Overview of TSCA Reform and Introduction to Key Provisions ... · Amended TSCA significantly...

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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

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)

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

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

“Inventory Reset”

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

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”

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 ”

evidence”

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

• Industry

Section 4 Testing ofSection 4. Testing of Chemical Substances and

Mi tMixtures

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

potential

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

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

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

Section 5 ManufacturingSection 5. Manufacturing and Processing Notices for New Chemicals and Significant New UsesSignificant New Uses

(NC/SNUs)

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

(C) NC/SNU not likely to present unreasonable risk

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

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

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

Section 6. Prioritization, Risk

Evaluation (RE) andEvaluation (RE), and Risk Management (RM) g ( )of Existing Chemicals

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,

storage near sources of drinking water,

diti f conditions of use,

Volume manufactured

Process to conduct REs

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)

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

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

proceed to RM

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

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

Scope of RE published 6 months after initiation

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

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

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

y qrule

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

imposing compliance dates

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

p g y pnational economy, national security, etc.

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

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

Other Provisions of NoteOther Provisions of Note

Confidential Business Information (CBI)( ) Preemption Judicial review Judicial review Fees Administration of the law

Questions/Discussion?

Th k YThank You

Charles M. AuerSenior Regulatory and Policy AdvisorSenior Regulatory and Policy Advisor

cauer@lawbc.com301-525-3467

Oscar Hernandez, Ph. D.Senior Regulatory Chemist

ohernandez@lawbc comohernandez@lawbc.com 571-733-0545

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