29–010 

Calendar No. 578 

112TH CONGRESS REPORT " ! SENATE 2d Session 112–264 

SAFE CHEMICALS ACT OF 2011 

DECEMBER 27, 2012.—Ordered to be printed 

Mrs. BOXER, from the Committee on Environment and Public 

Works, submitted the following 

R E P O R T 

together with 

MINORITY VIEWS 

[To accompany S. 847] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Environment and Public Works, to which was 

referred the bill (S. 847) to amend the Toxic Substances Control 

Act to ensure that risks from chemicals are adequately understood 

and managed, and for other purposes, having considered the same, 

reports favorably thereon with amendments and recommends that 

the bill, as amended, do pass. 

PURPOSES OF THE LEGISLATION

To amend the Toxic Substances Control Act (42 U.S.C. 2601 et 

seq.) to enhance protections for public health and to better safeguard environmental quality by ensuring that risks from toxic 

chemicals are adequately understood and managed, and for other 

purposes. 

GENERAL STATEMENT AND BACKGROUND

Summary 

The Safe Chemicals Act (S. 847) would give the Environmental 

Protection Agency (EPA) several new tools to address chemical substances and mixtures in commerce, including: 


tjames on DSK6SPTVN1PROD with 
2 

• Requiring manufacturers to develop and submit safety 

data for each chemical they produce, while avoiding duplicative 

or unnecessary testing; • Prioritizing chemicals based on risk, so that the EPA can 

focus its resources on evaluating those chemicals that are most 

likely to cause harm while also working through the backlog 

of untested existing chemicals; • Placing the burden of proof on chemical manufacturers to 

demonstrate the safety of their chemicals; • Restricting uses of chemicals that cannot be proven safe; • Establishing a public database to catalog the information 

submitted by chemical manufacturers and contained in the 

EPA’s safety determinations; • Promoting innovation in research and the development of 

safer chemical alternatives; and • Encouraging new, safe chemicals onto the market using an 

expedited review process. 

Need for the Safe Chemicals Act of 2011 

President Ford signed TSCA into law in 1976, and since then 

Congress has added three chemical-specific titles on asbestos, indoor radon, and lead. TSCA regulates the manufacture, importation, and processing of chemicals. TSCA does not regulate some 

types of chemical substances, such as pesticides, tobacco, and nuclear materials. 

TSCA gives EPA authority to compile an inventory of existing 

chemical substances, known as the TSCA Chemical Substance Inventory (Inventory). The data was submitted from 1975–1978 and 

the first list was published in 1979 (approximately 55,000 chemicals were in commerce). Currently, the Inventory lists more than 

84,000 chemical substances. The listing is based solely on whether 

substances were or are available for sale and use in the U.S. The 

list grows as new chemicals enter the marketplace. 

The EPA’s ability to use TSCA has been impacted by a 1991 

court decision that requires the Agency to prove that each individual use of a chemical presents an unreasonable risk and EPA’s 

proposed action is the least burdensome option to address such 

risks before EPA can restrict each such use. Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (1991). 

The Government Accountability Office (GAO) has conducted a 

number of investigations on the EPA’s risk assessments and toxic 

substances policies in the last few years. Such GAO investigations 

have included: ‘‘Toxic Substances Control Act: Legislative Changes 

Could Make the Act More Effective’’ (1994); ‘‘Chemical Regulation: 

Options Exist to Improve EPA’s Ability to Assess Health Risks and 

Manage Its Chemical Review Program’’ (2005); ‘‘Chemical Regulation: Approaches in the United States, Canada, and the European 

Union’’ (2005); ‘‘Chemical Regulation: Comparison of U.S. and Recently Enacted European Union Approaches to Protect Against the 

Risks of Toxic Chemicals’’ (2007); and ‘‘Chemical Assessments, Low 

Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA’s Integrated Risk Information System’’ (2008). 

In January 2009, GAO placed EPA’s chemical management program on its list of ‘‘high risk’’ programs. GAO, High Risk Series: 


tjames on DSK6SPTVN1PROD with 
3 

An Update (2009). The GAO determined that the program is a 

major management challenge for EPA using the following description: 

Transforming EPA’s processes for assessing and controlling toxic 

chemicals. EPA has failed to develop sufficient chemical assessment information to limit public exposure to many chemicals that 

may pose substantial health risks. In January 2009, GAO added a 

new issue—the need to transform EPA’s process for assessing and 

controlling toxic chemicals—to its list of high-risk areas warranting 

increased attention by Congress and the executive branch. 

Principles of TSCA Reform 

There are a series of principles on reforming the Toxic Substances Control Act (TSCA), from the EPA, various States, and a 

national chemical industry association. 

EPA principles of TSCA reform 

On September 29, 2009, EPA Administrator Lisa Jackson released principles for chemical management legislation to help inform Congressional efforts to reauthorize and strengthen TSCA’s 

effectiveness. The Agency’s principles state: 

The U.S. Environmental Protection Agency (EPA) is committed 

to working with the Congress, members of the public, the environmental community, and the chemical industry to reauthorize the 

Toxic Substances Control Act (TSCA). The Administration believes 

it is important to work together to quickly modernize and strengthen the tools available in TSCA to increase confidence that chemicals used in commerce, which are vital to our Nation’s economy, are 

safe and do not endanger the public health and welfare of consumers, workers, and especially sensitive sub-populations such as 

children, or the environment. 

The following Essential Principles for Reform of Chemicals Management Legislation (Principles) are provided to help inform efforts 

under way in this Congress to reauthorize and significantly 

strengthen the effectiveness of TSCA. These Principles present Administration goals for updated legislation that will give EPA the 

mechanisms and authorities to expeditiously target chemicals of 

concern and promptly assess and regulate new and existing chemicals. 

Principle No. 1: Chemicals should be reviewed against safety standards that are based on sound science and reflect 

risk-based criteria protective of human health and the 

environment 

EPA should have clear authority to establish safety standards 

that are based on scientific risk assessments. Sound science should 

be the basis for the assessment of chemical risks, while recognizing 

the need to assess and manage risk in the face of uncertainty. 

Principle No. 2: Manufacturers should provide EPA with the 

necessary information to conclude that new and existing chemicals are safe and do not endanger public 

health or the environment 

Manufacturers should be required to provide sufficient hazard, 

exposure, and use data for a chemical to support a determination 


tjames on DSK6SPTVN1PROD with 
4 

by the Agency that the chemical meets the safety standard. Exposure and hazard assessments from manufacturers should be required to include a thorough review of the chemical’s risks to sensitive subpopulations. 

Where manufacturers do not submit sufficient information, EPA 

should have the necessary authority and tools, such as data call in, 

to quickly and efficiently require testing or obtain other information from manufacturers that is relevant to determining the safety 

of chemicals. EPA should also be provided the necessary authority 

to efficiently follow up on chemicals which have been previously assessed (e.g., requiring additional data or testing, or taking action 

to reduce risk) if there is a change which may affect safety, such 

as increased production volume, new uses or new information on 

potential hazards or exposures. EPA’s authority to require submission of use and exposure information should extend to downstream 

processors and users of chemicals. 

Principle No. 3: Risk management decisions should take 

into account sensitive subpopulations, cost, availability 

of substitutes and other relevant considerations 

EPA should have clear authority to take risk management actions when chemicals do not meet the safety standard, with flexibility to take into account a range of considerations, including children’s health, economic costs, social benefits, and equity concerns. 

Principle No. 4: Manufacturers and EPA should assess and 

act on priority chemicals, both existing and new, in a 

timely manner 

EPA should have authority to set priorities for conducting safety 

reviews on existing chemicals based on relevant risk and exposure 

considerations. Clear, enforceable and practicable deadlines applicable to the Agency and industry should be set for completion of 

chemical reviews, in particular those that might impact sensitive 

sub-populations. 

Principle No. 5: Green chemistry should be encouraged and 

provisions assuring transparency and public access to 

information should be strengthened 

The design of safer and more sustainable chemicals, processes, 

and products should be encouraged and supported through research, education, recognition, and other means. The goal of these 

efforts should be to increase the design, manufacture, and use of 

lower risk, more energy efficient and sustainable chemical products 

and processes. 

TSCA reform should include stricter requirements for a manufacturer’s claim of Confidential Business Information (CBI). Manufacturers should be required to substantiate their claims of confidentiality. Data relevant to health and safety should not be claimed or 

otherwise treated as CBI. EPA should be able to negotiate with 

other governments (local, state, and foreign) on appropriate sharing 

of CBI with the necessary protections, when necessary to protect 

public health and safety. 


tjames on DSK6SPTVN1PROD with 
5 

Principle No. 6: EPA should be given a sustained source of 

funding for implementation 

Implementation of the law should be adequately and consistently 

funded, in order to meet the goal of assuring the safety of chemicals, and to maintain public confidence that EPA is meeting that 

goal. To that end, manufacturers of chemicals should support the 

costs of Agency implementation, including the review of information provided by manufacturers. 

Senator Inhofe’s principles of TSCA reform 

Senator Inhofe has also stated his fundamental principle for reforming TSCA. These principles are: 

• Use data and methods based on the best available science and 

risk-based assessment. 

• Include cost/benefit considerations for the private-sector and 

consumers. 

• Protect proprietary business information, as well as information that should be protected for security reasons. 

• Prioritize reviews for existing chemicals. 

• Does not include any provision that encourages litigation or 

citizen suits. 

• Does not include any provision that compels product substitution. 

Selected State Principles of TSCA Reform 

Several states have also demonstrated an interest in reforming 

TSCA. The States of California, New Hampshire, Connecticut, New 

Jersey, Illinois, New York, Maine, Oregon, Maryland, Vermont, 

Massachusetts, Washington, and Michigan issued a set of principles on the reform of TSCA. These principles state: 

Require Chemical Data Reporting. Chemical and product manufacturers should be required to develop and provide chemical 

health and safety information, as well as exposure and use data, 

including the presence of toxic chemicals in products and the associated chemical hazards and risks, to regulators, businesses, and 

the public. 

Demonstrate Chemicals and Products Are Safe. Manufacturers 

should provide the necessary information to regulators to conclude 

that new and existing chemicals and products in commerce are safe 

and do not endanger the public or the environment. The public has 

a right to expect that the products they use are safe. 

Prioritize Chemicals of Concern. Government should identify and 

prioritize chemicals of concern in order to regulate the most problematic chemicals in commerce, and have the authority to take 

timely action to protect people and the environment. Sufficient resources should be made available to support these actions. 

Protect the Most Vulnerable. Chemical regulation should be designed to protect the most vulnerable, including pregnant women 

and children. 

Promote Safer Chemicals and Products. Based on green chemistry principles, manufacturers should be required to assess and 

identify safer alternatives to problematic chemicals of concern. Government should establish protocols for evaluating potential alternatives to chemicals of concern. 


tjames on DSK6SPTVN1PROD with 
6 

Address Emerging Contaminants. Emerging chemicals of concern, including nanoscale materials, need to be assessed for public 

and environmental safety before they go into widespread commerce 

and use. 

Strengthen Federal Law & Preserve States’ Rights. States acknowledge the need for a strong federal chemical regulation system, while expressly preserving the authority of state and localities 

to implement measures to manage chemicals of concern. 

Fund State Programs. Effective state-federal governance should 

enhance the role of states in TSCA implementation, promote data 

and information sharing, and provide sustained funding for state 

programs. The states are in a unique position to provide innovative, cost-effective solutions for chemicals of concern prioritization, 

interstate data sharing, and safer chemical alternatives assessments. 

Industry Association’s Principles on TSCA Reform 

The American Chemistry Council has also issued ‘‘10 Principles 

for Modernizing TSCA.’’ These principles state: 

The American Chemistry Council and its members support Congress’ effort to modernize our nation’s chemical management system. Such a system should place protecting the public health as its 

highest priority, and should include strict government oversight. It 

should also preserve America’s role as the world’s leading innovator 

and employer in the creation of safe and environmentally sound 

technologies and products of the business of chemistry. 

The current chemical management law, the Toxic Substances 

Control Act (TSCA), is more than 30 years old. It should be modernized to keep pace with advances in science and technology. 

Moreover, the law must provide the Environmental Protection 

Agency with the resources and the authority to do its job effectively. 

We have previously offered general concepts on which to base a 

modern chemical management system. This document expands 

upon those concepts and begins to provide more detail, which we 

hope will be useful to policy makers. We will continue to refine the 

details of our principles for modernizing TSCA and are committed 

to working with all stakeholders toward enactment of effective legislation. 

1. Chemicals should be safe for their intended use. 

• Ensuring chemical safety is a shared responsibility of industry 

and EPA. 

• Industry should have the responsibility for providing sufficient 

information for EPA to make timely decisions about safety. 

• EPA should have the responsibility for making safe use determinations for high priority chemicals, focusing on their most significant uses and exposures. 

• Safe use determinations should integrate hazard, use, and exposure information, and incorporate appropriate safety factors. 

• Consideration of the benefits of chemicals being evaluated, the 

cost of methods to control their risks, and the benefits and costs of 

alternatives should be part of EPA’s risk management decision 

making, but should not be part of its safe use determinations. 

• Other agencies, such as FDA and CPSC, should continue to 

make safety decisions for products within their own jurisdictions. 


tjames on DSK6SPTVN1PROD with 
7 

2. EPA should systematically prioritize chemicals for purposes of 

safe use determinations. • Government and industry resources should be focused on 

chemicals of highest concern. • The priorities should reflect considerations such as the volume 

of a chemical in commerce; its uses, including whether it is formulated in products for children; its detection in biomonitoring programs; its persistent or bioaccumulative properties; and the adequacy of available information. 

3. EPA should act expeditiously and efficiently in making safe 

use determinations. • Since a chemical may have a variety of uses, resulting in different exposure potentials, EPA should consider the various uses 

and focus on those resulting in the most significant exposures. 

4. EPA should complete safe use determinations within set timeframes. • Companies that manufacture, import, process, distribute, or 

use chemicals should be required to provide EPA with relevant information to the extent necessary for EPA to make safe use determinations. • Companies throughout the chain of commerce should be responsible for providing necessary hazard, use, and exposure information. • EPA should be authorized to require companies, as appropriate, to generate relevant new data and information to the extent 

reasonably necessary to make safe use determinations without having to prove risk as a prerequisite or engaging in protracted rulemaking. • Testing of chemicals should progress to more complex and expensive tests through a tiered approach as needed to identify hazards and exposures of specific concern. • To minimize animal testing, existing data should be considered 

prior to new testing, and validated alternatives to animal testing 

should be used wherever feasible. 

• Existing data and information should be leveraged in EPA’s 

safe use determinations, including data and information from other 

mandatory and voluntary programs such as REACH and the U.S. 

High Production Volume challenge. 

5. Potential risks faced by children should be an important factor 

in safe use determinations. 

• Safe use determinations should consider the effects of a chemical on children and their exposure to the chemical. 

• Safe use determinations should consider whether an extra 

margin of safety is needed to protect children. 

6. EPA should be empowered to impose a range of controls to ensure that chemicals are safe for their intended use. 

• The controls could range from actions such as labeling, handling instructions, exposure limits and engineering controls to use 

restrictions and product bans. 

• The controls should be appropriate for managing the risk, taking into account alternatives, benefits, costs, and uncertainty. 

7. Companies and EPA should work together to enhance public 

access to chemical health and safety information. 

• EPA should make chemical hazard, use, and exposure information available to the public in electronic databases. 


tjames on DSK6SPTVN1PROD with 
8 

• Other governments should have access to confidential information submitted under TSCA, subject to appropriate and reliable 

protections. 

• Companies claiming confidentiality in information submittals 

should have to justify those claims on a periodic basis. 

• Reasonable protections for confidential as well as proprietary 

information should be provided. 

8. EPA should rely on scientifically valid data and information, 

regardless of its source, including data and information reflecting 

modern advances in science and technology. 

• EPA should establish transparent and scientifically sound criteria for evaluating all of the information on which it makes decisions to ensure that it is valid, using a framework that addresses 

the strengths and limitations of the study design, the reliability of 

the test methods, and the quality of the data. 

• EPA should encourage use of good laboratory practices, peer 

review, standardized protocols, and other methods to ensure scientific quality. 

9. EPA should have the staff, resources, and regulatory tools it 

needs to ensure the safety of chemicals. 

• EPA’s budget for TSCA activities should be commensurate 

with its chemical management responsibilities. 

10. A modernized TSCA should encourage technological innovation and a globally competitive industry in the United States. 

• A new chemical management system should preserve and enhance the jobs and innovative products and technologies contributed by the business of American chemistry. 

• Implementation of TSCA should encourage product and technology innovation by providing industry certainty about the use of 

chemicals. 

Public health, environmental, and labor’s principles for reforming 

TSCA 

A coalition of public health, environmental, labor and business 

representatives also issued ‘‘A Platform for Reform of the Toxic 

Substances Control Act.’’ This platform states: 

A reformed Toxic Substances Control Act (TSCA) would serve as 

the backbone of a sound and comprehensive chemicals policy that 

protects public health and the environment, while restoring the 

luster of safety to U.S. goods in the world market. Any effective reform of TSCA should: 

• Immediately Initiate Action on the Worst Chemicals: Persistent, bioaccumulative toxicants (PBTs) are uniquely hazardous. 

Any such chemical to which people could be exposed should be 

phased out of commerce. Exposure to other toxic chemicals, such as 

formaldehyde, that have already been extensively studied, should 

be reduced to the maximum extent feasible. 

• Require Basic Information for All Chemicals: Manufacturers 

should be required to provide basic information on the health hazards associated with their chemicals, how they are used, and the 

ways that the public or workers could be exposed. 

• Protect the Most Vulnerable: Chemicals should be assessed 

against a health standard that explicitly requires protection of the 

most vulnerable subpopulations. That population is likely to usuVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00008 Fmt 6659 Sfmt 6602 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
9 

ally be children, but it could also be workers, pregnant women, or 

another vulnerable population. • Use the Best Science and Methods: The National Academy of 

Sciences’ recommendations for reforming risk assessment at the 

Environmental Protection Agency (EPA) should be adopted. Regulators should expand development and use of information gleaned 

from ‘‘biomonitoring,’’ the science of detecting human chemical contamination, to inform and impel efforts to reduce these exposures. • Hold Industry Responsible for Demonstrating Chemical Safety: 

Unlike pharmaceuticals, chemicals are currently presumed safe 

until proven harmful. The burden of proving harm falls entirely on 

EPA. Instead, chemical manufacturers should be responsible for 

demonstrating the safety of their products. • Ensure Environmental Justice: Effective reform should contribute substantially to reducing the disproportionate burden of 

toxic chemical exposure placed on people of color, low income people and indigenous communities. • Enhance Government Coordination: The EPA should work effectively with other agencies, such as FDA, that have jurisdiction 

over some chemical exposures. The ability of the states to enact 

tougher chemical policies should be maintained and state/federal 

cooperation on chemical safety encouraged. • Promote Safer Alternatives: There should be national support 

for basic and applied research into green chemistry and engineering, and policy should favor chemicals and products that are shown 

to be benign over those with potential health hazards. • Ensure the Right to Know: The public, workers, and the marketplace should have full access to information about the health 

and environmental hazards of chemicals and the way in which government safety decisions are made. 

In light of this and other information, the Committee moved to 

consider Senator Lautenberg’s bill, S. 847, in order to advance the 

efforts to increase protections for public health and environmental 

quality, strengthen the public’s right-to-know about chemical substances and mixtures, and promote the use of safe chemicals in 

commerce. 

Senator Lautenberg’s Amendment to S. 847 

At the Committee’s business meeting in July, 2012, Senator Lautenberg offered an amendment to his introduced bill that modified 

the underlying text while maintaining the essential elements of the 

introduced bill. The amendment sought to better focus resources on 

evaluating priority chemicals by directing EPA to evaluate chemicals in stages, screen chemicals to limit the number that require 

a full safety standard determination, and prioritize chemicals in 

need of safety standard determinations. The amendment directed 

EPA to rely on existing information first and require additional 

testing only to the extent necessary to demonstrate safety. The 

amendment also modified the bill’s protections for confidential 

business information (CBI) and provisions to encourage innovation 

in the development of chemicals. Specifically, EPA was directed to 

provide varying levels of CBI protection depending on the information’s category, and companies were provided with options to quickly bring new chemicals into commerce through a process that is 

similar to existing TSCA requirements. 


tjames on DSK6SPTVN1PROD with 
10 

SECTION-BY-SECTION ANALYSIS

Section 1. Short title 

Section 1 provides that the short title of the bill is the ‘‘Safe 

Chemicals Act of 2011’’. 

Sec. 2. Purposes 

Section 2 defines the purpose for which the bill was created. 

Sec. 3. Findings, policy and goal 

Section 3 contains the findings that support enactment of the 

bill; the policies that guide application of the bill, and the goals 

that the bill seeks to achieve. 

Sec. 4. Definitions 

Section 4 contains the definitions of the bill. 

Sec. 5. Minimum information sets and testing of chemical substances 

Section 5 describes the processes used to ensure that required information is submitted under the Act. 

Subsection (a) describes the minimum sets of information that 

manufacturers and others would have to submit to EPA for chemicals. The section requires a tiered approach to requiring such information, along with the requirements for information quality and 

reliability and alternative testing methods. 

Subsection (b) describes the broad testing authority provided to 

the Administrator. 

Subsection (c) describes specific requirements for test rules and 

orders, including factors that EPA must consider when requiring 

testing and methodologies and protocols for such tests. 

Subsection (d) describes the exemptions from testing rules and 

order and various methods of reimbursement. 

Subsection (e) describes the requirement for notice related to 

testing rules and orders. 

Subsection (f) describes the process for agencies working to share 

information concerning chemical substances. 

Subsection (g) describes the certification requirements that apply 

to a testing rule or order. 

Sec. 6. New chemical substances and new uses of chemical substances 

Subsection (a) contains definitions that apply to this section. 

Subsection (b) contains the requirements for the manufacture or 

process of new chemical substances. 

Subsection (c) contains the requirements for new uses of existing 

chemical substances. 

Subsection (d) describes the notice requirements that apply to 

new chemical substances. 

Subsection (e) describes requirements that apply to chemical substances that exhibit special substance characteristics. 

Subsection (f) describes the requirements for data and other factors that apply to the manufacturing or processing of certain chemical substances. 


tjames on DSK6SPTVN1PROD with 
11 

Subsection (g) describes the notice requirements for certain 

chemical substances. 

Subsection (h) describes the procedures and requirements for 

EPA determinations that certain chemical substances or uses may 

be exempt from certain requirements based on a scientific consensus of intrinsic safety. 

Subsection (i) describes the certification requirements that apply 

under this section or a rule or order issued promulgated or issued 

under this section. 

Sec. 7. Batching, categorization, prioritization, safety standard determination, and risk management. 

Section 7 amends sections 6 and 202 of TSCA to include new 

text. 

Section 7(a) amends section 6 of TSCA as follows: 

Subsection (a) of section 6 of TSCA, as amended, describes the 

requirements of the batching process that the Administrator shall 

use for reviewing chemical substances. 

Subsection (b) of section 6 of TSCA, as amended, describes the 

categorization and prioritization process that the Administrator 

shall implement for chemical substances. 

Subsection (c) of section 6 of TSCA, as amended, describes the 

legal effect of the Administrator’s determinations under this section. 

Subsection (d) of section 6 of TSCA, as amended, describes the 

responsibilities and requirements for the process of making safety 

standards determinations for chemical substances. 

Subsection (e) of section 6 of TSCA, as amended, describes the 

process for taking expedited action to address chemical substances 

of very high concern. 

Subsection (f) of section 6 of TSCA, as amended, describes the requirements that apply to the Administrator issuing a risk management order under subsections (d) and (e). 

Subsection (g) of section 6 of TSCA, as amended, describes the 

requirements that apply to the Administrator issuing a quality control order. 

Subsection (h) of section 6 of TSCA, as amended, describes the 

exemptions that apply to certain restrictions contained in various 

provisions of TSCA. 

Subsection (i) of section 6 of TSCA, as amended, describes special 

requirements that apply to mercury. 

Subsection (j) of section 6 of TSCA, as amended, describes special 

requirements that apply to asbestos. 

Subsection (k) of section 6 of TSCA, as amended, describes the 

certification requirements that apply to submissions made under 

this section. 

Subsection (l) of section 6 of TSCA, as amended, describes the effective date of any regulation or order under this section. 

Section 7(b) amends section 202(3) of TSCA by amending the definition of asbestos. 

Sec. 8. Imminent hazards 

Section 8 amends section 7 of TSCA to include new text. 


tjames on DSK6SPTVN1PROD with 
12 

Subsection (a) describes the scope of the Administrator’s authority to commence civil actions and undertake other measures to address imminent hazards under this law. 

Subsection (b) describes the scope of relief authorized under this 

law. 

Sec. 9. Reporting and retention of information 

Section 9 amends section 8 of TSCA to include new text. 

Subsection (a) of section 8 of TSCA, as amended, contains the 

definitions that apply to this section. 

Subsection (b) of section 8 of TSCA, as amended, describes the 

applicable scope and criteria that apply to identifying chemical substances. 

Subsection (c) of section 8 of TSCA, as amended, describes the 

periodic reporting requirements for manufacturers and processors 

of certain chemical substances and provides the Administrator with 

rulemaking authority to implement such provisions. 

Subsection (d) of section 8 of TSCA, as amended, describes the 

requirements that apply to support the declarations and reports required under this section. 

Subsection (e) of section 8 of TSCA, as amended, describes the 

Administrator’s authority to issue rules for the provision of information to assist the Administrator in the administration of the 

law. 

Subsection (f) of section 8 of TSCA, as amended, describes the requirements for updating information under this section. 

Subsection (g) of section 8 of TSCA, as amended, describes the 

Administrator’s authority to issue rules or order requiring the 

maintenance of records of chemical substances and to report on 

chemical substances. 

Subsection (h) of section 8 of TSCA, as amended, describes the 

requirements for the Administrator to maintain an inventory of 

chemical substances. 

Subsection (i) of section 8 of TSCA, as amended, describes the 

public’s access to information under this law. 

Subsection (j) of section 8 of TSCA, as amended, describes the requirements and Administrator’s authority related to the retention 

and submission of records concerning significant adverse reactions. 

Subsection (k) of section 8 of TSCA, as amended, describes the 

requirements concerning submission of and request for information 

in the possession of other federal agencies. 

Subsection (l) of section 8 of TSCA, as amended, describes the requirements to provide the Administrator with notice of information 

concerning the presence of a substantial risk of injury to health or 

the environment from a chemical substance. 

Subsection (m) of section 8 of TSCA, as amended, describes the 

certification requirements that apply to information submitted 

under this section. 

Subsection (n) of section 8 of TSCA, as amended, describes scope 

of the Administrator’s authority to implement and enforce reporting requirements under this section. 

Sec. 10. Relationship to other Federal laws 

Section 10 amends section 9 of TSCA. 


tjames on DSK6SPTVN1PROD with 
13 

Subsection (1) describes the scope of the Administrator’s authority to notify and request that another federal agency act to address 

risks related to a failure to meet the safety standard under this 

title, as well as the Administrator’s authority to act in lieu of another agency’s failure to act following a request for action by the 

Administrator. 

Sec. 11. Inspections and subpoenas 

Section 11 amends section 11 of TSCA. 

Subsection (a) describes the locations and samples that the Administrator can access and the methods that the Administrator can 

use to conduct inspections under this law. 

Subsection (b) describes the scope the Administrator’s authority 

to conduct inspections under this law. 

Subsection (c) describes the Administrator’s information gathering authorities under this law. 

Subsection (d) describes the Administrator’s authorities to issue 

warrants under this law. 

Sec. 12. Exports 

Section 12 amends section 12 of TSCA to ensure this section is 

consistent with the policies and provisions of TSCA, as amended by 

this Act. 

Sec. 13. Entry into Customs Territory of the United States 

Section 13 amends section 13 of TSCA to ensure this section is 

consistent with the policies and provisions of TSCA, as amended by 

this Act, and shifting federal responsibilities since TSCA was enacted. 

Sec. 14. Disclosure of data 

Section 14 replaces section 14 of TSCA. 

Subsection (a) describes the legal scope of the data disclosure requirements under this law. 

Subsection (b) describes the categories of confidential business 

information under this law. 

Subsection (c) describes the designations and treatment of confidential business information under this law. 

Subsection (d) describes the civil penalties for wrongful disclosure or wrongful requests for protection under this law. 

Subsection (e) describes Congress’ access to information under 

this law. 

Subsection (f) describes the special rules that apply to information concerning risks to workers under this law. 

Sec. 15. Prohibited acts 

Section 15 amends section 15 of TSCA to make technical and 

conforming changes to TSCA and to expand the types of wrongful 

acts that are prohibited by this Act. 

Sec. 16. Penalties 

Section 16 amends section 16 of TSCA to make technical and 

conforming changes to TSCA and to enhance the penalties for certain violations of this law. 


tjames on DSK6SPTVN1PROD with 
14 

Sec. 17. Specific enforcement and seizure 

Section 17 amends section 17 of TSCA to make technical and 

conforming changes to TSCA and to enhance the Administrator’s 

authority to compel compliance with this law. 

Sec. 18. Preemption 

Section 18 clarifies the legal effect of this Act on other State and 

local laws. 

Sec. 19. Judicial review 

Section 19 amends section 19 of TSCA to make technical and 

conforming changes to TSCA and to enhance the scope of judicial 

review for certain violations of this law. 

Sec. 20. Citizens’ civil actions 

Section 20 amends section 20 of TSCA to make technical and 

conforming changes to TSCA and to enhance the authority of citizen attorneys generals to assist in the enforcement of the provisions of this law. 

Sec. 21. Citizens’ petitions 

Section 21 amends section 21 of TSCA to make technical and 

conforming changes to TSCA and to enhance the ability of citizens 

to petition for action that is consistent with the provisions of the 

law. 

Sec. 22. Employment effects 

Section 22 amends section 24 of TSCA to make technical and 

conforming changes to TSCA and to modify the scope of the amended text. 

Sec. 23. Administration of the Toxic Substances Control Act 

Section 23 amends section 26 of TSCA to facilitate the Administrator’s expeditious implementation of this law. 

Sec. 24. State programs 

Section 24 amends section 28 of TSCA to enhance the Administrator’s coordination with states relating to data sharing and management of chemical substances. 

Sec. 25. Authorization or appropriations 

This section authorizes appropriations as are necessary to carry 

out this Act. 

Sec. 26. Additional requirements 

Section 26 amends TSCA to create a new section 29, which authorizes the Children’s Environmental Health Research Program. 

Subsection (a) of the new section 29 describes the timeline for 

creation and consultation requirements of the program, and authorizes the Administrator to enter into contracts or to make 

grants under the program. 

Subsection (b) describes the requirements for an Interagency 

Science Advisory Board on Children’s Health Research. 

Subsection (c) requires the creation of biomonitoring requirements related to prenatal and infant exposure to chemicals. 


tjames on DSK6SPTVN1PROD with 
15 

Sec. 30. Reduction in animal-based testing 

Section 30 amends TSCA to create a new section 30 that is designed to minimize the use of animal-based testing of chemical substances or mixtures. 

Subsection (a) requires the Administrator to take actions to facilitate and fund studies that minimize the use of animals. 

Subsection (b) requires the Administrator to create an Interagency Science Advisory Board on Alternative Testing Methods. 

Subsection (c) describes the actions needed to implement the alternative testing methods program. 

Subsection (d) establishes the criteria for adapting or waiving the 

animal testing requirements. 

Sec. 31. Safer alternatives and green chemistry and engineering 

Section 31 creates a new section 31 of TSCA that authorizes a 

green chemistry and engineering program. 

Subsection (a) requires the Administrator to establish the green 

chemistry and engineering program. 

Subsection (b) requires the Administrator to establish a Green 

Chemistry Research Network. 

Subsection (c) requires the Administrator to make grants to promote the green chemistry and engineering program. 

Subsection (d) requires the Administrator to establish a Green 

Chemistry Workforce Education and Training Program. 

Sec. 32. Cooperation with international efforts 

Section 32 creates a new section 32 of TSCA that authorizes the 

Administrator to cooperate in international efforts to develop a 

common protocol or database of chemical substances and to develop 

safer alternatives to chemical substances. 

Sec. 33. Reliable information and advice 

Section 33 creates a new section 33 of TSCA that requires the 

Administrator take certain actions to ensure data reliability. 

Sec. 34. Hot spots 

Section 34 creates a new section 34 of TSCA that requires the 

Administrator to identify localities that are disproportionately exposed to chemical substances or mixtures. 

Subsection (a) contains the definitions that apply to this section. 

Subsection (b) requires that the Administrator promulgate regulations to establish criteria to define disproportionate exposure and 

identify localities disproportionately exposed. 

Subsection (c) requires that the Administrator identify localities 

that are disproportionately exposed, described the data that may be 

used and requirements for public participation. 

Subsection (d) requires that the Administrator publish a locality 

list. 

Subsection (e) describes the legal scope of this section. 

Subsection (f) requires that the Administrator publish and update action plans to carry out this section. 

Subsection (g) requires an annual report to Congress on progress 

in carrying out this section. 


tjames on DSK6SPTVN1PROD with 
16 

Sec. 35. Application of this act to Federal agencies 

Section 35 creates a new section 35 of TSCA that applies the Act 

to all federal agencies. 

Subsection (a) requires federal agencies to comply with substantive and procedural requirements of this Act. 

Subsection (b) describes the substantive and procedural requirements that apply to all federal agencies. 

Subsection (c) waives the sovereign immunity of the United 

States with respect to those applicable substantive and procedural 

requirements. 

Subsection (d) makes clear that federal agents, employees, or officers acting within the scope of their employment cannot be held 

personally liable for civil penalties under the Act. 

Subsection (e) makes clear that federal agents, employees, or officers are subject to criminal sanctions under the Act. 

