49–010 

Calendar No. 121 

114TH CONGRESS REPORT " ! SENATE 1st Session 114–67 

FRANK R. LAUTENBERG CHEMICAL SAFETY FOR THE 

21ST CENTURY ACT 

JUNE 18, 2015.—Ordered to be printed 

Mr. INHOFE, from the Committee on Environment and Public 

Works, submitted the following 

R E P O R T 

together with 

MINORITY VIEWS 

[To accompany S. 697] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Environment and Public Works, to which was 

referred the bill (S. 697) to amend the Toxic Substances Control 

Act to reauthorize and modernize that Act, and for other purposes, 

having considered the same, reports favorably thereon with an 

amendment in the nature of a substitute and recommends the bill, 

as amended, do pass. 

GENERAL STATEMENT AND BACKGROUND

S. 697, the Frank R. Lautenberg Chemical Safety for the 21st 

Century Act, amends the Toxic Substances Control Act (TSCA), the 

fundamental Federal law regulating the manufacture, processing, 

distribution in commerce, use and disposal of chemical substances. 

The Act is named for the late Frank R. Lautenberg, the Senate’s 

long time champion for effective reform of TSCA in order to protect 

against risks to human health and the environment. Before 2012, 

Senator Lautenberg (D–NJ) had introduced TSCA reform legislation in five consecutive Congresses. Beginning in early 2013, Senator Lautenberg worked closely with Senator David Vitter (R–LA) 

to craft the Chemical Safety Improvement Act (CSIA), which was 

introduced in May, 2013 (S. 1009). The bill represented the very 


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first bi-partisan TSCA reform proposal, and garnered the support 

of 26 additional members of the Senate. Sadly, Senator Lautenberg 

passed away shortly after S. 1009 was introduced. Although the 

Committee held a hearing on general TSCA reform with discussions of S. 1009, no further action on the bill was taken before the 

113th Congress adjourned. 

Following Senator Lautenberg’s death, Senator Tom Udall (D– 

NM) stepped in to fill the late Senator’s leadership role working to 

pass bipartisan TSCA reform. Senators Udall and Vitter introduced 

a modified version of S. 1009 on March 10, 2015, which reflected 

over a year of negotiations and building upon the original CSIA. 

The new bill, S. 697, contains many important enhancements to 

the framework first negotiated by Senators Lautenberg and Vitter. 

On April 28, 2015, the Committee held a business meeting on S. 

697. The Committee adopted an amendment in the nature of a substitute offered by Senator Vitter that won the support of Senators 

Whitehouse (D–RI), Merkley (D–OR), Booker (D–NJ) and Carper 

(D–DE). The substitute reflects additional modifications to the bill 

intended to address the concerns of stakeholders in several key 

areas. The bi-partisan substitute marks an important milestone in 

TSCA reform, and reflects the spirit of compromise that Frank 

Lautenberg championed during his tenure in the Senate. 

TSCA (Pub.L. 94–469, 90 Stat. 2004, 15 U.S.C. 2601 et seq.) was 

enacted in 1976. TSCA gives EPA the authority to review new 

chemicals before they are manufactured, to gather information on 

existing chemicals in commerce, and to regulate unreasonable risks 

to health and the environment from the manufacture, processing, 

distribution in commerce, use or disposal of chemical substances. 

TSCA is one of many statutes that regulate chemicals; its unique 

focus is on industrial chemicals in commerce. TSCA does not give 

EPA the authority to regulate pesticides; food, drugs and cosmetics; 

nuclear materials, firearms and ammunition, or tobacco. 

In the years since TSCA was first enacted, it has become clear 

that effective implementation of TSCA by the Environmental Protection Agency (EPA) has been challenged by shortcomings in the 

statute itself, and by several key decisions of Federal Courts and 

the Agency’s interpretation of those decisions. S. 697, as reported 

by the Committee, is intended to enhance confidence in the federal 

chemical regulatory system, provide EPA the authority necessary 

for efficient and effective regulation of chemical risks, and foster 

safety and innovation in commercial chemistry. Importantly, S. 697 

is designed to ensure that the competitive advantage of the U.S. 

chemical industry is not eroded by regulatory mandates and that 

industry is subject to a more consistent set of regulations that 

equally protect citizens across the nation. 

S. 697 is intended to address significant concerns about the existing provisions of TSCA and its implementation. 

Testing of chemical substances and mixtures 

Section 4 of TSCA provides EPA the authority to require manufacturers to test chemicals, but requires EPA to justify a testing requirement based on either a finding that the substance may 

present an unreasonable risk of injury to health or the environment, or that the production of a substantial quantity of the substance may create exposures to humans or the environment. EPA 


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can require testing through test rules or through enforceable consent agreements (ECAs). 

Concern has been raised that EPA’s decisions to require testing 

must be supported by an a priori finding that is often difficult to 

make in the absence of the information that testing would provide. 

EPA has succeeded in requiring the testing under section 4 of only 

about 200 chemicals in TSCA’s almost 40 years. In addition, the existing TSCA rulemaking process can place a significant burden on 

EPA, and test rules can sometimes take many years to complete. 

When EPA has proposed TSCA test rules, EPA has sometimes required testing based on a ‘‘checklist,’’ rather than identifying specific information needs to inform what testing is required. 

Manufacturing and processing notices 

A new chemical (not on the TSCA inventory) cannot be manufactured in or imported to the U.S. without EPA review under TSCA 

section 5. The section also provides EPA authority to identify and 

review significant new uses of a chemical substance. Companies 

must first submit a pre-manufacture notice (PMN) and EPA must 

review the PMN. Current law gives the Agency the authority to 

deny a PMN and prevent the substance from moving into commerce. The PMN must include information on chemical identity, 

anticipated production volumes, intended categories of use, molecular formula and any available test data on that chemical. EPA 

uses this information to develop hazard and exposure/release profiles for the chemical which are based on both actual data on the 

notified chemical, as well as data from other structurally similar 

chemicals and information derived from computer modeling. EPA 

can determine that more testing is needed to complete its review, 

allow manufacture to commence with restrictions, or not allow 

manufacture to commence. Once manufacture commences, a chemical is added to the TSCA Inventory only after the manufacturer 

files a ‘‘Notice of Commencement’’ with EPA. At that point, other 

companies may manufacture, process or use the chemical without 

prior notification unless EPA has designated such activity as a significant new use requiring such notification. 

Despite the completion of many reviews of new chemicals under 

section 5, concerns have been raised that it does not require EPA 

to make an affirmative finding that a new chemical or a significant 

new use is not likely to present an unreasonable risk. EPA’s test 

rule authority constrains the Agency’s ability to mandate new testing when necessary to support review of a new chemical or significant new use. 

Regulation of hazardous chemical substances and mixtures 

Section 6 of TSCA provides EPA broad authority to regulate existing chemicals. Based on an EPA finding that a chemical substance or mixture ‘‘presents or will present an unreasonable risk of 

injury to health or the environment,’’ EPA can impose a variety of 

risk management measures, including use restrictions, limitations 

on production volumes, warning labels, recordkeeping or product or 

disposal bans. When EPA chooses to impose restrictions under Section 6, it must use the ‘‘least burdensome’’ requirements. 

EPA must apply its section 6 authority through rulemaking. In 

applying the unreasonable risk standard, EPA must consider a vaVerDate Sep 11 2014 05:10 Jun 23, 2015 Jkt 049010 PO 00000 Frm 00003 Fmt 6659 Sfmt 6602 E:\HR\OC\SR067.XXX SR067

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riety of risk-related and cost/benefit factors including: the effects of 

a substance on health and the magnitude of exposure of humans; 

the effects of a substance on the environment and the magnitude 

of exposure of the environment; the benefits of the substance for 

various uses and the availability of substitutes for such uses; and 

the reasonably ascertainable economic consequences of the rule, 

after considering the effect on the national economy, small business, technological innovation, the environment and public health. 

Between 1978 and 1990, EPA successfully used Section 6 to regulate specific uses of the following chemical substances: halogenated 

chlorofluoroalkanes; TCDD; three new chemical substances used in 

metalworking fluids; and hexavalent chromium. None of these 

rulemakings were judicially challenged. In contrast to these 

rulemakings, EPA’s regulation to ban asbestos from most products 

through a TSCA section 6(a) rule was much broader in scope and 

was challenged in Corrosion Proof Fittings et al. v. U.S. EPA. The 

Fifth Circuit Court of Appeals decision in this case struck down the 

asbestos rule, in part because of ‘‘the agency’s reliance upon flawed 

methodology and its failure to consider factors and alternatives 

that TSCA explicitly requires it to consider.’’ Despite direction from 

the court, EPA did not re-propose its rulemaking on asbestos and 

EPA has never used Section 6 since that decision. 

Substantial stakeholder attention has been focused on the shortcomings in section 6, and S. 697 attempts to address these concerns. EPA’s application of the ‘‘unreasonable risk’’ standard for 

regulatory action has been hampered by the statutory language 

itself, which suggests that cost and benefit considerations must be 

applied to the Agency’s decisions on the health and environmental 

risks posed by a chemical substance. The requirement that EPA 

choose the ‘‘least burdensome’’ regulatory control for a chemical 

substance has been viewed as a requirement that EPA assess the 

costs and burdens of all possible regulatory and chemical options. 

Further, there is no requirement in section 6 that EPA systematically assess existing chemicals in commerce, and no direction to the 

Agency on how the Agency identifies what chemical substances 

warrant assessment. 

Reporting and retention of information 

Section 8 is the information gathering and reporting section of 

TSCA. Under the section, EPA can require companies to submit information on categories of use, quantities, by-products, and health 

and environmental effects of chemicals, and has used this authority 

to require periodic updating of chemicals on the TSCA Inventory 

that meet certain production volume thresholds. The section also 

requires EPA to compile and maintain the TSCA Inventory, which 

represents all chemicals commercialized under TSCA since its inception. Some chemicals may no longer be in commerce but continue to be listed on the Inventory. 

The section also requires companies to record and retain allegations of significant adverse reactions to any substances; to submit, 

where requested by rule, lists/copies of ongoing and completed, or 

unpublished health and safety studies; and to immediately report 

information—not otherwise available to EPA—which reasonably 

supports the conclusion that a chemical presents a ‘‘substantial 

risk’’ to health or the environment. 


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Several aspects of Section 8 have been the subject of stakeholder 

concerns. The TSCA Inventory does not accurately reflect the number of chemicals actually in commerce, as it is a historical database 

containing those substances ‘‘grandfathered’’ into TSCA in 1979 

(when EPA established the Inventory by rule) and those substances 

added to the Inventory after the pre-manufacturing review process. 

Additionally, some of the substances on the Inventory are the subject of confidentiality claims that have not been systematically reviewed by the Agency. 

Disclosure of data 

Section 14 of TSCA provides an affirmative, broad statement of 

protection from disclosure for information qualifying under the section 552(b)(4) exemption of the Freedom of Information Act (FOIA), 

i.e., ‘‘trade secrets and commercial or financial information obtained from a person and privileged or confidential.’’ Generally, 

EPA cannot disclose confidential business information (CBI), and 

where disclosure is allowed, the Agency must follow procedures designed to protect the submitter’s rights, such as advance written 

notice to the submitter. Section 14 does specifically permit EPA to 

release CBI to U.S. government employees in connection with their 

official duties to protect health or environment or for law enforcement purposes, to Federal contractors for work related to TSCA, 

when necessary to protect health or the environment from unreasonable risk of injury, or when relevant in a court proceeding under 

TSCA. 

Section 14 also provides that the broad protection afforded CBI 

does not prohibit the disclosure of health and safety information in 

studies related a chemical or mixture that is in commercial distribution, that is the subject of a TSCA section 4 test rule, or is 

subject to a PMN or a significant new use notice (SNUN) requirement under section 5. Nothing in the section authorizes EPA to release any data that would disclose processes used in the manufacturing or processing of a chemical or mixture or, in the case of a 

mixture, the portion of the mixture comprised by any of the chemicals in the mixture. 

Section 14 and EPA’s implementation of it has been criticized by 

some for failing to require a systematic review of confidentiality 

claims, or up-front substantiation of confidentiality claims. Lacking 

any mechanism for review by EPA or for companies to declassify 

past CBI claims that are no longer needed, stakeholders have indicated a concern that there is an over-abundance of CBI claims, 

some of which may not be legitimate. Concern has also been raised 

that TSCA does not authorize EPA to share CBI with State governments or other professionals such as first responders, who may 

need access to it in the performance of their duties. 

Preemption 

TSCA Section 18 recognizes that States can have a role in regulating chemicals, and preempts State action only when EPA has 

acted on a chemical through a rule or order under TSCA. Under 

the section, new and existing State requirements on a chemical 

substance can be established or continue in effect if they are identical to the EPA requirement, if they are adopted under the authority of the Clean Air Act or any other federal law, or if they prohibit 


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the use of such substance or mixture in such State or political subdivision. Upon application of a State or political subdivision of a 

State, EPA can waive the preemptive effect of an EPA rule or order 

on State action, if 1) compliance with an action taken under State 

law would not cause violations of the EPA rule or order and 2) the 

State action provides a significantly higher level of protection from 

risk and does not unduly burden interstate commerce. 

Some stakeholders have raised concern that TSCA has not fostered a robust Federal chemical regulatory system, which has resulted in a number of States becoming more active on chemical regulatory matters. In their view, a proliferation of different State requirements will create confusion for the general public, and significantly increase the cost and burden of regulatory compliance for 

chemical manufacturers, importers and users while failing to apply 

any protections to more than a relatively small number of citizens. 

Others have expressed concern that States not be constrained in 

their ability to protect health and the environment, particularly 

when state or local conditions associated with chemical substances 

subject to TSCA raise potential concerns. These stakeholders also 

point out that actions by even one state can affect products nationwide. 

Administration 

Section 26 of TSCA authorizes EPA to require the payment of a 

reasonable fee from any person required to submit data under sections 4 or 5. The fee is capped at $2,500, or in the case of a small 

business, $100. To date, EPA has established a fee only for the submittal of pre-manufacturing notices under section 5. In FY2014, 

EPA generated approximately $1.1 million in fee revenue under 

this requirement. This revenue is directed to the general treasury, 

not directly to EPA. 

All stakeholders have indicated an interest in ensuring that EPA 

has the resources necessary to implement a robust chemical regulatory system, including prioritization screening, safety assessments and determinations, and regulation of new and existing 

chemical substances where required to manage risks to health and 

the environment. 

OBJECTIVES OF THE LEGISLATION

S. 697 would reauthorize and modernize the Toxic Substances 

Control Act (TSCA). 

SECTION-BY-SECTION ANALYSIS

Section 1. Short title 

Names S. 697 as the ‘‘Frank R. Lautenberg Chemical Safety for 

the 21st Century Act.’’ The late Senator Frank Lautenberg was an 

ardent proponent of modifications to TSCA during his lifetime. 

Section 2. Findings, policy and intent 

Section 2 of S. 697 amends Section 2 of TSCA in several respects 

to make clear Congressional intent for reforming TSCA to provide 

broad protection of human health and the environment, to improve 

availability of information about chemicals, and to clarify that 


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nothing in the bill is intended to affect common law rights and 

remedies. 

S. 697 does not amend TSCA’s existing policy provisions in Section 2(b), indicating the Committees intent to leave intact existing 

TSCA policy relating to the need for adequate data about chemicals, adequate authority to regulate chemicals that present an unreasonable risk, and the exercise of EPA’s authority in a manner 

that does not create unnecessary economic barriers to technological 

innovation. 

Section 3. Definitions 

Section 3 of S. 697 incorporates several new definitions in TSCA. 

Definitions of ‘‘conditions of use,’’ ‘‘potentially exposed or susceptible population’’, ‘‘safety assessment,’’ ‘‘safety determination’’ and 

‘‘safety standard’’ are included in the bill. S. 697 does not change 

other existing TSCA definitions, such as the definition of a ‘‘processor’’ or what is defined as or specifically excluded from the definition of a ‘‘chemical substance.’’ 

Further, S. 697 as approved by the Committee reverts to the 

term ‘‘injury’’ when used in the context of unreasonable risk, instead of the term ‘‘harm’’ as in the bill as introduced. This change 

ensures that other provisions of TSCA not amended by S. 697 require no conforming change. The Committee intends no modification of EPA’s interpretation of the term ‘‘injury’’. 

‘‘Conditions of Use’’ is a term used throughout S. 697 to describe 

the context in which EPA will apply the safety standard in safety 

assessments and determinations. The term means the ‘‘intended, 

known, or reasonably foreseeable circumstances’’ under which a 

chemical substance is manufactured, processed, distributed in commerce, used or disposed of. The term is not intended to include ‘‘intentional misuse’’ of chemicals. 

‘‘Potentially exposed or susceptible population’’ is defined as ‘‘1 or 

more groups of individuals’’ in the general population who may be 

‘‘differentially exposed’’ to a chemical under the conditions or use, 

or ‘‘susceptible to greater adverse health consequences’’ from chemical exposures than the general population. The definition makes 

clear that when identified by EPA, it may include groups such as 

infants, children, pregnant women, workers and the elderly. The 

term is used in the definition of ‘‘safety standard’’ to make clear 

that in applying the standard to a population, the population must 

be ‘‘relevant’’ to the safety assessment and determination for the 

substance, and that identified risks specific to such populations 

must be addressed. 

In the context of safety assessments and determinations, if conditions of use suggest differential exposures to one or more groups 

of individuals or the conditions of use impact individuals who are 

more susceptible, EPA must take those exposures into account and 

establish risk management measures necessary and sufficient to 

protect those populations. Importantly, the definition does not 

mean that in applying the safety standard, EPA is required to protect each susceptible ‘‘individual’’ in the population or groups of individuals in all safety assessments and determinations. Rather, in 

safety assessments and determinations in which a population is 

relevant, the Administrator is to protect that population as well as 

the population as a whole from ‘‘unreasonable risk.’’ 


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‘‘Safety assessment’’ means an assessment of the risk posed by 

a chemical substance under the conditions of use, integrating hazard, use and exposure information about the chemical. Under S. 

697, the safety assessment must precede EPA’s safety determination. 

‘‘Safety Determination’’ means an EPA determination as to 

whether a chemical substance meets the safety standard under the 

conditions of use. Under S. 697, if EPA makes a determination that 

a chemical substance does not meet the safety standard, the Agency must establish risk management measures, by rule, that ensure 

the safety standard is met under the conditions of use. 

‘‘Safety Standard’’ means ‘‘a standard that ensures, without taking into consideration cost or other nonrisk factors, that no unreasonable risk of injury to health or the environment will result from 

exposure to a chemical substance under the conditions of use . . .’’ 

This standard uses the same term as in current TSCA, but makes 

an important change to ensure that the standard including its reference to unreasonable risk, is to be applied by EPA without regard to cost or other non-risk factors. Furthermore, other relevant 

references to the term in the legislation and throughout TSCA were 

modified to make clear that when the term ‘‘unreasonable risk’’ is 

used, the term is to be applied without taking into account cost and 

other non-risk factors. This modification addresses one of the key 

criticisms of TSCA. The definition also makes clear that the safety 

standard applies to specific ‘‘conditions of use’’ identified by EPA. 

The standard is intended to ensure that EPA protects against unreasonable risks of injury to the general population as well as any 

potentially exposed or susceptible population that EPA has identified as ‘‘relevant’’ to the safety assessment and determination for 

the chemical. 

Section 4. Policies, procedures and guidance 

Section 4 of S. 697 creates a new Section 3A in TSCA. The section 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, procedures and guidance can continue to be used as the new 

ones are developed and are to be integrated into them to the maximum extent practicable. EPA is to review its policies, procedures 

and guidance every five years, and to update them to reflect emerging science. Policies, procedures and guidance are to address testing, prioritization screening, review of new chemicals and significant new uses, safety assessments and determinations, as well as 

use of science in making these decisions, including policies aimed 

at reducing animal testing. The section also establishes a new Scientific Advisory Committee on Chemicals to provide EPA independent scientific advice. The section makes clear the Committee’s 

intent that EPA’s policies, procedures and guidance should reflect 

the best available science and be transparent to the public. 

It is the Committee’s intent that decision-making under TSCA be 

‘‘consistent with the best available science.’’ The science EPA relies 

on to make safety determinations should describe and document 

any assumptions and methods used, and should address variability, 

uncertainty, the degree of independent verification and peer review. The section also requires that decisions be based on the 


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weight of the scientific evidence, by which the Committee intends 

that EPA consider all information in a systematic and integrative 

framework to consider the relevance of different information. The 

Committee believes there is significant value, where available and 

appropriate, in EPA’s use of peer reviewed information, standardized test design and methods, consistent data evaluation procedures and good laboratory practices to ensure transparent, understandable, and reproducible chemical reviews. EPA guidance 

should also address transparency about the sources of funding for 

generation and assessment of information and, if appropriate, consideration of recommendations from NAS reports. The section is intended to ensure that EPA safety assessments and determinations 

are clear to the public, and based on credible, reliable scientific information. 

The section also requires EPA to consider reasonably available 

information about potential hazards and exposures of a chemical 

substance under the conditions of use when making decisions 

under TSCA. The bill gives EPA the authority to require testing 

when needed to ensure decisions are based on sufficient information. The Committee intends that EPA systematically search for 

and identify relevant information that is available to inform safety 

assessments and determinations, both to minimize the potential for 

duplicative testing and unnecessary animal testing. The information EPA considers in its decision-making and the quality of that 

information is critical to giving the public greater confidence in 

EPA decisions. 

The section also clarifies that EPA mandates for the generation 

of new information relevant to safety assessments and determinations must be science-based and driven by the need for the information. EPA is to specifically address exposure potential as a factor in decisions to require new testing. 

The existing provisions of TSCA do not require EPA to systematically assess and determine the safety of priority chemicals. Consequently, there are relatively few EPA policies and procedures in 

place to address the safety assessment, safety determination and 

rulemaking requirements of Section 6. It is the Committee’s intention that EPA rely on existing processes, such as those established 

under the Agency’s TSCA Work Plan Chemical program, to manage 

the process as new policies and procedures are developed. 

The Committee believes strongly that public confidence in the 

federal chemical regulatory system will be enhanced with improved 

public access to, and an understanding of, the information on which 

EPA bases its safety assessments and determinations. Under this 

section, EPA is required to make available to the public a nontechnical summary of each safety assessment and safety determination, 

to provide the public an opportunity to comment on the proposed 

assessment and safety determination, and to list the studies EPA 

considered and the policies and procedures EPA followed in the 

safety assessment and determination. EPA is also to describe the 

manner in which aggregate exposures, or significant subsets of exposures, to a chemical substance under the conditions of use will 

be considered, and explain the basis for that consideration in the 

final safety assessment. 

The section also establishes a new Science Advisory Committee 

on Chemicals. The new advisory committee is intended to provide 


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EPA independent advice on the scientific and technical aspects of 

implementation. The advisory committee is subject to the requirements of the Federal Advisory Committee Act to ensure transparency, balance and public access to its deliberations. The Committee intends that the advisory committee represent a broad 

range of scientific expertise and interests including individuals 

with scientific expertise in public health and industry. 

Section 5: Testing of chemical substances or mixtures 

Section 5 of S. 697 amends section 4 of TSCA. The amendments 

provide EPA with broad authority to obtain new information on 

chemical substances at all stages of the safety review and evaluation process (for new chemicals; in limited circumstances for 

prioritization; for safety assessments and safety determinations of 

existing chemicals; and for any necessary risk management rulemaking) and for export notification purposes. 

The amendments address two significant shortcomings identified 

in TSCA: The requirement that testing be conducted only through 

rulemaking; and the ‘‘Catch-22’’ that EPA must first make a finding of potential ‘‘unreasonable risk’’ or substantial production and 

release or exposure before it can require testing by manufacturers 

or processors. Under the section, EPA can mandate new testing by 

rule, order and consent agreement. It is the Committee’s intent 

that EPA use its authority to require the development of new information judiciously, and only when needed to implement key provisions of the Act. 

In order to avoid duplicative testing, the section allows one company to conduct toxicity testing on behalf of other companies and 

to obtain fair and equitable reimbursement for developing the data. 

The bill also clarifies language regarding the reimbursement period 

for such testing. 

The section makes clear that the EPA may not establish minimum information requirements for all chemicals. It is the Committee’s expectations that testing requirements will be tailored to the 

nature of the chemical substances, hazards, exposures and conditions of use under consideration in the review and evaluation process. 

For many years, the Committee has supported efforts to reduce 

the unnecessary use of animals in chemical testing. S. 697 includes 

extensive provisions by which EPA is to minimize the use of animals in testing chemicals under TSCA. EPA is to consider integrated testing strategies, greater efficiencies in testing through category approaches and formation of consortia, tiered testing and assessment strategies, and alternative testing methods, among others. Importantly, EPA is to develop a strategic plan to promote the 

development and implementation of reliable alternative test methods to reduce, refine, or replace the use of laboratory animals. The 

Committee takes note that EPA’s Office of Research and Development (ORD) has and is developing non-animal screening tests (including the use of computational toxicology), and continues work on 

application of those methodologies in chemical risk assessment. 

The Committee recognizes that in some cases, suitable alternatives for animal tests are not currently available. The Committee 

believes, however, that where scientifically reliable alternatives 

exist that will generate equivalent information, EPA can request, 


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and in some cases should require, a non-animal test to first be 

used. The Committee does not intend to require manufacturers or 

processors to shoulder duplicative test burdens; EPA should look to 

the use of non-animal tests that provide reliable, high quality information that can replace or supplement animal tests. The testing requirements reflect the Committee’s interest in assuring that the 

development of new information under a modernized TSCA should 

be consistent with best available science, and as informative, efficient and cost effective as possible. 

Section 5 requires that voluntary testing conducted for TSCA 

purposes be first attempted using an alternative or non-animal test 

method or approach that the Administrator has determined to be 

scientifically reliable, relevant, and capable of providing information equivalent to that produced by a test using animals. The Committee expects EPA to be diligent in developing a list of approved 

non-animal test methods and strategies. The provision makes clear 

that the requirement does not prohibit the use of an animal test 

for purposes other than voluntary testing for TSCA purposes, or for 

subsequent tests conducted for TSCA purposes. 

Section 6. Prioritization screening. 

Section 6 of S. 697 creates a new section 4A in TSCA. The section 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. This 

section establishes a process that assures every chemical in commerce is subject to a systematic review by EPA through the screening and prioritization process. 

In general, EPA is to focus the prioritization screening process on 

chemicals that are in active commerce in the United States. 

Amendments to section 8 require EPA to identify substances on the 

TSCA Inventory that are in active commerce or inactive. The Committee recognizes, however, that there may be exposures of concern 

from substances that are not currently or no longer in commerce, 

and the section provides EPA authority to prioritize inactive substances that meet certain criteria. 

The Committee does not expect EPA to prioritize all active substances at one time. The section requires EPA to conduct 

prioritization screening based on EPA’s ability to complete safety 

assessments and determinations. This approach provides appropriate notice about the substances subject to the prioritization process to interested stakeholders, and an opportunity to provide EPA 

information relevant to the prioritization decision and any subsequent safety assessment and determination. In the Committee’s 

view, this is an improvement over EPA simply compiling a long list 

of chemical priorities that could trigger unwarranted de-selection 

decisions in the marketplace or become out of date because of reliance on older information. 

To address concerns that EPA undertake a minimum number of 

reviews and increase ‘‘through-put’’ in the assessment process over 

time, EPA is to establish an initial list of at least 10 high and 10 

low priority substances within 180 days of enactment. Within 3 

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priority substances have undergone or are undergoing safety assessments, and additional low-priority substances sufficient to ensure that at least a total of 20 low-priority substances have been 

so designated. These numbers are to increase to at least 25 highand low-priorities no later than 5 years after enactment. The section contains explicit authority for EPA to draw on the existing 

TSCA Work Plan Chemical list (about 90 substances EPA has already prioritized based on hazard, exposure, persistence and bioaccumulation, using its existing TSCA authority). The Work Plan 

chemicals are, in effect, substances EPA has already prioritized for 

review; the Committee does not intend that EPA start work anew 

on these substances. The section requires that no less than 50% of 

the substances prioritized by EPA be drawn from the Work Plan 

Chemicals list, until safety assessments and safety determinations 

have been completed for all Work Plan Chemicals. As the safety assessment and determination process is completed for each high priority substance, it must be replaced by at least one new high priority chemical. 

The section establishes general criteria for prioritization screening decisions, for EPA to use in establishing more specific criteria 

by rule. By including these mandatory criteria in the statute, it is 

the Committee’s intent to require EPA to ensure that important, 

broad science-based considerations, classifications and designations 

drive the prioritization screening process, without locking EPA into 

specific designations based upon ever-changing science. 

The substitute approved by the Committee modifies the criteria 

for prioritization designations by authorizing EPA to designate 

high priorities on the basis of ‘‘significant’’ hazard and exposure, 

rather than the ‘‘high’’ hazard and ‘‘widespread’’ exposure thresholds in S. 697 as introduced. A lack of information is also a sufficient basis to designate a substance as a high priority. 

Persistent, bioaccumulative and toxic (PBT) substances are a 

class of substances with recognized health and environmental concerns arising from their particular hazard and exposure characteristics. The substitute approved by the Committee requires EPA to 

give a preference, in setting the priority list, to TSCA Work Plan 

chemicals that are both persistent and bioaccumulative. Consistent 

with the risk-based approach of the legislation, the persistent and 

bioaccumulative chemicals listed in the TSCA Work Plan chemicals 

were so identified because they also present potential toxicity and 

exposure concerns. 

Prioritization screening decisions, including decisions to change a 

prioritization from low priority to high priority, or vice versa, are 

subject to public notice and comment. The substitute approved by 

the Committee clarifies that the public will have 90 days to comment on proposed prioritization decisions. 

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. The Committee intends that 

EPA adequately justify prioritization decisions, which it should 

fully describe when seeking comment on the proposed designation. 

All priority designations are subject to review and revision at any 

time, based on information available to the Administrator. 

EPA is to strive to complete the prioritization process of all 

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count the resources available to complete safety assessments and 

determinations. Prioritization decisions may be postponed where 

development of additional information is needed, which EPA may 

request or require using its authority under section 4. Where testing was required for prioritization, the Administrator shall designate the chemical substance as a high or low priority not later 

than 90 days after receipt of information satisfying the requirement. The prioritization screening process is subject to review and 

modification every 5 years, to ensure that the process is operating 

efficiently and effectively. 

The Committee also expects that EPA will over time increase the 

number of substances for which safety assessments and determinations are conducted, particularly as the Agency gains experience 

and expertise in applying the new process. Several provisions of 

this section are aimed at increasing through-put, and thereby 

meeting the Committee’s objective of addressing the backlog of 

unassessed chemicals in commerce, increasing public confidence, 

providing more certainty for regulated manufacturers and processors, and addressing key health and environmental concerns. 

The section provides manufacturers an opportunity to request 

that EPA designate a substance as an ‘‘additional priority’’ for safety assessment, subject to the payment of 100% of the costs associated with the safety assessment and determination. The substitute 

clarifies that granting a specific request to designate ‘‘additional 

priorities’’ is at EPA’s discretion, and that such substances are in 

addition to substances designated by EPA as high priorities, and 

hence do not limit the number of high priorities required to be designated by EPA; they only add to the total number of chemicals the 

Agency can review. In order to ensure that a significant majority 

of EPA’s activity is focused on the substances the Agency identified 

as high priorities, the substitute approved by the Committee directs that, if sufficient manufacturer requests are made, a minimum of 25 percent, and a maximum of 30 percent, of the cumulative number of high-priority chemicals in the safety evaluation 

process can be designated under this approach. For example, if 

EPA has designated 100 high priority chemicals since the date of 

enactment, then EPA can have designated and have conducted or 

be conducting safety assessments and safety determinations on a 

minimum of 25 and a maximum of 30 industry petitioned chemicals in addition to the 100 high priority chemicals. This approach 

is intended to allow EPA to review more chemicals than their appropriated resources would otherwise allow. 

The section also includes a provision intended to increase EPA’s 

safety assessment and determination of the TSCA Work Plan 

chemicals. For Work Plan chemicals for which EPA has not yet 

commenced safety assessments and determinations, manufacturers 

can request EPA to do so, subject to an agreement to pay 50% of 

the costs of the review. EPA has full discretion to approve or deny 

these petitions although the Committee intends for EPA to utilize 

this provision, resources allowing, to conduct safety assessments 

and determinations of all Work Plan chemicals as quickly as possible. The fees should allow for additional EPA priorities to be reviewed where the Agency would otherwise not have the necessary 

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turers and processors to defray the costs of these reviews creates 

potential cost savings and efficiencies for EPA. 

In order to bring to EPA’s attention state governments’ interest 

in a particular chemical substance, the section also requires States 

to notify EPA when they propose or take administrative action or 

enact a law to prohibit or restrict a chemical that EPA has not designated as a high-priority. If certain conditions are met, EPA must 

conduct a prioritization screening for the substance. The provision 

is intended to ensure that state concerns and information are entered into the national system for EPA review and, where appropriate, assessment and regulation to extend protections nationwide 

where they otherwise may have only been limited to an individual 

state, thereby serving the greater national interest. The section 

makes clear, however, that nothing in the state notification requirement pre-empts state law or actions, or requires EPA approval of the state law or actions. 

The section also makes clear that an EPA priority designation 

shall not be construed to affect the manufacture, processing, distribution, use or disposal of a chemical or regulation of those activities. By this, the Committee intends to clarify that prioritization 

screening decisions do not have any formal regulatory effect in and 

of themselves. Prioritization designations are not definitive decisions on whether a chemical substance is safe for intended conditions of use or not safe and requires risk management. 

Prioritization designations are simply designed to identify chemical 

substances that are likely to meet the safety standard (in the case 

of low priority designations) or identify chemical substances that 

require further assessment (in the case of high priority designations), which in the latter case will lead to a determination as to 

whether a chemical substance meets the safety standard or needs 

regulation. 

Section 7. New chemicals and significant new uses 

Section 7 of S. 697 amends section 5 of TSCA. The amendment 

modifies the new chemical review process by requiring that EPA 

make the determination that a new chemical substance or a significant new use is likely to meet the safety standard before it can be 

commercially manufactured or processed. The section allows EPA 

to postpone a decision on a new chemical until additional information is generated using EPA’s authority under section 4. The section also prohibits manufacture or processing of a new chemical or 

significant new use found not likely to meet the safety standard except in compliance with any conditions or restrictions imposed by 

EPA sufficient to ensure likely safety. As with other provisions of 

S. 697, the section ensures transparency in all EPA decisions on 

new chemicals or significant new uses. The section also retains 

EPA authority to establish or continue appropriate, long-standing 

exemptions. 

The Committee intends the amendments to section 5 to ensure 

that EPA conducts an appropriate review of the potential health 

and environmental effects of new chemicals, while supporting the 

ability of manufacturers and processors to innovate and bring to 

market new chemicals and products through a flexible, targeted review process. The Committee notes that, in general, current law 

gives EPA more authority to review new chemicals than existing 


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chemicals, and consistent with current law the Agency should continue the practice of completing new chemical reviews within 90 

days to the maximum extent practicable. 

Under this section, EPA is to conduct an initial review of a premanufacture notice (PMN) for a new chemical substance, develop 

a profile of the substance and its exposure potential, and apply the 

safety standard. Consistent with existing law, the PMN submitter 

must provide EPA all available relevant information, including information on the intended conditions of use and reasonably anticipated exposures. The Committee intends that the review of the 

PMN should be conducted in that context. 

The Committee recognizes that new chemicals may not have as 

robust a data set as existing chemicals. The testing authority provided to EPA under section 5 of S. 697 is intended to ensure EPA 

can obtain necessary information to review a PMN application. It 

is also the Committee’s intent that EPA continue to apply its professional and scientific expertise, experience and judgment, developed through its implementation of TSCA’s current new chemicals 

review program. EPA has pioneered the application of new approaches such as structure activity relationships, ‘‘read-across’’ information from other relevant chemicals, and new models and profiles in the new chemical review program to provide greater predictability and transparency. While some of these approaches can 

have limitations, they should assist EPA in reviewing new chemicals against the safety standard as applied in this section. 

Under this section, where EPA imposes a requirement on the 

submitter of a notice under section 5 through a consent agreement 

or order, the Agency is required to consider whether to issue a Significant New Use Rule (SNUR) to extend the requirements to other 

manufacturers and processors of the same chemical after it is 

added to the TSCA Inventory. Where EPA decides not to issue a 

SNUR, it is required to publish a statement describing the reasons 

for not doing so. The Committee does not intend that EPA interpret its authority under this section to adopt a blanket policy of 

issuing a Significant New Use Rule (SNUR) for every new chemical 

substance. Rather, the Committee expects that EPA will apply its 

SNUR authority judiciously where appropriate and necessary to ensure protection of health and the environment. 

The section clarifies that EPA may require significant new use 

notification (SNUN) for import or processing of a chemical as part 

of an article or a category of articles, if EPA makes an affirmative 

finding in a SNUR that the ‘‘reasonable potential for exposure’’ to 

the chemical through the article ‘‘warrants notification.’’ The Committee intends this provision to clarify the application of SNUR notification provisions to imported articles and does not intend this 

provision to compel changes to EPA’s general policy regarding 

treatment of articles in SNURs. 

The section also continues current TSCA practice of not imposing 

a minimum data set requirement on all new chemicals; rather, any 

requirements to develop new information are determined on a 

chemical-by-chemical basis. This is consistent with the Committee’s 

finding that, under S. 697, the information requirements of section 

5, coupled with EPA’s robust new chemical review process, are protective of health and the environment. With the requirement that 

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ard,’’ the section provides EPA adequate authority to both review 

and, where warranted, regulate new chemical substances, while 

preserving the elements of TSCA that promote innovation in new 

chemistries. Although the section does not impose a minimum data 

requirement for new chemicals, EPA is provided with improved authority to require testing under section 5 of S. 697, without having 

to demonstrate potential risk to require testing. The requirements 

of section 5 of S. 697 to minimize animal testing also apply. 

If EPA finds that a new chemical substance is not likely to meet 

the safety standard, EPA must apply restrictions sufficient to ensure that the chemical substance is likely to meet the safety standard under the conditions of use. Under the section, EPA also retains the authority to approve a PMN for a new chemical subject 

to the condition to conduct testing. In addition, the section adds a 

new requirement that new chemical substances that have PBT 

characteristics be subject to conditions that reduce potential exposure to the maximum extent practicable. 

The section retains the statutory exemptions from section 5 of 

TSCA and the regulatory authority for EPA to continue existing exemptions, such as the polymer and low volume exemptions, among 

others. The Committee recognizes that appropriate exemptions are 

a critical component of TSCA, because they help focus EPA’s activity on high-priority potential risks to health and the environment. 

Section 8. Safety assessments and safety determinations 

Section 8 of S. 697 amends Section 6 of TSCA. The section requires EPA to conduct a safety assessment and safety determination for all high priority substances and additional priorities. Importantly, the section establishes strict, enforceable deadlines for 

EPA action under this section: Within 6 months of designation of 

a chemical substance as a high priority, EPA must define the scope 

of the assessment and determination, including the conditions of 

use and potentially exposed or susceptible populations 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. With the exception of the 6 month deadline 

for defining the scope of a safety assessment and determination, 

EPA is permitted, with adequate public justification, to extend the 

deadlines for an aggregate period not to exceed 2 years. 

In order to ensure that relevant ongoing work at EPA continues, 

the Agency is expressly authorized to initiate assessments, or continue assessments that have already been initiated, prior to establishment of the new policies and procedures, 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 whether a substance meets the safety standard or does 

not meet the safety standard. If a substance is found not to meet 

the safety standard, EPA must impose the risk management measures necessary to ensure the safety standard is met. If the safety 

standard cannot be met through other risk management measures, 

a ban or phase out of the substance is generally required, but subject to certain time-limited exemptions. Consequently, the law is 

amended so EPA is better able to ban or phase out the substance. 


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All safety determinations are subject to public notice and comment, 

as are all risk management rules. 

EPA has been able to regulate only a handful of existing chemicals under Section 6 of TSCA over its history. Some have argued 

that one of the causes of Section 6’s failure was its blurring the 

lines between what should be pure safety reviews with non-risk 

factors. Under existing TSCA, EPA’s authority to find unreasonable 

risk and regulate a chemical substance has been interpreted to require the consideration of cost and benefits as part of fundamental 

decisions on safety, to the detriment of health and environmental 

protection. 

Section 8 of S. 697 addresses this criticism by requiring that EPA 

conduct a risk-based safety assessment and make a risk-based safety determination of each high-priority substance. The term ‘‘safety 

determination’’ is defined in section 3 to mean ‘‘a determination by 

the Administrator as to whether a chemical substance meets the 

safety standard under the conditions of use.’’ The term ‘‘safety 

standard’’ is in turn defined in section 3 to mean: 

‘‘a standard that ensures, without taking into consideration 

costs or other nonrisk factors, that no unreasonable risk of 

injury to human health or the environment will result 

from exposure to a chemical substance under the conditions of use, including no unreasonable risk of injury to— 

(A) the general population; or 

(B) any potentially exposed or susceptible population 

that the Administrator has identified as relevant to the 

safety assessment and safety determination for a chemical 

substance.’’ 

The Committee intends that the phrase ‘‘without taking into consideration costs or other nonrisk factors’’ be interpreted to mean 

that EPA must determine that a chemical substance meets the 

safety standard, or not, based solely on risk to human health and 

the environment—the integration of hazard and exposure information about a chemical—and not on the basis of other factors such 

as consideration of the costs or benefits of the substance or of possible restrictions on the substance. 

Thus, this section addresses one of the most significant problems 

identified in current TSCA. Under the definition of the safety 

standard in section 3 invoked in this section, cost and other factors 

such as technical feasibility are to play no part in EPA’s safety determinations. EPA’s safety determinations—whether a substance 

meets or does not meet the safety standard—are to be based only 

on health and environmental considerations. In addition, if a substance fails to meet the safety standard, the remedy EPA imposes 

must enable the substance to meet the safety standard under the 

conditions of use, which again, is based only on health and environmental considerations. The section therefore ‘‘de-couples’’ the Agency’s science-based risk decision about a chemical’s safety under its 

intended conditions of use from the Agency’s decision on how to 

manage unreasonable risks where chemicals do not meet the safety 

standard under intended conditions of use. 

EPA is authorized to postpone a determination (within the legislation’s deadlines) if additional information is necessary. Consistent 

with current law, if the chemical substance is likely to result in a 


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risk of serious or widespread injury to health or the environment 

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 and final 

publication (for substances found to meet the safety standard) or 

the date of promulgation of the final risk management rule (for 

substances found to not meet the safety standard). 

The substitute approved by the Committee makes several improvements to the risk management provisions of S. 697. Consistent with changes made in section 7 related to new chemicals 

and significant new uses, section 8 requires EPA to impose risk 

management restrictions on persistent, bioaccumulative and toxic 

(PBT) substances for uses or conditions of use found not to meet 

the safety standard that reduce exposures ‘‘to the maximum extent 

practicable.’’ For PBT Work Plan chemicals and in assessing subsequent high priority chemicals, the Committee believes that EPA’s 

Framework for Metals Risk Assessment (EPA 120/R–07/001) 

(March 2007) should be consulted for metals and metal compounds. 

In addition, because the application of criteria applied in the 

prioritization screening process is not a definitive assessment of 

PBT characteristics, the Agency should consider whether substances that might otherwise be considered to have PBT characteristics should be addressed in a different way (e.g., substances that 

bioaccumulate but do not biomagnify), or whether substances that 

may not meet traditional PBT criteria should nonetheless be considered PBTs (e.g., substances that bioaccumulate in blood rather 

than fat tissue). 

