TOXIC SUBSTANCES CONTROL ACT:EPA IMPLEMENTATON
Nancy B. Beck, PhD, DABTOffice of Chemical Safety and Pollution Prevention
U.S. Environmental Protection Agency
November 13, 2017
beck.nancy@epa.gov

The New Law• “The Frank R. Lautenberg Chemical Safety for the 21stCentury Act”
o Amends and updates the Toxic Substances Control Act(TSCA)o Signed by the President on June 22, 2016
o Effective immediately• Significanceo First major update to TSCA in 40 years (1976)
o Passed with overwhelming bipartisan support in both the
U.S. House and Senate
o Received support from chemical industry and downstream
users of chemicals, NGOs, and other stakeholders

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TSCA Implementation Milestones
Day 1 (June 22, 2016)

New chemicals – implement all new requirements, including affirmative
determinations
Existing Chemicals – apply new risk-based approach and scientificstandards for evaluations and risk management rules
CBI – review chem ID claims (and subset of other claims) within 90 days

By 6 months (December 2016)






Propose TSCA Framework rules (prioritization, risk evaluation, andactive/inactive inventory rules)
Publish list of first 10 chemicals for risk evaluation
Publish annual risk evaluation plan
Determine whether “small business” definition warrants revision
Report to Congress on capacity to implement

By 1 Year (June 2017)


Finalize TSCA Framework rules
Finalize scopes for first 10 risk evaluations
Publish Guidance to Assist Interested Persons in Developing andSubmitting Draft Risk Evaluations
Establish Science Advisory Committee on Chemicals

3TSCA Implementation Milestones
By 2 Years (June 2018)
 Publish strategic plan for non-animal testing methodologies
 Finalize all necessary policies, procedures and guidance for TSCA
implementation
 Publish guidance re: generic names for chem ID
 Receive active/inactive notices from manufacturers and processors (~Oct2018) and update inventory listings (~Nov 2018)
 Propose rule for reviewing all chem ID claims (~Nov 2018)
 Propose rule for TSCA user fees (target date early 2018)

By 3.5 Years (late 2019)
 Finalize first 10 risk evaluations; initiate risk management if warranted Finalize rule for reviewing chem ID claims for active chems (~Nov 2019)
 Designate 20 High-Priority and 20 Low-Priority chemicals (~Dec 2019)
 Propose risk management rule for certain PBT chemicals (~Dec 2019)

By 5 Years (June 2021)
 Complete review of CBI claims for chem ID
 Report to Congress on implementation of non-animal testing plan Finalize PBT rule (~December 2020)
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TSCA Inventory for Active/Inactive
Chemicals• Industry must report on the chemicals they manufactured,and may report on chemicals they processed, in previous 10
years
o Chemicals will be designated as active or inactive• Final rule signed June 22, 2017
• Currently in the 180-day reporting period (ending Feb, 2018)5

Evaluating Risks of Existing Chemicals

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The New Law
Changes Related to Existing Chemicals• Mandatory duty on EPA to evaluate existing chemicals – clear andenforceable deadlines• Chemical assessment is risk-based; without consideration of costs orother non-risk factors• Persistent, Bioaccumulative and Toxic Chemicals: Fast-track to addresscertain PBT chemicals already on TSCA Work Plan
• Must consider risks to potentially exposed or susceptible subpopulations
determined to be relevant to the evaluation• Unreasonable risks identified in risk evaluation must be addressed• Expanded authority to more quickly require development of chemical
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information when neededThe New Law• Requires EPA to promulgate a number of rules (collectively, the“Framework Rules”) to set up the procedures EPA will use to
implement, and otherwise align, EPA’s chemical management
program with the new requirements and responsibilities in the law:o Fees Rule*o Active/Inactive Inventory Reporting Ruleo Prioritization Ruleo Risk Evaluation Rule
 Signed June 22, 2017
 Published in FR July 20, 2017
 Effective September 18, 2017

*No statutory deadline for Fees Rule8

Prioritization
Statutory Requirements• EPA must establish a risk-based screening process andcriteria for designating a chemical substance as either:o High-Priority Substance, ORo Low-Priority Substance• Some parts of process and criteria specified in TSCA:
o Steps and timeframes in the process
o Definitions for High- and Low-Priority Substanceso Preferences for certain TSCA Work Plan chemicals
o Criteria against which chemicals must be screened (e.g.,
Hazard, Exposure, Persistence, Bioaccumulation, Toxicity,
Cancer)9

