This presentation provides an overview of recent amendments to the federal Toxic Substances Control Act (TSCA). On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law, substantially amending TSCA. The new law, which received bipartisan support in both the U.S. House of Representatives and the Senate, includes much needed improvements such as requirements that EPA evaluate existing chemicals, a new risk-based safety standard, and increased public transparency of chemical information.

1. THE FRANK R. LAUTENBERG CHEMICAL
SAFETY FOR THE 21ST CENTURY ACT :
REQUIREMENTS AND EPA IMPLEMENTATION
1
Office of Pollution Prevention & Toxics
US EPA
September 2017

2. Meet Your Moderator
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Rick Foote
Triumvirate Environmental

3. During This Webinar
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 All lines will be muted.
 Communicate via the questions tab in your
webinar panel.
 Unanswered questions will be responded to
after the webinar.
 Webinar recording and slides will be
emailed to you tomorrow.

4. Meet Your Presenter
4
Jessica Barkas
Environmental Protection Agency

5. Outline of Presentation
Significant Changes and Improvements to the Law
• New Chemicals
• Existing Chemicals
• Mercury Compounds
• New Requirements
– Collections of Fees
– Potentially exposed or susceptible subpopulations
– Testing Authority
– Alternatives to Animal Testing
– Relationship to State Laws
– Confidential Business Information
– Scientific Requirements
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6. The New Law – Amended TSCA
• The “Frank R. Lautenberg Chemical Safety for
the 21st Century Act” was signed by President
Obama; immediately went into effect on June
22, 2016
• Amends and updates the Toxic Substances
Control Act (TSCA) of 1976
• Passed by large bipartisan margins in the U.S.
House (403 to 12) and unanimously in Senate
• Received support from chemical industry and
downstream users of chemicals, NGOs and
other stakeholders
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7. New Chemicals: Background
• Mandated by section 5 of TSCA, EPA's New
Chemicals Program helps manage the potential risk
to human health and the environment from
chemicals new to the marketplace.
• Section 5 requires anyone who plans to
manufacture (including import) a new chemical
substance for a non-exempt commercial purpose
to provide EPA with pre-manufacture notice (PMN)
before initiating the activity.
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8. New Chemicals:
Review and Determination
• EPA must now make an affirmative finding on new
chemicals or significant new uses of existing
chemicals before entry into marketplace
Old TSCA: New chemicals enter marketplace absent EPA action
• Types of Determinations:
– Presents an unreasonable risk,
– May present an unreasonable risk,
– Substance is or will be produced in substantial quantities
plus significant or substantial exposure/release,
– Is not likely to present an unreasonable risk, or
– Information is insufficient to permit a reasoned
evaluation of the risk.
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9. New Chemicals:
Types of Outcomes
Presents an unreasonable risk
- That the relevant chemical substance or
significant new use presents an unreasonable
risk of injury to health or the environment
- Regulation under section 5(f) – Protection
Against Unreasonable Risks
• Section 5(f) order or section 6(a) proposed
rule
• Restriction or prohibition of manufacturing,
processing, distribution in commerce, or
disposal of chemical substance or specific use
of chemical substance to the extent necessary
to protect against the unreasonable risk
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10. New Chemicals:
Types of Outcomes
May present an unreasonable risk
- 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 substances, or any combination of such
activities, may present an unreasonable risk of injury to
health or the environment
- Regulation under section 5(e) – Regulation Pending the
Development of Information
• Section 5(e) order – Typically a consent order with
limitations to the extent necessary to protect against
unreasonable risk
• Commercialization only in compliance with order
• Testing generally due at a specified point after
commercialization of the chemical substance, unless risks
cannot be mitigated then testing needed before
commercialization of the chemical substance 10