Subsection (f) describes criteria for the President to grant exemptions under the Act. 

Subsection (g) authorizes the Administrator to take administrative enforcement action against Federal agencies for noncompliance 

with the Act. 

Sec. 36. Implementation of Stockholm Convention, the LRTAP 

POPS Protocol, and the Rotterdam Convention 

Section 36 creates a new section 36 of TSCA that provides implementation language that will facilitate ratification of the Stockholm 

Convention and related global treaties on persistent organic pollutants (POPs), to allow the United States to reassert global leadership on POPs and strengthen the Unites States’ role in international negotiations on additional chemical substances of concern. 

Subsection (a) contains the definitions that apply to this section. 

Subsection (b) describes the procedures for the United States’ implementation of the international agreements on POPs. 

Subsection (c) provides that the requirements of this section will 

be enforced in the same manner as rules and orders under section 

6 of TSCA. 

Subsection (d) provides conforming amendments. 

LEGISLATIVE HISTORY

Senator Lautenberg introduced S. 847 on April 14, 2011, with 

Senators Boxer, Franken, Klobuchar and Schumer as original cosponsors. The bill was received, read twice and referred to the 

Committee on Environment and Public Works. On July 25, 2012, 

the Committee on Environment and Public Works met to consider 

the bill. The bill was ordered reported favorably with amendment 

by a vote of 10 ayes and 8 nays. 

HEARINGS

In the 112th Congress, on February 3, 2011, the Subcommittee 

on Superfund, Toxics and Environmental Health hearing entitled, 

‘‘Assessing the Effectiveness of U.S. Chemical Safety Laws.’’ 

On November 17, 2011, the Full Committee on Environment and 

Public Works and the Subcommittee on Superfund, Toxics and Environmental Health held a joint hearing entitled, ‘‘Legislative Hearing on the Safe Chemicals Act.’’ 


tjames on DSK6SPTVN1PROD with 
17 

On July 24, 2012, the Full Committee on Environment and Public Works and the Subcommittee on Superfund, Toxics, and Environmental Health held a joint hearing entitled, ‘‘Oversight of EPA 

Authorities and Actions to Control Exposures to Toxic Chemicals.’’ 

ROLLCALL VOTES

The Committee on Environment and Public Works met to consider S. 847 on July 25, 2012. The bill, as amended, was ordered 

reported favorably by a vote of 10 yeas to 8 nays. 

REGULATORY IMPACT STATEMENT

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

Rules of the Senate, the Committee makes evaluation of the regulatory impact of the reported bill. The Committee finds that it is 

impracticable to determine the exact regulatory impact because of 

the necessary future agency rules and activities to implement the 

Act. 

MANDATES ASSESSMENT

In compliance with the Unfunded Mandates Reform Act of 1995 

(Pub. L. 104–4), the Committee finds that this legislation would 

impose intergovernmental mandates or private sector mandates as 

those terms are defined in the Unfunded Mandates Reform Act 

(UMRA). The Congressional Budget Office concurs, finding S. 847 

contains intergovernmental or private-sector mandates as defined 

in the UMRA. 

OCTOBER 1, 2012. 

Hon. BARBARA BOXER, 

Chairman, Committee on Environment and Public Works, 

U.S. Senate, Washington, DC. 

DEAR MADAM CHAIRMAN: The Congressional Budget Office has 

prepared the enclosed cost estimate for S. 847, the Safe Chemicals 

Act of 2011. 

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

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

Sincerely, 

DOUGLAS W. ELMENDORF. 

Enclosure. 

S. 847—Safe Chemicals Act of 2011 

Summary: S. 847 would modify the Toxic Substances Control Act 

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

processing of chemicals, with the aim of shifting the burden from 

the Environmental Protection Agency (EPA) to chemical manufacturers to prove that substances are safe before they enter the marketplace. This new responsibility for chemical manufacturers would 

be accomplished primarily by increasing the amount of information 

about chemical toxicity and usage that they would be required to 

submit to EPA. Enacting this legislation also would require EPA 

to undertake other activities that would encourage and support the 

development of safer alternatives to existing hazardous chemical 

substances. 


tjames on DSK6SPTVN1PROD with 
18 

CBO estimates that implementing this legislation would cost 

$128 million over the next five years, assuming appropriation of 

the necessary amounts, as EPA would incur additional administrative costs to meet the new requirements imposed by S. 847. 

Enacting S. 847 could affect direct spending and revenues because the bill would increase some existing civil and criminal penalties for violations of TSCA, establish some new civil and criminal 

penalties for violations related to that act, and authorize EPA to 

charge fees to chemical manufacturers. Therefore, pay-as-you-go 

procedures apply to S. 847. CBO estimates that any changes in revenues and direct spending would not be significant. 

S. 847 would impose intergovernmental and private-sector mandates, as defined in the Unfunded Mandates Reform Act (UMRA), 

by regulating the manufacture, processing, use, and disposal of 

chemicals. Because the mandates on intergovernmental entities 

would depend on the scope of future regulations, CBO cannot determine whether the aggregate cost of the mandates would exceed 

the annual threshold established in UMRA ($73 million in 2012, 

adjusted annually for inflation). Because a large number of chemicals could be affected by the new requirements, CBO estimates 

that the aggregate cost of the private-sector mandates would probably exceed the annual threshold ($146 million in 2012, adjusted 

annually for inflation.) 

CBO has not reviewed provisions in section 26 of S. 847 that 

would implement international agreements for mandates. Section 4 

of UMRA excludes from the application of that act any legislative 

provisions that are necessary for the ratification or implementation 

of international treaty obligations. CBO has determined that those 

provisions fall within that exclusion. 

Major Provisions: The bill’s major provisions would: 

• Require EPA, as part of the chemical approval process, to 

establish requirements for what data firms must submit so 

that EPA can assess risk; 

• Require EPA to prioritize all chemicals already in use so 

that their safety and the methods used to manage their risks 

can be evaluated; 

• Require EPA to establish a health-based standard for 

chemical use and require that chemical manufacturers produce 

scientific data demonstrating adherence to that standard; 

• Authorize EPA, in some cases, to issue administrative orders instead of rules, exempt certain EPA decisions from judicial review, and increase public access to EPA’s decisions and 

information about chemicals; 

• Allow EPA to implement three international agreements 

pertaining to organic pollutants and hazardous chemicals; and 

• Require EPA to establish a program to create market incentives for the development of safer alternatives to chemicals, 

establish a children’s environmental health research program, 

and conduct a study to determine the presence of certain 

chemicals in pregnant women and infants. 

Estimated cost to the Federal Government: The estimated budgetary impact of S. 847 is shown in the following table. The costs 

of this legislation fall within budget function 300 (natural resources 

and environment). 


tjames on DSK6SPTVN1PROD with 
19 

By fiscal year, in millions of dollars— 

2013 2014 2015 2016 2017 2013– 

2017 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Estimated Authorization Level ...................................................... 30 30 30 30 30 150 

Estimated Outlays ........................................................................ 12 26 30 30 30 128 

Note: Implementing S. 847 also could increase revenue collections and related direct spending from fines and penalties, but CBO estimates 

that any collections over the 2013–2022 period would not be significant. 

Basis of estimate: For this estimate, CBO assumes that S. 847 

will be enacted near the end of 2012 and that the necessary 

amounts will be appropriated each year. 

Spending subject to appropriation 

While some EPA activities currently performed under TSCA 

would be replaced by new requirements under S. 847, 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 

(such as acid rain) and on other information provided by the agency. According to EPA, the agency currently requires, on average, an 

appropriation of about $105 million annually to implement and enforce TSCA. That funding supports about 360 employees and includes about $5 million for grants to states to enforce TSCA. Subject to appropriation of the necessary amounts, CBO estimates that 

EPA would require about $30 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 primarily on producing guidance documents and cost-benefit analyses 

and performing other administrative tasks related to the rulemaking process for new chemicals and substances already in use. 

EPA also would establish internal processes and information technology systems necessary to prioritize the analysis of tens of thousands of chemicals and to implement other related programs in 

subsequent years. According to the agency, such activities are routinely carried out by contractors; as a result, the majority of the estimated $30 million annual funding needed over this period would 

cover contractor costs. By 2015, as more implementation and enforcement of the new provisions of TSCA would begin, CBO estimates that EPA would shift funding to cover additional personnel. 

Direct spending and revenues 

Enacting S. 847 also could affect direct spending and revenues 

because this bill would increase some existing civil and criminal 

penalties as well as establish some new fines. 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. 

Implementing this legislation also would authorize EPA to 

charge fees to chemical manufacturers who are required to submit 

data under the bill. The legislation indicates that such fees could 

be used to defray the cost of administering the changes proposed 


tjames on DSK6SPTVN1PROD with 
20 

by this bill. Any additional fees collected under this provision 

would be recorded as an increase in revenues in the budget. However, because those fees could not be charged until sufficient 

amounts have been appropriated to EPA for the TSCA regulatory 

program, no additional revenues can be attributed directly to enacting S. 847. 

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 2013–2022 period. 

Intergovernmental and private-sector impact: The bill would authorize EPA to develop new regulations for the use and disposal of 

chemicals and the inspection of facilities where chemicals are 

stored. Such regulations would constitute intergovernmental mandates, as defined in UMRA. The bill would impose an additional 

intergovernmental mandate by preempting state regulations that 

conflict with federal requirements. Because the scope of future regulations is unclear and the number of intergovernmental entities 

potentially affected by the requirements is unknown, CBO cannot 

determine whether the aggregate cost of the intergovernmental 

mandates would exceed the annual threshold established in UMRA 

($73 million in 2012, adjusted annually for inflation). 

The bill would impose private-sector mandates on manufacturers 

and processors of chemicals by requiring them to submit additional 

data and comply with safety standards. Both new and existing 

chemicals currently sold in the United States would be subject to 

the mandates in the bill. According to information from industry 

experts, manufacturers and processors of chemicals could incur 

costs of $1 million or more per chemical to demonstrate compliance 

with safety standards. In addition to the requirements on manufacturers and processors, any regulations governing the use and disposal of chemicals and the inspection of facilities also would impose 

mandates on private entities. Because a large number of entities 

would likely be affected by the new requirements, CBO estimates 

that the aggregate cost of the private-sector mandates would probably exceed the annual threshold established in UMRA ($146 million in 2012, adjusted annually for inflation.) 

CBO has not reviewed legislative provisions in section 26 that 

would implement international agreements for mandates. Section 4 

of UMRA excludes from the application of that act any legislative 

provisions that are necessary for the ratification or implementation 

of international treaty obligations. CBO has determined that those 

provisions fall within that exclusion. 

Estimate prepared by: Federal Spending: Susanne Mehlman; Impact on State, Local, and Tribal Governments: Melissa Merrell; Impact on the Private Sector: Amy Petz. 

Estimate approved by: Theresa Gullo, Deputy Assistant Director 

for Budget Analysis. 


tjames on DSK6SPTVN1PROD with 
(21) 

MINORITY VIEWS 

BACKGROUND

S. 847, the Safe Chemicals Act (SCA), finishes its fourth congress 

without bipartisan or industry support. Although the bill’s author 

notes the importance of having a strong chemical regulatory framework at the federal level, the legislation, both as originally introduced and as amended in committee, represents an unworkable 

program that would likely be crippling to manufacturing in the 

United States. Despite efforts from the minority to both contribute 

in a constructive manner as well as to bring the regulated community to the table the intransigent nature of the authors and the majority on this issue continue to bog down reform. Accordingly, the 

minority finds it difficult to ascertain if the legislation is intended 

as anything more than a fundraising tool for the environmental 

left. 

The minority finds ample reason for reforming industrial chemical regulation currently managed under the Toxic Substances Control Act (TSCA). Ongoing challenges with the U.S. Environmental 

Protection Agency’s (EPA) chemical risk assessment programs and 

the lack of sound science at the agency necessitate reform. Most notably, the National Academy of Sciences’ review of formaldehyde 

(issued in April 2011) expressed continued frustration with the 

quality, methodology and transparency of the conclusions EPA had 

achieved, and were ‘‘recurring’’. Current reforms being undertaken 

by the agency are insufficient and strengthening of data quality 

and transparency laws are appropriate. 

EXAMPLES OF PROBLEMS WITH THE SCA

1. Safety Standard Can Not Be Applied: The safety standard 

called for in the SCA cannot practically be applied to the diverse 

array of chemicals regulated under TSCA. It imposes a standard 

that in essence mandates a showing that the chemical, in all applications, causes no harm, which may be impossible to demonstrate. 

This could adversely impact the ability of American companies to 

manufacture everything from automobile components to advanced 

medical equipment. 

2. Aggregate Exposure Assessments Only Worsens the Safety 

Standard Problem: The requirement, under the SCA, to demonstrate that no harm will result from aggregate exposure to the 

chemical necessitates an analysis of every human and environmental exposure to a specific chemical from all sources—even natural sources. Many chemicals have thousands of uses, making this 

requirement technically and practically impossible to meet. This is 

an example of overregulation—a provision that neither the regulated entities nor the regulator can possibly fulfill. 


tjames on DSK6SPTVN1PROD with 
22 

3. The SCA Would Significantly Stifle Domestic Research and Development of New Chemicals: The SCA seeks to fix a system that 

is not broken by discarding the successful new chemicals review 

program that exists today in TSCA in favor of a new, highly inflexible and overly burdensome structure. This review and approval 

process would undoubtedly stifle US research and development of 

innovative chemicals and applications. Furthermore, the lack of 

predictability in the proposed new and untested process, stemming 

from undefined data generation requirements to extended EPA review times, only compounds this problem, particularly for chemical 

uses that undergo constant improvement. 

4. The SCA Fails to Balance Calls for Greater Transparency with 

Sensitive Business Information Needs: The SCA provides EPA with 

the authority to needlessly abandon long-standing law and practice 

governing the protection of sensitive confidential business information. There are no qualifications or criteria as to how this authority 

should be applied—a glaring omission that might be expected to 

lead to arbitrary decision-making. The lack of transparency and 

predictability built into the authority is legitimate cause for concern. The threat to the protection of legitimate trade secrets and 

commercially sensitive information is further worsened by the SCA 

provisions that mandate disclosure of commercially sensitive information solely because of presence of certain hazard characteristics 

in a substance. No consideration is given as to how the substance 

is used, or what the actual exposure to the substance is: basically, 

the actual risk, if any, posed by use of the substance is irrelevant. 

The information protection provisions in the SCA create a strong 

disincentive to any business to perform research and development 

of new and innovative products in the United States. 

5. Data and Information Gathering Authority Is Needlessly 

Overbroad: Any provision that would give EPA authority to require 

the generation of new, relevant data should be based on the proposition that this ‘‘missing’’ data is necessary for the evaluative process. Legitimate need for information should be the driver. The 

SCA, however takes an entirely different approach by mandating 

that EPA establish ‘‘minimum information sets’’ as EPA ‘‘determines appropriate’’ and requiring that these shall include ‘‘sufficient information’’ for EPA to conduct an assessment of the chemical. The SCA sets no limits on the authority of EPA. Conducting 

testing or gathering information solely for the sake of generating 

and compiling information is burdensome and wasteful, both for 

businesses that must devote enormous resources to comply and on 

government that must then accept and handle volumes of information it did not need. 

6. The SCA Not Only Fails to Address One of the Major Criticisms of TSCA, It Worsens the Problem: The perceived lack of a 

strong, central federal chemical management system has been offered as a reason why states and municipalities have felt compelled 

to enact chemical management legislation. This burdensome patchwork of at times inconsistent regulations, would be eliminated, the 

argument goes, if there was a strong and effective TSCA. Having 

one chemical regulatory system administered at the federal level 

and eliminating the need for a state and local regulations would 

make compliance more practical, provide uniform protection, and 


tjames on DSK6SPTVN1PROD with 
23 

promote a stronger economy by reducing unnecessary burdens on 

businesses and state and local governments. Yet, even after imposing hosts of new and burdensome requirements, the SCA fails to 

limit the continued growth of state and local regulation, thereby increasing the significant burden on American industry. 

Thanks to our abundant fossil fuel supplies, made available 

through our advances in hydraulic fracturing and directional drilling technologies, the chemical manufacturing sector is seeing resurgence in investment and jobs in the United States. Despite four 

years of dismal economic growth, the domestic fossil fuel and chemical manufacturing sector has been a bright spot. Accordingly, it remains imperative that we do not stifle the economic and job potential of these industries with a regulatory framework that is unworkable, but rather focus on enhancing consumer protections and 

improving the law through reasonable bipartisan reform that 

would strengthen consumer confidence while protecting our economy and jobs. 

JIM INHOFE. 

DAVID VITTER. 


tjames on DSK6SPTVN1PROD with 
24 

1The Toxic Substances Control Act (15 U.S.C. 2601–2692) consists of Public Law 94–469 (Oct. 

11, 1976; 90 Stat. 2003) and the amendments made by subsequent enactments. 

CHANGES IN EXISTING LAW

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

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

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

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

* * * * * * * 

TOXIC SUBSTANCES CONTROL ACT 

* * * * * * * 

TOXIC SUBSTANCES CONTROL ACT 1

[As Amended Through P.L. 110–414, Enacted October 14, 2008] 

TITLE I—CONTROL OF TOXIC SUBSTANCES 

SECTION 1. SHORT TITLE AND TABLE OF CONTENTS. 

This Act may be cited as the ‘‘Toxic Substances Control Act’’. 

TABLE OF CONTENTS 

TITLE I—CONTROL OF TOXIC SUBSTANCES 

Sec. 1. Short title and table of contents. 

Sec. 2. øFindings, policy and intent¿ Findings, policy, and goal. 

Sec. 3. Definitions. 

Sec. 4. øTesting of chemical substances and mixtures¿ Minimum data set and testing of chemical substances. 

Sec. 5. Manufacturing and processing notices. 

Sec. 6. øRegulation of hazardous chemical substances and mixtures¿ Prioritization, 

safety standard determination, and risk management. 

Sec. 28. State programs. 

Sec. 29. Children’s Environmental Health Research Program. 

Sec. 30. Reduction of animal-based testing. 

Sec. 31. Safer alternatives and green chemistry and engineering. 

Sec. 32. Cooperation with international efforts. 

Sec. 33. Reliable information and advice. 

Sec. 34. Hot spots. 

Sec. 35. Application of this Act to Federal agencies. 

Sec. 36. Implementation of Stockholm Convention, the LRTAP Pops Protocol, and 

the Rotterdam Convention. 

Sec. 37. Annual report. 

Sec. 38. Authorization of appropriations. 

Sec. ø29. Authorization for appropriations. 

Sec. ø30. Annual report. 


tjames on DSK6SPTVN1PROD with 
25 

Sec. ø31. Effective date.¿ 

* * * * * * * 

SEC. 2. FINDINGS, POLICY, AND øINTENT¿ goal. 

ø(a) FINDINGS.—The Congress finds that— 

ø(1) human beings and the environment are being exposed 

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

ø(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 

ø(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. 

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

ø(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; 

ø(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 

ø(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. 

ø(c) INTENT OF CONGRESS.—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.¿ 

(a) FINDINGS.—Congress finds that— 

(1) each year human beings and the environment are exposed 

to a large number of chemical substances; 

(2) the chemical industry, an important part of the United 

States economy, provides valuable products that are used in diverse manufacturing industries and other commercial, institutional, and consumer applications; 

(3) more than 3 decades after the enactment of this Act, people and the environment in the United States are still exposed 

to thousands of chemicals whose safety has not been adequately 

reviewed and may harm health and the environment; 

(4) the incidence of some diseases and disorders linked to 

chemical substance exposures is on the rise; 


tjames on DSK6SPTVN1PROD with 
26 

(5) biomonitoring of chemical substances in humans reveals 

that people in the United States carry hundreds of hazardous 

chemicals in their bodies; 

(6) the concentrations of certain chemical substances that persist and accumulate are increasing in the environment and in 

human bodies and are found across the world, including in the 

remote Arctic in which Native Americans face increasing contamination of traditional foods; 

(7) differences in metabolism and physiology at certain stages 

of development can make infants and children more vulnerable 

than adults to the effects of chemical exposure, especially exposure that occurs in utero, during infancy, and during other critical periods of development; 

(8) manufacturers and processors of chemicals should supply 

sufficient health and environmental information before distributing products in commerce; 

(9) the Administrator must have and exercise the authority to 

develop sufficient information to assess chemical safety, and to 

act effectively when the Administrator obtains information that 

indicates there are risks of harmful exposure to chemical substances; 

(10) there is significant global trade in the chemical sector 

and many of the companies that conduct business in the United 

States must also comply with chemical safety regulatory programs in other countries, and the data that is generated to comply with those other regulatory programs may be useful in understanding hazards and exposures of chemical substances presented in the United States; and 

(11) a revised policy on the safety of chemical substances will 

assist in renewing the manufacturing sector of the United 

States, create new and safer jobs, spur innovations in green 

chemistry, restore confidence domestically and internationally 

in the safety of products of the United States, and ensure that 

products of the United States remain competitive in the global 

market. 

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

(1) to protect the health of children, workers, consumers, and 

the public, and to protect the environment from harmful exposures to chemical substances; 

(2) to promote the use of safer alternatives and other actions 

that reduce the use of and exposure to hazardous chemical substances and reward innovation toward safer chemicals, processes, and products; 

(3) to require that chemicals in commerce meet a risk-based 

safety standard that protects vulnerable and affected populations and the environment; 

(4) to require companies to provide sufficient health and environmental information for the chemical substances that the 

companies manufacture, process, or import as a condition of allowing those companies to distribute chemical substances in 

commerce; 

(5) to improve the quality of information on chemical safety 

and use; 


tjames on DSK6SPTVN1PROD with 
27 

1 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. 

(6) to guarantee the right of the public and workers to know 

about the hazards and uses of chemical substances that the 

public and workers may be exposed to by maximizing public access to information on chemical safety and use; and 

(7) to strengthen cooperation between and among the Federal 

Government and State, municipal, tribal, and foreign governments. 

(c) GOAL.—It is the goal of the United States to address the harmful exposure of vulnerable or affected populations to chemical substances caused by the distribution of chemical substances in commerce by— 

(1) reviewing all chemical substances for safety and identifying the highest priority chemical substances for expedited review; 

(2) determining whether chemical substances in commerce 

meet the safety standard under this title; 

(3) applying appropriate restrictions to the use of a chemical 

substance, where warranted; and 

(4) encouraging the replacement of harmful chemicals and 

processes with safer alternatives. 

SEC. 3. DEFINITIONS. 

As used in this Act: 

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

the Environmental Protection Agency. 

(2) AGGREGATE EXPOSURE.— 

(A) IN GENERAL.—Subject to subparagraph (B), the term 

‘aggregate exposure’ means exposure from all sources of a 

chemical substance, including exposure from— 

(i) the manufacture, processing, distribution, use, 

and disposal of that chemical substance; and 

(ii) all other sources of that chemical substance, including— 

(I) contamination of food, air, water, soil, and 

house dust from current or prior uses or activity; 

(II) accidental releases; 

(III) permitted sources of pollution; 

(IV) nonpoint sources of pollution; 

(V) documented background levels from natural 

and anthropogenic sources; and 

(VI) a mixture or article containing that chemical substance. 

(B) INCLUSIONS.—The term ‘aggregate exposure’ includes 

exposure from a chemical substance that is not considered 

to be a chemical substance under this Act solely because of 

the use of that substance as, or in, a food, food additive, 

cosmetic, or device (as those terms are defined in section 

201 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 321)). 

(3) BIOACCUMULATIVE.— 

(A) IN GENERAL.—The term ‘bioaccumulative’ means, 

with respect to a chemical substance or mixture, that the 


tjames on DSK6SPTVN1PROD with 
28 

chemical substance or mixture, as determined by the Administrator, can significantly accumulate in biota, as indicated through monitoring data, or is highly likely to accumulate in biota, as indicated by other evidence. 

(B) UPDATE.—To reflect the best available science, the 

Administrator may, by rule, revise the definition of the 

term ‘bioaccumulative’ in such a way that reflects the state 

of the science and provides for equal or greater protection 

of human health and the environment. 

(4) CHEMICAL IDENTITY.—The term ‘chemical identity’ includes— 

(A) each common and trade name of a chemical substance; 

(B) the name of a chemical substance appearing in International Union of Pure and Applied Chemistry nomenclature and the most current Collective Index format; 

(C) each Chemical Abstracts Service registration number 

of a chemical substance; and 

(D) the molecular structure of a chemical substance. 

ø(2)¿(5)ø(2)(A) Except as provided in subparagraph (B)¿ 

(5) CHEMICAL SUBSTANCE.— (A) IN GENERAL.—Except as provided in subparagraphs 

(B) and (C), 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. 

ø(B) Such term¿ 

(B) EXCLUSIONS.—The term ‘chemical substance’ 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) 


tjames on DSK6SPTVN1PROD with 
29 

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). 

(C) INCLUSIONS.—Notwithstanding molecular identity, 

the Administrator may determine that a variant of a chemical substance is a new chemical substance under section 

5(a)(6). 

ø(3)¿(6) 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). 

(7) CUMULATIVE EXPOSURE.—The term ‘cumulative exposure’ 

means the sum of aggregate exposure to each of the chemical 

substances that are known or suspected to contribute appreciably to the risk of the same or a similar adverse effect. 

ø(4) 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.¿ 

(8) DISTRIBUTE IN COMMERCE.—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 that chemical substance), mean— 

(A) to sell, or the sale of, the substance, mixture, or article in commerce; 

(B) to introduce or deliver for introduction into commerce, or the introduction or delivery for introduction into 

commerce of, the substance, mixture, or article; 

(C) to hold, or the holding of, the substance, mixture, or 

article after its introduction into commerce; or 

(D) to export or offer for export the substance, mixture, or 

article. 

(9) END CONSUMER.—The term ‘end consumer’ means an individual or other entity that purchases and uses or consumes a 

chemical substance (or mixture or article containing that chemical substance). 

ø(5)¿(10) The term ‘‘environment’’ includes water,ambient 

and indoor air, and land and the interrelationship which exists 

among and between water, air, and land and all living things. 

(11) FEDERAL AGENCY.—The term ‘Federal agency’ means any 

department, agency, or other instrumentality of the Federal 

Government, any independent agency or establishment of the 

Federal Government including any Government corporation, 

and the Government Printing Office. 

ø(6)¿(12) 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 expoVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00029 Fmt 6602 Sfmt 6602 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
30 

sure to a chemical substance or mixture, toxicological, clinical, 

and ecological studies of a chemical substance or mixture, and 

any test performed pursuant to this Act. 

ø(7)¿(13) The term ‘‘manufacture’’ means to import into the 

customs territory of the United States (as defined in general 

note 2 of the Harmonized Tariff Schedules of the United 

States), produce, or manufacture. 

ø(8)¿(14) The term ‘‘mixture’’ means any combination of two 

or more chemical substances if the combination does not occur 

in nature and is not, in whole or in part, the result of a chemical reaction; except that such term does include any combination which occurs, in whole or in part, as a result of a chemical 

reaction if none of the chemical substances comprising the 

combination is a new chemical substance and if the combination could have been manufactured for commercial purposes 

without a chemical reaction at the time the chemical substances comprising the combination were combined. 

ø(9)¿(15) The term ‘‘new chemical substance’’ means any 

chemical substance øwhich is not included in the chemical substance list compiled and published under section 8(b)¿ for 

which the manufacturer or processor of the chemical substance 

has not submitted a declaration under section 8(a). (16) PERSISTENT.— (A) IN GENERAL.—The term ‘persistent’ means, with respect to a chemical substance or mixture, that the chemical 

substance or mixture, as determined by the Administrator, 

significantly persists in 1 or more environmental media, as 

indicated by monitoring data or other evidence. 

(B) UPDATE.—To reflect the best available science, the 

Administrator may, by rule, revise the definition of the 

term ‘persistent’ in such a way that reflects the state of the 

science and provides for equal or greater protection of 

human health and the environment. 

(17) PERSON.— 

(A) IN GENERAL.—The term ‘person’ means an individual, 

trust, firm, joint stock company, corporation (including a 

Government corporation), partnership, association, State, 

municipality, commission, political subdivision of a State, 

or any interstate body. 

(B) INCLUSIONS.—The term ‘person’ includes each Federal agency and any officer, agent, or employee of a Federal 

agency. 

ø(10)¿(18) The term ‘‘process’’ means the preparation of a 

chemical substance or mixture, after its manufacture, for distribution in commerce— 

(A) in the same form or physical state as, or in a different form or physical state from, that in which it was received by the person so preparing such substance or mixture, or 

(B) as part of an article containing the chemical substance or mixture. 

ø(11)¿(19) The term ‘‘processor’’ means any person who processes a chemical substance or mixture. 

(20) SPECIAL SUBSTANCE CHARACTERISTIC.— 


tjames on DSK6SPTVN1PROD with 
31 

(A) IN GENERAL.—The term ‘special substance characteristic’ means a physical, chemical, or biological characteristic, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect 

the risks posed by substances exhibiting that characteristic. 

(B) CONSIDERATIONS.—In determining the existence of 

special substance characteristics, the Administrator may 

consider— 

(i) size or size distribution; 

(ii) shape and surface structure; 

(iii) reactivity; and 

(iv) any other properties that may significantly affect 

the risks posed. 

ø(12) The term ‘‘standards for the development of test data’’ 

means a prescription of— 

ø(A) the— 

ø(i) health and environmental effects, and 

ø(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 

ø(B) to the extent necessary to assure that data respecting such effects and characteristics are reliable and adequate— 

ø(i) the manner in which such data are to be developed, 

ø(ii) the specification of any test protocol or methodology to be employed in the development of such data, 

and 

ø(iii) such other requirements as are necessary to 

provide such assurance.¿ 

ø(13)¿(21) 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. 

(22) TOXIC.—The term ‘toxic’, with respect to a chemical substance or mixture, means that the chemical substance or mixture has a toxicological property— 

(A) meeting the criteria for Category 1 or Category 2 for 

any of the toxicity endpoints established by the Globally 

Harmonized System for the Classification and Labeling of 

Hazardous Substances; 

(B) that causes an adverse effect that has been demonstrated in humans or other exposed organisms; or 

(C) for which the weight of evidence (such as demonstration of an adverse effect described in subparagraph (B), 

laboratory studies, or data for a chemical from the same 

chemical class that exhibits that adverse effect) demonstrates the potential for an adverse effect in humans or 

other exposed organisms. 


tjames on DSK6SPTVN1PROD with 
32 

(23) TOXICOLOGICAL PROPERTY.—The term ‘toxicological property’ means actual or potential toxicity or other adverse effects 

of a chemical substance or mixture, including actual or potential effects of exposure to a chemical substance or mixture on— 

(A) mortality; 

(B) morbidity, including carcinogenesis; 

(C) reproduction; 

(D) growth and development; 

(E) the immune system; 

(F) the endocrine system; 

(G) the brain or nervous system; 

(H) other organ systems; or 

(I) any other biological functions in humans or 

nonhuman organisms. 

ø(14)¿(24) The term ‘‘United States’’, when used in the geographic sense, means all of the States. 

(25) VULNERABLE HUMAN POPULATION.—The term ‘vulnerable 

human population’ means a human population that is subject 

to disproportionate exposure to, or the potential for disproportionate adverse effect from exposure to, a chemical substance or 

mixture, including— 

(A) infants, children, and adolescents; 

(B) pregnant women; 

(C) elderly; 

(D) individuals with preexisting medical conditions; 

(E) workers that work with chemical substances and mixtures; and 

(F) members of any other appropriate population identified by the Administrator. 

* * * * * * * 

øSEC. 4. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES. 

ø(a) TESTING REQUIREMENTS.—If the Administrator finds that— 

ø(1)(A)(i) the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or 

that any combination of such activities, may present an unreasonable risk of injury to health or the environment, 

ø(ii) there are insufficient data and experience upon which 

the effects of such manufacture, distribution in commerce, 

processing, use, or disposal of such substance or mixture or of 

any combination of such activities on health or the environment can reasonably be determined or predicted, and 

ø(iii) testing of such substance or mixture with respect to 

such effects is necessary to develop such data; or 

ø(B)(i) a chemical substance or mixture is or will be produced 

in substantial quantities, and (I) it enters or may reasonably 

be anticipated to enter the environment in substantial quantities or (II) there is or may be significant or substantial 

human exposure to such substance or mixture, 

ø(ii) there are insufficient data and experience upon which 

the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any 

combination of such activities on health or the environment 

can reasonably be determined or predicted, and 


tjames on DSK6SPTVN1PROD with 
33 

ø(iii) testing of such substance or mixture with respect to 

such effects is necessary to develop such data; and 

ø(2) in the case of a mixture, the effects which the mixture’s 

manufacture, distribution in commerce, processing, use, or disposal or any combination of such activities may have on health 

or the environment may not be reasonably and more efficiently 

determined or predicted by testing the chemical substances 

which comprise the mixture; 

the Administrator shall by rule require that testing be conducted 

on such substance or mixture to develop data with respect to the 

health and environmental effects for which there is an insufficiency 

of data and experience and which are relevant to a determination 

that the manufacture, distribution in commerce, processing, use, or 

disposal of such substance or mixture, or that any combination of 

such activities, does or does not present an unreasonable risk of injury to health or the environment. 

ø(b)(1) TESTING REQUIREMENT RULE.—A rule under subsection 

(a) shall include— 

ø(A) identification of the chemical substance or mixture for 

which testing is required under the rule, 

ø(B) standards for the development of test data for such substance or mixture, and 

ø(C) with respect to chemical substances which are not new 

chemical substances and to mixtures, a specification of the period (which period may not be of unreasonable duration) within 

which the persons required to conduct the testing shall submit 

to the Administrator data developed in accordance with the 

standards referred to in subparagraph (B). 