EPA is to impose risk management on articles only to the extent 

necessary to address the identified risks of the chemical substance 

from the article in order for EPA to determine that the chemical 

substance meets the safety standard. EPA is to exempt replacement parts that are manufactured prior to the effective date of the 

rule for articles that are first manufactured prior to the effective 

date of the rule unless it finds the replacement parts contribute 

significantly to the identified risk. 

It is critical to a workable chemical management structure that 

EPA be afforded some level of discretion in implementing a ban or 

phase-out. However, to address concerns that the compliance date 

for such restrictions on a chemical substance not be unduly long, 

the section requires EPA to make compliance with such a rule 

mandatory in as short a period as practicable. 

Notably, the section eliminates the controversial provision of existing TSCA that requires EPA to adopt the ‘‘least burdensome’’ 

regulatory requirement. This has been viewed by the Agency as a 

major road block to successful TSCA implementation because of the 

evidentiary and analytic burdens associated with justifying that 

each proposed regulatory action was the least burdensome requirement needed to ensure a chemical did not pose an unreasonable 

risk. While this requirement has been removed, the Committee 

maintains a strong continued interest in ensuring any regulatory 

decisions under this act undergo an implementable yet robust consideration of costs and benefits. This section requires EPA to assess 

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enced the choice of regulatory requirements, but is not intended to 

establish a least burdensome requirement. EPA is authorized to exempt certain uses of a chemical substance if compliance with the 

regulatory restriction would harm national security, cause significant disruption of the national economy, or interfere with critical 

or essential uses. In the case of a ban or phase-out of a chemical 

substance, any exemption adopted by EPA can only last for a period of 5 years, subject to renewal. 

Section 9. Imminent hazards 

Section 9 of S. 697 amends section 7 of TSCA. The amendments 

make no substantive policy change in EPA’s authority to protect 

against unreasonable risks associated with imminent hazards from 

certain chemical substances. The amendment updates and conforms the section to the new authority provided under S. 697. 

Section 10: Information collection and reporting 

Section 10 of S. 697 amends section 8 of TSCA, the general information collection and reporting authorities under the Act. The section ensures that EPA’s information collection and reporting requirements produce a more complete picture of chemical substances 

in active commerce in the United States. The section also requires 

EPA to review all prior claims for the protection of confidential 

chemical identities for active substances within 5 years of enactment. The section provides authority to apply reporting and recordkeeping requirements to both manufacturers and processors. 

Although TSCA currently gives authority to EPA to collect information from processors, EPA has not chosen to do so. It is the 

Committee’s intent that manufacturers (including importers) and 

processors have reporting obligations only where appropriate and 

necessary to enable EPA to understand what chemicals are actually in active commerce, to gain access to information necessary to 

implement this Act, and to keep the information updated. These reporting obligations should be appropriately tailored to ensure that 

reporting burdens on any particular sector are equitable, undue 

burdens on small manufacturers and processors are minimized, 

and reporting requirements are applied to those persons likely to 

have information relevant to the effective implementation of this 

title. The Committee expects EPA to use the information generated 

by periodic reporting obligations to provide relevant information on 

chemical uses and possible exposures, and improve the ability of 

the Administrator to conduct prioritization screening, safety assessments and safety determinations, and to promulgate and implement appropriate risk management rules. 

TSCA requires a chemical substance to be listed on the TSCA Inventory before it is commercialized. However, TSCA does not require EPA on an ongoing basis to identify which substances on the 

Inventory are actually in commerce. With approximately 84,000 

substances now on the Inventory—but less than 8,000 chemical 

substances reported under the EPA’s Chemical Data Reporting 

Rule as being produced in volumes above the rule’s reporting 

threshold—it is important that EPA (and the American public) 

have a better picture of what substances are in actual commerce 

at any given time. The failure to identify active substances has created confusion. 


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S. 697 addresses this problem by requiring that EPA categorize 

the substances on the TSCA Inventory as active or inactive. The 

categorization process is critical to the success of EPA’s 

prioritization process, which focuses primarily on active substances. 

Importantly, the section does not authorize EPA to remove substances from the Inventory. Instead, manufacturers or processors 

who wish to designate an inactive substance as active have an obligation to notify EPA. Manufacturers of an inactive substance may 

return the substance to the active inventory with a simple notification to EPA, at which time the substance becomes subject to the 

prioritization screening, safety assessment and determination processes. 

Section 10 also requires EPA to develop a plan within 1 year of 

enactment to review all prior claims for the protection of confidential chemical identity that manufacturers or processors of active 

substances wish to maintain, within 5 years after the active list is 

compiled. The Committee intends that EPA review all such confidentiality claims, consistent with the requirements of section 14 

of this Act, to ensure that appropriate information relevant to 

health and safety of chemicals is publicly available. 

Under TSCA, numerous nomenclature conventions exist that 

may prevent the efficient distribution of chemicals into commerce. 

It is the intent of the Committee that the provisions of section 10 

related to nomenclature will resolve these issues by requiring the 

Administrator to develop new guidance that will establish equivalency between these conventions, while preserving certain nomenclature approaches that have significant value. It will also permit 

any chemical substance appearing multiple times, each with a different Chemical Abstract Service (CAS) number, to be treated by 

the Agency as a single chemical substance. This will help prevent 

duplicative safety assessments and determinations by ensuring 

that substantially equivalent chemicals are considered at the same 

time, as appropriate. The Committee believes this approach will 

also help enhance EPA’s ability to evaluate substances from new 

sources against existing substances for equivalence, enabling similar substances to rely on the Inventory listing of an existing substance. The Committee also intends that EPA’s guidance should address those instances where multiple, different substances share 

the same CAS number. These substances may have different hazard profiles, but these distinguishing characteristics are not transparent to the public and stakeholders. 

Current TSCA provides EPA the authority to list a category of 

substances on the inventory, rather than list individually each 

chemical substance within a category. S. 697 maintains this authority to ensure that minor modification or variations in the formulation or structure of a chemical substance that have insignificant health or environmental consequences would not be automatically subject to the notification requirements of section 5. The Committee believes that EPA’s current policy of not requiring notification for variations in naturally-occurring substances or mixtures 

should generally be continued. 

Section 10 continues the practice under current TSCA to ensure 

that any substance that is exempt from the premanufacturing notification (PMN) process under Section 6 of S. 697 is exempt from 

designation as active or inactive on the chemical inventory. 


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Section 11. Relationship to other Federal laws 

Section 11 amends section 9 of TSCA, which provides EPA discretionary authority to refer a concern about an unreasonable risk 

of injury to another Federal Agency, when the authority to address 

the risk may be more efficiently or effectively regulated by the 

other Agency. For example, if the Administrator finds that disposal 

of a chemical substance may pose risks that could be prevented or 

reduced under the Solid Waste Disposal Act, the Administrator 

should ensure that the relevant office of the EPA receives that information. Section 11 conforms this authority to the provisions of 

S. 697. It further requires EPA to share information relevant to 

preventing or mitigating exposures or releases of a chemical substance under another Federal law with any relevant Federal agencies or offices within EPA. 

Section 12. Research, development, collection, dissemination, and 

utilization of data 

Section 12 makes a minor conforming amendment to section 10 

of TSCA to ensure an appropriate reference to the Department of 

Health and Human Services. 

Section 13. Exports 

Section 13 of S. 697 amends the export notification requirements 

established in section 12 of TSCA. The amendments conform the 

export notification requirements to the requirements of the Act by 

requiring prior notice of exports of substances that are not likely 

to meet, or that do not meet, the safety standard and are subject 

to proposed or final restrictions. The section requires EPA to promulgate rules to implement the notification requirements. 

The substitute strikes the amendments to section 13 of TSCA 

that were in S. 697 as introduced. Thus, S. 697 makes no changes 

to the current import requirements under TSCA. 

Section 14. Confidential information 

Section 14 of S. 697 amends section 14 of TSCA to make several 

important modifications to the process by which confidential business information (CBI) can be protected against disclosure or disclosed. In general, it is the Committee’s intent to balance the need 

for protection from disclosure for information qualifying under the 

section b(4) exemption of the Freedom of Information Act (FOIA) 

(i.e., ‘‘trade secrets and commercial or financial information obtained from a person and privileged or confidential’’) with the needs 

to ensure access to such information under appropriate conditions 

by those who need it to perform their duties, and to maximize public availability of health and environmental information relating to 

chemical substances in commerce. Striking a balance between protecting trade secrets and sensitive commercial and financial information and broadening access to information on chemicals is essential to encourage innovation and economic competitiveness within 

the chemical industry and those industries that use chemistry, 

while better informing the decisions made about chemicals by different levels of government, companies throughout the supply 

chain, and the general public. 

Under this section, all information sought to be protected from 

disclosure must meet certain criteria, and all such claims must be 


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asserted. Section 14(b) identifies certain commercial and financial 

business information that has been consistently recognized as 

qualifying as CBI under existing TSCA. This type of information 

(e.g., marketing and sales information) does not require the same 

degree of substantiation by industry or review by EPA as other 

types of information, and is therefore distinguished from types of 

information that must be substantiated and reviewed by EPA. 

Section 14(c) identifies the types of information that will not be 

protected from disclosure and the circumstances under which protection will not be afforded. Section 14(c)(1) retains virtually verbatim the language of existing section 14(b)(1), relating to the disclosure of confidential information in the context of a health and 

safety study. The adoption of this provision of existing law does not 

signal the Committee’s intent to agree or disagree with EPA’s interpretation of the provision to date. Rather, it reflects the significant debate over the scope and interpretation of the provision, 

which could not be successfully resolved. The section retains clear 

direction that the Administrator is not authorized to release any 

information that would disclose a process used in the manufacturing or processing of a chemical substance or mixture, or the portion of a mixture comprised by any chemical substance in the mixture. The Committee expects that EPA will ensure that health and 

environmental effects information from health and safety studies is 

disclosed, while appropriately protecting CBI contained within a 

study. 

The section also makes clear the Committee’s intent that EPA 

disclose all information not entitled to protection, while ensuring 

that all information that qualifies for protection from disclosure 

that is included in a submission that is otherwise not entitled to 

protection from disclosure be protected. This approach is intended 

to address the confusion that can exist when information that 

qualifies for protection is included in a submission that is otherwise not entitled to protection from disclosure. 

The section also establishes a rebuttable presumption that CBI 

related to substances subject to a ban or phase-out shall be made 

public, with the requirement that EPA provide advance notice of 

the disclosure to the CBI claimant. The presumption is based on 

the principle that the public interest in disclosing confidential information concerning a chemical subject to a ban or phase-out can 

outweigh the claimant’s interest. The required notice provides the 

CBI claimant an opportunity to rebut the presumption by appealing or legally challenging an EPA determination, and ensures that 

appropriate information is made public while protecting important 

property rights. 

Under the section, all new claims for protection of information 

not presumed to be protected from disclosure must be substantiated by the claimant. The section is consistent with well-established criteria and requirements for the protection of trade secrets 

and other confidential information. For claims to protect chemical 

identity as confidential, the claimant must submit a structurallydescriptive generic name that is to be publicly disclosed. Generic 

names should disclose information such as the type, class, or family 

to which a chemical belongs, without revealing specific chemical 

identity. 


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Section 14(e) identifies exceptions to CBI protection. Several exceptions—for disclosure to a Federal officer or employee under any 

law to protect health and the environment, for disclosure to Federal contractors under certain circumstances, and for disclosure 

when the Administrator determines disclosure is necessary to protect health and the environment—are based on existing TSCA. 

These provisions signal no change in current policy on these disclosures. It is also the Committee’s intent to make clear that nothing 

in section 14 constitutes a bar to the rules of civil or criminal procedure in cases litigated in the U.S. courts. Appropriate protections 

against disclosure in such cases can still be sought by litigants in 

a court of law. 

The section reflects a change in CBI policy by authorizing EPA, 

for the first time, to share CBI with a State or a political subdivision of a State on written request. It is the Committee’s view that 

sharing of CBI with State or local authorities is only authorized 

under this Act when the recipient establishes that it has adequate 

authority and sufficient mechanisms in place to protect the information, by agreement with the Administrator. The procedures applied by State or local authorities to protect confidential information must be comparable to the procedures used by the Administrator to safeguard such information. The Committee expects EPA 

to ensure that disclosures to State and local governments under 

this provision will be protected from disclosure to the same extent 

as under Federal law. Without those protections, EPA should not 

release CBI to a State or political subdivision of a State. The Administrator must also notify the person who submitted the CBI 

that it has been disclosed to a State or political subdivision. 

The section also includes provisions on sharing CBI with health 

and environmental protection professionals in certain cases and 

under certain conditions. The provision is modeled on a similar program established in the Emergency Planning and Community 

Right to Know Act (EPCRA). The provision ensures that treating 

physicians, nurses, agents of poison control centers, public health 

or environmental officials of a State or political subdivision of a 

State, and first responders have appropriate, timely access to information, while still protecting CBI from disclosures more broadly. 

The Committee believes this provision will help remedy a deficiency in current TSCA by improving access to information while 

protecting proprietary information. 

Under the current provisions of TSCA there is no effective mechanism requiring the Administrator to review and evaluate a CBI 

claim, or for companies to re-evaluate prior claims or to re-substantiate claims. Section 14(f) is designed to address this situation. The 

section provides clear direction that EPA should review and make 

determinations on CBI claims in a timely manner. All claims for 

the protection of confidential chemical identity must be reviewed, 

and EPA must review a representative subset of all other CBI 

claims. 

The section also limits CBI protections for substantiated claims 

to an initial period of 10 years, renewable upon re-substantiation. 

A 10-year period for CBI claims is consistent with that provided 

under the vast majority of Federal CBI programs. The section 

specifies that the requirements to re-substantiate a prior claim are 

to be consistent with and no more or less burdensome than the 


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original substantiation. The Committee intends that there be no 

upper limit on the number of extensions available for CBI protection, so long as the claimant can make the appropriation substantiation of the claim. 

The section also provides the Administrator authority or a mandate to require re-substantiation of CBI claims in certain circumstances. This provision does not require EPA to review all CBI 

claims for chemical substances designated as high priorities. 

Finally, section 14 provides that information that is required to 

be disclosed or otherwise made public under Federal law, or is already publicly available cannot be newly protected as CBI under 

TSCA. This provision is consistent with current law and practice 

related to CBI protection. 

Section 15. Prohibited acts 

Section 15 of S. 697 amends section 15 of TSCA to conform to 

the requirements of the Act. 

Section 16. Penalties 

Section 16 of S. 697 amends section 16 of TSCA to increases civil 

penalties from $25,000 to $37,500 per violation to be consistent 

with other laws administered by EPA. The section also modifies the 

existing criminal penalty for violations that create an imminent 

danger of death or serious bodily injury, based on similar provisions in other federal environmental laws. 

Section 17. State-Federal relationship 

Section 17 of S. 697 makes several amendments to section 18 of 

TSCA to address the relationship between federal law and the laws 

of states or political subdivisions of states related to chemical regulation. Because TSCA regulates products manufactured for national 

and international commercial use, the Committee strongly intends 

S. 697 to establish a robust, nationally uniform program for the effective regulation of chemicals consistent with Article 1, Section 8, 

Clause 3 of the U.S. Constitution. It is the Committee’s view that 

the prioritization, safety assessment and determination, and regulatory provisions establish a credible national program to protect 

health and the environment from the unmanaged risks of chemical 

substances in such a way that the need for separate state or local 

action may be minimized. It is the Committee’s expectation that 

EPA will make appropriate efforts to engage State governments— 

particularly state agencies tasked with protecting public health and 

the environment—interested in chemical regulatory matters in the 

prioritization screening, safety assessment and determination, and 

risk management processes established under this Act. 

The section specifically replaces the term ‘‘requirements’’ with 

the phrase ‘‘statute or administrative action’’ in describing the extent of preemption that would apply to state actions and any subsequent use of the word ‘‘requirements’’ is not intended to extend to 

common law tort claims or decisions. By the addition of several 

savings clauses, the Committee wishes to send a strong signal that 

preemption under section 17 of the legislation does not apply to 

tort claims. 

The section changes in some ways the circumstances under 

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empt certain state actions. TSCA section 18 currently preempts 

state law when EPA has issued a testing rule under Section 4 or 

a rule or order under Sections 5 or 6 with respect to a chemical 

substance. More specifically, TSCA generally preempts State and 

local requirements applicable to the same chemical substance if the 

State or local requirement is designed to gather the same or similar information as the Section 4 rule, or to protect against the same 

risks as the Section 5 or 6 rule or order, unless the State or local 

requirement is identical to the EPA requirement, is adopted pursuant to another Federal law, or completely prohibits the manufacture or processing of the substance or mixture within the State or 

political subdivision. Under current TSCA, a State may request 

that EPA issue a waiver from the preemption provision. 

Section 17’s preemption provisions follow a framework that is in 

many ways similar to current law. State actions regarding testing, 

the notification of significant new uses, and the restriction of highpriority substances for which EPA has completed a safety determination and either has found that the substance meets the safety 

standard, or has found that it does not meet the safety standard 

and has completed a final risk management rule, would be preempted, to the extent the same uses and conditions of use are included in the scope of the EPA action. For example, if EPA has 

completed a safety assessment and safety determination for a 

chemical substance and finds the chemical substance meets the 

safety standard, that action preempts state restrictions on that 

substance only for the uses and/or conditions of use included in the 

EPA review. If EPA implements risk management requirements on 

a chemical substance, that action would also preempt state restrictions on that chemical substance, but only those state restrictions 

that apply to the same uses and/or conditions of use addressed by 

EPA’s rule. Thus, the section establishes clear direction that preemptive effects on State law are limited to the specified regulatory 

actions taken by EPA with respect to a specific chemical substance 

or category of substances, and then only to the uses or conditions 

of use addressed by that EPA action. 

The Administrator’s commencement of a safety assessment of a 

high-priority chemical will preempt the implementation of any new 

state restriction on that chemical once the scope of the safety assessment has been defined and published by EPA (under section 6, 

no later than 6 months after designation as a high priority). The 

preemptive effect will continue until EPA publishes the safety determination. During this period, states can continue working on 

legislation and rules to restrict chemicals, but this preemption 

would prevent a final rule from taking effect unless a waiver is 

granted, the safety determination is finalized and the chemical substance is found to not meet the safety standard, or the deadline for 

completing the safety determination lapses also leading to the 

granting of a waiver. Existing state statutes or administrative actions on individual high priority chemicals are in no way preempted by this provision. 

Section 17(d) makes clear that certain state laws that are not restrictions on chemical manufacturing and use are not preempted 

under S. 697. As under current TSCA the section makes clear that 

a state or local requirement adopted pursuant to another federal 

statute is not preempted. In addition, restrictions states put in 


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place under their own authority to protect air quality, water quality, or waste treatment or disposal are not pre-empted, as long as 

those restrictions do not address the same hazards and exposures, 

with respect to the same conditions of use, as those included in the 

scope of the safety determination but are inconsistent with the action of the Administrator or would cause a violation of an applicable action by the Administrator under section 5 or 6. This approach 

is appropriate for the considerable body of law regulating chemical 

releases to the environment, such as air and water quality, where 

the states have traditionally had a significant regulatory role and 

often have a uniquely local concern. 

The section clarifies that an EPA action will not preempt state 

actions that do not directly prohibit or otherwise restrict the manufacturing, processing, distribution in commerce of a chemical substance, as well as where the state action is not otherwise required 

by or inconsistent with an action under sections 4, 5 or 6. Similarly, state chemical disclosure and other information-related obligations would not be preempted by EPA action under TSCA, as 

they do not directly restrict a chemical. The Committee expects 

that such state laws are established to enhance information on 

chemical substances, rather than being used to impose effective 

bans or other substantial restrictions on chemical manufacture, 

processing, distribution in commerce, use or disposal. 

As in current law, the section also allows states to enforce State 

law requirements that are identical to requirements mandated by 

EPA under sections 4, 5 or 6. S. 697 provides that either a state 

or the Federal government can levy a penalty and sanction a violation of the law, but not both. In further ensuring equitable and consistent enforcement of federal chemical regulations, State penalties 

and sanctions can be no more stringent than those available to the 

Federal government. 

The section provides that existing EPA regulations remain in 

force unless modified or eliminated under this Act, and that any 

preemptive effect of those regulations that pre-dates enactment of 

S. 697 continues in accordance with the preemption provisions in 

effect when those rules were put in place under the law. The Committee intends to make clear that nothing in S. 697 affirmatively 

modifies or eliminates the preemptive effect of a Federal decision 

in effect prior to the date of enactment, nor that EPA’s ability to 

revisit previous rulemakings through the administrative process is 

in any way diminished. 

In order to efficiently address the potential preemptive effect of 

EPA decisions on the body of existing state laws affecting chemical 

substances, S. 697 creates an exemption from preemption for all 

chemical specific actions taken prior to August 1, 2015. This provision is intended to ‘‘grandfather’’ existing state prohibitions or restrictions on chemical manufacturing, processing, use, distribution 

in commerce, or disposal of a chemical substance. 

In addition, the section adopts similar language to section 231(b) 

of the Consumer Product Safety Improvement Act (CPSIA), which 

was intended to exclude California’s ‘‘Proposition 65’’ requirements 

from federal preemption under that Act. It is the Committee’s intent that adopting this provision in S. 697 would effectively achieve 

the same result. 


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Currently, TSCA provides states an opportunity to seek a waiver 

from preemption following final EPA action, under certain circumstances. S. 697 adopts a similar approach, and provides an additional waiver opportunity for states related to the preemptive effect of EPA’s initiation of a safety assessment and determination 

on new state regulation. 

When EPA has made a final decision or taken an action under 

section 4, 5 or 6 that has a preemptive effect, a State may seek and 

be granted a waiver when EPA determines that: there are compelling local health or environmental conditions; compliance with the 

state requirement would not unduly burden interstate commerce 

(consistent with the Commerce Clause of the U.S. Constitution); or 

cause a violation of federal law (consistent with the Supremacy 

Clause of the U.S. Constitution); and the requirement is consistent 

with sound objective scientific practices, the weight of the evidence 

and the best available science. This waiver opportunity is modeled 

on the existing provisions of section 18 of TSCA, but includes additional conditions for granting such a waiver, consistent with the 

Committee’s intent that S. 697 establish a robust, nationally uniform program for the effective regulation of chemicals. 

As noted earlier, EPA’s commencement of a safety assessment 

preempts certain new state actions on a chemical substance, running from the date on which the scope of EPA’s review is defined 

and published, ending on the date the safety determination is published or the maximum deadline of 5 years for a determination 

under Section 6 as amended is missed. Even during this interim 

period, a State may seek and EPA shall grant a waiver when compliance with the state requirement would not unduly burden interstate commerce (again, consistent with the Commerce Clause of the 

U.S. Constitution), or cause a violation of federal law (again, consistent with the Supremacy Clause of the U.S. Constitution), and 

the concern of the state or political subdivision is based in peer-reviewed science. The Committee’s intent is that this last condition 

requires that a State’s waiver application should be based on credible science citing one or more studies published in a peer reviewed 

journal, or a study by an institution like the National Academy of 

Sciences with a peer review process. This language does not require 

that a state’s waiver application be evaluated on the weight of the 

evidence. 

State waiver requests are subject to notice and comment, and 

EPA decisions on them must be made within a specified period of 

time, and are considered final agency actions subject to judicial review by any person. If a court does not act on a petition for judicial 

review, within 90 days, the waiver again applies and the state may 

proceed with implementation of its restriction. For waivers sought 

during the period EPA is reviewing a chemical substance, if EPA 

fails to adhere to the deadline established in section 6 for safety 

assessments and determinations, or fails to meet the deadlines for 

action on a waiver application, a waiver shall be automatically approved. 

The Committee intends that the compelling state circumstances 

or interests identified in a waiver application for a state to act after 

final EPA action should generally follow the practice of other federal agencies applying similar provisions. For example, a Department of Energy (‘‘DOE’’) regulation allows States to petition for a 


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preemption exemption for energy conservation standards for which 

there is already a federal standard. 10 C.F.R. § 431.422. The State 

must show that an exemption is needed to meet ‘‘unusual and compelling State or local energy interests.’’ This is defined to mean ‘‘interests which are substantially different in nature or magnitude 

from those prevailing in the U.S. generally . . .’’ 

Similarly, under the Federal Food, Drug, and Cosmetic Act 

(FFDCA), the Food and Drug Administration (FDA) in reviewing 

medical devices can exempt a State requirement from preemption 

if there are ‘‘compelling local conditions.’’ 21 U.S.C. § 360k. The 

FDA’s regulations define this phrase to mean ‘‘any factors, considerations, or circumstances prevailing in, or characteristic of, the geographic area or population of the State or political subdivision 

that justify exemption preemption.’’ 

The section authorizes any person to seek judicial review of an 

EPA decision to designate a substance as a low priority chemical. 

The Committee expects that if EPA applies the low priority designation based on information sufficient to establish that the chemical substance is likely to meet the safety standard, judicial review 

of a low priority designation will be sought infrequently, particularly as the ability of state governments to act on all chemical substances not designated as a high priority remains intact because 

low priority determinations have no preemptive or regulatory affect. 

The section establishes several savings clauses. Federal court 

precedent establishes that preemption is a matter of Congressional 

intent. Gade v. Nat’l Solid Wastes Mgmt Ass’n, 505 U.S. 88, 96 

(1992). The Supreme Court has given effect to saving clauses and 

found that they save common law tort claims from a statute’s preemption language. See, e.g., Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861, 868 (2000) (holding common law actions not preempted due to a saving clause despite a preemption clause that 

could otherwise be reasonably interpreted broadly to preempt such 

claims). The savings clauses in S. 697 are intended as a clear statement that the preemption provisions do not apply to tort claims. 

Current section 18 of TSCA does not preempt or displace any private common law rights or statutory remedies for civil relief, or 

penalties for criminal conduct. Similarly, section 17 of S. 697 

makes clear that nothing in the Act should be interpreted to preempt, supplant, or displace common law rights or statutorily enacted remedies for civil damages or a criminal penalty. The Committee believes that this clarification is useful to ensure that S. 697 

results in no unintended contraction of any private legal rights, 

and particularly to further clarify that nothing in the revision of 

section 18 should be interpreted to apply to tort claims. 

Section 18. Judicial review 

Section 18 of S. 697 amends section 19 of TSCA. S. 697 makes 

no change to the existing standard of judicial review in section 19 

of TSCA. Several other provisions of this section make changes to 

conform section 19 to the requirements of the Act. 

Section 19. Citizens’ petitions 

Section 19 of S. 697 amends section 20 of TSCA to make changes 

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ments of the Act. No substantive or policy change is intended by 

these amendments. 

Section 20. Employment effects 

Section 20 of S. 697 makes a minor conforming change in section 

21 of TSCA. 

Section 21. Studies 

Section 21 of S. 697 repeals section 25 of TSCA. Section 25 required the Administrator to conduct an indemnification study and 

a study on classification, storage and retrieval of information on 

chemicals. These studies are not necessary under a modernized 

TSCA, particularly given the widespread availability of information 

on chemical substances in electronic format. 

Section 22. Administration 

Section 22 of S. 697 amends Section 26 of TSCA to expand EPA’s 

existing TSCA fee authority. In the Committee’s view, the provisions will help ensure that funds sufficient to defray a substantial 

portion of EPA expenses in information collection and processing, 

prioritization, safety assessment and determination, and regulation 

under the Act are provided through user fees. 

The section authorizes EPA to raise fees to defray approximately 

25% of the cost of implementation, to a maximum of $18 million. 

All fee revenue would be directed to a new TSCA Implementation 

Fund, to ensure that resources will be directly available to EPA to 

more efficiently run the program. Similar to user fees in several 

other federal product assessment programs (such as the Pesticide 

Registration Improvement Act), fee authority is conditioned on continued federal appropriations and to subsequent Congressional reauthorization. 

The section authorizes EPA to adjust fees for inflation and to ensure that funds are sufficient to conduct the activities covered by 

the fees. The section also directs EPA to avoid surpluses. As provided in section 4A of S. 697, manufacturers or processors of chemicals EPA decides to assess as ‘‘additional priorities’’ will pay 100% 

of the costs of safety assessments and determinations, while 50% 

of the costs of conducting company-requested safety assessments 

and determinations on TSCA Work Plan chemicals are to be paid 

by the company. 

The section provides that fees may not be assessed for a fiscal 

year unless the amount of appropriations (excluding fees) is equal 

to or greater than the amount of appropriations for fiscal year 

2015. This provision is modeled after a similar provision in the Pesticide Registration Improvement Act. The Committee intends this 

provision to ensure that appropriations are not reduced because of 

the revenue collected through fees, but rather that the fees supplement appropriated resources available to the Agency. The payment 

of fees for ‘‘additional priorities’’ and for company-requested reviews of TSCA Work Plan chemicals should not be subject to the 

condition for continued federal appropriations. 

The section establishes audit and transparency requirements in 

EPA’s implementation of the fee program. 


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With these provisions, it is the Committee’s intent to ensure that 

EPA has the resources it needs to implement the new and 

strengthened regulatory requirements of a modernized TSCA. 

Section 23. Development and evaluation of test methods and sustainable chemistry 

Section 23 of S. 697 amends section 27 of TSCA to establish an 

interagency Sustainable Chemistry program to promote and coordinate Federal sustainable chemistry research, development, demonstration, training and other activities. The interagency group is 

to include representatives of the National Science Foundation, the 

National Institute of Standards and Technology, and other agencies 

with interests in sustainable chemistry. The section provides no 

new appropriations authority, but directs the relevant agencies to 

coordinate their budgets to provide appropriate support to the program. Section 23 is intended to ensure that EPA and the federal 

government support education, research and development, into 

new, sustainable chemistries. 

The Committee questions whether or to what extent the EPA labeling program will be needed for, or appropriately applied to, 

chemicals for which EPA conducts safety assessments and determinations under EPA’s strengthened authorities under S. 697; specifically, the Committee is concerned that the labeling program, if 

applied to chemicals EPA has found meet the safety standard, 

could risk consumer confusion in the marketplace if another program within the Agency then identifies ‘‘safer’’ alternatives. It is 

the expectation of the Committee that, given the new authorities 

and responsibilities of the Agency under S. 697, the agency’s toxics 

office will focus primarily on implementation and enforcement of S. 

697, and consider use of any existing private sector voluntary consensus standards as an alternative to further expanding or utilizing certain aspects of the Safer Choice program. 

Section 24. State programs 

Section 24 makes a minor conforming change to section 28 of 

TSCA, relating to federal grants to support state programs. 

Section 25. Authorization of appropriations 

Section 25 of S. 697 repeals section 29 of TSCA, relating to authorized appropriations. 

Section 26. Annual report 

Section 26 of S. 697 amends section 30 of TSCA to add several 

elements to the annual report required of EPA to Congress on implementation of the Act including the number of notices received 

under section 5 as amended, and for chemical substances subject 

to a rule, testing consent agreement, or order under section 4 as 

amended. 

Section 27. Effective date 

Section 27 of S. 697 modifies Section 31 of TSCA to make clear 

that nothing in the Act shall be interpreted retroactively to any 

Federal, State, or maritime legal action commenced prior to the effective date. 


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LEGISLATIVE HISTORY

Senator Udall introduced S. 697 on March 10, 2015. The bill was 

referred to the Committee on Environment and Public Works. A 

legislative hearing on the bill was held on March 18, 2015. The 

Committee considered the bill in a business meeting on April 28, 

2015. An amendment in the nature of a substitute was approved, 

and the Committee ordered the bill reported to the Senate. 

ROLL CALL VOTES

The Committee on Environment and Public Works met to consider S. 697 on April 28, 2015. The committee favorably reported 

the bill, as amended by a substitute offered by Senators Vitter, 

Whitehouse, Merkley and Booker, by a roll call vote of 15–5. 

Amendments rejected 

A total of 6 amendments to the bill were offered and not approved by the Committee, as follows: 

1. Gillibrand #1—Amendment striking a section of S. 697 that 

prohibits states from taking action in regulating high priority 

chemicals upon the initiation of the Safety Assessment by EPA (rejected by a roll call vote of 8 yeas, 12 nays). 

2. Boxer-Sanders-Markey #2—Amendment requiring expedited 

consideration of the regulation of all forms of asbestos, instead of 

requiring a safety assessment be completed (rejected by a roll call 

vote of 9 yeas, 11 nays). 

3. Markey #1—Amendment including a provision for chemicals 

requiring expedited action (rejected by a roll call vote of 8 yeas, 12 

nays). 

4. Markey #2—Amendment allowing additional time to comply 

with certain restrictions in cases of technological infeasibility (rejected by a roll call vote of 9 yeas, 11 nays). 

5. Boxer-Carper #3—Amendment addressing chemical contamination of drinking water supplies by requiring consideration of 

whether a chemical substance is stored near drinking water 

sources when prioritizing chemicals for assessments (rejected by a 

roll call vote of 10 yeas, 10 nays). 

6. Boxer-Markey-Sanders #5—Amendment strengthening protections for children and communities from disease clusters and providing community disease cluster technical assistance grants (rejected by a roll call vote of 10 yeas, 10 nays). 

Final Committee vote to report 

S. 697, as amended by the Vitter/Whitehouse/Merkley/Booker 

substitute, was approved and ordered to be reported to the full 

Senate. The roll call vote to report the bill was 15 to 5 in favor 

(Senators Inhofe, Vitter, Barrasso, Capito, Crapo, Boozman, Sessions, Wicker, Fischer, Rounds, Sullivan, Carper, Whitehouse, 

Merkley and Booker voted yea, and Senators Boxer, Cardin, Sanders, Gillibrand, and Markey voted nay). 

REGULATORY IMPACT STATEMENT

In compliance with section 11(b) of rule XXVI of the Standing 

Rules of the Senate, the committee finds that S. 697 does create 

additional regulatory burdens on manufacturers, processors and 


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importers and users of chemical substances. These burdens include 

fees authorized under S. 697 of up to $18 million annually. According to the Environmental Protection Agency, there are approximately 13,500 chemical manufacturing facilities in the United 

States owned by more than 9,000 companies. There is no information on the number of users of chemical substances. It is not practicable to quantify the number of entities affected, the precise economic impact on those entities, or the additional paperwork that 

may result from regulations to be promulgated under S. 697. However, the committee notes that the Congressional Budget Office has 

found that the cost of the mandates in the bill to private and public 

sector entities will not be substantial. The committee finds that S. 

697 will not cause any adverse impact on the personal privacy of 

individuals. 

MANDATES ASSESSMENT

In compliance with the Unfunded Mandates Reform Act of 1995 

(Public Law 104–4), the committee notes that the Congressional 

Budget Office found, ‘‘S. 697 would impose intergovernmental and 

private-sector mandates, as defined in the Unfunded Mandates Reform Act (UMRA), on manufacturers, processors, importers, and 

users of chemical substances. The bill also would impose intergovernmental mandates on state agencies. CBO estimates that the aggregate cost of those mandates would fall below the annual thresholds established in UMRA for intergovernmental and private-sector 

mandates ($77 million and $154 million in 2015, respectively, adjusted annually for inflation).’’ 

COST OF LEGISLATION

JUNE 5, 2015. 

Hon. JIM INHOFE, 

Chairman, Committee on Environment and Public Works, 

U.S. Senate, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for S. 697, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Susanne S. Mehlman. 

Sincerely, 

KEITH HALL. 

Enclosure. 

S. 697—Frank R. Lautenberg Chemical Safety for the 21st Century 

Act 

Summary: S. 697 would modify the Toxic Substances Control Act 

(TSCA), the law that regulates the manufacture, importation, and 

processing of chemicals, with the aim of strengthening the Environmental Protection Agency’s (EPA’s) ability to evaluate and regulate 

potentially hazardous chemicals. 

CBO estimates that EPA would incur additional administrative 

costs over the 2016–2020 period to meet the new requirements imposed by S. 697; however, we also estimate that under the bill EPA 

would collect sufficient fees from chemical manufacturers and processors to offset the cost of conducting the activities proposed under 


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this legislation. On net, we estimate that implementing this legislation would reduce discretionary costs by $8 million over the next 

five years, assuming appropriation actions consistent with provisions of the bill. 

Enacting S. 697 could affect direct spending and revenues because the bill would increase some existing civil and criminal penalties for violations of TSCA. Therefore, pay-as-you-go procedures 

apply. CBO estimates that any changes in revenues and direct 

spending would not be significant. 

S. 697 would impose intergovernmental and private-sector mandates, as defined in the Unfunded Mandates Reform Act (UMRA), 

on manufacturers, processors, importers, and users of chemical 

substances. The bill also would impose intergovernmental mandates on state agencies. CBO estimates that the aggregate cost of 

those mandates would fall below the annual thresholds established 

in UMRA for intergovernmental and private-sector mandates ($77 

million and $154 million in 2015, respectively, adjusted annually 

for inflation). 

Major provisions: The bill’s major provisions would: • Require EPA to develop policies, procedures, and guidance 

to address the process for testing and evaluating the safety of 

chemical substances; • Authorize EPA to obtain new information on chemical substances from manufacturers and processors at all stages of the 

safety evaluation process; • Require EPA to establish and implement a risk-based 

prioritization process to screen all chemicals now in use; • Address when federal actions under TSCA preempt requirements of state and local governments related to restricting and banning chemical substances; • Require EPA to update its process for reviewing industry 

requests that information submitted to the agency be kept confidential; and, • Require EPA to establish a new schedule for charging fees 

to chemical manufacturers who are required to submit data to 

the agency or who request that EPA assess certain chemicals 

that are not yet prioritized for review by EPA. 

Estimated cost to the Federal Government: The estimated budgetary impact of S. 697 is shown in the following table. The costs 

of this legislation fall within budget function 300 (natural resources 

and environment). 

By fiscal year, in millions of dollars— 

2016 2017 2018 2019 2020 2016– 

2020 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Administrative Expenses under TSCA: 

Estimated Authorization Level ............................................. 17 17 17 17 17 85 

Estimated Outlays ............................................................... 7 14 17 17 17 72 

Offsetting Fee Collections: 

Estimated Authorization Level ............................................. ¥4 ¥10 ¥16 ¥25 ¥25 ¥80 

Estimated Outlays ............................................................... ¥4 ¥10 ¥16 ¥25 ¥25 ¥80 

Total Changes: 

Estimated Budget Authority ....................................... 13 7 1 ¥8 ¥8 5 

Estimated Budget Outlays ......................................... 3 4 1 ¥8 ¥8 ¥8 

Note: TSCA = Toxic Substances Control Act. 


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Basis of estimate: For this estimate, CBO assumes that S. 697 

will be enacted near the end of 2015 and that the necessary 

amounts will be appropriated each year. 

Spending subject to appropriation 

While some of the requirements in S. 697 are similar to activities 

currently performed by EPA under TSCA, CBO estimates that implementing this legislation would increase EPA’s workload for regulating chemical safety by about 30 percent each year. That estimate is based on historical information about how other large regulatory programs have been implemented by EPA and on expectations of the additional workload provided by the agency. According 

to EPA, the agency currently requires, on average, an appropriation of about $58 million annually to implement and enforce EPA’s 

Chemical Risk Review and Reduction program under TSCA. That 

funding supports roughly 245 employees. Subject to the appropriation of the necessary amounts, CBO estimates that EPA would require about $17 million annually over the next five years to cover 

the costs of additional personnel, contractors, and other administrative activities associated with meeting the new requirements of 

this legislation. 

Over the next two years, CBO expects that EPA would focus on 

implementing S. 697 primarily by producing guidance documents 

and cost-benefit analyses and performing other administrative 

tasks related to the rulemaking process for the review of the safety 

of new chemicals and substances currently in use. EPA would establish internal processes and information technology systems to 

prioritize the analysis of tens of thousands of chemicals. According 

to the agency, such activities are routinely carried out by contractors; as a result, most of the estimated $17 million in annual funding needed over this period would cover contractor costs. By 2018, 

enforcement of the new provisions of TSCA would begin and CBO 

estimates that EPA would shift funding to cover additional government personnel. CBO estimates that spending on new administrative activities over the next five years would total $72 million. 

Under the legislation EPA would be authorized to charge two 

types of fees. One would be imposed on chemical manufacturers 

and processors who are required to submit certain types of notices 

or requests for exemptions under the bill. In addition, EPA could 

charge fees to manufacturers and processors who request that EPA 

conduct safety assessments and safety determinations for chemicals that have not been designated a priority for further assessment. 

Under the bill total collections of fees for firms submitting notices and requests for exemptions could not exceed $18 million annually. CBO estimates that EPA would begin collecting those fees 

in 2017 and that such collections would total $6 million in that 

first year. By 2019, we expect that as more chemicals are reviewed 

by EPA, collections would reach $18 million annually. Based on information from EPA, CBO estimates that collections from firms requesting safety assessments and determinations would begin in 

2016 and would total $4 million in that year. By 2019 we estimate 

that collections would total $7 million annually. S. 697 specifies 

that all additional fees collected by EPA would be recorded in the 

budget as offsetting collections (an offset to appropriated spending). 


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CBO estimates that those collections would total $80 million over 

the next five years. Thus, enacting this legislation would result in 

a net reduction in spending of $8 million over the 2016–2020 period, assuming future appropriations acts are consistent with 

CBO’s estimates. 

Direct spending and revenues 

Enacting S. 697 also could affect direct spending and revenues 

because this bill would increase some existing civil and criminal 

penalties. Criminal penalties are recorded as revenues, then deposited in the Crime Victims Fund, and later spent; civil penalties are 

recorded as revenues. CBO estimates that any increase in criminal 

or civil penalties under the bill would not be significant. 

Pay-As-You-Go considerations: The Statutory Pay-As-You-Go Act 

of 2010 establishes budget-reporting and enforcement procedures 

for legislation affecting direct spending or revenues. CBO estimates 

that any increase in revenues and direct spending resulting from 

changes in criminal or civil penalties would not be significant over 

the 2016–2025 period. 

Intergovernmental and Private-Sector Impact: S. 697 would impose intergovernmental and private-sector mandates, as defined in 

UMRA, on manufacturers, processors, importers, and users of 

chemical substances. The bill also would impose intergovernmental 

mandates on state agencies. CBO estimates that the aggregate cost 

of those mandates would fall below the annual thresholds established in UMRA for intergovernmental and private-sector mandates ($77 million and $154 million in 2015, respectively, adjusted 

annually for inflation). 

Mandates that apply to both public and private entities 

S. 697 would modify the standard used to determine whether a 

chemical substance poses an unreasonable risk to human health or 

the environment and would allow EPA to regulate the manufacture, processing, distribution, use, and disposal of chemical substances to ensure the standard is met. If EPA determines that 

some chemical substances do not meet the standard and issues regulations for those substances, the bill would impose an intergovernmental and private-sector mandate. EPA would have the authority 

to adopt a range of regulatory options to address risks from chemical substances. For example, EPA could require manufacturers to 

put warning labels on selected chemicals. EPA also could require 

users of chemicals, such as public and private universities conducting research, to handle or dispose of selected chemicals in a 

certain way. Based on information from industry experts, CBO expects that the annual cost of any restriction would not be substantial. Also, because of the amount of time involved in assessing the 

risk of each chemical, any restrictions imposed would apply to few 

chemicals in the first five years the mandate is in effect. Therefore, 

CBO estimates that the cost of the mandate would be small for 

both public and private entities during that time. 