11. New Chemicals:
Types of Outcomes
Insufficient To Make a Reasoned Evaluation
- 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
- Regulation under section 5(e)–Regulation
Pending the Development of Information
• Section 5(e) order –Typically a consent order
• Testing generally required before commercialization
of the chemical substance can occur
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12. New Chemicals:
Types of Outcomes
Not Likely To Present An Unreasonable Risk
- Not likely to present an unreasonable risk of
injury to health or the environment including an
unreasonable risk to a relevant potentially
exposed or susceptible subpopulation under the
conditions of use
- Commercialization of the chemical substance
can commence after the determination is made,
not withstanding any remaining portion of the
review period
• Section 5(g)–EPA must also publish a statement of
this finding in the Federal Register
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13. Overview of EPA Assessments
• TSCA requires new chemical manufacturers to submit only
studies or data in their possession or control (i.e., no
minimum set of toxicity or fate studies are required)
• Because no test data are required to be submitted with a
notification, predictive models/technical tools and
professional judgment are used by EPA to assess potential
risks
• Evaluation of risks from new chemical substances are
considered throughout their product life-cycle
• EPA focuses on exposure to workers, site-specific
assessment of environmental and general population
exposure, and consumer exposure
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14. Conditions of Use
• 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”
• EPA uses the information provided by the submitter, information
in the literature, attributes of the chemical substance (e.g.,
physical-chemical properties)
• EPA also uses information on analog(s) for the chemical
substance including available data, information in the literature,
attributes of the analog (e.g., physical-chemical properties) and
any difference in these attributes from the subject chemical
substance
• Information on downstream processing and use of the chemical
substance and analogs
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15. Additional Information
• Public meeting materials from December
2016 go into more detail on changes to the
New Chemicals Review program:
– https://www.epa.gov/assessing-and-managing-
chemicals-under-tsca/public-meeting-
reviewing-new-chemicals-under-toxic
• More on new chemicals generally, and
recent news:
– https://www.epa.gov/reviewing-new-chemicals-
under-toxic-substances-control-act-tsca
15

16. • Mandatory duty for EPA to evaluate existing chemicals with
clear and enforceable deadlines
– Old TSCA: No duty to review; no deadlines for action
• Newly amended TSCA requires EPA to evaluate the risk of
existing chemicals and dictates the number of chemicals to be
evaluated and timelines for evaluation
• TSCA requires EPA to promulgate procedural rules to align
EPA’s existing chemical management program with the new
requirements and responsibilities in TSCA:
– Active/Inactive Inventory (final rule on August 11, 2017)
– Prioritization (final rule on June 22, 2017)
– Risk Evaluation (final rule on June 22, 2017)
Existing Chemicals

17. Existing Chemicals:
TSCA Inventory
• Industry must report on the chemicals they
manufactured or processed in previous 10 years to
determine if chemicals are currently “active” in the
marketplace
• A final rule requiring manufacturers to report was
published on August 11, 2017.
- Chemicals will be designated as active or
inactive
- No pre-manufacture notices required to move
from inactive to active status
- More information: https://www.epa.gov/tsca-
inventory/tsca-inventory-notification-active-
inactive-rule
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18. Low-
Priority
High-
Priority
No Unreasonable
Risk
Unreasonable
Risk
Risk Management Action
Statutory Deadline = 2 to 4
years for Final Rule
Pipeline for Existing Chemical Review
and Management
Identification of
First 10 Chemicals
Risk Evaluation
Statutory Deadlines = 6 Months for Final Scope;
3 to 3.5 Years for Final Risk Evaluation
- 20 Ongoing Evaluations by December 2019
- New Evaluation to begin as one is
completed
Initiate
Prioritization
90-day
public
comment
90-day
public
comment
Screening
Review and
Proposed
Priority
Designation
Final
Priority
Designation
Statutory Deadline = Min 9 Months to Max 12 Months
Prioritization
Identification of
candidate chemical

19. Existing Chemicals:
Prioritization
EPA must establish a risk-based process and criteria
to identify high- and low-priority substances:
• High priority – the chemical may present
an unreasonable risk of injury to health or
the environment due to potential hazard
and route of exposure, including risk to
“potentially exposed or susceptible
subpopulations”
• Low priority – the chemical does not meet
the standard for high-priority
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20. • Begins pipeline for review and risk management
• Selected candidate and proposed designation is published
in Federal Register for 90 day comment period before final
designation
• Once a chemical is in the prioritization process, TSCA does
not contemplate any opportunity for pause:
– Prioritization (min 9 months to max 12 months), to
– Risk Evaluation (max 3 to 3.5 years), to
– Risk Management (max 2 to 4 years)
• Final rule to identify chemicals for risk evaluation was
published June 22, 2017.
• More information: https://www.epa.gov/assessing-and-
managing-chemicals-under-tsca/prioritizing-existing-
chemicals-risk-evaluation
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Existing Chemicals:
Prioritization