øIn determining the standards and period to be included, pursuant 

to subparagraphs (B) and (C), in a rule under subsection (a), the 

Administrator’s considerations shall include the relative costs of 

the various test protocols and methodologies which may be required under the rule and the reasonably foreseeable availability of 

the facilities and personnel needed to perform the testing required 

under the rule. Any such rule may require the submission to the 

Administrator of preliminary data during the period prescribed 

under subparagraph (C). 

ø(2)(A) The health and environmental effects for which standards 

for the development of test data may be prescribed include carcinogenesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synergistic effects, and any other effect which may present 

an unreasonable risk of injury to health or the environment. The 

characteristics of chemical substances and mixtures for which such 

standards may be prescribed include persistence, acute toxicity, 

subacute toxicity, chronic toxicity, and any other characteristic 

which may present such a risk. The methodologies that may be 

prescribed in such standards include epidemiologic studies, serial 

or hierarchical tests, in vitro tests, and whole animal tests, except 

that before prescribing epidemiologic studies of employees, the Administrator shall consult with the Director of the National Institute 

for Occupational Safety and Health. 

ø(B) From time to time, but not less than once each 12 months, 

the Administrator shall review the adequacy of the standards for 

development of data prescribed in rules under subsection (a) and 


tjames on DSK6SPTVN1PROD with 
34 

shall, if necessary, institute proceedings to make appropriate revisions of such standards. 

ø(3)(A) A rule under subsection (a) respecting a chemical substance or mixture shall require the persons described in subparagraph (B) to conduct tests and submit data to the Administrator on 

such substance or mixture, except that the Administrator may permit two or more of such persons to designate one such person or 

a qualified third party to conduct such tests and submit such data 

on behalf of the persons making the designation. 

ø(B) The following persons shall be required to conduct tests and 

submit data on a chemical substance or mixture subject to a rule 

under subsection (a): 

ø(i) Each person who manufactures or intends to manufacture such substance or mixture if the Administrator makes a 

finding described in subsection (a)(1)(A)(ii) or (a)(1)(B)(ii) with 

respect to the manufacture of such substance or mixture. 

ø(ii) Each person who processes or intends to process such 

substance or mixture if the Administrator makes a finding described in subsection (a)(1)(A)(ii) or (a)(1)(B)(ii) with respect to 

the processing of such substance or mixture. 

ø(iii) Each person who manufactures or processes or intends 

to manufacture or process such substance or mixture if the Administrator makes a finding described in subsection (a)(1)(A)(ii) 

or (a)(1)(B)(ii) with respect to the distribution in commerce, 

use, or disposal of such substance or mixture. 

ø(4) Any rule under subsection (a) requiring the testing of and 

submission of data for a particular chemical substance or mixture 

shall expire at the end of the reimbursement period (as defined in 

subsection (c)(3)(B)) which is applicable to test data for such substance or mixture unless the Administrator repeals the rule before 

such date; and a rule under subsection (a) requiring the testing of 

and submission of data for a category of chemical substances or 

mixtures shall expire with respect to a chemical substance or mixture included in the category at the end of the reimbursement period (as so defined) which is applicable to test data for such substance or mixture unless the Administrator before such date repeals the application of the rule to such substance or mixture or 

repeals the rule. 

ø(5) Rules issued under subsection (a) (and any substantive 

amendment thereto or repeal thereof) shall be promulgated pursuant to section 553 of title 5, United States Code, except that (A) 

the Administrator shall give interested persons an opportunity for 

the oral presentation of data, views, or arguments, in addition to 

an opportunity to make written submission; (B) a transcript shall 

be made of any oral presentation; and (C) the Administrator shall 

make and publish with the rule the findings described in paragraph (1)(A) or (1)(B) of subsection (a) and, in the case of a rule 

respecting a mixture, the finding described in paragraph (2) of such 

subsection. 

ø(c) EXEMPTION.—(1) Any person required by a rule under subsection (a) to conduct tests and submit data on a chemical substance or mixture may apply to the Administrator (in such form 

and manner as the Administrator shall prescribe) for an exemption 

from such requirement. 


tjames on DSK6SPTVN1PROD with 
35 

ø(2) If, upon receipt of an application under paragraph (1), the 

Administrator determines that— 

ø(A) the chemical substance or mixture with respect to which 

such application was submitted is equivalent to a chemical 

substance or mixture for which data has been submitted to the 

Administrator in accordance with a rule under subsection (a) 

or for which data is being developed pursuant to such a rule, 

and 

ø(B) submission of data by the applicant on such substance 

or mixture would be duplicative of data which has been submitted to the Administrator in accordance with such rule or 

which is being developed pursuant to such rule, 

the Administrator shall exempt, in accordance with paragraph (3) 

or (4), the applicant from conducting tests and submitting data on 

such substance or mixture under the rule with respect to which 

such application was submitted. 

ø(3)(A) If the exemption under paragraph (2) of any person from 

the requirement to conduct tests and submit test data on a chemical substance or mixture is granted on the basis of the existence 

of previously submitted test data and if such exemption is granted 

during the reimbursement period for such test data (as prescribed 

by subparagraph (B)), then (unless such person and the persons referred to in clauses (i) and (ii) agree on the amount and method 

of reimbursement) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in 

an amount determined under rules of the Administrator)— 

ø(i) to the person who previously submitted such test data, 

for a portion of the costs incurred by such person in complying 

with the requirement to submit such data, and 

ø(ii) to any other person who has been required under this 

subparagraph to contribute with respect to such costs, for a 

portion of the amount such person was required to contribute. 

øIn promulgating rules for the determination of fair and equitable 

reimbursement to the persons described in clauses (i) and (ii) for 

costs incurred with respect to a chemical substance or mixture, the 

Administrator shall, after consultation with the Attorney General 

and the Federal Trade Commission, consider all relevant factors, 

including the effect on the competitive position of the person required to provide reimbursement in relation to the person to be reimbursed and the share of the market for such substance or mixture of the person required to provide reimbursement in relation to 

the share of such market of the persons to be reimbursed. An order 

under this subparagraph shall, for purposes of judicial review, be 

considered final agency action. 

ø(B) For purposes of subparagraph (A), the reimbursement period for any test data for a chemical substance or mixture is a period— 

ø(i) beginning on the date such data is submitted in accordance with a rule promulgated under subsection (a), and 

ø(ii) ending— 

ø(I) five years after the date referred to in clause (i), or 

ø(II) at the expiration of a period which begins on the 

date referred to in clause (i) and which is equal to the peVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00035 Fmt 6602 Sfmt 6602 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
36 

riod which the Administrator determines was necessary to 

develop such data, 

whichever is later. 

ø(4)(A) If the exemption under paragraph (2) of any person from 

the requirement to conduct tests and submit test data on a chemical substance or mixture is granted on the basis of the fact that 

test data is being developed by one or more persons pursuant to a 

rule promulgated under subsection (a), then (unless such person 

and the persons referred to in clauses (i) and (ii) agree on the 

amount and method of reimbursement) the Administrator shall 

order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the 

Administrator)— 

ø(i) to each such person who is developing such test data, for 

a portion of the costs incurred by each such person in complying with such rule, and 

ø(ii) to any other person who has been required under this 

subparagraph to contribute with respect to the costs of complying with such rule, for a portion of the amount such person 

was required to contribute. 

øIn promulgating rules for the determination of fair and equitable 

reimbursement to the persons described in clauses (i) and (ii) for 

costs incurred with respect to a chemical substance or mixture, the 

Administrator shall, after consultation with the Attorney General 

and the Federal Trade Commission, consider the factors described 

in the second sentence of paragraph (3)(A). An order under this 

subparagraph shall, for purposes of judicial review, be considered 

final agency action. 

ø(B) If any exemption is granted under paragraph (2) on the 

basis of the fact that one or more persons are developing test data 

pursuant to a rule promulgated under subsection (a) and if after 

such exemption is granted the Administrator determines that no 

such person has complied with such rule, the Administrator shall 

(i) after providing written notice to the person who holds such exemption and an opportunity for a hearing, by order terminate such 

exemption, and (ii) notify in writing such person of the requirements of the rule with respect to which such exemption was granted. 

ø(d) NOTICE.—Upon the receipt of any test data pursuant to a 

rule under subsection (a), the Administrator shall publish a notice 

of the receipt of such data in the Federal Register within 15 days 

of its receipt. Subject to section 14, each such notice shall (1) identify the chemical substance or mixture for which data have been received; (2) list the uses or intended uses of such substance or mixture and the information required by the applicable standards for 

the development of test data; and (3) describe the nature of the test 

data developed. Except as otherwise provided in section 14, such 

data shall be made available by the Administrator for examination 

by any person. 

ø(e) 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 under 

subsection (a). In making such a recommendation with respect to 


tjames on DSK6SPTVN1PROD with 
37 

1So in law. Probably should be ‘‘preceding’’. 

any chemical substance or mixture, the committee shall consider 

all relevant factors, including— 

ø(i) the quantities in which the substance or mixture is or 

will be manufactured, 

ø(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, 

ø(iv) the extent to which human beings are or will be exposed to the substance or mixture, 

ø(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, 

ø(vi) the existence of data concerning the effects of the substance or mixture on health or the environment, 

ø(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 

ø(viii) the reasonably foreseeable availability of facilities and 

personnel for performing testing on the substance or mixture. 

øThe 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) 

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). 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. 

ø(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 1 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, 


tjames on DSK6SPTVN1PROD with 
38 

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) 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. 

ø(2)(A) The committee established by paragraph (1)(A) shall consist of eight members as follows: 

ø(i) One member appointed by the Administrator from the 

Environmental Protection Agency. 

ø(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. 

ø(iii) One member appointed by the Chairman of the Council 

on Environmental Quality from the Council or its officers or 

employees. 

ø(iv) One member appointed by the Director of the National 

Institute for Occupational Safety and Health from officers or 

employees of the Institute. 

ø(v) One member appointed by the Director of the National 

Institute of Environmental Health Sciences from officers or 

employees of the Institute. 

ø(vi) One member appointed by the Director of the National 

Cancer Institute from officers or employees of the Institute. 

ø(vii) One member appointed by the Director of the National 

Science Foundation from officers or employees of the Foundation. 

ø(viii) One member appointed by the Secretary of Commerce 

from officers or employees of the Department of Commerce. 

ø(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. 

ø(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. 

ø(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. 


tjames on DSK6SPTVN1PROD with 
39 

ø(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 promulgated or order 

issued thereunder, for a period of at least 12 months after termination of service on the committee. 

ø(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 promulgated or order issued thereunder. 

ø(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. 

ø(D) The Administrator shall provide the committee such administrative support services as may be necessary to enable the committee to carry out its function under this subsection. 

ø(f) REQUIRED ACTIONS.—Upon the receipt of— 

ø(1) any test data required to be submitted under this Act, 

or 

ø(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. 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. 

ø(g) PETITION FOR STANDARDS FOR THE DEVELOPMENT OF TEST

DATA.—A person intending to manufacture or process a chemical 

substance for which notice is required under section 5(a) and who 

is not required under a rule under subsection (a) to conduct tests 

and submit data on such substance may petition the Administrator 

to prescribe standards for the development of test data for such 

substance. The Administrator shall by order either grant or deny 

any such petition within 60 days of its receipt. If the petition is 

granted, the Administrator shall prescribe such standards for such 

substance within 75 days of the date the petition is granted. If the 

petition is denied, the Administrator shall publish, subject to section 14, in the Federal Register the reasons for such denial.¿ 

SEC. 4. MINIMUM INFORMATION SETS AND TESTING OF CHEMICAL 

SUBSTANCES. 

(a) MINIMUM INFORMATION SETS.— 


tjames on DSK6SPTVN1PROD with 
40 

(1) RULE.— (A) IN GENERAL.—Subject to subparagraphs (B) and (C), 

and not later than 1 year after the date of enactment of the 

Safe Chemicals Act of 2011, the Administrator shall establish, by rule, such minimum information sets as the Administrator determines to be appropriate to evaluate chemical substances under sections 5 and 6. 

(B) GENERAL REQUIREMENTS.—The rule promulgated 

pursuant to subparagraph (A) shall— 

(i) provide for varied or tiered information to be provided for different chemical substances; 

(ii) identify the particular minimum information set 

that applies to a chemical substance; 

(iii) require each minimum information set to include sufficient information for the Administrator to 

conduct a screening-level risk assessment of the chemical substance, including information on the characteristics, toxicological properties, environmental and biological fate and behavior, exposure, and use of a chemical substance; 

(iv) specify information quality and reliability requirements applicable to the information submitted in 

the minimum information sets; and 

(v) accommodate the use of alternative testing methods and testing strategies to generate information 

quickly, at low cost, and with reduced use of animalbased testing, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput 

screening, to the extent such methods and strategies 

would yield information of equivalent quality and reliability. 

(C) SPECIFIC REQUIREMENTS.—The rule promulgated 

pursuant to subparagraph (A) shall establish minimum information sets sufficient for the Administrator to administer this Act, including to carry out— 

(i) categorization of new chemical substances under 

section 5(b)(2), including the identification of information— 

(I) sufficiently robust to generally support the 

categorization of a new chemical substance as a 

substance of very low concern under section 

5(b)(2)(D)(iii)(II); and 

(II) in the absence of which the Administrator 

shall designate a new chemical substance to be a 

substance with insufficient information under section 5(b)(2)(D)(iv); 

(ii) categorization of existing chemical substances 

under section 6(b)(3), including the identification of information— 

(I) sufficiently robust to generally support the 

categorization of an existing chemical substance as 

a substance of very low concern under section 

6(b)(3)(B)(ii); and 


tjames on DSK6SPTVN1PROD with 
41 

(II) in the absence of which the Administrator 

shall designate an existing chemical substance to 

be a substance with insufficient information under 

section 6(b)(3)(B)(iv); 

(iii) assignment of chemical substances to priority 

classes under section 6(b)(4); 

(iv) safety standard determinations— 

(I) for new uses of existing chemical substances 

under section 5(b)(2); and 

(II) for chemical substances under section 6(d); 

and 

(v) safety standard redeterminations under section 

6(d)(5)(E). 

(2) SUBMISSION OF MINIMUM INFORMATION SET.—Each manufacturer and processor of a chemical substance shall submit the 

minimum information set for the chemical substance to the Administrator— 

(A) for new chemical substances, concurrent with the notice required under section (5)(b)(1)(A); and 

(B) for existing chemical substances, as specified in section 6 or otherwise specified by the Administrator in the 

rule promulgated pursuant to paragraph (1)(A). 

(3) PROHIBITION.—In addition to any other authorities available under this Act, the Administrator may, by order, take any 

action authorized under section 6(f) if a manufacturer or processor is in violation of paragraph (2). 

(b) TESTING.— 

(1) GENERAL SUBMISSIONS.— 

(A) IN GENERAL.—The Administrator may, by rule or 

order, require testing with respect to any chemical substance, and the submission of test results by a specified 

date, as appropriate for making any determination or carrying out any provision of this Act. Such testing may be required— 

(i) to provide information in addition to the information specified in any applicable minimum information 

set under subsection (a); and 

(ii) of persons to whom the Administrator decides not 

to apply a requirement to submit a minimum information set under subsection (a). 

(B) EFFECT ON OTHER AUTHORITY.—Nothing in this paragraph limits the authority of the Administrator under paragraph (2). 

(2) SAMPLE SUBMISSIONS.— 

(A) IN GENERAL.—The Administrator may, by rule or 

order, require the submission of a sample of any chemical 

substance in such manner as the Administrator determines 

enables the Administrator to conduct any tests necessary 

for making any determination or carrying out any provision of this Act. 

(B) EFFECT ON OTHER AUTHORITY.—Nothing in this paragraph limits the authority of the Administrator under paragraph (1). 


tjames on DSK6SPTVN1PROD with 
42 

(3) PROHIBITION.—In addition to any other authorities available under this Act, the Administrator may, by order, take any 

action authorized under section 6(f) if a manufacturer or processor is in violation of a rule or order under paragraph (1). 

(4) EXEMPTION.—If a manufacturer or processor ceases all 

manufacture or processing of a chemical substance pursuant to 

its submission of a declaration of cessation of manufacture or 

processing under section 8(b)(4) for the chemical substance, the 

manufacturer or processor shall be exempted from the requirements of this subsection. 

(c) TEST RULES OR ORDERS.— (1) IN GENERAL.—A rule or order issued under subsection (b) 

shall include— 

(A) identification of the chemical substance for which 

testing is required under the rule or order; 

(B) standards for the development of test information for 

that substance; and 

(C) a specification of the period (which may not be of unreasonable duration) within which the persons required to 

conduct the testing shall submit to the Administrator information developed in accordance with the standards referred to in subparagraph (B). 

(2) CONSIDERATIONS.— (A) IN GENERAL.—In determining the standards and period to be required under subparagraphs (B) and (C) of 

paragraph (1), the Administrator shall consider— 

(i) the relative costs of the various test protocols and 

methodologies that may be required under the rule or 

order; and 

(ii) the reasonably foreseeable availability of the facilities and personnel needed to perform the testing required under the rule. 

(B) PRELIMINARY INFORMATION.—Any rule or order 

issued by the Administrator under this subsection may require a manufacturer or processor to submit preliminary 

information during the period described in paragraph 

(1)(C). 

(3) TYPES OF HEALTH AND ENVIRONMENTAL INFORMATION.— (A) IN GENERAL.—The Administrator may prescribe 

standards for the development of test information under 

this subsection for health and environmental information, 

including— 

(i) information pertaining to carcinogenesis, 

mutagenesis, teratogenesis, behavioral disorders, or cumulative, synergistic, or any other effect that may be 

considered in a safety standard determination; 

(ii) information pertaining to exposure to the chemical substance, including information regarding the 

presence of the chemical substance in human blood, 

fluids, or tissue; and 

(iii) information pertaining to— 

(I) bioaccumulation; 

(II) persistence; 

(III) acute toxicity; 


tjames on DSK6SPTVN1PROD with 
43 

(IV) subacute toxicity; 

(V) chronic toxicity; and 

(VI) any other characteristic that may present an 

adverse effect. 

(B) METHODOLOGIES.— (i) IN GENERAL.—The Administrator may prescribe 

methodologies in standards for the development of test 

information, including— 

(I) epidemiologic studies; 

(II) biomonitoring or environmental monitoring 

studies; 

(III) serial or hierarchical tests; 

(IV) in vitro tests; 

(V) whole animal tests, consistent with section 

30; and 

(VI) any other methodology deemed appropriate 

by the Administrator. 

(ii) REQUIREMENT.—Prior to prescribing epidemiologic studies of employees, the Administrator shall consult with the Director of the National Institute for Occupational Safety and Health. 

(C) REVIEW.—Periodically, but not less frequently than 

once every 3 years, the Administrator shall— 

(i) review the adequacy of the standards for development of information prescribed under subparagraph 

(A); and 

(ii) if necessary, institute proceedings to make appropriate revisions of those standards. 

(4) PERSONS REQUIRED TO CONDUCT TESTS AND SUBMIT IN- FORMATION.— (A) IN GENERAL.—Except as provided in subparagraph 

(B), a rule or order under subsection (b) respecting a chemical substance shall specify the persons required to conduct 

tests and submit information to the Administrator on the 

substance. 

(B) EXCEPTION.—The Administrator may permit 2 or 

more of the persons described in subparagraph (A) to designate 1 of the persons or a qualified third party to conduct 

the tests and submit the information on behalf of the persons making the designation. 

(C) LIABILITY.—All persons described in subparagraphs 

(A) and (B) shall remain liable for compliance with any requirements subject to the designation. 

(5) EXPIRATION OF RULES AND ORDERS.— 

(A) IN GENERAL.—Any rule or order under subsection (b) 

that requires the testing and submission of information for 

a particular chemical substance shall expire at the end of 

the applicable reimbursement period (as defined in subsection (d)(3)) unless, prior to that date, the Administrator 

withdraws the rule or order. 

(B) CATEGORY OF CHEMICAL SUBSTANCES.—A rule or 

order under subsection (b) that requires the testing and 

submission of information for a category of chemical substances shall expire with respect to a chemical substance inVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00043 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
44 

cluded in the category at the end of the applicable reimbursement period (as defined in subsection (d)(3)) unless, 

prior to that date, the Administrator withdraws the rule or 

order with respect to the substance entirely. 

(d) EXEMPTIONS.— (1) IN GENERAL.—Any person required by a rule or order 

under subsections (a) or (b) to conduct tests and submit information for a chemical substance may apply to the Administrator (in such form and manner as the Administrator determines necessary) for an exemption from the requirement. 

(2) ACTION BY ADMINISTRATOR.—In accordance with paragraph (3) or (4), the Administrator shall exempt an applicant 

under paragraph (1), if, on receipt of the application, the Administrator determines that— 

(A) the chemical substance for which the application was 

submitted is equivalent to a chemical substance for 

which— 

(i) information has been submitted to the Administrator in accordance with a rule or order under subsection (a) or (b); or 

(ii) information is being developed in accordance 

with the rule or order; and 

(B) submission of information by the applicant for the 

substance would be duplicative of information that— 

(i) has been submitted to the Administrator in accordance with the rule or order under subsection (a) or 

(b); or 

(ii) is being developed in accordance with the rule or 

order. 

(3) REIMBURSEMENT DUE TO EXEMPTION.— (A) DEFINITION OF REIMBURSEMENT PERIOD.—In this 

paragraph, the term ‘reimbursement period’, with respect to 

any test information for a chemical substance, means a period that— 

(i) begins on the date on which the test information 

is submitted in accordance with a rule or order issued 

under subsection (a) or (b); and 

(ii) ends on the later of— 

(I) 5 years after the date referred to in clause (i); 

and 

(II) the date which, as determined by the Administrator, provides the applicant with a time period 

which is sufficient to develop the test information. 

(B) REIMBURSEMENT FOR PREVIOUSLY SUBMITTED TEST

INFORMATION.— 

(i) IN GENERAL.—Except as provided in clause (ii), 

for an exemption under paragraph (2)(B)(i), if the exemption is granted during the reimbursement period 

for the test information, the Administrator shall order 

the person granted the exemption to provide fair and 

equitable reimbursement (in an amount determined by 

the Administrator) to— 

(I) the person who previously submitted the test 

information, for a portion of the costs incurred by 


tjames on DSK6SPTVN1PROD with 
45 

the person in complying with the information submission requirement; and 

(II) any other person who has been required 

under this subsection to contribute with respect to 

the costs, for a portion of the amount the person 

was required to contribute. 

(ii) EXCEPTION.—Clause (i) shall not apply if there is 

agreement on the amount and method of reimbursement between an exempted person described in clause 

(i) and the persons described in subclauses (I) and (II) 

of that clause. 

(iii) CONSIDERATIONS.—In promulgating rules for the 

determination of fair and equitable reimbursement to 

the persons described in subclauses (I) and (II) of 

clause (i) 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— 

(I) the effect on the competitive position of the 

person required to provide reimbursement in relation to the person to be reimbursed; and 

(II) the share of the market for the substance of 

the person required to provide reimbursement in 

relation to the share of the market of the persons 

to be reimbursed. 

(C) REIMBURSEMENT DUE TO EXEMPTION FOR TEST INFORMATION BEING DEVELOPED IN ACCORDANCE WITH RULE OR

ORDER.— 

(i) IN GENERAL.—Except as provided in clause (ii), 

for an exemption under paragraph (2)(B)(ii), the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an 

amount determined by the Administrator) to— 

(I) each person who is developing the test information, for the portion of the costs incurred by 

each person in complying with the rule or order; 

and 

(II) any other person who has been required 

under this subsection to contribute with respect to 

the costs of complying with the rule or order, for 

a portion of the amount the person was required to 

contribute. 

(ii) EXCEPTION.—Clause (i) shall not apply if there is 

agreement on the amount and method of reimbursement between an exempted person described in clause 

(i) and the persons described in subclauses (I) and (II) 

of that clause. 

(iii) CONSIDERATIONS.—In promulgating rules for the 

determination of fair and equitable reimbursement to 

the persons described in subclauses (I) and (II) of 

clause (i) for costs incurred with respect to a chemical 

substance, the Administrator shall, after consultation 

with the Attorney General and the Federal Trade ComVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00045 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
46 

mission, consider the factors described in subparagraph (B)(iii). 

(iv) LACK OF COMPLIANCE.—If any exemption is 

granted under paragraph (2) on the basis that 1 or 

more persons are developing test information pursuant 

to a rule or order promulgated or issued under subsection (a) or (b), and after the exemption is granted, 

the Administrator determines that no person has complied with the rule or order, the Administrator shall— 

(I) after providing written notice and an opportunity for a hearing to the person who holds the 

exemption, by order, terminate the exemption; and 

(II) notify in writing the person of the requirements of the rule or order with respect to which the 

exemption was granted. 

(e) NOTICE.— (1) IN GENERAL.—Not later than 15 days after the date of receipt of any test information pursuant to a rule or order under 

subsection (a) or (b), the Administrator shall publish in the 

Federal Register a notice of the receipt of the test information. 

(2) REQUIREMENTS.—Subject to section 14, each notice shall— 

(A) identify the chemical substance for which information 

has been received; 

(B) list— 

(i) the commercial and consumer uses or intended 

commercial and consumer uses of the substance known 

to the Administrator; and 

(ii) the information required by the applicable standards for the development of test information; and 

(C) describe the nature of the test information developed. 

(3) AVAILABILITY.—Subject to section 14, the Administrator 

shall make the test information described in this subsection 

available on a publicly accessible Internet site. 

(f) REQUESTS FROM OTHER AGENCIES FOR ADDITIONAL INFORMATION OR TESTING.— (1) IN GENERAL.—The head of a Federal agency may request 

the Administrator to seek the information on behalf of that 

agency if the head of that Federal agency determines that— 

(A) information relating to a chemical substance, including information derived from new testing or monitoring, 

would assist that Federal agency in carrying out the duties 

or exercising the authority of that agency; but 

(B) the requested information is not available to that 

agency. 

(2) DUTY OF ADMINISTRATOR.—Not later than 60 days after 

the date of receipt of a request under paragraph (1), the Administrator shall— 

(A) subject to section 14, make the information available 

to the requesting agency or institution; 

(B) issue a request under section 8(k) to require— 

(i) the submission of existing pertinent information to 

the Administrator; and 

(ii) a copy of any such submission to be furnished to 

the requesting agency or institution; 


tjames on DSK6SPTVN1PROD with 
47 

(C) issue a rule or order under subsection (b)— 

(i) to develop the information; and 

(ii) to require the developed information to be furnished to the requesting agency or institution; or 

(D) publish in the Federal Register the reason for which 

none of the actions described in this paragraph were taken. 

(g) CERTIFICATION.—Each person who submits information under 

this section or under a rule or an order promulgated or issued by 

the Administrator under this section shall accompany the information with a certification signed by a responsible official that each 

statement contained in the submission— 

(1) is accurate and reliable; and 

(2) includes all material facts known to, in the possession or 

control of, or reasonably ascertainable by, the person. 

øSEC. 5. MANUFACTURING AND PROCESSING NOTICES. 

ø(a) IN GENERAL.—(1) Except as provided in subsection (h), no 

person may— 

ø(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 

ø(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), of such person’s intention to manufacture or process 

such substance and such person complies with any applicable requirement of subsection (b). 

ø(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— 

ø(A) the projected volume of manufacturing and processing 

of a chemical substance, 

ø(B) the extent to which a use changes the type or form of 

exposure of human beings or the environment to a chemical 

substance, 

ø(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 

ø(D) the reasonably anticipated manner and methods of 

manufacturing, processing, distribution in commerce, and disposal of a chemical substance. 

ø(b) SUBMISSION OF TEST DATA.—(1)(A) If (i) a person is required 

by subsection (a)(1) to submit a notice to the Administrator before 

beginning the manufacture or processing of a chemical substance, 

and (ii) such person is required to submit test data for such substance pursuant to a rule promulgated under section 4 before the 

submission of such notice, such person shall submit to the Administrator such data in accordance with such rule at the time notice is 

submitted in accordance with subsection (a)(1). 

ø(B) If— 

ø(i) a person is required by subsection (a)(1) to submit a notice to the Administrator, and 


tjames on DSK6SPTVN1PROD with 
48 

ø(ii) such person has been granted an exemption under section 4(c) from the requirements of a rule promulgated under 

section 4 before the submission of such notice, 

such person may not, before the expiration of the 90-day period 

which begins on the date of the submission in accordance with such 

rule of the test data the submission or development of which was 

the basis for the exemption, manufacture such substance if such 

person is subject to subsection (a)(1)(A) or manufacture or process 

such substance for a significant new use if the person is subject to 

subsection (a)(1)(B). 

ø(2)(A) If a person— 

ø(i) is required by subsection (a)(1) to submit a notice to the 

Administrator before beginning the manufacture or processing 

of a chemical substance listed under paragraph (4), and 

ø(ii) is not required by a rule promulgated under section 4 

before the submission of such notice to submit test data for 

such substance, such person shall submit to the Administrator 

data prescribed by subparagraph (B) at the time notice is submitted in accordance with subsection (a)(1). 

ø(B) Data submitted pursuant to subparagraph (A) shall be data 

which the person submitting the data believes show that— 

ø(i) in the case of a substance with respect to which notice 

is required under subsection (a)(1)(A), the manufacture, processing, distribution in commerce, use, and disposal of the 

chemical substance or any combination of such activities will 

not present an unreasonable risk of injury to health or the environment, or 

ø(ii) in the case of a chemical substance with respect to 

which notice is required under subsection (a)(1)(B), the intended significant new use of the chemical substance will not 

present an unreasonable risk of injury to health or the environment. 

ø(3) Data submitted under paragraph (1) or (2) shall be made 

available, subject to section 14, for examination by interested persons. 

ø(4)(A)(i) The Administrator may, by rule, compile and keep current a list of chemical substances with respect to which the Administrator finds that the manufacture, processing, distribution in 

commerce, use, or disposal, or any combination of such activities, 

presents or may present an unreasonable risk of injury to health 

or the environment. 

ø(ii) In making a finding under clause (i) that the manufacture, 

processing, distribution in commerce, use, or disposal of a chemical 

substance or any combination of such activities presents or may 

present an unreasonable risk of injury to health or the environment, the Administrator shall consider all relevant factors, including— 

ø(I) the effects of the chemical substance on health and the 

magnitude of human exposure to such substance; and 

ø(II) the effects of the chemical substance on the environment and the magnitude of environmental exposure to such 

substance. 

ø(B) The Administrator shall, in prescribing a rule under subparagraph (A) which lists any chemical substance, identify those 


tjames on DSK6SPTVN1PROD with 
49 

uses, if any, which the Administrator determines, by rule under 

subsection (a)(2), would constitute a significant new use of such 

substance. 

ø(C) Any rule under subparagraph (A), and any substantive 

amendment or repeal of such a rule, shall be promulgated pursuant 

to the procedures specified in section 553 of title 5, United States 

Code, except that (i) the Administrator shall give interested persons an opportunity for the oral presentation of data, views, or arguments, in addition to an opportunity to make written submissions, (ii) a transcript shall be kept of any oral presentation, and 

(iii) the Administrator shall make and publish with the rule the 

finding described in subparagraph (A). 

ø(c) 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. 

ø(d) CONTENT OF NOTICE; PUBLICATIONS IN THE FEDERAL REG- ISTER.—(1) The notice required by subsection (a) shall include— 

ø(A) insofar as known to the person submitting the notice or 

insofar as reasonably ascertainable, the information described 

in subparagraphs (A), (B), (C), (D), (F), and (G) of section 

8(a)(2), and 

ø(B) in such form and manner as the Administrator may prescribe, any test data in the possession or control of the person 

giving such notice which are related to the effect of any manufacture, processing, distribution in commerce, use, or disposal 

of such substance or any article containing such substance, or 

of any combination of such activities, on health or the environment, and 

ø(C) a description of any other data concerning the environmental and health effects of such substance, insofar as known 

to the person making the notice or insofar as reasonably ascertainable. Such a notice shall be made available, subject to section 14, for examination by interested persons. 

ø(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) or of data under subsection (b), the 

Administrator shall publish in the Federal Register a notice 

which— 

ø(A) identifies the chemical substance for which notice or 

data has been received; 

ø(B) lists the uses or intended uses of such substance; and 

ø(C) in the case of the receipt of data under subsection (b), 

describes the nature of the tests performed on such substance 

and any data which was developed pursuant to subsection (b) 

or a rule under section 4. 

A notice under this paragraph respecting a chemical substance 

shall identify the chemical substance by generic class unless the 

Administrator determines that more specific identification is required in the public interest. 


tjames on DSK6SPTVN1PROD with 
50 

ø(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) 

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. 

ø(e) REGULATION PENDING DEVELOPMENT OF INFORMATION.— (1)(A) If the Administrator determines that— 

ø(i) the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of a chemical substance with respect to 

which notice is required by subsection (a); and 

ø(ii)(I) in the absence of sufficient information to permit the 

Administrator to make such an evaluation, the manufacture, 

processing, distribution in commerce, use, or disposal of such 

substance, or any combination of such activities, may present 

an unreasonable risk of injury to health or the environment, or 

ø(II) such substance is or will be produced in substantial 

quantities, and such substance either enters or may reasonably 

be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human 

exposure to the substance,the Administrator may issue a proposed order, to take effect on the expiration of the notification 

period applicable to the manufacturing or processing of such 

substance under subsection (a), (b), or (c), to prohibit or limit 

the manufacture, processing, distribution in commerce, use, or 

disposal of such substance or to prohibit or limit any combination of such activities. 

ø(B) A proposed order may not be issued under subparagraph (A) 

respecting a chemical substance (i) later than 45 days before the 

expiration of the notification period applicable to the manufacture 

or processing of such substance under subsection (a), (b), or (c), and 

(ii) unless the Administrator has, on or before the issuance of the 

proposed order, notified, in writing, each manufacturer or processor, as the case may be, of such substance of the determination 

which underlies such order. 

