Tuesday, March 10, 2015
Jennifer Talhelm (Tom Udall), 202.228.6870,
Cheyenne Klotz (David Vitter), 202.224.4623,

The Frank R. Lautenberg Chemical Safety for the 21st
Century Act
After almost two years of deliberations and negotiations with interested senators and stakeholders,
Senators Tom Udall and David Vitter will introduce the new version of the Chemical Safety
Improvement Act (S.1009) that was introduced in 2013 by Senators Frank Lautenberg and David Vitter.
The legislation has been the subject of a hearing, stakeholder meetings, and deliberations with all
affected communities. Several senators have weighed in on pieces of the legislation and affected the
final product. In February 2014, 11 Democratic Senators wrote a letter asking for improvements on the
health and environmental portions of the bill. Every issue raised was addressed.
The bill is a sincere effort at compromise to fix a broken chemical regulatory program. The Toxic
Substances Control Act was passed in 1976 and is the last remaining landmark environmental
legislation that has not been amended or reformed (Clean Air Act, Clean Water Act, Safe Drinking
Water Act, etc.). Instead, it was eviscerated by a 1991 court case when the Environmental Protection
Agency (EPA) failed to ban asbestos.
Americans deserve regulatory certainty that the EPA is overseeing the safety of our chemicals in
commerce. This legislation does that.

Core Provisions
! Strengthens the Safety Standard
• Mandates that EPA base chemical safety decisions solely on considerations of risk to public
health and the environment. The legislation makes clear that costs and benefits may not factor
into a chemical safety evaluation.
• Eliminates the Toxic Substances Control Act’s (TSCA) “least burdensome” requirement for
regulating a chemical, which prevented EPA from banning asbestos.



! Mandates safety reviews for new and existing chemicals
• Requires that all chemicals in commerce, including those "grandfathered" under TSCA, undergo
safety reviews.
• Requires a safety finding for new chemicals before they can enter the market.
! Strengthens Protections for the Most Vulnerable
• Places greater emphasis on and requires protection of those who may be more exposed or
particularly vulnerable to the effects of exposure to chemicals, and clearly defines them for the
first time as including infants, children, pregnant women, workers and the elderly.
! Sets Aggressive and Attainable Deadlines
• Imposes at least 15 deadlines for EPA action, developed with input from the Agency.
! Creates additional requirements and sets reasonable limits on Confidential Business Information
• Requires that confidentiality claims be substantiated up front and imposes a 10-year, renewable
time limit on such claims.
• Requires EPA to review claims that protect the identities of chemicals in commerce.
! Preserves Existing Private Rights of Action
• Clarifies that the existing right of Americans to sue and seek damages when they believe harm
has been done is not affected by the bill.
• Makes clear that nothing in the bill affects the ability of litigants to obtain confidential
information in a judicial proceeding.
! Balances State and Federal Regulations
• Grandfathers in state regulations on chemicals enacted prior to Jan. 1, 2015.
• States can act to restrict a chemical until and unless EPA takes up that same chemical and
addresses the same uses.
• State actions that do not restrict a chemical or are taken to address a different problem are not
• Includes a waiver process for states to set different regulations than EPA during the safety
assessment and after a final rule.
• Once EPA acts on a chemical substance, a uniform federal standard is applied across the nation,
which creates more regulatory certainty and equally protects citizens across the country.