Prioritization Outcomes•

High-priority substance – may present an
unreasonable risk of injury to health or the environment
because of a potential hazard and a potential route of
exposure under the conditions of use, including an
unreasonable risk to a “potentially exposed or susceptible
subpopulation”, without consideration of costs or other nonrisk factors•

Low-priority substance – EPA concludes, based on
information sufficient to establish, that the chemical does notmeet the standard for high-priority
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Prioritization Process and Timeline11

Priority Designation Process• Proposed designation announced in Federal Registero Accompanied by identification of information, analysis, andbasis used to support the proposed designationo Triggers 90-day public comment period
 Final designation, including rationale, announced in Federal Register
following consideration of comments• EPA will designate as “high-priority” if information remains
insufficient after extension of public comment period
following imposition of test requirements.
• TSCA prohibits consideration of costs or other non-riskfactors during this process
12Revision/Effects of Designation• May revise from “low” to “high” based on reasonably
available informationo Restart prioritization process and redo all steps• “Low-Priority” means do not proceed to risk evaluation at thistime
o not a finding of “does not present an unreasonable risk”• “High-Priority” triggers immediate initiation of risk evaluationo not a finding of “presents an unreasonable risk”
13Next-steps: Prioritization Process• The final rule does not include a ‘pre-prioritization process’as proposed.
• EPA will be initiating additional public comment opportunities
to address this step.
• This process will help the Agency identify potential candidate
chemicals ready for Prioritization.
o EPA expects to hold a public meeting in December.

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Evaluating Risks of Existing
Chemicals

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Risk Evaluation
Statutory Requirements• EPA must establish by rule a process for risk evaluation
Determine if a chemical presents an unreasonable risk of injury tohealth or the environment under conditions of use
o Without consideration of cost or other non-risk factors
o Including unreasonable risk to potentially exposed or susceptible
subpopulation(s) determined to be relevant to the evaluation• This process must be completed within 3 – 3.5 years• For each risk evaluation completed, EPA must designate a
new high-priority chemical• By December of 2019, EPA must have initiated 20 highpriority chemicals for risk evaluationo Additional risk evaluations may come from manufacturer requests
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Risk Evaluation
Statutory Requirements•

First 10 Chemicals for Risk Evaluation – Announced December 19, 2016•

Scope –Publish within 6 months of initiation – Published June 22, 2017o Must identify hazards, exposure, conditions of use, potentially exposed or susceptible
subpopulation(s) the EPA expects to consider•

Draft Risk Evaluationo Hazard Assessment – identification of types of hazards to human health and/or theenvironmento Exposure Assessment – the duration, intensity, frequency, and number of exposures under
the conditions of use
o Risk Characterization – integration of hazards and exposure into estimates of risko Determination of Unreasonable Risk – does or does not present an unreasonable risko Peer review – all evaluations will be peer reviewed
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o Publication and 30 day public comment periodRisk Evaluation Process andTimeline
Prioritization
First 10Chemicals

High-Priority

Final

45-daypubliccomment

Interagency
Collaboration

Risk Evaluation

Scope
Draft

Manufacturer
Requests

HazardAssessment
Exposure
Assessment

Risk
Characterization

Draft Risk
Evaluation

Peer
Review

Final Risk
Evaluation

60-day publiccomment

Statutory Deadlines = 6 Months for Final Scope; 3 to 3.5 Years for Final Risk Evaluation

Risk Management
ActionStatutory Deadline = 2 to
4 years for Final Rule

Unreasonable
Risk

No
Unreasonable
Risk
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Risk Evaluation
Statutory Requirements•

Draft Risk Evaluation/Risk Characterization:o Integrate and assess available information on hazards and exposures for the conditions ofuse, including information on specific risks of injury to health or the environment andinformation on potentially exposed or susceptible subpopulationso Describe whether aggregate or sentinel exposures were considered, and the basiso Account for the likely duration, intensity, frequency & number of exposures under theconditions of use
o Describe the weight of the scientific evidence for the identified hazard and exposure
o Developed without consideration of cost or other non-risk factors
o Publish in Federal Registero At least a 30-day public comment period•

Final Risk Evaluationo Complete within 3 years of initiation; with potential 6 month extensiono Publish in Federal Register19

