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[Senate Report 114-67]
[From the U.S. Government Publishing Office]

                                                      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 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 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 
variety 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.
    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 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 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.''
    ``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 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 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, 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 years of enactment, EPA is to have 
designated additional high-priority substances sufficient to 
ensure that at least a total of 20 high-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 high- 
and 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 chemicals in active commerce in a timely manner, taking 
into account 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 resources to add throughput into the system. 
Requiring manufacturers 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 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 pre-manufacture 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 EPA find a new 
chemical must be ``likely to meet the safety standard,'' 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. 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 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 the 
costs, benefits, and feasibility of regulatory options the 
Administrator has considered, and describe how that assessment 
influenced 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.
    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.

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 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 structurally-descriptive 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.
    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 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 
which certain decisions or actions taken by the Administrator 
preempt 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 high-priority 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 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.
    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 preemption exemption 
for energy conservation standards for which there is already a 
federal standard. 10 C.F.R. Sec. 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. 
Sec. 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 necessary to conform the citizens' petition process to 
the requirements 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.
    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.

                          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 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 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.

    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). 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 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.

                             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. 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.
                        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 [black 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.--[It 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 environmental, 
        economic, and social impact of any action the 
        Administrator takes or proposes to take under this Act 
        , as provided under this Act.
          (2) Reform.--[It 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\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.
---------------------------------------------------------------------------
  (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) of the Poultry Products Inspection Act), meat and 
meat food products (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.
  [(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.
  [(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.
  [(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.
  [(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.
  [(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.
  [(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
                          (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.
  [(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.
  [(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.
  [(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.
  [(13)] (18) The term ``State'' means any State of the United 
States, the District of Columbia, the Commonwealth of Puerto 
Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa, 
the Northern Mariana Islands, or any other territory or 
possession of the United States.
  [(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 [and,] 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 National Academy of Sciences 
                that provide advice regarding 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 [this 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 [making 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 [the 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 that the 
                Administrator shall not interpret the lack of 
                exposure 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, [require] the Administrator 
                [to] 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;
                                  (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, 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.

  [(a) Testing Requirements.--If the Administrator finds that--
          [(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,
          [(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
          [(iii) testing of such substance or mixture with 
        respect to such effects is necessary to develop such 
        data; or
          [(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,
          [(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
          [(iii) testing of such substance or mixture with 
        respect to such effects is necessary to develop such 
        data; and
          [(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.
  [(b)(1) Testing Requirement Rule.--A rule under subsection 
(a) shall include--
          [(A) identification of the chemical substance or 
        mixture for which testing is required under the rule,
          [(B) standards for the development of test data for 
        such substance or mixture, and
          [(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).
[In 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).
  [(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.
  [(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.
  [(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.
  [(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):
          [(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.
          [(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.
          [(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.
  [(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 repeals the 
application of the rule to such substance or mixture or repeals 
the rule.
  [(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.
  [(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.
  [(2) If, upon receipt of an application under paragraph (1), 
the Administrator determines that--
          [(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
          [(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.
  [(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)--
          [(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
          [(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 or mixture, 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 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.
  [(B) For purposes of subparagraph (A), the reimbursement 
period for any test data for a chemical substance or mixture is 
a period--
          [(i) beginning on the date such data is submitted in 
        accordance with a rule promulgated under subsection 
        (a), and
          [(ii) ending--
                  [(I) five years after the date referred to in 
                clause (i), or
                  [(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.
  [(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)--
          [(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
          [(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.
[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 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.
  [(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 requirements of the rule with 
respect to which such exemption was granted.
  [(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.--[Subject to section 3A(h),] [t] 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;
                          (iii) test protocols and 
                        methodologies for the development of 
                        [test 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;
                          (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;
                  (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 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 [a] no person 
                [covered 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.--
                  (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.
  [(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 [rule] rule, testing consent agreement, or 
order [under 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 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 [under 
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 [under 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 [rulemaking] proceeding [under 
subsection (a)] under this subsection or if such a proceeding 
is not initiated within such period, publish in the Federal 
Register the Administrator's reason for not initiating such a 
proceeding.
---------------------------------------------------------------------------
    \3\So in law. Probably should be ``preceding''.
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  (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 [rule] 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 Act or of any [rule] 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.
  [(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 [from 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. [This 
subsection shall not take effect until two years after the 
effective date of this Act.]
  [(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) [Establishment 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 `high-priority 
                substances'); and
                  (B) a low priority for a safety assessment 
                and safety determination (referred to in this 
                Act as `low-priority substances').
          (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 
                substances.--
                          (i) Active substances.--In carrying 
                        out paragraph (1), the Administrator 
                        shall take into consideration active 
                        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 substance 
                        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 low-priority 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;
                  (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 low-
                priority 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 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 [as] 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
                          (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);
                          (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) [Exceptions.--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 
                [this 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 [chemicals] substances identified 
                under [subsection (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 [(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.--
                  (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.