21. Existing Chemicals:
Risk Evaluation
• High priority designation triggers risk evaluation
to be completed in 3 years
• EPA must have a process for risk evaluation
– To determine if a chemical presents an
unreasonable risk of injury to health or the
environment under the conditions of use
– Without consideration of cost or other non-risk
factors
– Including unreasonable risk to potentially exposed
or susceptible subpopulation(s)
• Chemicals assessed against only a risk-based
safety standard
• Old TSCA – Risk-benefit balancing standard
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22. Existing Chemicals:
Risk Evaluation
• Other requirements of risk evaluations include:
- Information on hazards and exposures for the
conditions of use of the chemical
- Describe consideration of aggregate or sentinel
exposures (law does not require cumulative exposure)
- Account for the likely duration, intensity, frequency,
and number of exposures under the conditions of use
- Describe the weight of the scientific evidence for the
identified hazard and exposure
• Policy Consideration
- Balance the need for transparency, without restricting
the specific science that will be used to conduct the
evaluations, allowing the Agency flexibility to adapt
and keep current with changing science as it conducts
TSCA evaluations into the future.
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23. Existing Chemicals:
Risk Evaluation
• Components of a risk evaluation include:
– Scope document (published 6 months after initiation)
» Analysis Plan and a Conceptual model
– Draft Risk Evaluation
» Hazard and exposure assessments, risk characterization,
unreasonable risk determination
» Peer Review
– Final Risk Evaluation (published 3-3.5 years)
• For each risk evaluation completed, EPA must designate a new high-
priority chemical
• Within 3 years, EPA must have 20 ongoing chemical risk evaluations
• At least 50% of these chemicals must come for the 2014 Update to the
TSCA Work Plan
• More information: https://www.epa.gov/assessing-and-managing-
chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca
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24. Existing Chemicals:
Initial 10 Risk Evaluations
• EPA was required to identify 10 chemicals from
the 2014 Update to TSCA Work Plan and formally
initiate risk evaluations by mid-December 2016
- 2014 Update to TSCA Work Plan lists 90
chemical substances for assessment by EPA
- Methodology was developed in 2012 and
involves screening process for hazard,
exposure, persistence and bioaccumulation
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25. • EPA published in the Federal Register a list of the first 10
chemicals for risk evaluation – December 19, 2016
• Public engagement on scope of risk evaluations
– EPA sought additional information on uses of each chemical by
March 15, 2017
• Final Scope Documents of risk evaluations published June 22, 2017.
• More information: https://www.epa.gov/assessing-and-managing-
chemicals-under-tsca/risk-evaluations-existing-chemicals-under-
tsca#ten
1,4-Dioxane
1-Bromopropane
Asbestos
Carbon Tetrachloride
Cyclic Aliphatic Bromide Cluster (HBCD)
Methylene Chloride (MC)
N-methylpyrrolidone (NMP)
Pigment Violet 29
Tetrachloroethylene, or perchloroethylene (perc)
Trichloroethylene (TCE)
Existing Chemicals:
Initial 10 Risk Evaluations

26. Existing Chemicals:
Manufacturer-
Requested Evaluations
• Establishes a process for manufacturers to request that
EPA evaluate specific chemicals, and pay costs as follows:
- For chemicals on the TSCA Workplan, manufacturers
pay 50% of costs; and
- For all other chemicals, manufacturers pay 100% of
costs
• Manufacturer requests subject to the following limitations:
- Do not count toward the 20 risk evaluations EPA must
have underway
- Administrator has discretion to grant manufacturer
requests, but these requests must be 25% to 50% of
ongoing reviews. 26

27. Existing Chemicals:
Risk Management
• The unreasonable risk(s) identified in the risk
evaluation must be eliminated
• Old TSCA –Significant risks might not be addressed due to cost/benefit
balancing and no mandate to act
• EPA must take risk management action in 2 years (with an
additional 2 if necessary) to address unreasonable risks
• In issuing a rule EPA must consider, “to the extent
practicable”:
- Benefits of the substance
- Reasonably ascertainable economic consequences of the rule,
including on the national economy, small business, and
innovation.
- Whether technically and economically feasible alternatives will be
a reasonably available substitute.
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28. • This action can include a range of actions for
chemical manufacturing, processing, or distributing in
commerce, as dictated by the law:
– Prohibiting or otherwise restricting
– Limiting volumes
– Limiting/prohibiting a particular use
– Warnings or instructions associated with a use
– Record keeping
– Regulating disposal methods
– Notification requirements to downstream users
• EPA must address the risk if it refers to another
federal agency, if that agency has failed to act
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Existing Chemicals:
Risk Management