Condition of Use• Means the circumstances, as determined by the Administrator, under whicha chemical substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, use, or disposed of.
o EPA generally does not view uses that are legacy uses and intentional
misuse (e.g., purposeful inhalation) as conditions of use• Statutory language for scope includes “that the Administrator expects toconsider”
o EPA may exclude from an individual risk evaluation some activities thatare conditions of use (e.g., de minimis use that presents low risk)• Risk determinations – A risk determination will be made for each use EPA
includes in the risk evaluationo EPA may make early determinations on use(s) once statutory andregulatory requirements for a risk evaluation, including a peer review, arefulfilled
20Best Available Science• Best available science – science that is reliable and unbiased. Use of best
available science involves the use of supporting studies conducted in accordancewith sound and objective science practices, including, when available, peer
reviewed science and supporting studies and data collected by accepted methods
or best available methods (if the reliability of the method and the nature of thedecision justifies use of the data)o Additionally, EPA will consider as applicable:
 The extent to which the scientific information, technical procedures, measures,
methods, protocols, methodologies, or models employed to generate the information
are reasonable for and consistent with the intended use of the information
 The extent to which the information is relevant for the Administrator’s use in
making a decision about a chemical substance or mixture The degree of clarity and completeness with which the data, assumptions,
methods, quality assurance, and analyses employed to generate the information are
documented
 The extent to which the variability and uncertainty in the information, or in theprocedures, measures, methods, protocols, methodologies, or models, areevaluated and characterized The extent of independent verification or peer review of the information or of the
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procedures, measures, methods, protocols, methodologies, or models

Weight of the Scientific Evidence• Means a systematic review method, applied in a manner suited to thenature of the evidence or decision, that uses a pre-established protocol tocomprehensively, objectively, transparently, and consistently, identify andevaluate each stream of evidence, including strengths, limitations, andrelevance of each study and to integrate evidence as necessary andappropriate based upon strengths, limitations, and relevanceo Consistent with legislative history
o EPA did not codify definition of “systematic review”

22Systematic Review• As defined by the Institute of Medicine systematic review “isa scientific investigation that focuses on a specific questionand uses explicit, pre-specified scientific methods to identify,
select, assess, and summarize the findings of similar but
separate studies. The goal of systematic review methods isto ensure that the review is complete, unbiased,
reproducible, and transparent”

23Systematic Review
Key Elements of a systematic review:• A clearly stated set of objectives (defining the question);• Developing a protocol which describes the specific criteria andapproaches that will be used throughout the process;• Applying the search strategy criteria in a literature search;• Selecting the relevant papers using predefined criteria;• Assessing the quality of the studies using predefined criteria;• Analyzing and synthesizing the data using the predefined
methodology;• Interpreting the results and presenting a summary of findings

24Definitions (cont’d)• Reasonably available information – information that EPA
possesses or can reasonably generate, obtain, and synthesize
for use, considering the [statutory] deadlines for completing theevaluation• includes confidential business information not available tothe public• Potentially exposed or susceptible subpopulation – groupof individuals[…]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 achemical substance or mixture, such as infants, children,
pregnant women, workers, or the elderly25Definitions (cont’d)• Aggregate exposure – combined exposures to an individualfrom a single chemical substance across multiple routes andacross multiple pathways• Sentinel exposure – the exposure from a single chemical
substance that represents the plausible upper bound of
exposure relative to all other exposures within a broad categoryof similar or related exposures

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Risk Characterization Summary
Consistent with 26(h), will contain:• Considerations regarding uncertainty and variability.
• Considerations of data quality.
• Considerations of alternative interpretations.
• Considerations for environmental risk evaluations.

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Risk Characterization Information
Quality Compliance
EPA should identify:• Each population addressed by an estimate of applicable risk effects;• the expected risk or central estimate of risk for the potentially exposed orsusceptible subpopulations affected;• each appropriate upper-bound or lower-bound estimate of risk;• each significant uncertainty identified in the process of the assessment of risk
effects and the studies that would assist in resolving the uncertainty; and• peer-reviewed studies known to the Agency that support, are directly relevant
to, or fail to support any estimate of risk effects and the methodology used toreconcile inconsistencies in the scientific information.
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Manufacturer Requests“The Administrator shall conduct and publish risk evaluations […] that a manufacturer ofthe chemical substance has requested, in a form and manner and using the criteriaprescribed by the Administrator”• Conditions of use – Manufacturers may request a risk evaluation for only usesof interest. EPA will identify other conditions of use that warrant inclusion in therisk evaluation.
• EPA’s process for granting/denying requesto Public Notification of Receipt – within 15 days of receipt
o EPA will identify any additional conditions of use for inclusion– 60 dayso Public Notice and Comment (submitted request and any additional conditionsof use to be considered) - open for 45 dayso EPA’s final decision – within 60 days after the end of the comment period.
The manufacturer may withdraw or the risk evaluation will continue.
 Total of 165 days from submission to grant/deny29