[SEC. 5. MANUFACTURING AND PROCESSING NOTICES.]

SEC. 5. NEW CHEMICALS AND SIGNIFICANT NEW USES.

  [(i)] (a) Definition.--For purposes of this section, the 
terms ``manufacture'' and ``process'' mean manufacturing or 
processing for commercial purposes.
  [(a)] (b) [In General] Notices.--(1) Except as provided in 
[subsection (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 [subsection (d)] subsection (c), of such 
person's intention to manufacture or process such substance 
[and 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 the notification for the import or processing 
        of a chemical substance as part of an article or 
        category of articles under paragraph (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.;
  [(d)] (c) Content of Notice; Publications in the Federal 
Register.--[(1) The notice required by subsection (a) 
subsection (b) shall include--
          [(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
          [(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
          [(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 [subsection (a)] 
subsection (b) [or 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 
        substance[; and] .
          [(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 [subsection 
(a) and for which the notification period prescribed by 
subsection (a), (b), or (c)] subsection (b) and for which the 
notification period prescribed by subsection (b) or (d) has not 
expired, and (B) each chemical substance for which such 
notification period has expired since the last publication in 
the Federal Register of such list.
  [(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).
  [(B) If--
          [(i) a person is required by subsection (a)(1) to 
        submit a notice to the Administrator, and
          [(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).
  [(2)(A) If a person--
          [(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
          [(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).
  [(B) Data submitted pursuant to subparagraph (A) shall be 
data which the person submitting the data believes show that--
          [(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
          [(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.
  [(3) Data submitted under paragraph (1) or (2) shall be made 
available, subject to section 14, for examination by interested 
persons.
  [(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, presents or may present an unreasonable 
risk of injury to health or the environment.
  [(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--
          [(I) the effects of the chemical substance on health 
        and the magnitude of human exposure to such substance; 
        and
          [(II) the effects of the chemical substance on the 
        environment and the magnitude of environmental exposure 
        to such substance.
  [(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.
  [(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)]
  [(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--
                  (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 [paragraph] 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.
                  (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 ranks high for 
                persistence and bioaccumulation, the 
                Administrator 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.
  [(e) Regulation Pending Development of Information.--(1)(A) 
If the Administrator determines 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
          [(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
          [(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.
  [(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 (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.
  [(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.
  [(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--
          [(I) the Administrator does not issue a proposed 
        order under paragraph (1) respecting such substance, or
          [(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).
  [(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.
  [(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
          [(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
          [(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.
  [(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.
  [(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.
  [(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.
  [(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)--
          [(A) a requirement limiting the amount of such 
        substance which may be manufactured, processed, or 
        distributed in commerce,
          [(B) a requirement described in paragraph (2), (3), 
        (4), (5), (6), or (7) of section 6(a), or
          [(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.
  [(3)(A) The Administrator may--
          [(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
          [(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 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.
  [(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.
  [(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).
  [(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.
  [(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.
          (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 [(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.
  [(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--
          [(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
          [(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.
  [(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)--
          [(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
          [(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.
  [(C) For purposes of this paragraph, the reimbursement period 
for any previously submitted data for a chemical substance is a 
period--
          [(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
          [(ii) ending--
                  [(I) five years after the date referred to in 
                clause (i), or
                  [(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.]
  [(3)] (2) The requirements of [subsections (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.
  [(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 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).
  [(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.
  [(6)] (5) Immediately upon receipt of an application under 
[paragraph (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.

[SEC. 6. REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND MIXTURES.]

SEC. 6. SAFETY ASSESSMENTS AND SAFETY DETERMINATIONS.