29. Existing Chemicals:
Persistent, Bioaccumulative and
Toxic Chemicals (PBT)
• Expedited action for certain PBT chemicals already on
TSCA Workplan
• No risk evaluation; only a use and exposure assessment
• Rules to reduce exposure to the extent practicable must be
proposed within 3 years of enactment and finalized 18
months later, unless a manufacturer requested a risk
evaluation by September 19, 2016
• Additional requirements encourage prioritization of other
PBTs in overall risk evaluation process
 Status
• 5 chemicals will get expedited action under TSCA 6(h)
• Manufacturer requests for risk evaluations were received for 2
PBT chemicals, which are thus excluded from the expedited
action requirements 29

30. Existing Chemicals:
Persistent, Bioaccumulative and
Toxic Chemicals (PBT)
• 5 chemicals that scored high for both persistence and
bioaccumulation, or high for one and either high or moderate
for another will get expedited action under TSCA 6(h):
– Decabromodiphenyl ethers (DecaBDE)
– Hexachlorobutadiene (HCBD)
– Pentachlorothiophenol (PCTP)
– Phenol, isopropylated, phosphate (3:1)
– 2,4,6-Tris(tert-butyl) phenol
• Manufacturer requests for risk evaluations were received for 2
PBT chemicals, which are thus excluded from the expedited
action requirements:
– Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-
naphthalenyl)
– Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-
naphthalenyl)
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31. Existing Chemicals:
Ongoing Risk Management
Rulemakings
• For chemical uses with completed risk assessments before June 22,
2016, showing unreasonable risk, Section 26 of TSCA allows EPA to
propose and issue final Section 6 rules consistent with those
assessments
• EPA has issued proposed rules concerning:
• TCE use in spot cleaning and aerosol degreasing (December 7, 2016)
• TCE use in vapor degreasing (January 19, 2017)
• Methylene chloride (MC) and N-methylpyrrolidone (NMP) in paint
removers (January 19, 2017)
• The risk assessments for TCE, MC, and NMP were finalized prior to June
22, 2016.
• More information: https://www.epa.gov/assessing-and-managing-
chemicals-under-tsca/current-chemical-risk-management-activities
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32. Mercury:
Compound Export Prohibition
and Reporting
• Prohibition
– Amended Law prohibits export of 5 mercury compounds as of January 1, 2020:
• Mercury (I) chloride or calomel (CASRN 10112–91–1)
• Mercury (II) oxide (CASRN 21908–53–2)
• Mercury (II) sulfate (CASRN 7783–35–9)
• Mercury (II) nitrate (CASRN 10045–94–0)
• Cinnabar or mercury sulphide (CASRN 1344–48–5)
- Allows for additions per EPA rulemaking or citizens’ petitions
- Exempts mercury compound wastes exported for disposal to OECD countries
• Reporting
- Amended law requires by June 22, 2021, reporting to address volumes,
methods of disposal, and other information on mercury compound wastes
exported for disposal
- As necessary, EPA must evaluate and recommend*:
- Comparable waste management options to the US, and
- Whether Congress should further limit export of mercury compounds
* EPA currently is not engaged in this assessment
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33. Mercury:
Supply, Use, and Trade Inventory
• Amended TSCA directs EPA to publish in the Federal Register an “inventory of
mercury supply, use, and trade in the United States” by April 1, 2017 and every
three years thereafter
– Defines “mercury” as “elemental mercury” or “a mercury compound”
– Requires EPA to identify any manufacturing processes or products that
intentionally add mercury and recommend actions for reductions in mercury
use
• Initial Inventory Report (available at:
https://www.regulations.gov/document?D=EPA-HQ-OPPT-2017-0127-0002)
– Compilation of publicly available data on the supply, use, and trade of
elemental mercury (CASRN 7439-97-6) and mercury compounds
• Mercury Inventory Reporting Rule
– Authorized by Lautenberg Act and required to be published by June 22, 2018
– Requires reporting from “persons who manufacture or import mercury or
mercury-added products or otherwise intentionally use mercury in a
manufacturing process”
– EPA currently is developing the proposed rule
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34. • TSCA gives EPA new authority to collect fees to help defray a portion of
implementation costs
• Fee structure must be established by rule, which is under development
(more info: https://www.epa.gov/assessing-and-managing-chemicals-
under-tsca/public-meeting-presentation-industry-consultation)
• EPA can collect fees from chemical manufacturers (including
importers) and processors who:
– Are required to submit test data (TSCA section 4);
– Submit notification of or information related to intent to manufacture a new
chemical or significant new use of a chemical (TSCA section 5);
– Manufacture or process a chemical substance that is subject to a risk
evaluation (TSCA section 6); or
– Request that the EPA conduct a risk evaluation, which is then granted, on an
existing chemical (TSCA section 6)
• Fees will go to a “TSCA Service Fee Fund” and are contingent on
Congress providing sufficient funds through normal appropriations
• The level of fees is to be set to cover 25% of relevant program costs,
initially capped at $25 million/yr (subject to change)
New Requirements:
Collection of Fees