Non-animal Testing Strategy
To promote the development and timely incorporation of the newscientifically valid test methods and strategies that are not based onvertebrate animals – not later than 2 years after the day ofenactment, develop a strategic plan to promote the development
and implementation of alternative test methods and strategies
to reduce, refine, or replace vertebrate animal testing andprovide information of equivalent or better scientific quality andrelevance fro assessing risk of injury to health or the environment ofchemical substances or mixtures.
• Public and invited expert meeting Nov 2-3, 2017
• Strategic Plan by June 201830

Use of Non-Vertebrate Data
• In compliance with the statute, EPA will work to reduce and replace, tothe extent practicable, the use of vertebrate animals in testingchemical substances as outlined in TSCA section 4(h).
• Where appropriate, to the extent practicable, and scientificallyjustified, EPA will require the development of information generated
without the use of new testing on vertebrates in performing risk
evaluation.
• Strategic Plan by June 2018.

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Initial 10 Risk Evaluations• The list of the initial 10 chemicals was published on Dec.
19, 2016
1, 4 Dioxane
1-Bromopropane
Asbestos
Carbon Tetrachloride
Cyclic Aliphatic Bromide Cluster(HBCD)

Methylene Chloride
N-Methylpyrolidone
Pigment Violet 29
Trichloroethylene
Tetrachloroethylene• Scope documents published June 22, 2017
• Problem Formulation documents expected Dec 2017-Jan2018
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Persistent, Bioaccumulative, and Toxic Chemicals•

Statute requires a fast-track process for certain PBT chemicals on the TSCA Work
Plan, unless a manufacturer requested a risk evaluation by Sep 19, 2016•

Use and exposure assessment required; No formal risk evaluation•

Rules to reduce exposure, to the extent practicable, must be proposed by June 2019and finalized 18 months later•

Additional requirements encourage consideration of other PBTs in overall risk
evaluation process•

Statuso 5 chemicals will get expedited action (Decabromodiphenyl ether (DecaBDE);
Hexachlorobutadiene (HCBD); Pentachlorothiophenol (PCTP); Phenol,
isopropylated, phosphate (3:1); 2,4,6-Tris(tert-butyl) phenol), based on use andexposure assessments for these chemicals.
o Manufacturer requests for risk evaluations were received for 2 PBT chemicals,
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which are thus excluded from the expedited action requirements

New Chemicals• New law requires EPA to make an affirmative finding on new chemicals
or significant new uses of existing chemicals, before those chemicals
can enter the market• Chemicals under review at time of enactment were considered“resubmitted” and review period restarted; additional notices continued
to come in, resulting in the need to re-review and “backlog”• Backlog was eliminated in August 2017
• Current focus is to continue to improve processes to meet new
requirements in law
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New Chemicals
Presents an
unreasonable risk

May present an
unreasonable risk

• Section 5(f) order• Section 6(a) proposed
rule• Restriction/prohibitionof manufacturing,processing,
distribution, or
disposal• Section 5(e) –Regulation pending
more information• Section 5(e) order –commercialization
only in compliancewith order• Testing required
before or after
commercialization

Is not likely topresent an
unreasonable risk
• Commercialization
can commence after
the determination is
made• Section 5(g) –Statement in the FR

Information is
insufficient topermit a reasoned
evaluation of therisk.
• Section 5(e) –Regulation pending
more information• Section 5(e) order• Testing required35

Next-Phase of Implementation Actions(Through Jan., 2018)
Problem Formulation••

As statutorily mandated, EPA published the Scope documents for the first 10
chemicals for risk evaluation
In Dec-Jan we will publish Problem Formulations which will further refine these Scope
documentso Consideration of existing regulations
o Refinement of conditions of use and other elements of the evaluationso Plan for systematic review

Prioritization Candidate Identification (PCI)•

Developing a stakeholder informed process to assist the Agency in identifying potential
candidate chemicals to move into the Prioritization process. Factors underconsideration include:o Balancing high and low priority candidate chemicals
o A chemical’s readiness (information availability/sufficiency)o EPA’s on-going work (SCIL, Work Plan chemicals, chemical data reporting)36