Mandates that apply to public entities only 

The bill would impose an intergovernmental mandate by preempting state regulations that conflict with the federal regulation 

of chemicals, but that preemption would impose no duty on states 


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that would result in additional spending or a loss of revenues. The 

bill also would impose a mandate on state agencies by requiring 

them to notify EPA whenever they propose an administrative action, enact a statute, or take regulatory action concerning a chemical that EPA has not designated as a high-priority substance. Information from EPA indicates that the cost of that notification 

mandate would be small. 

Mandates that apply to private entities only 

The bill would amend provisions in TSCA that apply to new and 

existing chemicals. The bill would impose new mandates and increase the cost of existing mandates on manufacturers, importers, 

and processors of chemical substances. Additionally, manufacturers 

and processors would be required to pay fees and submit data to 

EPA for use carrying out safety assessments and regulations to ensure safety. Finally, the bill could impose a mandate on importers 

of some items containing chemical substances. 

Based on information from industry experts, CBO expects that 

the incremental cost of those mandates would not be substantial. 

The bill would limit the amount of mandatory fees that EPA could 

collect to $18 million annually. Manufacturers and processors of existing chemical substances currently report information to EPA 

under programs such as the Chemical Data Reporting rule and the 

High Production Volume Challenge Program, which is voluntary. 

Based on information from industry experts, CBO expects that submitting new data to EPA for safety assessments could cost up to 

$1 million per chemical substance. However, the annual number of 

existing chemicals that would be subject to the data submission requirements would be limited. 

Estimate prepared by: Federal spending: Susanne Mehlman; Impact on state, local, and tribal governments: Jon Sperl; Impact on 

the private sector: Amy Petz. 

Estimate approved by: Theresa Gullo, Assistant Director for 

Budget Analysis. 


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MINORITY VIEWS

MINORITY VIEWS OF BOXER, CARDIN, SANDERS, GILLIBRAND, AND MARKEY ON S. 697, AS REPORTED BY THE 

EPW COMMITTEE 

Protecting people from harmful chemicals is a fundamental goal. 

It is clear that our current chemical regulation law—the Toxic Substances Control Act (TSCA)—is broken. Reform of this law must 

avoid creating loopholes that could result in a failure once again. 

In a key 1991 court decision, EPA’s plan to phase out asbestos 

uses was overturned despite overwhelming evidence about the dangers of this chemical. Since this case, EPA has been unable to address the most dangerous chemicals being used today. 

Reform of this failed law is needed. Any action by Congress must 

be better than current law and must ensure families have additional protections. Important clarifications and improvements are 

needed to ensure that S. 697, as reported by the EPW Committee, 

clearly addresses the threats dangerous chemicals pose. 

The version of the bill reported by the EPW Committee makes 

vital improvements to the introduced bill, including removing preemption of state air and water laws, allowing co-enforcement of 

chemical restrictions by the States, allowing judicial review of 

chemicals designated as ‘‘low priority’’, and removing a harmful 

provision that would have undermined EPA’s ability to restrict the 

import of dangerous chemicals from foreign countries. 

This is important progress. However, the bill needs further improvement to make sure that TSCA reform addresses the most 

dangerous chemicals without being mired in years of litigation. 

That is why the following public health, labor, and environmental 

organizations do not support the bill reported by the EPW Committee and have called for additional changes. 

• Safer Chemicals, Healthy Families Coalition (represents 450 organizations dedicated to reforming toxics laws) 

• Asbestos Disease Awareness Organization 

• Breast Cancer Fund 

• AFL-CIO 

• Center for Environmental Health 

• Environmental Working Group 

• California Attorney General 

IMPROVEMENTS NEEDED TO S. 697

Allow States to Protect Their Citizens Until EPA Acts—The bill 

reported by the EPW Committee stops States from regulating a 

chemical as soon as EPA begins its assessment of the chemical and 

many years before a Federal restriction is actually put in place. 


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The bill creates a waiver process that would allow States to petition EPA to move forward. This process is complicated, subject to 

litigation, and leaves great uncertainty about the ability of States 

to protect their citizens before federal safeguards are finalized. 

States need greater certainty that they can act until Federal restrictions under TSCA are in place and effective so that they can 

ensure public health is protected. 

Act on Known Dangers—The bill should make it clear that 

known chemical threats, such as asbestos and chemicals that accumulate in the body, will be addressed. The bill would encourage 

EPA to consider persistent and bioaccumulative chemicals, but 

would not require action. Furthermore, asbestos, which is estimated to kill 15,000 people every year, is not specifically addressed 

or prioritized in the bill despite its known dangers. The bill does 

not prioritize or address chemicals stored near sources of drinking 

water that could spill and contaminate drinking water supplies. Finally, the bill should provide the tools necessary to investigate, undertake actions, and coordinate responses to address disease clusters. Chemicals that present known threats such as these should 

be specifically addressed in the bill to guarantee that action is 

taken. 

Ensure EPA Can Take Action to Address Dangerous Chemicals— 

The current TSCA law contains a number of flaws that make the 

adoption of strong public health protections against the most dangerous types of chemicals an extremely and unnecessarily difficult 

task. The bill reported by the EPW Committee does not sufficiently 

address these flaws. S. 697 maintains elements of the current ‘‘unreasonable risk’’ safety standard for EPA actions to ban or restrict 

exposure to toxic substances. The bill also maintains the ‘‘substantial evidence’’ legal standard that was an important reason for the 

failure of the current TSCA law. Legislation to reform TSCA should 

be clear that this legal standard does not create an unnecessary 

hurdle to implementing restrictions on chemicals that have been 

proven to be a danger. 

Meaningfully Improve Scope and Speed of Chemical Reviews— 

The bill should do more to ensure meaningful progress to assess 

and act on chemicals that present a danger to public health. S. 697 

requires EPA to begin studying the safety of 25 chemicals within 

the first 5 years. According to EPA there are at least 1,000 chemicals that are dangerous enough to require further study immediately. The bill should require EPA to address this concern and 

provide the resources to assess the most dangerous chemicals in 

commerce as quickly as possible. 

As S. 697 moves forward, we stand ready to work with our colleagues to address the issues identified here and pass TSCA reform 

that protects our children and families from the threat of dangerous chemicals. 

BARBARA BOXER. 

BENJAMIN L. CARDIN. 

BERNARD SANDERS. 

KIRSTEN GILLIBRAND. 

EDWARD MARKEY. 


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CHANGES IN EXISTING LAW

In compliance with section 12 of rule XXVI of the Standing Rules 

of the Senate, changes in existing law made by the bill as reported 

are shown as follows: Existing law proposed to be omitted is enclosed in øblack brackets¿, new matter is printed in italic, existing 

law in which no change is proposed is shown in roman: 

* * * * * * * 

TOXIC SUBSTANCES CONTROL ACT 

* * * * * * * 

SEC. 2. FINDINGS, POLICY, AND INTENT. 

(a) FINDINGS.—The Congress finds that— 

(1) human beings and the environment are being exposed 

each year to a large number of chemical substances and mixtures. 

(2) among the many chemical substances and mixtures 

which are constantly being developed and produced, there are 

some whose manufacture, processing, distribution in commerce, use, or disposal may present an unreasonable risk of injury to health or the environment; and 

(3) the effective regulation of interstate commerce in such 

chemical substances and mixtures also necessitates the regulation of intrastate commerce in such chemical substances and 

mixtures. 

(b) POLICY.—It is the policy of the United States that— 

(1) adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such data should be 

the responsibility of those who manufacture and those who 

process such chemical substances and mixtures; 

(2) adequate authority should exist to regulate chemical substances and mixtures which present an unreasonable risk of 

injury to health or the environment, and to take action with 

respect to chemical substances and mixtures which are imminent hazards; and 

(3) authority over chemical substances and mixtures should 

be exercised in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation 

while fulfilling the primary purpose of this Act to assure that 

such innovation and commerce in such chemical substances 

and mixtures do not present an unreasonable risk of injury to 

health or the environment. 

(c) INTENT OF CONGRESS.—øIt is the intent¿ 

(1) ADMINISTRATION.—It is the intent of Congress that the 

Administrator shall carry out this Act in a reasonable and prudent manner, and that the Administrator shall consider the enVerDate Sep 11 2014 05:10 Jun 23, 2015 Jkt 049010 PO 00000 Frm 00039 Fmt 6601 Sfmt 6601 E:\HR\OC\SR067.XXX SR067

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2 In Public Law 94–469, which enacted this section, the word ‘‘the’’ was lower case. ‘‘The’’ has 

been shown capitalized to reflect the probable intent of Congress. 

vironmental, economic, and social impact of any action the Administrator takes or proposes to take under this Act , as provided under this Act. (2) REFORM.—øIt is the intent of Congress that reform of this 

Act¿ This Act, including reforms in accordance with the 

amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act— 

(A) shall be administered in a manner that— 

(i) protects the health of children, pregnant women, 

the elderly, workers, consumers, the general public, 

and the environment from the risks of harmful exposures to chemical substances and mixtures; and 

(ii) ensures that appropriate information on chemical 

substances and mixtures is available to public health 

officials and first responders in the event of an emergency; and 

(B) shall not displace or supplant common law rights of 

action or remedies for civil relief. 

SEC. 3. DEFINITIONS. 

As used in this Act: 

(1) The 2 term ‘‘Administrator’’ means the Administrator of the 

Environmental Protection Agency. 

(2)(A) Except as provided in subparagraph (B), the term ‘‘chemical substance’’ means any organic or inorganic substance of a particular molecular identity, including— 

(i) any combination of such substances occurring in whole or 

in part as a result of a chemical reaction or occurring in nature, and 

(ii) any element or uncombined radical. 

(B) Such term does not include— 

(i) any mixture, 

(ii) any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or 

distributed in commerce for use as a pesticide, 

(iii) tobacco or any tobacco product, 

(iv) any source material, special nuclear material, or byproduct material (as such terms are defined in the Atomic Energy 

Act of 1954 and regulations issued under such Act), 

(v) any article the sale of which is subject to the tax imposed 

by section 4181 of the Internal Revenue Code of 1954 (determined without regard to any exemptions from such tax provided by section 4182 or 4221 or any other provision of such 

Code), and 

(vi) any food, food additive, drug, cosmetic, or device (as such 

terms are defined in section 201 of the Federal Food, Drug, 

and Cosmetic Act) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. 

The term ‘‘food’’ as used in clause (vi) of this subparagraph includes 

poultry and poultry products (as defined in sections 4(e) and 4(f) 

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ucts (as defined in section 1(j) of the Federal Meat Inspection Act), 

and eggs and egg products (as defined in section 4 of the Egg Products Inspection Act). 

(3) The term ‘‘commerce’’ means trade, traffic, transportation, or 

other commerce (A) between a place in a State and any place outside of such State, or (B) which affects trade, traffic, transportation, or commerce described in clause (A). 

(4) CONDITIONS OF USE.—The term ‘conditions of use’ means 

the intended, known, or reasonably foreseeable circumstances 

the Administrator determines a chemical substance is manufactured, processed, distributed in commerce, used, or disposed of. 

ø(4)¿ (5) The terms ‘‘distribute in commerce’’ and ‘‘distribution in 

commerce’’ when used to describe an action taken with respect to 

a chemical substance or mixture or article containing a substance 

or mixture mean to sell, or the sale of, the substance, mixture, or 

article in commerce; to introduce or deliver for introduction into 

commerce, or the introduction or delivery for introduction into commerce of, the substance, mixture, or article; or to hold, or the holding of, the substance, mixture, or article after its introduction into 

commerce. 

ø(5)¿ (6) The term ‘‘environment’’ includes water, air, and land 

and the interrelationship which exists among and between water, 

air, and land and all living things. 

ø(6)¿ (7) The term ‘‘health and safety study’’ means any study of 

any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological 

studies, studies of occupational exposure to a chemical substance or 

mixture, toxicological, clinical, and ecological studies of a chemical 

substance or mixture, and any test performed pursuant to this Act. 

ø(7)¿ (8) The term ‘‘manufacture’’ means to import into the customs territory of the United States (as defined in general note 2 

of the Harmonized Tariff Schedules of the United States), produce, 

or manufacture. 

ø(8)¿ (9) The term ‘‘mixture’’ means any combination of two or 

more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except that such term does include any combination which occurs, in whole or in part, as a result of a chemical reaction if none 

of the chemical substances comprising the combination is a new 

chemical substance and if the combination could have been manufactured for commercial purposes without a chemical reaction at 

the time the chemical substances comprising the combination were 

combined. 

ø(9)¿ (10) The term ‘‘new chemical substance’’ means any chemical substance which is not included in the chemical substance list 

compiled and published under section 8(b). 

(11) POTENTIALLY EXPOSED OR SUSCEPTIBLE POPULATION.— 

The term ‘potentially exposed or susceptible population’ means 

1 or more groups— 

(A) of individuals within the general population who may 

be— 

(i) differentially exposed to chemical substances 

under the conditions of use; or 


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(ii) susceptible to greater adverse health consequences 

from chemical exposures than the general population; 

and 

(B) that when identified by the Administrator may include such groups as infants, children, pregnant women, 

workers, and the elderly. 

ø(10)¿ (12) The term ‘‘process’’ means the preparation of a chemical substance or mixture, after its manufacture, for distribution in 

commerce— 

(A) in the same form or physical state as, or in a different 

form or physical state from, that in which it was received by 

the person so preparing such substance or mixture, or 

(B) as part of an article containing the chemical substance 

or mixture. 

ø(11)¿ (13) The term ‘‘processor’’ means any person who processes a chemical substance or mixture. 

(14) SAFETY ASSESSMENT.—The term ‘safety assessment’ 

means an assessment of the risk posed by a chemical substance 

under the conditions of use, integrating hazard, use, and exposure information regarding the chemical substance. 

(15) SAFETY DETERMINATION.—The term ‘safety determination’ means a determination by the Administrator as to whether 

a chemical substance meets the safety standard under the conditions of use. 

(16) SAFETY STANDARD.—The term ‘safety standard’ means a 

standard that ensures, without taking into consideration cost or 

other nonrisk factors, that no unreasonable risk of injury to 

health or the environment will result from exposure to a chemical substance under the conditions of use, including no unreasonable risk of injury to— 

(A) the general population; or 

(B) any potentially exposed or susceptible population that 

the Administrator has identified as relevant to the safety 

assessment and safety determination for a chemical substance. 

ø(12)¿ (17) The term ‘‘standards for the development of test data’’ 

means a prescription of— 

(A) the— 

(i) health and environmental effects, and 

(ii) information relating to toxicity, persistence, and 

other characteristics which affect health and the environment, 

for which test data for a chemical substance or mixture are to 

be developed and any analysis that is to be performed on such 

data, and 

(B) to the extent necessary to assure that data respecting 

such effects and characteristics are reliable and adequate— 

(i) the manner in which such data are to be developed, 

(ii) the specification of any test protocol or methodology 

to be employed in the development of such data, and 

(iii) such other requirements as are necessary to provide 

such assurance. 

ø(13)¿ (18) The term ‘‘State’’ means any State of the United 

States, the District of Columbia, the Commonwealth of Puerto Rico, 


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the Virgin Islands, Guam, the Canal Zone, American Samoa, the 

Northern Mariana Islands, or any other territory or possession of 

the United States. 

ø(14)¿ (19) The term ‘‘United States’’, when used in the geographic sense, means all of the States. 

SEC. 3A. POLICIES, PROCEDURES, AND GUIDANCE. 

(a) DEFINITION OF GUIDANCE.—In this section, the term ‘guidance’ 

includes any significant written guidance of general applicability 

prepared by the Administrator. 

(b) DEADLINE.—Not later than 2 years after the date of enactment 

of the Frank R. Lautenberg Chemical Safety for the 21st Century 

Act, the Administrator shall develop, after providing public notice 

and an opportunity for comment, any policies, procedures, and 

guidance the Administrator determines to be necessary to carry out 

sections 4, 4A, 5, and 6, including the policies, procedures, and 

guidance required by this section. 

(c) USE OF SCIENCE.— 

(1) IN GENERAL.—The Administrator shall establish policies, 

procedures, and guidance on the use of science in making decisions under sections 4, 4A, 5, and 6. 

(2) GOAL.—A goal of the policies øand,¿ procedures , and 

guidance described in paragraph (1) shall be to make the basis 

of decisions clear to the public. 

(3) REQUIREMENTS.—The policies, procedures, and guidance 

issued under this section shall describe the manner in which 

the Administrator shall ensure that — 

(A) decisions made by the Administrator— 

(i) are based on information, procedures, measures, 

methods, and models employed in a manner consistent 

with the best available science; 

(ii) take into account the extent to which— 

(I) assumptions and methods are clearly and 

completely described and documented; 

(II) variability and uncertainty are evaluated 

and characterized; and 

(III) the information has been subject to independent verification and peer review; and 

(iii) are based on the weight of the scientific evidence, 

by which the Administrator considers all information 

in a systematic and integrative framework to consider 

the relevance of different information; 

(B) to the extent practicable and if appropriate, the use 

of peer review, standardized test design and methods, consistent data evaluation procedures, and good laboratory 

practices will be encouraged; 

(C) a clear description of each individual and entity that 

funded the generation or assessment of information, and 

the degree of control those individuals and entities had over 

the generation, assessment, and dissemination of information (including control over the design of the work and the 

publication of information) is made available; and 

(D) if appropriate, the recommendations in reports of the 

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ing assessing the hazards, exposures, and risks of chemical 

substances are considered. 

(d) EXISTING EPA POLICIES, PROCEDURES, AND GUIDANCE.—The 

policies, procedures, and guidance described in subsection (b) shall 

incorporate, as appropriate, existing relevant hazard, exposure, and 

risk assessment guidelines and methodologies, data evaluation and 

quality criteria, testing methodologies, and other relevant guidelines 

and policies of the Environmental Protection Agency. 

(e) REVIEW.—Not later than 5 years after the date of enactment 

of øthis section¿ the Frank R. Lautenberg Chemical Safety for the 

21st Century Act, and not less frequently than once every 5 years 

thereafter, the Administrator shall— 

(1) review the adequacy of any policies, procedures, and guidance developed under this section, including animal, nonanimal, and epidemiological test methods and procedures for 

assessing and determining risk under this Act; and 

(2) after providing public notice and an opportunity for comment, revise the policies, procedures, and guidance if necessary 

to reflect new scientific developments or understandings. 

‘‘(f) SOURCES OF INFORMATION.—In ømaking any decision with respect to a chemical substance under section 4, 4A, 5, or¿ carrying 

out sections 4, 4A, 5, and 6, the Administrator shall take into consideration information relating to øthe hazards and exposures of¿ 

a chemical substance ,including hazard and exposure information, 

under the conditions of use that is reasonably available to the Administrator, including information that is— 

(1) submitted to the Administrator pursuant to any rule, consent agreement, order, or other requirement of this Act, or on a 

voluntary basis, including pursuant to any request made under 

this Act, by— 

(A) manufacturers or processors of a substance; 

(B) the public; 

(C) other Federal departments or agencies; or 

(D) the Governor of a State or a State agency with responsibility for protecting health or the environment; 

(2) submitted to a governmental entity in any jurisdiction 

pursuant to a governmental requirement relating to the protection of health or the environment; or 

(3) identified through an active search by the Administrator 

of information sources that are publicly available or otherwise 

accessible by the Administrator. 

(g) TESTING OF CHEMICAL SUBSTANCES AND MIXTURES.— 

(1) IN GENERAL.—The Administrator shall establish policies 

and procedures for the testing of chemical substances or mixtures under section 4. 

(2) GOAL.—A goal of the policies and procedures established 

under paragraph (1) shall be to make the basis of decisions 

clear to the public. 

(3) CONTENTS.—The policies and procedures established 

under paragraph (1) shall— 

‘‘(A) address how and when the exposure level or exposure potential of a chemical substance would factor into 

decisions to require new testing, subject to the condition 

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sure information as a lack of exposure or exposure potential; 

(B) describe the manner in which the Administrator will 

determine that additional information is necessary to carry 

out this Act, including information relating to potentially 

exposed or susceptible populations; 

(C) require the Administrator to consult with the Director 

of the National Institute for Occupational Safety and 

Health prior to prescribing epidemiologic studies of employees; and 

(D)require that prior to making a request or adopting a 

requirement for testing using vertebrate animals, 

ørequire¿ the Administrator øto¿ shall take into consideration, as appropriate and to the extent practicable, reasonably available— 

(i) toxicity information; 

(ii) computational toxicology and bioinformatics; 

(iii) high-throughput screening methods and the prediction models of those methods; and 

(iv) scientifically reliable and relevant alternatives to 

tests on animals that would provide equivalent information. 

(h) SAFETY ASSESSMENTS AND SAFETY DETERMINATIONS.— 

(1) SCHEDULE.— 

(A) IN GENERAL.—The Administrator shall inform the 

public regarding the schedule for the completion of each 

safety assessment and safety determination as soon as practicable after designation as a high-priority substance pursuant to section 4A. 

(B) DIFFERING TIMES.—The Administrator may allot different times for different chemical substances in the schedules under this paragraph, subject to the condition that all 

schedules shall comply with the deadlines established 

under section 6. 

(C) ANNUAL PLAN.—At the beginning of each calendar 

year, the Administrator shall identify the substances subject to safety assessments and safety determinations to be 

completed that year. 

(2) POLICIES AND PROCEDURES FOR SAFETY ASSESSMENTS AND

SAFETY DETERMINATIONS.— 

(A) IN GENERAL.—The Administrator shall establish, by 

rule, policies and procedures regarding the manner in 

which the Administrator shall carry out section 6. 

(B) GOAL.—A goal of the policies and procedures under 

this paragraph shall be to make the basis of decisions of 

the Administrator clear to the public. 

(C) MINIMUM REQUIREMENTS.—At a minimum, the policies and procedures under this paragraph shall— 

(i) describe— 

(I) the manner in which the Administrator will 

identify informational needs and seek that information from the public; 


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(II) the information (including draft safety assessments) that may be submitted by interested individuals or entities, including States; and 

(III) the criteria by which that information will 

be evaluated; 

(ii) require the Administrator— 

(I)(aa) to define the scope of the safety assessment and safety determination to be conducted 

under section 6, including the hazards, exposures, 

conditions of use, and potentially exposed and susceptible populations that the Administrator expects 

to consider in a safety assessment; 

(bb) to explain the basis for the scope of the safety assessment and safety determination; and 

(cc) to accept comments regarding the scope of 

the safety assessment and safety determination; 

and 

(II)(aa) to identify the items described in subclause (I) that the Administrator has considered in 

the final safety assessment; and 

(bb) to explain the basis for the consideration of 

those items; 

(iii) describe the manner in which aggregate exposures, or significant subsets of exposures, to a chemical 

substance under the conditions of use will be considered, and explain the basis for that consideration in 

the final safety assessment; 

(iv) require that each safety assessment and safety 

determination shall include— 

(I) a description of the weight of the scientific 

evidence of risk; and 

(II) a summary of the information regarding the 

impact on health and the environment of the chemical substance that was used to make the assessment or determination, including, as available, 

mechanistic, animal toxicity, and epidemiology 

studies; 

(v) establish a timely and transparent process for 

evaluating whether new information submitted or obtained after the date of a final safety assessment or 

safety determination warrants reconsideration of the 

safety assessment or safety determination; and 

(vi) when relevant information is provided or otherwise made available to the Administrator, shall consider the extent of Federal regulation under other Federal laws. 

(D) GUIDANCE.— 

(i) IN GENERAL.—Not later than 1 year after the date 

of enactment of the Frank R. Lautenberg Chemical 

Safety for the 21st Century Act, the Administrator 

shall develop guidance to assist interested persons in 

developing their own draft safety assessments and 

other information for submission to the Administrator, 


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which may be considered at the discretion of the Administrator. 

(ii) REQUIREMENT.—The guidance shall, at a minimum, address the quality of the information submitted and the process to be followed in developing a 

draft safety assessment for consideration by the Administrator. 

(i) PUBLICLY AVAILABLE INFORMATION.—Subject to section 14, the 

Administrator shall— 

(1) make publicly available a nontechnical summary, and the 

final version, of each safety assessment and safety determination; 

(2) provide public notice and an opportunity for comment on 

each proposed safety assessment and safety determination; and 

(3) make public in a final safety assessment and safety determination— 

(A) the list of studies considered by the Administrator in 

carrying out the safety assessment or safety determination; 

and 

(B) the list of policies, procedures, and guidance that 

were followed in carrying out the safety assessment or safety determination. 

(j) CONSULTATION WITH SCIENCE ADVISORY COMMITTEE ON

CHEMICALS.— 

(1) ESTABLISHMENT.—Not later than 1 year after the date of 

enactment of this section, the Administrator shall establish an 

advisory committee, to be known as the ‘Science Advisory Committee on Chemicals’ (referred to in this subsection as the ‘Committee’). 

(2) PURPOSE.—The purpose of the Committee shall be to provide independent advice and expert consultation, on the request 

of the Administrator, with respect to the scientific and technical 

aspects of issues relating to the implementation of this title. 

(3) COMPOSITION.—The Committee shall be composed of representatives of such science, government, labor, public health, 

public interest, animal protection, industry, and other groups as 

the Administrator determines to be advisable, including, at a 

minimum, representatives that have specific scientific expertise 

in the relationship of chemical exposures to women, children, 

and other potentially exposed or susceptible populations. 

(4) SCHEDULE.—The Administrator shall convene the Committee in accordance with such schedule as the Administrator 

determines to be appropriate, but not less frequently than once 

every 2 years. 

(5) RELATIONSHIP TO OTHER LAW.—All proceedings and meetings of the Committee shall be subject to the Federal Advisory 

Committee Act (5 U.S.C. App.). 

SEC. 4. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES. 

ø(a) TESTING REQUIREMENTS.—If the Administrator finds that— 

ø(1)(A)(i) the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or 

that any combination of such activities, may present an unreasonable risk of injury to health or the environment, 


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ø(ii) there are insufficient data and experience upon which 

the effects of such manufacture, distribution in commerce, 

processing, use, or disposal of such substance or mixture or of 

any combination of such activities on health or the environment can reasonably be determined or predicted, and 

ø(iii) testing of such substance or mixture with respect to 

such effects is necessary to develop such data; or 

ø(B)(i) a chemical substance or mixture is or will be produced 

in substantial quantities, and (I) it enters or may reasonably 

be anticipated to enter the environment in substantial quantities or (II) there is or may be significant or substantial 

human exposure to such substance or mixture, 

ø(ii) there are insufficient data and experience upon which 

the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any 

combination of such activities on health or the environment 

can reasonably be determined or predicted, and 

ø(iii) testing of such substance or mixture with respect to 

such effects is necessary to develop such data; and 

ø(2) in the case of a mixture, the effects which the mixture’s 

manufacture, distribution in commerce, processing, use, or disposal or any combination of such activities may have on health 

or the environment may not be reasonably and more efficiently 

determined or predicted by testing the chemical substances 

which comprise the mixture; 

the Administrator shall by rule require that testing be conducted 

on such substance or mixture to develop data with respect to the 

health and environmental effects for which there is an insufficiency 

of data and experience and which are relevant to a determination 

that the manufacture, distribution in commerce, processing, use, or 

disposal of such substance or mixture, or that any combination of 

such activities, does or does not present an unreasonable risk of injury to health or the environment. 

ø(b)(1) TESTING REQUIREMENT RULE.—A rule under subsection 

(a) shall include— 

ø(A) identification of the chemical substance or mixture for 

which testing is required under the rule, 

ø(B) standards for the development of test data for such substance or mixture, and 

ø(C) with respect to chemical substances which are not new 

chemical substances and to mixtures, a specification of the period (which period may not be of unreasonable duration) within 

which the persons required to conduct the testing shall submit 

to the Administrator data developed in accordance with the 

standards referred to in subparagraph (B). 

øIn determining the standards and period to be included, pursuant 

to subparagraphs (B) and (C), in a rule under subsection (a), the 

Administrator’s considerations shall include the relative costs of 

the various test protocols and methodologies which may be required under the rule and the reasonably foreseeable availability of 

the facilities and personnel needed to perform the testing required 

under the rule. Any such rule may require the submission to the 

Administrator of preliminary data during the period prescribed 

under subparagraph (C). 


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ø(2)(A) The health and environmental effects for which standards 

for the development of test data may be prescribed include carcinogenesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synergistic effects, and any other effect which may present 

an unreasonable risk of injury to health or the environment. The 

characteristics of chemical substances and mixtures for which such 

standards may be prescribed include persistence, acute toxicity, 

subacute toxicity, chronic toxicity, and any other characteristic 

which may present such a risk. The methodologies that may be 

prescribed in such standards include epidemiologic studies, serial 

or hierarchical tests, in vitro tests, and whole animal tests, except 

that before prescribing epidemiologic studies of employees, the Administrator shall consult with the Director of the National Institute 

for Occupational Safety and Health. 

ø(B) From time to time, but not less than once each 12 months, 

the Administrator shall review the adequacy of the standards for 

development of data prescribed in rules under subsection (a) and 

shall, if necessary, institute proceedings to make appropriate revisions of such standards. 

ø(3)(A) A rule under subsection (a) respecting a chemical substance or mixture shall require the persons described in subparagraph (B) to conduct tests and submit data to the Administrator on 

such substance or mixture, except that the Administrator may permit two or more of such persons to designate one such person or 

a qualified third party to conduct such tests and submit such data 

on behalf of the persons making the designation. 

ø(B) The following persons shall be required to conduct tests and 

submit data on a chemical substance or mixture subject to a rule 

under subsection (a): 

ø(i) Each person who manufactures or intends to manufacture such substance or mixture if the Administrator makes a 

finding described in subsection (a)(1)(A)(ii) or (a)(1)(B)(ii) with 

respect to the manufacture of such substance or mixture. 

ø(ii) Each person who processes or intends to process such 

substance or mixture if the Administrator makes a finding described in subsection (a)(1)(A)(ii) or (a)(1)(B)(ii) with respect to 

the processing of such substance or mixture. 

ø(iii) Each person who manufactures or processes or intends 

to manufacture or process such substance or mixture if the Administrator makes a finding described in subsection (a)(1)(A)(ii) 

or (a)(1)(B)(ii) with respect to the distribution in commerce, 

use, or disposal of such substance or mixture. 

ø(4) Any rule under subsection (a) requiring the testing of and 

submission of data for a particular chemical substance or mixture 

shall expire at the end of the reimbursement period (as defined in 

subsection (c)(3)(B)) which is applicable to test data for such substance or mixture unless the Administrator repeals the rule before 

such date; and a rule under subsection (a) requiring the testing of 

and submission of data for a category of chemical substances or 

mixtures shall expire with respect to a chemical substance or mixture included in the category at the end of the reimbursement period (as so defined) which is applicable to test data for such substance or mixture unless the Administrator before such date reVerDate Sep 11 2014 05:10 Jun 23, 2015 Jkt 049010 PO 00000 Frm 00049 Fmt 6601 Sfmt 6601 E:\HR\OC\SR067.XXX SR067

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peals the application of the rule to such substance or mixture or 

repeals the rule. 

ø(5) Rules issued under subsection (a) (and any substantive 

amendment thereto or repeal thereof) shall be promulgated pursuant to section 553 of title 5, United States Code, except that (A) 

the Administrator shall give interested persons an opportunity for 

the oral presentation of data, views, or arguments, in addition to 

an opportunity to make written submission; (B) a transcript shall 

be made of any oral presentation; and (C) the Administrator shall 

make and publish with the rule the findings described in paragraph (1)(A) or (1)(B) of subsection (a) and, in the case of a rule 

respecting a mixture, the finding described in paragraph (2) of such 

subsection. 

ø(c) EXEMPTION.—(1) Any person required by a rule under subsection (a) to conduct tests and submit data on a chemical substance or mixture may apply to the Administrator (in such form 

and manner as the Administrator shall prescribe) for an exemption 

from such requirement. 

ø(2) If, upon receipt of an application under paragraph (1), the 

Administrator determines that— 

ø(A) the chemical substance or mixture with respect to which 

such application was submitted is equivalent to a chemical 

substance or mixture for which data has been submitted to the 

Administrator in accordance with a rule under subsection (a) 

or for which data is being developed pursuant to such a rule, 

and 

ø(B) submission of data by the applicant on such substance 

or mixture would be duplicative of data which has been submitted to the Administrator in accordance with such rule or 

which is being developed pursuant to such rule, 

the Administrator shall exempt, in accordance with paragraph (3) 

or (4), the applicant from conducting tests and submitting data on 

such substance or mixture under the rule with respect to which 

such application was submitted. 

ø(3)(A) If the exemption under paragraph (2) of any person from 

the requirement to conduct tests and submit test data on a chemical substance or mixture is granted on the basis of the existence 

of previously submitted test data and if such exemption is granted 

during the reimbursement period for such test data (as prescribed 

by subparagraph (B)), then (unless such person and the persons referred to in clauses (i) and (ii) agree on the amount and method 

of reimbursement) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in 

an amount determined under rules of the Administrator)— 

ø(i) to the person who previously submitted such test data, 

for a portion of the costs incurred by such person in complying 

with the requirement to submit such data, and 

ø(ii) to any other person who has been required under this 

subparagraph to contribute with respect to such costs, for a 

portion of the amount such person was required to contribute. 

øIn promulgating rules for the determination of fair and equitable 

reimbursement to the persons described in clauses (i) and (ii) for 

costs incurred with respect to a chemical substance or mixture, the 

Administrator shall, after consultation with the Attorney General 


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and the Federal Trade Commission, consider all relevant factors, 

including the effect on the competitive position of the person required to provide reimbursement in relation to the person to be reimbursed and the share of the market for such substance or mixture of the person required to provide reimbursement in relation to 

the share of such market of the persons to be reimbursed. An order 

under this subparagraph shall, for purposes of judicial review, be 

considered final agency action. 

ø(B) For purposes of subparagraph (A), the reimbursement period for any test data for a chemical substance or mixture is a period— 

ø(i) beginning on the date such data is submitted in accordance with a rule promulgated under subsection (a), and 

ø(ii) ending— 

ø(I) five years after the date referred to in clause (i), or 

ø(II) at the expiration of a period which begins on the 

date referred to in clause (i) and which is equal to the period which the Administrator determines was necessary to 

develop such data, 

whichever is later. 

ø(4)(A) If the exemption under paragraph (2) of any person from 

the requirement to conduct tests and submit test data on a chemical substance or mixture is granted on the basis of the fact that 

test data is being developed by one or more persons pursuant to a 

rule promulgated under subsection (a), then (unless such person 

and the persons referred to in clauses (i) and (ii) agree on the 

amount and method of reimbursement) the Administrator shall 

order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the 

Administrator)— 

ø(i) to each such person who is developing such test data, for 

a portion of the costs incurred by each such person in complying with such rule, and 

ø(ii) to any other person who has been required under this 

subparagraph to contribute with respect to the costs of complying with such rule, for a portion of the amount such person 

was required to contribute. 

øIn promulgating rules for the determination of fair and equitable 

reimbursement to the persons described in clauses (i) and (ii) for 

costs incurred with respect to a chemical substance or mixture, the 

Administrator shall, after consultation with the Attorney General 

and the Federal Trade Commission, consider the factors described 

in the second sentence of paragraph (3)(A). An order under this 

subparagraph shall, for purposes of judicial review, be considered 

final agency action. 

ø(B) If any exemption is granted under paragraph (2) on the 

basis of the fact that one or more persons are developing test data 

pursuant to a rule promulgated under subsection (a) and if after 

such exemption is granted the Administrator determines that no 

such person has complied with such rule, the Administrator shall 

(i) after providing written notice to the person who holds such exemption and an opportunity for a hearing, by order terminate such 

exemption, and (ii) notify in writing such person of the requireVerDate Sep 11 2014 05:10 Jun 23, 2015 Jkt 049010 PO 00000 Frm 00051 Fmt 6601 Sfmt 6601 E:\HR\OC\SR067.XXX SR067

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ments of the rule with respect to which such exemption was granted. 

ø(d) NOTICE.—Upon the receipt of any test data pursuant to a 

rule under subsection (a), the Administrator shall publish a notice 

of the receipt of such data in the Federal Register within 15 days 

of its receipt. Subject to section 14, each such notice shall (1) identify the chemical substance or mixture for which data have been received; (2) list the uses or intended uses of such substance or mixture and the information required by the applicable standards for 

the development of test data; and (3) describe the nature of the test 

data developed. Except as otherwise provided in section 14, such 

data shall be made available by the Administrator for examination 

by any person.¿ 

(a) DEVELOPMENT OF NEW INFORMATION ON CHEMICAL SUBSTANCES AND MIXTURES.— 

(1) IN GENERAL.—The Administrator may require the development of new information relating to a chemical substance or 

mixture in accordance with this section if the Administrator determines that the information is necessary— 

(A) to review a notice under section 5(d) or to perform a 

safety assessment or safety determination under section 6; 

(B) to implement a requirement imposed in a consent 

agreement or order issued under section 5(d)(4) or under a 

rule promulgated under section 6(d)(3); 

(C) pursuant to section 12(a)(4); or 

(D) at the request of the implementing authority under 

another Federal law, to meet the regulatory testing needs of 

that authority. 

(2) LIMITED TESTING FOR PRIORITIZATION PURPOSES.— 

(A) IN GENERAL.—Except as provided in subparagraph 

(B), the Administrator may require the development of new 

information for the purposes of section 4A. 

(B) PROHIBITION.—Testing required under subparagraph 

(A) shall not be required for the purpose of establishing or 

implementing a minimum information requirement. 

(C) LIMITATION.—The Administrator may require the development of new information pursuant to subparagraph 

(A) only if the Administrator determines that additional information is necessary to establish the priority of a chemical substance. 

(3) FORM.—øSubject to section 3A(h),¿ øt¿ The Administrator 

may require the development of information described in paragraph (1) or (2) by— 

(A) promulgating a rule; 

(B) entering into a testing consent agreement; or 

(C) issuing an order. 

(4) CONTENTS.— 

(A) IN GENERAL.—A rule, testing consent agreement, or 

order issued under this subsection shall include— 

(i) identification of the chemical substance or mixture 

for which testing is required; 

(ii) identification of the persons required to conduct 

the testing; 


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(iii) test protocols and methodologies for the development of øtest data and¿ information for the chemical 

substance or mixture, including specific reference to 

any reliable nonanimal test procedures; and 

(iv) specification of the period within which individuals and entities required to conduct the testing shall 

submit to the Administrator the information developed 

in accordance with the procedures described in clause 

(iii). 

(B) CONSIDERATIONS.—In determining the procedures 

and period to be required under subparagraph (A), the Administrator shall take into consideration— 

(i) the relative costs of the various test protocols and 

methodologies that may be required; and 

(ii) the reasonably foreseeable availability of facilities 

and personnel required to perform the testing. 

(b) STATEMENT OF NEED.— 

(1) IN GENERAL.—In promulgating a rule, entering into a testing consent agreement, or issuing an order for the development 

of additional information (including information on exposure or 

exposure potential) pursuant to this section, the Administrator 

shall— 

(A) identify the need intended to be met by the rule, 

agreement, or order; 

(B) explain why information reasonably available to the 

Administrator at that time is inadequate to meet that need, 

including a reference, as appropriate, to the information 

identified in paragraph (2)(B); and 

(C) explain the basis for any decision that requires the 

use of vertebrate animals. 

(2) EXPLANATION IN CASE OF ORDER.— (A) IN GENERAL.—If the Administrator issues an order 

under this section, the Administrator shall issue a statement providing a justification for why issuance of an order 

is warranted instead of promulgating a rule or entering 

into a testing consent agreement. 

(B) CONTENTS.—A statement described in subparagraph 

(A) shall contain a description of— 

(i) information that is readily accessible to the Administrator, including information submitted under 

any other provision of law; 

(ii) the extent to which the Administrator has obtained or attempted to obtain the information through 

voluntary submissions; and 

(iii) any information relied on in safety assessments 

for other chemical substances relevant to the chemical 

substances that would be the subject of the order. 

(c) REDUCTION OF TESTING ON VERTEBRATES.— 

(1) IN GENERAL.—The Administrator shall minimize, to the 

extent practicable, the use of vertebrate animals in testing of 

chemical substances or mixtures, by— 

(A) encouraging and facilitating— 

(i) the use of integrated and tiered testing and assessment strategies; 


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(ii) the use of best available science in existence on 

the date on which the test is conducted; 

(iii) the use of test methods that eliminate or reduce 

the use of animals while providing information of high 

scientific quality; 

(iv) the grouping of 2 or more chemical substances 

into scientifically appropriate categories in cases in 

which testing of a chemical substance would provide 

reliable and useful information on other chemical substances in the category; 

(v) the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests; 

and 

(vi) the submission of information from— 

(I) animal-based studies; and 

(II) emerging methods and models; and 

(B) funding research and validation studies to reduce, refine, and replace the use of animal tests in accordance with 

this subsection. 

(2) IMPLEMENTATION OF ALTERNATIVE TESTING METHODS.—To 

promote the development and timely incorporation of new testing methods that are not based on vertebrate animals, the Administrator shall— 

(A) not later than 2 years after the date of enactment of 

the Frank R. Lautenberg Chemical Safety for the 21st Century Act, develop a strategic plan to promote the development and implementation of alternative test methods and 

testing strategies to generate information under this title 

that can reduce, refine, or replace the use of vertebrate animals, including toxicity pathway-based risk assessment, in 

vitro studies, systems biology, computational toxicology, 

bioinformatics, and high-throughput screening; 

(B) as practicable, ensure that the strategic plan developed under subparagraph (A) is reflected in the development of requirements for testing under this section; 

(C) identify in the strategic plan developed under subparagraph (A) particular alternative test methods or testing 

strategies that do not require new vertebrate animal testing 

and are scientifically reliable, relevant, and capable of providing information of equivalent scientific reliability and 

quality to that which would be obtained from vertebrate 

animal testing; 

(D) provide an opportunity for public notice and comment 

on the contents of the plan developed under subparagraph 

(A), including the criteria for considering scientific reliability, relevance, and equivalent information and the test 

methods and strategies identified in subparagraph (C); 

(E) beginning on the date that is 5 years after the date 

of enactment of the Frank R. Lautenberg Chemical Safety 

for the 21st Century Act and every 5 years thereafter, submit to Congress a report that describes the progress made 

in implementing this subsection and goals for future alternative test methods implementation; 


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(F) fund and carry out research, development, performance assessment, and translational studies to accelerate the 

development of test methods and testing strategies that reduce, refine, or replace the use of vertebrate animals in any 

testing under this title; and 

(G) identify synergies with the related information requirements of other jurisdictions to minimize the potential 

for additional or duplicative testing. 

(3) CRITERIA FOR ADAPTING OR WAIVING ANIMAL TESTING REQUIREMENTS.—On request from a manufacturer or processor 

that is required to conduct testing of a chemical substance or 

mixture on vertebrate animals under this section, the Administrator may adapt or waive the requirement, if the Administrator determines that— 

(A) there is sufficient evidence from several independent 

sources of information to support a conclusion that a chemical substance or mixture has, or does not have, a particular property if the information from each individual 

source alone is insufficient to support the conclusion; 

(B) as a result of 1 or more physical or chemical properties of the chemical substance or mixture or other 

toxicokinetic considerations— 

(i) the substance cannot be absorbed; or 

(ii) testing for a specific endpoint is technically not 

practicable to conduct; or 

(C) a chemical substance or mixture cannot be tested in 

vertebrate animals at concentrations that do not result in 

significant pain or distress, because of physical or chemical 

properties of the chemical substance or mixture, such as a 

potential to cause severe corrosion or severe irritation to the 

tissues of the animal. 