Short title and Intent (amending TSCA Sections 1 and 2)
To amend the Toxic Substances Control Act (TSCA) to protect public health and the environment from
the risks of all chemical substances in commerce.
Definitions (amending TSCA Section 3)
Defines “conditions of use” to ensure that EPA is focused on uses of chemical substances that are
known, intended or reasonably foreseeable. Defines a new safety standard of no unreasonable risk of
harm to health or the environment from exposure to a chemical substance under the conditions of use,
including no unreasonable risk to sensitive populations. By definition, cost and other non-risk factors
cannot be considered in applying the safety standard. Also defines the term potentially exposed or
susceptible populations, and the safety assessment and determination elements of safety evaluations
required under the bill.
Policies, Procedures and Guidance (new Section 3A)
Requires EPA to develop any necessary policies, procedures and guidance not later than two years after
enactment. In order to ensure that EPA can quickly implement the Act, existing policies and guidance
can be used as the new ones are developed. EPA is to review policies, procedures and guidance every
five years, and to update them to reflect emerging science. Policies, procedures and guidance are to
address testing, safety assessments and determinations, and science, including policies aimed at
reducing animal testing. Establishes a new Scientific Advisory Committee on Chemicals to provide
EPA independent scientific advice.
Testing of Chemical Substances and Mixtures (amending TSCA Section 4)
Authorizes EPA to obtain new information on chemical substances at all stages of the safety evaluation
process (new chemicals and prioritization, safety assessment and safety determination of existing
chemicals) and for export notification purposes. EPA can mandate new testing by rule, order and
consent agreement. Requires the Administrator to minimize the use of animals in testing through
specific testing mandates, a strategic plan and research on non-animal test methods. In order to avoid
duplicative testing, the bill allows one company to conduct toxicity testing on behalf of other companies
and to obtain fair and equitable reimbursement for developing the data. In order to avoid unnecessary
testing, the data set may be tailored to specific chemicals or category of chemicals.
Prioritization Screening (new Section 4A)
Requires EPA to establish a risk-based prioritization screening process, by rule, within one year of
enactment. Under the prioritization screening process, EPA is to designate substances as high or low
priority for safety assessment and determination, and possible regulation. EPA is to establish an
interim list of at least 10 high and 10 low priority substances within 180 days of enactment, drawing on
the existing TSCA Work Plan Chemical list (a list of about 100 substances EPA has prioritized for
hazard, exposure, persistence and bioaccumulation). Within 3 years of enactment, EPA is to have
designated at least 20 high priority and 20 low priority chemicals. No later than 5 years after
enactment, a total number of 25 high priority and 25 low priority substances are to have been
designated. As the safety assessment and determination process is completed for each high priority
substance, it must be replaced by a new high priority chemical.
The bill establishes criteria for prioritization screening decisions, including the recommendations of a
Governor or State. States may seek judicial review of EPA decisions to designate a substance as a low
priority. The lack of information is a sufficient basis to designate a substance as a high priority.
Prioritization screening decisions are subject to public notice and comment. Prioritization screening


decisions may be postponed where development of additional information is needed, which EPA may
request or require.
EPA decisions to designate a substance as a low priority must be based on information sufficient to
establish that the substance is likely to meet the safety standard. All priority designations are subject to
review and revision at any time, based on information available to the Administrator.
EPA is to make an effort to complete the prioritization process of all chemicals in active commerce in a
timely manner, taking into account the resources available to complete safety assessments and
determinations. As provided in Section 23 of the bill, EPA is to develop and implement a user fee
program to generate a level of funding sufficient to defray about 25% of the Agency’s costs of program
implementation, including safety evaluations and any necessary regulations. The prioritization
screening process is subject to review and modification every 5 years, to ensure that the process is
operating efficiently and effectively.
Provides manufacturers an opportunity to request that EPA designate a substance as an “additional
priority” for safety evaluation, subject to the payment of 100% of the costs associated with the safety
assessment and determination. In order to ensure that EPA’s activity is focused on the substances it has
identified as high priorities, no more than 15 percent of the total number of chemicals in the safety
evaluation process can be designated under this approach.
New Chemicals and Significant New Uses (amending TSCA Section 5)
Amends the new chemical review process of TSCA by requiring that EPA determine that a new
chemical substance or a significant new use is likely to meet the safety standard before it is approved
for commercial manufacturing or processing. Allows EPA to postpone a decision on a new chemical
until additional information is generated. Prohibits manufacture or processing of a new chemical or
significant new use except in compliance with any conditions or restrictions imposed by EPA sufficient
to ensure likely safety. Ensures transparency in all EPA decisions on new chemicals or significant new
Continues appropriate, long-standing exemptions established by EPA under existing TSCA authority.
Safety Assessments and Determinations (Section 6)
Requires EPA to conduct a safety assessment and safety determination for all high priority substances.
Establishes strict deadlines for EPA action under this section:
• Within 6 months of designation as a high priority, EPA must define the scope of the assessment
and determination, including the conditions of use that will be evaluated.
• Safety assessments and determinations must be completed within 3 years of designation.
• If EPA finds a chemical does not meet the safety standard, risk management measures must be
imposed within 2 years.
• EPA is permitted to extend these deadlines for an aggregate period not to exceed 2 years upon
showing of cause.
EPA is expressly authorized to initiate assessments or continue assessments that have already been
initiated, for substances such as those identified by EPA in its TSCA Work Plan Chemical program.
In the safety assessment and determination process, EPA is to determine that a substance meets the
safety standard, or does not meet the safety standard.