ø(C) If a manufacturer or processor of a chemical substance to be 

subject to a proposed order issued under subparagraph (A) files 

with the Administrator (within the 30-day period beginning on the 

date such manufacturer or processor received the notice required 

by subparagraph (B)(ii)) objections specifying with particularity the 

provisions of the order deemed objectionable and stating the 

grounds therefor, the proposed order shall not take effect. 

ø(2)(A)(i) Except as provided in clause (ii), if with respect to a 

chemical substance with respect to which notice is required by subsection (a), the Administrator makes the determination described 

in paragraph (1)(A) and if— 

ø(I) the Administrator does not issue a proposed order under 

paragraph (1) respecting such substance, or 

ø(II) the Administrator issues such an order respecting such 

substance but such order does not take effect because objections were filed under paragraph (1)(C) with respect to it,the 

Administrator, through attorneys of the Environmental ProtecVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00050 Fmt 6602 Sfmt 6602 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
51 

tion Agency, shall apply to the United States District Court for 

the District of Columbia or the United States district court for 

the judicial district in which the manufacturer or processor, as 

the case may be, of such substance is found, resides, or transacts business for an injunction to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal 

of such substance (or to prohibit or limit any combination of 

such activities). 

ø(ii) If the Administrator issues a proposed order under paragraph (1)(A) respecting a chemical substance but such order does 

not take effect because objections have been filed under paragraph 

(1)(C) with respect to it, the Administrator is not required to apply 

for an injunction under clause (i) respecting such substance if the 

Administrator determines, on the basis of such objections, that the 

determinations under paragraph (1)(A) may not be made. 

ø(B) A district court of the United States which receives an application under subparagraph (A)(i) for an injunction respecting a 

chemical substance shall issue such injunction if the court finds 

that— 

ø(i) the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of a chemical substance with respect to 

which notice is required by subsection (a); and 

ø(ii)(I) in the absence of sufficient information to permit the 

Administrator to make such an evaluation, the manufacture, 

processing, distribution in commerce, use, or disposal of such 

substance, or any combination of such activities, may present 

an unreasonable risk of injury to health or the environment, or 

ø(II) such substance is or will be produced in substantial 

quantities, and such substance either enters or may reasonably 

be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human 

exposure to the substance. 

ø(C) Pending the completion of a proceeding for the issuance of 

an injunction under subparagraph (B) respecting a chemical substance, the court may, upon application of the Administrator made 

through attorneys of the Environmental Protection Agency, issue a 

temporary restraining order or a preliminary injunction to prohibit 

the manufacture, processing, distribution in commerce, use, or disposal of such a substance (or any combination of such activities) if 

the court finds that the notification period applicable under subsection (a), (b), or (c) to the manufacturing or processing of such 

substance may expire before such proceeding can be completed. 

ø(D) After the submission to the Administrator of test data sufficient to evaluate the health and environmental effects of a chemical substance subject to an injunction issued under subparagraph 

(B) and the evaluation of such data by the Administrator, the district court of the United States which issued such injunction shall, 

upon petition, dissolve the injunction unless the Administrator has 

initiated a proceeding for the issuance of a rule under section 6(a) 

respecting the substance. If such a proceeding has been initiated, 

such court shall continue the injunction in effect until the effective 

date of the rule promulgated in such proceeding or, if such proVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00051 Fmt 6602 Sfmt 6602 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
52 

ceeding is terminated without the promulgation of a rule, upon the 

termination of the proceeding, whichever occurs first. 

ø(f) PROTECTION AGAINST UNREASONABLE RISKS.—(1) If the Administrator finds that there is a reasonable basis to conclude that 

the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance with respect to which notice is required by subsection (a), or that any combination of such activities, 

presents or will present an unreasonable risk of injury to health or 

environment before a rule promulgated under section 6 can protect 

against such risk, the Administrator shall, before the expiration of 

the notification period applicable under subsection (a), (b), or (c) to 

the manufacturing or processing of such substance, take the action 

authorized by paragraph (2) or (3) to the extent necessary to protect against such risk. 

ø(2) The Administrator may issue a proposed rule under section 

6(a) to apply to a chemical substance with respect to which a finding was made under paragraph (1)— 

ø(A) a requirement limiting the amount of such substance 

which may be manufactured, processed, or distributed in commerce, 

ø(B) a requirement described in paragraph (2), (3), (4), (5), 

(6), or (7) of section 6(a), or 

ø(C) any combination of the requirements referred to in subparagraph (B). Such a proposed rule shall be effective upon its 

publication in the Federal Register. Section 6(d)(2)(B) shall 

apply with respect to such rule. 

ø(3)(A) The Administrator may— 

ø(i) issue a proposed order to prohibit the manufacture, processing, or distribution in commerce of a substance with respect 

to which a finding was made under paragraph (1), or 

ø(ii) apply, through attorneys of the Environmental Protection Agency, to the United States District Court for the District 

of Columbia or the United States district court for the judicial 

district in which the manufacturer, or processor, as the case 

may be, of such substance, is found, resides, or transacts business for an injunction to prohibit the manufacture, processing, 

or distribution in commerce of such substance. A proposed 

order issued under clause (i) respecting a chemical substance 

shall take effect on the expiration of the notification period applicable under subsection (a), (b), or (c) to the manufacture or 

processing of such substance. 

ø(B) If the district court of the United States to which an application has been made under subparagraph (A)(ii) finds that there is 

a reasonable basis to conclude that the manufacture, processing, 

distribution in commerce, use, or disposal of the chemical substance with respect to which such application was made, or that 

any combination of such activities, presents or will present an unreasonable risk of injury to health or the environment before a rule 

promulgated under section 6 can protect against such risk, the 

court shall issue an injunction to prohibit the manufacture, processing or distribution in commerce of such substance or to prohibit 

any combination of such activities. 

ø(C) The provisions of subparagraphs (B) and (C) of subsection 

(e)(1) shall apply with respect to an order issued under clause (i) 


tjames on DSK6SPTVN1PROD with 
53 

of subparagraph (A); and the provisions of subparagraph (C) of subsection (e)(2) shall apply with respect to an injunction issued under 

subparagraph (B). 

ø(D) If the Administrator issues an order pursuant to subparagraph (A)(i) respecting a chemical substance and objections are 

filed in accordance with subsection (e)(1)(C), the Administrator 

shall seek an injunction under subparagraph (A)(ii) respecting such 

substance unless the Administrator determines, on the basis of 

such objections, that such substance does not or will not present an 

unreasonable risk of injury to health or the environment. 

ø(g) STATEMENT OF REASONS FOR NOT TAKING ACTION.—If the 

Administrator has not initiated any action under this section or 

section 6 or 7 to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance, 

with respect to which notification or data is required by subsection 

(a)(1)(B) or (b), before the expiration of the notification period applicable to the manufacturing or processing of such substance, the 

Administrator shall publish a statement of the Administrator’s reasons for not initiating such action. Such a statement shall be published in the Federal Register before the expiration of such period. 

Publication of such statement in accordance with the preceding 

sentence is not a prerequisite to the manufacturing or processing 

of the substance with respect to which the statement is to be published. 

ø(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— 

ø(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, and 

ø(B) under such restrictions as the Administrator considers 

appropriate. 

ø(2)(A) The Administrator may, upon application, exempt any 

person from the requirement of subsection (b)(2) to submit data for 

a chemical substance. If, upon receipt of an application under the 

preceding sentence, the Administrator determines that— 

ø(i) the chemical substance with respect to which such application was submitted is equivalent to a chemical substance for 

which data has been submitted to the Administrator as required by subsection (b)(2), and 

ø(ii) submission of data by the applicant on such substance 

would be duplicative of data which has been submitted to the 

Administrator in accordance with such subsection, the Administrator shall exempt the applicant from the requirement to 

submit such data on such substance. No exemption which is 

granted under this subparagraph with respect to the submission of data for a chemical substance may take effect before the 

beginning of the reimbursement period applicable to such data. 

ø(B) If the Administrator exempts any person, under subparagraph (A), from submitting data required under subsection (b)(2) 


tjames on DSK6SPTVN1PROD with 
54 

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)— 

ø(i) to the person who previously submitted the data on 

which the exemption was based, for a portion of the costs incurred by such person in complying with the requirement 

under subsection (b)(2) to submit such data, and 

ø(ii) to any other person who has been required under this 

subparagraph to contribute with respect to such costs, for a 

portion of the amount such person was required to contribute. 

In promulgating rules for the determination of fair and equitable reimbursement to the persons described in clauses (i) and 

(ii) for costs incurred with respect to a chemical substance, the 

Administrator shall, after consultation with the Attorney General and the Federal Trade Commission, consider all relevant 

factors, including the effect on the competitive position of the 

person required to provide reimbursement in relation to the 

persons to be reimbursed and the share of the market for such 

substance of the person required to provide reimbursement in 

relation to the share of such market of the persons to be reimbursed. For purposes of judicial review, an order under this 

subparagraph shall be considered final agency action. 

ø(C) For purposes of this paragraph, the reimbursement period 

for any previously submitted data for a chemical substance is a period— 

ø(i) beginning on the date of the termination of the prohibition, imposed under this section, on the manufacture or processing of such substance by the person who submitted such 

data to the Administrator, and 

ø(ii) ending— 

ø(I) five years after the date referred to in clause (i), or 

ø(II) at the expiration of a period which begins on the 

date referred to in clause (i) and is equal to the period 

which the Administrator determines was necessary to develop such data, whichever is later. 

ø(3) The requirements of subsections (a) and (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— 

ø(A) scientific experimentation or analysis, or 

ø(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. 


tjames on DSK6SPTVN1PROD with 
55 

ø(4) 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). 

ø(5) The Administrator may, upon application, make the requirements of subsections (a) and (b) inapplicable with respect to the 

manufacturing or processing of any chemical substance (A) which 

exists temporarily as a result of a chemical reaction in the manufacturing or processing of a mixture or another chemical substance, 

and (B) to which there is no, and will not be, human or environmental exposure. 

ø(6) Immediately upon receipt of an application under paragraph 

(1) or (5) 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. 

ø(i) DEFINITION.—For purposes of this section, the terms ‘‘manufacture’’ and ‘‘process’’ mean manufacturing or processing for commercial purposes.¿ 

SEC. 5. NEW CHEMICAL SUBSTANCES AND NEW USES OF CHEMICAL 

SUBSTANCES. 

(a) DEFINITIONS.—In this section: 

(1) MANUFACTURE AND PROCESS.—The terms ‘manufacture’ 

and ‘process’ mean manufacture or process, respectively, for 

commercial purposes. 

(2) TEST MARKETING.—The term ‘test marketing’ does not include any provision of a chemical substance or mixture, or an 

article containing a chemical substance or mixture, to an end 

consumer of the chemical substance, mixture, or article. 

(b) NEW CHEMICAL SUBSTANCES.— 

(1) NOTICES.—Except as provided in subsection (h), no person 

may manufacture a new chemical substance, or process the 

chemical substance for a use that is proposed to meet the criteria described in section 6(h)(2)(B), unless— 

(A) the person submits to the Administrator a notice, in 

accordance with subsection (g)(1)(A), of the intention of the 

person to manufacture or process the substance; 

(B) the person complies with subsection (f); and 

(C) the Administrator finds that— 

(i) the new chemical substance is likely to meet the 

safety standard under section 6(d), which shall be limited to substances assigned by the Administrator to 1 

of the categories described in paragraph (2)(D)(iii); or 

(ii) the person has established by clear and convincing evidence that 1 or more uses of the new chemVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00055 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
56 

ical substance meet the criteria described in section 

6(h)(2)(B), in which case— 

(I) the Administrator may by order allow the 

person to manufacture or process the substance 

only for such use or uses in accordance with subparagraph (A) of section 6(h)(2); 

(II) the procedures and requirements specified in 

subparagraphs (A), (C), (D), and (E) of section 

6(h)(2) shall apply; and 

(III) the Administrator shall not, upon receipt of 

a notice of commencement for the chemical substance under subsection (d), add the chemical substance to the active inventory established under 

section 8(h)(1). 

(2) CATEGORIZATION OF NEW CHEMICAL SUBSTANCES.— 

(A) RULE.—Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator 

shall promulgate a rule that— 

(i) designates the categories in accordance with subparagraph (D) and specifies the process and criteria 

the Administrator will use to categorize new chemical 

substances; and 

(ii) describes criteria and factors the Administrator 

will use to assess weight of evidence and the quality 

and reliability of information used to inform categorization decisions. 

(B) INFORMATION SOURCES.—In categorizing a new chemical substance, the Administrator shall consider information on the substance available to the Administrator at the 

time the categorization decision is to be made, including information— 

(i) received by the Administrator from the manufacturer or processor of the substance in accordance with 

subsection (f); 

(ii) submitted to a governmental body in another jurisdiction, to the extent that the information is accessible to the Administrator; 

(iii) derived through application of validated structure-activity relationship or other models developed by 

the Administrator to estimate the environmental and 

human health effects, environmental and biological 

fate and behavior, and exposure potential of chemical 

substances; 

(iv) inferred based on the degree of similarity of the 

structure or properties of the new chemical substance to 

those of 1 or more other chemical substances for which 

reliable information exists that is relevant to predicting 

the potential environmental or human health effects, 

environmental or biological fate and behavior, or exposure potential of the new chemical substance; and 

(v) any additional information the Administrator determines is needed to categorize the substance, including information identified as needed based on the analVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00056 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
57 

ysis by the Administrator of estimated or inferred information described in clauses (iii) and (iv). 

(C) TIMING.—Not later than 90 days after the date of receipt of a notice under paragraph (1)(A), the Administrator 

shall assign the new chemical substance for which the notice was submitted to 1 of the categories described in subparagraph (D). 

(D) CATEGORIES.— (i) IN GENERAL.—The rule promulgated pursuant to 

subparagraph (A) shall incorporate, establish criteria 

for, and further specify as needed, the categories described in this subparagraph, to 1 of which each new 

chemical substance for which a notice is submitted 

pursuant to paragraph (1) shall be assigned. 

(ii) SUBSTANCES OF VERY HIGH CONCERN.— (I) IN GENERAL.—The Administrator shall designate as a substance of very high concern any new 

chemical substance that— 

(aa) is toxic, persists in the environment, 

and is bioaccumulative; or 

(bb) is highly hazardous. 

(II) REQUIREMENTS.— (aa) IN GENERAL.—The Administrator shall 

allow the submitter of a notice under paragraph (1)(A) for a new chemical substance assigned to the category described in this clause 

to manufacture or process the new chemical 

substance only in accordance with paragraph 

(1)(C)(ii). 

(bb) PROHIBITION.—No other person may 

manufacture or process the chemical substance 

unless the person has submitted a notice pursuant to paragraph (1) and the requirements 

of paragraph (1)(C)(ii) have been met with respect to that notice. 

(iii) SUBSTANCES LIKELY TO MEET THE SAFETY

STANDARD.— (I) IN GENERAL.— (aa) The Administrator shall designate as a 

substance likely to meet the safety standard 

any new chemical substance that the Administrator determines, based on available information, would likely meet the safety standard 

under section 6(d)— 

(AA) for uses and under conditions specified by the submitter of the notice for the 

new chemical substance pursuant to paragraph (1); or 

(BB) for uses and under additional conditions that could be specified by the Administrator in making a safety standard 

determination for the substance. 

(bb) The Administrator shall assign to the 

category described in item (aa) any new chemVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00057 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
58 

ical substance that meets the criteria specified 

in subclause (II) or (III). 

(II) SUBSTANCES OF VERY LOW CONCERN.— (aa) IN GENERAL.—Within the category described in subclause (I), the Administrator 

shall designate as a substance of very low concern any new chemical substance that, based 

on robust information, the Administrator determines possesses intrinsic low-hazard properties so that no further action by the Administrator is warranted unless and until the Administrator receives new information that warrants a different categorization of the chemical 

substance. 

(bb) BASIS OF DESIGNATION.—In identifying 

new chemical substances to be placed in the 

category described in this subclause, the Administrator shall base the designation of a 

new chemical substance as a substance of very 

low concern on the applicable minimum information set required under section 4, unless the 

Administrator determines that such designation of a particular new chemical substance— 

(AA) can be made to a high degree of 

confidence based on less information; or 

(BB) requires information in addition to 

the full minimum information set to address conflicting or ambiguous findings, 

in which case the Administrator may require the development and submission of 

the additional information. 

(III) SUBSTANCES TO UNDERGO SAFETY STAND- ARD DETERMINATIONS.—Within the category described in subclause (I), the Administrator shall 

designate as a substance to undergo a safety 

standard determination any new chemical substance that the Administrator determines, based on 

a screening of available use, hazard, and exposure 

information, has information available for the 

chemical substance that is sufficiently robust to determine that the chemical substance does not meet 

the criteria for the categories described in subclause (II) or clause (ii) or (iv). 

(IV) REQUIREMENT.—For a new chemical substance designated as likely to meet the safety 

standard pursuant to subclause (II) or (III), the 

Administrator shall, upon submission of a notice 

of commencement described in subsection (d)— 

(aa) add the chemical substance to the active inventory described in section 8(h)(1); and 

(bb) for a chemical substance designated to 

undergo a safety standard determination, at 

the discretion of the Administrator accounting 

for timing of the submission and workload 


tjames on DSK6SPTVN1PROD with 
59 

considerations, add the chemical substance to 

the current batch or hold the substance until 

the next batch of substances to be prioritized 

in accordance with section 6(b)(4). 

(V) MANUFACTURING AND PROCESSING.—Pending 

the completion of a safety standard determination 

under section 6(d), a chemical substance designated as a substance likely to meet the safety 

standard may be manufactured or processed for 

uses and under conditions specified by the Administrator in determining that the chemical substance is likely to meet the safety standard— 

(aa) by the submitter of the notice for the 

chemical substance submitted pursuant to 

paragraph (1)(A), upon submission of a notice 

for the chemical substance pursuant to subsection (d); 

(bb) by other manufacturers of the chemical 

substance, once the chemical substance has 

been placed on the active inventory described 

in section 8(h)(1), upon submission of a declaration for the chemical substance pursuant 

to section 8(b)(1)(B); or 

(cc) by processors of the substance, upon 

compliance with the requirements of section 

8(e). 

(iv) SUBSTANCES WITH INSUFFICIENT INFORMATION.— (I) IN GENERAL.—The Administrator shall designate as a substance with insufficient information 

any new chemical substance for which the Administrator concludes, after gathering and screening 

available use, hazard, and exposure information, 

that needed information for the chemical substance 

is not available, is insufficient, or is not of sufficient quality and reliability to allow for an informed categorization decision. 

(II) REQUIRED SUBMISSION.—For substances designated under this clause, the Administrator shall 

require submission of the applicable minimum information set specified under section 4 as needed 

to inform categorization decisionmaking for new 

chemical substances. 

(III) RECATEGORIZATION.—Following submission 

of the applicable minimum information set for the 

chemical substance pursuant to subclause (II), the 

Administrator shall recategorize the chemical substance using the categories and process described 

in this paragraph. 

(IV) PROHIBITION.—Notwithstanding paragraph 

(1)(C)(ii), no person may manufacture or process a 

chemical substance designated under this clause 

until and unless the information described in subclause (II) has been submitted and the Administrator has recategorized the substance, at which 


tjames on DSK6SPTVN1PROD with 
60 

time the provisions applicable to the category to 

which the substance has been assigned shall apply. 

(v) SUBSTANCES UNLIKELY TO MEET THE SAFETY

STANDARD.— (I) IN GENERAL.—The Administrator shall designate as a substance unlikely to meet the safety 

standard any new chemical substance that the Administrator determines, based on available information, would be unlikely to meet the safety standard under section 6(d)— 

(aa) for uses and under conditions specified 

by the submitter of the notice for the chemical 

substance pursuant to paragraph (1); or 

(bb) for other uses or under additional conditions that the Administrator may evaluate 

in making a safety standard determination for 

the chemical substance. 

(II) PROHIBITION.—Except as provided under 

clause (ii), no person may manufacture or process 

a chemical substance designated under this clause. 

(c) NEW USES OF EXISTING CHEMICAL SUBSTANCES.— (1) NEW USES OF EXISTING CHEMICAL SUBSTANCES PRIOR TO

SAFETY STANDARD DETERMINATION.— (A) IN GENERAL.—Except as provided in subparagraph 

(B), with respect to an existing chemical substance for 

which the Administrator has not made a safety standard 

determination under section 6(d), no person may manufacture or process the chemical substance— 

(i) for a use that was not ongoing on the date of enactment of the Safe Chemicals Act of 2011; or 

(ii) at a volume that is significantly increased from 

the volume as of the date of enactment of the Safe 

Chemicals Act of 2011. 

(B) EXCEPTION.—A person may manufacture or process a 

chemical substance in a manner prohibited by subparagraph (A) if— 

(i) the person submits to the Administrator the notice 

specified in subsection (g)(1)(B); 

(ii) the person complies with subsection (f); and 

(iii) such manufacturing or processing is consistent 

with subsection (b)(2)(D)(iii)(V). 

(C) GUIDANCE.—Not later than 90 days after the date of 

enactment of the Safe Chemicals Act of 2011, the Administrator shall issue guidance for the purpose of identifying 

what constitute new uses and significantly increased production volumes under this paragraph. 

(2) NEW USES OF EXISTING CHEMICAL SUBSTANCES THAT MEET

THE SAFETY STANDARD.— 

(A) IN GENERAL.—For an existing chemical substance for 

which the Administrator has determined under section 6(d) 

that the manufacturers and processors of the chemical substance have established that the substance meets the applicable safety standard, no person may manufacture, process, 

distribute in commerce, use, or dispose of the chemical subVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00060 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
61 

stance, or a mixture or article containing the chemical substance for uses, at production volumes, or in manners other 

than those the Administrator specified in the safety standard determination, unless— 

(i) the person submits to the Administrator a notice 

in accordance with subsection (g)(1)(C) of the intention 

of the person to manufacture, process, distribute in 

commerce, use, or dispose of the chemical substance, or 

a mixture or article containing the chemical substance, 

for the new use or at a new production volume, or in 

such other manner that is inconsistent with a specified 

condition or term in the safety standard determination 

made by the Administrator for that substance; and 

(ii) the Administrator determines that the person 

submitting the notice has established that the chemical 

substance will continue to meet the safety standard if 

the allowed uses, production volumes, or other specified 

conditions or terms for that substance, are revised to 

encompass the new use, new production volume, or 

other manner of manufacturing, processing, distribution in commerce, use, or disposal. 

(B) AMENDMENT TO SAFETY STANDARD DETERMINATION.— If the conditions described in clauses (i) and (ii) of subparagraph (A) are satisfied, the Administrator shall, by 

order, amend the safety standard determination for the 

chemical substance to include the new use, production volume, or other manner of manufacturing or processing 

among the allowed uses, production volumes, or manners of 

manufacturing, processing, distribution in commerce, use, 

or disposal of the chemical substance. 

(C) SAFETY STANDARD DETERMINATION.— (i) IN GENERAL.—Except as provided in clauses (ii) 

and (iii), not later than 180 days after the date of receipt of a notice pursuant to subparagraph (A)(i), the 

Administrator shall determine whether the person submitting the notice has established that the chemical 

substance will continue to meet the safety standard 

under section 6(d). 

(ii) EXTENSION.—The Administrator may extend the 

determination deadline under clause (i) by 1 or more 

additional periods not to exceed 1 year in the aggregate, in such manner as the Administrator determines 

necessary. 

(iii) FAILURE TO MAKE A TIMELY DETERMINATION.— 

The failure of the Administrator to make a timely determination in accordance with this paragraph shall 

not be sufficient to satisfy subparagraph (A)(ii). 

(d) NOTICE OF COMMENCEMENT.— 

(1) IN GENERAL.—Not later than 30 days after the date on 

which a manufacturer or processor commences manufacturing 

or processing of a new chemical substance, the manufacturer or 

processor shall submit to the Administrator a notice of commencement of manufacture or processing. 

(2) REQUIREMENTS.—The notice of commencement shall— 


tjames on DSK6SPTVN1PROD with 
62 

(A) be considered equivalent to the declaration required 

under subparagraph (A) or (C) of section 8(b)(2); and 

(B) include the information described in section 8(b)(5). 

(3) WITHDRAWAL.—A person who has submitted a notice for 

a chemical substance under subsection (b) or (c), and has not 

commenced with manufacture or processing of the substance, 

may withdraw the notice. 

(e) CHEMICAL SUBSTANCES EXHIBITING SPECIAL SUBSTANCE

CHARACTERISTICS.— 

(1) DETERMINATION.—The Administrator shall determine by 

order or rule that a variant of a chemical substance exhibiting 

1 or more special substance characteristics— 

(A) is a use that is separate from any use of the chemical 

substance that does not exhibit the special substance characteristics; or 

(B) is a distinct chemical substance. 

(2) REQUIREMENTS FOR VARIANTS THAT ARE SEPARATE

USES.—In the case of a chemical substance that the Administrator determines to be a separate use based on the special substance characteristics of the chemical substance, the manufacturer or processor shall satisfy such further conditions as the 

Administrator establishes, by order or rule. 

(3) REQUIREMENTS FOR VARIANTS THAT ARE DISTINCT CHEMICAL SUBSTANCES.—In the case of a chemical substance that the 

Administrator determines to be a distinct chemical substance 

based on the special substance characteristics of the chemical 

substance, and that is not listed on the active inventory established under section 8(h)(1), the manufacturer or processor 

shall comply with the requirements of subsection (b). 

(f) SUBMISSION OF DATA.— 

(1) IN GENERAL.—A person shall submit to the Administrator 

data in accordance with the rule or order at the time that notice 

is submitted under subsection (b) or (c) if the person is required 

to submit to the Administrator— 

(A) under subsection (b) or (c), a notice prior to beginning 

the manufacture or processing of a chemical substance; and 

(B) under section 4(b), test data for the chemical substance prior to the submission of the notice. 

(2) AVAILABILITY.—Subject to section 14, the Administrator 

shall make any test data submitted under paragraph (1) available on a publicly accessible Internet site. 

(3) TIMING.—Except as provided under subsection 

(b)(2)(D)(iv), the Administrator may require a person subject to 

an information requirement for a chemical substance under this 

subsection or section 4 to submit the information— 

(A) prior to and as a condition of the Administrator assigning the substance to a category; 

(B) as a condition of commencement of manufacture or 

processing; or 

(C) as a condition of exceeding a specified manufacturing 

volume or expanding use of the substance. 

(g) CONTENT AND AVAILABILITY OF NOTICE.— 

(1) CONTENT.— 


tjames on DSK6SPTVN1PROD with 
63 

(A) NEW CHEMICAL SUBSTANCES.—A notice under subsection (b)(1) shall include— 

(i) the chemical identity and any special substance 

characteristics of the chemical substance; 

(ii) the identity and primary business location of the 

manufacturer; 

(iii) the information described in section 

8(h)(5)(B)(ii); 

(iv) the minimum information set described in section 4(a), where applicable; and 

(v) a statement that— 

(I) the new chemical substance is likely to meet 

the safety standard under section 6(d); or 

(II) the 1 or more uses proposed for the new 

chemical substance meet the criteria described in 

section 6(h)(2)(B). 

(B) NEW USES OF EXISTING CHEMICAL SUBSTANCES PRIOR

TO SAFETY STANDARD DETERMINATION.—A notice under 

subsection (c)(1) shall include all updates to the declaration 

described in section 8(b)(2) and information described in 

section 8(h)(5)(B)(ii) that is relevant to the new use, new 

production volume, or other new manner of manufacturing 

or processing. 

(C) NEW USES OF EXISTING CHEMICAL SUBSTANCES THAT

MEET THE SAFETY STANDARD.—A notice under subsection 

(c)(2) shall include— 

(i) all updates to the declaration described in section 

8(b)(2); 

(ii) information described in section 8(h)(5)(B)(ii) 

that is relevant to the new use, new production volume, 

or other new manner of manufacturing or processing; 

(iii) all updates to the minimum information set described in section 4(a) relevant to the new use, new production volume, or other new manner of manufacturing 

or processing; and 

(iv) a statement that the chemical substance will continue to meet the safety standard if the allowed uses, 

production volumes, or other specified conditions or 

terms for that chemical substance are revised to encompass the new use, production volume, or other manner 

of manufacturing or processing. 

(2) AVAILABILITY.—Subject to section 14, the Administrator 

shall make the notices under paragraph (1) available on a publicly accessible Internet site. 

(3) PUBLIC INFORMATION.—Subject to section 14, not later 

than 5 days (excluding Saturdays, Sundays, and legal holidays) after the date of the receipt of a notice under subsection 

(b), (c), or (d), or of data under subsection (f), the Administrator 

shall make available on a publicly accessible Internet site a notice that— 

(A) identifies the chemical substance for which notice or 

information has been received; 

(B) lists the uses or intended uses of the chemical substance; 


tjames on DSK6SPTVN1PROD with 
64 

(C) for substances for which a notice is submitted under 

subsection (b)(1), is promptly updated to specify the category to which the Administrator has assigned the substance pursuant to subsection (b)(2) once the assignment 

has been made; 

(D) in the case of the receipt of data under subsection (f), 

describes— 

(i) the nature of the tests performed with respect to 

the chemical substance; and 

(ii) any data that were received under subsection (f) 

or a rule or order under section 4; and 

(E) references the availability of the minimum information set, where applicable. 

(4) LIST OF NOTICES.—At the beginning of each month, the 

Administrator shall make available on a publicly accessible 

Internet site a list of each chemical substance for which a notice 

has been received under subsection (b), (c), or (d). 

(h) EXEMPTIONS.— 

(1) INTRINSICALLY SAFE SUBSTANCES.— 

(A) EXEMPTION.— 

(i) IN GENERAL.—If the Administrator determines 

that scientific consensus exists that the intrinsic properties of a new chemical substance are such that the 

chemical substance does not and would not pose any 

risk of injury to human health or the environment 

under any intended or reasonably anticipated levels of 

production, patterns of use, or exposures arising at any 

stage across the lifecycle of the chemical substance, the 

Administrator may, by order, exempt the chemical substance, or particular uses of such substances, from 1 or 

more of the requirements of this section. 

(ii) BASIS OF DETERMINATION.—A determination 

under clause (i)— 

(I) shall be based on consideration of the intrinsic properties of the chemical substance; and 

(II) shall not be based on findings or assumptions of low human or environmental exposure to 

such substances. 

(B) NOTICE OF DETERMINATION AND EXEMPTION.—Not 

later than 30 days after providing an exemption pursuant 

to subparagraph (A), the Administrator shall publish in the 

Federal Register a notice that— 

(i) subject to section 14, provides the specific identity 

of the chemical substance or category; 

(ii) if a particular use of the chemical substance is 

exempted under subparagraph (A), describes the particular use of the chemical substance that the Administrator has exempted; and 

(iii) explains and documents the basis for the determination and exemption of the Administrator. 

(C) RECONSIDERATION OF EXEMPTION.— 

(i) IN GENERAL.—The Administrator may reconsider 

and revoke or modify any exemption provided under 


tjames on DSK6SPTVN1PROD with 
65 

subparagraph (A) at any time if the Administrator determines that— 

(I) the conditions specified in subparagraph (A) 

are no longer met; or 

(II) such action is necessary to protect human 

health or the environment or is otherwise in the 

public interest. 

(ii) PUBLICATION.—In the event of a revocation or 

modification under clause (i), the Administrator shall 

publish a notice of the grounds for the revocation. 

(D) PRIOR REGULATORY EXEMPTIONS.— (i) REVIEW.— (I) IN GENERAL.—Not later than 180 days after 

the date of enactment of the Safe Chemicals Act of 

2011, the Administrator shall review exemptions 

that were granted pursuant to subsection (h)(4) of 

this section as in effect on the day before that date 

of enactment. 

(II) EFFECT OF EXEMPTION.—An exemption described in subclause (I) shall continue to be in effect until the date on which the Administrator determines, by order, that— 

(aa) the exemption is not appropriate under 

this section, at which time the exemption shall 

cease to be in effect; or 

(bb) the exemption is appropriate under this 

section, at which time the Administrator may 

issue an order to modify or continue in effect 

the exemption pursuant to subparagraph (A). 

(ii) POLYMERIC CHEMICAL SUBSTANCES.—Notwithstanding subparagraph (A) and any previously issued 

exemption applicable to polymeric chemical substances— 

(I) subsection (d) shall apply to new polymeric 

chemical substances eligible for the previously 

issued exemption— 

(aa) during the period prior to a determination by the Administrator pursuant to clause 

(i) applicable to such substances; and 

(bb) after a determination by the Administrator pursuant to clause (i)(II)(bb) that continuation of the prior exemption is appropriate 

for some or all such substances, for such substances to which the continuation applies; and 

(II) all of this section shall apply to new polymeric chemical substances eligible for the previously issued exemption after a determination by 

the Administrator pursuant to clause (i)(II)(aa) 

that continuation of the prior exemption is not appropriate for some or all such substances, for such 

substances to which the determination applies. 

(E) NO LIMITATION ON AUTHORITY.—Nothing in this 

paragraph limits or otherwise affects the authority of the 

Administrator under any other provision of this Act. 


tjames on DSK6SPTVN1PROD with 
66 

(2) TEST MARKETING PURPOSES.—Subject to paragraph (6), 

the Administrator may, upon application, exempt any person 

from any requirement of subsection (b), (c), or (f) to permit the 

person to manufacture or process a chemical substance for test 

marketing purposes— 

(A) upon a showing by the person, in a manner that the 

Administrator determines, that the manufacture, processing, distribution in commerce, use, and disposal of the 

chemical substance (including any combination of those activities) will not endanger human health or the environment; and 

(B) under such restrictions as the Administrator considers appropriate. 