(4) VOLUNTARY TESTING.— 

(A) IN GENERAL.—Any person developing information for 

submission under this title on a voluntary basis and not 

pursuant to any request or requirement by the Administrator shall first attempt to develop the information by 

means of an alternative or nonanimal test method or testing strategy that the Administrator has determined under 

paragraph (2)(C) to be scientifically reliable, relevant, and 

capable of providing equivalent information, before conducting new animal testing. 

(B) EFFECT OF PARAGRAPH.—Nothing in this paragraph— 

(i) requires the Administrator to review the basis on 

which the person is conducting testing described in 

subparagraph (A); 

(ii) prohibits the use of other test methods or testing 

strategies by any person for purposes other than developing information for submission under this title on a 

voluntary basis; or 

(iii) prohibits the use of other test methods or testing 

strategies by any person, subsequent to the attempt to 

develop information using the test methods and testing 


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strategies identified by the Administrator under paragraph (2)(C). 

(d) TESTING REQUIREMENTS.— 

(1) IN GENERAL.—The Administrator may require the development of information by— 

(A) manufacturers and processors of the chemical substance or mixture; and 

(B) subject to paragraph (3), persons that begin to manufacture or process the chemical substance or mixture— 

(i) after the effective date of the rule, testing consent 

agreement, or order; but 

(ii) before the period ending on the later of— 

(I) 5 years after the date referred to in clause (i); 

or 

(II) the last day of the period that begins on the 

date referred to in clause (i) and that is equal to 

the period that the Administrator determines was 

necessary to develop the information. 

(2) DESIGNATION.—The Administrator may permit 2 or more 

persons identified in subparagraph (A) or (B) of paragraph (1) 

to designate 1 of the persons or a qualified third party— 

(A) to develop the information; and 

(B) to submit the information on behalf of the persons 

making the designation. 

(3) EXEMPTIONS.— 

(A) IN GENERAL.—A person otherwise subject to a rule, 

testing consent agreement, or order under this section may 

submit to the Administrator an application for an exemption on the basis that the information is being developed by 

a person designated under paragraph (2). 

(B) FAIR AND EQUITABLE REIMBURSEMENT TO DESIGNEE.— 

(i) IN GENERAL.—If the Administrator accepts an application submitted under subparagraph (A), the Administrator shall direct the applicant to provide to the 

person designated under paragraph (2) fair and equitable reimbursement, as agreed to between the applicant and the designee. 

(ii) ARBITRATION.—If the applicant and a person designated under paragraph (2) cannot reach agreement 

on the amount of fair and equitable reimbursement, the 

amount shall be determined by arbitration. 

(C) TERMINATION.—If, after granting an exemption under 

this paragraph, the Administrator determines that øa¿ no 

person øcovered by the exemption has failed to comply¿ 

designated under paragraph (2) has complied with the 

rule, testing consent agreement, or order, the Administrator shall— 

(i) by order, terminate the exemption; and 

(ii) notify in writing each person that received an exemption of the requirements with respect to which the 

exemption was granted. 

(4) TIERED TESTING.— 


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(A) IN GENERAL.—Except as provided in subparagraph 

(D), the Administrator shall employ a tiered screening and 

testing process, under which the results of screening-level 

tests or assessments of available information inform the decision as to whether 1 or more additional tests are necessary. 

(B) SCREENING-LEVEL TESTS.— 

(i) IN GENERAL.—The screening-level tests required 

for a chemical substance or mixture may include tests 

for hazard (which may include in silico, in vitro, and 

in vivo tests), environmental and biological fate and 

transport, and measurements or modeling of exposure 

or exposure potential, as appropriate. 

(ii) USE.—Screening-level tests shall be used— 

(I) to screen chemical substances or mixtures for 

potential adverse effects; and 

(II) to inform a decision of the Administrator regarding whether more complex or targeted additional testing is necessary. 

(C) ADDITIONAL TESTING.—If the Administrator determines under subparagraph (B) that additional testing is 

necessary to provide more definitive information for safety 

assessments or safety determinations, the Administrator 

may require more advanced tests for potential health or environmental effects or exposure potential. 

(D) ADVANCED TESTING WITHOUT SCREENING.—The Administrator may require more advanced testing without 

conducting screening-level testing when other information 

available to the Administrator justifies the advanced testing, pursuant to guidance developed by the Administrator 

under this section. 

(e) TRANSPARENCY.—Subject to section 14, the Administrator shall 

make available to the public all testing consent agreements and orders and all information submitted under this section. 

ø(e)¿ (f) PRIORITY LIST.—(1)(A) There is established a committee 

to make recommendations to the Administrator respecting the 

chemical substances and mixtures to which the Administrator 

should give priority consideration for the promulgation of a ørule¿ 

rule, testing consent agreement, or order øunder subsection (a)¿ 

under this subsection. In making such a recommendation with respect to any chemical substance or mixture, the committee shall 

consider all relevant factors, including— 

(i) the quantities in which the substance or mixture is or will 

be manufactured, 

(ii) the quantities in which the substance or mixture enters 

or will enter the environment, 

(iii) the number of individuals who are or will be exposed to 

the substance or mixture in their places of employment and 

the duration of such exposure, 

(iv) the extent to which human beings are or will be exposed 

to the substance or mixture, 

(v) the extent to which the substance or mixture is closely related to a chemical substance or mixture which is known to 


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3So in law. Probably should be ‘‘preceding’’. 

present an unreasonable risk of injury to health or the environment , without taking into account cost or other nonrisk factors, 

(vi) the existence of data concerning the effects of the substance or mixture on health or the environment, 

(vii) the extent to which testing of the substance or mixture 

may result in the development of data upon which the effects 

of the substance or mixture on health or the environment can 

reasonably be determined or predicted, and 

(viii) the reasonably foreseeable availability of facilities and 

personnel for performing testing on the substance or mixture. 

The recommendations of the committee shall be in the form of a 

list of chemical substances and mixtures which shall be set forth, 

either by individual substance or mixture or by groups of substances or mixtures, in the order in which the committee determines the Administrator should take action øunder subsection (a)¿ 

under this subsection with respect to the substances and mixtures. 

In establishing such list, the committee shall give priority attention 

to those chemical substances and mixtures which are known to 

cause or contribute to or which are suspected of causing or contributing to cancer, gene mutations, or birth defects. The committee 

shall designate chemical substances and mixtures on the list with 

respect to which the committee determines the Administrator 

should, within 12 months of the date on which such substances and 

mixtures are first designated, initiate a proceeding øunder subsection (a)¿ under this subsection. The total number of chemical 

substances and mixtures on the list which are designated under 

the preceding sentence may not, at any time, exceed 50. 

(B) As soon as practicable but not later than nine months after 

the effective date of this Act, the committee shall publish in the 

Federal Register and transmit to the Administrator the list and 

designations required by subparagraph (A) together with the reasons for the committee’s inclusion of each chemical substance or 

mixture on the list. At least every six months after the date of the 

transmission to the Administrator of the list pursuant to the 

preceeding 3 sentence, the committee shall make such revisions in 

the list as it determines to be necessary and shall transmit them 

to the Administrator together with the committee’s reasons for the 

revisions. Upon receipt of any such revision, the Administrator 

shall publish in the Federal Register the list with such revision, 

the reasons for such revision, and the designations made under 

subparagraph (A). The Administrator shall provide reasonable opportunity to any interested person to file with the Administrator 

written comments on the committee’s list, any revision of such list 

by the committee, and designations made by the committee, and 

shall make such comments available to the public. Within the 12- 

month period beginning on the date of the first inclusion on the list 

of a chemical substance or mixture designated by the committee 

under subparagraph (A) the Administrator shall with respect to 

such chemical substance or mixture either initiate a ørulemaking¿ 

proceeding øunder subsection (a)¿ under this subsection or if such 

a proceeding is not initiated within such period, publish in the FedVerDate Sep 11 2014 05:10 Jun 23, 2015 Jkt 049010 PO 00000 Frm 00058 Fmt 6601 Sfmt 6601 E:\HR\OC\SR067.XXX SR067

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eral Register the Administrator’s reason for not initiating such a 

proceeding. 

(2)(A) The committee established by paragraph (1)(A) shall consist of eight members as follows: 

(i) One member appointed by the Administrator from the Environmental Protection Agency. 

(ii) One member appointed by the Secretary of Labor from officers or employees of the Department of Labor engaged in the 

Secretary’s activities under the Occupational Safety and 

Health Act of 1970. 

(iii) One member appointed by the Chairman of the Council 

on Environmental Quality from the Council or its officers or 

employees. 

(iv) One member appointed by the Director of the National 

Institute for Occupational Safety and Health from officers or 

employees of the Institute. 

(v) One member appointed by the Director of the National 

Institute of Environmental Health Sciences from officers or 

employees of the Institute. 

(vi) One member appointed by the Director of the National 

Cancer Institute from officers or employees of the Institute. 

(vii) One member appointed by the Director of the National 

Science Foundation from officers or employees of the Foundation. 

(viii) One member appointed by the Secretary of Commerce 

from officers or employees of the Department of Commerce. 

(B)(i) An appointed member may designate an individual to serve 

on the committee on the member’s behalf. Such a designation may 

be made only with the approval of the applicable appointing authority and only if the individual is from the entity from which the 

member was appointed. 

(ii) No individual may serve as a member of the committee for 

more than four years in the aggregate. If any member of the committee leaves the entity from which the member was appointed, 

such member may not continue as a member of the committee, and 

the member’s position shall be considered to be vacant. A vacancy 

in the committee shall be filled in the same manner in which the 

original appointment was made. 

(iii) Initial appointments to the committee shall be made not 

later than the 60th day after the effective date of this Act. Not 

later than the 90th day after such date the members of the committee shall hold a meeting for the selection of a chairperson from 

among their number. 

(C)(i) No member of the committee, or designee of such member, 

shall accept employment or compensation from any person subject 

to any requirement of this Act or of any ørule¿ rule, testing consent 

agreement, or order promulgated or order issued thereunder, for a 

period of at least 12 months after termination of service on the 

committee. 

(ii) No person, while serving as a member of the committee, or 

designee of such member, may own any stocks or bonds, or have 

any pecuniary interest, of substantial value in any person engaged 

in the manufacture, processing, or distribution in commerce of any 

chemical substance or mixture subject to any requirement of this 


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Act or of any ørule¿ rule, testing consent agreement, or order promulgated or order issued thereunder. 

(iii) The Administrator, acting through attorneys of the Environmental Protection Agency, or the Attorney General may bring an 

action in the appropriate district court of the United States to restrain any violation of this subparagraph. 

(D) The Administrator shall provide the committee such administrative support services as may be necessary to enable the committee to carry out its function under this subsection. 

ø(f)¿ (g) REQUIRED ACTIONS.—Upon the receipt of— 

(1) any test data required to be submitted under this Act, or 

(2) any other information available to the Administrator, 

which indicates to the Administrator that there may be a reasonable basis to conclude that a chemical substance or mixture presents or will present a significant risk of serious or widespread 

harm to human beings øfrom cancer, gene mutations, or birth defects¿, the Administrator shall, within the 180-day period beginning on the date of the receipt of such data or information, initiate 

appropriate action under section 5, 6, or 7 to prevent or reduce to 

a sufficient extent such risk or publish in the Federal Register a 

finding that such risk is not unreasonable , without taking into account cost or other nonrisk factors. For good cause shown the Administrator may extend such period for an additional period of not 

more than 90 days. The Administrator shall publish in the Federal 

Register notice of any such extension and the reasons therefor. A 

finding by the Administrator that a risk is not unreasonable shall 

be considered agency action for purposes of judicial review under 

chapter 7 of title 5, United States Code. øThis subsection shall not 

take effect until two years after the effective date of this Act.¿ 

ø(g) PETITION FOR STANDARDS FOR THE DEVELOPMENT OF TEST

DATA.—A person intending to manufacture or process a chemical 

substance for which notice is required under section 5(a) and who 

is not required under a rule under subsection (a) to conduct tests 

and submit data on such substance may petition the Administrator 

to prescribe standards for the development of test data for such 

substance. The Administrator shall by order either grant or deny 

any such petition within 60 days of its receipt. If the petition is 

granted, the Administrator shall prescribe such standards for such 

substance within 75 days of the date the petition is granted. If the 

petition is denied, the Administrator shall publish, subject to section 14, in the Federal Register the reasons for such denial.¿ 

SEC. 4A. PRIORITIZATION SCREENING. 

(a) øEstablishment and List of Substances¿.Prioritization Screening Process— 

(1) IN GENERAL.—Not later than 1 year after the date of enactment of this section, the Administrator shall establish, by 

rule, a risk-based screening process and explicit criteria for 

identifying existing chemical substances that are— 

(A) a high priority for a safety assessment and safety determination under section 6 (referred to in this Act as ‘highpriority substances’); and 

(B) a low priority for a safety assessment and safety determination (referred to in this Act as ‘low-priority substances’). 


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(2) INITIAL LIST OF HIGH- AND LOW-PRIORITY SUBSTANCES.— (A) IN GENERAL.—Before the date of promulgation of the 

rule under paragraph (1) and not later than 180 days after 

the date of enactment of this section, the Administrator— 

(i) shall take into consideration and publish an initial list of high-priority substances and low-priority 

substances; and 

(ii) pursuant to section 6(b), may initiate or continue 

safety assessments and safety determinations for those 

high-priority substances. 

(B) REQUIREMENTS.— (i) IN GENERAL.—The initial list of chemical substances shall contain at least 10 high-priority substances, at least 5 of which are drawn from the list of 

chemical substances identified by the Administrator in 

the October 2014 TSCA Work Plan and subsequent updates, and at least 10 low-priority substances. 

(ii) SUBSEQUENTLY IDENTIFIED SUBSTANCES.—Insofar 

as possible, at least 50 percent of all substances subsequently identified by the Administrator as high-priority 

substances shall be drawn from the list of chemical 

substances identified by the Administrator in the October 2014 TSCA Work Plan and subsequent updates, 

until all Work Plan chemicals have been designated 

under this subsection. 

(iii) PERSISTENCE AND BIOACCUMULATION.—In developing the initial list and in identifying additional 

high-priority substances, the Administrator shall give 

preference to chemical substances scored as high for 

persistence and bioaccumulation in the October 2014 

TSCA Work Plan and subsequent updates. 

(C) ADDITIONAL CHEMICAL REVIEWS.—The Administrator 

shall, as soon as practicable and not later than— 

(i) 3 years after the date of enactment of the Frank 

R. Lautenberg Chemical Safety for the 21st Century 

Act, add additional high-priority substances sufficient 

to ensure that at least a total of 20 high-priority substances have undergone or are undergoing the process 

established in section 6(a), and additional low-priority 

substances sufficient to ensure that at least a total of 

20 low-priority substances have been designated; and 

(ii) 5 years after the date of enactment of the Frank 

R. Lautenberg Chemical Safety for the 21st Century 

Act, add additional high-priority substances sufficient 

to ensure that at least a total of 25 high-priority substances have undergone or are undergoing the process 

established in section 6(a), and additional low-priority 

substances sufficient to ensure that at least a total of 

25 low-priority substances have been designated. 

(3) IMPLEMENTATION.— (A) CONSIDERATION OF ACTIVE AND INACTIVE SUB- STANCES.— (i) ACTIVE SUBSTANCES.—In carrying out paragraph 

(1), the Administrator shall take into consideration acVerDate Sep 11 2014 05:10 Jun 23, 2015 Jkt 049010 PO 00000 Frm 00061 Fmt 6601 Sfmt 6601 E:\HR\OC\SR067.XXX SR067

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tive substances, as determined under section 8, which 

may include chemical substances on the interim list of 

active substances established under that section. 

(ii) INACTIVE SUBSTANCES.—In carrying out paragraph (1), the Administrator may take into consideration inactive substances, as determined under section 

8, that the Administrator determines— 

(I)(aa) have not been subject to a regulatory or 

other enforceable action by the Administrator to 

ban or phase out the substances; and 

(bb) have the potential for high hazard and 

widespread exposure; or 

(II)(aa) have been subject to a regulatory or other 

enforceable action by the Administrator to ban or 

phase out the substances; and 

(bb) with respect to which there exists the potential for residual high hazards or widespread exposures not otherwise addressed by the regulatory or 

other action. 

(iii) REPOPULATION.— 

(I) IN GENERAL.—On the completion of a safety 

determination under section 6 for a chemical substance, the Administrator shall remove the chemical substance from the list of high-priority substances established under this subsection. 

(II) ADDITIONS.—The Administrator shall add at 

least 1 chemical substance to the list of high-priority substances for each chemical substance removed from the list of high-priority substances established under this subsection, until a safety assessment and safety determination is completed for 

all high-priority substances. 

(III) LOW-PRIORITY SUBSTANCES.—If a low-priority substance is subsequently designated as a 

high-priority substance, the Administrator shall 

remove that substance from the list of low-priority 

substances. 

(B) TIMELY COMPLETION OF PRIORITIZATION SCREENING

PROCESS.— 

(i) IN GENERAL.—The Administrator shall— 

(I) exept as provided under paragraph (2),not 

later than 180 days after the effective date of the 

final rule under paragraph (1), begin the 

prioritization screening process; and 

(II) make every effort to complete the designation 

of all active substances as high-priority substances 

or low-priority substances in a timely manner. 

(ii) DECISIONS ON SUBSTANCES SUBJECT TO TESTING

FOR PRIORITIZATION PURPOSES.—Not later than 90 days 

after the date of receipt of information regarding a 

chemical substance complying with a rule, testing consent agreement, or order issued under section 4(a)(2), 

the Administrator shall designate the chemical subVerDate Sep 11 2014 05:10 Jun 23, 2015 Jkt 049010 PO 00000 Frm 00062 Fmt 6601 Sfmt 6601 E:\HR\OC\SR067.XXX SR067

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stance as a high-priority substance or low-priority substance. 

(iii) CONSIDERATION.— 

(I) IN GENERAL.—The Administrator shall screen 

substances and designate high-priority substances 

taking into consideration the ability of the Administrator to schedule and complete safety assessments and safety determinations under section 6 in 

a timely manner. 

(II) ANNUAL GOAL.—The Administrator shall 

publish an annual goal for the number of chemical 

substances to be subject to the prioritization 

screening process. 

(C) SCREENING OF CATEGORIES OF SUBSTANCES.—The Administrator may screen categories of chemical substances to 

ensure an efficient prioritization screening process to allow 

for timely and adequate designations of high-priority substances and low-priority substances and safety assessments 

and safety determinations for high-priority substances. 

(D) PUBLICATION OF LIST OF CHEMICAL SUBSTANCES.— 

The Administrator shall keep current and publish a list of 

chemical substances that— 

(i) are being considered in the prioritization screening process and the status of the chemical substances 

in the prioritization process, including those chemical 

substances for which prioritization decisions have been 

deferred; and 

(ii) are designated as high-priority substances or lowpriority substances, including the bases for such designations. 

(4) CRITERIA.—The criteria described in paragraph (1) shall 

account for— 

(A) the recommendation of the Governor of a State or a 

State agency with responsibility for protecting health or the 

environment from chemical substances appropriate for 

prioritization screening; 

(B) the hazard and exposure potential of the chemical 

substance (or category of substances), including persistence, 

bioaccumulation, and specific scientific classifications and 

designations by authoritative governmental entities; 

(C) the conditions of use or significant changes in the 

conditions of use of the chemical substance; 

(D) evidence and indicators of exposure potential to humans or the environment from the chemical substance, including potentially exposed or susceptible populations; 

(E) the volume of a chemical substance manufactured or 

processed; 

(F) whether the volume of a chemical substance as reported under a rule promulgated pursuant to section 8(a) 

has significantly increased or decreased during the period 

beginning on the date of a previous report or the date on 

which a notice has been submitted under section 5(b) for 

that chemical substance; 


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(G) the availability of information regarding potential 

hazards and exposures required for conducting a safety assessment or safety determination, with limited availability 

of relevant information to be a sufficient basis for designating a chemical substance as a high-priority substance, 

subject to the condition that limited availability shall not 

require designation as a high-priority substance; and 

(H) the extent of Federal or State regulation of the chemical substance or the extent of the impact of State regulation of the chemical substance on the United States, with 

existing Federal or State regulation of any uses evaluated 

in the prioritization screening process as a factor in designating a chemical substance to be a high-priority or a lowpriority substance. 

(b) PRIORITIZATION SCREENING PROCESS AND DECISIONS.— 

(1) IN GENERAL.—The prioritization screening process developed under subsection (a) shall include a requirement that the 

Administrator shall— 

(A) identify the chemical substances being considered for 

prioritization; 

(B) request interested persons to supply information regarding the chemical substances being considered; 

(C) apply the criteria identified in subsection (a)(4); and 

(D) subject to paragraph (5) and using the information 

available to the Administrator at the time of the decision, 

identify a chemical substance as a high-priority substance 

or a low-priority substance. 

(2) INTEGRATION OF INFORMATION.—The prioritization screening decision regarding a chemical substance shall integrate any 

hazard and exposure information relating to the chemical substance that is available to the Administrator. 

(3) IDENTIFICATION OF HIGH-PRIORITY SUBSTANCES.—The Administrator— 

(A) shall identify as a high-priority substance a chemical 

substance that, relative to other active chemical substances, 

the Administrator determines has the potential for significant hazard and significant exposure; 

(B) may identify as a high-priority substance a chemical 

substance that, relative to other active chemical substances, 

the Administrator determines has the potential for significant hazard or significant exposure; and 

(C) may identify as a high-priority substance an inactive 

substance, as determined under subsection (a)(3)(A)(ii) and 

section 8(b), that the Administrator determines warrants a 

safety assessment and safety determination under section 6. 

(4) IDENTIFICATION OF LOW-PRIORITY SUBSTANCES.—The Administrator shall identify as a low-priority substance a chemical substance that the Administrator concludes has information sufficient to establish that the chemical substance is likely 

to meet the safety standard. 

(5) DEFERRING A DECISION.—If the Administrator determines 

that additional information is required to establish the priority 

of a chemical substance under this section, the Administrator 


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may defer the prioritization screening decision for a reasonable 

period— 

(A) to allow for the submission of additional information 

by an interested person and for the Administrator to evaluate the additional information; or 

(B) to require the development of information pursuant to 

a rule, testing consent agreement, or order issued under 

section 4(a)(2). 

(6) DEADLINES FOR SUBMISSION OF INFORMATION.—If the Administrator requests the development or submission of information under this section, the Administrator shall establish a 

deadline for submission of the information. 

(7) NOTICE AND COMMENT.—The Administrator shall— 

(A) publish, including in the Federal Register, the proposed decisions made under paragraphs (3), (4), and (5) 

and the basis for the decisions; and 

(B) provide 90 days for public comment. 

(8) REVISIONS OF PRIOR DESIGNATIONS.— 

(A) IN GENERAL.—At any time, and at the discretion of 

the Administrator, the Administrator may revise the designation of a chemical substance as a high-priority substance or a low-priority substance based on information 

available to the Administrator after the date of the determination under paragraph (3) or (4). 

(B) LIMITED AVAILABILITY.—If limited availability of relevant information was a basis in the designation of a 

chemical substance as a high-priority substance, the Administrator shall reevaluate the prioritization screening of 

the chemical substance on receiving the relevant information. 

(9) OTHER INFORMATION RELEVANT TO PRIORITIZATION.— 

(A) IN GENERAL.—If, after the date of enactment of the 

Frank R. Lautenberg Chemical Safety for the 21st Century 

Act, a State proposes an administrative action or enacts a 

statute or takes an administrative action to prohibit or otherwise restrict the manufacturing, processing, distribution 

in commerce, or use of a chemical substance that the Administrator has not øas¿ designated as a high-priority substance, the Governor or State agency with responsibility 

for implementing the statute or administrative action shall 

notify the Administrator. 

(B) REQUESTS FOR INFORMATION.—Following receipt of a 

notification provided under subparagraph (A), the Administrator may request any available information from the 

Governor or the State agency with respect to— 

(i) scientific evidence related to the hazards, exposures and risks of the chemical substance under the 

conditions of use which the statute or administrative 

action is intended to address; 

(ii) any State or local conditions which warranted 

the statute or administrative action; 

(iii) the statutory or administrative authority on 

which the action is based; and 


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(iv) any other available information relevant to the 

prohibition or other restriction, including information 

on any alternatives considered and their hazards, exposures, and risks. 

(C) PRIORITIZATION SCREENING.—The Administrator 

shall conduct a prioritization screening under this subsection for all substances that— 

(i) are the subject of notifications received under subparagraph (A); and 

(ii) the Administrator determines— 

(I) are likely to have significant health or environmental impacts; 

(II) are likely to have significant impact on interstate commerce; or 

(III) have been subject to a prohibition or other 

restriction under a statute or administrative action 

in 2 or more States. 

(D) AVAILABILITY TO PUBLIC.—Subject to section 14 and 

any applicable State law regarding the protection of confidential information provided to the State or to the Administrator, the Administrator shall make information received 

from a Governor or State agency under subparagraph (A) 

publicly available. 

(E) EFFECT OF PARAGRAPH.—Nothing in this paragraph 

shall preempt a State statute or administrative action, require approval of a State statute or administrative action, 

or apply section 15 to a State. 

(10) REVIEW.—Not less frequently than once every 5 years 

after the date on which the process under this subsection is established, the Administrator shall— 

(A) review the process on the basis of experience and taking into consideration resources available to efficiently and 

effectively screen and prioritize chemical substances; and 

(B) if necessary, modify the prioritization screening process. 

(11) EFFECT.—Subject to section 18, a designation by the Administrator under this section with respect to a chemical substance shall not affect— 

(A) the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance; or 

(B) the regulation of those activities. 

(c) ADDITIONAL PRIORITIES FOR SAFETY ASSESSMENTS AND DETERMINATIONS.— 

(1) REQUIREMENTS.— 

(A) IN GENERAL.—The prioritization screening process developed under subsection (a) shall— 

(i) include a process by which a manufacturer or 

processor of an active chemical substance that has not 

been designated a high-priority substance or is not in 

the process of a prioritization screening by the Administrator, may request that the Administrator designate 

the substance as an additional priority for a safety assessment and safety determination, subject to the payment of fees pursuant to section 26(b)(3)(E); 


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(ii) specify the information to be provided in such requests; and 

(iii) specify the criteria the Administrator shall use to 

determine whether or not to grant such a request, 

which shall include whether the substance is subject to 

restrictions imposed by statutes enacted or administrative actions taken by 1 or more States on the manufacture, processing, distribution in commerce, or use of the 

substance. 

(B) PREFERENCE.—Subject to paragraph (2), in deciding 

whether to grant requests under this subsection the Administrator shall give a preference to requests concerning substances for which the Administrator determines that restrictions imposed by 1 or more States have the potential to 

have a significant impact on interstate commerce or health 

or the environment. 

(C) øExceptions.—Requests¿ Exceptions.—Chemical substances for which requests have been granted under this 

subsection shall not be subject to subsection (a)(3)(A)(iii) or 

section 18(b). 

(2) LIMITATIONS.—In considering whether to grant a request 

submitted under paragraph (1), the Administrator shall ensure 

that— 

(A) if a sufficient number of additional priority requests 

meet the requirements of paragraph (1), not less than 25 

percent, or more than 30 percent, of the cumulative number 

of substances designated to undergo safety assessments and 

safety determinations under øthis section¿ subsections 

(a)(2) and (b)(3) are substances designated under the process and criteria pursuant to paragraph (1); 

(B) the resources allocated to conducting safety assessments and safety determinations for additional priorities 

designated under this subsection are proportionate to the 

number of such substances relative to the total number of 

substances designated to undergo safety assessments and 

safety determinations under this section; and 

(C) the number of additional priority requests stipulated 

under subparagraph (A) is in addition to the total number 

of high-priority øchemicals¿ substances identified under 

øsubsection (a)(2)(B)¿ subsections (a)(2) and (b)(3). 

(3) ADDITIONAL REVIEW OF WORK PLAN CHEMICALS FOR SAFETY ASSESSMENT AND SAFETY DETERMINATION.—In the case of a 

request under paragraph (1) with respect to a chemical substance identified by the Administrator in the October 2014 

Work Plan— 

(A) the 30-percent cap specified in paragraph (2)(A) shall 

not apply and the addition of Work Plan chemicals shall 

be at the discretion of the Administrator; and 

(B) notwithstanding paragraph ø(6)¿ (1)(C),, requests for 

additional Work Plan chemicals under this subsection 

shall be considered high-priority chemicals subject to section 18(b) but not subsection (a)(3)(A)(iii). 

(4) REQUIREMENTS.— 


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(A) IN GENERAL.—The public shall be provided notice 

and an opportunity to comment on requests submitted 

under this subsection. 

(B) DECISION BY ADMINISTRATOR.—Not later than 180 

days after the date on which the Administrator receives a 

request under this subsection, the Administrator shall decide whether or not to grant the request. 

(C) ASSESSMENT AND DETERMINATION.—If the Administrator grants a request under this subsection, the safety assessment and safety determination— 

(i) shall be conducted in accordance with the deadlines and other requirements of sections 3A(i) and 6; 

and 

(ii) shall not be expedited or otherwise subject to special treatment relative to high-priority substances designated pursuant to subsection (b)(3) that are undergoing safety assessments and safety determinations. 

øSEC. 5. MANUFACTURING AND PROCESSING NOTICES.¿ 

SEC. 5. NEW CHEMICALS AND SIGNIFICANT NEW USES. 

ø(i)¿ (a) DEFINITION.—For purposes of this section, the terms 

‘‘manufacture’’ and ‘‘process’’ mean manufacturing or processing for 

commercial purposes. 

ø(a)¿ (b) øIn General¿ Notices.—(1) Except as provided in 

øsubsection (h)¿ paragraph (3) and subsection (h), no person may— 

(A) manufacture a new chemical substance on or after the 

30th day after the date on which the Administrator first publishes the list required by section 8(b), or 

(B) manufacture or process any chemical substance for a use 

which the Administrator has determined, in accordance with 

paragraph (2), is a significant new use, 

unless such person submits to the Administrator, at least 90 days 

before such manufacture or processing, a notice, in accordance with 

øsubsection (d)¿ subsection (c), of such person’s intention to manufacture or process such substance øand such person complies with 

any applicable requirement of subsection (b)¿. (2) A determination by the Administrator that a use of a chemical substance is a significant new use with respect to which notification is required under paragraph (1) shall be made by a rule promulgated after a consideration of all relevant factors, including— 

(A) the projected volume of manufacturing and processing of 

a chemical substance, 

(B) the extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance, 

(C) the extent to which a use increases the magnitude and 

duration of exposure of human beings or the environment to a 

chemical substance, and 

(D) the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal 

of a chemical substance. 

(3) ARTICLE CONSIDERATION.—The Administrator may require 

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graph (1)(B) if the Administrator makes an affirmative finding 

in a rule under paragraph (2) that the reasonable potential for 

exposure to the chemical substance through the article or category of articles subject to the rule warrants notification.; 

ø(d)¿ (c) CONTENT OF NOTICE; PUBLICATIONS IN THE FEDERAL

REGISTER.—ø(1) The notice required by subsection (a) subsection 

(b) shall include— 

ø(A) insofar as known to the person submitting the notice or 

insofar as reasonably ascertainable, the information described 

in subparagraphs (A), (B), (C), (D), (F), and (G) of section 

8(a)(2), and 

ø(B) in such form and manner as the Administrator may prescribe, any test data in the possession or control of the person 

giving such notice which are related to the effect of any manufacture, processing, distribution in commerce, use, or disposal 

of such substance or any article containing such substance, or 

of any combination of such activities, on health or the environment, and 

ø(C) a description of any other data concerning the environmental and health effects of such substance, insofar as known 

to the person making the notice or insofar as reasonably ascertainable. 

Such a notice shall be made available, subject to section 14, for examination by interested persons.¿ 

(1) IN GENERAL.—The notice required by subsection (b) shall 

include, with respect to a chemical substance— 

(A) the information required by sections 720.45 and 

720.50 of title 40, Code of Federal Regulations (or successor 

regulations); and 

(B) information regarding conditions of use and reasonably anticipated exposures. 

(2) Subject to section 14, not later than five days (excluding Saturdays, Sundays and legal holidays) after the date of the receipt of 

a notice under øsubsection (a)¿ subsection (b) øor of data under 

subsection (b)¿, the Administrator shall publish in the Federal Register a notice which— 

(A) identifies the chemical substance for which notice or data 

has been received;and 

(B) lists the uses or intended uses of such substanceø; and¿ 

. 

ø(C) in the case of the receipt of data under subsection (b), 

describes the nature of the tests performed on such substance 

and any data which was developed pursuant to subsection (b) 

or a rule under section 4. 

A notice under this paragraph respecting a chemical substance 

shall identify the chemical substance by generic class unless the 

Administrator determines that more specific identification is required in the public interest.¿ 

(3) At the beginning of each month the Administrator shall publish a list in the Federal Register of (A) each chemical substance 

for which notice has been received under øsubsection (a) and for 

which the notification period prescribed by subsection (a), (b), or 

(c)¿ subsection (b) and for which the notification period prescribed 

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stance for which such notification period has expired since the last 

publication in the Federal Register of such list. 

ø(b) SUBMISSION OF TEST DATA.—(1)(A) If (i) a person is required 

by subsection (a)(1) to submit a notice to the Administrator before 

beginning the manufacture or processing of a chemical substance, 

and (ii) such person is required to submit test data for such substance pursuant to a rule promulgated under section 4 before the 

submission of such notice, such person shall submit to the Administrator such data in accordance with such rule at the time notice is 

submitted in accordance with subsection (a)(1). 

ø(B) If— 

ø(i) a person is required by subsection (a)(1) to submit a notice to the Administrator, and 

ø(ii) such person has been granted an exemption under section 4(c) from the requirements of a rule promulgated under 

section 4 before the submission of such notice, 

such person may not, before the expiration of the 90-day period 

which begins on the date of the submission in accordance with such 

rule of the test data the submission or development of which was 

the basis for the exemption, manufacture such substance if such 

person is subject to subsection (a)(1)(A) or manufacture or process 

such substance for a significant new use if the person is subject to 

subsection (a)(1)(B). 

ø(2)(A) If a person— 

ø(i) is required by subsection (a)(1) to submit a notice to the 

Administrator before beginning the manufacture or processing 

of a chemical substance listed under paragraph (4), and 

ø(ii) is not required by a rule promulgated under section 4 

before the submission of such notice to submit test data for 

such substance, 

such person shall submit to the Administrator data prescribed by 

subparagraph (B) at the time notice is submitted in accordance 

with subsection (a)(1). 

ø(B) Data submitted pursuant to subparagraph (A) shall be data 

which the person submitting the data believes show that— 

ø(i) in the case of a substance with respect to which notice 

is required under subsection (a)(1)(A), the manufacture, processing, distribution in commerce, use, and disposal of the 

chemical substance or any combination of such activities will 

not present an unreasonable risk of injury to health or the environment, or 

ø(ii) in the case of a chemical substance with respect to 

which notice is required under subsection (a)(1)(B), the intended significant new use of the chemical substance will not 

present an unreasonable risk of injury to health or the environment. 

ø(3) Data submitted under paragraph (1) or (2) shall be made 

available, subject to section 14, for examination by interested persons. 

ø(4)(A)(i) The Administrator may, by rule, compile and keep current a list of chemical substances with respect to which the Administrator finds that the manufacture, processing, distribution in 

commerce, use, or disposal, or any combination of such activities, 


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presents or may present an unreasonable risk of injury to health 

or the environment. 

ø(ii) In making a finding under clause (i) that the manufacture, 

processing, distribution in commerce, use, or disposal of a chemical 

substance or any combination of such activities presents or may 

present an unreasonable risk of injury to health or the environment, the Administrator shall consider all relevant factors, including— 

ø(I) the effects of the chemical substance on health and the 

magnitude of human exposure to such substance; and 

ø(II) the effects of the chemical substance on the environment and the magnitude of environmental exposure to such 

substance. 

ø(B) The Administrator shall, in prescribing a rule under subparagraph (A) which lists any chemical substance, identify those 

uses, if any, which the Administrator determines, by rule under 

subsection (a)(2), would constitute a significant new use of such 

substance. 

ø(C) Any rule under subparagraph (A), and any substantive 

amendment or repeal of such a rule, shall be promulgated pursuant 

to the procedures specified in section 553 of title 5, United States 

Code, except that (i) the Administrator shall give interested persons an opportunity for the oral presentation of data, views, or arguments, in addition to an opportunity to make written submissions, (ii) a transcript shall be kept of any oral presentation, and 

(iii) the Administrator shall make and publish with the rule the 

finding described in subparagraph (A)¿ 

ø(c)¿ (d) EXTENSION OF NOTICE PERIOD.—The Administrator may 

for good cause extend for additional periods (not to exceed in the 

aggregate 90 days) the period, prescribed by subsection (a) or (b) 

before which the manufacturing or processing of a chemical substance subject to such subsection may begin. Subject to section 14, 

such an extension and the reasons therefor shall be published in 

the Federal Register and shall constitute a final agency action subject to judicial review.¿ 

(d) REVIEW OF NOTICE.— 

(1) INITIAL REVIEW.— 

(A) IN GENERAL.—Subject to subparagraph (B), not later 

than 90 days after the date of receipt of a notice submitted 

under subsection (b), the Administrator shall— 

(i) conduct an initial review of the notice; 

(ii) as needed, develop a profile of the relevant chemical substance and the potential for exposure to humans and the environment; and 

(iii) make any necessary determination under paragraph (3). 

(B) EXTENSION.—Except as provided in paragraph (5), 

the Administrator may extend the period described in subparagraph (A) for good cause for 1 or more periods, the 

total of which shall be not more than 90 days. 

(2) INFORMATION SOURCES.—In evaluating a notice under 

paragraph (1), the Administrator shall take into consideration— 


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(A) any relevant information identified in subsection 

(c)(1); and 

(B) any other relevant additional information available 

to the Administrator. 

(3) DETERMINATIONS.—Before the end of the applicable period 

for review under paragraph (1), based on the information described in paragraph (2), and subject to section 18(g), the Administrator shall determine that— 

(A) the relevant chemical substance or significant new 

use is not likely to meet the safety standard, in which case 

the Administrator shall take appropriate action under 

paragraph (4); 

(B) the relevant chemical substance or significant new 

use is likely to meet the safety standard, in which case the 

Administrator shall allow the review period to expire without additional restrictions; or 

(C) additional information is necessary in order to make 

a determination under subparagraph (A) or (B), in which 

case the Administrator shall take appropriate action under 

øparagraph¿ paragraphs (4) and (5). 

(4) RESTRICTIONS.— 

(A) DETERMINATION BY ADMINISTRATOR.— 

(i) IN GENERAL.—If the Administrator makes a determination under subparagraph (A) or (C) of paragraph 

(3) with respect to a notice submitted under subsection 

(b)— 

(I) the Administrator, before the end of the applicable period for review under paragraph (1) and 

by consent agreement or order, as appropriate, 

shall prohibit or otherwise restrict the manufacture, processing, use, distribution in commerce, or 

disposal (as applicable) of the chemical substance, 

or of the chemical substance for a significant new 

use, without compliance with the restrictions specified in the consent agreement or order that the Administrator determines are sufficient to ensure that 

the chemical substance or significant new use is 

likely to meet the safety standard; and 

(II) no person may commence manufacture of the 

chemical substance, or manufacture or processing 

of the chemical substance for a significant new use, 

except in compliance with the restrictions specified 

in the consent agreement or order. 

(ii) LIKELY TO MEET STANDARD.—If the Administrator makes a determination under subparagraph (B) 

of paragraph (3) with respect to a chemical substance 

or significant new use for which a notice was submitted under subsection (b), at the end of the applicable period for review under paragraph (1), the submitter of the notice may commence manufacture for 

commercial purposes of the chemical substance or manufacture or processing of the chemical substance for a 

significant new use. 


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(B) REQUIREMENTS.—Not later than 90 days after issuing 

a consent agreement or order under subparagraph (A), the 

Administrator shall— 

(i) take into consideration whether to promulgate a 

rule pursuant to subsection (b)(2) that identifies as a 

significant new use any manufacturing, processing, 

use, distribution in commerce, or disposal of the chemical substance, or of the chemical substance for a new 

use, that is not in compliance with the restrictions imposed by the consent agreement or order; and 

(ii)(I) initiate a rulemaking described in clause (i); or 

(II) publish a statement describing the reasons of the 

Administrator for not initiating a rulemaking. 

(C) INCLUSIONS.—A prohibition or other restriction under 

subparagraph (A) may include, as appropriate— 

(i) subject to section 18(g), a requirement that a 

chemical substance shall be marked with, or accompanied by, clear and adequate minimum warnings and 

instructions with respect to use, distribution in commerce, or disposal, or any combination of those activities, with the form and content of the minimum warnings and instructions to be prescribed by the Administrator 

(ii) a requirement that manufacturers or processors 

of the chemical substance shall— 

(I) make and retain records of the processes used 

to manufacture or process, as applicable, the chemical substance; or 

(II) monitor or conduct such additional tests as 

are reasonably necessary to address potential risks 

from the manufacture, processing, distribution in 

commerce, use, or disposal, as applicable, of the 

chemical substance, subject to section 4; 

(iii) a restriction on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce— 

(I) in general; or 

(II) for a particular use; 

(iv) a prohibition or other restriction of— 

(I) the manufacture, processing, or distribution 

in commerce of the chemical substance for a significant new use; 

(II) any method of commercial use of the chemical substance; or 

(III) any method of disposal of the chemical substance; or 

(v) a prohibition or other restriction on the manufacture, processing, or distribution in commerce of the 

chemical substance— 

(I) in general; or 

(II) for a particular use. 

(D) PERSISTENT AND BIOACCUMULATIVE SUBSTANCES.— For a chemical substance the Administrator determines 

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ministrator shall, in selecting among prohibitions and 

other restrictions that the Administrator determines are 

sufficient to ensure that the chemical substance is likely to 

meet the safety standard, reduce potential exposure to the 

substance to the maximum extent practicable. 

(E) WORKPLACE EXPOSURES.—The Administrator shall 

consult with the Assistant Secretary of Labor for Occupational Safety and Health prior to adopting any prohibition 

or other restriction under this subsection to address workplace exposures. 

(F) DEFINITION OF REQUIREMENT.—For purposes of this 

Act, the term ‘requirement’ as used in this section does not 

displace common law. 

(5) ADDITIONAL INFORMATION.—If the Administrator determines under paragraph (3)(C) that additional information is 

necessary to conduct a review under this subsection, the Administrator— 

(A) shall provide an opportunity for the submitter of the 

notice to submit the additional information; 

(B) may, by agreement with the submitter, extend the review period for a reasonable time to allow the development 

and submission of the additional information; 

(C) may promulgate a rule, enter into a testing consent 

agreement, or issue an order under section 4 to require the 

development of the information; and 

(D) on receipt of information the Administrator finds 

supports the determination under paragraph (3), shall 

promptly make the determination. 