If a substance is found not to meet the safety standard under the conditions of use, EPA must impose
the risk management measures necessary to ensure the safety standard is met. If the safety standard
cannot be met through risk management measures, EPA is authorized to ban or phase out the
substance. All safety determinations are subject to public notice and comment, as are any risk
management rules. Cost and technical feasibility are to be considered only in the choice of applicable
risk management rule. The bill eliminates the controversial provision of existing TSCA that requires
EPA to adopt the least burdensome regulatory requirement.
EPA is authorized to postpone a determination if additional information is necessary. If the chemical
substance is likely to cause an unreasonable risk of harm before the effective date of a rule, EPA is
authorized to declare a proposed rule to be effective upon publication in the Federal Register. Safety
determinations and associated safety assessments are considered final agency action effective upon
completion (for substances found to meet the safety standard) or the effective date of the requisite final
risk management rule (for substances found to not meet the safety standard).
Information Collection and Reporting (amending TSCA Section 8)
Ensures that EPA’s information collection and reporting requirements produce a more complete picture
of chemical substances in active commerce in the United States, and applies reporting and
recordkeeping requirements to both manufacturers and processors. Requires EPA to review all claims
for the protection of chemical identity against disclosure (as confidential business information) within 5
years of enactment. Requires EPA to keep the list of active and inactive chemical substances up to date.
Exports and Imports (amending TSCA Sections 12 and 13)
Conforms the export and import notification requirements established by current TSCA to the
requirements of the Act. Mandates that exporters provide prior notice of exports of substances that are
not likely to meet, or that do not meet, the safety standard. Requires the United States to refuse the
entry of any import that does not meet the safety standard or for which a regulation banning the
substance has been promulgated. Requires importers of substances to certify compliance with the Act,
and authorizes EPA to require certification of articles containing regulated substances where
Confidential Information (amending TSCA Section 14)
As a condition for protecting confidential information from disclosure, requires that all confidentiality
claims be asserted and meet specific requirements. All information must be disclosed to EPA; claims to
protect information against disclosure only apply to possible public disclosures. Establishes a
presumption of protection for a limited set of information generally considered to be proprietary, such
as sales information and customer lists. Requires the up-front substantiation of all other confidentiality
claims, including claims to protect chemical identity from disclosure. Requires EPA to review all claims
for protection of chemical identity, and a representative subset of all other claims.
Establishes exceptions from protection against disclosure, including information already in the public
domain, information EPA believes must be disclosed to protect health and the environment, and
disclosures to state agencies, as well as to medical personnel, first responders, and government health
and environmental officials in emergency and non-emergency situations subject to certain conditions.
Information not protected from disclosure must be made public. Information that qualifies for
protection against disclosure will be protected for 10 years. The period of protection may be extended
upon re-substantiation of the confidentiality claim. Provides for appropriate notice to owners of
confidential information when claims expire or when confidential information will be disclosed.