(3) EQUIVALENT CHEMICAL SUBSTANCES.— 

(A) IN GENERAL.—The Administrator shall, upon application, fully or partially exempt any person from the requirement to submit any data under subsection (b) or (f) if, on 

receipt of an application, the Administrator determines 

that— 

(i) the chemical substance for which the application 

was submitted is equivalent to a chemical substance 

for which data has been submitted to the Administrator as required by this Act; and 

(ii) submission of data by the applicant on the chemical substance would be duplicative of data which has 

been submitted to the Administrator in accordance 

with this Act. 

(B) EFFECTIVE DATE.—No exemption under this paragraph may take effect before the beginning of the reimbursement period applicable to the data. 

(C) FAIR AND EQUITABLE REIMBURSEMENT.— 

(i) DEFINITION OF REIMBURSEMENT PERIOD.—In this 

subparagraph, the term ‘reimbursement period’, with 

respect to any previously submitted data for a chemical 

substance, means a period— 

(I) beginning on the date of the termination of 

the prohibition, imposed under this section, on the 

manufacture or processing of the chemical substance by the person who submitted the data to the 

Administrator; and 

(II) ending on the later of— 

(aa) the date that is 5 years after the date 

referred to in subclause (I); or 

(bb) the expiration of the period, which begins on the date referred to in subclause (I) 

and is equal to the period that the Administrator determines to be necessary to develop 

the data. 

(ii) REIMBURSEMENT.—Except as provided in clause 

(iii), if the Administrator exempts any person, under 

subparagraph (A), and the exemption is granted during the reimbursement period for that data, the Administrator shall order the person granted the exemption to 


tjames on DSK6SPTVN1PROD with 
67 

provide fair and equitable reimbursement (in an 

amount determined by 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 the person in complying with the requirement under this title to submit the data; and 

(II) to any other person who has been required 

under this subparagraph to contribute with respect 

to the costs, for a portion of the amount the person 

was required to contribute. 

(iii) EXCEPTION.—Clause (ii) shall not apply if the 

person exempted under that clause and the persons described in subclauses (I) and (II) of that clause agree 

on the amount and method of reimbursement. 

(iv) CONSIDERATIONS.—In promulgating rules for the 

determination of fair and equitable reimbursement to 

the persons described in subclauses (I) and (II) of 

clause (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— 

(I) the effect on the competitive position of the 

person required to provide reimbursement in relation to the persons to be reimbursed; and 

(II) the share of the market for the chemical substance of the person required to provide reimbursement to the share of the market of the persons to 

be reimbursed. 

(4) SMALL QUANTITIES SOLELY FOR EXPERIMENTATION, RE- SEARCH, AND ANALYSIS.— (A) IN GENERAL.—If the conditions described in subparagraph (B) are met, subsections (b), (c), and (f) shall not 

apply with respect to the manufacturing or processing of 

any chemical substance that 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— 

(i) scientific experimentation or analysis; or 

(ii) chemical research on, or analysis of the chemical 

substance or another chemical substance, including 

such research or analysis for the development of a 

product. 

(B) CONDITIONS.—All persons engaged in the experimentation, research, or analysis for a manufacturer or processor shall be notified (in such form and manner as the Administrator may prescribe) of any risk to human health 

that the manufacturer, processor, or the Administrator has 

reason to believe may be associated with that chemical substance. 

(5) TEMPORARY EXISTENCE.—Subject to paragraph (6), the 

Administrator may, upon application, exempt from subsections 

(b), (c), and (f) the manufacturing or processing of any chemical 

substance— 


tjames on DSK6SPTVN1PROD with 
68 

(A) that 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) PUBLICATION.— (A) IN GENERAL.—As soon as practicable after the date of 

receipt of an application under paragraph (2) or (5), the 

Administrator shall publish in the Federal Register notice 

of the receipt of the application. 

(B) REQUIREMENTS.—The Administrator shall— 

(i) give interested persons an opportunity to comment 

upon any application described in subparagraph (A); 

(ii) not later than 45 days after the date of receipt of 

an application, approve or deny the application; and 

(iii) publish in the Federal Register notice of the approval or denial of the application. 

(i) CERTIFICATION.—Each submission required under this section 

or under a rule or an order promulgated or issued by the Administrator under this section shall be accompanied by a certification 

signed by a responsible official of the manufacturer or processor 

that each statement contained in the submission— 

(1) is accurate and reliable; and 

(2) includes all material facts required by the applicable provision of this section or rule or order under this section. 

øSEC. 6. REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND 

MIXTURES. 

ø(a) SCOPE OF REGULATION.—If the Administrator finds that 

there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents, or will present an unreasonable risk of injury to health or 

the environment, the Administrator shall by rule apply one or more 

of the following requirements to such substance or mixture to the 

extent necessary to protect adequately against such risk using the 

least burdensome requirements: 

ø(1) A requirement (A) prohibiting the manufacturing, processing, or distribution in commerce of such substance or mixture, or (B) limiting the amount of such substance or mixture 

which may be manufactured, processed, or distributed in commerce. 

ø(2) A requirement— 

ø(A) prohibiting the manufacture, processing, or distribution in commerce of such substance or mixture for (i) 

a particular use or (ii) a particular use in a concentration 

in excess of a level specified by the Administrator in the 

rule imposing the requirement, or 

ø(B) limiting the amount of such substance or mixture 

which may be manufactured, processed, or distributed in 

commerce for (i) a particular use or (ii) a particular use in 

a concentration in excess of a level specified by the Administrator in the rule imposing the requirement. 

ø(3) A requirement that such substance or mixture or any 

article containing such substance or mixture be marked with 


tjames on DSK6SPTVN1PROD with 
69 

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. 

ø(4) A requirement that manufacturers and processors of 

such substance or mixture make and retain records of the processes used to manufacture or process such substance or mixture and monitor or conduct tests which are reasonable and 

necessary to assure compliance with the requirements of any 

rule applicable under this subsection. 

ø(5) A requirement prohibiting or otherwise regulating any 

manner or method of commercial use of such substance or mixture. 

ø(6)(A) A requirement prohibiting or otherwise regulating 

any manner or method of disposal of such substance or mixture, or of any article containing such substance or mixture, by 

its manufacturer or processor or by any other person who uses, 

or disposes of, it for commercial purposes. 

ø(B) A requirement under subparagraph (A) may not require 

any person to take any action which would be in violation of 

any law or requirement of, or in effect for, a State or political 

subdivision, and shall require each person subject to it to notify each State and political subdivision in which a required 

disposal may occur of such disposal. 

ø(7) A requirement directing manufacturers or processors of 

such substance or mixture (A) to give notice of such unreasonable risk of injury to distributors in commerce of such substance or mixture and, to the extent reasonably ascertainable, 

to other persons in possession of such substance or mixture or 

exposed to such substance or mixture, (B) to give public notice 

of such risk of injury, and (C) to replace or repurchase such 

substance or mixture as elected by the person to which the requirement is directed. 

Any requirement (or combination of requirements) imposed under 

this subsection may be limited in application to specified geographic areas. 

ø(b) QUALITY CONTROL.—If the Administrator has a reasonable 

basis to conclude that a particular manufacturer or processor is 

manufacturing or processing a chemical substance or mixture in a 

manner which unintentionally causes the chemical substance or 

mixture to present or which will cause it to present an unreasonable risk of injury to health or the environment— 

ø(1) the Administrator may by order require such manufacturer or processor to submit a description of the relevant quality control procedures followed in the manufacturing or processing of such chemical substance or mixture; and 

ø(2) if the Administrator determines— 

ø(A) that such quality control procedures are inadequate 

to prevent the chemical substance or mixture from presenting such risk of injury, the Administrator may order 

the manufacturer or processor to revise such quality control procedures to the extent necessary to remedy such inadequacy; or 


tjames on DSK6SPTVN1PROD with 
70 

ø(B) that the use of such quality control procedures has 

resulted in the distribution in commerce of chemical substances or mixtures which present an unreasonable risk of 

injury to health or the environment, the Administrator 

may order the manufacturer or processor to (i) give notice 

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. 

øA determination under subparagraph (A) or (B) of paragraph (2) 

shall be made on the record after opportunity for hearing in accordance with section 554 of title 5, United States Code. Any manufacturer or processor subject to a requirement to replace or repurchase 

a chemical substance or mixture may elect either to replace or repurchase the substance or mixture and shall take either such action in the manner prescribed by the Administrator. 

ø(c) PROMULGATION OF SUBSECTION (a) RULES.—(1) In promulgating any rule under subsection (a) with respect to a chemical 

substance or mixture, the Administrator shall consider and publish 

a statement with respect to— 

ø(A) the effects of such substance or mixture on health and 

the magnitude of the exposure of human beings to such substance or mixture, 

ø(B) the effects of such substance or mixture on the environment and the magnitude of the exposure of the environment to 

such substance or mixture, 

ø(C) the benefits of such substance or mixture for various 

uses and the availability of substitutes for such uses, and 

ø(D) the reasonably ascertainable economic consequences of 

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

øIf the Administrator determines that a risk of injury to health or 

the environment could be eliminated or reduced to a sufficient extent by actions taken under another Federal law (or laws) administered in whole or in part by the Administrator, the Administrator 

may not promulgate a rule under subsection (a) to protect against 

such risk of injury unless the Administrator finds, in the Administrator’s discretion, that it is in the public interest to protect against 

such risk under this Act. In making such a finding the Administrator shall consider (i) all relevant aspects of the risk, as determined by the Administrator in the Administrator’s discretion, (ii) 

a comparison of the estimated costs of complying with actions 

taken under this Act and under such law (or laws), and (iii) the relative efficiency of actions under this Act and under such law (or 

laws) to protect against such risk of injury. 

ø(2) When prescribing a rule under subsection (a) the Administrator shall proceed in accordance with section 553 of title 5, 

United States Code (without regard to any reference in such section to sections 556 and 557 of such title), and shall also (A) pubVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00070 Fmt 6602 Sfmt 6602 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
71 

lish 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). 

ø(3) Informal hearings required by paragraph (2)(C) shall be conducted by the Administrator in accordance with the following requirements: 

ø(A) Subject to subparagraph (B), an interested person is entitled— 

ø(i) to present such person’s position orally or by documentary submissions (or both), and 

ø(ii) if the Administrator determines that there are disputed issues of material fact it is necessary to resolve, to 

present such rebuttal submissions and to conduct (or have 

conducted under subparagraph (B)(ii)) such cross-examination of persons as the Administrator determines (I) to be 

appropriate, and (II) to be required for a full and true disclosure with respect to such issues. 

ø(B) The Administrator may prescribe such rules and make 

such rulings concerning procedures in such hearings to avoid 

unnecessary costs or delay. Such rules or rulings may include 

(i) the imposition of reasonable time limits on each interested 

person’s oral presentations, and (ii) requirements that any 

cross-examination to which a person may be entitled under 

subparagraph (A) be conducted by the Administrator on behalf 

of that person in such manner as the Administrator determines (I) to be appropriate, and (II) to be required for a full 

and true disclosure with respect to disputed issues of material 

fact. 

ø(C)(i) Except as provided in clause (ii), if a group of persons 

each of whom under subparagraphs (A) and (B) would be entitled to conduct (or have conducted) cross-examination and who 

are determined by the Administrator to have the same or similar interests in the proceeding cannot agree upon a single representative of such interests for purposes of cross-examination, 

the Administrator may make rules and rulings (I) limiting the 

representation of such interest for such purposes, and (II) governing the manner in which such cross-examination shall be 

limited. 

ø(ii) When any person who is a member of a group with respect to which the Administrator has made a determination 

under clause (i) is unable to agree upon group representation 

with the other members of the group, then such person shall 

not be denied under the authority of clause (i) the opportunity 

to conduct (or have conducted) cross-examination as to issues 

affecting the person’s particular interests if (I) the person satisfies the Administrator that the person has made a reasonable 

and good faith effort to reach agreement upon group representation with the other members of the group and (II) the Administrator determines that there are substantial and relevant 


tjames on DSK6SPTVN1PROD with 
72 

issues which are not adequately presented by the group representative. 

ø(D) A verbatim transcript shall be taken of any oral presentation made, and cross-examination conducted in any informal 

hearing under this subsection. Such transcript shall be available to the public. 

ø(4)(A) The Administrator may, pursuant to rules prescribed by 

the Administrator, provide compensation for reasonable attorneys’ 

fees, expert witness fees, and other costs of participating in a rulemaking proceeding for the promulgation of a rule under subsection 

(a) to any person— 

ø(i) who represents an interest which would substantially 

contribute to a fair determination of the issues to be resolved 

in the proceeding, and 

ø(ii) if— 

ø(I) the economic interest of such person is small in comparison to the costs of effective participation in the proceeding by such person, or 

ø(II) such person demonstrates to the satisfaction of the 

Administrator that such person does not have sufficient resources adequately to participate in the proceeding without 

compensation under this subparagraph. 

øIn determining for purposes of clause (i) if an interest will substantially contribute to a fair determination of the issues to be resolved in a proceeding, the Administrator shall take into account 

the number and complexity of such issues and the extent to which 

representation of such interest will contribute to widespread public 

participation in the proceeding and representation of a fair balance 

of interests for the resolution of such issues. 

ø(B) In determining whether compensation should be provided to 

a person under subparagraph (A) and the amount of such compensation, the Administrator shall take into account the financial 

burden which will be incurred by such person in participating in 

the rulemaking proceeding. The Administrator shall take such action as may be necessary to ensure that the aggregate amount of 

compensation paid under this paragraph in any fiscal year to all 

persons who, in rulemaking proceedings in which they receive compensation, are persons who either— 

ø(i) would be regulated by the proposed rule, or 

ø(ii) represent persons who would be so regulated, 

may not exceed 25 per centum of the aggregate amount paid as 

compensation under this paragraph to all persons in such fiscal 

year. 

ø(5) Paragraphs (1), (2), (3), and (4) of this subsection apply to 

the promulgation of a rule repealing, or making a substantive 

amendment to, a rule promulgated under subsection (a). 

ø(d) EFFECTIVE DATE.—(1) The Administrator shall specify in 

any rule under subsection (a) the date on which it shall take effect, 

which date shall be as soon as feasible. 

ø(2)(A) The Administrator may declare a proposed rule under 

subsection (a) to be effective upon its publication in the Federal 

Register and until the effective date of final action taken, in accordance with subparagraph (B), respecting such rule if— 

ø(i) the Administrator determines that— 


tjames on DSK6SPTVN1PROD with 
73 

ø(I) the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance or mixture subject to such proposed rule or any combination of 

such activities is likely to result in an unreasonable risk 

of serious or widespread injury to health or the environment before such effective date; and 

ø(II) making such proposed rule so effective is necessary 

to protect the public interest; and 

ø(ii) in the case of a proposed rule to prohibit the manufacture, processing, or distribution of a chemical substance or 

mixture because of the risk determined under clause (i)(I), a 

court has in an action under section 7 granted relief with respect to such risk associated with such substance or mixture. 

øSuch a proposed rule which is made so effective shall not, for purposes of judicial review, be considered final agency action. 

ø(B) If the Administrator makes a proposed rule effective upon 

its publication in the Federal Register, the Administrator shall, as 

expeditiously as possible, give interested persons prompt notice of 

such action, provide reasonable opportunity, in accordance with 

paragraphs (2) and (3) of subsection (c), for a hearing on such rule, 

and either promulgate such rule (as proposed or with modifications) or revoke it; and if such a hearing is requested, the Administrator shall commence the hearing within five days from the date 

such request is made unless the Administrator and the person 

making the request agree upon a later date for the hearing to 

begin, and after the hearing is concluded the Administrator shall, 

within ten days of the conclusion of the hearing, either promulgate 

such rule (as proposed or with modifications) or revoke it.¿ 

SEC. 6. BATCHING, CATEGORIZATION, PRIORITIZATION, SAFETY 

STANDARD DETERMINATION, AND RISK MANAGEMENT. 

(a) BATCHING.— (1) IN GENERAL.—To ensure that an efficient and orderly 

process and pace is established for the determination of safety 

of chemical substances in commerce and the application of risk 

management measures as needed, the Administrator shall establish a system for assigning chemical substances into batches 

in accordance with this subsection. 

(2) REQUIREMENTS.— 

(A) TIMING.—Not later than 270 days after the date of 

enactment of the Safe Chemicals Act of 2011, and not less 

frequently than once every 5 years thereafter until all chemical substances listed on the active portion of the inventory 

established under section 8(h)(1) have been assigned to a 

batch, the Administrator shall assign chemical substances 

on the active portion of the inventory to batches of chemical 

substances under this subsection. 

(B) NUMBER.—Each batch established under this subsection shall include a number of chemical substances approximately equal to the number of chemical substances for 

which reports are submitted to the Administrator under the 

chemical data reporting rule as of the date of enactment of 

the Safe Chemicals Act of 2011. 

(C) PUBLICATION.—The Administrator shall publish, subject to section 14, the list of chemical substances assigned 


tjames on DSK6SPTVN1PROD with 
74 

to each batch promptly on designation of the chemical substances to the batch. 

(3) INITIAL BATCH.— (A) IN GENERAL.—Subject to subparagraph (B), the initial batch of chemical substances designated under paragraph (2)(A) shall include the chemical substances for 

which reports are submitted to the Administrator under the 

chemical data reporting rule as of the date of enactment of 

the Safe Chemicals Act of 2011. 

(B) INCLUSIONS AND EXCLUSIONS.—Notwithstanding subparagraph (A), the Administrator may— 

(i) include in the initial batch chemical substances 

that— 

(I) are manufactured at volumes below the 

threshold used under the chemical data reporting 

rule to designate chemical substances subject to 

basic reporting under that rule; but 

(II) are used or released into the environment in 

a manner that the Administrator determines warrants early evaluation; and 

(ii) exclude from the initial batch chemical substances that— 

(I) are reported to the Administrator under the 

chemical data reporting rule; but 

(II) are used or released into the environment in 

a manner that the Administrator determines does 

not warrant early evaluation. 

(4) SUBSEQUENT BATCHES.—The Administrator shall assign 

chemical substances to subsequent batches in a manner that the 

Administrator determines reflects the extent to which the chemical substances warrant earlier or later evaluation. 

(b) CATEGORIZATION AND PRIORITIZATION.— 

(1) REGULATIONS.—Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator 

shall promulgate regulations that— 

(A) establish the categories and specify the process and 

criteria the Administrator will use to categorize chemical 

substances, which shall be consistent with paragraph 

(3)(B), beginning with those chemical substances assigned 

to the initial batch described in subsection (a)(3); 

(B) designate the process and criteria the Administrator 

will use to prioritize chemical substances that are placed in 

the category of chemical substances to undergo safety 

standard determinations, which shall be consistent with 

the priorities described in paragraph (4); 

(C) describe how the categorization and prioritization 

process and criteria relate to, and take into account, the 

categorization and prioritization decisions made in other 

jurisdictions, including States and foreign governments; 

and 

(D) describe criteria and factors the Administrator will 

use to weigh evidence and assess the quality and reliability 

of information used to inform categorization and 

prioritization decisions. 


tjames on DSK6SPTVN1PROD with 
75 

(2) INFORMATION SOURCES.— (A) IN GENERAL.—In making categorization and 

prioritization decisions, the Administrator shall take into 

consideration information regarding chemical substances 

that is available to the Administrator at the time the decisions are made, including information that is— 

(i) received by the Administrator from manufacturers 

or processors pursuant to requirements under section 

8(b) and (c); 

(ii) included in any minimum information set required under section 4; 

(iii) submitted to the Administrator that is relevant 

to the categorization or prioritization of the chemical 

substance; and 

(iv) identified through an active search by the Administrator of information sources that are publicly 

available or otherwise accessible to the Administrator. 

(B) INFORMATION FROM MANUFACTURERS AND PROC- ESSORS.— 

(i) IN GENERAL.—Subject to clause (ii), on designation by the Administrator under paragraph (3)(B)(iii) 

of a chemical substance safety standard determination, 

any manufacturer or processor of a designated chemical substance and any trade association or voluntary 

consortium that represents a manufacturer or processor 

of a designated chemical substance may provide to the 

Administrator information that— 

(I) relates to the chemical substances manufactured or processed by the applicable manufacturer 

or processor; 

(II) is in the possession of, or known to, the manufacturer, processor, trade association, or consortium; and 

(III) is not already available to the Administrator. 

(ii) REQUIREMENT.—If a manufacturer, processor, 

trade association, or consortium elects to provide information to the Administrator under clause (i), the manufacturer, processor, trade association, or consortium 

shall provide all relevant information in the possession 

of, or known to, the manufacturer, processor, trade association, or consortium for each chemical substance 

designated by the Administrator that is manufactured 

or processed by the applicable manufacturer or processor. 

(iii) METHOD OF SUBMISSION.—Information described 

in this subparagraph may be submitted to the Administrator by— 

(I) a manufacturer or processor— 

(aa) on an individual basis; or 

(bb) through a trade association or voluntary consortium; and 

(II) a trade association or voluntary consortium 

that has developed relevant information on behalf 


tjames on DSK6SPTVN1PROD with 
76 

of the manufacturers or processors of designated 

chemical substances represented by the trade association or voluntary consortium. 

(3) CATEGORIZATION OF CHEMICAL SUBSTANCES.— (A) TIMING.— (i) INITIAL BATCH.—Not later than 180 days after the 

date of promulgation of regulations pursuant to paragraph (1), the Administrator shall publish, subject to 

section 14, the category assignments for the initial 

batch of chemical substances identified under subsection (a)(3), using the categories described in subparagraph (B). 

(ii) SUBSEQUENT BATCHES.—Not later than 180 days 

after the date on which the Administrator designates 

each subsequent batch of chemical substances under 

subsection (a)(2)(A), the Administrator shall publish 

the category assignments for the chemical substances 

in the batch. 

(B) CATEGORIES.—The regulation promulgated pursuant 

to paragraph (1) shall incorporate, establish criteria for, 

and further specify as needed, the following categories into 

which chemical substances in each batch shall be placed: 

(i) SUBSTANCES OF VERY HIGH CONCERN.— (I) IN GENERAL.—The Administrator shall designate as substances of very high concern those 

chemical substances— 

(aa) for which there is evidence of widespread exposure and that— 

(AA) are toxic, persist in the environment, and are bioaccumulative; or 

(BB) are highly hazardous; 

(bb) that are subject to regulation under section 6 or 7 of this Act (as in effect on the day 

before the date of enactment of the Safe 

Chemicals Act of 2011); or 

(cc) that are subject to a voluntary phaseout, administered by the Administrator, that 

has been completed or is underway at the time 

the category designation is made. 

(II) INFORMATION SET.—A minimum information 

set, as specified under section 4, need not be submitted or otherwise available for a chemical substance to be designated a substance of very high 

concern under this clause. 

(ii) SUBSTANCES OF VERY LOW CONCERN.— 

(I) IN GENERAL.—The Administrator shall designate as substances of very low concern those 

chemical substances that, based on robust information, the Administrator determines possess intrinsic low-hazard properties such that no further 

action by the Administrator is warranted, unless 

the Administrator receives new information that 

warrants a different categorization of the chemical 

substance. 


tjames on DSK6SPTVN1PROD with 
77 

(II) FACTORS FOR CONSIDERATION.—In designating chemical substances to be placed in the very 

low concern category under this clause, the Administrator shall— 

(aa) take into consideration whether chemical substances in commerce have received, as 

of the date of enactment of the Safe Chemicals 

Act of 2011, exemptions under section 5 of this 

Act (as in effect on the day before the date of 

enactment of the Safe Chemicals Act of 2011) 

based on anticipated low intrinsic hazard; and 

(bb) in general, base the designation on a 

minimum information set as required under 

section 4, unless the Administrator determines 

that such designation of a particular chemical 

substance— 

(AA) can be made to a high degree of 

confidence based on less information; or 

(BB) requires information in addition to 

the full minimum information set to address conflicting or ambiguous findings, 

in which case the Administrator may require the development and submission of 

the additional information. 

(iii) SUBSTANCES TO UNDERGO SAFETY STANDARD DETERMINATIONS.—The Administrator shall designate as 

substances to undergo safety standard determinations 

those chemical substances that the Administrator determines— 

(I) based on a screening of available use, hazard, 

and exposure information, do not meet the criteria 

for the categories described in clauses (i) and (ii); 

and 

(II) are the subject of available information that 

is sufficiently robust to inform prioritization decisions to be made for the chemical substances under 

paragraph (4). 

(iv) SUBSTANCES WITH INSUFFICIENT INFORMATION.— 

(I) IN GENERAL.—The Administrator shall designate as substances with insufficient information 

those chemical substances for which the Administrator determines, after gathering and screening 

available use, hazard, and exposure information, 

that information is not available, is insufficient, or 

is not of sufficient quality and reliability to allow 

for an informed categorization decision. 

(II) MINIMUM INFORMATION SET.— 

(aa) IN GENERAL.—For chemical substances 

designated under this clause, the Administrator shall require submission of the applicable minimum information set specified under 

section 4 as needed to inform categorization 

decisionmaking. 


tjames on DSK6SPTVN1PROD with 
78 

(bb) TIMING.—The minimum information set 

shall be submitted to the Administrator— 

(AA) not later than 5 years after the 

date of enactment of the Safe Chemicals 

Act of 2011 for the initial batch of chemical substances identified under subsection 

(a)(3); and 

(BB) not later than 5 years after the assignment of a chemical substance to the 

category under this clause for subsequent 

batches. 

(III) RECATEGORIZATION.— (aa) IN GENERAL.—After submission of the 

minimum information set for a chemical substance pursuant to subclause (I), the Administrator shall recategorize the chemical substance using the categories and process described in this paragraph. 

(bb) DISCRETION OF ADMINISTRATOR.—The 

Administrator, taking into account the timing 

of the submission and workload considerations, may— 

(AA) add a chemical substance to a current batch; or 

(BB) hold the chemical substance until 

the next batch of chemical substances for 

recategorization. 

(4) PRIORITIZATION OF CHEMICAL SUBSTANCES.— (A) TIMING.— (i) INITIAL BATCH.—Not later than 270 days after the 

date of promulgation of regulations pursuant to paragraph (1), the Administrator shall publish, subject to 

section 14, the priority class assignments, using the 

priority classes described in subparagraph (B), for the 

chemical substances in the initial batch of chemical 

substances identified under subsection (a)(3) that the 

Administrator has assigned to the category of chemical 

substances to undergo safety standard determinations. 

(ii) SUBSEQUENT BATCHES.—Not later than 270 days 

after the date on which the Administrator designates 

each subsequent batch of chemical substances under 

subsection (a)(2)(A), the Administrator shall publish 

the priority class assignments for the chemical substances in the batch that the Administrator has assigned to the category of chemical substances to undergo safety standard determinations. 

(B) CRITERIA.—The criteria used by the Administrator to 

assign chemical substances to priority classes shall take 

into account— 

(i) potential impacts of the chemical substance on 

human health and the environment; 

(ii) the hazard potential of the chemical substance, 

including classifications and designations of hazard 

characteristics by other authoritative entities; 


tjames on DSK6SPTVN1PROD with 
79 

(iii) the potential for exposure to the chemical substance; and 

(iv) measurements of exposure for a given pathway of 

exposure, if available and reliable, in preference to less 

direct indicators of, or surrogates for, exposure potential for the same pathway. 

(C) PRIORITY CLASSES.—The regulations promulgated 

pursuant to paragraph (1) shall establish the following priority classes and criteria, and further specify the process 

the Administrator will use to assign to the priority classes 

the chemical substances in each batch that the Administrator has assigned to the category of chemical substances 

to undergo safety standard determinations: 

(i) PRIORITY CLASS 1.— (I) IN GENERAL.—In each batch, the Administrator shall designate as Priority Class 1 those 

chemical substances that the Administrator determines warrant safety standard determinations in 

the near term. 

(II) INITIAL ASSIGNMENT.—The Administrator 

shall in each batch initially designate as Priority 

Class 1 chemical substances that possess relatively 

greater hazard potential and for which there is evidence of more significant or widespread exposure. 

(III) REASSIGNMENT.—As safety standard determinations for the chemical substance are completed, the Administrator may designate as Priority Class 1 any chemical substance initially assigned to a lower priority class, including chemical 

substances— 

(aa) posing significant hazard concerns but 

of less or unknown exposure concern; 

(bb) posing significant exposure concern but 

of less or unknown hazard concern; or 

(cc) posing less hazard and exposure concerns. 

(IV) FACTORS FOR CONSIDERATION.—In determining the number of chemical substances to be 

placed in Priority Class 1, the Administrator shall 

seek to balance considerations relating to— 

(aa) the number of chemical substances for 

which safety standard determinations need to 

be conducted; 

(bb) the resources available to the Administrator for conducting safety standard determinations; and 

(cc) the deadlines for completion of safety 

standard determinations specified in subsection (d)(4). 

(ii) PRIORITY CLASS 2.— (I) IN GENERAL.—The Administrator shall designate as Priority Class 2 those chemical substances that the Administrator determines are of 

lower priority than Priority Class 1 substances 


tjames on DSK6SPTVN1PROD with 
80 

with respect to the timing for conducting safety 

standard determinations. 

(II) MINIMUM INFORMATION SET.— (aa) IN GENERAL.—For chemical substances 

designated under this clause, the Administrator shall require submission of the applicable minimum information set specified under 

section 4 as needed to inform prioritization decisionmaking. 

(bb) TIMING.—The minimum information set 

shall be submitted to the Administrator— 

(AA) not later than 5 years after the 

date of enactment of the Safe Chemicals 

Act of 2011 for chemical substances in the 

initial batch identified under subsection 

(a)(3) that are assigned to Priority Class 

2; and 

(BB) not later than 5 years after the assignment of a chemical substance to Priority Class 2 under this clause for subsequent batches. 

(III) REPRIORITIZATION.—After submission of the 

minimum information set for a chemical substance 

under subclause (II), the Administrator shall, if 

warranted, recategorize or otherwise reprioritize 

the chemical substance using the priority classes 

and process described in this paragraph, together 

with other chemical substances in the batch undergoing prioritization at the time of the submission. 

(IV) REPRIORITIZATION TO PRIORITY CLASS 1.—As 

safety standard determinations are completed on 

Priority Class 1 chemical substances pursuant to 

subsection (d), the Administrator shall reprioritize 

Priority Class 2 substances as Priority Class 1 at 

a pace consistent with— 

(aa) the resources available to the Administrator for conducting safety standard determinations; and 

(bb) the deadlines for completion of safety 

standard determinations specified in subsection (d)(4). 

(iii) PRIORITY CLASS 3.— 

(I) IN GENERAL.—The Administrator shall designate as Priority Class 3 those chemical substances that the Administrator determines may be 

set aside for further assessment until such time 

as— 

(aa) safety standard determinations are 

completed on all Priority Class 1 and 2 substances; or 

(bb) new information arises that warrants 

reprioritization of such a substance to a higher 

priority class. 

(II) MINIMUM INFORMATION SET.— 


tjames on DSK6SPTVN1PROD with 
81 

(aa) IN GENERAL.—For a chemical substance 

designated under this clause, the Administrator shall not require submission of the applicable minimum information set specified 

under section 4 until such time as the chemical substance is reassigned to Priority Class 1 

or 2. 

(bb) SUBMISSION.—On reassignment of a 

chemical substance to Priority Class 1 or 2 

under item (aa), the minimum information set 

shall be submitted to the Administrator not 

later than 5 years after the date of the reassignment. 

(III) REPRIORITIZATION.—After submission of the 

minimum information set for a chemical substance 

pursuant to subclause (II), the Administrator shall 

reprioritize the chemical substance using the priority classes and process described in this paragraph, together with chemical substances in the 

batch undergoing prioritization at the time of the 

submission. 

(IV) REPRIORITIZATION TO PRIORITY CLASSES 1

AND 2.—In conjunction with the reprioritization by 

the Administrator of Priority Class 2 substances as 

Priority Class 1, the Administrator shall 

reprioritize Priority Class 3 substances as Priority 

Class 1 or 2, at a pace consistent with— 

(aa) the resources available to the Administrator for conducting safety standard determinations; and 

(bb) the deadlines for completion of safety 

standard determinations specified in subsection (d)(4). 

(c) TREATMENT AS FINAL AGENCY ACTION; NO JUDICIAL REVIEW; 

NONDISCRETIONARY DUTY.— 

(1) IN GENERAL.—The designation by the Administrator of 

batches of chemical substances pursuant to subsection (a), the 

assignment of chemical substances to categories pursuant to 

subsection (b)(3), and the assignment of chemical substances to 

priority classes pursuant to subsection (b)(4), including any determination of the Administrator to include a specific chemical 

substance in, or exclude a specific chemical substance from, a 

designated batch, category, or priority class under this section, 

shall not be— 

(A) considered to be a final agency action for the purpose 

of subchapter II of chapter 5, and chapter 7, of title 5, 

United States Code (commonly known as ‘the Administrative Procedure Act’); or 

(B) subject to judicial review. 

(2) FAILURE TO ACT.—A failure by the Administrator to designate or publish a list of chemical substances assigned to a 

batch, category, or priority class in accordance with this subsection shall be— 


tjames on DSK6SPTVN1PROD with 
82 

(A) considered to be a failure to perform a nondiscretionary duty; and 

(B) subject to judicial review. 

(d) SAFETY STANDARD DETERMINATIONS FOR CHEMICAL SUB- STANCES.— 

(1) IN GENERAL.— (A) APPLICATION.—This paragraph applies to any determination or redetermination regarding whether a chemical 

substance meets the safety standards of this Act. 

(B) RESPONSIBILITIES.— (i) IN GENERAL.—For purposes of this Act, each manufacturer and processor of a chemical substance shall 

at all times bear the burden of proof in any legal proceeding relating to a decision of the Administrator regarding whether the chemical substance meets the safety standard. 

(ii) DUTIES.—For purposes of this Act— 

(I) it shall be the duty of the manufacturer or 

processor of a chemical substance to provide sufficient information for the Administrator to determine whether the chemical substance meets the 

safety standard; and 

(II) it shall be the duty of the Administrator to 

determine whether a chemical substance meets the 

safety standard. 

