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SOT RASSSOT RASS
Overview of TSCA Reform and Introduction to Key Provisions in New Lautenberg LawC h l M A d O H dC h a r l e s M . A u e r a n d O s c a r H e r n a n d e z
October 12, 2016
© 2016 Bergeson & Campbell, PC. All Rights Reserved.© 2016 Bergeson & Campbell, P.C. All Rights Reserved.
Our Overview Focuses on Key ChangesOur Overview Focuses on Key Changes
Introduction to new TSCA
Key definitions
Science requirements
Testing (Section 4)
New chemicals and significant new uses g(Section 5)
Existing chemicals prioritization, risk evaluation, d i k (S i 6)and risk management (Section 6)
Inventory Reset (Section 8)
© 2016 Bergeson & Campbell, PC. All Rights Reserved. 2
Introduction to New TSCAIntroduction to New TSCA
Lautenberg fundamentally changes U.S. federal h t h i l tapproach to chemicals management
Introduces new concepts and approaches
Reflects careful balancing of interests Reflects careful balancing of interests
Centralizing concept is unreasonable risk, the evaluation of which: Does not include consideration of cost/benefit factors
Focuses on conditions of use as determined by the U S Environmental Protection Agency (EPA)U.S. Environmental Protection Agency (EPA)
Includes consideration of potentially exposed or susceptible subpopulations identified as relevant by EPA
© 2016 Bergeson & Campbell, PC. All Rights Reserved.
EPA
3
TSCA Sections 4 5 6 & 8TSCA Sections 4, 5, 6, & 8
Amended TSCA significantly changes provisions in these core sections of the law
Section 4 provides additional new testing th it t EPAauthority to EPA
Section 5 on new chemicals retains much of the original approach but makes important changesoriginal approach but makes important changes
Section 6 significantly revises approach to existing chemical risk assessment and risk gmanagement compared to old TSCA
Section 8 requires EPA to implement an
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“Inventory Reset”
4
Key DefinitionsKey Definitions
Conditions of Use (COU): “… the circumstances, as determined by [EPA],
under which a chemical is intended, known, or reasonably foreseen to be manufacturedreasonably foreseen to be manufactured, processed, [etc.]”
Role of COU• Under Section 5 applies to some but not all
provisions
S 6• Under Section 6 applies generally to prioritizations and risk evaluations, and to some risk management actions
© 2016 Bergeson & Campbell, PC. All Rights Reserved. 5
Key Definitions (cont’d)Key Definitions (cont d) Potentially exposed or susceptible
subpopulations (PESS):subpopulations (PESS): “a group of individuals within the general
population identified by [EPA] who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical…, such as infants, children, pregnant women, workers, or the elderly.”
“Protocols and methodologies for the Protocols and methodologies for the development of information”
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Science RequirementsScience Requirements These apply to all science-based decisions under
Sections 4, 5, and 6 Scientific Standards (Section 26(h))
• Requires the U.S. Environmental Protection Agency (EPA) science decisions to be done in manner “consistent with the best available science”
– Enumerates several “considerations” regarding scientific information and methods
Reasonableness for the intended use
Relevance
Clarity and completeness of documentation of scientific evidence
Variability and uncertainty
Extent of independent verification or peer review
Weight of the Scientific Evidence (Section 26(i))• EPA decisions must be “based on the weight of the scientific
id ”
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evidence”
7
Science Requirements (cont’d)Science Requirements (cont d) Consultation with Science Advisory
Committee on Chemicals (SACC)Committee on Chemicals (SACC) Establishes SACC to provide independent advice
and expert consultation Composed of representatives from following
groups:• Science
• Government
• Labor
• Public healthPublic health
• Public interest
• Animal protection
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• Industry
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Section 4 Testing ofSection 4. Testing of Chemical Substances and
Mi tMixtures
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Section 4 Process to Require Testing Additional new authority at Section 4(a)(2) allows
EPA to use rules, orders, and consent agreements to obtain needed testingagreements to obtain needed testing EPA required to determine that the information is
“necessary” for any of several purposes, including
• Review Section 5 notice or for Section 6(b) risk evaluation (RE)
• Establish priority under Section 6(b)• Establish priority under Section 6(b)
EPA required to
• issue “statement of need”
• use tiered testing
Explicitly allows testing for exposure and exposure t ti l
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potential
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Animal Welfare ProvisionsAnimal Welfare Provisions
Section 4(h) requires that EPA: reduce and replace vertebrate testing to
extent practicable, scientifically justified, etc.