EPA is to develop a system of unique identifiers for confidential chemical identities to ensure that all
relevant information is disclosed when the claim expires or is withdrawn.
Penalties (amending TSCA Section 16)
Increases existing TSCA penalties from $25,000 to $37,500 per violation. Establishes a criminal penalty
for violations that create an imminent danger of death or serious bodily injury, based on similar
provisions in other federal environmental laws.
State-Federal Relationship (amending TSCA Section 18)
Delineates the relationship of State governments and the federal government by preserving the ability
of States to regulate chemical substances that have not been designated as high priority substances or
subject to a safety assessment or determination. Preempts state government action only on a chemicalspecific basis consistent with the scope of EPA’s assessments and determinations. New state
requirements that prohibit or otherwise restrict a chemical cannot be imposed once EPA has designated
it as a high priority and developed a scope of review for a safety assessment and determination which
must be done within 6 months of making a high-priority designation. Existing and new state
requirements to require testing are preempted once EPA has issued a rule or order under Section 4.
Use notifications are preempted if EPA requires the same notification through a significant new use
rule under section 5. Existing and new state requirements that prohibit or otherwise restrict a chemical
cannot be imposed once EPA has completed a safety assessment and determination under section 6, or,
for a chemical EPA finds does not meet the safety standard, upon issuance of the final risk management
rule. The preemptive effect of any EPA action is limited to the scope of the applicable decision (for
example, the conditions of use included in the scope of a safety assessment and determination).
Creates an explicit exception from preemption for State actions under authority of any other federal
law, or under state law related to air or water quality, waste treatment or disposal, and for reporting
and information collection requirements. Further creates two exceptions from preemption for state
actions to prohibit or restrict a chemical substance taken before January 1, 2015, and for any state law in
effect on August 31, 2003.
Provides States the ability to obtain a waiver from preemption for compelling local conditions. States
may seek judicial review of EPA decisions on waivers. Also allows States to seek judicial review of
EPA decisions on States’ low-priority recommendations under section 4A.
Makes clear that nothing in the Act affects a common law or statutory cause of action for civil relief or
to address criminal conduct, including causes of action for personal injury, wrongful death, or strict
liability, among others. Also makes clear that nothing in the Act has an effect on private remedies,
including the admissibility into evidence of any information or decision under the Act.
Section 23 (amending TSCA Section 26)
Expands the existing TSCA fee authority to ensure that funds sufficient to defray a portion of EPA
expenses in prioritization, safety assessment and determination and implementation of the Act are
provided through user fees. Authorizes EPA to raise fees to defray approximately 25% of the cost of
implementation, to a maximum of $18 million. All fee revenue is directed to a new TSCA
Implementation Fund, to ensure that resources will be directly available to EPA . Similar to user fees in
several other federal product assessment programs, fee authority is conditioned upon continued federal
Authorizes EPA to adjust fees for inflation and to ensure sufficiency of funds and avoid surpluses.
Requires manufacturers of “additional priorities” identified under Section 4A to pay 100% of the costs


of safety assessments and determinations. Establishes audit and transparency requirements in EPA’s
implementation of the fee program.
Section 24 (amending TSCA Section 27)
Establishes a new Sustainable Chemistry program, designed to ensure that EPA and the federal
government support education, and research and development, into new, sustainable chemistries.
Conforming Changes
Makes appropriate conforming changes to Section 7 (Imminent Hazards), Section 9 (Relationship to
Other Federal Laws), Section 16 (Prohibited Acts), Section 19 (Judicial Review), and Section 21
(Citizens’ Petitions), among others, to conform those sections to the provisions of the Act.



The Frank R. Lautenberg Chemical Safety for the 21st Century Act
Existing Chemicals

Enforceable Deadlines (can be extended up to 2 more years)
Up to 3 Years

6 mos



High Priority
High hazard
high exposure

Tens of


Low Priority
Likely to meet
safety standard
(States may
Not Prioritized
Deferred due to
insufficient info

May issue an
order to
additional data

Safety standard: "No unreasonable risk to
human health or the environment."
•  Based solely on risks to health and
•  EPA cannot consider costs
•  Eliminates "least burdensome" requirement

•  Specific Criteria
•  EPA has
discretion to
•  Max of 15% of

Up to 2 Years

Meets safety

Risk Management


EPA imposes needed
prohibitions or
restrictions by rule

Does NOT
safety standard

EPA must
establish scope
within 6 months

EPA imposes full ban;
must consider costs,
availability of

Not enough
information to

May issue an
to require




Certain new actions on high-priority
chemicals are prohibited
Existing state actions remain in effect
Only applies to uses within scope of
EPA’s assessment (determined within 6
mos. of High Priority designation).
States can seek waiver.
State actions restricting production,
distribution, processing or use taken after
1/1/15 are generally preempted.
Other state actions remain in effect or
can be taken.
States can seek waiver.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act
New Chemicals


initial review
of chemical

Chemical is NOT
likely to meet the
safety standard

EPA must prohibit or
impose restrictions
sufficient to meet
likely-safe standard

Chemical is likely
to meet the safety

Chemical may enter


May issue order to
additional data

EPA must prohibit or
impose restrictions
sufficient to meet
likely-safe standard,
pending additional

How the Toxic Substances Control Act Works
Existing Chemicals

All 62,000 chemicals presumed safe
and "grandfathered in“

EPA lacks mandate to
assess safety

remain on


passed in

Does the
chemical pose

In a small number of cases, EPA
has identified a reason to conduct
a risk assessment.

EPA must find

conducted on
less than 2%
of chemicals

1.  significant risk
2.  that the
benefits of
restricting the
outweigh the


EPA may impose
restrictions. But
only "least
inadequacy of all
less burdensome

Only 5 chemicals
(partially) restricted
under TSCA. EPA's
asbestos restrictions
could not stand
up to court