(2) ASSESSMENT OF RISK.— (A) ASSESSMENT.— (i) IN GENERAL.—A chemical substance that undergoes a safety standard determination under this section 

may be manufactured, processed, or distributed in 

commerce only if the Administrator determines that the 

chemical substance— 

(I) meets the safety standard, taking into account 

any existing conditions or controls already in effect; or 

(II) can meet the safety standard for all or some 

uses through the imposition of additional conditions. 

(ii) REQUIREMENT.—Any assessment of risk used to 

support a determination that a chemical substance 

meets the safety standard under clause (i) shall be conducted by employees of the Environmental Protection 

Agency who are competent to conduct such assessments. 

(B) SAFETY STANDARD.— 

(i) IN GENERAL.—The Administrator shall base a determination of whether a safety standard for a chemical substance has been met under subparagraph (A) 

solely on considerations of human health and the environment, including the health of vulnerable populations. 

(ii) CONSIDERATIONS.—In making a safety standard 

determination under this subsection, for each chemical 

substance, the Administrator shall— 


tjames on DSK6SPTVN1PROD with 
83 

(I) to the extent practicable, review and incorporate any available scientific information relating 

to the effect of cumulative exposure relevant to that 

chemical substance on human health and the environment; and 

(II) find that a chemical substance meets the 

safety standard only if the Administrator finds 

that there is a reasonable certainty that no harm 

will result to human health or the environment 

from aggregate exposure to the chemical substance. 

(C) FINANCIAL INTERESTS.—No person conducting an assessment described in subparagraph (A), or a peer review 

of such an assessment, may have a direct or indirect financial interest in the outcome of the assessment. 

(D) METHODOLOGY.— 

(i) IN GENERAL.—Subject to clause (ii), the Administrator shall use the best available science when conducting an assessment described in subparagraph (A). 

(ii) CONSIDERATIONS.—For the purpose of determining the current best available science the Administrator shall base the determination on the recommendations of the National Academy of Sciences in 

the report entitled ‘Science and Decisions’. 

(iii) REVIEW.—Not later than 5 years after the date 

of enactment of the Safe Chemicals Act of 2011, and 

not less frequently than once every 5 years thereafter, 

the Administrator shall review the methodology under 

this paragraph and may revise the methodology to reflect new scientific developments or understandings. 

(E) SCOPE.—An assessment described in subparagraph 

(A) shall address health or environmental impacts including potential or demonstrated cancer and noncancer 

endpoints. 

(F) TRANSPARENCY.—In carrying out this subsection, the 

Administrator shall ensure that the approaches and resulting assessments are communicated in a manner that is 

transparent and understandable to— 

(i) the public; and 

(ii) risk managers. 

(G) MANUFACTURE OR PROCESSING FOR EXPORT.—In the 

case of a chemical substance that is manufactured or processed in whole or in part for export, in determining whether 

the chemical substance meets the safety standard under 

subparagraph (A)(i), the Administrator shall take into account any risk— 

(i) that the chemical substance may pose in the 

United States, including risks involving long-range 

transport of the chemical substance in the environment; 

or 

(ii) involving the import of articles and mixtures containing the chemical substance. 

(H) RISK ASSESSMENT NOT REQUIRED.—The Administrator shall not be required to conduct a risk assessment to 


tjames on DSK6SPTVN1PROD with 
84 

determine that a manufacturer or processor has not met the 

burden of proof under paragraph (1)(B). 

(I) NO JUDICIAL REVIEW.—A determination by the Administrator that a manufacturer or processor has not established that the chemical substance meets the applicable 

safety standard under this subsection shall not be subject 

to judicial review. 

(3) INFORMATION FOR SAFETY STANDARD DETERMINATIONS.— 

(A) IN GENERAL.—In making a safety standard determination with respect to a chemical substance, the Administrator— 

(i) shall take into consideration information regarding the chemical substance that is already available to 

the Administrator at the time the determination is to 

be made, including information— 

(I) received by the Administrator from manufacturers or processors under this section or section 8; 

(II) contained in any minimum information sets 

previously required under section 4; 

(III) voluntarily submitted by manufacturers 

and processors in accordance with subsection 

(b)(2)(B); 

(IV) submitted by any other party to the Administrator that is relevant to the conduct of a safety 

standard determination of the chemical substance; 

or 

(V) identified through an active search by the 

Administrator of information sources that are publicly available or otherwise accessible to the Administrator; 

(ii) shall require information needed to complete the 

applicable minimum information set for the chemical 

substance required under section 4(a); 

(iii) may require, by regulation or order pursuant to 

section 4(b) or 8(e), manufacturers or processors of the 

chemical substance to develop and submit any additional information the Administrator determines is 

needed to conduct the safety standard determination of 

the chemical substance; and 

(iv) shall take into consideration, but not rely on, assessments of safety or analyses of the effectiveness of existing control measures— 

(I) submitted to the Administrator by any party; 

or 

(II) conducted by a governmental entity in another jurisdiction. 

(4) TIMING OF SAFETY STANDARD DETERMINATIONS.— 

(A) PRIORITY CLASS 1.— 

(i) IN GENERAL.—Beginning with chemical substances initially designated as Priority Class 1 under 

subsection (b)(4)(C)(i), the Administrator shall conduct 

safety standard determinations of all chemical substances assigned to the category of substances to underVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00084 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
85 

go safety standard determinations pursuant to subsection (b)(3)(B)(iii). 

(ii) INITIAL BATCH.—Not later than 5 years after the 

date of enactment of the Safe Chemicals Act of 2011, 

the Administrator shall complete and publish safety 

standard determinations for all chemical substances 

designated as Priority Class 1 substances in the initial 

batch of chemical substances identified under subsection (a)(3). 

(iii) SUBSEQUENT BATCHES.—Not later than 5 years 

after the date on which the Administrator designates 

chemical substances as Priority Class 1 in each subsequent batch of chemical substances under subsection 

(a)(2)(A), the Administrator shall complete and publish 

safety standard determinations for those Priority Class 

1 substances in the batch. 

(B) PRIORITY CLASSES 2 AND 3.— (i) IN GENERAL.—Each chemical substance initially 

designated as Priority Class 2 or 3 shall become subject to reprioritization and safety standard determinations in accordance with subsection (b)(4). 

(ii) REPRIORITIZATION.—Not later than 5 years after 

the date on which the Administrator designates a Priority Class 2 or 3 substance to be Priority Class 1, the 

Administrator shall complete and publish the safety 

standard determination on the chemical substance. 

(C) NOTICE OF OVERDUE DETERMINATION.—If the Administrator fails to act by an applicable deadline under subparagraph (A) or (B), each manufacturer and processor of 

a chemical substance for which the Administrator has 

failed to act shall provide to the Administrator, the public, 

employees and recognized bargaining agents of any employees who are represented by bargaining agents of the manufacturer or processor, and each known customer who has 

purchased the chemical substance within a reasonable 

timeframe, as determined by the Administrator by regulation or order, a written notice that a determination by the 

Administrator of the safety of the chemical substance is 

pending. 

(D) FAILURE OF MANUFACTURER OR PROCESSOR TO MEET

DUTIES.—If a manufacturer or processor fails to meet any 

duty under this paragraph for a chemical substance, the 

Administrator, by order, may take any action authorized 

under subsection (f). 

(5) OUTCOME OF SAFETY STANDARD DETERMINATIONS.— 

(A) DETERMINATION.— 

(i) IN GENERAL.—In making a safety standard determination for a chemical substance, the Administrator, 

by order, shall determine or redetermine, as appropriate, whether the manufacturers and processors of 

the chemical substance have established that the chemical substance meets the safety standard. 

(ii) CONCURRENT PUBLICATION.—The Administrator— 


tjames on DSK6SPTVN1PROD with 
86 

(I) shall seek to publish safety standard determination and risk management decisions concurrently, to the maximum extent practicable; but 

(II) shall not unduly delay the issuance of any 

safety standard determination if more information 

or analysis is required to make a determination regarding risk management. 

(iii) OTHER REQUIREMENTS.—The Administrator— 

(I) may publish safety standard determinations 

for chemical substances individually or in groups; 

but 

(II) shall publish completed determinations— 

(aa) not less frequently than annually; and 

(bb) at a pace sufficient to demonstrate 

steady progress toward completing all such 

safety standard determinations within the required timeframe. 

(iv) PUBLIC NOTICE AND COMMENT.—The Administrator shall provide reasonable public notice and opportunity for comment on all published safety standard 

determinations through any reasonable means of publication and solicitation of comments, including electronic means. 

(B) POSITIVE SAFETY STANDARD DETERMINATION WITHOUT

NEW CONDITIONS.—If the Administrator determines that a 

chemical substance meets the safety standard for all current uses and under conditions currently used, the Administrator shall specify in the order— 

(i) the allowed uses of the chemical substance, which 

shall be limited to the uses evaluated in the determination; and 

(ii) conditions on the specified uses that are currently 

used and are to be followed to ensure the safety standard is met, including conditions relating to the manufacture, processing, use, distribution in commerce, or 

disposal of a chemical substance or mixture or article 

containing the chemical substance. 

(C) POSITIVE SAFETY STANDARD DETERMINATION WITH

NEW CONDITIONS.—If the Administrator determines that a 

chemical substance can only meet the safety standard for a 

subset of all current uses or only under conditions beyond 

those currently used, the Administrator shall specify in the 

order— 

(i) the allowed uses of the chemical substance, which 

shall be limited to the uses evaluated in the determination that the Administrator determines meet the safety 

standard; and 

(ii) all current and all newly required conditions on 

the specified uses needed to ensure the safety standard 

is met, including conditions relating to the manufacture, processing, use, distribution in commerce, or disposal of a chemical substance or mixture or article containing the chemical substance, and any conditions described in subsection (f). 


tjames on DSK6SPTVN1PROD with 
87 

(D) EFFECTIVE DATE FOR POSITIVE SAFETY STANDARD DE- TERMINATION.— (i) WITHOUT NEW CONDITIONS.—Effective beginning 

on the date that is 90 days after the date of a determination by the Administrator under subparagraph 

(B), no person shall manufacture, process, or distribute 

in commerce the chemical substance subject to the determination, or any mixture or article containing the 

chemical substance, for any use or under any condition 

other than those specified in the determination order. 

(ii) WITH NEW CONDITIONS.—Effective beginning on 

the date that is 18 months after the date of a determination by the Administrator under subparagraph 

(C), except as provided in clause (iii), no person shall 

manufacture, process, or distribute in commerce the 

chemical substance subject to the determination, or any 

mixture or article containing the chemical substance, 

for any use or under any condition other than those 

specified in the determination order. 

(iii) EXCEPTIONAL CIRCUMSTANCE.—The Administrator may grant a manufacturer or processor of a 

chemical substance a 1-time extension of the deadline 

for complying with a restriction under clause (ii), for a 

period of not longer than 5 years after the date of the 

determination by the Administrator under subparagraph (C), if the manufacturer or processor demonstrates— 

(I) a compelling technological need to continue a 

restricted activity beyond the applicable 18-month 

time period; or 

(II) that a factor wholly beyond the control of the 

manufacturer or processor prevents compliance 

with the restriction within that 18-month time period. 

(E) REDETERMINATION.— (i) IN GENERAL.—The Administrator shall initiate a 

redetermination of whether a chemical substance meets 

the safety standard if new information or significant 

changes in manufacture, processing, use, or distribution in commerce of the chemical substance, or mixtures or articles containing the chemical substance, 

raise a credible question as to whether the chemical 

substance continues to meet the safety standard. 

(ii) NEW METHODOLOGIES.—The Administrator may 

initiate a redetermination of whether a chemical substance meets the safety standard if significant changes 

have occurred in the methodologies used in the initial 

safety standard determination such that a redetermination using the newer methodologies would provide 

a significantly improved determination of the safety of 

the chemical substance. 

(iii) NEW INFORMATION.—For a chemical substance 

for which a safety standard determination has been 

completed, the Administrator shall assess, on an ongoVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00087 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
88 

ing basis, new information, including that obtained 

from reporting under section 8, to decide whether such 

information raises a credible question as to whether a 

chemical substance continues to meet the safety standard 

(iv) PETITION FOR REDETERMINATION.— (I) IN GENERAL.—Any person may petition the 

Administrator for a redetermination of whether a 

chemical substance continues to meet the safety 

standard. 

(II) BASIS.—A person shall include in a petition 

under this clause a description of the basis for requesting the redetermination. 

(III) ACTION BY ADMINISTRATOR.—On receipt of a 

petition under this clause, the Administrator 

shall— 

(aa) not later than 30 days after the date of 

receipt, publish in the Federal Register a notice of receipt of the petition that specifies the 

chemical identity of the chemical substance to 

which the petition pertains; 

(bb) make the petition available on request; 

(cc) provide a reasonable opportunity for 

public review and comment on the petition 

and give due consideration to any comments 

received; 

(dd) decide whether to make the requested 

redetermination; and 

(ee) not later than 180 days after the date of 

receipt, publish in the Federal Register the decision and the basis for the decision. 

(v) DEADLINE FOR COMPLETION.—Each redetermination carried out under this subparagraph shall be completed by not later than 3 years after the date of the decision to make the redetermination. 

(F) NEGATIVE SAFETY STANDARD DETERMINATION.— (i) RESTRICTION.—Except as provided in clause (ii) 

and subsection (h), effective beginning on the date that 

is 18 months after the date on which the Administrator 

makes a determination under this subsection that a 

chemical substance fails to meet the safety standard, 

regardless of whether additional restrictions on use or 

risk management conditions are imposed, no person 

shall manufacture, process, or distribute in commerce 

that chemical substance or any mixture or article containing the chemical substance. 

(ii) EXCEPTIONAL CIRCUMSTANCE.—The Administrator may grant a manufacturer or processor of a 

chemical substance a 1-time extension of the deadline 

for complying with the restriction under clause (i), for 

a period of not longer than 5 years after the date of the 

determination by the Administrator under this subparagraph, if the manufacturer or processor demonstrates— 


tjames on DSK6SPTVN1PROD with 
89 

(I) a compelling technological need to continue a 

restricted activity beyond the applicable 18-month 

time period; or 

(II) that a factor wholly beyond the control of the 

manufacturer or processor prevents compliance 

with the restriction within that 18-month time period. 

(e) EXPEDITED ACTION FOR SUBSTANCES OF VERY HIGH CON- CERN.— 

(1) USE AND EXPOSURE ASSESSMENT.— (A) IN GENERAL.—Not later than 180 days after the date 

on which a chemical substance is assigned to the category 

of substances of very high concern under subsection 

(b)(3)(B)(i), the Administrator may require, by order pursuant to section 8(g), the submission by manufacturers or 

processors of the chemical substance of any additional information the Administrator determines to be necessary to 

conduct an expedited assessment of the known uses of, and 

exposures to, the chemical substance. 

(B) PUBLICATION.—Not later than 1 year after the date 

on which a chemical substance is assigned to the category 

of substances of very high concern under subsection 

(b)(3)(B)(i), the Administrator shall complete and publish 

an identification and assessment of the known uses of, and 

exposures to, the chemical substance. 

(2) EXPOSURE REDUCTION.— (A) USE RESTRICTIONS AND OTHER CONDITIONS.—As soon 

as practicable, but not later than 18 months, after the date 

on which a chemical substance is assigned to the category 

of substances of very high concern under subsection 

(b)(3)(B)(i), the Administrator shall impose, by order, use 

restrictions and other conditions, including the conditions 

specified in subsection (f), on the manufacturing, processing, use, distribution in commerce, and disposal of the 

chemical substance that the Administrator determines to be 

necessary to achieve the maximum practicable reduction in 

human or environmental exposure to the chemical substance. 

(B) TIMING.—Except as provided in subparagraph (C) 

and subsection (h), effective beginning on the date that is 

18 months after the date of issuance by the Administrator 

of the order described in subparagraph (A), no person shall 

manufacture, process, or distribute in commerce the chemical substance subject to the determination, or any mixture 

or article containing the chemical substance, for any use or 

under any condition other than those specified in the order 

issued under subparagraph (A). 

(C) EXCEPTIONAL CIRCUMSTANCE.—The Administrator 

may grant a manufacturer or processor of a chemical substance a 1-time extension of the deadline for complying 

with the restriction under subparagraph (B), for a period of 

not longer than 5 years after the date of the determination 

by the Administrator under this paragraph, if the manufacturer or processor demonstrates— 


tjames on DSK6SPTVN1PROD with 
90 

(i) a compelling technological need to continue a restricted activity beyond the applicable 18-month time 

period; or 

(ii) that a factor wholly beyond the control of the 

manufacturer or processor prevents compliance with 

the restriction within that 18-month time period. 

(3) RESIDUAL RISK ASSESSMENT.—Not later than 1 year after 

the deadline specified in paragraph (2)(B), or of an alternative 

deadline provided under paragraph (2)(C), the Administrator 

shall— 

(A) determine whether the chemical substance meets the 

safety standard for the chemical substance, taking into account the residual risk posed by continued exposure to the 

chemical substance; and 

(B) impose any additional restrictions on use or other 

conditions under subsection (f) that the Administrator determines to be necessary to ensure that the chemical substance meets the safety standard. 

(f) RISK MANAGEMENT.—In issuing an order under subsection (d) 

or (e), the Administrator may impose conditions on the manufacture, processing, use, distribution in commerce, or disposal of a 

chemical substance, or mixture or article containing a chemical substance, including a requirement— 

(1) limiting the quantity of the chemical substance (or mixture or article containing that chemical substance) that may be 

manufactured, processed, or distributed in commerce; 

(2)(A) prohibiting the manufacturing, processing, or distribution in commerce of the chemical substance (or mixture or article containing that chemical substance) for a particular use in 

a concentration in excess of a level specified by the Administrator; or 

(B) limiting the quantity of the chemical substance (or mixture or article containing that chemical substance) that 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; 

(3) that the chemical substance (or mixture, or article containing that chemical substance) be marked with, or accompanied by, clear and adequate warnings and instructions with 

respect to use, distribution in commerce, or disposal, or any 

combination of such activities, with the form and content of the 

warnings and instructions prescribed by the Administrator; 

(4) that manufacturers and processors of the chemical substance (or mixture or article containing that chemical substance)— 

(A) make and retain records of the processes used to 

manufacture or process the chemical substance (or mixture 

or article containing that chemical substance); and 

(B) monitor or conduct tests that are reasonable and necessary to ensure compliance with this Act; 

(5) prohibiting or otherwise regulating any manner or method 

of commercial use of the chemical substance (or mixture or article containing that chemical substance); 


tjames on DSK6SPTVN1PROD with 
91 

(6) prohibiting or otherwise regulating any manner or method 

of disposal of the chemical substance, mixture, or article, by— 

(A) the manufacturer or processor of the chemical substance (or mixture or article containing that chemical substance); or 

(B) any other person that uses or disposes of the chemical 

substance (or mixture or article containing that chemical 

substance) for commercial purposes; 

(7) that the manufacturers and processors of the chemical 

substance, mixture, or article develop a risk reduction management plan, under subsection (h) or (e) of this section, to achieve 

a risk reduction specified by the Administrator; or 

(8) that the Administrator otherwise determines is appropriate. 

(g) QUALITY CONTROL ORDERS.— (1) IN GENERAL.—If the Administrator has a reasonable basis 

to conclude that a particular manufacturer or processor is manufacturing or processing a chemical substance in a manner that 

may present a substantial endangerment to health or the environment, the Administrator may require, by order, that the 

manufacturer or processor submit to the Administrator a description of the quality control procedures followed in the manufacturing or processing of the chemical substance or mixture. 

(2) ORDERS.— (A) IN GENERAL.—If the Administrator determines that 

quality control procedures described in paragraph (1) are 

inadequate to prevent a chemical substance from presenting 

a risk of injury to human health or the environment, the 

Administrator may order the manufacturer or processor to 

revise the quality control procedures to the extent necessary 

to remedy the inadequacy. 

(B) SUBSTANTIAL ENDANGERMENT.—If the Administrator 

determines that quality control procedures described in 

paragraph (1) have resulted in the distribution in commerce of a chemical substance that may present a substantial endangerment to human health or the environment, the 

Administrator may order the manufacturer or processor— 

(i) to give notice of the endangerment to— 

(I) processors or distributors (or both) in commerce of the chemical substance or mixture; and 

(II) to the extent reasonably ascertainable, any 

other person in possession of or exposed to the 

chemical substance or mixture; 

(ii) to give public notice of the endangerment; and 

(iii) to provide for the replacement or repurchase, as 

prescribed by the Administrator, of the chemical substance as the Administrator determines to be necessary 

to adequately protect human health or the environment. 

(h) EXEMPTIONS TO RESTRICTIONS.— (1) APPLICATION.—This subsection applies to the restrictions 

established under section 5(b)(1)(C)(ii)(I), subsection (d)(5), and 

subsection (e). 

(2) EXEMPTIONS.— 


tjames on DSK6SPTVN1PROD with 
92 

(A) IN GENERAL.— 

(i) REQUEST.—A person who manufacturers, processes, distributes in commerce, uses, or disposes of a 

chemical substance, or a mixture or article containing 

a chemical substance may request an exemption from 

any restriction referred to in paragraph (1) to which 

they are subject for a specified use of the chemical substance. 

(ii) ORDER.—The Administrator may grant, by order, 

an exemption from any restriction referred to in paragraph (1) for a period of not longer than 5 years if the 

person has established by clear and convincing evidence that the uses to be exempted meet the exemption 

criteria described in subparagraph (B). 

(B) CRITERIA.—The Administrator may grant an exemption for the use of a chemical substance under subparagraph (A)(ii) if— 

(i) the exemption is in the paramount interest of national security; 

(ii) the lack of availability of the chemical substance 

would cause significant disruption in the national 

economy; or 

(iii) the use for which the exemption is sought is a 

critical or essential use for which— 

(I) no feasible safer alternative for the specified 

use of the chemical substance is available; or 

(II) the specified use of the chemical substance, 

as compared to all available alternatives, provides 

a substantial net benefit to human health, the environment, or public safety. 

(C) PUBLIC NOTICE.—If the Administrator grants an exemption for a chemical substance under this paragraph— 

(i) the manufacturer or processor of the chemical 

substance shall provide a notice of the exemption to 

each known purchaser of— 

(I) the chemical substance; and 

(II) a mixture or article containing the chemical 

substance; and 

(ii) the Administrator shall provide the public with 

a notice of the exemption. 

(D) RENEWAL.—The Administrator may renew, by order, 

an exemption under this paragraph for 1 or more additional 5-year periods if the Administrator concludes, after 

providing public notice and an opportunity for comment, 

that the use of the chemical substance continues to meet the 

criteria described in subparagraph (B). 

(E) CONDITIONS.— 

(i) IN GENERAL.—The Administrator may impose, by 

order, any condition on an exemption issued under this 

paragraph that the Administrator determines to be necessary to ensure the protection of human health and 

the environment on the use of a chemical substance exempted under this paragraph. 


tjames on DSK6SPTVN1PROD with 
93 

(ii) COMPLIANCE.—Effective immediately after the 

Administrator establishes conditions on an exempted 

use under clause (i), the manufacturing, processing, or 

distribution in commerce of the chemical substance, or 

any mixture or article containing the chemical substance, shall be prohibited except to the extent that the 

conditions are satisfied. 

(3) RESALE OF USED ARTICLES.— 

(A) IN GENERAL.—The restrictions referred to in paragraph (1) shall not apply to the resale of an article subject 

to a restriction under subsection (b) if the article has previously been used by an end consumer. 

(B) COMPLIANCE.—The Administrator may utilize the authorities contained in section 7 to address potential threats 

to public health and the environment from such articles. 

(4) EXTENSIONS OF EFFECTIVE DATES FOR RETAIL SALE OF ARTICLES TO END CONSUMERS.— 

(A) IN GENERAL.—Except as provided in subparagraph 

(B), in the case of the retail sale to an end consumer of a 

chemical substance (or mixture or article containing that 

chemical substance) that is subject to a restriction described in paragraph (1), the Administrator may extend, by 

order, the effective date of the restriction by a period of not 

longer than 3 years, if the Administrator determines that 

the extension— 

(i) is necessary and appropriate to allow for depletion 

of the existing retail inventory; and 

(ii) will not present a substantial endangerment to 

human health or the environment. 

(B) EXCEPTION.—An extension under subparagraph (A) 

shall not apply to any retailer that the Administrator determines has failed to comply with an order requesting information issued by the Administrator pursuant to section 8; 

ø(e)¿(i) 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 


tjames on DSK6SPTVN1PROD with 
94 

1Section 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. 

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) 1 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) Any rule under paragraph (1), (2)(B), or (3)(B) shall be promulgated in accordance with paragraphs (2), (3), and (4) of subsection (c). 


tjames on DSK6SPTVN1PROD with 
95 

(5) This subsection does not limit the authority of the Administrator, under any other provision of this Act or any other Federal 

law, to take action respecting any polychlorinated biphenyl. 

ø(f) MERCURY.— ø(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. 

ø(2) EXCEPTIONS.—Paragraph (1) shall not apply to— 

ø(A) a transfer between Federal agencies of elemental 

mercury for the sole purpose of facilitating storage of mercury to carry out this Act; or 

ø(B) a conveyance, sale, distribution, or transfer of coal. 

ø(3) LEASES OF FEDERAL COAL.—Nothing in this subsection 

prohibits the leasing of coal.¿ 

øSEC. 7. IMMINENT HAZARDS. 

ø(a) ACTIONS AUTHORIZED AND REQUIRED.—(1) The Administrator may commence a civil action in an appropriate district court 

of the United States— 

ø(A) for seizure of an imminently hazardous chemical substance or mixture or any article containing such a substance 

or mixture, 

ø(B) for relief (as authorized by subsection (b)) against any 

person who manufactures, processes, distributes in commerce, 

or uses, or disposes of, an imminent hazardous chemical substance or mixture or any article containing such a substance 

or mixture, or 

ø(C) for both such seizure and relief. 

øA civil action may be commenced under this paragraph notwithstanding the existence of a rule under section 4, 5, 6, or title IV 

or an order under section 5 or title IV, and notwithstanding the 

pendency of any administrative or judicial proceeding under any 

provision of this Act. 

ø(2) If the Administrator has not made a rule under section 6(a) 

immediately effective (as authorized by subsection 6(d)(2)(A)(i)) 

with respect to an imminently hazardous chemical substance or 

mixture, the Administrator shall commence in a district court of 

the United States with respect to such substance or mixture or article containing such substance or mixture a civil action described 

in subparagraph (A), (B), or (C) of paragraph (1). 

ø(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. 

ø(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 


tjames on DSK6SPTVN1PROD with 
96 

1 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. 

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. 

ø(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. 

ø(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. 

ø(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. 

ø(C) Subpoenas 1 requiring attendance of witnesses in an action 

brought under subsection (a) may be served in any judicial district. 

ø(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. 

ø(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). 

ø(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. 

ø(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 


tjames on DSK6SPTVN1PROD with 
97 

likely to result in such injury to health or the environment before 

a final rule under section 6 can protect against such risk.¿ 

SEC. 7. IMMINENT HAZARDS. 

(a) ACTIONS AUTHORIZED AND REQUIRED.— 

(1) IN GENERAL.—The Administrator may commence a civil 

action in an appropriate district court of the United States 

for— 

(A) seizure of a chemical substance or mixture, or any article containing a chemical substance or mixture, that may 

present an imminent and substantial endangerment to 

health or the environment; 

(B) relief authorized under subsection (b) against any 

person that— 

(i) manufactures, processes, distributes in commerce, 

uses, or disposes of a chemical substance or mixture, or 

any article containing a chemical substance or mixture, 

if the manufacture, processing, distribution in commerce, use, or disposal may present an imminent and 

substantial endangerment to health or the environment; or 

(ii) contributes to an activity described in clause (i); 

or 

(C) both seizure and relief described in subparagraphs 

(A) and (B), respectively. 

(2) OTHER ACTIONS.— 

(A) IN GENERAL.—The Administrator may issue such orders as are necessary to protect health or the environment 

from any manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, 

or any article containing such a substance or mixture, that 

may present an imminent and substantial endangerment to 

health or the environment, as determined by the Administrator. 

(B) REQUIREMENT.—An order under subparagraph (A) 

may include such requirements imposed on the manufacture, processing, distribution in commerce, use, or disposal 

of a chemical substance or mixture, or article containing 

the chemical substance or mixture, as the Administrator determines are necessary to protect health or the environment, 

including— 

(i) the requirements described in section 6(c); and 

(ii) the relief authorized under subsection (b). 

(3) RELATIONSHIP TO EXISTING RULES, ORDERS, AND PROCEEDINGS.—A civil action may be commenced under paragraph 

(1), or other action may be taken under paragraph (2), notwithstanding— 

(A) the existence of a rule or order under this Act; and 

(B) the pendency of any administrative or judicial proceeding under this Act. 

(b) RELIEF AUTHORIZED.— 

(1) IN GENERAL.—The district court of the United States in 

which a civil action under subsection (a)(1) is brought shall 

have jurisdiction to grant such temporary or permanent relief 


tjames on DSK6SPTVN1PROD with 
98 

as are necessary to protect health or the environment from the 

risk associated with the activity involved in the civil action. 

(2) TYPES OF RELIEF.—In the case of a civil action under subsection (a)(1) brought against a person that manufactures, processes, distributes in commerce, uses, or disposes of a chemical 

substance or mixture or an article containing a chemical substance or mixture, the relief authorized by paragraph (1) may 

include— 

(A) the issuance of a mandatory order imposing any of 

the requirements described in section 6(c); and 

(B) in the case of purchasers of the substance, mixture, 

or article known to the defendant— 

(i) notification to the purchasers of the risk associated with the substance, mixture, or article; 

(ii) public notice of the risk; 

(iii) recall; 

(iv) the replacement or repurchase of the substance, 

mixture, or article; or 

(v) any combination of the actions described in section 6(c) or in clauses (i) through (iv) of this subparagraph; or 

(C) such other relief as is necessary to protect health or 

the environment from the risk associated with the activity 

involved in the civil action. 

(3) SEIZURE AND CONDEMNATION.— (A) IN GENERAL.—A civil action under subsection (a)(1) 

against a chemical substance, mixture, or article may be 

proceeded against by process of libel for seizure and condemnation of the chemical substance, mixture, or article. 

(B) PROCEEDINGS.—Proceedings in a civil action described in subparagraph (A) shall conform, to the maximum extent practicable, to proceedings in rem in admiralty. 

(c) VENUE AND CONSOLIDATION.— 

(1) VENUE.— (A) IN GENERAL.—A civil action under subsection (a)(1) 

against a person that 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 in any judicial district in which any of the defendants is found, resides, or transacts business. 

(B) PROCESS.—Process in an action described in subparagraph (A) may be served on a defendant in any other district in which the defendant resides or may be found. 

(C) CHEMICAL SUBSTANCES, MIXTURES, OR ARTICLES.—A 

civil action under subsection (a)(1) against a chemical substance, mixture, or article may be brought in any United 

States district court within the jurisdiction of which the 

chemical substance, mixture, or article is found. 

(D) MULTIPLE JUDICIAL DISTRICTS.—In determining the 

judicial district in which a civil action may be brought 

under subsection (a)(1) in instances in which the action 

may be brought in more than 1 judicial district, the AdVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00098 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
99 

ministrator shall take into account the convenience of the 

parties. 

(E) SUBPOENAS.—Subpoenas requiring attendance of witnesses in a civil action brought under subsection (a)(1) may 

be served in any judicial district. 

(2) CONSOLIDATION.—If proceedings under subsection (a)(1) 

involving identical chemical substances, mixtures, or articles 

are pending in courts in 2 or more judicial districts, the proceedings shall be consolidated for trial by order of any such 

court on application reasonably made by any party in interest, 

on notice to all parties in interest. 

øSEC. 8. REPORTING AND RETENTION OF INFORMATION. 

ø(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 

ø(B) each person (other than a small manufacturer or processor) who manufactures or processes or proposes to manufacture or process— 

ø(i) a mixture, or 

ø(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, 

øshall 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. 

øThe 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. 

ø(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: 

ø(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. 

ø(B) The categories or proposed categories of use of each 

such substance or mixture. 


tjames on DSK6SPTVN1PROD with 
100 

ø(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. 

ø(D) A description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or 

mixture. 

ø(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. 

ø(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. 

øTo the extent feasible, the Administrator shall not require under 

paragraph (1), any reporting which is unnecessary or duplicative. 

ø(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). 

ø(ii) The Administrator may by rule require a small manufacturer or processor of a chemical substance or mixture— 

ø(I) subject to a rule proposed or promulgated under section 

4, 5(b)(4), or 6, or an order in effect under section 5(e), or 

ø(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). 

ø(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). 

ø(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 AdminisVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00100 Fmt 6602 Sfmt 9001 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
101 

trator) 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. 

ø(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. 

ø(c) RECORDS.—Any person who manufactures, processes, or distributes in commerce any chemical substance or mixture shall 

maintain records of significant adverse reactions to health or the 

environment, as determined by the Administrator by rule, alleged 

to have been caused by the substance or mixture. Records of such 

adverse reactions to the health of employees shall be retained for 

a period of 30 years from the date such reactions were first reported to or known by the person maintaining such records. Any 

other record of such adverse reactions shall be retained for a period 

of five years from the date the information contained in the record 

was first reported to or known by the person maintaining the 

record. Records required to be maintained under this subsection 

shall include records of consumer allegations of personal injury or 

harm to health, reports of occupational disease or injury, and reports or complaints of injury to the environment submitted to the 

manufacturer, processor, or distributor in commerce from any 

source. Upon request of any duly designated representative of the 

Administrator, each person who is required to maintain records 

under this subsection shall permit the inspection of such records 

and shall submit copies of such records. 