35. New Requirements:
Potentially Exposed or
Susceptible Subpopulations
• “means a group of individuals within the general
population identified by the Administrator 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 substance or
mixture, such as infants, children, pregnant women,
workers, or the elderly.”
• Applicable for both for new and existing chemicals.
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36. New Requirements:
Testing Authority
• New authority to issue orders to require testing, in
addition to rulemaking authority, to speed the process
of prioritization and risk evaluation.
– Where EPA determines a chemical may present an
unreasonable risk, or
– Specified purposes with explanation as to why an
order is warranted rather than a test rule or consent
agreement.
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37. New Requirements:
Alternatives to Animal Testing
• “The Administrator shall reduce and replace, to the
extent practicable, scientifically justified, and
consistent with the policies of this title, the use of
vertebrate animals in the testing of chemical
substances or mixtures…”
• “…not later than 2 years after the date of
enactment….develop a strategic plan to promote
the development and implementation of alternative
test methods and strategies to reduce, refine, or
replace vertebrate animal testing and provide
information of equivalent or better scientific quality
and relevance for assessing risks of injury to health
or the environment…” (by June of 2018)
37

38. New Requirements:
Relationship to State Laws
• States can impose restrictions that are:
– Identical to Federal requirements;
– Adopted under the authority of the federal law
– Adopted under state air or water quality or waste treatment or disposal law
• The law does not prevent states from action on chemical risk that the EPA has
NOT acted on
• A state cannot prohibit all use of the chemical in the state, except via co-
enforcement or a waiver
• Any state action taken on a chemical prior to April 22, 2016, or taken under a
law in effect on Aug. 31, 2003 remains in place
• States are barred, except via a waiver, from imposing a new restriction on a
chemical once EPA designates it as high-priority and publishes the scope of the
risk evaluation, ending when EPA publishes a final risk evaluation or misses the
deadline for doing so, whichever is earlier; states can impose new restrictions
during any required rulemaking.
38

39. New Requirements:
Confidential Business Information
• Amended law limits any presumption of protection from disclosure of
chemical identities to the period before they enter the market; and any
such claim for a chemical after market entry has to be substantiated and
reviewed by EPA.
• Exclusion of health and safety studies and their underlying data from being
claimed as CBI.
– Exceptions – if disclosure would disclose processes used in manufacturing or processing, and in
the case of a mixture if disclosure would disclose a portion of the mixture
• With some exceptions, CBI claims are required to be substantiated at the
time they are asserted, and EPA is required to review and approve or deny
all chemical identity claims, and at least 25% of all other claims.
• Claims expire after 10 years unless re-substantiated and approved
• Disclose CBI upon request from a state, tribe, or local government; health
and environmental professionals; and emergency response officials
• More information: https://www.epa.gov/tsca-cbi
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40. New Requirements:
Scientific Requirements
• Requires EPA to base decisions on the “best available science”
and on the “weight of scientific evidence” and also consider:
– Whether the information and the methods to obtain the information
are reasonable for and consistent with the intended use of the
information
– The extent to which the information is relevant
– The degree of clarity and completeness of data, assumptions, methods,
quality assurance, and analyses
– The extent to which the variability and uncertainty in the information
are evaluated and characterized
– The extent of independent verification or peer review of the
information.
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41. More information
• TSCA hotline:
– Phone: 202-554-1404
Fax: 202-554-5603
E-mail: tsca-hotline@epa.gov
Hours: 8:30 a.m. to 5:00 p.m. EST, Monday
– Friday
• EPA website:
– https://www.epa.gov/assessing-and-
managing-chemicals-under-tsca/frank-r-
lautenberg-chemical-safety-21st-century-
act
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42. Thank You!
Contact:
• Jessica Barkas: barkas.Jessica@epa.gov
• Rick Foote: rfoote@triumvirate.com
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