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
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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?
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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
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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
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Section 6
Prioritization; risk
evaluation; risk
management
Criteria, quotas,
deadlines
Certain PBTs get exposure evaluation + restrictions
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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
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Other Major Changes
• Inventory resetSection 8
• CBI substantiation, 10-year limitSection 14
• PreemptionSection 18
• Fees
• Science standardsSection 26
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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
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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
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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
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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
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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
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Later Years
3½ years after enactment (+ extensions)
• Complete risk evaluations on the 1st 10 chemicals
4½ years after enactment (+ extensions)
• Complete PBT rulemakings
• Propose risk management rules for 1st 10 chemicals found to present an unreasonable risk
5½ years after enactment (+ extensions)
• Final risk management rules for 1st 10 chemicals found to present an unreasonable risk
6½ years after enactment (+ extensions)
• Complete risk evaluations on 20 high-priority chemicals
• Complete review of confidential chemicals on active list
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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
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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
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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 ….
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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?
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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
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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
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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
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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)
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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
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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)
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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
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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
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Mark N. Duvall
(202) 789-6090
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Questions?
Thank you!