ø(d) HEALTH AND SAFETY STUDIES.—The Administrator shall promulgate rules under which the Administrator shall require any 

person who manufactures, processes, or distributes in commerce or 

who proposes to manufacture, process, or distribute in commerce 

any chemical substance or mixture (or with respect to paragraph 

(2), any person who has possession of a study) to submit to the Administrator— 

ø(1) lists of health and safety studies (A) conducted or initiated by or for such person with respect to such substance or 

mixture at any time, (B) known to such person, or (C) reasonably ascertainable by such person, except that the Administrator may exclude certain types or categories of studies from 

the requirements of this subsection if the Administrator finds 

that submission of lists of such studies are unnecessary to 

carry out the purposes of this Act; and 

ø(2) copies of any study contained on a list submitted pursuant to paragraph (1) or otherwise known by such person. 

ø(e) NOTICE TO ADMINISTRATOR OF SUBSTANTIAL RISKS.—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 


tjames on DSK6SPTVN1PROD with 
102 

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. 

ø(f) DEFINITIONS.—For purposes of this section, the terms ‘‘manufacture’’ and ‘‘process’’ mean manufacture or process for commercial 

purposes.¿ 

SEC. 8. REPORTING AND RETENTION OF INFORMATION. 

(a) DEFINITIONS.—In this section: 

(1) KNOWN TO, OR REASONABLY ASCERTAINABLE BY.—The 

term ‘‘known to, or reasonably ascertainable by’’ has the meaning given the term in section 704.3 of title 40, Code of Federal 

Regulations (or successor regulations). 

(2) MANUFACTURE AND PROCESS.—The terms ‘‘manufacture’’ 

and ‘‘process’’ mean manufacture and process, respectively, for 

commercial purposes. 

(b) DECLARATIONS OF CHEMICAL SUBSTANCES IN COMMERCE.— 

(1) SCOPE AND CRITERIA.— 

(A) SCOPE.—The declarations described in this subsection 

shall apply only to chemical substances in commerce as of 

the date of enactment of the Safe Chemicals Act of 2011. 

(B) CRITERIA.—The following criteria shall apply in identifying chemical substances to which the declarations described in this subsection apply: 

(i) CURRENT COMMERCIAL INTEREST.—A chemical 

substance in which a manufacturer or processor has a 

current commercial interest shall include only chemical 

substances that the manufacturer or processor— 

(I) is currently manufacturing or processing; or 

(II) has manufactured or processed in the recent 

past and expects to manufacture or process again 

in the near future. 

(ii) POTENTIAL COMMERCIAL INTEREST.—A chemical 

substance in which a manufacturer or processor has a 

potential commercial interest shall include only a 

chemical substance that may serve as a reasonable substitute for a chemical substance in which the manufacturer or processor has declared a current commercial 

interest. 

(C) GUIDANCE.—Not later than 90 days after the date of 

enactment of the Safe Chemicals Act of 2011, the Administrator shall issue guidance further describing the criteria 

described in subparagraph (B) and specifying the supporting information manufacturers and processors are to 

include in declarations they submit pursuant to paragraph 

(2) or (3) for chemical substances in which they have a current or potential commercial interest. 

(2) DECLARATION OF CURRENT COMMERCIAL INTEREST IN A

CHEMICAL SUBSTANCE.— 

(A) IN GENERAL.—Notwithstanding any other provision of 

law, not later than 180 days after the date of enactment of 

the Safe Chemicals Act of 2011, each manufacturer of a 

chemical substance in which the manufacturer has a curVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00102 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
103 

rent commercial interest shall submit to the Administrator 

a declaration of the interest for the chemical substance. 

(B) EXCLUSIONS OR EXEMPTIONS.—Declarations are required for all chemical substances in which a manufacturer 

has a current commercial interest, notwithstanding any exclusions or exemptions from other notification or reporting 

requirements provided in any other provision of this Act. 

(C) PROCESSORS.—A processor of a chemical substance in 

which the processor has a current commercial interest that 

meets the criteria described in paragraph (1)(B)(i) may voluntarily submit to the Administrator a declaration for the 

chemical substance. Such a declaration shall be submitted 

not later than 1 year after the date of enactment of the Safe 

Chemicals Act of 2011. 

(3) DECLARATION OF POTENTIAL COMMERCIAL INTEREST IN A

CHEMICAL SUBSTANCE.— (A) A manufacturer or processor may voluntarily submit 

to the Administrator, not later than 180 days after the date 

of enactment of the Safe Chemicals Act of 2011, a declaration for a chemical substance in which the manufacturer or 

processor— 

(i) does not have a current commercial interest; but 

(ii) has a potential commercial interest that meets 

the criteria described in paragraph (1)(B)(ii). 

(B) If a manufacturer or processor commences the manufacture or processing of a chemical substance for which it 

submitted a declaration under this paragraph, the manufacturer or processor shall comply with the requirements of 

subsection (h)(5)(B). 

(4) DECLARATION OF CESSATION OF MANUFACTURING OR PROC- ESSING.—A former or current manufacturer or processor of a 

chemical substance in which the manufacturer or processor no 

longer has a commercial interest may voluntarily submit to the 

Administrator, not later than 180 days after the date of enactment of the Safe Chemicals Act of 2011, a declaration that the 

manufacturer or processor has ceased, or will cease not later 

than 180 days after the date on which the declaration is submitted, all production, importation, processing, and export of 

the chemical substance. 

(5) CONTENTS.—A declaration submitted under this subsection shall include for each chemical substance— 

(A) the chemical identity and any special substance characteristics of the chemical substance; 

(B) the identity and primary business location of the 

manufacturer or processor; and 

(C) information supporting the declarant’s basis for meeting the applicable criteria under paragraph (1)(B). 

(6) REVIEW BY ADMINISTRATOR.— 

(A) IN GENERAL.—The Administrator shall— 

(i) review each declaration received under this subsection to determine whether the declaration conforms 

to the criteria and requirements of this subsection; and 

(ii)(I) for a chemical substance for which 1 or more 

conforming declarations are submitted under paraVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00103 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
104 

graph (2), add the chemical substance to the list of active chemical substances in the inventory established 

under subsection (h)(1); 

(II) for a chemical substance for which the only conforming declarations submitted for the substance are 

submitted under paragraph (3), add the chemical substance to the list of inactive chemical substances in the 

inventory established under subsection (h)(5); and 

(III) for a chemical substance for which the only conforming declarations submitted for the substance are 

submitted under paragraph (4), or for which no declaration has been submitted, remove the chemical substance from the inventories established under subsection (h). 

(B) REVISIONS.—The Administrator shall allow a manufacturer or processor, as applicable, to promptly revise and 

resubmit any declaration submitted to the Administrator 

under this subsection if the Administrator determines that 

any omission or error in the original declaration was not 

intentional. 

(c) PERIODIC REPORTING BY MANUFACTURERS.— (1) IN GENERAL.—The Administrator shall— 

(A) maintain the periodic reporting program of the agency applicable to manufacturers of chemical substances set 

forth in part 711 of title 40, Code of Federal Regulations 

(as in effect on the date of enactment of the Safe Chemicals 

Act of 2011), unless such reporting requirements are superseded pursuant to subparagraph (B); or 

(B) establish a new periodic reporting program consistent 

with this subsection. 

(2) RULEMAKING.— (A) IN GENERAL.—Not later than 180 days after the date 

of enactment of the Safe Chemicals Act of 2011, the Administrator shall specify, by rule— 

(i) the chemical substances for which periodic reporting is required; and 

(ii) the information a chemical manufacturer is required to submit to the Administrator for the chemical 

substances included under the periodic reporting program. 

(B) EXEMPTIONS.—The rule promulgated under subparagraph (A) may exempt certain manufacturers, including 

small manufacturers, from— 

(i) a requirement to participate in the periodic reporting program, if the Administrator determines that the 

participation of those manufacturers would not assist 

in the administration of this Act; or 

(ii) specific reporting requirements, if the Administrator determines that the value of a particular reporting requirement, for the administration of this Act, 

would not be commensurate with the burden of the requirement on submitters. 

(C) CONTENTS.—The rule promulgated under subparagraph (A) shall, at a minimum, require each manufacturer 


tjames on DSK6SPTVN1PROD with 
105 

of a chemical substance included in the periodic reporting 

program to submit to the Administrator— 

(i) the chemical identity and any special substance 

characteristics of the chemical substance, the identity 

and primary business location of the manufacturer, 

and any updates to the supporting information submitted by the manufacturer in any declaration for an 

included chemical substance submitted under subsection (b); 

(ii) a list of health and safety studies conducted or 

initiated by or for, known to, or reasonably ascertainable by, the manufacturer with respect to each included 

chemical substance; 

(iii) a copy of each study described in clause (ii) in 

the possession or control of the manufacturer that has 

not previously been submitted to the Administrator; 

and 

(iv) all other information specified by the Administrator in the rules promulgated under this subsection 

that is known to, in the possession or control of, or reasonably ascertainable by, the manufacturer or processor that has not previously been submitted to the Administrator regarding— 

(I) the physical, chemical, and toxicological properties of the chemical substance; 

(II) the manufacturer’s annual production volume of the chemical substance; 

(III) the uses of, and exposure and fate information relating to the manufacturer’s production or 

import of the chemical substance; and 

(IV) the name and location of each facility to 

which the manufacturer sends the chemical substance after manufacture for subsequent processing, distribution, or use. 

(d) RECORDS TO SUPPORT DECLARATIONS AND PERIODIC RE- PORTS.— 

(1) IN GENERAL.—Each manufacturer and processor of a 

chemical substance that is distributed in commerce shall— 

(A) maintain records of the information submitted to the 

Administrator under subsections (b) and (c), as well as supporting information; and 

(B) submit those records or that information to the Administrator upon request by the Administrator. 

(2) BURDEN OF PROOF.—Each manufacturer and processor 

that submits to the Administrator a declaration under subsection (b) or a notice under subsection (h)(5)(B) shall at all 

times bear the burden of proving that the manufacturer or processor— 

(A) has a current or potential commercial interest in the 

applicable chemical substance; or 

(B) has ceased the production, importation, processing, 

and export of, the applicable chemical substance. 

(e) SUBSTANCE IDENTIFICATION AND INFORMATION FOR CHEMICAL

PROCESSORS.— 


tjames on DSK6SPTVN1PROD with 
106 

(1) RULEMAKING.— 

(A) IN GENERAL.—Not later than 1 year after the date of 

enactment of the Safe Chemicals Act of 2011, the Administrator shall specify, by rule, the information that chemical 

processors are required to submit for chemical substances 

under this subsection as will assist the Administrator in 

the administration of this Act. 

(B) EXEMPTIONS.—The rule promulgated under this 

paragraph may exempt certain processors, including small 

processors, from— 

(i) a requirement to participate in the periodic reporting program, if the Administrator determines that the 

participation of those processors would not assist in the 

administration of this Act; or 

(ii) specific reporting requirements, if the Administrator determines that the value of a particular reporting requirement, for the administration of this Act, 

would not be commensurate with the burden of the requirement on submitters. 

(2) INFORMATION REQUIREMENTS.—The rule promulgated 

under paragraph (1) shall— 

(A) specify the information that processors are required to 

submit for chemical substances that are— 

(i) processed for use in 1 or more consumer or commercial product categories, as determined by the Administrator; and 

(ii) intentionally added to 1 or more products during 

processing and not incidental to the end uses of the 

products; 

(B) require each processor of a chemical substance identified under subparagraph (A) to submit the information 

specified in clauses (i) through (iii) of subparagraph (C) for 

the chemical substance, and to submit the information 

specified in clauses (iv) through (viii) of subparagraph 

(C)— 

(i) separately for each applicable consumer and commercial product category; and 

(ii) in aggregate form, taking into account the use by 

the processor of the chemical substance in all product 

categories; 

(C) require each processor of a chemical substance identified under subparagraph (A) to identify in the submission 

of the processor— 

(i) the corporate name and primary business location 

of the processor; 

(ii) the chemical identity and any special substance 

characteristics of the chemical substance; 

(iii) the applicable consumer or commercial product 

category or categories for which the processor processes 

the chemical substance; 

(iv) the annual volume of the chemical substance 

processed by the submitter; 


tjames on DSK6SPTVN1PROD with 
107 

(v) any products intended for use by children aged 14 

years or younger for use in which the processor processes the chemical substance; 

(vi) the concentration range within which the maximum concentration of the substance used in each consumer and commercial product category falls; 

(vii) the range within which the total number of commercial workers reasonably likely to be exposed to the 

chemical substance at the processing site falls; and 

(viii) any other information regarding processing activities or product descriptors relating to the processor’s 

processing of the chemical substance identified by the 

Administrator as necessary to understand the potential 

exposure from processed chemical substances or products in which the chemical substances are used; and 

(D) require each processor to periodically report the information described in subparagraphs (B) and (C) for the 

chemical substances described in subparagraph (A). 

(3) RECORDS.—The rules promulgated under paragraph (1) 

shall require processors of chemical substances to which those 

rules apply— 

(A) to maintain records of the information described in 

paragraph (2); and 

(B) to submit those records to the Administrator upon request by the Administrator. 

(f) UPDATING OF INFORMATION.— (1) IN GENERAL.—Each manufacturer or processor of a chemical substance that submits information to the Administrator 

under subsection (c) or (e) shall update the information— 

(A) at a minimum every 4 years; and 

(B) at any time that— 

(i) the manufacturer or processor obtains knowledge 

of, comes into possession of, or generates significant 

new information regarding the production, processing, 

use, distribution, hazard, or exposure potential of the 

chemical substance; or 

(ii) there is a significant change in the production, 

distribution in commerce, or use of the chemical substance by or known to the manufacturer or processor. 

(2) GUIDANCE.—Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall 

issue guidance on what constitutes significant new information 

regarding or significant changes in the production, distribution 

in commerce, or use of a chemical substance. 

(g) REPORTS.— 

(1) REQUIREMENT.— 

(A) IN GENERAL.—Except as provided in paragraph (2), 

the Administrator may by rule or order require any person 

who manufactures, processes, distributes in commerce, uses, 

or disposes of a chemical substance, or a mixture or article 

containing the chemical substance to maintain records of 

and report by a specified date any existing information concerning the substance that, in the judgment of the Administrator, would assist the Administrator in— 


tjames on DSK6SPTVN1PROD with 
108 

(i) making a safety standard determination with respect to a chemical substance; 

(ii) determining testing or information needs for a 

chemical substance; 

(iii) assigning a chemical substance to a batch, category, or priority class pursuant to section 6; 

(iv) evaluating, developing, and implementing risk 

management conditions for a chemical substance; 

(v) assessing hazards, exposures, or risks related to 

the manufacture, use, distribution, processing, or disposal of a chemical substance; 

(vi) determining compliance with any provision of 

this Act; or 

(vii) any other aspect of administering this Act. 

(B) CHARACTERISTICS.—The Administrator may by rule 

or order require that any report or information submitted 

pursuant to this Act include chemical identity and special 

substance characteristics, as appropriate to the chemical 

substance that is the subject of the report or information. 

(C) REQUIRED INFORMATION.—The Administrator shall 

by rule or order specify or modify the information that is 

required to be submitted with a particular report or information submission to establish the chemical identity and 

special substance characteristics of the subject chemical 

substance (or mixture or article containing that chemical 

substance) for the purposes of the report or information 

submission. 

(2) EXEMPTIONS.— (A) SMALL QUANTITIES FOR RESEARCH OR ANALYSIS.—In 

the case of the manufacture, processing, distribution in 

commerce, use, or disposal of a chemical substance in small 

quantities (as defined by the Administrator by rule) solely 

for purposes of scientific experimentation or analysis or 

chemical research (including any such research or analysis 

for the development of a product), the Administrator may 

promulgate a rule or order under paragraph (1) only to the 

extent that the Administrator determines that the maintenance of records, submission of reports, or both, is necessary for the effective enforcement of this Act. 

(B) SMALL BUSINESS.—The rules promulgated under this 

subsection may exempt certain small businesses from the 

rules promulgated under this subsection, if the Administrator determines that the participation of those small businesses would not assist in the administration of this Act. 

(h) INVENTORIES.— 

(1) ACTIVE INVENTORY.—The Administrator shall compile, 

keep current, and, subject to section 14, publish a list of each 

chemical substance that is manufactured or processed in the 

United States. 

(2) CONTENTS.— (A) IN GENERAL.—The list shall consist of those chemical 

substances for which— 

(i) a notice is submitted under section 5(d), consistent 

with the requirements of section 5(b); or 


tjames on DSK6SPTVN1PROD with 
109 

(ii) a valid declaration is submitted under paragraph 

(2) of subsection (b). 

(B) EXCLUSIONS.—The list shall not include— 

(i) any chemical substance for which the only declarations submitted are submitted under paragraph (3) 

or (4) of subsection (b), or for which no declaration has 

been submitted; or 

(ii) any chemical substance for which an exemption 

has been granted under section 5(b)(1)(C)(ii) or section 

6(h)(2). 

(3) TIMING.— 

(A) IN GENERAL.—Except as provided in paragraph 

(2)(B), for a chemical substance for which a notice is submitted under section 5(d), the chemical substance shall be 

included in the list established under paragraph (1) as of 

the earliest date (as determined by the Administrator) on 

which the substance was manufactured or processed in the 

United States. 

(B) PUBLICATION.—The Administrator shall first publish 

a list under paragraph (1) not later than 1 year after the 

date of enactment of the Safe Chemicals Act of 2011. 

(4) SMALL QUANTITIES FOR RESEARCH OR ANALYSIS.—The Administrator shall not include in the list established under paragraph (1) any chemical substance that 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, the substance or 

another substance, including research or analysis for the development of a product. 

(5) INACTIVE INVENTORY.— 

(A) IN GENERAL.—The Administrator shall compile, keep 

current, and, subject to section 14, publish an inactive list 

on which the Administrator shall include each chemical 

substance for which the only declarations submitted for the 

substance are submitted under subsection (b)(3). 

(B) REQUIREMENTS.—If a manufacturer or processor commences the manufacture or processing of a chemical substance on the inactive list, the manufacturer or processor 

shall— 

(i) not less than 30 days before recommencing the 

manufacture or processing of the chemical substance, 

notify the Administrator; and 

(ii) provide with the notification under clause (i)— 

(I) the chemical identity and any special substance characteristics of the chemical substance; 

(II) the identity and primary business location of 

the manufacturer; 

(III) a list of health and safety studies conducted 

or initiated by or for, known to, or reasonably ascertainable by, the manufacturer or processor with 

respect to the chemical substance; 

(IV) upon request of the Administrator, a copy of 

each study described in subclause (III) in the posVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00109 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
110 

session or control of the manufacturer that has not 

previously been submitted to the Administrator; 

(V) the projected annual manufacturing or processing volume for the chemical substance for each 

of the subsequent 3 years; 

(VI) the name and location of each facility to 

which the chemical substance is expected to be 

sent, after manufacture or processing, for subsequent processing, distribution in commerce, or use; 

and 

(VII) all other existing information known to, in 

the possession or control of, or reasonably ascertainable by the manufacturer or processor that has 

not previously been submitted to the Administrator 

regarding— 

(aa) the toxicological properties of the chemical substance; and 

(bb) the uses of, and exposure and fate information relating to, the chemical substance. 

(C) ADMINISTRATOR ACTIONS.—For any chemical substance for which the Administrator receives a valid notification under subparagraph (B), the Administrator shall 

promptly— 

(i) move the chemical substance to the active inventory established under paragraph (1); and 

(ii) add the chemical substance to the current batch 

of chemical substances identified pursuant to section 

6(a), and categorize the chemical substance with other 

chemical substances in the batch, pursuant to section 

6(b). 

(D) ADMINISTRATION.—Disclosure of any information provided in the notice described in subparagraph (B) shall be 

subject to section 14. 

(6) CHEMICALS NOT LISTED ON OR REMOVED FROM THE INVENTORIES.—If a manufacturer or processor seeks to commence the 

manufacture or processing of a chemical substance that is not 

listed on the inventories established under paragraph (1) or (5), 

or that has been removed from the inventories pursuant to subsection (b)(6)(A)(ii)(III), the manufacturer or processor shall 

comply with section 5. 

(i) PUBLIC ACCESS TO SIGNIFICANT INFORMATION.— 

(1) ELECTRONIC DATABASE.—Not later than 1 year after the 

date of enactment of the Safe Chemicals Act of 2011, the Administrator, through collaboration as appropriate, shall establish— 

(A) an electronic, Internet-accessible database for the 

storing and sharing of information relating to the toxicity 

and use of, and exposure to, chemical substances; and 

(B) procedures for use in maintaining and updating the 

database. 

(2) PUBLIC ACCESS.—Not later than 18 months after the date 

of enactment of the Safe Chemicals Act of 2011 or for decisions 

made or information submitted after that 18-month period, not 

later than 90 days after the date on which a decision is made 


tjames on DSK6SPTVN1PROD with 
111 

by the Administrator or information submitted under this title 

is received by the Administrator, the Administrator shall, subject to section 14, make available to the public via the Internetaccessible database described in paragraph (1) a description of 

all significant— 

(A) decisions made by the Administrator under this title; 

and 

(B) information submitted pursuant to this title. 

(j) RECORDS OF SIGNIFICANT ADVERSE REACTIONS.— (1) IN GENERAL.—Any person that manufactures, processes, or 

distributes in commerce any chemical substance shall maintain, 

and on request submit to the Administrator, records of significant adverse reactions to human health or the environment, as 

determined by the Administrator by rule, alleged to have been 

caused by the substance or mixture. 

(2) DURATION.— (A) IN GENERAL.—Records of the adverse reactions to the 

health of employees shall be retained for a period of 30 

years after the date on which the reactions were first reported to or known by the person maintaining the records. 

(B) OTHER RECORDS.—Any record of other adverse reactions shall be retained for a period of 5 years after the date 

on which information contained in the record was first reported to or known by the person maintaining the record. 

(3) CONTENTS.—Records required to be maintained under 

this subsection shall include— 

(A) records of consumer allegations of personal injury or 

harm to health; 

(B) reports of occupational disease or injury; and 

(C) reports or complaints of injury to the environment 

submitted to the manufacturer, processor, or distributor in 

commerce from any source. 

(k) INFORMATION IN THE POSSESSION OF OTHER FEDERAL AGEN- CIES.— 

(1) SYNOPSES.— (A) IN GENERAL.—Notwithstanding any other provision of 

law, from time to time, each Federal agency and Federal 

institution shall submit to the Administrator a synopsis of 

the data and records in the possession or control of the 

agency or institution, respectively, that may be useful to the 

Administrator in carrying out this Act. 

(B) FORMAT AND CONTENT.—Not later than 1 year after 

the date of enactment of the Safe Chemicals Act of 2011, 

the Administrator shall prescribe, by order, the format, content, and level of detail of the synopses. 

(C) INITIAL SUBMISSION.—Not later than 18 months after 

the date of enactment of the Safe Chemicals Act of 2011, 

each Federal agency and Federal institution shall make the 

initial submission of a synopsis of the agency and institution, respectively, to the Administrator. 

(D) UPDATES.—At least once every 3 years, each Federal 

agency and Federal institution shall— 

(i) update the synopsis of the agency and institution, 

respectively; and 


tjames on DSK6SPTVN1PROD with 
112 

(ii) submit the updated synopsis to the Administrator. 

(2) REQUESTS BY THE ADMINISTRATOR.—Notwithstanding any 

other provision of law, on the request of the Administrator, any 

information in the possession or control of an agency or institution relating to a hazard of, use of, exposure to, or risk of, a 

chemical substance (or mixture or article containing that chemical substance) shall be submitted to the Administrator. 

(l) NOTICE TO ADMINISTRATOR OF SUBSTANTIAL RISKS.—Any person that manufactures, processes, or distributes in commerce a 

chemical substance and that obtains information that reasonably 

supports the conclusion that the substance presents a substantial 

risk of injury to health or the environment shall immediately inform 

the Administrator of the information unless the person has actual 

knowledge that the Administrator has been adequately informed of 

the information. 

(m) CERTIFICATION.—Each submission required pursuant to this 

section or pursuant to a rule or an order promulgated or issued by 

the Administrator under this section, other than a submission under 

subsection (k), shall be accompanied by a certification signed by a 

responsible official of the manufacturer, processor, distributor, user, 

or disposer of a chemical substance that each statement contained 

in the submission— 

(1) is accurate and reliable; and 

(2) includes all material facts required by the applicable provision of this section or rule or order under this section. 

(n) ADMINISTRATION.— (1) IN GENERAL.—Nothing in this section limits the authority 

of the Administrator to require reporting under any other provision of this Act by any person who manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance, 

or a mixture or article containing a chemical substance. 

(2) VIOLATIONS.—In addition to all other authorities available for the enforcement of this Act, the Administrator may, by 

order, take any action authorized under section 6(f) if a person 

who manufactures, processes, distributes in commerce, uses, or 

disposes of a chemical substance, or a mixture or article containing a chemical substance violates any provision of this section. 

(1) REPORT.— 

(A) IN GENERAL.—If the Administrator determines that 

the manufacture, processing, distribution in commerce, use, 

or disposal of a chemical substance, or that any combination of those activities, does not meet a safety standard 

under this title or requires conditions or restrictions in 

order to the meet the safety standard, and the Administrator determines that action may be taken under a Federal 

law not administered by the Administrator to address the 

uses of, or exposure to, the chemical substance, the Administrator shall submit to the agency that administers the 

Federal law a report that— 

(i) describes with specification the activity or combination of activities that prevent the chemical substance from meeting the safety standard or restrictions 


tjames on DSK6SPTVN1PROD with 
113 

or conditions required to meet the safety standard 

under this title; 

(ii) requests that the agency— 

(I) determine whether the 1 or more actions may 

be taken under Federal law administered by the 

agency; 

(II) if the agency determines under clause (i) that 

the 1 or more actions may be taken, initiate and 

provide a timetable for the 1 or more actions; and 

(III) respond to the Administrator with respect to 

the matters described in the report; and 

(iii) includes a detailed statement of the information 

on which the report is based. 

(B) PUBLICATION.—A report of the Administrator submitted under subparagraph (A) shall be promptly published in the Federal Register. 

(C) ACTION BY RECIPIENT AGENCY.—Not later than 90 

days after the date of receipt of a report from the Administrator under subparagraph (A), or by such earlier date as 

the Administrator may specify in such a report, an agency 

that receives the report shall— 

(i) make all determinations requested by the Administrator in the report; 

(ii) take all action necessary to ensure that a chemical substance meets the safety standard under this 

title, if appropriate; 

(iii) include with the response of the agency a detailed statement of the findings and conclusions of the 

agency; and 

(iv) publish that statement in the Federal Register. 

(2) INITIATION OF ACTION.—If the Administrator submits a report under paragraph (1) with respect to a chemical substance 

to an agency, and the agency that receives the report initiates, 

within the period specified in the request under paragraph (1), 

a civil action under Federal law administered by the agency to 

ensure that a chemical substance meets the safety standard 

under this title, or requires restrictions or conditions to meet 

that safety standard, the Administrator may not take action 

under this Act with respect to the civil action (other than any 

action taken pursuant to section 7). 

SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS. 

(a) LAWS NOT ADMINISTERED BY THE ADMINISTRATOR.—ø(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 and determines, in the Administrator’s 

discretion, that such risk 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— 


tjames on DSK6SPTVN1PROD with 
114 

ø(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 

ø(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 

ø(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. 

ø(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— 

ø(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 

ø(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 with respect to such risk.¿ 

(3) NO ACTION.—The Administrator may, by order, initiate 

action or a combination of actions under this Act to ensure compliance with the safety standard for a chemical substance under 

this title if— 

(A) the Administrator submits a report under paragraph 

(1) with respect to a chemical substance; and 

(B) the agency to which the report was submitted— 

(i) determines that action cannot be taken under the 

authorities of the agency; 

(ii) does not initiate action, if appropriate, within the 

period specified in the request under paragraph (1); 

(iii) does not complete the action within the timeframe provided by the agency; or 

(iv) fails to respond. 

ø(3)¿ ø(4) If the Administrator has initiated action under section 

6 or 7¿ 

(4) CONSULTATION.—If the Administrator has initiated action 

under this Act 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 


tjames on DSK6SPTVN1PROD with 
115 

purpose of avoiding duplication of Federal action øagainst 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, øthe Administrator shall not¿ Administrator 

(1) 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 healthø.¿; and 

(2) shall ensure that any actions to address workplace exposures 

that the Administrator takes or requires to be taken by manufacturers or processors of a chemical substance are consistent with the industrial hygiene hierarchy of controls 

(d) COORDINATION.—In administering this Act, the Administrator 

shall consult and coordinate with the Secretary of Health, Education, and Welfare 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 øwhile imposing the least burdens of duplicative requirements on those subject to the Act and for other purposes¿. The Administrator shallø, 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). 

øSEC. 11. INSPECTIONS AND SUBPOENAS. 

ø(a) IN GENERAL.—For purposes of administering this Act, the 

Administrator, and any duly designated representative of the Administrator, may inspect any establishment, facility, or other premises in which chemical substances, mixtures, or products subject to 

title IV are manufactured, processed, stored, or held before or after 

their distribution in commerce and any conveyance being used to 

transport chemical substances, mixtures, such products, or such articles in connection with distribution in commerce. Such an inspection may only be made upon the presentation of appropriate credentials and of a written notice to the owner, operator, or agent in 

charge of the premises or conveyance to be inspected. A separate 

notice shall be given for each such inspection, but a notice shall not 

be required for each entry made during the period covered by the 

inspection. Each such inspection shall be commenced and comVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00115 Fmt 6602 Sfmt 6602 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
116 

pleted with reasonable promptness and shall be conducted at reasonable times, within reasonable limits, and in a reasonable manner. 

ø(b) SCOPE.—(1) Except as provided in paragraph (2), an inspection conducted under subsection (a) shall extend to all things within the premises or conveyance inspected (including records, files, 

papers, processes, controls, and facilities) bearing on whether the 

requirements of this Act applicable to the chemical substances, 

mixtures, or products subject to title IV within such premises or 

conveyance have been complied with. 

ø(2) No inspection under subsection (a) shall extend to— 

ø(A) financial data, 

ø(B) sales data (other than shipment data), 

ø(C) pricing data, 

ø(D) personnel data, or 

ø(E) research data (other than data required by this Act or 

under a rule promulgated thereunder), 

unless, the nature and extent of such data are described with reasonable specificity in the written notice required by subsection (a) 

for such inspection. 

ø(c) SUBPOENAS.—In carrying out this Act, the Administrator 

may by subpoena require the attendance and testimony of witnesses and the production of reports, papers, documents, answers 

to questions, and other information that the Administrator deems 

necessary. Witnesses shall be paid the same fees and mileage that 

are paid witnesses in the courts of the United States. In the event 

of contumacy, failure, or refusal of any person to obey any such 

subpoena, any district court of the United States in which venue 

is proper shall have jurisdiction to order any such person to comply 

with such subpoena. Any failure to obey such an order of the court 

is punishable by the court as a contempt thereof.¿ 

SEC. 11. INSPECTIONS AND SUBPOENAS. 

(a) INSPECTIONS.— 

(1) IN GENERAL.—For purposes of administering this Act, the 

Administrator, and any duly designated representative of the 

Administrator, may inspect— 

(A) any establishment, facility, or other premises in 

which chemical substances, mixtures, or articles subject to 

this Act are manufactured, processed, stored, or held before 

or after distribution in commerce; 

(B) any conveyance being used to transport such chemical 

substances, mixtures, or articles in connection with distribution in commerce; and 

(C) any place at which records relating to the chemical 

substances, mixtures, or articles, or otherwise relating to 

compliance with this Act, are held. 

(2) METHOD.—Each inspection under paragraph (1) shall 

be— 

(A) commenced and completed with reasonable promptness; and 

(B) conducted at reasonable times, within reasonable limits, and in a reasonable manner. 


tjames on DSK6SPTVN1PROD with 
117 

(3) SAMPLES.—The Administrator, and any duly designated 

representative of the Administrator, may inspect and obtain 

samples of any— 

(A) chemical substance, mixture, or article; and 

(B) container or labeling of a chemical substance, mixture, or article. 

(b) SCOPE.—An inspection conducted under subsection (a) shall 

extend to all things within the premises or conveyance inspected (including records, files, papers, processes, controls, and facilities) regarding whether the owner or operator of the premises, conveyance, 

or records has complied with provisions of this Act applicable to the 

chemical substances, mixtures, articles, or records. 

(c) INFORMATION GATHERING.— 

(1) IN GENERAL.—In carrying out this Act, the Administrator 

may require the attendance and testimony of witnesses and the 

production of such reports, papers, documents, items, answers 

to questions, and other information, including the development 

of analyses and other information, as the Administrator determines to be necessary. 

(2) PAYMENT OF WITNESSES.—A witness described in paragraph (1) shall be paid the same fees and mileage that are paid 

witnesses in the courts of the United States. 

(d) WARRANTS.—For purposes of enforcing this Act, upon a showing to an officer or court of competent jurisdiction that there is reason to believe that a provision of this Act has been violated, officers 

or employees duly designated by the Administrator are empowered 

to obtain and to execute warrants authorizing— 

(1) entry, inspection, and copying of records for purposes of 

this Act; and 

(2) the seizure of any chemical substance, mixture, or article 

that is in violation of this Act. 

SEC. 12. EXPORTS. 

ø(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— 

ø(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 

ø(B) such substance, mixture, or article (when distributed in 

commerce), or any container in which it is enclosed (when so 

distributed), bears a stamp or label stating that such substance, mixture, or article is intended for export. 