ø(e) REGULATION PENDING DEVELOPMENT OF INFORMATION.— 

(1)(A) If the Administrator determines that— 

ø(i) the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of a chemical substance with respect to 

which notice is required by subsection (a); and 

ø(ii)(I) 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 

substance, or any combination of such activities, may present 

an unreasonable risk of injury to health or the environment, or 

ø(II) such substance is or will be produced in substantial 

quantities, and such substance either enters or may reasonably 

be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human 

exposure to the substance, 

the Administrator may issue a proposed order, to take effect on the 

expiration of the notification period applicable to the manufacturing or processing of such substance under subsection (a), (b), or 

(c), to prohibit or limit the manufacture, processing, distribution in 

commerce, use, or disposal of such substance or to prohibit or limit 

any combination of such activities. 

ø(B) A proposed order may not be issued under subparagraph (A) 

respecting a chemical substance (i) later than 45 days before the 

expiration of the notification period applicable to the manufacture 

or processing of such substance under subsection (a), (b), or (c), and 


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(ii) unless the Administrator has, on or before the issuance of the 

proposed order, notified, in writing, each manufacturer or processor, as the case may be, of such substance of the determination 

which underlies such order. 

ø(C) If a manufacturer or processor of a chemical substance to be 

subject to a proposed order issued under subparagraph (A) files 

with the Administrator (within the 30-day period beginning on the 

date such manufacturer or processor received the notice required 

by subparagraph (B)(ii)) objections specifying with particularity the 

provisions of the order deemed objectionable and stating the 

grounds therefor, the proposed order shall not take effect. 

ø(2)(A)(i) Except as provided in clause (ii), if with respect to a 

chemical substance with respect to which notice is required by subsection (a), the Administrator makes the determination described 

in paragraph (1)(A) and if— 

ø(I) the Administrator does not issue a proposed order under 

paragraph (1) respecting such substance, or 

ø(II) the Administrator issues such an order respecting such 

substance but such order does not take effect because objections were filed under paragraph (1)(C) with respect to it, 

the Administrator, through attorneys of the Environmental Protection Agency, shall apply to the United States District Court for the 

District of Columbia or the United States district court for the judicial district in which the manufacturer or processor, as the case 

may be, of such substance is found, resides, or transacts business 

for an injunction to prohibit or limit the manufacture, processing, 

distribution in commerce, use, or disposal of such substance (or to 

prohibit or limit any combination of such activities). 

ø(ii) If the Administrator issues a proposed order under paragraph (1)(A) respecting a chemical substance but such order does 

not take effect because objections have been filed under paragraph 

(1)(C) with respect to it, the Administrator is not required to apply 

for an injunction under clause (i) respecting such substance if the 

Administrator determines, on the basis of such objections, that the 

determinations under paragraph (1)(A) may not be made. 

ø(B) A district court of the United States which receives an application under subparagraph (A)(i) for an injunction respecting a 

chemical substance shall issue such injunction if the court finds 

that— 

(i) the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of a chemical substance with respect to 

which notice is required by subsection (a); and 

ø(ii)(I) 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 

substance, or any combination of such activities, may present 

an unreasonable risk of injury to health or the environment, or 

ø(II) such substance is or will be produced in substantial 

quantities, and such substance either enters or may reasonably 

be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human 

exposure to the substance. 


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ø(C) Pending the completion of a proceeding for the issuance of 

an injunction under subparagraph (B) respecting a chemical substance, the court may, upon application of the Administrator made 

through attorneys of the Environmental Protection Agency, issue a 

temporary restraining order or a preliminary injunction to prohibit 

the manufacture, processing, distribution in commerce, use, or disposal of such a substance (or any combination of such activities) if 

the court finds that the notification period applicable under subsection (a), (b), or (c) to the manufacturing or processing of such 

substance may expire before such proceeding can be completed. 

ø(D) After the submission to the Administrator of test data sufficient to evaluate the health and environmental effects of a chemical substance subject to an injunction issued under subparagraph 

(B) and the evaluation of such data by the Administrator, the district court of the United States which issued such injunction shall, 

upon petition, dissolve the injunction unless the Administrator has 

initiated a proceeding for the issuance of a rule under section 6(a) 

respecting the substance. If such a proceeding has been initiated, 

such court shall continue the injunction in effect until the effective 

date of the rule promulgated in such proceeding or, if such proceeding is terminated without the promulgation of a rule, upon the 

termination of the proceeding, whichever occurs first. 

ø(f) PROTECTION AGAINST UNREASONABLE RISKS.—(1) If the Administrator finds that there is a reasonable basis to conclude that 

the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance with respect to which notice is required by subsection (a), or that any combination of such activities, 

presents or will present an unreasonable risk of injury to health or 

environment before a rule promulgated under section 6 can protect 

against such risk, the Administrator shall, before the expiration of 

the notification period applicable under subsection (a), (b), or (c) to 

the manufacturing or processing of such substance, take the action 

authorized by paragraph (2) or (3) to the extent necessary to protect against such risk. 

ø(2) The Administrator may issue a proposed rule under section 

6(a) to apply to a chemical substance with respect to which a finding was made under paragraph (1)— 

ø(A) a requirement limiting the amount of such substance 

which may be manufactured, processed, or distributed in commerce, 

ø(B) a requirement described in paragraph (2), (3), (4), (5), 

(6), or (7) of section 6(a), or 

ø(C) any combination of the requirements referred to in subparagraph (B). 

Such a proposed rule shall be effective upon its publication in the 

Federal Register. Section 6(d)(2)(B) shall apply with respect to such 

rule. 

ø(3)(A) The Administrator may— 

ø(i) issue a proposed order to prohibit the manufacture, processing, or distribution in commerce of a substance with respect 

to which a finding was made under paragraph (1), or 

ø(ii) apply, through attorneys of the Environmental Protection Agency, to the United States District Court for the District 

of Columbia or the United States district court for the judicial 


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district in which the manufacturer, or processor, as the case 

may be, of such substance, is found, resides, or transacts business for an injunction to prohibit the manufacture, processing, 

or distribution in commerce of such substance. 

A proposed order issued under clause (i) respecting a chemical substance shall take effect on the expiration of the notification period 

applicable under subsection (a), (b), or (c) to the manufacture or 

processing of such substance. 

ø(B) If the district court of the United States to which an application has been made under subparagraph (A)(ii) finds that there is 

a reasonable basis to conclude that the manufacture, processing, 

distribution in commerce, use, or disposal of the chemical substance with respect to which such application was made, or that 

any combination of such activities, presents or will present an unreasonable risk of injury to health or the environment before a rule 

promulgated under section 6 can protect against such risk, the 

court shall issue an injunction to prohibit the manufacture, processing or distribution in commerce of such substance or to prohibit 

any combination of such activities. 

ø(C) The provisions of subparagraphs (B) and (C) of subsection 

(e)(1) shall apply with respect to an order issued under clause (i) 

of subparagraph (A); and the provisions of subparagraph (C) of subsection (e)(2) shall apply with respect to an injunction issued under 

subparagraph (B). 

ø(D) If the Administrator issues an order pursuant to subparagraph (A)(i) respecting a chemical substance and objections are 

filed in accordance with subsection (e)(1)(C), the Administrator 

shall seek an injunction under subparagraph (A)(ii) respecting such 

substance unless the Administrator determines, on the basis of 

such objections, that such substance does not or will not present an 

unreasonable risk of injury to health or the environment. 

ø(g) STATEMENT OF REASONS FOR NOT TAKING ACTION.—If the 

Administrator has not initiated any action under this section or 

section 6 or 7 to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance, 

with respect to which notification or data is required by subsection 

(a)(1)(B) or (b), before the expiration of the notification period applicable to the manufacturing or processing of such substance, the 

Administrator shall publish a statement of the Administrator’s reasons for not initiating such action. Such a statement shall be published in the Federal Register before the expiration of such period. 

Publication of such statement in accordance with the preceding 

sentence is not a prerequisite to the manufacturing or processing 

of the substance with respect to which the statement is to be published.¿ 

(e) NOTICE OF COMMENCEMENT.— 

(1) IN GENERAL.—Not later than 30 days after the date on 

which a manufacturer that has submitted a notice under subsection (b) commences nonexempt commercial manufacture of a 

chemical substance, the manufacturer shall submit to the Administrator a notice of commencement that identifies— 

(A) the name of the manufacturer; and 

(B) the initial date of nonexempt commercial manufacture. 


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(2) WITHDRAWAL.—A manufacturer or processor that has submitted a notice under subsection (b), but that has not commenced nonexempt commercial manufacture or processing of 

the chemical substance, may withdraw the notice. 

(f) FURTHER EVALUATION.—The Administrator may review a 

chemical substance under section 4A at any time after the Administrator receives— 

(1) a notice of commencement for a chemical substance under 

subsection (c); or 

(2) new information regarding the chemical substance. 

(g) TRANSPARENCY.—Subject to section 14, the Administrator 

shall make available to the public— 

(1) all notices, determinations, consent agreements, rules, and 

orders of the Administrator; and 

(2) all information submitted or issued under this section. 

(h) EXEMPTIONS.—(1) The Administrator may, upon application, 

exempt any person from any requirement of subsection ø(a) or¿ (b) 

to permit such person to manufacture or process a chemical substance for test marketing purposes— 

(A) upon a showing by such person satisfactory to the Administrator that the manufacture, processing, distribution in 

commerce, use, and disposal of such substance, and that any 

combination of such activities, for such purposes will not 

present any unreasonable risk of injury to health or the environment , without taking into account cost or other nonrisk factors and 

(B) under such restrictions as the Administrator considers 

appropriate. 

ø(2)(A) The Administrator may, upon application, exempt any 

person from the requirement of subsection (b)(2) to submit data for 

a chemical substance. If, upon receipt of an application under the 

preceding sentence, the Administrator determines that— 

ø(i) the chemical substance with respect to which such application was submitted is equivalent to a chemical substance for 

which data has been submitted to the Administrator as required by subsection (b)(2), and 

ø(ii) submission of data by the applicant on such substance 

would be duplicative of data which has been submitted to the 

Administrator in accordance with such subsection, 

the Administrator shall exempt the applicant from the requirement 

to submit such data on such substance. No exemption which is 

granted under this subparagraph with respect to the submission of 

data for a chemical substance may take effect before the beginning 

of the reimbursement period applicable to such data. 

ø(B) If the Administrator exempts any person, under subparagraph (A), from submitting data required under subsection (b)(2) 

for a chemical substance because of the existence of previously submitted data and if such exemption is granted during the reimbursement period for such data, then (unless such person and the persons referred to in clauses (i) and (ii) agree on the amount and 

method of reimbursement) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the Administrator)— 


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ø(i) to the person who previously submitted the data on 

which the exemption was based, for a portion of the costs incurred by such person in complying with the requirement 

under subsection (b)(2) to submit such data, and 

ø(ii) to any other person who has been required under this 

subparagraph to contribute with respect to such costs, for a 

portion of the amount such person was required to contribute. 

In promulgating rules for the determination of fair and equitable 

reimbursement to the persons described in clauses (i) and (ii) for 

costs incurred with respect to a chemical substance, the Administrator shall, after consultation with the Attorney General and the 

Federal Trade Commission, consider all relevant factors, including 

the effect on the competitive position of the person required to provide reimbursement in relation to the persons to be reimbursed 

and the share of the market for such substance of the person required to provide reimbursement in relation to the share of such 

market of the persons to be reimbursed. For purposes of judicial review, an order under this subparagraph shall be considered final 

agency action. 

ø(C) For purposes of this paragraph, the reimbursement period 

for any previously submitted data for a chemical substance is a period— 

ø(i) beginning on the date of the termination of the prohibition, imposed under this section, on the manufacture or processing of such substance by the person who submitted such 

data to the Administrator, and 

ø(ii) ending— 

ø(I) five years after the date referred to in clause (i), or 

ø(II) at the expiration of a period which begins on the 

date referred to in clause (i) and is equal to the period 

which the Administrator determines was necessary to develop such data, 

whichever is later.¿ 

ø(3)¿ (2) The requirements of øsubsections (a) and (b)¿ subsection 

(b) do not apply with respect to the manufacturing or processing of 

any chemical substance which is manufactured or processed, or 

proposed to be manufactured or processed, only in small quantities 

(as defined by the Administrator by rule) solely for purposes of— 

(A) scientific experimentation or analysis, or 

(B) chemical research on, or analysis of such substance or 

another substance, including such research or analysis for the 

development of a product, 

if all persons engaged in such experimentation, research, or analysis for a manufacturer or processor are notified (in such form and 

manner as the Administrator may prescribe) of any risk to health 

which the manufacturer, processor, or the Administrator has reason to believe may be associated with such chemical substance. 

ø(4)¿ (3) The Administrator may, upon application and by rule, 

exempt the manufacturer of any new chemical substance from all 

or part of the requirements of this section if the Administrator determines that the manufacture, processing, distribution in commerce, use, or disposal of such chemical substance, or that any 

combination of such activities, will not present an unreasonable 

risk of injury to health or the environment. A rule promulgated 


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under this paragraph (and any substantive amendment to, or repeal of, such a rule) shall be promulgated in accordance with paragraphs (2) and (3) of section 6(c). 

ø(5)¿ (4) The Administrator may, upon application, make the requirements of subsections (a) and (b) inapplicable with respect to 

the manufacturing or processing of any chemical substance (A) 

which exists temporarily as a result of a chemical reaction in the 

manufacturing or processing of a mixture or another chemical substance, and (B) to which there is no, and will not be, human or environmental exposure. 

ø(6)¿ (5) Immediately upon receipt of an application under 

øparagraph (1) or (5) paragraph (1) or (4) the Administrator shall 

publish in the Federal Register notice of the receipt of such application. The Administrator shall give interested persons an opportunity to comment upon any such application and shall, within 45 

days of its receipt, either approve or deny the application. The Administrator shall publish in the Federal Register notice of the approval or denial of such an application. 

øSEC. 6. REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND 

MIXTURES.¿ 

SEC. 6. SAFETY ASSESSMENTS AND SAFETY DETERMINATIONS. 

ø(a) SCOPE OF REGULATION.—If the Administrator finds that 

there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents, or will present an unreasonable risk of injury to health or 

the environment, the Administrator shall by rule apply one or more 

of the following requirements to such substance or mixture to the 

extent necessary to protect adequately against such risk using the 

least burdensome requirements: 

ø(1) A requirement (A) prohibiting the manufacturing, processing, or distribution in commerce of such substance or mixture, or (B) limiting the amount of such substance or mixture 

which may be manufactured, processed, or distributed in commerce. 

ø(2) A requirement— 

ø(A) prohibiting the manufacture, processing, or distribution in commerce of such substance or mixture for (i) 

a particular use or (ii) a particular use in a concentration 

in excess of a level specified by the Administrator in the 

rule imposing the requirement, or 

ø(B) limiting the amount of such substance or mixture 

which may be manufactured, processed, or distributed in 

commerce for (i) a particular use or (ii) a particular use in 

a concentration in excess of a level specified by the Administrator in the rule imposing the requirement. 

ø(3) A requirement that such substance or mixture or any 

article containing such substance or mixture be marked with 

or accompanied by clear and adequate warnings and instructions with respect to its use, distribution in commerce, or disposal or with respect to any combination of such activities. The 

form and content of such warnings and instructions shall be 

prescribed by the Administrator. 


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ø(4) A requirement that manufacturers and processors of 

such substance or mixture make and retain records of the processes used to manufacture or process such substance or mixture and monitor or conduct tests which are reasonable and 

necessary to assure compliance with the requirements of any 

rule applicable under this subsection. 

ø(5) A requirement prohibiting or otherwise regulating any 

manner or method of commercial use of such substance or mixture. 

ø(6)(A) A requirement prohibiting or otherwise regulating 

any manner or method of disposal of such substance or mixture, or of any article containing such substance or mixture, by 

its manufacturer or processor or by any other person who uses, 

or disposes of, it for commercial purposes. 

ø(B) A requirement under subparagraph (A) may not require 

any person to take any action which would be in violation of 

any law or requirement of, or in effect for, a State or political 

subdivision, and shall require each person subject to it to notify each State and political subdivision in which a required 

disposal may occur of such disposal. 

ø(7) A requirement directing manufacturers or processors of 

such substance or mixture (A) to give notice of such unreasonable risk of injury to distributors in commerce of such substance or mixture and, to the extent reasonably ascertainable, 

to other persons in possession of such substance or mixture or 

exposed to such substance or mixture, (B) to give public notice 

of such risk of injury, and (C) to replace or repurchase such 

substance or mixture as elected by the person to which the requirement is directed. 

Any requirement (or combination of requirements) imposed under 

this subsection may be limited in application to specified geographic areas. 

ø(b) QUALITY CONTROL.—If the Administrator has a reasonable 

basis to conclude that a particular manufacturer or processor is 

manufacturing or processing a chemical substance or mixture in a 

manner which unintentionally causes the chemical substance or 

mixture to present or which will cause it to present an unreasonable risk of injury to health or the environment— 

ø(1) the Administrator may by order require such manufacturer or processor to submit a description of the relevant quality control procedures followed in the manufacturing or processing of such chemical substance or mixture; and 

ø(2) if the Administrator determines— 

ø(A) that such quality control procedures are inadequate 

to prevent the chemical substance or mixture from presenting such risk of injury, the Administrator may order 

the manufacturer or processor to revise such quality control procedures to the extent necessary to remedy such inadequacy; or 

ø(B) that the use of such quality control procedures has 

resulted in the distribution in commerce of chemical substances or mixtures which present an unreasonable risk of 

injury to health or the environment, the Administrator 

may order the manufacturer or processor to (i) give notice 


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of such risk to processors or distributors in commerce of 

any such substance or mixture, or to both, and, to the extent reasonably ascertainable, to any other person in possession of or exposed to any such substance, (ii) to give 

public notice of such risk, and (iii) to provide such replacement or repurchase of any such substance or mixture as 

is necessary to adequately protect health or the environment. 

A determination under subparagraph (A) or (B) of paragraph (2) 

shall be made on the record after opportunity for hearing in accordance with section 554 of title 5, United States Code. Any manufacturer or processor subject to a requirement to replace or repurchase 

a chemical substance or mixture may elect either to replace or repurchase the substance or mixture and shall take either such action in the manner prescribed by the Administrator. 

ø(c) PROMULGATION OF SUBSECTION (a) RULES.—(1) In promulgating any rule under subsection (a) with respect to a chemical 

substance or mixture, the Administrator shall consider and publish 

a statement with respect to— 

ø(A) the effects of such substance or mixture on health and 

the magnitude of the exposure of human beings to such substance or mixture, 

ø(B) the effects of such substance or mixture on the environment and the magnitude of the exposure of the environment to 

such substance or mixture, 

ø(C) the benefits of such substance or mixture for various 

uses and the availability of substitutes for such uses, and 

ø(D) the reasonably ascertainable economic consequences of 

the rule, after consideration of the effect on the national economy, small business, technological innovation, the environment, and public health. 

If the Administrator determines that a risk of injury to health or 

the environment could be eliminated or reduced to a sufficient extent by actions taken under another Federal law (or laws) administered in whole or in part by the Administrator, the Administrator 

may not promulgate a rule under subsection (a) to protect against 

such risk of injury unless the Administrator finds, in the Administrator’s discretion, that it is in the public interest to protect against 

such risk under this Act. In making such a finding the Administrator shall consider (i) all relevant aspects of the risk, as determined by the Administrator in the Administrator’s discretion, (ii) 

a comparison of the estimated costs of complying with actions 

taken under this Act and under such law (or laws), and (iii) the relative efficiency of actions under this Act and under such law (or 

laws) to protect against such risk of injury. 

ø(2) When prescribing a rule under subsection (a) the Administrator shall proceed in accordance with section 553 of title 5, 

United States Code (without regard to any reference in such section to sections 556 and 557 of such title), and shall also (A) publish a notice of proposed rulemaking stating with particularity the 

reason for the proposed rule; (B) allow interested persons to submit 

written data, views, and arguments, and make all such submissions publicly available; (C) provide an opportunity for an informal 

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priate, a final rule based on the matter in the rulemaking record 

(as defined in section 19(a)), and (E) make and publish with the 

rule the finding described in subsection (a). 

ø(3) Informal hearings required by paragraph (2)(C) shall be conducted by the Administrator in accordance with the following requirements: 

ø(A) Subject to subparagraph (B), an interested person is entitled— 

ø(i) to present such person’s position orally or by documentary submissions (or both), and 

ø(ii) if the Administrator determines that there are disputed issues of material fact it is necessary to resolve, to 

present such rebuttal submissions and to conduct (or have 

conducted under subparagraph (B)(ii)) such cross-examination of persons as the Administrator determines (I) to be 

appropriate, and (II) to be required for a full and true disclosure with respect to such issues. 

ø(B) The Administrator may prescribe such rules and make 

such rulings concerning procedures in such hearings to avoid 

unnecessary costs or delay. Such rules or rulings may include 

(i) the imposition of reasonable time limits on each interested 

person’s oral presentations, and (ii) requirements that any 

cross-examination to which a person may be entitled under 

subparagraph (A) be conducted by the Administrator on behalf 

of that person in such manner as the Administrator determines (I) to be appropriate, and (II) to be required for a full 

and true disclosure with respect to disputed issues of material 

fact. 

ø(C)(i) Except as provided in clause (ii), if a group of persons 

each of whom under subparagraphs (A) and (B) would be entitled to conduct (or have conducted) cross-examination and who 

are determined by the Administrator to have the same or similar interests in the proceeding cannot agree upon a single representative of such interests for purposes of cross-examination, 

the Administrator may make rules and rulings (I) limiting the 

representation of such interest for such purposes, and (II) governing the manner in which such cross-examination shall be 

limited. 

ø(ii) When any person who is a member of a group with respect to which the Administrator has made a determination 

under clause (i) is unable to agree upon group representation 

with the other members of the group, then such person shall 

not be denied under the authority of clause (i) the opportunity 

to conduct (or have conducted) cross-examination as to issues 

affecting the person’s particular interests if (I) the person satisfies the Administrator that the person has made a reasonable 

and good faith effort to reach agreement upon group representation with the other members of the group and (II) the Administrator determines that there are substantial and relevant 

issues which are not adequately presented by the group representative. 

ø(D) A verbatim transcript shall be taken of any oral presentation made, and cross-examination conducted in any informal 


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hearing under this subsection. Such transcript shall be available to the public. 

ø(4)(A) The Administrator may, pursuant to rules prescribed by 

the Administrator, provide compensation for reasonable attorneys’ 

fees, expert witness fees, and other costs of participating in a rulemaking proceeding for the promulgation of a rule under subsection 

(a) to any person— 

ø(i) who represents an interest which would substantially 

contribute to a fair determination of the issues to be resolved 

in the proceeding, and 

ø(ii) if— 

ø(I) the economic interest of such person is small in comparison to the costs of effective participation in the proceeding by such person, or 

ø(II) such person demonstrates to the satisfaction of the 

Administrator that such person does not have sufficient resources adequately to participate in the proceeding without 

compensation under this subparagraph. 

In determining for purposes of clause (i) if an interest will substantially contribute to a fair determination of the issues to be resolved 

in a proceeding, the Administrator shall take into account the number and complexity of such issues and the extent to which representation of such interest will contribute to widespread public 

participation in the proceeding and representation of a fair balance 

of interests for the resolution of such issues. 

ø(B) In determining whether compensation should be provided to 

a person under subparagraph (A) and the amount of such compensation, the Administrator shall take into account the financial 

burden which will be incurred by such person in participating in 

the rulemaking proceeding. The Administrator shall take such action as may be necessary to ensure that the aggregate amount of 

compensation paid under this paragraph in any fiscal year to all 

persons who, in rulemaking proceedings in which they receive compensation, are persons who either— 

ø(i) would be regulated by the proposed rule, or 

ø(ii) represent persons who would be so regulated, 

may not exceed 25 per centum of the aggregate amount paid as 

compensation under this paragraph to all persons in such fiscal 

year. 

ø(5) Paragraphs (1), (2), (3), and (4) of this subsection apply to 

the promulgation of a rule repealing, or making a substantive 

amendment to, a rule promulgated under subsection (a). 

ø(d) EFFECTIVE DATE.—(1) The Administrator shall specify in 

any rule under subsection (a) the date on which it shall take effect, 

which date shall be as soon as feasible. 

ø(2)(A) The Administrator may declare a proposed rule under 

subsection (a) to be effective upon its publication in the Federal 

Register and until the effective date of final action taken, in accordance with subparagraph (B), respecting such rule if— 

ø(i) the Administrator determines that— 

ø(I) the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance or mixture subject to such proposed rule or any combination of 

such activities is likely to result in an unreasonable risk 


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of serious or widespread injury to health or the environment before such effective date; and 

ø(II) making such proposed rule so effective is necessary 

to protect the public interest; and 

ø(ii) in the case of a proposed rule to prohibit the manufacture, processing, or distribution of a chemical substance or 

mixture because of the risk determined under clause (i)(I), a 

court has in an action under section 7 granted relief with respect to such risk associated with such substance or mixture. 

Such a proposed rule which is made so effective shall not, for purposes of judicial review, be considered final agency action. 

ø(B) If the Administrator makes a proposed rule effective upon 

its publication in the Federal Register, the Administrator shall, as 

expeditiously as possible, give interested persons prompt notice of 

such action, provide reasonable opportunity, in accordance with 

paragraphs (2) and (3) of subsection (c), for a hearing on such rule, 

and either promulgate such rule (as proposed or with modifications) or revoke it; and if such a hearing is requested, the Administrator shall commence the hearing within five days from the date 

such request is made unless the Administrator and the person 

making the request agree upon a later date for the hearing to 

begin, and after the hearing is concluded the Administrator shall, 

within ten days of the conclusion of the hearing, either promulgate 

such rule (as proposed or with modifications) or revoke it.¿ 

(a) IN GENERAL.—The Administrator— 

(1) shall conduct a safety assessment and make a safety determination of each high-priority substance in accordance with 

subsections (b) and (c); 

(2) shall, as soon as practicable and not later than 6 months 

after the date on which a chemical substance is designated as 

a high-priority substance, define and publish the scope of the 

safety assessment and safety determination to be conducted pursuant to this section, including the hazards, exposures, conditions of use, and potentially exposed or susceptible populations 

that the Administrator expects to consider; 

(3) as appropriate based on the results of a safety determination, shall establish restrictions pursuant to subsection (d); 

(4) shall complete a safety assessment and safety determination not later than 3 years after the date on which a chemical 

substance is designated as a high-priority substance; 

(5) shall promulgate a final rule pursuant to subsection (d) 

by not later than 2 years after the date on which the safety determination is completed; and 

(6) may extend any deadline under øthis subsection¿ paragraph (4) or (5) for a reasonable period of time after an adequate public justification, subject to the condition that the aggregate length of all extensions of deadlines under 

øparagraphs (4) and (5) and¿ this subsection, plus any deferral 

under subsection (c)(2) does not exceed 2 years. 

(b) PRIOR ACTIONS AND NOTICE OF EXISTING INFORMATION.— (1) PRIOR-INITIATED ASSESSMENTS.— (A) IN GENERAL.—Nothing in this Act prevents the Administrator from initiating a safety assessment or safety determination regarding a chemical substance, or from conVerDate Sep 11 2014 05:10 Jun 23, 2015 Jkt 049010 PO 00000 Frm 00085 Fmt 6601 Sfmt 6601 E:\HR\OC\SR067.XXX SR067

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tinuing or completing such a safety assessment or safety determination that was initiated before the date of enactment 

of the Frank R. Lautenberg Chemical Safety for the 21st 

Century Act, prior to the effective date of the policies and 

procedures required to be established by the Administrator 

under section 3A or 4A. 

(B) INTEGRATION OF PRIOR POLICIES AND PROCEDURES.— 

As policies and procedures under section 3A and 4A are established, to the maximum extent practicable, the Administrator shall integrate the policies and procedures into ongoing safety assessments and safety determinations. 

(2) ACTIONS COMPLETED PRIOR TO COMPLETION OF POLICIES

AND PROCEDURES.—Nothing in this Act requires the Administrator to revise or withdraw a completed safety assessment, 

safety determination, or rule solely because the action was 

completed prior to the completion of a policy or procedure established under section 3A or 4A, and the validity of a completed assessment, determination, or rule shall not be determined based on the content of such a policy or procedure. 

(3) NOTICE OF EXISTING INFORMATION.— 

(A) IN GENERAL.—The Administrator shall, where such 

information is available, take notice of existing information 

regarding hazard and exposure published by other Federal 

agencies and the National Academies and incorporate the 

information in safety assessments and safety determinations with the objective of increasing the efficiency of the 

safety assessments and safety determinations. 

(B) INCLUSION OF INFORMATION.—Existing information 

described in subparagraph (A) should be included to the extent practicable and where the Administrator determines 

the information is relevant and scientifically reliable. 

(c) SAFETY DETERMINATIONS.— 

(1) IN GENERAL.—Based on a review of the information available to the Administrator, including draft safety assessments 

submitted by interested persons, and subject to section 18, the 

Administrator shall determine that— 

(A) the relevant chemical substance meets the safety 

standard; 

(B) the relevant chemical substance does not meet the 

safety standard, in which case the Administrator shall, by 

rule under subsection (d)— 

(i) impose restrictions necessary to ensure that the 

chemical substance meets the safety standard under 

the conditions of use; or 

(ii) if the safety standard cannot be met with the application of restrictions, ban or phase out the chemical 

substance, as appropriate; or 

(C) additional information is necessary in order to make 

a determination under subparagraph (A) or (B), in which 

case the Administrator shall take appropriate action under 

paragraph (2). 

(2) ADDITIONAL INFORMATION.—If the Administrator determines that additional information is necessary to make a safety 


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assessment or safety determination for a high-priority substance, the Administrator— 

(A) shall provide an opportunity for interested persons to 

submit the additional information; 

(B) may promulgate a rule, enter into a testing consent 

agreement, or issue an order under section 4 to require the 

development of the information; 

(C) may defer, for a reasonable period consistent with the 

deadlines described in subsection (a), a safety assessment 

and safety determination until after receipt of the information; and 

(D) consistent with the deadlines described in subsection 

(a), on receipt of information the Administrator finds supports the safety assessment and safety determination, shall 

make a determination under paragraph (1). 

(3) ESTABLISHMENT OF DEADLINE.—In requesting the development or submission of information under this section, the Administrator shall establish a deadline for the submission of the 

information. 

(d) RULE.— 

(1) IMPLEMENTATION.—If the Administrator makes a determination under subsection (c)(1)(B) with respect to a chemical 

substance, the Administrator shall promulgate a rule establishing restrictions necessary to ensure that the chemical substance meets the safety standard. 

(2) SCOPE.— (A) IN GENERAL.—The rule promulgated pursuant to this 

subsection— 

(i) may apply to mixtures containing the chemical 

substance, as appropriate; 

(ii) shall include dates by which compliance is mandatory, which— 

(I) shall be as soon as practicable; 

(II) in the case of a ban or phase-out of the 

chemical substance, shall implement the ban or 

phase-out in as short a period as practicable; and 

(III) as determined by the Administrator, may 

vary for different affected persons; and 

(iii) shall exempt replacement parts that are manufactured prior to the effective date of the rule for articles that are first manufactured prior to the effective 

date of the rule unless the Administrator finds the replacement parts contribute significantly to the identified risk; and 

(iv) shall, in selecting among prohibitions and other 

restrictions, apply such prohibitions or other restrictions to articles containing the chemical substance only 

to the extent necessary to address the identified risks in 

order to determine that the chemical substance meets 

the safety standard. 

(B) PERSISTENT AND BIOACCUMULATIVE SUBSTANCES.— For a chemical substance the Administrator determines 

ranks high for persistence and bioaccumulation, the Administrator shall, in selecting among prohibitions and 


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other restrictions that the Administrator determines are 

sufficient to ensure that the chemical substance meets the 

safety standard, reduce exposure to the substance to the 

maximum extent practicable. 

(C) WORKPLACE EXPOSURES.—The Administrator shall 

consult with the Assistant Secretary of Labor for Occupational Safety and Health before adopting any prohibition 

or other restriction under this subsection to address workplace exposures. 

(D) DEFINITION OF REQUIREMENT.—For the purposes of 

this Act, the term ‘requirement’ as used in this section does 

not displace common law. 

(3) RESTRICTIONS.—A restriction under paragraph (1) may include, as appropriate— 

(A) subject to section 18, a requirement that a chemical 

substance shall be marked with, or accompanied by, clear 

and adequate minimum warnings and instructions with respect to use, distribution in commerce, or disposal, or any 

combination of those activities, with the form and content 

of the minimum warnings and instructions to be prescribed 

by the Administrator; 

(B) a requirement that manufacturers or processors of the 

chemical substance shall— 

(i) make and retain records of the processes used to 

manufacture or process the chemical substance; 

(ii) describe and apply the relevant quality control 

procedures followed in the manufacturing or processing 

of the substance; or 

(iii) monitor or conduct tests that are reasonably necessary to ensure compliance with the requirements of 

any rule under this subsection; 

(C) a restriction on the quantity of the chemical substance that may be manufactured, processed, or distributed 

in commerce; 

(D) a requirement to ban or phase out, or any other rule 

regarding, the manufacture, processing, or distribution in 

commerce of the chemical substance for— 

(i) a particular use; 

(ii) a particular use at a concentration in excess of a 

level specified by the Administrator; or 

(iii) all uses; 

(E) a restriction on the quantity of the chemical substance that may be manufactured, processed, or distributed 

in commerce for— 

(i) a particular use; or 

(ii) a particular use at a concentration in excess of a 

level specified by the Administrator; 

(F) a requirement to ban, phase out, or otherwise restrict 

any method of commercial use of the chemical substance; 

(G) a requirement to ban, phase out, or otherwise restrict 

any method of disposal of the chemical substance or any 

article containing the chemical substance; and 

(H) a requirement directing manufacturers or processors 

of the chemical substance to give notice of the AdministraVerDate Sep 11 2014 05:10 Jun 23, 2015 Jkt 049010 PO 00000 Frm 00088 Fmt 6601 Sfmt 6601 E:\HR\OC\SR067.XXX SR067

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tor’s determination under subsection (c)(1)(B) to distributors in commerce of the chemical substance and, to the extent reasonably ascertainable, to other persons in the chain 

of commerce in possession of the chemical substance. 

(4) ANALYSIS FOR RULEMAKING.— (A) CONSIDERATIONS.—In deciding which restrictions to 

impose under paragraph (3) as part of developing a rule 

under paragraph (1), the Administrator shall take into consideration, to the extent practicable based on reasonably 

available information, the quantifiable and nonquantifiable 

costs and benefits of the proposed regulatory action and of 

the 1 or more primary alternative regulatory actions considered by the Administrator. 

(B) ALTERNATIVES.—As part of the analysis, the Administrator shall review any 1 or more technically and economically feasible alternatives to the chemical substance 

that the Administrator determines are relevant to the 

rulemaking. 

(C) PUBLIC AVAILABILITY.—In proposing a rule under 

paragraph (1), the Administrator shall make publicly 

available any analysis conducted under this paragraph. 

(D) STATEMENT REQUIRED.—In making final a rule under 

paragraph (1), the Administrator shall include a statement 

describing how the analysis considered under subparagraph (A) was taken into account. 

(5) EXEMPTIONS.— (A) IN GENERAL.—The Administrator may exempt 1 or 

more uses of a chemical substance from any restriction in 

a rule promulgated under paragraph (1) if the Administrator determines that— 

(i) the rule cannot be complied with, without— 

(I) harming national security; 

(II) causing significant disruption in the national economy due to the lack of availability of a 

chemical substance; or 

(III) interfering with a critical or essential use 

for which no technically and economically feasible 

safer alternative is available, taking into consideration hazard and exposure; or 

(ii) the use of the chemical substance, as compared to 

reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety. 

(B) EXEMPTION ANALYSIS.—In proposing a rule under 

paragraph (1) that includes an exemption under this paragraph, the Administrator shall make publicly available any 

analysis conducted under this paragraph to assess the need 

for the exemption. 

(C) STATEMENT REQUIRED.—In making final a rule under 

paragraph (1) that includes an exemption under this paragraph, the Administrator shall include a statement describing how the analysis considered under subparagraph (B) 

was taken into account. 

(D) ANALYSIS IN CASE OF BAN OR PHASE-OUT.—In determining whether an exemption should be granted under this 


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paragraph for a chemical substance for which a ban or 

phase-out is proposed, the Administrator shall take into 

consideration, to the extent practicable based on reasonably 

available information, the quantifiable and nonquantifiable 

costs and benefits of the 1 or more technically and economically feasible alternatives to the chemical substance most 

likely to be used in place of the chemical substance under 

the conditions of use if the rule is promulgated. 

(E) CONDITIONS.—As part of a rule promulgated under 

paragraph (1), the Administrator shall include conditions 

in any exemption established under this paragraph, including reasonable recordkeeping, monitoring, and reporting requirements, to the extent that the Administrator determines 

the conditions are necessary to protect health and the environment while achieving the purposes of the exemption. 

(F) DURATION.— 

(i) IN GENERAL.—The Administrator shall establish, 

as part of a rule under paragraph (1) that contains an 

exemption under this paragraph, a time limit on any 

exemption for a time to be determined by the Administrator as reasonable on a case-by-case basis. 

(ii) AUTHORITY OF ADMINISTRATOR.—The Administrator, by rule, may extend, modify, or eliminate the exemption if the Administrator determines, on the basis 

of reasonably available information and after adequate 

public justification, the exemption warrants extension 

or is no longer necessary. 

(iii) CONSIDERATIONS.— (I) IN GENERAL.—Subject to subclause (II), the 

Administrator shall issue exemptions and establish 

time periods by considering factors determined by 

the Administrator to be relevant to the goals of fostering innovation and the development of alternatives that meet the safety standard. 

(II) LIMITATION.—Any renewal of an exemption 

in the case of a rule requiring the ban or phaseout of a chemical substance shall not exceed 5 

years. 

(e) IMMEDIATE EFFECT.—The Administrator may declare a proposed rule under subsection (d)(1) to be effective on publication of 

the rule in the Federal Register and until the effective date of final 

action taken respecting the rule, if— 

(1) the Administrator determines that— 

(A) the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance or mixture 

subject to the proposed rule or any combination of those activities is likely to result in a risk of serious or widespread 

injury to health or the environment before the effective date; 

and 

(B) making the proposed rule so effective is necessary to 

protect the public interest; and 

(2) in the case of a proposed rule to prohibit the manufacture, 

processing, or distribution in commerce of a chemical substance 

or mixture because of the risk determined under paragraph 


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(1)(A), a court has granted relief in an action under section 7 

with respect to that risk associated with the chemical substance or mixture. 

(f) FINAL AGENCY ACTION.—Under this section and subject to section 18— 

(1) a safety determination, and the associated safety assessment, for a chemical substance that the Administrator determines under subsection (c) meets the safety standard, shall be 

considered to be a final agency action, effective beginning on the 

date of issuance of the final safety determination; and 

(2) a final rule promulgated under subsection (d)(1), and the 

associated safety assessment and safety determination that a 

chemical substance does not meet the safety standard, shall be 

considered to be a final agency action, effective beginning on the 

date of promulgation of the final rule. 

ø(e)¿ (g) POLYCHLORINATED BIPHENYLS.—(1) Within six months 

after the effective date of this Act the Administrator shall promulgate rules to— 

(A) prescribe methods for the disposal of polychlorinated 

biphenyls, and 

(B) require polychlorinated biphenyls to be marked with 

clear and adequate warnings, and instructions with respect to 

their processing, distribution in commerce, use, or disposal or 

with respect to any combination of such activities. 

Requirements prescribed by rules under this paragraph shall be 

consistent with the requirements of paragraphs (2) and (3). 

(2)(A) Except as provided under subparagraph (B), effective one 

year after the effective date of this Act no person may manufacture, process, or distribute in commerce or use any polychlorinated 

biphenyl in any manner other than in a totally enclosed manner. 

(B) The Administrator may by rule authorize the manufacture, 

processing, distribution in commerce or use (or any combination of 

such activities) of any polychlorinated biphenyl in a manner other 

than in a totally enclosed manner if the Administrator finds that 

such manufacture, processing, distribution in commerce, or use (or 

combination of such activities) will not present an unreasonable 

risk of injury to health or the environment. 

(C) For the purposes of this paragraph, the term ‘‘totally enclosed 

manner’’ means any manner which will ensure that any exposure 

of human beings or the environment by the polychlorinated 

biphenyl will be insignificant as determined by the Administrator 

by rule. 

(3)(A) Except as provided in subparagraphs (B), (C), and (D)— 

(i) no person may manufacture any polychlorinated biphenyl 

after two years after the effective date of this Act, and 

(ii) no person may process or distribute in commerce any polychlorinated biphenyl after two and one-half years after such 

date. 

(B) Any person may petition the Administrator for an exemption 

from the requirements of subparagraph (A), and the Administrator 

may grant by rule such an exemption if the Administrator finds 

that— 

(i) an unreasonable risk of injury to health or environment 

would not result, and 


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4Section 317(a) of Public Law 109–364 (120 Stat. 2142) amends paragraph (3) of section 6(e). 

Subsection (b) of section 317 of such Public Law provides as follows: 

(b) SUNSET DATE.—The amendments made by subsection (a) shall cease to have effect on September 30, 2012. The termination of the authority to grant exemptions pursuant to such amendments shall not effect the validity of any exemption granted prior to such date. 

(ii) good faith efforts have been made to develop a chemical 

substance which does not present an unreasonable risk of injury to health or the environment and which may be substituted for such polychlorinated biphenyl. 

An exemption granted under this subparagraph shall be subject to 

such terms and conditions as the Administrator may prescribe and 

shall be in effect for such period (but not more than 1 year from 

the date it is granted, except as provided in subparagraph (D)) as 

the Administrator may prescribe. 

(C) Subparagraph (A) shall not apply to the distribution in commerce of any polychlorinated biphenyl if such polychlorinated 

biphenyl was sold for purposes other than resale before two and 

one-half years after the date of enactment of this Act. 

(D) 4 The Administrator may extend an exemption granted pursuant to subparagraph (B) that has not yet expired for a period not 

to exceed 60 days for the purpose of authorizing the Secretary of 

Defense and the Secretaries of the military departments to provide 

for the transportation into the customs territory of the United 

States of polychlorinated biphenyls generated by or under the control of the Department of Defense for purposes of their disposal, 

treatment, or storage in the customs territory of the United States 

if those polychlorinated biphenyls are already in transit from their 

storage locations but the Administrator determines, in the sole discretion of the Administrator, they would not otherwise arrive in the 

customs territory of the United States within the period of the 

original exemption. The Administrator shall promptly publish notice of such extension in the Federal Register.¿ 

ø(4) Any rule under paragraph (1), (2)(B), or (3)(B) shall be promulgated in accordance with paragraphs (2), (3), and (4) of subsection (c).¿ 

ø(5)¿ (4) This subsection does not limit the authority of the Administrator, under any other provision of this Act or any other Federal law, to take action respecting any polychlorinated biphenyl. 

ø(f)¿ (h) MERCURY.— 

(1) PROHIBITION ON SALE, DISTRIBUTION, OR TRANSFER OF

ELEMENTAL MERCURY BY FEDERAL AGENCIES.—Except as provided in paragraph (2), effective beginning on the date of enactment of this subsection, no Federal agency shall convey, 

sell, or distribute to any other Federal agency, any State or 

local government agency, or any private individual or entity 

any elemental mercury under the control or jurisdiction of the 

Federal agency. 

(2) EXCEPTIONS.—Paragraph (1) shall not apply to— 

(A) a transfer between Federal agencies of elemental 

mercury for the sole purpose of facilitating storage of mercury to carry out this Act; or 

(B) a conveyance, sale, distribution, or transfer of coal. 