develop and implement strategic plan to promote alternative test methods
i l di li t f lt ti th d d d• including list of alternative methods deemed qualified for use, and
need to use alternative methods inneed to use alternative methods in developing voluntary testing for submission under TSCA
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Section 4. Testing of Chemical Substances Section 4. Testing of Chemical Substances and Mixtures New law appears to solves many of
the problems of TSCA Section 4the problems of TSCA Section 4Findings proved difficult to satisfyR l b d t ti l dRule-based testing was slow and uneven
Should allow EPA to efficiently meet many if not most of itsmany, if not most, of its testing/information needs
Ability to require prioritization testingAbility to require prioritization testing should ensure informed screening process
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Section 4. Testing: Science AspectsSection 4. Testing: Science Aspects
Tiered testing and Section 6 prioritization Ability to go directly to
advanced/confirmatory testing Exposure and exposure potential testing Protocols and methodologies Protocols and methodologiesNeed to identify and demonstrate vertebrate
animal alternativesanimal alternatives
Develop exposure test guidelines
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Section 5 ManufacturingSection 5. Manufacturing and Processing Notices for New Chemicals and Significant New UsesSignificant New Uses
(NC/SNUs)
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Section 5. New Chemicals (NC)Section 5. New Chemicals (NC)
New law retains much of TSCA with i t t himportant changes Requires EPA determination on all NCs Three alternative determinations at
Section 5(a)(3):(A) NC/SNU t bl i k(A) NC/SNU presents an unreasonable risk
(B)(i) Available information is insufficient to permit reasoned evaluation of health and environmental effects or (ii)(I) NC/SNU may present unreasonable risk or (ii)(II) it has substantial production and exposure, or
© 2016 Bergeson & Campbell, PC. All Rights Reserved.
(C) NC/SNU not likely to present unreasonable risk
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Section 5. New Chemicals (cont’d)Section 5. New Chemicals (cont d) If EPA determines:
(A) or (B), it is required to regulate under Section 5(f) or Section 5(e), respectively
(C), it must publish/explain “not likely to present (C), it must publish/explain not likely to present unreasonable risk” finding
§5 limits ability to regulate articles § y gusing SNU rule authority but
Requires EPA to also apply a SNURequires EPA to also apply a SNU rule after taking control action or explain its “why not” reasoning
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p y g
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Outline of Section 5(e) Regulatory ProcessProcessIf EPA makes a (B)
determination, it is required to issue a Section 5(e) orderControl must be to “the extent
necessary” to protect against an y p gunreasonable riskManufacture/processing of p g
NC/SNU can commence only in compliance with order
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Section 5. Science ImplicationsSection 5. Science Implications Effect of “insufficient information” determination could be
significant
Requirement to explain drops will increase transparency
Appears to maintain EPA’s ability to rely on its prior assessment approaches including Structure Activityassessment approaches, including Structure-Activity Relationships (SAR), exposure models
Requirement on EPA to review and take required actions as needed will likely lead to more frequent controls
No specific or additional requirements for nanomaterials and genetically modified microorganisms likely means g y g ythat EPA will continue to apply prior approaches although “insufficient information” could have important effect
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Section 6. Prioritization, Risk
Evaluation (RE) andEvaluation (RE), and Risk Management (RM) g ( )of Existing Chemicals
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Section 6(b). Existing Chemicals ( ) gPrioritization and Risk Evaluation (RE) Within 1 year, EPA require to establish by rule:y , q y
Risk-based prioritization process, including
• Criteria for high- vs. low-priority
• Describe process and how EPA will consider hazard and exposure potential, including
persistence and bioaccumulation, persistence and bioaccumulation,
PESS,
storage near sources of drinking water,
diti f conditions of use,
Volume manufactured
Process to conduct REs
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EPA plans to get proposal out this year20
Section 6(b)(1). ExistingSection 6(b)(1). Existing Chemicals PrioritizationPrioritization applies risk-based screening pp gprocess to designate high- versus low-priorities based on following standards:
High-priority: without consideration of costs/nonrisk factors, chemical may presentan unreasonable risk, because of a potentialan unreasonable risk, because of a potential hazard and a potential route of exposure under the COU, including to a PESS identified as relevant by EPAas relevant by EPA High-priorities must undergo risk evaluation (RE)
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Section 6(b)(1). Existing ( )( ) gChemicals Prioritization (cont’d) Low-priority: EPA concludes it has p y
“sufficient information to establish” that chemical does not meet the high-priority standardstandard. Low-priority determinations are subject to judicial
review
Where information is insufficient to support low-priority, default decision is high-priority
Prioritization timeline = 9-12 months
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Section 6(b)(2) ExistingSection 6(b)(2). Existing Chemicals RE Risk evaluation standard:
to determine whether chemical, under its diti f t blconditions of use, presents an unreasonable
risk, without consideration of costs/nonriskwithout consideration of costs/nonriskfactors, but including unreasonable risks to PESS id tifi d l t b EPAidentified as relevant by EPA
All chemicals meeting this standard must proceed to RM
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proceed to RM
23
Section 6(b)(4). Existing ChemicalsSection 6(b)(4). Existing Chemicals RE (cont’d)
Conclusions that a RE chemical does not meet this standard, i.e., that it does not present unreasonable risk arepresent unreasonable risk, are issued by order and subject to legal challengelegal challenge
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Section 6(b). Existing Chemicals RERE Various requirements must be met in
conducting RE:conducting RE: Integrate and assess available information on hazards
and exposures for COU, including PESS aspects
Describe whether aggregate or sentinel exposures under COU were considered
Not consider costs or nonrisk factors Not consider costs or nonrisk factors
Take into account duration, intensity, frequency, under COU
Describe weight of the scientific evidence
RE timeline = 3 years + 6 month extension
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Scope of RE published 6 months after initiation
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Minimum Goals for Section 6 Prioritizations and REs
6 h f RE d 6 months after enactment, REs underway on 10 chemicals
3 years later, REs underway on 20 high-3 years later, REs underway on 20 highpriority cases and at least 20 chemicals designated as low-priority
EPA also required to designate one high- EPA also required to designate one high-priority chemical upon completion of each RE M f t t d f EPA Manufacturers can request and pay for EPA RE and “interested persons” can submit draft REs
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Section 6(b). Science AspectsSection 6(b). Science Aspects
Science requirements and relationship to EPA RAGs, EAGs, work plan process, data , p p ,quality requirementsAssessment of metals andAssessment of metals and metal compounds
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Sections 6. Existing Chemicals RM
For chemicals meeting RE standard, EPA required to take RM action within 2 years, extendable for 2take RM action within 2 years, extendable for 2 additional yearsRegulatory standard: action must be taken to the “extent necessary so that the chemical no longer y gpresents an unreasonable risk “New law: Deletes TSCA’s “least burdensome” languageDeletes TSCAs least burdensome languageSimplifies procedural requirements for Section 6 actionRequires EPA to “factor in” and publish statements on:
• Health and environmental effects/magnitude of exposures
• Benefits of the chemical for various uses
• Reasonably ascertainable economic consequences of the
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y qrule
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Section 6. Existing Chemicals RMSection 6. Existing Chemicals RM (cont’d)When EPA effectively bansWhen EPA effectively bans one or more uses it must also consider availability of it must also consider availability of
“technically and economically feasible alternatives that benefit health or the environment”
RM action “shall be as soon as practicable”practicable EPA has some flexibility in imposing compliance dates
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imposing compliance dates
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Section 6 RM Exemptions/LimitationsSection 6. RM Exemptions/Limitations
Law includes various limitations/ exemptions if requirements can beexemptions if requirements can be met:Limitation on regulating articlesLimitation on regulating articlesExemptions:
• For certain replacement parts forFor certain replacement parts for complex durable and consumer goods
• From a ban or phase-out requirement can be granted by EPA if e gcan be granted by EPA if, e.g.,
– “Critical or essential use”– Compliance would significantly disrupt
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p g y pnational economy, national security, etc.
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Section 8(b)(4) -- Inventory ResetSection 8(b)(4) Inventory Reset
TSCA Inventory first established in 1979 and currently contains over 80 000 “existingcurrently contains over 80,000 existing chemicals”
Reset process:p By June 2017, EPA must promulgate rule to “reset” the
Inventory to distinguish actives vs inactives
Manufacturers required to notify; processors can be Manufacturers required to notify; processors can be included in rule
Reporting:• Inventory substances manufactured or processed in the
ten years prior to enactment
• Six month reporting period
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Section 8(b)(4) -- Inventory Reset ( t’d)(cont’d)
Reset process (cont’d): If a notice is received, substance is designated as
“ ti ”“active”
If no notice is received, substance is designated as “inactive”
• Inactive substances stay on the Inventory
Inactive chemicals can be returned to active status via d ti t EPAadvance notice to EPA
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Other Provisions of NoteOther Provisions of Note
Confidential Business Information (CBI)( ) Preemption Judicial review Judicial review Fees Administration of the law
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Questions/Discussion?
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Th k YThank You
Charles M. AuerSenior Regulatory and Policy AdvisorSenior Regulatory and Policy Advisor
Oscar Hernandez, Ph. D.Senior Regulatory Chemist
ohernandez@lawbc [email protected] 571-733-0545
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