toxic substances control act (tsca) reform: what's new & how it may affect you
TRANSCRIPT
THE FRANK R. LAUTENBERG CHEMICAL
SAFETY FOR THE 21ST CENTURY ACT :REQUIREMENTS AND EPA IMPLEMENTATION
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Office of Pollution Prevention & ToxicsUS EPA
September 2017
Meet Your Moderator
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Rick Foote
Triumvirate Environmental
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.
Meet Your Presenter
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Jessica Barkas
Environmental Protection Agency
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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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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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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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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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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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
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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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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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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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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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
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• 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
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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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
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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• 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
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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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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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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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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• 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-Dioxane1-BromopropaneAsbestosCarbon TetrachlorideCyclic Aliphatic Bromide Cluster (HBCD)
Methylene Chloride (MC)N-methylpyrrolidone (NMP)Pigment Violet 29Tetrachloroethylene, or perchloroethylene (perc)Trichloroethylene (TCE)
Existing Chemicals: Initial 10 Risk Evaluations
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
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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• 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
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
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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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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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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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 rule33
• 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
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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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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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)
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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.
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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-cbi39
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. 40
More information
• TSCA hotline:– Phone: 202-554-1404
Fax: 202-554-5603E-mail: [email protected]: 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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