(3) LEASES OF FEDERAL COAL.—Nothing in this subsection 

prohibits the leasing of coal. 


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SEC. 7. IMMINENT HAZARDS. 

ø(a) ACTIONS AUTHORIZED AND REQUIRED.—(1) The Administrator may commence a civil action in an appropriate district court 

of the United States— 

ø(A) for seizure of an imminently hazardous chemical substance or mixture or any article containing such a substance 

or mixture, 

ø(B) for relief (as authorized by subsection (b)) against any 

person who manufactures, processes, distributes in commerce, 

or uses, or disposes of, an imminent hazardous chemical substance or mixture or any article containing such a substance 

or mixture, or 

ø(C) for both such seizure and relief. 

A civil action may be commenced under this paragraph notwithstanding the existence of a rule under section 4, 5, 6, or title IV 

or an order under section 5 or title IV, and notwithstanding the 

pendency of any administrative or judicial proceeding under any 

provision of this Act. 

ø(2) If the Administrator has not made a rule under section 6(a) 

immediately effective (as authorized by subsection 6(d)(2)(A)(i)) 

with respect to an imminently hazardous chemical substance or 

mixture, the Administrator shall commence in a district court of 

the United States with respect to such substance or mixture or article containing such substance or mixture a civil action described 

in subparagraph (A), (B), or (C) of paragraph (1).¿ 

(a) CIVIL ACTIONS.— 

(1) IN GENERAL.—The Administrator may commence a civil 

action in an appropriate United States district court for— 

(A) seizure of an imminently hazardous chemical substance or mixture or any article containing the chemical 

substance or mixture; 

(B) relief (as authorized by subsection (b)) against any 

person that manufactures, processes, distributes in commerce, uses, or disposes of, an imminently hazardous chemical substance or mixture or any article containing the 

chemical substance or mixture; or 

(C) both seizure described in subparagraph (A) and relief 

described in subparagraph (B). 

(2) RULE, ORDER, OR OTHER PROCEEDING.—A civil action may 

be commenced under this paragraph, notwithstanding— 

(A) the existence of a decision, rule, consent agreement, or 

order by the Administrator under section 4, 4A, 5, or 6 or 

title IV or VI; or 

(B) the pendency of any administrative or judicial proceeding under any provision of this Act. 

(b) RELIEF AUTHORIZED.—(1) The district court of the United 

States in which an action under subsection (a) is brought shall 

have jurisdiction to grant such temporary or permanent relief as 

may be necessary to protect health or the environment from the 

øunreasonable¿ risk associated with the chemical substance, mixture, or article involved in such action. 

(2) In the case of an action under subsection (a) brought against 

a person who manufactures, processes, or distributes in commerce 

a chemical substance or mixture or an article containing a chemical 


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5 In Public Law 94–469, the word ‘‘subpoenas’’ is spelled ‘‘subpeonas’’. The spelling is corrected 

in this print to reflect the probable intent of Congress. 

substance or mixture, the relief authorized by paragraph (1) may 

include the issuance of a mandatory order requiring (A) in the case 

of purchasers of such substance, mixture, or article known to the 

defendant, notification to such purchasers of the risk associated 

with it; (B) public notice of such risk; (C) recall; (D) the replacement or repurchase of such substance, mixture, or article; or (E) 

any combination of the actions described in the preceding clauses. 

(3) In the case of an action under subsection (a) against a chemical substance, mixture, or article, such substance, mixture, or article may be proceeded against by process of libel for its seizure and 

condemnation. Proceedings in such an action shall conform as nearly as possible to proceedings in rem in admiralty. 

(c) VENUE AND CONSOLIDATION.—(1)(A) An action under subsection (a) against a person who manufactures, processes, or distributes a chemical substance or mixture or an article containing 

a chemical substance or mixture may be brought in the United 

States District Court for the District of Columbia or for any judicial 

district in which any of the defendants is found, resides, or transacts business; and process in such an action may be served on a 

defendant in any other district in which such defendant resides or 

may be found. An action under subsection (a) against a chemical 

substance, mixture, or article may be brought in any United States 

district court within the jurisdiction of which the substance, mixture, or article is found. 

(B) In determining the judicial district in which an action may 

be brought under subsection (a) in instances in which such action 

may be brought in more than one judicial district, the Administrator shall take into account the convenience of the parties. 

(C) Subpoenas 5 requiring attendance of witnesses in an action 

brought under subsection (a) may be served in any judicial district. 

(2) Whenever proceedings under subsection (a) involving identical 

chemical substances, mixtures, or articles are pending in courts in 

two or more judicial districts, they shall be consolidated for trial by 

order of any such court upon application reasonably made by any 

party in interest, upon notice to all parties in interest. 

(d) ACTION UNDER SECTION 6.—Where appropriate, concurrently 

with the filing of an action under subsection (a) or as soon thereafter as may be practicable, the Administrator shall initiate a proceeding for the promulgation of a rule under øsection 6(a)¿ section 

ø6(c)¿ 6(d). 

(e) REPRESENTATION.—Notwithstanding any other provision of 

law, in any action under subsection (a), the Administrator may direct attorneys of the Environmental Protection Agency to appear 

and represent the Administrator in such an action. 

(f) DEFINITION.—For the purposes of subsection (a), the term ‘‘imminently hazardous chemical substance or mixture’’ means a chemical substance or mixture which presents an imminent øand unreasonable¿ risk of serious or widespread injury to health or the environment. Such a risk to health or the environment shall be considered imminent if it is shown that the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance 


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or mixture, or that any combination of such activities, is likely to 

result in such injury to health or the environment before a final 

rule under section 6 can protect against such risk. 

SEC. 8. REPORTING AND RETENTION OF INFORMATION. 

(a) REPORTS.—(1) The Administrator shall promulgate rules 

under which— 

(A) each person (other than a small manufacturer or processor) who manufactures or processes or proposes to manufacture or process a chemical substance (other than a chemical 

substance described in subparagraph (B)(ii) shall maintain 

such records, and shall submit to the Administrator such reports, as the Administrator may reasonably require, and 

(B) each person (other than a small manufacturer or processor) who manufactures or processes or proposes to manufacture or process— 

(i) a mixture, or 

(ii) a chemical substance in small quantities (as defined 

by the Administrator by rule) solely for purposes of scientific experimentation or analysis or chemical research 

on, or analysis of, such substance or another substance, including any such research or analysis for the development 

of a product, 

shall maintain records and submit to the Administrator reports 

but only to the extent the Administrator determines the maintenance of records or submission of reports, or both, is necessary for the effective enforcement of this Act. 

The Administrator may not require in a rule promulgated under 

this paragraph the maintenance of records or the submission of reports with respect to changes in the proportions of the components 

of a mixture unless the Administrator finds that the maintenance 

of such records or the submission of such reports, or both, is necessary for the effective enforcement of this Act. For purposes of the 

compilation of the list of chemical substances required under subsection (b), the Administrator shall promulgate rules pursuant to 

this subsection not later than 180 days after the effective date of 

this Act. 

(2) The Administrator may require under paragraph (1) maintenance of records and reporting with respect to the following insofar 

as known to the person making the report or insofar as reasonably 

ascertainable: 

(A) The common or trade name, the chemical identity, and 

molecular structure of each chemical substance or mixture for 

which such a report is required. 

(B) The categories or proposed categories of use of each such 

substance or mixture. 

(C) The total amount of each substance and mixture manufactured or processed, reasonable estimates of the total amount 

to be manufactured or processed, the amount manufactured or 

processed for each of its categories of use, and reasonable estimates of the amount to be manufactured or processed for each 

of its categories of use or proposed categories of use. 

(D) A description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or 

mixture. 


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(E) All existing data concerning the environmental and 

health effects of such substance or mixture. 

(F) The number of individuals exposed, and reasonable estimates of the number who will be exposed, to such substance 

or mixture in their places of employment and the duration of 

such exposure. 

(G) In the initial report under paragraph (1) on such substance or mixture, the manner or method of its disposal, and 

in any subsequent report on such substance or mixture, any 

change in such manner or method. 

To the extent feasible, the Administrator shall not require under 

paragraph (1), any reporting which is unnecessary or duplicative. 

(3)(A)(i) The Administrator may by rule require a small manufacturer or processor of a chemical substance to submit to the Administrator such information respecting the chemical substance as the 

Administrator may require for publication of the first list of chemical substances required by subsection (b). 

(ii) The Administrator may by rule require a small manufacturer 

or processor of a chemical substance or mixture— 

(I) subject to a rule proposed or promulgated under section 

4, ø5(b)(4)¿ 5, or 6, or an order in effect under section 4 or section ø5(e),¿ 5(d)(4) or 

(II) with respect to which relief has been granted pursuant 

to a civil action brought under section 5 or 7, 

to maintain such records on such substance or mixture, and to submit to the Administrator such reports on such substance or mixture, as the Administrator may reasonably require. A rule under 

this clause requiring reporting may require reporting with respect 

to the matters referred to in paragraph (2). 

(B) The Administrator, after consultation with the Administrator 

of the Small Business Administration, shall by rule prescribe 

standards for determining the manufacturers and processors which 

qualify as small manufacturers and processors for purposes of this 

paragraph and paragraph (1). 

(4) RULES.— (A) DEADLINE.— (i) IN GENERAL.—Not later than 2 years after the 

date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator 

shall promulgate rules requiring the maintenance of 

records and the reporting of information known or reasonably ascertainable by the person making the report, 

including rules requiring processors to report information, so that the Administrator has the information 

necessary to carry out sections 4 and 6. 

(ii) MODIFICATION OF PRIOR RULES.—In carrying out 

this subparagraph, the Administrator may modify, as 

appropriate, rules promulgated before the date of enactment of the Frank R. Lautenberg Chemical Safety 

for the 21st Century Act. 

(B) CONTENTS.—The rules promulgated pursuant to subparagraph (A)— 

(i) may impose different reporting and recordkeeping 

requirements on manufacturers and processors; and 


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(ii) shall include the level of detail necessary to be reported, including the manner by which use and exposure information may be reported. 

(C) ADMINISTRATION.—In implementing the reporting 

and recordkeeping requirements under this paragraph, the 

Administrator shall take measures— 

(i) to limit the potential for duplication in reporting 

requirements; 

(ii) to minimize the impact of the rules on small 

manufacturers and processors; and 

(iii) to apply any reporting obligations to those persons likely to have information relevant to the effective 

implementation of this title. 

(5) GUIDANCE.—The Administrator shall develop guidance relating to the information required to be reported under the rules 

promulgated under this subsection. 

(b) INVENTORY.—(1) The Administrator shall compile, keep current, and publish a list of each chemical substance which is manufactured or processed in the United States. Such list shall at least 

include each chemical substance which any person reports, under 

section 5 or subsection (a) of this section, is manufactured or processed in the United States. Such list may not include any chemical 

substance which was not manufactured or processed in the United 

States within three years before the effective date of the rules promulgated pursuant to the last sentence of subsection (a)(1). In the 

case of a chemical substance for which a notice is submitted in accordance with section 5, such chemical substance shall be included 

in such list as of the earliest date (as determined by the Administrator) on which such substance was manufactured or processed in 

the United States. The Administrator shall first publish such a list 

not later than 315 days after the effective date of this Act. The Administrator shall not include in such list any chemical substance 

which is manufactured or processed only in small quantities (as defined by the Administrator by rule) solely for purposes of scientific 

experimentation or analysis or chemical research on, or analysis of, 

such substance or another substance, including such research or 

analysis for the development of a product. 

(2) To the extent consistent with the purposes of this Act, the Administrator may, in lieu of listing, pursuant to paragraph (1), a 

chemical substance individually, list a category of chemical substances in which such substance is included. 

(3) NOMENCLATURE.— 

(A) IN GENERAL.—In carrying out paragraph (1), the Administrator shall— 

(i) maintain the use of Class 2 nomenclature in use 

on the date of enactment of the Frank R. Lautenberg 

Chemical Safety for the 21st Century Act; 

(ii) maintain the use of the Soap and Detergent Association Nomenclature System, published in March 

1978 by the Administrator in section 1 of addendum 

III of the document entitled ‘Candidate List of Chemical Substances’, and further described in the appendix 

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stances Control Act Substances Inventory (EPA Document No. EPA–560/7–85–002a); and 

(iii) treat all components of categories that are considered to be statutory mixtures under this Act as being 

included on the list published under paragraph (1) 

under the Chemical Abstracts Service numbers for the 

respective categories, including, without limitation— 

(I) cement, Portland, chemicals, CAS No. 65997– 

15–1; 

(II) cement, alumina, chemicals, CAS No. 

65997–16–2; 

(III) glass, oxide, chemicals, CAS No. 65997–17– 

3; 

(IV) frits, chemicals, CAS No. 65997–18–4; 

(V) steel manufacture, chemicals, CAS No. 

65997–19–5; and 

(VI) ceramic materials and wares, chemicals, 

CAS No. 66402–68–4. 

(B) MULTIPLE NOMENCLATURE CONVENTIONS.— 

(i) IN GENERAL.—If an existing guidance allows for 

multiple nomenclature conventions, the Administrator 

shall— 

(I) maintain the nomenclature conventions for 

substances; and 

(II) develop new guidance that— 

(aa) establishes equivalency between the nomenclature conventions for chemical substances on the list published under paragraph 

(1); and 

(bb) permits persons to rely on the new guidance for purposes of determining whether a 

chemical substance is on the list published 

under paragraph (1). 

(ii) MULTIPLE CAS NUMBERS.—For any chemical substance appearing multiple times on the list under different Chemical Abstracts Service numbers, the Administrator shall develop guidance recognizing the multiple listings as a single chemical substance. 

(4) CHEMICAL SUBSTANCES IN COMMERCE.— (A) RULES.— 

(i) IN GENERAL.—Not later than 1 year after the date 

of enactment of the Frank R. Lautenberg Chemical 

Safety for the 21st Century Act, the Administrator, by 

rule, shall require manufacturers and processors to notify the Administrator, by not later than 180 days after 

the date of promulgation of the rule, of each chemical 

substance on the list published under paragraph (1) 

that the manufacturer or processor, as applicable, has 

manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the 

day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. 

(ii) ACTIVE SUBSTANCES.—The Administrator shall, 

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stances for which notices are received under clause (i) 

to be active substances on the list published under 

paragraph (1). 

(B) CONFIDENTIAL CHEMICAL SUBSTANCES.—The rule promulgated by the Administrator pursuant to subparagraph 

(A) shall require— 

(i) the Administrator to maintain the list under 

paragraph (1), which shall include a confidential portion and a nonconfidential portion consistent with this 

section and section 14; 

(ii) a manufacturer or processor that is submitting a 

notice pursuant to subparagraph (A) for a chemical 

substance on the confidential portion of the list published under paragraph (1) to indicate in the notice 

whether the manufacturer or processor seeks to maintain any existing claim for protection against disclosure of the specific identity of the substance as confidential pursuant to section 14; and 

(iii) the substantiation of those claims pursuant to 

section 14 and in accordance with the review plan described in subparagraph (C). 

(C) REVIEW PLAN.—Not later than 1 year after the date 

on which the Administrator compiles the initial list of active substances pursuant to subparagraph (A), the Administrator shall promulgate a rule that establishes a plan to review all claims to protect the specific identities of chemical 

substances on the confidential portion of the list published 

under paragraph (1) that are notified pursuant to subparagraph (A) or identified as active substances under subsection (f)(1). 

(D) REQUIREMENTS OF REVIEW PLAN.—The review plan 

under subparagraph (C) shall— 

(i) require, at the time requested by the Administrator, all manufacturers or processors asserting claims 

under subparagraph (B) to substantiate the claim unless the manufacturer or processor has substantiated 

the claim in a submission made to the Administrator 

during the 5-year period ending on the date of the request by the Administrator; 

(ii) require the Administrator, in accordance with 

section 14— 

(I) to review each substantiation— 

(aa) submitted pursuant to clause (i) to determine if the claim warrants protection from 

disclosure; and 

(bb) submitted previously by a manufacturer 

or processor and relied on in lieu of the substantiation required pursuant to clause (i), if 

the substantiation has not been previously reviewed by the Administrator, to determine if 

the claim warrants protection from disclosure; 

(II) approve, modify, or deny each claim; and 

(III) except as provided in this section and section 14, protect from disclosure information for 


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which the Administrator approves such a claim for 

a period of 10 years, unless, prior to the expiration 

of the period— 

(aa) the person notifies the Administrator 

that the person is withdrawing the confidentiality claim, in which case the Administrator 

shall promptly make the information available 

to the public; or 

(bb) the Administrator otherwise becomes 

aware that the need for protection from disclosure can no longer be substantiated, in which 

case the Administrator shall take the actions 

described in section 14(g)(2); and 

(iii) encourage manufacturers or processors that have 

previously made claims to protect the specific identities 

of chemical substances identified as inactive pursuant 

to subsection (f)(2) to review and either withdraw or 

substantiate the claims. 

(E) TIMELINE FOR COMPLETION OF REVIEWS.— 

(i) IN GENERAL.—The Administrator shall implement 

the review plan so as to complete reviews of all claims 

specified in subparagraph (C) not later than 5 years 

after the date on which the Administrator compiles the 

initial list of active substances pursuant to subparagraph (A). 

(ii) CONSIDERATIONS.— (I) IN GENERAL.—The Administrator may extend 

the deadline for completion of the reviews for not 

more than 2 additional years, after an adequate 

public justification, if the Administrator determines that the extension is necessary based on the 

number of applicable claims needing review and 

the available resources. 

(II) ANNUAL GOAL.—The Administrator shall 

publish an annual goal for the number of reviews 

to be completed over the course of implementation 

of the plan. 

(5) ACTIVE AND INACTIVE SUBSTANCES.— (A) IN GENERAL.—The Administrator shall maintain and 

keep current designations of active substances and inactive 

substances on the list published under paragraph (1). 

(B) UPDATE.—The Administrator shall update the list of 

chemical substances designated as active substances as 

soon as practicable after the date of publication of the most 

recent data reported under— 

(i) part 711 of title 40, Code of Federal Regulations 

(or successor regulations); and 

(ii) the rules promulgated pursuant to subsection 

(a)(4). 

(C) CHANGE TO ACTIVE STATUS.— (i) IN GENERAL.—Any person that intends to manufacture or process for a nonexempt commercial purpose 

a chemical substance that is designated as an inactive 

substance shall notify the Administrator before the 


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date on which the inactive substance is manufactured 

or processed. 

(ii) CONFIDENTIAL CHEMICAL IDENTITY CLAIMS.—If a 

person submitting a notice under clause (i) for an inactive substance on the confidential portion of the list 

published under paragraph (1) seeks to maintain an 

existing claim for protection against disclosure of the 

specific identity of the inactive substance as confidential, the person shall— 

(I) in the notice submitted under clause (i), assert the claim; and 

(II) by not later than 30 days after providing the 

notice under clause (i), substantiate the claim. 

(iii) ACTIVE STATUS.—On receiving a notification 

under clause (i), the Administrator shall— 

(I) designate the applicable chemical substance 

as an active substance; 

(II) pursuant to section 14, promptly review any 

claim and associated substantiation submitted 

pursuant to clause (ii) for protection against disclosure of the specific identity of the chemical substance and approve, modify, or deny the claim; 

(III) except as provided in this section and section 14, protect from disclosure the specific identity 

of the chemical substance for which the Administrator approves a claim under subclause (II) for a 

period of not less than 10 years, unless, prior to 

the expiration of the period— 

(aa) the person notifies the Administrator 

that the person is withdrawing the confidentiality claim, in which case the Administrator 

shall promptly make the information available 

to the public; or 

(bb) the Administrator otherwise becomes 

aware that the need for protection from disclosure can no longer be substantiated, in which 

case the Administrator shall take the actions 

described in section 14(g)(2); and 

(IV) pursuant to section 4A, review the priority 

of the chemical substance as the Administrator determines to be necessary. 

(D) CATEGORY STATUS.—The list of inactive substances 

shall not be considered to be a category for purposes of section 26(c). 

(6) INTERIM LIST OF ACTIVE SUBSTANCES.—Prior to the promulgation of the rule required under øthis subsection¿ paragraph (4)(A), the Administrator shall designate the chemical 

substances reported under part 711 of title 40, Code of Federal 

Regulations (or successor regulations), during the reporting period that most closely preceded the date of enactment of the 

Frank R. Lautenberg Chemical Safety for the 21st Century 

Act, as the interim list of active substances for the purposes of 

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(7) PUBLIC PARTICIPATION.—Subject to this subsection, the 

Administrator shall make available to the public— 

(A) the specific identity of each chemical substance on the 

nonconfidential portion of the list published under paragraph (1) that the Administrator has designated as— 

(i) an active substance; or 

(ii) an inactive substance; 

(B) the accession number, generic name, and, if applicable, premanufacture notice case number for each chemical 

substance on the confidential portion of the list published 

under paragraph (1) for which a claim of confidentiality 

was received and approved by the Administrator pursuant 

to section 14; and 

(C) subject to section 14(g), the specific identity of any active substance for which— 

(i) no claim of protection against disclosure of the 

specific identity of the active substance pursuant to this 

subsection was received; 

(ii) a claim for protection against disclosure of the 

specific identity of the active substance has been denied 

by the Administrator; or 

(iii) the time period for protection against disclosure 

of the specific identity of the active substance has expired. 

(8) LIMITATION.—No person may assert a new claim under 

this subsection for protection from disclosure of a specific identity of any active or inactive chemical substance for which a notice is received under paragraph (4)(A)(i) or (5)(C)(i) that is not 

on the confidential portion of the list published under paragraph (1). 

(9) CERTIFICATION.—Under the ørule¿ rules promulgated 

under this subsection, manufacturers and processors shall be 

required— 

(A) to certify that each report the manufacturer or processor submits complies with the requirements of the rule, 

and that any confidentiality claims are true and correct; 

and 

(B) to retain a record supporting the certification for a 

period of 5 years beginning on the last day of the submission period. 

* * * * * * * 

(e) NOTICE TO ADMINISTRATOR OF SUBSTANTIAL RISKS.—øAny 

person¿ 

(1) IN GENERAL.—Any person who manufactures, processes, 

or distributes in commerce a chemical substance or mixture 

and who obtains information which reasonably supports the 

conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of such information unless 

such person has actual knowledge that the Administrator has 

been adequately informed of such information. 

(2) APPLICABILITY.—Any person may submit to the Administrator information reasonably supporting the conclusion that a 

chemical substance or mixture presents, will present, or does 


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not present a substantial risk of injury to health and the environment. 

(f) DEFINITIONS.—øFor purposes of this section, the¿ In this section: 

(1) ACTIVE SUBSTANCE.—The term ‘active substance’ means a 

chemical substance— 

(A) that has been manufactured or processed for a nonexempt commercial purpose at any point during the 10-year 

period ending on the date of enactment of the Frank R. 

Lautenberg Chemical Safety for the 21st Century Act; 

(B) that is added to the list published under subsection 

(b)(1) after that date of enactment; or 

(C) for which a notice is received under subsection 

(b)(5)(C). 

(2) INACTIVE SUBSTANCE.—The term ‘inactive substance’ 

means a chemical substance on the list published under subsection (b)(1) that does not meet any of the criteria described in 

paragraph (1). 

(3) MANUFACTURE; PROCESS.—Theterms ‘‘manufacture’’ and 

‘‘process’’ mean manufacture or process for commercial purposes. 

SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS. 

(a) LAWS NOT ADMINISTERED BY THE ADMINISTRATOR.—(1) If the 

Administrator has reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a 

chemical substance or mixture, or that any combination of such activities, øpresents or will present an unreasonable risk of injury to 

health or the environment¿ does not meet the safety standard and 

determines, in the Administrator’s discretion, that øsuch risk¿ the 

risk posed by the substance or mixture may be prevented or reduced 

to a sufficient extent by action taken under a Federal law not administered by the Administrator, the Administrator shall submit to 

the agency which administers such law a report which describes 

such risk and includes in such description a specification of the activity or combination of activities which the Administrator has reason to believe so presents such risk. Such report shall also request 

such agency— 

(A)(i) to determine if the risk described in such report may 

be prevented or reduced to a sufficient extent by action taken 

under such law, and 

(ii) if the agency determines that such risk may be so prevented or reduced, to issue an order declaring whether or not 

the activity or combination of activities specified in the description of such risk presents such risk; and 

(B) to respond to the Administrator with respect to the matters described in subparagraph (A). 

Any report of the Administrator shall include a detailed statement 

of the information on which it is based and shall be published in 

the Federal Register. The agency receiving a request under such a 

report shall make the requested determination, issue the requested 

order, and make the requested response within such time as the 

Administrator specifies in the request, but such time specified may 

not be less than 90 days from the date the request was made. The 

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ment of the findings and conclusions of the agency and shall be 

published in the Federal Register. 

(2) If the Administrator makes a report under paragraph (1) with 

respect to a chemical substance or mixture and the agency to which 

such report was made either— 

(A) issues an order declaring that the activity or combination 

of activities specified in the description of the risk described in 

the report does not present the risk described in the report, or 

(B) initiates, within 90 days of the publication in the Federal 

Register of the response of the agency under paragraph (1), action under the law (or laws) administered by such agency to 

protect against such risk associated with such activity or combination of activities, 

the Administrator may not take any action under øsection 6 or 7¿ 

section 6(d) or section 7 with respect to such risk. 

(3) If the Administrator has initiated action under øsection 6 or 

7¿ section 6(d) or 7 with respect to a risk associated with a chemical substance or mixture which was the subject of a report made 

to an agency under paragraph (1), such agency shall before taking 

action under the law (or laws) administered by it to protect against 

such risk consult with the Administrator for the purpose of avoiding duplication of Federal action against such risk. 

(b) LAWS ADMINISTERED BY THE ADMINISTRATOR.—The Administrator shall coordinate actions taken under this Act with actions 

taken under other Federal laws administered in whole or in part 

by the Administrator. If the Administrator determines that a risk 

to health or the environment associated with a chemical substance 

or mixture could be eliminated or reduced to a sufficient extent by 

actions taken under the authorities contained in such other Federal 

laws, the Administrator shall use such authorities to protect 

against such risk unless the Administrator determines, in the Administrator’s discretion, that it is in the public interest to protect 

against such risk by actions taken under this Act. This subsection 

shall not be construed to relieve the Administrator of any requirement imposed on the Administrator by such other Federal laws. 

(c) OCCUPATIONAL SAFETY AND HEALTH.—In exercising any authority under this Act, the Administrator shall not, for purposes of 

section 4(b)(1) of the Occupational Safety and Health Act of 1970, 

be deemed to be exercising statutory authority to prescribe or enforce standards or regulations affecting occupational safety and 

health. 

(d) COORDINATION.—In administering this Act, the Administrator 

shall consult and coordinate with the Secretary of øHealth, Education, and Welfare¿ Health and Human Services and the heads of 

any other appropriate Federal executive department or agency, any 

relevant independent regulatory agency, and any other appropriate 

instrumentality of the Federal Government for the purpose of 

achieving the maximum enforcement of this Act while imposing the 

least burdens of duplicative requirements on those subject to the 

Act and for other purposes. The Administrator shall, in the report 

required by section 30, report annually to the Congress on actions 

taken to coordinate with such other Federal departments, agencies, 

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ity under this Act with the authority granted under other Acts referred to in subsection (b). 

(e) EXPOSURE INFORMATION.—If the Administrator obtains information related to exposures or releases of a chemical substance that 

may be prevented or reduced under another Federal law, including 

laws not administered by the Administrator, the Administrator 

shall make such information available to the relevant Federal agency or office of the Environmental Protection Agency. 

SEC. 10. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION 

AND UTILIZATION OF DATA. 

(a) AUTHORITY.—The Administrator shall, in consultation and cooperation with the Secretary of øHealth, Education, and Welfare¿ 

Health and Human Services and with other heads of appropriate 

departments and agencies, conduct such research, development, 

and monitoring as is necessary to carry out the purposes of this 

Act. The Administrator may enter into contracts and may make 

grants for research, development, and monitoring under this subsection. Contracts may be entered into under this subsection without regard to sections 3648 and 3709 of the Revised Statutes (31 

U.S.C. 529, 14 U.S.C. 5). 

(b) DATA SYSTEMS.—(1) The Administrator shall establish, administer, and be responsible for the continuing activities of an 

interagency committee which shall design, establish, and coordinate an efficient and effective system, within the Environmental 

Protection Agency, for the collection, dissemination to other Federal 

departments and agencies, and use of data submitted to the Administrator under this Act. 

(2)(A) The Administrator shall, in consultation and cooperation 

with the Secretary of øHealth, Education, and Welfare¿ Health and 

Human Services and other heads of appropriate departments and 

agencies design, establish, and coordinate an efficient and effective 

system for the retrieval of toxicological and other scientific data 

which could be useful to the Administrator in carrying out the purposes of this Act. Systematized retrieval shall be developed for use 

by all Federal and other departments and agencies with responsibilities in the area of regulation or study of chemical substances 

and mixtures and their effect on health or the environment. 

(B) The Administrator, in consultation and cooperation with the 

Secretary of øHealth, Education, and Welfare¿ Health and Human 

Services, may make grants and enter into contracts for the development of a data retrieval system described in subparagraph (A). 

Contracts may be entered into under this subparagraph without regard to sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 

529, 41 U.S.C. 5). 

(c) SCREENING TECHNIQUES.—The Administrator shall coordinate, with the Assistant Secretary for Health of the Department of 

øHealth, Education, and Welfare¿ Health and Human Services, research undertaken by the Administrator and directed toward the 

development of rapid, reliable, and economical screening techniques 

for carcinogenic, mutagenic, teratogenic, and ecological effects of 

chemical substances and mixtures. 

(d) MONITORING.—The Administrator shall, in consultation and 

cooperation with the Secretary of øHealth, Education, and Welfare¿ 

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search aimed at the development, in cooperation with local, State, 

and Federal agencies, of monitoring techniques and instruments 

which may be used in the detection of toxic chemical substances 

and mixtures and which are reliable, economical, and capable of 

being implemented under a wide variety of conditions. 

(e) BASIC RESEARCH.—The Administrator shall, in consultation 

and cooperation with the Secretary of øHealth, Education, and 

Welfare¿ Health and Human Services, establish research programs 

to develop the fundamental scientific basis of the screening and 

monitoring techniques described in subsections (c) and (d), the 

bounds of the reliability of such techniques, and the opportunities 

for their improvement. 

(f) TRAINING.—The Administrator shall establish and promote 

programs and workshops to train or facilitate the training of Federal laboratory and technical personnel in existing or newly developed screening and monitoring techniques. 

(g) EXCHANGE OF RESEARCH AND DEVELOPMENT RESULTS.—The 

Administrator shall, in consultation with the Secretary of øHealth, 

Education, and Welfare¿ Health and Human Services and other 

heads of appropriate departments and agencies, establish and coordinate a system for exchange among Federal, State, and local authorities of research and development results respecting toxic 

chemical substances and mixtures, including a system to facilitate 

and promote the development of standard data format and analysis 

and consistent testing procedures. 

* * * * * * * 

SEC. 12. EXPORTS. 

(a) IN GENERAL.—(1) Except as provided in paragraph (2) and 

subsections (b) and (c), this Act (other than section 8) shall not 

apply to any chemical substance, mixture, or to an article containing a chemical substance or mixture, if— 

(A) it can be shown that such substance, mixture, or article 

is being manufactured, processed, or distributed in commerce 

for export from the United States, unless such substance, mixture, or article was, in fact, manufactured, processed, or distributed in commerce, for use in the United States, and 

(B) such substance, mixture, or article (when distributed in 

commerce), or any container in which it is enclosed (when so 

distributed), bears a stamp or label stating that such substance, mixture, or article is intended for export. 

ø(2) Paragraph (1) shall not apply to any chemical substance, 

mixture, or article if the Administrator finds that the substance, 

mixture, or article will present an unreasonable risk of injury to 

health within the United States or to the environment of the 

United States. The Administrator may require, under section 4, 

testing of any chemical substance or mixture exempted from this 

Act by paragraph (1) for the purpose of determining whether or not 

such substance or mixture presents an unreasonable risk of injury 

to health within the United States or to the environment of the 

United States.¿ 

(2) EXCEPTION.—Paragraph (1) shall not apply to any chemical substance that the Administrator determines— 


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(A) under section 5 is not likely to meet the safety standard; or 

(B) under section 6 does not meet the safety standard. 

(3) WAIVERS.—For a mixture or article containing a chemical 

substance described in paragraph (2), the Administrator may— 

(A) determine that paragraph (1) shall not apply to the 

mixture or article; or 

(B) establish a threshold concentration in a mixture or 

article at which paragraph (1) shall not apply. 

(4) TESTING.—The Administrator may require testing under 

section 4 of any chemical substance or mixture exempted from 

this Act under paragraph (1) for the purpose of determining 

whether the chemical substance or mixture meets the safety 

standard within the United States. 

ø(b) NOTICE.—ø(1) If any person exports or intends to export to 

a foreign country a chemical substance or mixture for which the 

submission of data is required under section 4 or 5(b), such person 

shall notify the Administrator of such exportation or intent to export and the Administrator shall furnish to the government of such 

country notice of the availability of the data submitted to the Administrator under such section for such substance or mixture. 

ø(2) If any person exports or intends to export to a foreign country a chemical substance or mixture for which an order has been 

issued under section 5 or a rule has been proposed or promulgated 

under section 5 or 6, or with respect to which an action is pending, 

or relief has been granted under section 5 or 7, such person shall 

notify the Administrator of such exportation or intent to export and 

the Administrator shall furnish to the government of such country 

notice of such rule, order, action, or relief.¿ 

(b) NOTICE.— 

(1) IN GENERAL.—A person shall notify the Administrator 

that the person is exporting or intends to export to a foreign 

country— 

(A) a chemical substance or a mixture containing a chemical substance that the Administrator has determined 

under section 5 is not likely to meet the safety standard 

and for which a prohibition or other restriction has been 

proposed or established under that section; 

(B) a chemical substance or a mixture containing a chemical substance that the Administrator has determined 

under section 6 does not meet the safety standard and for 

which a prohibition or other restriction has been proposed 

or established under that section; 

(C) a chemical substance for which the United States is 

obligated by treaty to provide export notification; 

(D) a chemical substance or mixture subject to a significant new use rule, or a prohibition or other restriction pursuant to a rule, order, or consent agreement in effect under 

this Act; or 

(E) a chemical substance or mixture for which the submission of information is required under section 4. 

(2) RULES.— (A) IN GENERAL.—The Administrator shall promulgate 

rules to carry out paragraph (1). 


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(B) CONTENTS.—The rules promulgated pursuant to subparagraph (A) shall— 

(i) include such exemptions as the Administrator determines to be appropriate, which may include exemptions identified under section 5(h); and 

(ii) indicate whether, or to what extent, the rules 

apply to articles containing a chemical substance or 

mixture described in paragraph (1). 

(3) NOTIFICATION.—The Administrator shall submit to the 

government of each country to which a chemical substance or 

mixture is exported— 

(A) for a chemical substance or mixture described in subparagraph (A), (B), or (D) of paragraph (1), a notice of the 

determination, rule, order, consent agreement, requirement, 

or designation; 

(B) for a chemical substance described in paragraph 

(1)(C), a notice that satisfies the obligation of the United 

States under the applicable treaty; and 

(C) for a chemical substance or mixture described in 

paragraph (1)(E), a notice of availability of the information 

on the chemical substance or mixture submitted to the Administrator. 

(c) PROHIBITION ON EXPORT OF ELEMENTAL MERCURY.— 

(1) PROHIBITION.—Effective January 1, 2013, the export of 

elemental mercury from the United States is prohibited. 

(2) INAPPLICABILITY OF SUBSECTION (a).—Subsection (a) shall 

not apply to this subsection. 

ø(3) REPORT TO CONGRESS ON MERCURY COMPOUNDS.— 

ø(A) REPORT.—Not later than one year after the date of 

enactment of the Mercury Export Ban Act of 2008, the Administrator shall publish and submit to Congress a report 

on mercuric chloride, mercurous chloride or calomel, mercuric oxide, and other mercury compounds, if any, that 

may currently be used in significant quantities in products 

or processes. Such report shall include an analysis of— 

ø(i) the sources and amounts of each of the mercury 

compounds imported into the United States or manufactured in the United States annually; 

ø(ii) the purposes for which each of these compounds 

are used domestically, the amount of these compounds 

currently consumed annually for each purpose, and 

the estimated amounts to be consumed for each purpose in 2010 and beyond; 

ø(iii) the sources and amounts of each mercury compound exported from the United States annually in 

each of the last three years; 

ø(iv) the potential for these compounds to be processed into elemental mercury after export from the 

United States; and 

ø(v) other relevant information that Congress should 

consider in determining whether to extend the export 

prohibition to include one or more of these mercury 

compounds. 


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ø(B) PROCEDURE.—For the purpose of preparing the report under this paragraph, the Administrator may utilize 

the information gathering authorities of this title, including sections 10 and 11.¿ 

ø(4)¿ (3) ESSENTIAL USE EXEMPTION.—(A) Any person residing in the United States may petition the Administrator for an 

exemption from the prohibition in paragraph (1), and the Administrator may grant by rule, after notice and opportunity for 

comment, an exemption for a specified use at an identified foreign facility if the Administrator finds that— 

(i) nonmercury alternatives for the specified use are not 

available in the country where the facility is located; 

(ii) there is no other source of elemental mercury available from domestic supplies (not including new mercury 

mines) in the country where the elemental mercury will be 

used; 

(iii) the country where the elemental mercury will be 

used certifies its support for the exemption; 

(iv) the export will be conducted in such a manner as to 

ensure the elemental mercury will be used at the identified facility as described in the petition, and not otherwise 

diverted for other uses for any reason; 

(v) the elemental mercury will be used in a manner that 

will protect human health and the environment, taking 

into account local, regional, and global human health and 

environmental impacts; 

(vi) the elemental mercury will be handled and managed 

in a manner that will protect human health and the environment, taking into account local, regional, and global 

human health and environmental impacts; and 

(vii) the export of elemental mercury for the specified 

use is consistent with international obligations of the 

United States intended to reduce global mercury supply, 

use, and pollution. 

(B) Each exemption issued by the Administrator pursuant to 

this paragraph shall contain such terms and conditions as are 

necessary to minimize the export of elemental mercury and ensure that the conditions for granting the exemption will be 

fully met, and shall contain such other terms and conditions as 

the Administrator may prescribe. No exemption granted pursuant to this paragraph shall exceed three years in duration and 

no such exemption shall exceed 10 metric tons of elemental 

mercury. 

(C) The Administrator may by order suspend or cancel an exemption under this paragraph in the case of a violation described in subparagraph (D). 

(D) A violation of this subsection or the terms and conditions 

of an exemption, or the submission of false information in connection therewith, shall be considered a prohibited act under 

section 15, and shall be subject to penalties under section 16, 

injunctive relief under section 17, and citizen suits under section 20. 

ø(5)¿ (4) CONSISTENCY WITH TRADE OBLIGATIONS.—Nothing 

in this subsection affects, replaces, or amends prior law relatVerDate Sep 11 2014 05:10 Jun 23, 2015 Jkt 049010 PO 00000 Frm 00109 Fmt 6601 Sfmt 9001 E:\HR\OC\SR067.XXX SR067

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ing to the need for consistency with international trade obligations. 

ø(6)¿ (5) EXPORT OF COAL.—Nothing in this subsection shall 

be construed to prohibit the export of coal. 

* * * * * * * 

øSEC. 14. DISCLOSURE OF DATA. 

ø(a) IN GENERAL.—Except as provided by subsection (b), any information reported to, or otherwise obtained by, the Administrator 

(or any representative of the Administrator) under this Act, which 

is exempt from disclosure pursuant to subsection (a) of section 552 

of title 5, United States Code, by reason of subsection (b)(4) of such 

section, shall, notwithstanding the provisions of any other section 

of this Act, not be disclosed by the Administrator or by any officer 

or employee of the United States, except that such information— 

ø(1) shall be disclosed to any officer or employee of the 

United States— 

ø(A) in connection with the official duties of such officer 

or employee under any law for the protection of health or 

the environment, or 

ø(B) for specific law enforcement purposes; 

ø(2) shall be disclosed to contractors with the United States 

and employees of such contractors if in the opinion of the Administrator such disclosure is necessary for the satisfactory 

performance by the contractor of a contract with the United 

States entered into on or after the date of enactment of this 

Act for the performance of work in connection with this Act 

and under such conditions as the Administrator may specify; 

ø(3) shall be disclosed if the Administrator determines it necessary to protect health or the environment against an unreasonable risk of injury to health or the environment; or 

ø(4) may be disclosed when relevant in any proceeding under 

this Act, except that disclosure in such a proceeding shall be 

made in such manner as to preserve confidentiality to the extent practicable without impairing the proceeding. 

øIn any proceeding under section 552(a) of title 5, United States 

Code, to obtain information the disclosure of which has been denied 

because of the provisions of this subsection, the Administrator may 

not rely on section 552(b)(3) of such title to sustain the Administrator’s action. 

ø(b) DATA FROM HEALTH AND SAFETY STUDIES.—(1) Subsection 

(a) does not prohibit the disclosure of— 

ø(A) any health and safety study which is submitted under 

this Act with respect to— 

ø(i) any chemical substance or mixture which, on the 

date on which such study is to be disclosed has been offered for commercial distribution, or 

ø(ii) any chemical substance or mixture for which testing 

is required under section 4 or for which notification is required under section 5, and 

ø(B) any data reported to, or otherwise obtained by, the Administrator from a health and safety study which relates to a 

chemical substance or mixture described in clause (i) or (ii) of 

subparagraph (A). 


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This paragraph does not authorize the release of any data which 

discloses processes used in the manufacturing or processing of a 

chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any 

of the chemical substances in the mixture. 

ø(2) If a request is made to the Administrator under subsection 

(a) of section 552 of title 5, United States Code, for information 

which is described in the first sentence of paragraph (1) and which 

is not information described in the second sentence of such paragraph, the Administrator may not deny such request on the basis 

of subsection (b)(4) of such section. 

ø(c) DESIGNATION AND RELEASE OF CONFIDENTIAL DATA.—ø(1) In 

submitting data under this Act, a manufacturer, processor, or distributor in commerce may (A) designate the data which such person believes is entitled to confidential treatment under subsection 

(a), and (B) submit such designated data separately from other 

data submitted under this Act. A designation under this paragraph 

shall be made in writing and in such manner as the Administrator 

may prescribe. 

ø(2)(A) Except as provided by subparagraph (B), if the Administrator proposes to release for inspection data which has been designated under paragraph (1)(A), the Administrator shall notify, in 

writing and by certified mail, the manufacturer, processor, or distributor in commerce who submitted such data of the intent to release such data. If the release of such data is to be made pursuant 

to a request made under section 552(a) of title 5, United States 

Code, such notice shall be given immediately upon approval of such 

request by the Administrator. The Administrator may not release 

such data until the expiration of 30 days after the manufacturer, 

processor, or distributor in commerce submitting such data has received the notice required by this subparagraph. 

ø(B)(i) Subparagraph (A) shall not apply to the release of information under paragraph (1), (2), (3), or (4) of subsection (a), except 

that the Administrator may not release data under paragraph (3) 

of subsection (a) unless the Administrator has notified each manufacturer, processor, and distributor in commerce who submitted 

such data of such release. Such notice shall be made in writing by 

certified mail at least 15 days before the release of such data, except that if the Administrator determines that the release of such 

data is necessary to protect against an imminent, unreasonable 

risk of injury to health or the environment, such notice may be 

made by such means as the Administrator determines will provide 

notice at least 24 hours before such release is made. 