  [(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:
          [(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.
          [(2) A requirement--
                  [(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
                  [(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.
          [(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.
          [(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.
          [(5) A requirement prohibiting or otherwise 
        regulating any manner or method of commercial use of 
        such substance or mixture.
          [(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.
          [(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.
          [(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.
  [(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--
          [(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
          [(2) if the Administrator determines--
                  [(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
                  [(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 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.
  [(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--
          [(A) the effects of such substance or mixture on 
        health and the magnitude of the exposure of human 
        beings to such substance or mixture,
          [(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,
          [(C) the benefits of such substance or mixture for 
        various uses and the availability of substitutes for 
        such uses, and
          [(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.
  [(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 hearing in 
accordance with paragraph (3); (D) promulgate, if appropriate, 
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).
  [(3) Informal hearings required by paragraph (2)(C) shall be 
conducted by the Administrator in accordance with the following 
requirements:
          [(A) Subject to subparagraph (B), an interested 
        person is entitled--
                  [(i) to present such person's position orally 
                or by documentary submissions (or both), and
                  [(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.
          [(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.
          [(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.
          [(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.
          [(D) A verbatim transcript shall be taken of any oral 
        presentation made, and cross-examination conducted in 
        any informal hearing under this subsection. Such 
        transcript shall be available to the public.
  [(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--
          [(i) who represents an interest which would 
        substantially contribute to a fair determination of the 
        issues to be resolved in the proceeding, and
          [(ii) if--
                  [(I) the economic interest of such person is 
                small in comparison to the costs of effective 
                participation in the proceeding by such person, 
                or
                  [(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.
  [(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--
          [(i) would be regulated by the proposed rule, or
          [(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.
  [(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).
  [(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.
  [(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--
          [(i) the Administrator determines that--
                  [(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 of serious or widespread 
                injury to health or the environment before such 
                effective date; and
                  [(II) making such proposed rule so effective 
                is necessary to protect the public interest; 
                and
          [(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.
  [(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 [this 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 [paragraphs (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 continuing 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 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 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 Administrator'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 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 
                                phase-out 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 (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.
  [(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
          (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.]
---------------------------------------------------------------------------
    \4\Section 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.
---------------------------------------------------------------------------
  [(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).]
  [(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.
  [(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.

SEC. 7. IMMINENT HAZARDS.

  [(a) Actions Authorized and Required.--(1) The Administrator 
may commence a civil action in an appropriate district court of 
the United States--
          [(A) for seizure of an imminently hazardous chemical 
        substance or mixture or any article containing such a 
        substance or mixture,
          [(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
          [(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.
  [(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 [unreasonable] 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 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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
  (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 
[section 6(a)] section [6(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 [and 
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 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.
          (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, [5(b)(4)] 5, or 6, or an order in effect 
        under section 4 or section [5(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
                          (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 A of 
                        volume I of the 1985 edition of the 
                        Toxic Substances 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, pursuant to 
                        paragraph (5)(A), designate chemical 
                        substances 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 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 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 [this 
        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 section 4A.
          (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 [rule] 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.--[Any 
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 not present a 
        substantial risk of injury to health and the 
        environment.
  (f) Definitions.--[For 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, [presents 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 [such 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 
response of an agency shall be accompanied by a detailed 
statement 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 [section 6 or 
7] section 6(d) or section 7 with respect to such risk.
  (3) If the Administrator has initiated action under [section 
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 [Health, 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, or 
instrumentalities, and on actions taken to coordinate the 
authority 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 [Health, 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 [Health, 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 [Health, 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 [Health, 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 [Health, Education, and 
Welfare] Health and Human Services, establish and be 
responsible for research 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 [Health, 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 
[Health, 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.
  [(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--
                  (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.
  [(b) Notice.--[(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.
  [(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).
                  (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.
          [(3) Report to congress on mercury compounds.--
                  [(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--
                          [(i) the sources and amounts of each 
                        of the mercury compounds imported into 
                        the United States or manufactured in 
                        the United States annually;
                          [(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;
                          [(iii) the sources and amounts of 
                        each mercury compound exported from the 
                        United States annually in each of the 
                        last three years;
                          [(iv) the potential for these 
                        compounds to be processed into 
                        elemental mercury after export from the 
                        United States; and
                          [(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.
                  [(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.]
          [(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.
          [(5)] (4) Consistency with trade obligations.--
        Nothing in this subsection affects, replaces, or amends 
        prior law relating to the need for consistency with 
        international trade obligations.
          [(6)] (5) Export of coal.--Nothing in this subsection 
        shall be construed to prohibit the export of coal.
           * * * * * * *

[SEC. 14. DISCLOSURE OF DATA.

