazonaws.com/asc/2016 Fall Conv... · 9 chemicals identified based on 2014 TSCA Work Plan ratings