ø(ii) Subparagraph (A) shall not apply to the release of information described in subsection (b)(1) other than information described 

in the second sentence of such subsection. 

ø(d) CRIMINAL PENALTY FOR WRONGFUL DISCLOSURE.—ø(1) Any 

officer or employee of the United States or former officer or employee of the United States, who by virtue of such employment or 

official position has obtained possession of, or has access to, material the disclosure of which is prohibited by subsection (a), and who 

knowing that disclosure of such material is prohibited by such subsection, willfully disclosures the material in any manner to any 

person not entitled to receive it, shall be guilty of a misdemeanor 


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and fined not more than $5,000 or imprisoned for not more than 

one year, or both. Section 1905 of title 18, United States Code, does 

not apply with respect to the publishing, divulging, disclosure, or 

making known of, or making available, information reported or otherwise obtained under this Act. 

ø(2) For the purposes of paragraph (1), any contractor with the 

United States who is furnished information as authorized by subsection (a)(2), and any employee of any such contractor, shall be 

considered to be an employee of the United States. 

ø(e) ACCESS BY CONGRESS.—Notwithstanding any limitation contained in this section or any other provision of law, all information 

reported to or otherwise obtained by the Administrator (or any representative of the Administrator) under this Act shall be made 

available, upon written request of any duly authorized committee 

of the Congress, to such committee.¿ 

SEC. 14. CONFIDENTIAL INFORMATION. 

(a) IN GENERAL.—Except as otherwise provided in this section, the 

Administrator shall not disclose information that is exempt from 

disclosure pursuant to subsection (a) of section 552 of title 5, United 

States Code, under subsection (b)(4) of that section— 

(1) that is reported to, or otherwise obtained by, the Administrator under this Act; and 

(2) for which the requirements of subsection (d) are met. 

(b) INFORMATION GENERALLY PROTECTED FROM DISCLOSURE.— 

The following information specific to, and submitted by, a manufacturer, processor, or distributor that meets the requirements of subsections (a) and (d) shall be presumed to be protected from disclosure, subject to the condition that nothing in this Act prohibits the 

disclosure of any such information, or information that is the subject of subsection (g)(3), through discovery, subpoena, other court 

order, or any other judicial process otherwise allowed under applicable Federal or State law: 

(1) Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article. 

(2) Marketing and sales information. 

(3) Information identifying a supplier or customer. 

(4) Details of the full composition of a mixture and the respective percentages of constituents. 

(5) Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, 

or product. 

(6) Specific production or import volumes of the manufacturer 

and specific aggregated volumes across manufacturers, if the 

Administrator determines that disclosure of the specific aggregated volumes would reveal confidential information. 

(7) Except as otherwise provided in this section, the specific 

identity of a chemical substance prior to the date on which the 

chemical substance is first offered for commercial distribution, 

including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify a specific chemical substance, if— 


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(A) the specific identity was claimed as confidential information at the time it was submitted in a notice under section 5; and 

(B) the claim— 

(i) is not subject to an exception under subsection (e); 

or 

(ii) has not subsequently been withdrawn or found by 

the Administrator not to warrant protection as confidential information under subsection (f)(2) or (g). 

(c) INFORMATION NOT PROTECTED FROM DISCLOSURE.—Notwithstanding subsections (a) and (b), the following information shall not 

be protected from disclosure: 

(1) INFORMATION FROM HEALTH AND SAFETY STUDIES.— 

(A) IN GENERAL.—Subject to subparagraph (B), subsection (a) does not prohibit the disclosure of— 

(i) any health and safety study that is submitted 

under this Act with respect to— 

(I) any chemical substance or mixture that, on 

the date on which the study is to be disclosed, has 

been offered for commercial distribution; or 

(II) any chemical substance or mixture for 

which— 

(aa) testing is required under section 4; or 

(bb) a notification is required under section 

5; or 

(ii) any information reported to, or otherwise obtained by, the Administrator from a health and safety 

study relating to a chemical substance or mixture described in subclause (I) or (II) of clause (i). 

(B) EFFECT OF PARAGRAPH.—Nothing in this paragraph 

authorizes the release of any information that discloses— 

(i) a process used in the manufacturing or processing of a chemical substance or mixture; or 

(ii) in the case of a mixture, the portion of the mixture comprised by any chemical substance in the mixture. 

(2) CERTAIN REQUESTS.—If a request is made to the Administrator under section 552(a) of title 5, United States Code, for information that is described in paragraph (1) that is not described in paragraph (1)(B), the Administrator may not deny 

the request on the basis of section 552(b)(4) of title 5, United 

States Code. 

(3) OTHER INFORMATION NOT PROTECTED FROM DISCLOSURE.— 

The following information is not protected from disclosure 

under this section: 

‘‘(A) For information submitted after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 

21st Century Act, the specific identity of a chemical substance as of the date on which the chemical substance is 

first offered for commercial distribution, if the person submitting the information does not meet the requirements of 

subsection (d). 

(B) A safety assessment developed, or a safety determination made, under section 6. 


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(C) Any general information describing the manufacturing volumes, expressed as specific aggregated volumes 

or, if the Administrator determines that disclosure of specific aggregated volumes would reveal confidential information, expressed in ranges. 

(D) A general description of a process used in the manufacture or processing and industrial, commercial, or consumer functions and uses of a chemical substance, mixture, 

or article containing a chemical substance or mixture, including information specific to an industry or industry sector that customarily would be shared with the general public or within an industry or industry sector. 

(4) MIXED CONFIDENTIAL AND NONCONFIDENTIAL INFORMATION .—Any information that is otherwise eligible for protection 

under this section and contained in a submission of information described in this subsection shall be protected from disclosure, if the submitter complies with subsection (d), subject to the 

condition that information in the submission that is not eligible 

for protection against disclosure shall be disclosed. 

(5) BAN OR PHASE-OUT.—If the Administrator promulgates a 

rule pursuant to section 6(d) that establishes a ban or phaseout of the manufacture, processing, or distribution in commerce 

of a chemical substance, subject to paragraphs (2), (3), and (4) 

of subsection (g), any protection from disclosure provided under 

this section with respect to the specific identity of the chemical 

substance and other information relating to the chemical substance shall no longer apply. 

(d) REQUIREMENTS FOR CONFIDENTIALITY CLAIMS.— 

(1) ASSERTION OF CLAIMS.— 

(A) IN GENERAL.—A person seeking to protect any information submitted under this Act from disclosure (including 

information described in subsection (b)) shall assert to the 

Administrator a claim for protection concurrent with submission of the information, in accordance with such rules 

regarding a claim for protection from disclosure as the Administrator has promulgated or may promulgate pursuant 

to this title. 

(B) INCLUSION.—An assertion of a claim under subparagraph (A) shall include a statement that the person has— 

(i) taken reasonable measures to protect the confidentiality of the information; 

(ii) determined that the information is not required 

to be disclosed or otherwise made available to the public under any other Federal law; 

(iii) a reasonable basis to conclude that disclosure of 

the information is likely to cause substantial harm to 

the competitive position of the person; and 

(iv) a reasonable basis to believe that the information 

is not readily discoverable through reverse engineering. 

(C) SPECIFIC CHEMICAL IDENTITY.—In the case of a claim 

under subparagraph (A) for protection against disclosure of 

a specific chemical identity, the claim shall include a structurally descriptive generic name for the chemical substance 


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that the Administrator may disclose to the public, subject 

to the condition that the generic name shall— 

(i) conform with guidance prescribed by the Administrator under paragraph (3)(A); and 

(ii) describe the chemical structure of the substance 

as specifically as practicable while protecting those features of the chemical structure— 

(I) that are considered to be confidential; and 

(II) the disclosure of which would be likely to 

harm the competitive position of the person. 

(D) PUBLIC INFORMATION.—No person may assert a 

claim under this section for protection from disclosure of 

information that is already publicly available. 

(2) ADDITIONAL REQUIREMENTS FOR CONFIDENTIALITY

CLAIMS.—Except for information described in paragraphs (1) 

through (7) of subsection (b), a person asserting a claim to protect information from disclosure under this Act shall substantiate the claim, in accordance with the rules promulgated and 

guidance issued by the Administrator. 

(3) GUIDANCE.—The Administrator shall develop guidance regarding— 

(A) the determination of structurally descriptive generic 

names, in the case of claims for the protection against disclosure of specific chemical identity; and 

(B) the content and form of the statements of need and 

agreements required under paragraphs (4), (5), and (6) of 

subsection (e). 

(4) CERTIFICATION.—An authorized official of a person described in paragraph (1)(A) shall certify that the information 

that has been submitted is true and correct. 

(e) EXCEPTIONS TO PROTECTION FROM DISCLOSURE.—Information 

described in subsection (a)— 

(1) shall be disclosed if the information is to be disclosed to 

an officer or employee of the United States in connection with 

the official duties of the officer or employee— 

(A) under any law for the protection of health or the environment; or 

(B) for a specific law enforcement purpose; 

(2) shall be disclosed if the information is to be disclosed to 

a contractor of the United States and employees of that contractor— 

(A) if, in the opinion of the Administrator, the disclosure 

is necessary for the satisfactory performance by the contractor of a contract with the United States for the performance of work in connection with this Act; and 

(B) subject to such conditions as the Administrator may 

specify; 

(3) shall be disclosed if the Administrator determines that 

disclosure is necessary to protect health or the environment; 

(4) shall be disclosed if the information is to be disclosed to 

a State or political subdivision of a State, on written request, 

for the purpose of development, administration, or enforcement 

of a law, if— 


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(A) 1 or more applicable agreements with the Administrator that conform with the guidance issued under subsection (d)(3)(B) ensure that the recipient will take appropriate measures, and has adequate authority, to maintain 

the confidentiality of the information in accordance with 

procedures comparable to the procedures used by the Administrator to safeguard the information; and 

(B) the Administrator notifies the person that submitted 

the information that the information has been disclosed to 

the State or political subdivision of a State; 

(5) shall be disclosed if a health or environmental professional employed by a Federal or State agency or a treating physician or nurse in a nonemergency situation provides a written 

statement of need and agrees to sign a written confidentiality 

agreement with the Administrator, subject to the conditions 

that— 

(A) the statement of need and confidentiality agreement 

shall conform with the guidance issued under subsection 

(d)(3)(B); 

(B) the written statement of need shall be a statement 

that the person has a reasonable basis to suspect that— 

(i) the information is necessary for, or will assist in— 

(I) the diagnosis or treatment of 1 or more individuals; or 

(II) responding to an environmental release or 

exposure; and 

(ii) 1 or more individuals being diagnosed or treated 

have been exposed to the chemical substance concerned, 

or an environmental release or exposure has occurred; 

and 

(C) the confidentiality agreement shall provide that the 

person will not use the information for any purpose other 

than the health or environmental needs asserted in the 

statement of need, except as otherwise may be authorized by 

the terms of the agreement or by the person submitting the 

information to the Administrator, except that nothing in 

this Act prohibits the disclosure of any such information 

through discovery, subpoena, other court order, or any 

other judicial process otherwise allowed under applicable 

Federal or State law; 

(6) shall be disclosed if in the event of an emergency, a treating physician, nurse, agent of a poison control center, public 

health or environmental official of a State or political subdivision of a State, or first responder (including any individual 

duly authorized by a Federal agency, State, or political subdivision of a State who is trained in urgent medical care or other 

emergency procedures, including a police officer, firefighter, or 

emergency medical technician) requests the information, subject 

to the conditions that— 

(A) the treating physician, nurse, agent, public health or 

environmental official of a State or a political subdivision 

of a State, or first responder shall have a reasonable basis 

to suspect that— 


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(i) a medical or public health or environmental emergency exists; 

(ii) the information is necessary for, or will assist in, 

emergency or first-aid diagnosis or treatment; or 

(iii) 1 or more individuals being diagnosed or treated 

have likely been exposed to the chemical substance concerned, or a serious environmental release of or exposure to the chemical substance concerned has occurred; 

(B) if requested by the person submitting the information 

to the Administrator, the treating physician, nurse, agent, 

public health or environmental official of a State or a political subdivision of a State, or first responder shall, as described in paragraph (5)— 

(i) provide a written statement of need; and 

(ii) agree to sign a confidentiality agreement; and 

(C) the written confidentiality agreement or statement of 

need shall be submitted as soon as practicable, but not necessarily before the information is disclosed; 

(7) may be disclosed if the Administrator determines that disclosure is relevant in a proceeding under this Act, subject to the 

condition that the disclosure shall be made in such a manner 

as to preserve confidentiality to the maximum extent practicable 

without impairing the proceeding; 

(8) shall be disclosed if the information is to be disclosed, on 

written request of any duly authorized congressional committee, 

to that committee; or 

(9) shall be disclosed if the information is required to be disclosed or otherwise made public under any other provision of 

Federal law. 

(f) DURATION OF PROTECTION FROM DISCLOSURE.— 

(1) IN GENERAL.— (A) INFORMATION PROTECTED FROM DISCLOSURE.—Subject 

to paragraph (2), the Administrator shall protect from disclosure information that meets the requirements of subsection (d) for a period of 10 years, unless, prior to the expiration of the period— 

(i) an affected person notifies the Administrator that 

the person is withdrawing the confidentiality claim, in 

which case the Administrator shall promptly make the 

information available to the public; or 

(ii) the Administrator otherwise becomes aware that 

the need for protection from disclosure can no longer be 

substantiated, in which case the Administrator shall 

take the actions described in subsection (g)(2). 

(B) EXTENSIONS.— 

(i) IN GENERAL.—Not later than the date that is 60 

days before the expiration of the period described in 

subparagraph (A), the Administrator shall provide to 

the person that asserted the claim a notice of the impending expiration of the period. 

(ii) STATEMENT.— (I) IN GENERAL.—Not later than the date that is 

30 days before the expiration of the period described in subparagraph (A), a person reasserting 


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the relevant claim shall submit to the Administrator a statement substantiating, in accordance 

with subsection (d)(2), the need to extend the period. 

(II) ACTION BY ADMINISTRATOR.—Not later than 

the date that is 30 days after the date of receipt 

of a statement under subclause (I), the Administrator shall— 

(aa) review the request; 

(bb) make a determination regarding whether the information for which the request is 

made continues to meet the relevant criteria 

established under this section; and 

(cc)(AA) grant an extension of not more than 

10 years; or 

(BB) deny the claim. 

(C) NO LIMIT ON NUMBER OF EXTENSIONS.—There shall 

be no limit on the number of extensions granted under subparagraph (B), if the Administrator determines that the relevant statement under subparagraph (B)(ii)(I)— 

(i) establishes the need to extend the period; and 

(ii) meets the requirements established by the Administrator. 

(2) REVIEW AND RESUBSTANTIATION.— (A) DISCRETION OF ADMINISTRATOR.—The Administrator 

may review, at any time, a claim for protection against disclosure under subsection (a) for information submitted to 

the Administrator regarding a chemical substance and require any person that has claimed protection for that information, whether before, on, or after the date of enactment 

of the Frank R. Lautenberg Chemical Safety for the 21st 

Century Act, to withdraw or reassert and substantiate or 

resubstantiate the claim in accordance with this section— 

(i) after the chemical substance is identified as a 

high-priority substance under section 4A; 

(ii) for any chemical substance for which the Administrator has made a determination under section 

6(c)(1)(C); 

(iii) for any inactive chemical substance identified 

under section 8(b)(5); or 

(iv) in limited circumstances, if the Administrator 

determines that disclosure of certain information currently protected from disclosure would assist the Administrator in conducting safety assessments and safety determinations under subsections (b) and (c) of section 6 or promulgating rules pursuant to section 6(d), 

subject to the condition that the information shall not 

be disclosed unless the claimant withdraws the claim 

or the Administrator determines that the information 

does not meet the requirements of subsection (d). 

(B) REVIEW REQUIRED.—The Administrator shall review 

a claim for protection from disclosure under subsection (a) 

for information submitted to the Administrator regarding a 

chemical substance and require any person that has 


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claimed protection for that information, whether before, on, 

or after the date of enactment of the Frank R. Lautenberg 

Chemical Safety for the 21st Century Act, to withdraw or 

reassert and substantiate or resubstantiate the claim in accordance with this section— 

(i) as necessary to comply with a request for information received by the Administrator under section 552 of 

title 5, United States Code; 

(ii) if information available to the Administrator provides a basis that the requirements of section 552(b)(4) 

of title 5, United States Code, are no longer met; or 

(iii) for any substance for which the Administrator 

has made a determination under section 6(c)(1)(B). 

(C) ACTION BY RECIPIENT.—If the Administrator makes a 

request under subparagraph (A) or (B), the recipient of the 

request shall— 

(i) reassert and substantiate or resubstantiate the 

claim; or 

(ii) withdraw the claim. 

(D) PERIOD OF PROTECTION.—Protection from disclosure 

of information subject to a claim that is reviewed and approved by the Administrator under this paragraph shall be 

extended for a period of 10 years from the date of approval, 

subject to any subsequent request by the Administrator 

under this paragraph. 

(3) UNIQUE IDENTIFIER.—The Administrator shall— 

(A)(i) develop a system to assign a unique identifier to 

each specific chemical identity for which the Administrator 

approves a request for protection from disclosure, other 

than a specific chemical identity or structurally descriptive 

generic term; and 

(ii) apply that identifier consistently to all information 

relevant to the applicable chemical substance; 

(B) annually publish and update a list of chemical substances, referred to by unique identifier, for which claims 

to protect the specific chemical identity from disclosure 

have been approved, including the expiration date for each 

such claim; 

(C) ensure that any nonconfidential information received 

by the Administrator with respect to such a chemical substance during the period of protection from disclosure— 

(i) is made public; and 

(ii) identifies the chemical substance using the 

unique identifier; and 

(D) for each claim for protection of specific chemical identity that has been denied by the Administrator on expiration of the period for appeal under subsection (g)(4), that 

has expired, or that has been withdrawn by the submitter, 

provide public access to the specific chemical identity clearly linked to all nonconfidential information received by the 

Administrator with respect to the chemical substance. 

(g) DUTIES OF ADMINISTRATOR.— 

(1) DETERMINATION.— 


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(A) IN GENERAL.—Except as provided in subsection (b), 

the Administrator shall, subject to subparagraph (C), not 

later than 90 days after the receipt of a claim under subsection (d), and not later than 30 days after the receipt of 

a request for extension of a claim under subsection (f), review and approve, modify, or deny the claim or request. 

(B) DENIAL OR MODIFICATION.— (i) IN GENERAL.—Except as provided in subsections 

(c) and (f), the Administrator shall deny a claim to protect a chemical identity from disclosure only if the person that has submitted the claim fails to meet the requirements of subsections (a) and (d). 

(ii) REASONS FOR DENIAL OR MODIFICATION.—The 

Administrator shall provide to a person that has submitted a claim described in clause (i) a written statement of the reasons for the denial or modification of 

the claim. 

(C) SUBSETS.—The Administrator shall— 

(i) except for claims described in subsection (b)(7), review all claims under this section for the protection 

against disclosure of the specific identity of a chemical 

substance; and 

(ii) review a representative subset, comprising at 

least 25 percent, of all other claims for protection 

against disclosure. 

(D) EFFECT OF FAILURE TO ACT.—The failure of the Administrator to make a decision regarding a claim for protection against disclosure or extension under this section 

shall not be the basis for denial or elimination of a claim 

for protection against disclosure. 

(2) NOTIFICATION.— (A) IN GENERAL.—Except as provided in subparagraph 

(B) and subsections (c), (e), and (f), if the Administrator denies or modifies a claim under paragraph (1), or promulgates a rule under section 6(d) establishing a ban or phaseout of a chemical substance, the Administrator shall notify, 

in writing and by certified mail, the person that submitted 

the claim of the intent of the Administrator to release the 

information. 

(B) RELEASE OF INFORMATION.— 

(i) IN GENERAL.—Except as provided in clause (ii), 

the Administrator shall not release information under 

this subsection until the date that is 30 days after the 

date on which the person that submitted the request receives notification under subparagraph (A). 

(ii) EXCEPTIONS.— 

(I) IN GENERAL.—For information under paragraph (3) or (8) of subsection (e), the Administrator 

shall not release that information until the date 

that is 15 days after the date on which the person 

that submitted the claim receives a notification, 

unless the Administrator determines that release of 

the information is necessary to protect against an 

imminent and substantial harm to health or the 


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environment, in which case no prior notification 

shall be necessary. 

(II) NO NOTIFICATION.—For information under 

paragraph (1), (2), (6), (7), or (9) of subsection (e), 

no prior notification shall be necessary. 

(3) REBUTTABLE PRESUMPTION.— (A) IN GENERAL.—With respect to notifications provided 

by the Administrator pursuant to subsection (c)(5), there 

shall be a rebuttable presumption that the public interest 

in disclosing confidential information related to a chemical 

substance subject to a rule promulgated under section 6(d) 

that establishes a ban or phase-out of the manufacture, 

processing, or distribution in commerce of the substance 

outweighs the proprietary interest in maintaining the protection from disclosure of that information. 

(B) REQUEST FOR NONDISCLOSURE.—A person that receives a notification under paragraph (2) with respect to the 

information described in subparagraph (A) may submit to 

the Administrator, before the date on which the information 

is to be released, a request with supporting documentation 

describing why the person believes some or all of that information should not be disclosed. 

(C) DETERMINATION BY ADMINISTRATOR.— (i) IN GENERAL.—Not later than 30 days after the 

Administrator receives a request under subparagraph 

(B), the Administrator shall determine, at the discretion of the Administrator, whether the documentation 

provided by the person making the request rebuts or 

does not rebut the presumption described in subparagraph (A), for all or a portion of the information that 

the person has requested not be disclosed. 

(ii) OBJECTIVE.—The Administrator shall make the 

determination with the objective of ensuring that information relevant to protection of health and the environment is disclosed to the maximum extent practicable. 

(D) TIMING.—Not later than 30 days after making the determination described in subparagraph (C), the Administrator shall make public the information the Administrator 

has determined is not to be protected from disclosure. 

(E) NO TIMELY REQUEST RECEIVED.—If the Administrator 

does not receive, before the date on which the information 

described in subparagraph (A) is to be released, a request 

pursuant to subparagraph (B), the Administrator shall 

promptly make public all of the information. 

(4) APPEALS.— 

(A) IN GENERAL.—If a person receives a notification 

under paragraph (2) and believes disclosure of the information is prohibited under subsection (a), before the date on 

which the information is to be released, the person may 

bring an action to restrain disclosure of the information 

in— 

(i) the United States district court of the district in 

which the complainant resides or has the principal 

place of business; or 


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(ii) the United States District Court for the District 

of Columbia. 

(B) NO DISCLOSURE.—The Administrator shall not disclose any information that is the subject of an appeal under 

this section before the date on which the applicable court 

rules on an action under subparagraph (A). 

(5) ADMINISTRATION.—In carrying out this subsection, the Administrator shall use the procedures described in part 2 of title 

40, Code of Federal Regulations (or successor regulations). 

(h) CRIMINAL PENALTY FOR WRONGFUL DISCLOSURE.— (1) OFFICERS AND EMPLOYEES OF UNITED STATES.— (A) IN GENERAL.—Subject to paragraph (2), a current or 

former officer or employee of the United States described in 

subparagraph (B) shall be guilty of a misdemeanor and 

fined under title 18, United States Code, or imprisoned for 

not more than 1 year, or both. 

(B) DESCRIPTION.—A current or former officer or employee of the United States referred to in subparagraph (A) 

is a current or former officer or employee of the United 

States who— 

(i) by virtue of that employment or official position 

has obtained possession of, or has access to, material 

the disclosure of which is prohibited by subsection (a); 

and 

(ii) knowing that disclosure of that material is prohibited by subsection (a), willfully discloses the material in any manner to any person not entitled to receive 

that material. 

(2) OTHER LAWS.—Section 1905 of title 18, United States 

Code, shall not apply with respect to the publishing, divulging, 

disclosure, making known of, or making available, information 

reported or otherwise obtained under this Act. 

(3) CONTRACTORS.—For purposes of this subsection, any contractor of the United States that is provided information in accordance with subsection (e)(2), including any employee of that 

contractor, shall be considered to be an employee of the United 

States. 

(i) APPLICABILITY.— (1) IN GENERAL.—Except as otherwise provided in this section, section 8, or any other applicable Federal law, the Administrator shall have no authority— 

(A) to require the substantiation or resubstantiation of a 

claim for the protection from disclosure of information submitted to the Administrator under this Act before the date 

of enactment of the Frank R. Lautenberg Chemical Safety 

for the 21st Century Act; or 

(B) to impose substantiation or resubstantiation requirements under this Act that are more extensive than those required under this section. 

(2) PRIOR ACTIONS.—Nothing in this Act prevents the Administrator from reviewing, requiring substantiation or resubstantiation for, or approving, modifying or denying any claim for 

the protection from disclosure of information before the effective 

date of such rules applicable to those claims as the AdminisVerDate Sep 11 2014 05:10 Jun 23, 2015 Jkt 049010 PO 00000 Frm 00122 Fmt 6601 Sfmt 9001 E:\HR\OC\SR067.XXX SR067

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trator may promulgate after the date of enactment of the Frank 

R. Lautenberg Chemical Safety for the 21st Century Act. 

SEC. 15. PROHIBITED ACTS. 

It shall be unlawful for any person to— 

ø(1) fail or refuse to comply with (A) any rule promulgated 

or order issued under section 4, (B) any requirement prescribed 

by section 5 or 6, (C) any rule promulgated or order issued 

under section 5 or 6, or (D) any requirement of title II or any 

rule promulgated or order issued under title II;¿ 

(1) fail or refuse to comply with— 

(A) any rule promulgated, consent agreement entered 

into, or order issued under section 4; 

(B) any requirement under section 5 or 6; 

(C) any rule promulgated, consent agreement entered 

into, or order issued under section 5 or 6; or 

(D) any requirement of, or any rule promulgated or order 

issued pursuant to title II; 

(2) use for commercial purposes a chemical substance or mixture which such person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of 

section 5 or 6, a rule or order under section 5 or 6, or an order 

issued in action brought under section 5 or 7; 

(3) fail or refuse to (A) establish or maintain records, (B) submit reports, notices, or other information, or (C) permit access 

to or copying of records, as required by this Act or a rule thereunder; or 

(4) fail or refuse to permit entry or inspection as required by 

section 11. 

SEC. 16. PENALTIES. 

(a) CIVIL.—(1) Any person who violates a provision of this Act or 

a rule or order promulgated or issued pursuant to this Act, including section 15 or 409 shall be liable to the United States for a civil 

penalty in an amount not to exceed ø$25,000¿ $37,500 for each 

such violation. Each day such a violation continues shall, for purposes of this subsection, constitute a separate øviolation of section 

15 or 409¿ violation of this Act. 

(2)(A) A civil penalty for a violation of section 15 or 409 shall be 

assessed by the Administrator by an order made on the record after 

opportunity (provided in accordance with this subparagraph) for a 

hearing in accordance with section 554 of title 5, United States 

Code. Before issuing such an order, the Administrator shall give 

written notice to the person to be assessed a civil penalty under 

such order of the Administrator’s proposal to issue such order and 

provide such person an opportunity to request, within 15 days of 

the date the notice is received by such person, such a hearing on 

the order. 

(B) In determining the amount of a civil penalty, the Administrator shall take into account the nature, circumstances, extent, 

and gravity of the violation or violations and, with respect to the 

violator, ability to pay, effect on ability to continue to do business, 

any history of prior such violations, the degree of culpability, and 

such other matters as justice may require. 


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(C) The Administrator may compromise, modify, or remit, with or 

without conditions, any civil penalty which may be imposed under 

this subsection. The amount of such penalty, when finally determined, or the amount agreed upon in compromise, may be deducted 

from any sums owing by the United States to the person charged. 

(3) Any person who requested in accordance with paragraph 

(2)(A) a hearing respecting the assessment of a civil penalty and 

who is aggrieved by an order assessing a civil penalty may file a 

petition for judicial review of such order with the United States 

Court of Appeals for the District of Columbia Circuit or for any 

other circuit in which such person resides or transacts business. 

Such a petition may only be filed within the 30-day period beginning on the date the order making such assessment was issued. 

(4) If any person fails to pay an assessment of a civil penalty— 

(A) after the order making the assessment has become a 

final order and if such person does not file a petition for judicial review of the order in accordance with paragraph (3), or 

(B) after a court in an action brought under paragraph (3) 

has entered a final judgment in favor of the Administrator, 

the Attorney General shall recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration 

of the 30-day period referred to in paragraph (3) or the date of such 

final judgment, as the case may be) in an action brought in any appropriate district court of the United States. In such an action, the 

validity, amount, and appropriateness of such penalty shall not be 

subject to review. 

(b) CRIMINAL.—øAny person who¿ 

(1) IN GENERAL.—Any person that; knowingly or willfully violates any provision of øsection 15 or 409¿ this Act shall, in addition to or in lieu of any civil penalty which may be imposed 

under subsection (a) of this section for such violation, be subject, upon conviction, to a fine of not more than ø$25,000¿ 

$50,000 for each day of violation, or to imprisonment for not 

more than one year, or both. 

(2) IMMINENT DANGER OF DEATH OR SERIOUS BODILY INJURY.— 

(A) IN GENERAL.—Any person that knowingly or willfully 

violates any provision of this Act, and that knows at the 

time of the violation that the violation places an individual 

in imminent danger of death or serious bodily injury, shall 

be subject on conviction to a fine of not more than 

$250,000, or imprisonment for not more than 15 years, or 

both. 

(B) ORGANIZATIONS.—An organization that commits a 

violation described in subparagraph (A) shall be subject on 

conviction to a fine of not more than $1,000,000 for each 

violation. 

(3) KNOWLEDGE OF IMMINENT DANGER OR INJURY.—For purposes of determining whether a defendant knew that the violation placed another individual in imminent danger of death or 

serious bodily injury— 

(A) the defendant shall be responsible only for actual 

awareness or actual belief possessed; and 


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(B) knowledge possessed by an individual may not be attributed to the defendant. 

* * * * * * * 

SEC. 18. PREEMPTION. 

ø(a) EFFECT ON STATE LAW.—(1) Except as provided in paragraph (2), nothing in this Act shall affect the authority of any State 

or political subdivision of a State to establish or continue in effect 

regulation of any chemical substance, mixture, or article containing 

a chemical substance or mixture. 

ø(2) Except as provided in subsection (b)— 

ø(A) if the Administrator requires by a rule promulgated 

under section 4 the testing of a chemical substance or mixture, 

no State or political subdivision may, after the effective date of 

such rule, establish or continue in effect a requirement for the 

testing of such substance or mixture for purposes similar to 

those for which testing is required under such rule; and 

ø(B) if the Administrator prescribes a rule or order under 

section 5 or 6 (other than a rule imposing a requirement described in subsection (a)(6) of section 6) which is applicable to 

a chemical substance or mixture, and which is designed to protect against a risk of injury to health or the environment associated with such substance or mixture, no State or political 

subdivision of a State may, after the effective date of such requirement, establish or continue in effect, any requirement 

which is applicable to such substance or mixture, or an article 

containing such substance or mixture, and which is designed 

to protect against such risk unless such requirement (i) is identical to the requirement prescribed by the Administrator, (ii) is 

adopted under the authority of the Clean Air Act or any other 

Federal law, or (iii) prohibits the use of such substance or mixture in such State or political subdivision (other than its use 

in the manufacture or processing of other substances or mixtures). 

ø(b) EXEMPTION.—Upon application of a State or political subdivision of a State the Administrator may by rule exempt from subsection (a)(2), under such conditions as may be prescribed in such 

rule, a requirement of such State or political subdivision designed 

to protect against a risk of injury to health or the environment associated with a chemical substance, mixture, or article containing 

a chemical substance or mixture if— 

ø(1) compliance with the requirement would not cause the 

manufacturing, processing, distribution in commerce, or use of 

the substance, mixture, or article to be in violation of the applicable requirement under this Act described in subsection (a)(2), 

and 

ø(2) the State or political subdivision requirement (A) provides a significantly higher degree of protection from such risk 

than the requirement under this Act described in subsection 

(a)(2) and (B) does not, through difficulties in marketing, distribution, or other factors, unduly burden interstate commerce.¿ 

(a) IN GENERAL.— 


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(1) ESTABLISHMENT OR ENFORCEMENT.—Except as provided 

in subsections (c), (d), (e), (f), and (g), and subject to paragraph 

(2), no State or political subdivision of a State may establish or 

continue to enforce any of the following: 

(A) TESTING AND INFORMATION COLLECTION.—A statute 

or administrative action to require the development of information on a chemical substance or category of substances that is reasonably likely to produce the same information required under section 4, 5, or 6 in— 

(i) a rule promulgated by the Administrator; 

(ii) a testing consent agreement entered into by the 

Administrator; or 

(iii) an order issued by the Administrator. 

(B) CHEMICAL SUBSTANCES FOUND TO MEET THE SAFETY

STANDARD OR RESTRICTED.—A statute or administrative action to prohibit or otherwise restrict the manufacture, 

processing, or distribution in commerce or use of a chemical substance— 

(i) found to meet the safety standard and consistent 

with the scope of the determination made under section 

6; or 

(ii) found not to meet the safety standard, after the 

effective date of the rule issued under section 6(d) for 

the substance, consistent with the scope of the determination made by the Administrator. 

(C) SIGNIFICANT NEW USE.—A statute or administrative 

action requiring the notification of a use of a chemical substance that the Administrator has specified as a significant 

new use and for which the Administrator has required notification pursuant to a rule promulgated under section 5. 

(2) EFFECTIVE DATE OF PREEMPTION.—Under this subsection, 

Federal preemption of State statutes and administrative actions 

applicable to specific substances shall not occur until the effective date of the applicable action described in paragraph (1) 

taken by the Administrator. 

(b) NEW STATUTES OR ADMINISTRATIVE ACTIONS CREATING PROHIBITIONS OR OTHER RESTRICTIONS.— 

(1) IN GENERAL.—Except as provided in subsections (c), (d), 

and (e), beginning on the date on which the Administrator defines the scope of a safety assessment and safety determination 

under section 6(a)(2) and ending on the date on which the Administrator publishes the safety determination, no State or political subdivision of a State may establish a statute or administrative action prohibiting or restricting the manufacture, processing, distribution in commerce or use of a chemical substance 

that is a high-priority substance designated under section 4A. 

(2) EFFECT OF SUBSECTION.— 

(A) IN GENERAL.—This subsection does not restrict the 

authority of a State or political subdivision of a State to 

continue to enforce any State statute enacted, or administrative action taken, prior to the date on which the Administrator defines the scope of a safety assessment and safety 

determination under section 6(a)(2). 


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(B) LIMITATION.—Subparagraph (A) does not allow a 

State or political subdivision of a State to enforce any new 

prohibition or restriction under a State statute or administrative action described in that subparagraph, if the prohibition or restriction is established after the date described 

in that subparagraph. 

(c) SCOPE OF PREEMPTION.—Federal preemption under subsections (a) and (b) of State statutes and administrative actions applicable to specific substances shall apply only to— 

(1) the chemical substances or category of substances subject 

to a rule, order, or consent agreement under section 4; 

(2) the uses or conditions of use of such substances that are 

identified by the Administrator as subject to review in a safety 

assessment and included in the scope of the safety determination made by the Administrator for the substance, or of any rule 

the Administrator promulgates pursuant to section 6(d); or 

(3) the uses of such substances that the Administrator has 

specified as significant new uses and for which the Administrator has required notification pursuant to a rule promulgated 

under section 5. 

(d) EXCEPTIONS.— (1) NO PREEMPTION OF STATE STATUTES AND ADMINISTRATIVE

ACTIONS.— 

(A) IN GENERAL.—Nothing in this Act, nor any amendment made by this Act, nor any rule, standard of performance, safety determination, or scientific assessment implemented pursuant to this Act, shall affect the right of a 

State or a political subdivision of a State to adopt or enforce any rule, standard of performance, safety determination, scientific assessment, or any protection for public 

health or the environment that— 

(i) is adopted or authorized under the authority of 

any other Federal law or adopted to satisfy or obtain 

authorization or approval under any other Federal 

law; 

(ii) implements a reporting, monitoring, disclosure, 

or other information obligation for the chemical substance not otherwise required by the Administrator 

under this Act or required under any other Federal 

law; 

(iii) is adopted pursuant to authority under a law of 

the State or political subdivision of the State related to 

water quality, air quality, or waste treatment or disposal, except to the extent that the action— 

(I) imposes a restriction on the manufacture, 

processing, distribution in commerce, or use of a 

chemical substance; and 

(II)(aa) addresses the same hazards and exposures, with respect to the same conditions of use as 

are included in the scope of the safety determination pursuant to section 6, but is inconsistent with 

the action of the Administrator; or 

(bb) would cause a violation of the applicable action by the Administrator under section 5 or 6; or 


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(iv) subject to subparagraph (B), is identical to a requirement prescribed by the Administrator. 

(B) IDENTICAL REQUIREMENTS.— 

(i) IN GENERAL.—The penalties and other sanctions 

applicable under State law in the event of noncompliance with the identical requirement shall be no more 

stringent than the penalties and other sanctions available to the Administrator under section 16 of this Act. 

(ii) PENALTIES.—In the case of an identical requirement, no State may assess a penalty for a specific violation for which the Administrator has already assessed a penalty under section 16, and the Administrator may not assess a penalty under section 16 for a 

specific violation for which a State has already assessed a penalty. 

(2) APPLICABILITY TO CERTAIN RULES OR ORDERS.—Notwithstanding subsection (e)— 

(A) nothing in this section shall be construed as modifying the effect under this section, as in effect on the day 

before the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, of any rule or order 

promulgated or issued under this Act prior to that effective 

date; and 

(B) with respect to a chemical substance or mixture for 

which any rule or order was promulgated or issued under 

section 6 prior to the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with regards 

to manufacturing, processing, distribution in commerce, 

use, or disposal of a chemical substance, this section (as in 

effect on the day before the effective date of the Frank R. 

Lautenberg Chemical Safety for the 21st Century Act) shall 

govern the preemptive effect of any rule or order that is promulgated or issued respecting such chemical substance or 

mixture under section 6 of this Act after that effective date, 

unless the latter rule or order is with respect to a chemical 

substance or mixture containing a chemical substance and 

follows a designation of that chemical substance as a highpriority substance under øsubsection (b) or (c) of¿ section 

4A (b) or as an additional priority for safety assessment 

and safety determination under section ø4A(d)¿ 4A(c). 

(e) PRESERVATION OF CERTAIN STATE LAW.— 

(1) IN GENERAL.—Nothing in this Act, subject to subsection 

(g) of this section, shall— 

(A) be construed to preempt or otherwise affect the authority of a State or political subdivision of a State to continue to enforce any action taken before August 1, 2015, 

under the authority of a State law that prohibits or otherwise restricts manufacturing, processing, distribution in 

commerce, use, or disposal of a chemical substance; or 

(B) be construed to preempt or otherwise affect any action 

taken pursuant to a State law that was in effect on August 

31, 2003. 


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(2) EFFECT OF SUBSECTION.—This subsection does not affect, 

modify, or alter the relationship between State and Federal law 

pursuant to any other Federal law. 

(f) STATE WAIVERS.— (1) DISCRETIONARY EXEMPTIONS.—Upon application of a 

State or political subdivision of a State, the Administrator may 

by rule, exempt from subsection (a), under such conditions as 

may be prescribed in the rule, a statute or administrative action 

of that State or political subdivision of the State that relates to 

the effects of, or exposure to, a chemical substance under the 

conditions of use if the Administrator determines that— 

(A) compelling State or local conditions warrant granting 

the waiver to protect health or the environment; 

(B) compliance with the proposed requirement of the 

State or political subdivision of the State would not unduly 

burden interstate commerce in the manufacture, processing, 

distribution in commerce, or use of a chemical substance; 

(C) compliance with the proposed requirement of the 

State or political subdivision of the State would not cause 

a violation of any applicable Federal law, rule, or order; 

and 

(D) based on the judgment of the Administrator, the proposed requirement of the State or political subdivision of 

the State is consistent with sound objective scientific practices, the weight of the evidence, and the best available 

science. 

(2) REQUIRED EXEMPTIONS.—Upon application of a State or 

political subdivision of a State, the Administrator shall exempt 

from subsection (b) a statute or administrative action of a State 

or political subdivision of a State that relates to the effects of 

exposure to a chemical substance under the conditions of use if 

the Administrator determines that— 

(A) compliance with the proposed requirement of the 

State will not unduly burden interstate commerce in the 

manufacture, processing, distribution in commerce, or use 

of a chemical substance; 

(B) compliance with the proposed requirement would not 

cause a violation of any applicable Federal law, rule, or 

order; and 

(C) the State or political subdivision of a State has a concern about the chemical substance or use of the chemical 

substance based in peer-reviewed science. 

(3) DETERMINATION OF A STATE WAIVER REQUEST.—The duty 

of the Administrator to grant or deny a waiver application shall 

be nondelegable and shall be exercised— 

(A) not later than 180 days after the date on which an 

application under paragraph (1) is submitted; and 

(B) not later than 90 days after the date on which an application under paragraph (2) is submitted. 

(4) FAILURE TO MAKE DETERMINATION.—If the Administrator 

fails to make a determination under paragraph (3)(B) during 

the 90-day period beginning on the date on which an application under paragraph (2) is submitted, the State statute or administrative action that was the subject of the application shall 


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not be considered to be an existing statute or administrative action for purposes of subsection ø(a)¿ (b) by reason of the failure 

of the Administrator to make a determination. 

(5) NOTICE AND COMMENT.—Except in the case of an application approved under paragraph (9), the application of a State 

or political subdivision of the State shall be subject to public 

notice and comment. 

(6) FINAL AGENCY ACTION.—The decision of the Administrator 

on the application of a State or political subdivision of the State 

shall be— 

(A) considered to be a final agency action; and 

(B) subject to judicial review. 

(7) DURATION OF WAIVERS.— 

(A) IN GENERAL.—Except as provided in subparagraph 

(B), a waiver granted under paragraph (2) or approved 

under paragraph (9) shall remain in effect— 

(i) until such time as the safety assessment and safety determination is completed; or 

(ii) subject to subparagraph (B), until judicial review 

of the failure of the Administrator to make a determination under paragraph (3) is sought under paragraph (8). 

(B) REINSTATEMENT OF WAIVER.—A waiver described in 

subparagraph (A)(ii) shall again take effect upon the earlier 

of— 

(i) the date of approval by the Administrator of the 

waiver application; 

(ii) the effective date of a court order directing the 

Administrator to approve the waiver application; or 

(iii) 90 days after the date on which judicial review 

under paragraph (8) is sought. 

(8) JUDICIAL REVIEW OF WAIVERS.—Not later than 60 days 

after the date on which the Administrator makes a determination on an application of a State or political subdivision of the 

State under paragraph (1) or (2), or not later than 60 days after 

the date on which the Administrator fails to make a determination under paragraph (3), any person may file a petition for judicial review in the United States Court of Appeals for the District of Columbia Circuit, which shall have exclusive jurisdiction over the determination. 

(9) APPROVAL.— 

(A) IN GENERAL.—If the Administrator fails to meet the 

deadline under section 6(a)(4) (including an extension 

granted under section 6(a)(6)), or the deadline established 

under paragraph (3)(B), the application of a State or political subdivision of a State under paragraph (2) shall be 

automatically approved. 