  [(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--
          [(1) shall be disclosed to any officer or employee of 
        the United States--
                  [(A) in connection with the official duties 
                of such officer or employee under any law for 
                the protection of health or the environment, or
                  [(B) for specific law enforcement purposes;
          [(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;
          [(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
          [(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.
[In 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.
  [(b) Data From Health and Safety Studies.--(1) Subsection (a) 
does not prohibit the disclosure of--
          [(A) any health and safety study which is submitted 
        under this Act with respect to--
                  [(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
                  [(ii) any chemical substance or mixture for 
                which testing is required under section 4 or 
                for which notification is required under 
                section 5, and
          [(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).
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.
  [(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.
  [(c) Designation and Release of Confidential Data.--[(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.
  [(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.
  [(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.
  [(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.
  [(d) Criminal Penalty for Wrongful Disclosure.--[(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 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.
  [(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.
  [(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--
                  (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.
                  (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 phase-out 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 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--
                  (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--
                          (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 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 
                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.--
                  (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 
                phase-out 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 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
                          (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 Administrator 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--
          [(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 [$25,000] 
$37,500 for each such violation. Each day such a violation 
continues shall, for purposes of this subsection, constitute a 
separate [violation 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.
  (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.--[Any person who]
          (1) In general.--Any person that; knowingly or 
        willfully violates any provision of [section 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 [$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
                  (B) knowledge possessed by an individual may 
                not be attributed to the defendant.
           * * * * * * *

SEC. 18. PREEMPTION.

  [(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.
  [(2) Except as provided in subsection (b)--
          [(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
          [(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).
  [(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--
          [(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
          [(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.--
          (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).
                  (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
                          (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 high-priority substance under 
                [subsection (b) or (c) of] section 4A (b) or as 
                an additional priority for safety assessment 
                and safety determination under section [4A(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.
          (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 not be 
        considered to be an existing statute or administrative 
        action for purposes of subsection [(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.--
                  (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 [section 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 enforcement proceeding) of [an 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 [paragraph (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.
  [(3) For purposes of this section, the term ``rulemaking 
record'' means--
          [(A) the rule being reviewed under this section;
          [(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;
---------------------------------------------------------------------------
    \6\So in law. Probably should be followed by a comma.
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          [(C) any transcript required to be made of oral 
        presentations made in proceedings for the promulgation 
        of such rule;
          [(D) any written submission of interested parties 
        respecting the promulgation of such rule; and
          [(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 (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 [section 
        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 [evidence in the rulemaking record (as 
        defined in subsection (a)(3)) taken as a whole;]
          [(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--
                  [(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
                  [(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
          [(iii) the court may not review the contents and 
        adequacy of--
                  [(I) any statement required to be made 
                pursuant to section 6(c)(1), or
                  [(II) 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 a review of the rulemaking record 
        taken as a whole.
[The 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 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 [an 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 [an 
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.
  [(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 [issued] 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 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,
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 
        [section 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.

  [(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--
          [(1) include an estimate of the probable cost of any 
        indemnification programs which may be recommended;
          [(2) include an examination of all viable means of 
        financing the cost of any recommended indemnification; 
        and
          [(3) be completed and submitted to Congress within 
        two years from the effective date of enactment of this 
        Act.
[The 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.
  [(b) Classification, Storage, and Retrieval Study.--The 
Council on Environmental Quality, in consultation with the 
Administrator, 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.
  [(b) Fees.--[(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.
  [(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
                          (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 under paragraph (1), consult and 
                meet with parties potentially 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.
                  (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 provision of this Act with respect to a chemical substance 
or mixture 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 [Health, 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 
[Health, 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 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 
[Health, 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 [Health, 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 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, 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.--
          (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)[,] ;
          (B) identify the agency or agencies of the State 
        which shall establish or operate, or both, the program 
        for which the application is submitted[,] ;
          (C) describe the actions proposed to be taken under 
        such program[,] ;
          (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 protection[,] ;
          (E) provide for the making of such reports and 
        evaluations as the Administrator may require[, 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.
  [(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.
  [(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.]

[SEC. 29. AUTHORIZATION FOR APPROPRIATIONS.

  [There 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;
          [(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 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.

  [Except 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 
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 [section 4(e)] section 4(f) of the Toxic 
Substances Control Act on the types of research that should be 
done.
           * * * * * * *

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