(B) REQUIREMENTS.—Notwithstanding paragraph (6), approval of a waiver application under subparagraph (A) for 

failure to meet the deadlines under section 6(a)(4) (including an extension granted under section 6(a)(6)) shall not be 

considered final agency action or be subject to judicial review or public notice and comment. 

(10) JUDICIAL REVIEW OF LOW-PRIORITY DECISIONS.— 


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(A) IN GENERAL.—Not later than 60 days after the publication of a designation under section 4A(b)(4), any person 

may commence a civil action to challenge the designation. 

(B) JURISDICTION.—The United States Court of Appeals 

for the District of Columbia Circuit shall have exclusive jurisdiction over a civil action filed under this paragraph. 

(g) SAVINGS.— (1) NO PREEMPTION OF COMMON LAW OR STATUTORY CAUSES

OF ACTION FOR CIVIL RELIEF OR CRIMINAL CONDUCT.— (A) IN GENERAL.—Nothing in this Act, nor any amendment made by this Act, nor any safety standard, rule, requirement, standard of performance, safety determination, 

or scientific assessment implemented pursuant to this Act, 

shall be construed to preempt, displace, or supplant any 

state or Federal common law rights or any state or Federal 

statute creating a remedy for civil relief, including those for 

civil damage, or a penalty for a criminal conduct. 

(B) CLARIFICATION OF NO PREEMPTION.—Notwithstanding any other provision of this Act, nothing in this 

Act, nor any amendments made by this Act, shall preempt 

or preclude any cause of action for personal injury, wrongful death, property damage, or other injury based on negligence, strict liability, products liability, failure to warn, 

or any other legal theory of liability under any State law, 

maritime law, or Federal common law or statutory theory. 

(2) NO EFFECT ON PRIVATE REMEDIES.— (A) IN GENERAL.—Nothing in this Act, nor any amendments made by this Act, nor any rules, regulations, requirements, safety assessments, safety determinations, scientific 

assessments, or orders issued pursuant to this Act shall be 

interpreted as, in either the plaintiff’s or defendant’s favor, 

dispositive in any civil action. 

(B) AUTHORITY OF COURTS.—This Act does not affect the 

authority of any court to make a determination in an adjudicatory proceeding under applicable State or Federal law 

with respect to the admission into evidence or any other use 

of this Act or rules, regulations, requirements, standards of 

performance, safety assessments, scientific assessments, or 

orders issued pursuant to this Act. 

SEC. 19. JUDICIAL REVIEW. 

(a) IN GENERAL.—(1)(A) Not later than 60 days after the date of 

the promulgation of a rule under øsection 4(a), 5(a)(2), 5(b)(4), 6(a), 

6(e), or 8, or under title II or IV¿ section 4(a), 5(d), 6(c), 6(d), 6(g), 

or 8, or title II or IV, any person may file a petition for judicial review of such rule with the United States Court of Appeals for the 

District of Columbia Circuit or for the circuit in which such person 

resides or in which such person’s principal place of business is located. Courts of appeals of the United States shall have exclusive 

jurisdiction of any action to obtain judicial review (other than in an 

enforcement proceeding) of such a rule if any district court of the 

United States would have had jurisdiction of such action but for 

this subparagraph. 

(B) Courts of appeals of the United States shall have exclusive 

jurisdiction of any action to obtain judicial review (other than in an 


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6So in law. Probably should be followed by a comma. 

enforcement proceeding) of øan order issued under subparagraph 

(A) or (B) of section 6(b)(1)¿ an order issued under this title if any 

district court of the United States would have had jurisdiction of 

such action but for this subparagraph. 

(2) Copies of any petition filed under øparagraph (1)(A)¿ paragraph (1) shall be transmitted forthwith to the Administrator and 

to the Attorney General by the clerk of the court with which such 

petition was filed. The provisions of section 2112 of title 28, United 

States Code, shall apply to the filing of the rulemaking record of 

proceedings on which the Administrator based the rule being reviewed under this section and to the transfer of proceedings between United States courts of appeals. 

ø(3) For purposes of this section, the term ‘‘rulemaking record’’ 

means— 

ø(A) the rule being reviewed under this section; 

ø(B) in the case of a rule under section 4(a), the finding required by such section, in the case of a rule under section 

5(b)(4), the finding required by such section, in the case of a 

rule under section 6(a) the finding required by section 5(f) or 

6(a), as the case may be, in the case of a rule under section 

6(a), the statement required by section 6(c)(1), and in the case 

of a rule under section 6(e), the findings required by paragraph 

(2)(B) or (3)(B) of such section, as the case may be 6 and in the 

case of a rule under title IV, the finding required for the 

issuance of such a rule; 

ø(C) any transcript required to be made of oral presentations 

made in proceedings for the promulgation of such rule; 

ø(D) any written submission of interested parties respecting 

the promulgation of such rule; and 

ø(E) any other information which the Administrator considers to be relevant to such rule and which the Administrator 

identified, on or before the date of the promulgation of such 

rule, in a notice published in the Federal Register.¿ 

(b) ADDITIONAL SUBMISSIONS AND PRESENTATIONS; MODIFICATIONS.—If in an action under this section to review a rule the petitioner or the Administrator applies to the court for leave to make 

additional oral submissions or written presentations respecting 

such rule and shows to the satisfaction of the court that such submissions and presentations would be material and that there were 

reasonable grounds for the submissions and failure to make such 

submissions and presentations in the proceeding before the Administrator, the court may order the Administrator to provide additional opportunity to make such submissions and presentations. 

The Administrator may modify or set aside the rule being reviewed 

or make a new rule by reason of the additional submissions and 

presentations and shall file such modified or new rule with the return of such submissions and presentations. The court shall thereafter review such new or modified rule. 

(c) STANDARD OF REVIEW.—(1)(A) Upon the filing of a petition 

under subsection (a)(1) for judicial review of a rule, the court shall 

have jurisdiction (i) to grant appropriate relief, including interim 

relief, as provided in chapter 7 of title 5, United States Code, and 


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(ii) except as otherwise provided in subparagraph (B), to review 

such rule in accordance with chapter 7 of title 5, United States 

Code. 

(B) Section 706 of title 5, United States Code, shall apply to review of a rule under this section, except that— 

(i) in the case of review of a rule under øsection 4(a), 5(b)(4), 

6(a), or 6(e)¿ section 4(a), 5(d), 6(d), or 6(g), the standard for 

review prescribed by paragraph (2)(E) of such section 706 shall 

not apply and the court shall hold unlawful and set aside such 

rule if the court finds that the rule is not supported by substantial øevidence in the rulemaking record (as defined in subsection (a)(3)) taken as a whole;¿ 

ø(ii) in the case of review of a rule under section 6(a), the 

court shall hold unlawful and set aside such rule if it finds 

that— 

ø(I) a determination by the Administrator under section 

6(c)(3) that the petitioner seeking review of such rule is 

not entitled to conduct (or have conducted) cross-examination or to present rebuttal submissions, or 

ø(II) a rule of, or ruling by, the Administrator under section 6(c)(3) limiting such petitioner’s cross-examination or 

oral presentations, 

has precluded disclosure of disputed material facts which was 

necessary to a fair determination by the Administrator of the 

rulemaking proceeding taken as a whole; and section 706(2)(D) 

shall not apply with respect to a determination, rule, or ruling 

referred to in subclause (I) or (II); and 

ø(iii) the court may not review the contents and adequacy 

of— 

ø(I) any statement required to be made pursuant to section 6(c)(1), or 

ø(II) any statement of basis and purpose required by section 553(c) of title 5, United States Code, to be incorporated in the rule¿ 

øexcept as part of a review of the rulemaking record taken as 

a whole. 

øThe term ‘‘evidence’’ as used in clause (i) means any matter in the 

rulemaking record.¿ 

(ii) the court may not review the contents and adequacy of any statement of basis and purpose required 

by section 553(c) of title 5, United States Code, to be incorporated in the rule, except as part of the rulemaking 

record, taken as a whole. 

(C) A determination, rule, or ruling of the Administrator described in subparagraph (B)(ii) may be reviewed only in an action 

under this section and only in accordance with such subparagraph. 

(2) The judgment of the court affirming or setting aside, in whole 

or in part, any rule reviewed in accordance with this section shall 

be final, subject to review by the Supreme Court of the United 

States upon certiorari or certification, as provided in section 1254 

of title 28, United States Code. 

(d) FEES AND COSTS.—The decision of the court in an action commenced under subsection (a), or of the Supreme Court of the 

United States on review of such a decision, may include an award 


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of costs of suit and reasonable fees for attorneys and expert witnesses if the court determines that such an award is appropriate. 

(e) OTHER REMEDIES.—The remedies as provided in this section 

shall be in addition to and not in lieu of any other remedies provided by law. 

* * * * * * * 

SEC. 21. CITIZENS’ PETITIONS. 

(a) IN GENERAL.—Any person may petition the Administrator to 

initiate a proceeding for the issuance, amendment, or repeal of a 

rule under section 4, 6, or 8 or øan order under section 5(e) or 

(6)(b)(2)¿ an order under section 4 or 5(d). (b) PROCEDURES.—(1) Such petition shall be filed in the principal 

office of the Administrator and shall set forth the facts which it is 

claimed establish that it is necessary to issue, amend, or repeal a 

rule under section 4, 6, or 8 or øan order under section 5(e), 

6(b)(1)(A), or 6(b)(1)(B)¿ an order under section 4 or 5(d). (2) The Administrator may hold a public hearing or may conduct 

such investigation or proceeding as the Administrator deems appropriate in order to determine whether or not such petition should be 

granted. 

(3) Within 90 days after filing of a petition described in paragraph (1), the Administrator shall either grant or deny the petition. 

If the Administrator grants such petition, the Administrator shall 

promptly commence an appropriate proceeding in accordance with 

section 4, 5, 6, or 8. If the Administrator denies such petition, the 

Administrator shall publish in the Federal Register the Administrator’s reasons for such denial. 

(4)(A) If the Administrator denies a petition filed under this section (or if the Administrator fails to grant or deny such petition 

within the 90-day period) the petitioner may commence a civil action in a district court of the United States to compel the Administrator to initiate a rulemaking proceeding as requested in the petition. Any such action shall be filed within 60 days after the Administrator’s denial of the petition or, if the Administrator fails to 

grant or deny the petition within 90 days after filing the petition, 

within 60 days after the expiration of the 90-day period. 

ø(B) In an action under subparagraph (A) respecting a petition 

to initiate a proceeding to issue a rule under section 4, 6, or 8 or 

an order under section 5(e) or 6(b)(2), the petitioner shall be provided an opportunity to have such petition considered by the court 

in a de novo proceeding. If the petitioner demonstrates to the satisfaction of the court by a preponderance of the evidence that—¿ 

(B) DE NOVO PROCEEDING.— 

(i) IN GENERAL.—In an action under subparagraph 

(A) to initiate a proceeding to promulgate a rule pursuant to section 4, 5, 6, or 8 or issue an order øissued¿ 

under section 4 or 5 (d), the petitioner shall be provided an opportunity to have the petition considered 

by the court in a de novo proceeding. 

(ii) DEMONSTRATION.— 

(I) IN GENERAL.—The court in a de novo proceeding under this subparagraph shall order the 

Administrator to initiate the action requested by 


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the petitioner if the petitioner demonstrates to the 

satisfaction of the court by a preponderance of the 

evidence that— 

(aa) in the case of a petition to initiate a 

proceeding for the issuance of a rule or order 

under section 4, the information available to 

the Administrator is insufficient for the Administrator to perform an action described in 

section 4, 4A, 5, or 6(d); 

(bb) in the case of a petition to issue an 

order under section 5(d), there is a reasonable 

basis to conclude that the chemical substance 

is not likely to meet the safety standard; 

(cc) in the case of a petition to initiate a proceeding for the issuance of a rule under section 

6(d), there is a reasonable basis to conclude 

that the chemical substance will not meet the 

safety standard; or 

(dd) in the case of a petition to initiate a 

proceeding for the issuance of a rule under section 8, there is a reasonable basis to conclude 

that the rule is necessary to protect health or 

the environment or ensure that the chemical 

substance meets the safety standard. 

(II) DEFERMENT.—The court in a de novo proceeding under this subparagraph may permit the 

Administrator to defer initiating the action requested by the petitioner until such time as the 

court prescribes, if the court finds that— 

(aa) the extent of the risk to health or the environment alleged by the petitioner is less than 

the extent of risks to health or the environment 

with respect to which the Administrator is taking action under this Act; and 

(bb) there are insufficient resources available to the Administrator to take the action requested by the petitioner. 

* * * * * * * 

SEC. 24. EMPLOYMENT EFFECTS. 

(a) IN GENERAL.—The Administrator shall evaluate on a continuing basis the potential effects on employment (including reductions in employment or loss of employment from threatened plant 

closures) of— 

(1) the issuance of a rule or order under section 4, 5, or 6, 

or 

(2) a requirement of section 5 or 6. 

(b)(1) INVESTIGATIONS.—Any employee (or any representative of 

an employee) may request the Administrator to make an investigation of— 

(A) a discharge or layoff or threatened discharge or layoff of 

the employee, or 

(B) adverse or threatened adverse effects on the employee’s 

employment, 


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allegedly resulting from a rule or order under section 4, 5, or 6 or 

a requirement of section 5 or 6. Any such request shall be made 

in writing, shall set forth with reasonable particularity the grounds 

for the request, and shall be signed by the employee, or representative of such employee, making the request. 

(2)(A) Upon receipt of a request made in accordance with paragraph (1) the Administrator shall (i) conduct the investigation requested, and (ii) if requested by any interested person, hold public 

hearings on any matter involved in the investigation unless the Administrator, by order issued within 45 days of the date such hearings are requested, denies the request for the hearings because the 

Administrator determines there are no reasonable grounds for 

holding such hearings. If the Administrator makes such a determination, the Administrator shall notify in writing the person requesting the hearing of the determination and the reasons therefor 

and shall publish the determination and the reasons therefor in the 

Federal Register. 

(B) If public hearings are to be held on any matter involved in 

an investigation conducted under this subsection— 

(i) at least five days’ notice shall be provided the person 

making the request for the investigation and any person identified in such request, 

(ii) such hearings shall be held in accordance with øsection 

6(c)(3),¿ the applicable requirements of this Act; and 

(iii) each employee who made or for whom was made a request for such hearings and the employer of such employee 

shall be required to present information respecting the applicable matter referred to in paragraph (1)(A) or (1)(B) together 

with the basis for such information. 

(3) Upon completion of an investigation under paragraph (2), the 

Administrator shall make findings of fact, shall make such recommendations as the Administrator deems appropriate, and shall 

make available to the public such findings and recommendations. 

(4) This section shall not be construed to require the Administrator to amend or repeal any rule or order in effect under this Act. 

SEC. 25. STUDIES. 

ø(a) INDEMNIFICATION STUDY.—The Administrator shall conduct 

a study of all Federal laws administered by the Administrator for 

the purpose of determining whether and under what conditions, if 

any, indemnification should be accorded any person as a result of 

any action taken by the Administrator under any such law. The 

study shall— 

ø(1) include an estimate of the probable cost of any indemnification programs which may be recommended; 

ø(2) include an examination of all viable means of financing 

the cost of any recommended indemnification; and 

ø(3) be completed and submitted to Congress within two 

years from the effective date of enactment of this Act. 

øThe General Accounting Office shall review the adequacy of the 

study submitted to Congress pursuant to paragraph (3) and shall 

report the results of its review to the Congress within six months 

of the date such study is submitted to Congress. 

ø(b) CLASSIFICATION, STORAGE, AND RETRIEVAL STUDY.—The 

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istrator, the Secretary of Health, Education, and Welfare, the Secretary of Commerce, and the heads of other appropriate Federal departments or agencies, shall coordinate a study of the feasibility of 

establishing (1) a standard classification system for chemical substances and related substances, and (2) a standard means for storing and for obtaining rapid access to information respecting such 

substances. A report on such study shall be completed and submitted to Congress not later than 18 months after the effective 

date of enactment of this Act.¿ 

SEC. 26. ADMINISTRATION OF THE ACT. 

(a) COOPERATION OF FEDERAL AGENCIES.—Upon request by the 

Administrator, each Federal department and agency is authorized— 

(1) to make its services, personnel, and facilities available 

(with or without reimbursement) to the Administrator to assist 

the Administrator in the administration of this Act; and 

(2) to furnish to the Administrator such information, data, 

estimates, and statistics, and to allow the Administrator access 

to all information in its possession as the Administrator may 

reasonably determine to be necessary for the administration of 

this Act. 

ø(b) FEES.—ø(1) The Administrator may, by rule, require the 

payment of a reasonable fee from any person required to submit 

data under section 4 or 5 to defray the cost of administering this 

Act. Such rules shall not provide for any fee in excess of $2,500 or, 

in the case of a small business concern, any fee in excess of $100. 

In setting a fee under this paragraph, the Administrator shall take 

into account the ability to pay of the person required to submit the 

data and the cost to the Administrator of reviewing such data. 

Such rules may provide for sharing such a fee in any case in which 

the expenses of testing are shared under section 4 or 5. 

ø(2) The Administrator, after consultation with the Administrator of the Small Business Administration, shall by rule prescribe 

standards for determining the persons which qualify as small business concerns for purposes of paragraph (1).¿ 

(b) FEES.— 

(1) IN GENERAL.—The Administrator shall establish, not later 

than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, by rule— 

(A) the payment of 1 or more reasonable fees as a condition of submitting a notice or requesting an exemption 

under section 5; 

(B) the payment of 1 or more reasonable fees by a manufacturer or processor that— 

(i) is required to submit a notice pursuant to the rule 

promulgated under section 8(b)(4)(A)(i) identifying a 

chemical substance as active; 

(ii) is required to submit a notice pursuant to section 

8(b)(5)(B)(i) changing the status of a chemical substance from inactive to active; 

(iii) is required to report information pursuant to the 

rules promulgated under section 8(a)(4); and 


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(iv) manufactures or processes a chemical substance 

subject to a safety assessment and safety determination 

pursuant to section 6. 

(2) UTILIZATION AND COLLECTION OF FEES.—The Administrator shall— 

(A) utilize the fees collected under paragraph (1) only to 

defray costs associated with the actions of the Administrator— 

(i) to collect, process, review, provide access to, and 

protect from disclosure (where appropriate) information 

on chemical substances under this Act; 

(ii) to review notices and make determinations for 

chemical substances under paragraphs (1) and (3) of 

section 5(d) and impose any necessary restrictions 

under section 5(d)(4); 

(iii) to make prioritization decisions under section 

4A; 

(iv) to conduct and complete safety assessments and 

determinations under section 6; and 

(v) to conduct any necessary rulemaking pursuant to 

section 6(d); 

(B) insofar as possible, collect the fees described in paragraph (1) in advance of conducting any fee-supported activity; 

(C) deposit the fees in the Fund established by paragraph 

(4)(A); and 

(D) not collect excess fees or retain a significant amount 

of unused fees. 

(3) AMOUNT AND ADJUSTMENT OF FEES; REFUNDS.—In setting 

fees under this section, the Administrator shall— 

(A) take into account the cost to the Administrator of conducting the activities described in paragraph (2); 

(B) prescribe lower fees for small business concerns, after 

consultation with the Administrator of the Small Business 

Administration; 

(C) set the fees established under paragraph (1) at levels 

such that the fees will, in aggregate, provide a sustainable 

source of funds to defray approximately 25 percent of the 

costs of conducting the activities identified in paragraph 

(2)(A), not to exceed $18,000,000, not including fees under 

subparagraph (E) of this paragraph; 

(D) reflect an appropriate balance in the assessment of 

fees between manufacturers and processors, and allow the 

payment of fees by consortia of manufacturers or processors; 

(E) for substances designated as additional priorities 

pursuant to section 4A(c), establish the fee at a level sufficient to defray the full costs to the Administrator of conducting the safety assessment and safety determination 

under section 6, except that for substances subject to section 

4A(c)(3), the Administrator shall establish the fee at a level 

sufficient to defray 50 percent of those costs; 

(F) prior to the establishment or amendment of any fees 

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tially subject to the fees or their representatives, subject to 

the condition that no obligation under the Federal Advisory 

Committee Act (5 U.S.C. App.) or subchapter III of chapter 

5 of title 5, United States Code, is applicable with respect 

to such meetings; 

(G) beginning with the fiscal year that is 3 years after the 

date of enactment of the Frank R. Lautenberg Chemical 

Safety for the 21st Century Act, and every 3 years thereafter, after consultation with parties potentially subject to 

the fees and their representatives, increase or decrease the 

fees established under paragraph (1) as necessary— 

(i) to ensure that funds deposited in the Fund are 

sufficient to conduct the activities identified in paragraph (2)(A) and the full cost or 50-percent portion of 

the costs of safety assessments and safety determinations pursuant to subparagraph (E); and 

(ii) to account for inflation; 

(H) adjust fees established under paragraph (1) as necessary to vary on account of differing circumstances, including reduced fees or waivers in appropriate circumstances, to reduce the burden on manufacturing or 

processing, remove barriers to innovation, or where the 

costs to the Administrator of collecting the fees exceed the 

fee revenue anticipated to be collected; and 

(I) if a notice submitted under section 5 is refused or subsequently withdrawn, refund the fee or a portion of the fee 

if no substantial work was performed on the notice. 

(4) TSCA IMPLEMENTATION FUND.— (A) ESTABLISHMENT.—There is established in the Treasury of the United States a fund, to be known as the ‘TSCA 

Implementation Fund’ (referred to in this subsection as the 

‘Fund’), consisting of— 

(i) such amounts as are deposited in the Fund under 

paragraph (2)(C); and 

(ii) any interest earned on the investment of amounts 

in the Fund; and 

(iii) any proceeds from the sale or redemption of investments held in the Fund. 

(B) CREDITING AND AVAILABILITY OF FEES.— (i) IN GENERAL.—Fees authorized under this section 

shall be collected and available for obligation only to 

the extent and in the amount provided in advance in 

appropriations Acts, and shall be available without fiscal year limitation. 

(ii) REQUIREMENTS.—Fees collected under this section shall not— 

(I) be made available or obligated for any purpose other than to defray the costs of conducting 

the activities identified in paragraph (2)(A); 

(II) otherwise be available for any purpose other 

than implementation of this Act; and 

(III) so long as amounts in the Fund remain 

available, be subject to restrictions on expenditures 

applicable to the Federal government as a whole. 


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(C) UNUSED FUNDS.—Amounts in the Fund not currently 

needed to carry out this subsection shall be— 

(i) maintained readily available or on deposit; 

(ii) invested in obligations of the United States or 

guaranteed by the United States; or 

(iii) invested in obligations, participations, or other 

instruments that are lawful investments for fiduciary, 

trust, or public funds. 

(D) MINIMUM AMOUNT OF APPROPRIATIONS.—Fees may 

not be assessed for a fiscal year under this section unless 

the amount of appropriations for salaries, contracts, and 

expenses for the functions (as in existence in fiscal year 

2015) of the Office of Pollution Prevention and Toxics of the 

Environmental Protection Agency for the fiscal year (excluding the amount of any fees appropriated for the fiscal 

year) are equal to or greater than the amount of appropriations for covered functions for fiscal year 2015 (excluding 

the amount of any fees appropriated for the fiscal year). 

(5) AUDITING.— 

(A) FINANCIAL STATEMENTS OF AGENCIES.—For the purpose of section 3515(c) of title 31, United States Code, the 

Fund shall be considered a component of an executive agency. 

(B) COMPONENTS.—The annual audit required under sections 3515(b) and 3521 of that title of the financial statements of activities under this subsection shall include an 

analysis of— 

(i) the fees collected under paragraph (1) and disbursed; 

(ii) compliance with the deadlines established in section 6 of this Act; 

(iii) the amounts budgeted, appropriated, collected 

from fees, and disbursed to meet the requirements of 

sections 4, 4A, 5, 6, 8, and 14, including the allocation 

of full time equivalent employees to each such section 

or activity; and 

(iv) the reasonableness of the allocation of the overhead associated with the conduct of the activities described in paragraph (2)(A). 

(C) INSPECTOR GENERAL.—The Inspector General of the 

Environmental Protection Agency shall— 

(i) conduct the annual audit required under this subsection; and 

(ii) report the findings and recommendations of the 

audit to the Administrator and to the appropriate committees of Congress. 

(6) TERMINATION.—The authority provided by this section 

shall terminate at the conclusion of the fiscal year that is 10 

years after the date of enactment of the Frank R. Lautenberg 

Chemical Safety for the 21st Century Act, unless otherwise reauthorized or modified by Congress. 

(c) ACTION WITH RESPECT TO CATEGORIES.—(1) Any action authorized or required to be taken by the Administrator under any 

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ture may be taken by the Administrator in accordance with that 

provision with respect to a category of chemical substances or mixtures. Whenever the Administrator takes action under a provision 

of this Act with respect to a category of chemical substances or 

mixtures, any reference in this Act to a chemical substance or mixture (insofar as it relates to such action) shall be deemed to be a 

reference to each chemical substance or mixture in such category. 

(2) For purposes of paragraph (1): 

(A) The term ‘‘category of chemical substances’’ means a 

group of chemical substances the members of which are similar 

in molecular structure, in physical, chemical, or biological 

properties, in use, or in mode of entrance into the human body 

or into the environment, or the members of which are in some 

other way suitable for classification as such for purposes of this 

Act, except that such term does not mean a group of chemical 

substances which are grouped together solely on the basis of 

their being new chemical substances. 

(B) The term ‘‘category of mixtures’’ means a group of mixtures the members of which are similar in molecular structure, 

in physical, chemical, or biological 1properties, in use, or in the 

mode of entrance into the human body or into the environment, or the members of which are in some other way suitable 

for classification as such for purposes of this Act. 

(d) ASSISTANCE OFFICE.—The Administrator shall establish in 

the Environmental Protection Agency an identifiable office to provide technical and other nonfinancial assistance to manufacturers 

and processors of chemical substances and mixtures respecting the 

requirements of this Act applicable to such manufacturers and 

processors, the policy of the Agency respecting the application of 

such requirements to such manufacturers and processors, and the 

means and methods by which such manufacturers and processors 

may comply with such requirements. 

(e) FINANCIAL DISCLOSURES.—(1) Except as provided under paragraph (3), each officer or employee of the Environmental Protection 

Agency and the Department of øHealth, Education, and Welfare¿ 

Health and Human Services who— 

(A) performs any function or duty under this Act, and 

(B) has any known financial interest (i) in any person subject 

to this Act or any rule or order in effect under this Act, or (ii) 

in any person who applies for or receives any grant or contract 

under this Act, 

shall, on February 1, 1978, and on February 1 of each year thereafter, file with the Administrator or the Secretary of øHealth, Education, and Welfare¿ Health and Human Services (hereinafter in 

this subsection referred to as the ‘‘Secretary’’), as appropriate, a 

written statement concerning all such interests held by such officer 

or employee during the preceding calendar year. Such statement 

shall be made available to the public. 

(2) The Administrator and the Secretary shall— 

(A) act within 90 days of the effective date of this Act— 

(i) to define the term ‘‘known financial interests’’ for purposes of paragraph (1), and 

(ii) to establish the methods by which the requirement 

to file written statements specified in paragraph (1) will be 


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monitored and enforced, including appropriate provisions 

for review by the Administrator and the Secretary of such 

statements; and 

(B) report to the Congress on June 1, 1978, and on June 1 

of each year thereafter with respect to such statements and the 

actions taken in regard thereto during the preceding calendar 

year. 

(3) The Administrator may by rule identify specific positions with 

the Environmental Protection Agency, and the Secretary may by 

rule identify specific positions with the Department of øHealth, 

Education, and Welfare¿ Health and Human Services, which are of 

a nonregulatory or nonpolicy-making nature, and the Administrator and the Secretary may by rule provide that officers or employees occupying such positions shall be exempt from the requirements of paragraph (1). 

(4) This subsection does not supersede any requirement of chapter 11 of title 18, United States Code. 

(5) Any officer or employee who is subject to, and knowingly violates, this subsection or any rule issued thereunder, shall be fined 

not more than $2,500 or imprisoned not more than one year, or 

both. 

(f) STATEMENT OF BASIS AND PURPOSE.—Any final order issued 

under this Act shall be accompanied by a statement of its basis and 

purpose. The contents and adequacy of any such statement shall 

not be subject to judicial review in any respect. 

(g) ASSISTANT ADMINISTRATOR.—(1) The President, by and with 

the advice and consent of the Senate, shall appoint an Assistant 

Administrator for Toxic Substances of the Environmental Protection Agency. Such Assistant Administrator shall be a qualified individual who is, by reason of background and experience, especially 

qualified to direct a program concerning the effects of chemicals on 

human health and the environment. Such Assistant Administrator 

shall be responsible for (A) the collection of data, (B) the preparation of studies, (C) the making of recommendations to the Administrator for regulatory and other actions to carry out the purposes 

and to facilitate the administration of this Act, and (D) such other 

functions as the Administrator may assign or delegate. 

(2) The Assistant Administrator to be appointed under paragraph 

(1) shall be in addition to the Assistant Administrators of the Environmental Protection Agency authorized by section 1(d) of Reorganization Plan No. 3 of 1970. 

(h) PRIOR ACTIONS.—Nothing in this Act eliminates, modifies, or 

withdraws any rule promulgated, order issued, or exemption established pursuant to this Act before the date of enactment of the Frank 

R. Lautenberg Chemical Safety for the 21st Century Act. 

SEC. 27. DEVELOPMENT AND EVALUATION OF TEST METHODS. 

(a) IN GENERAL.—The Secretary of øHealth, Education, and Welfare¿ Health and Human Services in consultation with the Administrator and acting through the Assistant Secretary for Health, 

may conduct, and make grants to public and nonprofit private entities and enter into contracts with public and private entities for, 

projects for the development and evaluation of inexpensive and efficient methods (1) for determining and evaluating the health and 

environmental effects of chemical substances and mixtures, and 


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their toxicity, persistence, and other characteristics which affect 

health and the environment, and (2) which may be used for the development of test data to meet the requirements of rules promulgated under section 4. The Administrator shall consider such methods in prescribing under section 4 standards for the development 

of test data. 

(b) APPROVAL BY SECRETARY.—No grant may be made or contract 

entered into under subsection (a) unless an application therefor has 

been submitted to and approved by the Secretary. Such an application shall be submitted in such form and manner and contain such 

information as the Secretary may require. The Secretary may apply 

such conditions to grants and contracts under subsection (a) as the 

Secretary determines are necessary to carry out the purposes of 

such subsection. Contracts may be entered into under such subsection without regard to sections 3648 and 3709 of the Revised 

Statutes (31 U.S.C. 529; 41 U.S.C. 5). 

(c) SUSTAINABLE CHEMISTRY PROGRAM.—The President shall establish an interagency Sustainable Chemistry Program to promote 

and coordinate Federal sustainable chemistry research, development, demonstration, technology transfer, commercialization, education, and training activities. 

(d) PROGRAM ACTIVITIES.—The activities of the Program shall be 

designed to— 

(1) provide sustained support for sustainable chemistry research, development, demonstration, technology transfer, commercialization, education, and training through— 

(A) coordination of sustainable chemistry research, development, demonstration, and technology transfer conducted 

at Federal laboratories and agencies; and 

(B) to the extent practicable, encouragement of consideration of sustainable chemistry in, as appropriate— 

(i) the conduct of Federal and State science and engineering research and development; and 

(ii) the solicitation and evaluation of applicable proposals for science and engineering research and development; 

(2) examine methods by which the Federal Government can 

create incentives for consideration and use of sustainable chemistry processes and products, including innovative financing 

mechanisms; 

(3) expand the education and training of undergraduate and 

graduate students and professional scientists and engineers, including through partnerships with industry, in sustainable 

chemistry science and engineering; 

(4) collect and disseminate information on sustainable chemistry research, development, and technology transfer including 

information on— 

(A) incentives and impediments to development, manufacturing, and commercialization; 

(B) accomplishments; 

(C) best practices; and 

(D) costs and benefits; 

(5) support (including through technical assistance, participation, financial support, or other forms of support) economic, 


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legal, and other appropriate social science research to identify 

barriers to commercialization and methods to advance commercialization of sustainable chemistry. 

(e) INTERAGENCY WORKING GROUP.— (1) ESTABLISHMENT.—Not later than 180 days after the date 

of enactment of the Frank R. Lautenberg Chemical Safety for 

the 21st Century Act, the President, in consultation with the Office of Science and Technology Policy, shall establish an Interagency Working Group that shall include representatives from 

the National Science Foundation, the National Institute of 

Standards and Technology, the Department of Energy, the Environmental Protection Agency, the Department of Agriculture, 

the Department of Defense, the National Institutes of Health, 

and any other agency that the President may designate to oversee the planning, management, and coordination of the Program. 

(2) GOVERNANCE.—The Director of the National Science 

Foundation and the Assistant Administrator for Research and 

Development of the Environmental Protection Agency, or their 

designees, shall serve as co-chairs of the Interagency Working 

Group. 

(3) RESPONSIBILITIES.—In overseeing the planning, management, and coordination of the Program, the Interagency Working Group shall— 

(A) establish goals and priorities for the Program, in consultation with the Advisory Council; 

(B) provide for interagency coordination, including budget coordination, of activities under the Program; 

(C) meet not later than 90 days from its establishment 

and periodically thereafter; and 

(D) establish and consult with an Advisory Council on a 

regular basis. 

(4) MEMBERSHIP.—The Advisory Council members shall not 

be employees of the Federal Government and shall include a diverse representation of knowledgeable individuals from the private sector (including small- and medium-sized enterprises 

from across the value chain), academia, State and tribal governments, and nongovernmental organizations and others who 

are in a position to provide expertise. 

(f) AGENCY BUDGET REQUESTS.— 

(1) IN GENERAL.—Each Federal agency and department participating in the Program shall, as part of its annual request 

for appropriations to the Office of Management and Budget, 

submit a report to the Office of Management and Budget that— 

(A) identifies the activities of the agency or department 

that contribute directly to the Program; and 

(B) states the portion of the agency or department’s request for appropriations that is allocated to those activities. 

(2) ANNUAL BUDGET REQUEST TO CONGRESS.—The President 

shall include in the annual budget request to Congress a statement of the portion of the annual budget request for each agency or department that will be allocated to activities undertaken 

pursuant to the Program. 

(g) REPORT TO CONGRESS.— 


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(1) IN GENERAL.—Not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 

21st Century Act, the Interagency Working Group shall submit 

a report to the Committee on Science, Space, and Technology 

and Committee on Energy and Commerce of the House of Representatives and the Committee on Environment and Public 

Works and the Committee on Commerce, Science, and Transportation of the Senate that shall include— 

(A) a summary of federally funded sustainable chemistry 

research, development, demonstration, technology transfer, 

commercialization, education, and training activities; 

(B) a summary of the financial resources allocated to sustainable chemistry initiatives; 

(C) an analysis of the progress made toward achieving 

the goals and priorities of this Act the program established 

pursuant to subsection (c), and recommendations for future 

program activities; 

(D) an assessment of the benefits of expanding existing, 

federally-supported regional innovation and manufacturing 

hubs to include sustainable chemistry and the value of directing the creation of 1 or more dedicated sustainable 

chemistry centers of excellence or hubs; and 

(E) an evaluation of steps taken and future strategies to 

avoid duplication of efforts, streamline interagency coordination, facilitate information sharing, and spread best 

practices between participating agencies in the Program. 

(2) SUBMISSION TO GAO.—The Interagency Working Group 

shall also submit the report described in paragraph (1) to the 

Government Accountability Office for consideration in future 

Congressional inquiries. 

SEC. 28. STATE PROGRAMS. 

(a) IN GENERAL.—For the purpose of complementing (but not reducing) the authority of, or actions taken by, the Administrator 

under this Act, the Administrator may make grants to States for 

the establishment and operation of programs to prevent or eliminate unreasonable risks within the States to health or the environment which are associated with a chemical substance or mixture 

and with respect to which the Administrator is unable or is not 

likely to take action under this Act for their prevention or elimination. The amount of a grant under this subsection shall be determined by the Administrator, except that no grant for any State 

program may exceed 75 per centum of the establishment and operation costs (as determined by the Administrator) of such program 

during the period for which the grant is made. 

(b) APPROVAL BY ADMINISTRATOR.—(1) No grant may be made 

under subsection (a) unless an application therefor is submitted to 

and approved by the Administrator. Such an application shall be 

submitted in such form and manner as the Administrator may require and shall— 

(A) set forth the need of the applicant for a grant under subsection (a)ø,¿ ; 

(B) identify the agency or agencies of the State which shall 

establish or operate, or both, the program for which the application is submittedø,¿ ; 


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(C) describe the actions proposed to be taken under such programø,¿ ; 

(D) contain or be supported by assurances satisfactory to the 

Administrator that such program shall, to the extent feasible, 

be integrated with other programs of the applicant for environmental and public health protectionø,¿ ; 

(E) provide for the making of such reports and evaluations 

as the Administrator may requireø, and¿ 

(F) contain such other information as the Administrator may 

prescribe. 

(2) The Administrator may approve an application submitted in 

accordance with paragraph (1) only if the applicant has established 

to the satisfaction of the Administrator a priority need, as determined under rules of the Administrator, for the grant for which the 

application has been submitted. Such rules shall take into consideration the seriousness of the health effects in a State which are 

associated with chemical substances or mixtures, including cancer, 

birth defects, and gene mutations, the extent of the exposure in a 

state of human beings and the environment to chemical substances 

and mixtures, and the extent to which chemical substances and 

mixtures are manufactured, processed, used, and disposed of in a 

State. 

ø(c) ANNUAL REPORTS.—Not later than six months after the end 

of each of the fiscal years 1979, 1980, and 1981, the Administrator 

shall submit to the Congress a report respecting the programs assisted by grants under subsection (a) in the preceding fiscal year 

and the extent to which the Administrator has disseminated information respecting such programs. 

ø(d) AUTHORIZATION.—For the purpose of making grants under 

subsection (a), there are authorized to be appropriated $1,500,000 

for each of the fiscal years 1982 and 1983. Sums appropriated 

under this subsection shall remain available until expended.¿ 

øSEC. 29. AUTHORIZATION FOR APPROPRIATIONS. 

øThere are authorized to be appropriated to the Administrator 

for purposes of carrying out this Act (other than sections 27 and 

28 and subsections (a) and (c) through (g) of section 10 thereof) 

$10,100,000 for the fiscal year ending September 30, 1977, 

$58,646,000 for the fiscal year 1982 and $62,000,000 for the fiscal 

year 1983. No part of the funds appropriated under this section 

may be used to construct any research laboratories.¿ 

SEC. 30. ANNUAL REPORT. 

The Administrator shall prepare and submit to the President and 

the Congress on or before January 1, 1978, and on or before January 1 of each succeeding year a comprehensive report on the administration of this Act during the preceding fiscal year. Such report shall include— 

(1) a list of the testing required under section 4 during the 

year for which the report is made and an estimate of the costs 

incurred during such year by the persons required to perform 

such tests; 

ø(2) the number of notices received during such year under 

section 5, the number of such notices received during such year 

under such section for chemical substances subject to a section 


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4 rule, and a summary of any action taken during such year 

under section 5(g);¿ 

(2)(A) the number of notices received during each year under 

section 5; and 

(B) the number of the notices described in subparagraph (A) 

for chemical substances subject to a rule, testing consent agreement, or order under section 4; 

(3) a list of rules issued during such year under section 6; 

(4) a list, with a brief statement of the issues, of completed 

or pending judicial actions under this Act and administrative 

actions under section 16 during such year; 

(5) a summary of major problems encountered in the administration of this Act; and 

(6) such recommendations for additional legislation as the 

Administrator deems necessary to carry out the purposes of 

this Act. 

SEC. 31. EFFECTIVE DATE. 

øExcept as provided in section 4(f), this¿ 

(a) IN GENERAL.—ThisAct shall take effect on January 1, 1977. 

(b) RETROACTIVE APPLICABILITY.—Nothing in this Act shall be interpreted to apply retroactively to any State, Federal, or maritime 

legal action commenced prior to the effective date of the Frank R. 

Lautenberg Chemical Safety for the 21st Century Act. 

COMPREHENSIVE ENVIRONMENTAL RESPONSE, 

COMPENSATION, AND LIABILITY ACT OF 1980 

* * * * * * * 

SEC. 101. For purpose of this title— 

(1)* * * 

* * * * * * * 

SEC. 104. (a)(1) Whenever (A) any hazardous substance is released or there is a substantial threat of such a release into the environment, or (B) there is a release or substantial threat of release 

into the environment of any pollutant or contaminant which may 

present an imminent and substantial danger to the public health 

or welfare, the President is authorized to act, consistent with the 

national contingency plan, to remove or arrange for the removal of, 

and provide for remedial action relating to such hazardous substance, pollutant, or contaminant at any time (including its removal from any contaminated natural resource), or take any other 

response measure consistent with the national contingency plan 

which the President deems necessary to protect the public health 

or welfare or the environment. When the President determines that 

such action will be done properly and promptly by the owner or operator of the facility or vessel or by any other responsible party, the 

President may allow such person to carry out the action, conduct 

the remedial investigation, or conduct the feasibility study in accordance with section 122. No remedial investigation or feasibility 

study (RI/FS) shall be authorized except on a determination by the 

President that the party is qualified to conduct the RI/FS and only 

if the President contracts with or arranges for a qualified person 

to assist the President in overseeing and reviewing the conduct of 

such RI/FS and if the responsible party agrees to reimburse the 


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Fund for any cost incurred by the President under, or in connection 

with, the oversight contract or arrangement. In no event shall a potentially responsible party be subject to a lesser standard of liability, receive preferential treatment, or in any other way, whether direct or indirect, benefit from any such arrangements as a response 

action contractor, or as a person hired or retained by such a response action contractor, with respect to the release or facility in 

question. The President shall give primary attention to those releases which the President deems may present a public health 

threat. 

* * * * * * * 

(i)(1) There is hereby established within the Public Health 

Service an agency, to be known as the Agency for Toxic Substances 

and Disease Registry, which shall report directly to the Surgeon 

General of the United States. The Administrator of said Agency 

shall, with the cooperation of the Administrator of the Environmental Protection Agency, the Commissioner of the Food and Drug 

Administration, the Directors of the National Institute of Medicine, 

National Institute of Environmental Health Sciences, National Institute of Occupational Safety and Health, Centers for Disease Control and Prevention, the Administrator of the Occupational Safety 

and Health Administration, the Administrator of the Social Security Administration, the Secretary of Transportation, and appropriate State and local health officials, effectuate and implement the 

health related authorities of this Act. In addition, said Administrator shall— 

* * * * * * * 

(5)(A) For each hazardous substance listed pursuant to paragraph (2), the Administrator of ATSDR (in consultation with the 

Administrator of EPA and other agencies and programs of the Public Health Service) shall assess whether adequate information on 

the health effects of such substance is available. For any such substance for which adequate information is not available (or under 

development), the Administrator of ATSDR, in cooperation with the 

Director of the National Toxicology Program, shall assure the initiation of a program of research designed to determine the health effects (and techniques for development of methods to determine 

such health effects) of such substance. Where feasible, such program shall seek to develop methods to determine the health effects 

of such substance in combination with other substances with which 

it is commonly found. Before assuring the initiation of such program, the Administrator of ATSDR shall consider recommendations 

of the Interagency Testing Committee established under øsection 

4(e)¿ section 4(f) of the Toxic Substances Control Act on the types 

of research that should be done. 

* * * * * * * 

Æ 


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