ø(2) Paragraph (1) shall not apply to any chemical substance, 

mixture, or article if the Administrator finds that the substance, 

mixture, or article will present an unreasonable risk of injury to 

health within the United States or to the environment of the 

United States. The Administrator may require, under section 4, 

testing of any chemical substance or mixture exempted from this 

Act by paragraph (1) for the purpose of determining whether or not 

such substance or mixture presents an unreasonable risk of injury 


tjames on DSK6SPTVN1PROD with 
118 

to health within the United States or to the environment of the 

United States.¿ 

ø(b)¿ (a) NOTICE.—(1) If any person exports øor intends to export¿ to a foreign country a chemical substance or mixture for 

which the submission of data is required under øsection 4 or 5(b)¿ 

section 4, 5, or 6(b), such person shall notify the Administrator of 

such exportation øor intent to export¿ , not later than 30 days after 

the date of exportation of the substance or mixture, and the Administrator shall promptly thereafter 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 øor intends to export¿ to a foreign country a chemical substance or mixture for which øan 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¿ an action has been 

taken pursuant to section 6 or 7, such person shall notify the Administrator of such exportation øor intent to export¿ , not later 

than 30 days after the date of exportation of the substance or mixture, and the Administrator shall promptly thereafter furnish to the 

government of such country notice of øsuch rule, order, action, or 

relief¿ the action taken pursuant to section 6 or 7. 

(3) CHANGE IN EXPORT STATUS.— 

(A) IN GENERAL.—Any person that has notified the Administrator of the exportation of a chemical substance or mixture 

under this section shall notify the Administrator of any change 

in the export status of the substance or mixture by not later 

than 30 days after such a change in status. 

(B) UPDATED NOTICE.—The Administrator shall promptly furnish an updated notice to the governments that have been notified pursuant to paragraphs (1) and (2) regarding the exportation of any chemical substance or mixture subject to this section if— 

(i) data for the substance or mixture have been received 

by the Administrator pursuant to section 4, 5, 6(b), or 8; 

(ii) a change has occurred in the export status of the substance or mixture; or 

(iii) a change has been made in any risk management action taken pursuant to section 6 or 7 for the substance or 

mixture. 

ø(c)¿ (b) PROHIBITION ON EXPORT OF ELEMENTAL MERCURY.— 

(1) PROHIBITION.—Effective January 1, 2013, the export of 

elemental mercury from the United States is prohibited. 

ø(2) INAPPLICABILITY OF SUBSECTION (a).—Subsection (a) 

shall not apply to this subsection.¿ 

ø(3)¿(2) 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— 


tjames on DSK6SPTVN1PROD with 
119 

(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. 

ø(4)¿(3) ESSENTIAL USE EXEMPTION.—(A) Any person residing 

in the United States may petition the Administrator for an exemption from the prohibition in paragraph (1), and the Administrator may grant by rule, after notice and opportunity for 

comment, an exemption for a specified use at an identified foreign facility if the Administrator finds that— 

(i) nonmercury alternatives for the specified use are not 

available in the country where the facility is located; 

(ii) there is no other source of elemental mercury available from domestic supplies (not including new mercury 

mines) in the country where the elemental mercury will be 

used; 

(iii) the country where the elemental mercury will be 

used certifies its support for the exemption; 

(iv) the export will be conducted in such a manner as to 

ensure the elemental mercury will be used at the identified facility as described in the petition, and not otherwise 

diverted for other uses for any reason; 

(v) the elemental mercury will be used in a manner that 

will protect human health and the environment, taking 

into account local, regional, and global human health and 

environmental impacts; 

(vi) the elemental mercury will be handled and managed 

in a manner that will protect human health and the environment, taking into account local, regional, and global 

human health and environmental impacts; and 

(vii) the export of elemental mercury for the specified 

use is consistent with international obligations of the 

United States intended to reduce global mercury supply, 

use, and pollution. 

(B) Each exemption issued by the Administrator pursuant to 

this paragraph shall contain such terms and conditions as are 


tjames on DSK6SPTVN1PROD with 
120 

necessary to minimize the export of elemental mercury and ensure that the conditions for granting the exemption will be 

fully met, and shall contain such other terms and conditions as 

the Administrator may prescribe. No exemption granted pursuant to this paragraph shall exceed three years in duration and 

no such exemption shall exceed 10 metric tons of elemental 

mercury. 

(C) The Administrator may by order suspend or cancel an exemption under this paragraph in the case of a violation described in subparagraph (D). 

(D) A violation of this subsection or the terms and conditions 

of an exemption, or the submission of false information in connection therewith, shall be considered a prohibited act under 

section 15, and shall be subject to penalties under section 16, 

injunctive relief under section 17, and citizen suits under section 20. 

ø(5)¿(4) CONSISTENCY WITH TRADE OBLIGATIONS.—Nothing in 

this subsection affects, replaces, or amends prior law relating 

to the need for consistency with international trade obligations. 

ø(6)¿(5) EXPORT OF COAL.—Nothing in this subsection shall 

be construed to prohibit the export of coal. 

(c) PUBLIC RECORDS.—The Administrator shall— 

(1) maintain copies of all current notices provided to other 

governments under this section; and 

(2) make such copies available to the public in electronic format. 

SEC. 13. ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES. 

(a) IN GENERAL.—(1) The øSecretary of the Treasury¿ Secretary 

of Homeland Security shall refuse entry into the customs territory 

of the United States (as defined in general note 2 of the Harmonized Tariff Schedule of the United States) of any chemical substance, mixture, or article containing a chemical substance or mixture offered for such entry øif—¿ 

ø(A) it fails to comply with any rule in effect under this Act, 

or 

ø(B) it is offered for entry in violation of section 5, 6, or title 

IV a rule or order under section 5, 6, or title IV or an order 

issued in a civil action brought under section 5, 7 or title IV.¿ 

if the substance, mixture, or article fails to comply with or is 

offered for entry in violation of any rule or order in effect under 

this Act. 

(2) If a chemical substance, mixture, or article is refused entry 

under paragraph (1), the øSecretary of the Treasury¿ Secretary of 

Homeland Security shall notify the consignee of such entry refusal, 

shall not release it to the consignee, and shall cause its disposal 

or storage (under such rules as the øSecretary of the Treasury¿ 

Secretary of Homeland Security may prescribe) if it has not been 

exported by the consignee within 90 days from the date of receipt 

of notice of such refusal, except that the øSecretary of the Treasury¿ Secretary of Homeland Security may, pending a review by the 

Administrator of the entry refusal, release to the consignee such 

substance, mixture, or article on execution of bond for the amount 

of the full invoice of such substance, mixture, or article (as such 

value is set forth in the customs entry), together with the duty 


tjames on DSK6SPTVN1PROD with 
121 

thereon. On failure to return such substance, mixture, or article for 

any cause to the custody of the øSecretary of the Treasury¿ Secretary of Homeland Security when demanded, such consignee shall 

be liable to the United States for liquidated damages equal to the 

full amount of such bond. All charges for storage, cartage, and 

labor on and for disposal of substances, mixtures, or articles which 

are refused entry or released under this section shall be paid by 

the owner or consignee, and in default of such payment shall constitute a lien against any future entry made by such owner or consignee. 

(3) IMPORT AS PART OF AN ARTICLE.—Chemical substances 

and mixtures imported as part of an article shall be subject to 

the same requirements under this Act as if the substances and 

mixtures had been imported in bulk, except as the Administrator may provide by rule under this Act, or as the Secretary 

of Homeland Security may provide by rule under subsection (b). 

(b) RULES.—The øSecretary of the Treasury¿ , Secretary of Homeland Security after consultation with the Administrator, shall issue 

rules for the administration of subsection (a) of this section. 

øSEC. 14. DISCLOSURE OF DATA. 

ø(a) IN GENERAL.—Except as provided by subsection (b), any information reported to, or otherwise obtained by, the Administrator 

(or any representative of the Administrator) under this Act, which 

is exempt from disclosure pursuant to subsection (a) of section 552 

of title 5, United States Code, by reason of subsection (b)(4) of such 

section, shall, notwithstanding the provisions of any other section 

of this Act, not be disclosed by the Administrator or by any officer 

or employee of the United States, except that such information— 

ø(1) shall be disclosed to any officer or employee of the 

United States— 

ø(A) in connection with the official duties of such officer 

or employee under any law for the protection of health or 

the environment, or 

ø(B) for specific law enforcement purposes; 

ø(2) shall be disclosed to contractors with the United States 

and employees of such contractors if in the opinion of the Administrator such disclosure is necessary for the satisfactory 

performance by the contractor of a contract with the United 

States entered into on or after the date of enactment of this 

Act for the performance of work in connection with this Act 

and under such conditions as the Administrator may specify; 

ø(3) shall be disclosed if the Administrator determines it necessary to protect health or the environment against an unreasonable risk of injury to health or the environment; or 

ø(4) may be disclosed when relevant in any proceeding under 

this Act, except that disclosure in such a proceeding shall be 

made in such manner as to preserve confidentiality to the extent practicable without impairing the proceeding. 

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. 


tjames on DSK6SPTVN1PROD with 
122 

ø(b) DATA FROM HEALTH AND SAFETY STUDIES.—(1) Subsection 

(a) does not prohibit the disclosure of— 

ø(A) any health and safety study which is submitted under 

this Act with respect to— 

ø(i) any chemical substance or mixture which, on the 

date on which such study is to be disclosed has been offered for commercial distribution, or 

ø(ii) any chemical substance or mixture for which testing 

is required under section 4 or for which notification is required under section 5, and 

ø(B) any data reported to, or otherwise obtained by, the Administrator from a health and safety study which relates to a 

chemical substance or mixture described in clause (i) or (ii) of 

subparagraph (A). 

This paragraph does not authorize the release of any data which 

discloses processes used in the manufacturing or processing of a 

chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any 

of the chemical substances in the mixture. 

ø(2) If a request is made to the Administrator under subsection 

(a) of section 552 of title 5, United States Code, for information 

which is described in the first sentence of paragraph (1) and which 

is not information described in the second sentence of such paragraph, the Administrator may not deny such request on the basis 

of subsection (b)(4) of such section. 

ø(c) DESIGNATION AND RELEASE OF CONFIDENTIAL DATA.—(1) In 

submitting data under this Act, a manufacturer, processor, or distributor in commerce may (A) designate the data which such person believes is entitled to confidential treatment under subsection 

(a), and (B) submit such designated data separately from other 

data submitted under this Act. A designation under this paragraph 

shall be made in writing and in such manner as the Administrator 

may prescribe. 

ø(2)(A) Except as provided by subparagraph (B), if the Administrator proposes to release for inspection data which has been designated under paragraph (1)(A), the Administrator shall notify, in 

writing and by certified mail, the manufacturer, processor, or distributor in commerce who submitted such data of the intent to release such data. If the release of such data is to be made pursuant 

to a request made under section 552(a) of title 5, United States 

Code, such notice shall be given immediately upon approval of such 

request by the Administrator. The Administrator may not release 

such data until the expiration of 30 days after the manufacturer, 

processor, or distributor in commerce submitting such data has received the notice required by this subparagraph. 

ø(B)(i) Subparagraph (A) shall not apply to the release of information under paragraph (1), (2), (3), or (4) of subsection (a), except 

that the Administrator may not release data under paragraph (3) 

of subsection (a) unless the Administrator has notified each manufacturer, processor, and distributor in commerce who submitted 

such data of such release. Such notice shall be made in writing by 

certified mail at least 15 days before the release of such data, except that if the Administrator determines that the release of such 

data is necessary to protect against an imminent, unreasonable 


tjames on DSK6SPTVN1PROD with 
123 

risk of injury to health or the environment, such notice may be 

made by such means as the Administrator determines will provide 

notice at least 24 hours before such release is made. 

ø(ii) Subparagraph (A) shall not apply to the release of information described in subsection (b)(1) other than information described 

in the second sentence of such subsection. 

ø(d) CRIMINAL PENALTY FOR WRONGFUL DISCLOSURE.—(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. 

ø(2) For the purposes of paragraph (1), any contractor with the 

United States who is furnished information as authorized by subsection (a)(2), and any employee of any such contractor, shall be 

considered to be an employee of the United States. 

ø(e) ACCESS BY CONGRESS.—Notwithstanding any limitation contained in this section or any other provision of law, all information 

reported to or otherwise obtained by the Administrator (or any representative of the Administrator) under this Act shall be made 

available, upon written request of any duly authorized committee 

of the Congress, to such committee.¿ 

SEC. 14. DISCLOSURE OF DATA. 

(a) APPLICABILITY.— (1) IN GENERAL.—Subject to paragraph (2) and except as provided under subsections (b) and (e), any information reported 

to, or otherwise obtained by, the Administrator (or any representative of the Administrator) that is exempt from disclosure 

under subsection (a) of section 552 of title 5, United States 

Code, (commonly known as the ‘‘Freedom of Information Act’’) 

under subsection (b)(4) of that section, shall not be disclosed by 

the Administrator or by any officer or employee of the United 

States, unless the designation of the information as exempt 

from disclosure is prohibited under Federal law. 

(2) EXEMPTIONS.— 

(A) MANDATORY EXEMPTIONS.—Notwithstanding any 

other provision of law, the Administrator shall disclose the 

information described in paragraph (1)— 

(i) to any officer or employee of the United States— 

(I) in connection with the official duties of that 

officer or employee under any law for the protection of human health or the environment; or 

(II) for specific law enforcement purposes; 

(ii) to a contractor with the United States and employees of that contractor if, in the opinion of the Administrator, the disclosure is necessary for the satisfactory performance by the contractor of a contract with 


tjames on DSK6SPTVN1PROD with 
124 

the United States entered into on or after the date of 

enactment of the Safe Chemicals Act of 2011 for the 

performance of work in connection with this Act and 

under such conditions as the Administrator may specify; 

(iii) if the Administrator determines that the disclosure is necessary to protect human health or the environment; 

(iv) on request, to a State or tribal government for 

the purpose of development or potential development, 

administration, or enforcement of a law, if 1 or more 

applicable agreements ensure that the recipient government will take appropriate steps, and has adequate authority, to maintain the confidentiality of the information in accordance with procedures comparable to those 

which the Administrator uses to safeguard the information; 

(v) on request, to public health or environmental 

health professionals or medical personnel if the Administrator determines that— 

(I) disclosure is in the public interest; 

(II) the recipient does not have a conflict of interest or competitive interest with respect to the submitter of the information; and 

(III) 1 or more applicable agreements are in 

place to ensure that the recipient of the information provides comparable protections to those provided by the Administrator to maintain the confidentiality of the information. 

(B) OPTIONAL EXEMPTIONS.—Notwithstanding any other 

provision of law, the Administrator may disclose the information described in paragraph (1) if 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 maximum extent practicable without impairing the proceeding. 

(3) EFFECT ON OTHER LAWS.—In any proceeding under section 

552(a) of title 5, United States Code (commonly referred to as 

the ‘Freedom of Information Act’), to obtain information, the 

disclosure of which has been denied pursuant to this section, 

the Administrator may not rely on subsection (b)(3) of that section to sustain the action of the Administrator. 

(b) CATEGORIES OF CONFIDENTIAL BUSINESS INFORMATION.— 

(1) INFORMATION THAT IS ALWAYS ELIGIBLE FOR PROTECTION.—Subject to subsection (a)(2) and any other applicable 

provision of Federal law, the Administrator shall review and 

approve a request that conforms to the requirements described 

in subsection (c)(2) to treat as confidential under this section 

the following information: 

(A) Precise information describing the manufacture, processing, or distribution of a chemical substance or mixture. 

(B) Marketing and sales information. 

(C) Information identifying the customers of a manufacturer, processor, or distributor. 


tjames on DSK6SPTVN1PROD with 
125 

(D) Details of the full composition of a mixture of a particular manufacturer or processor. 

(E) Precise information about the use, function, or application of a chemical substance or mixture in a process, mixture, or product of a particular manufacturer or processor. 

(F) Precise production or import volumes of a particular 

manufacturer, processor, or distributor. 

(2) INFORMATION THAT MAY BE ELIGIBLE FOR PROTECTION.— (A) IN GENERAL.—Subject to subsection (a) and any other 

applicable provision of Federal law, and except as provided 

in paragraphs (1) and (3), information submitted by a 

manufacturer, processor, or distributor to the Administrator may be protected if the manufacturer, processor, or 

distributor complies with subsection (c)(2) and the Administrator determines that a request to maintain the confidentiality of the information meets the applicable requirements 

of this subsection and any rule promulgated by the Administrator under subsection (c)(1). 

(B) IDENTITIES OF CERTAIN CHEMICAL SUBSTANCES.— (i) IN GENERAL.—Notwithstanding subparagraph (A), 

the Administrator shall not disclose precise information on the identity of a chemical substance if— 

(I) the manufacturer or processor of the substance has, in accordance with subsection (c)(2)— 

(aa) included in a notice under section 5(b) 

a request, including a justification and documentation for the request, that the identity of 

the substance be treated as confidential business information; or 

(bb) submitted to the Administrator not 

later than 180 days after the date of enactment of the Safe Chemicals Act of 2011 a request, including a justification and documentation for the request, that the identity of 

a substance for which a notice has been submitted under section 5(b) as of the date of enactment of the Safe Chemicals Act of 2011 be 

treated as confidential business information; 

and 

(II) the Administrator determines that— 

(aa) the request complies with all applicable 

requirements of this section; 

(bb) the chemical identity is not readily discoverable through reverse engineering; 

(cc) the manufacturer or processor takes reasonable measures to protect the confidentiality 

of the chemical substance; 

(dd) no other Federal statute requires disclosure; 

(ee) disclosure of the identity of the chemical 

substance would cause financial or competitive 

harm to the manufacturer or processor; 

(ff) the chemical substance is not, based on 

information that is initially available or that 


tjames on DSK6SPTVN1PROD with 
126 

later becomes available to the Administrator, a 

known or probable reproductive, developmental, neurological, or immunological toxicant, carcinogen, or mutagen; 

(gg) the chemical substance is not persistent, 

bioaccumulative, and toxic; and 

(hh) if a safety standard determination has 

been made for a chemical substance, the Administrator determines that the chemical substance meets the applicable safety standard either under current conditions or under additional conditions required by the Administrator. 

(ii) NOTICE.—In cases where all of the requirements 

specified in clause (i) are met— 

(I) the notice required to be made public by the 

Administrator under section 5(f)(3) shall include a 

justification for the determination of the Administrator and identify the chemical substance by generic class unless the Administrator determines 

that more specific identification is required in the 

public interest; and 

(II) as part of a claim to protect the identity of 

a chemical substance under subsection (c)(2), a 

manufacturer or processor may provide a ‘public 

name’ for the chemical substance for use by the 

Administrator when sharing information on the 

chemical substance under this subsection. The 

public names should disclose a maximum amount 

of information on the chemical structure of the 

substance, while protecting those features of the 

chemical structure that are considered confidential 

and the disclosure of which would potentially 

harm the owner of that information. 

(iii) DURATION OF PROTECTION FOR CHEMICAL IDEN- TITY.—Notwithstanding subsection (c)(1)(B)(iv), the 

identity of a chemical substance for which a request 

has been submitted pursuant to clause (i)(I) and meets 

the requirements of clause (i) shall be protected as confidential business information— 

(I) for such period of time as the Administrator, 

after reviewing the request, determines to be reasonable; and 

(II) upon expiration of a time period specified 

under this clause, for an additional 5-year period, 

if the Administrator, after reviewing the request, 

determines that the request for protection continues 

to meet the criteria established in this subparagraph. 

(iv) PUBLICATION REQUIREMENT.—The Administrator 

shall annually publish a notice that— 

(I) includes an updated, cumulative list of each 

new chemical substance for which the Administrator has approved a request to protect informaVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00126 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
127 

tion under this paragraph, identified by a unique 

identifier, other than the precise chemical identity, 

and including the period of time for which the protection applies; and 

(II) for each chemical substance for which the 

protection provided under this paragraph has expired, provides the precise identity of the chemical 

substance, and provides public access to any information that had been submitted to the Administrator which concealed the identity of the chemical 

substance in accordance with this paragraph. 

(C) IMPURITIES.—Notwithstanding subparagraph (A), the 

Administrator may determine not to disclose information 

relating to the degree of purity or the identity of impurities 

present in a chemical substance or mixture if the Administrator determines that knowledge of the information would 

reveal processes used in the manufacturing or processing of 

the chemical substance or mixture. 

(3) INFORMATION THAT IS NEVER ELIGIBLE FOR PROTECTION.— 

(A) IN GENERAL.—Except as provided in paragraph (2), 

the Administrator shall disclose the following information: 

(i) The identity of a chemical substance. 

(ii) Any safety standard determination developed 

under section 6, including supporting analysis developed by the Administrator. 

(iii) Any health and safety study data that is submitted under this Act with respect to— 

(I) any chemical substance or mixture— 

(aa) that has been offered for commercial 

distribution as of the date on which the study 

is to be disclosed; or 

(bb) for which testing is required under section 4 or for which notification is required 

under section 5; and 

(II) any data reported to, or otherwise obtained 

by, the Administrator from a health and safety 

study that relates to a chemical substance or mixture described in subclause (I). 

(iv) Health and safety data in notices of substantial 

risk submitted pursuant to section 8(l) and in the underlying studies. 

(v) General information describing the manufacturing volumes, expressed in ranges, and industrial, 

commercial, or consumer functions and uses of a chemical substance or mixture. 

(vi) Any information indicating the presence of a 

chemical substance in consumer products intended for 

use, or reasonably expected to be used, by children aged 

14 years or younger, if— 

(I) the Administrator, or another authoritative 

body, has determined that the chemical substance— 


tjames on DSK6SPTVN1PROD with 
128 

(aa) is a known or probable reproductive, 

developmental, neurological, or immunological 

toxicant, carcinogen, or mutagen; or 

(bb) is persistent, bioaccumulative, and 

toxic; or 

(II) for a chemical substance for which a safety 

standard determination has been made, the Administrator has not found that the chemical substance meets the safety standard. 

(B) PROHIBITION.—Nothing in this paragraph authorizes 

the release of any data that discloses a process 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. 

(C) APPLICABILITY OF OTHER LAWS.—Except as provided 

in paragraph (2), if the Administrator receives a request for 

information under section 552(a) of title 5, United States 

Code, (commonly known as the ‘Freedom of Information 

Act’) for information described in subparagraph (A), which 

is not information described in subparagraph (B), the Administrator shall not deny the request under subsection 

(b)(4) of that section. 

(c) DESIGNATION AND TREATMENT OF CONFIDENTIAL BUSINESS INFORMATION.— 

(1) DUTIES OF THE ADMINISTRATOR.— 

(A) RULES.—Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator 

shall promulgate rules that specify— 

(i) the acceptable bases on which written requests to 

maintain confidentiality of information may be approved, which shall be consistent with the requirements 

of this section; 

(ii) the nature of the documentation and justification 

that must accompany such a request; and 

(iii) the types of information the Administrator determines warrant protection for an indefinite period of 

time, for which the term of confidentiality specified in 

subparagraph (B)(iv)(I) shall not apply. 

(B) REVIEW OF REQUESTS.— 

(i) IN GENERAL.—Not later than 90 days after the 

date of receipt of information under paragraph (2), the 

Administrator shall review a request to maintain confidentiality of information submitted under this Act 

and determine whether to approve, modify, or deny 

that request based on the regulations promulgated by 

the Administrator under subparagraph (A). 

(ii) PROCESS.—The Administrator shall, in accordance with clause (i)— 

(I) review all requests received to maintain confidentiality of submitted information; or 

(II) if it is not feasible for the Administrator to 

review all of the requests— 


tjames on DSK6SPTVN1PROD with 
129 

(aa) review all requests relating to information described in subsection (b)(2)(B); and 

(bb) review a representative subset that includes not less than 25 percent of all other requests received; and 

(III) publish in the Federal Register on at least 

an annual basis a description of the number and 

types of requests received and reviewed by the Administrator. 

(iii) DENIALS.—If a request to maintain confidentiality of submitted information is denied in accordance with subparagraph (D), the Administrator shall 

promptly make the information available to the public 

in accordance with section 8(i)(2). 

(iv) APPROVALS.—If a request to maintain confidentiality of submitted information is approved, the Administrator shall— 

(I) except with respect to requests subject to a 

rule issued pursuant to subparagraph (A)(iii) and 

requests submitted pursuant to subsection 

(b)(2)(B)(i)(I), specify a time period not to exceed 5 

years for which the submitted information shall be 

kept confidential, unless the information otherwise 

becomes available to the public during the period; 

and 

(II) upon the expiration of the protection period, 

make the information available to the public unless the manufacturer, processor, or distributor has 

submitted, documented, and justified to the satisfaction of the Administrator and in accordance 

with this subsection the basis for a renewal of the 

protection, for a time period not to exceed 5 years. 

(C) AUTHORITY OF THE ADMINISTRATOR.—Nothing in subparagraph (A) or (B) limits the authority of the Administrator to determine that particular information, previously 

treated as confidential, is no longer entitled to confidential 

treatment. 

(D) NOTIFICATIONS.— 

(i) IN GENERAL.—Except as provided in clause (ii), if 

the Administrator proposes to release information for 

which a request for confidential treatment has been approved under this section, the Administrator shall electronically notify the manufacturer, processor, or distributor in commerce who submitted the request of the 

intent of the Administrator to release the information 

not less than 15 days prior to the release of the information. 

(ii) ADMINISTRATION.—The Administrator shall release the information described in clause (i) in accordance with the disclosure and procedural requirements 

of section 552 of title 5, United States Code (commonly 

known as the ‘Freedom of Information Act’), except 

that— 


tjames on DSK6SPTVN1PROD with 
130 

(I) if the release of the information is to be made 

pursuant to a request made under section 552(a) of 

title 5, United States Code, the notice shall be 

given immediately upon approval of the request by 

the Administrator; 

(II) if the Administrator determines that the release of information pursuant to subsection 

(a)(2)(A)(iii) is necessary to protect against imminent and substantial harm to human health or the 

environment, no notice shall be required; and 

(III) the requirements of this subparagraph shall 

not apply to the release of information under— 

(aa) clauses (i) through (iii) of subsection 

(a)(2)(A); or 

(bb) subsection (b)(3)(A). 

(2) DUTIES OF MANUFACTURERS, PROCESSORS, AND DISTRIBU- TORS.— 

(A) IN GENERAL.—In submitting data under this Act, a 

manufacturer, processor, or distributor in commerce may— 

(i) designate information, other than information described in subsection (b)(3), for which the manufacturer, processor, or distributor requests confidential 

treatment under subsection (a) or (b); and 

(ii) submit the designated data separately from other 

data submitted under this Act. 

(B) REQUIREMENTS.—A designation under this paragraph shall be made in writing and in such manner as the 

Administrator may prescribe, and shall include— 

(i) documentation and justification for each request 

for confidentiality, except for requests relating to the information described in subsection (b)(1); 

(ii) the period of time for which maintenance of confidentiality of the information is requested except with 

respect to requests subject to a rule issued pursuant to 

subsection (c)(1)(A)(iii); 

(iii) a certification that the information is not otherwise publicly available; 

(iv) separate copies of all submitted information, 

with 1 copy containing and 1 copy excluding the information to which the request applies; and 

(v) any additional information required by the Administrator. 

(C) REQUEST FOR RENEWAL.—Prior to the expiration of 

the specified time period determined by the Administrator 

under paragraph (1)(B)(iv), a manufacturer, processor, or 

distributor may submit a request for renewal of protection 

for protected information. This request for renewal shall 

follow the same procedures and requirements as the initial 

submission under subparagraphs (A) and (B). 

(d) CIVIL PENALTY FOR WRONGFUL DISCLOSURE OR WRONGFUL

REQUESTS FOR PROTECTION.— 

(1) IN GENERAL.—Any officer or employee of the United States 

or former officer or employee of the United States, who, by virtue of employment or official position has obtained possession 


tjames on DSK6SPTVN1PROD with 
131 

of, or has access to, material the disclosure of which is prohibited by subsection (a), and who knowing that disclosure of the 

material is prohibited by that subsection, willfully discloses the 

material in any manner to any person not entitled to receive the 

information, shall be subject to appropriate disciplinary action 

and subject to a civil money penalty of not more than $10,000 

for each violation. 

(2) APPLICABILITY OF OTHER LAWS.—Section 1905 of title 18, 

United States Code, shall not apply with respect to the publishing, divulging, disclosure, making known, or making available of, information reported or otherwise obtained under this 

Act. 

(3) CONTRACTORS.—For the purposes of paragraph (1), any 

contractor with the United States who is furnished information 

as authorized by subsection (a)(2), including any employee of 

such a contractor, shall be considered to be an employee of the 

United States. 

(4) FALSE REQUESTS.—Any officer or employee of a company 

that submits information under this Act who willfully designates information as eligible for confidential treatment, knowing that the information is ineligible for such treatment, shall 

be subject to a civil money penalty of not more than $10,000 for 

each such violation. 

(e) ACCESS BY CONGRESS.—Notwithstanding 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, on written request 

of any duly authorized committee of Congress, to that committee. 

(f) RISK INFORMATION FOR WORKERS.—The Administrator shall 

facilitate the sharing of information that pertains to chemical substances or mixtures or articles containing chemical substances that 

workers may come into contact with or may otherwise be exposed to 

during the course of work with those workers and representatives of 

each certified or recognized bargaining agent representing those 

workers. Nothing in this subsection authorizes disclosure of information other than those disclosures that may be made pursuant to 

subsections (a) through (e). 

SEC. 15. PROHIBITED ACTS. 

It shall be unlawful for any person to— 

ø(1) fail or refuse to comply with (A) any rule promulgated 

or order issued under section 4, (B) any requirement prescribed 

by section 5 or 6, (C) any rule promulgated or order issued 

under section 5 or 6, or (D) any requirement of title II or any 

rule promulgated or order issued under title II;¿ 

(1) fail or refuse to comply with any rule, order, prohibition, 

restriction, or other requirement imposed by this Act or by the 

Administrator under this Act; 

(2) øuse¿ manufacture, process, distribute in commerce, use, 

or dispose of for commercial purposes a chemical substance øor 

mixture¿ , mixture, or articleø 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¿ any rule, order, prohibition, restriction, or other reVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00131 Fmt 6602 Sfmt 6602 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
132 

quirement imposed by this Act or by the Administrator under 

this Act; 

(3) fail or refuse to (A) establish or maintain acurate and 

complete records, (B) submit or make accurate and complete reports, notices, information submissions, disclosures, declarations, certifications, or other information, or (C) permit access 

to or copying of records, as required by this Act or a rule thereunder; øor¿ 

(4) fail or refuse to permit entry or inspection as required by 

section 11ø.¿; 

(5) make or submit a statement, declaration, disclosure, certification, writing, data set, or representation that is materially 

false, in whole or in part, or to falsify or conceal any material 

fact, in taking any action or making any communication pursuant to this Act or pursuant to any rule or order promulgated 

or issued under this Act; or 

(6) take any action prohibited by this Act. 

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, as described insection 15 or 409 shall be liable to the United States for 

a civil penalty in an amount not to exceed ø$25,000¿ $37,500 for 

each such violation. Each day such a violation continues shall, for 

purposes of this subsection, constitute a separate øviolation of section 15 or 409¿ violation of this Act. (2) In the case of any violation described in paragraph (1), 

the Administrator may commence a civil action in the appropriate United States district court to assess penalties pursuant 

to that paragraph. 

ø(2)¿(3)(A) A civil penalty for a violation of this Act, as described 

in 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, øwithin 15 days of¿ not later than 15 days after 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. 

ø(3)¿(4) Any person who requested in accordance with 

øparagraph (2)(A)¿ paragraph (3)(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 


tjames on DSK6SPTVN1PROD with 
133 

order with øthe United States Court of Appeals for the District of 

Columbia Circuit or for any other circuit¿ the appropriate district 

court of the United States for the district 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. 

ø(4)¿(5) 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 øparagraph (3)¿ 

paragraph (4), or 

(B) after a court in an action brought under øparagraph (3)¿ 

paragraph (4) 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 øparagraph (3)¿ paragraph (4) 

or the date of such final judgment, as the case may be) in an action 

brought in any appropriate district court of the United States. In 

such an action, the validity, amount, and appropriateness of such 

penalty shall not be subject to review. 

(b) CRIMINAL.—øAny person¿ 

(1) IN GENERAL.—Any person who knowingly øor willfully¿ 

violates any provision of this Act, as described in section 15 or 

409 shall, in addition to or in lieu of any civil penalty which 

may be imposed under subsection (a) of this section for such 

violation, be subject, upon conviction, to a fine of not more 

than ø$25,000¿ $50,000 for each day of violation, or to imprisonment for not more than øone year¿ 5 years, or both. 

(2) IMMINENT DANGER OF DEATH OR SERIOUS BODILY IN- JURY.— 

(A) IN GENERAL.—Any individual who knowingly violates 

any provision of this Act and who knows at the time that 

the violation places another person in imminent danger of 

death or serious bodily injury shall upon conviction be subject to a fine of not more than $250,000, or imprisonment 

of not more than 15 years, or both. 

(B) OTHER PERSONS.—A person that is not an individual 

shall, upon conviction of violating this paragraph, be subject to a fine of not more than $1,000,000. 

SEC. 17. SPECIFIC ENFORCEMENT AND SEIZURE. 

(a) SPECIFIC ENFORCEMENT.—ø(1) The district courts of the 

United States shall have jurisdiction over civil actions to— 

ø(A) restrain any violation of section 15 or 409, 

ø(B) restrain any person from taking any action prohibited 

by section 5, 6, or title IV, or by a rule or order under section 

5, 6, or title IV, 

ø(C) compel the taking of any action required by or under 

this Act, or¿ 

(1) AUTHORITY OF THE ADMINISTRATOR.— 

(A) IN GENERAL.—The Administrator may commence a 

civil action in the appropriate United States district court 

to compel compliance of any person with any provision of 


tjames on DSK6SPTVN1PROD with 
134 

this Act or any rule or order promulgated pursuant to this 

Act. 

(B) ENFORCEMENT.—The authority of the Administrator 

to enforce this Act includes the authority— 

(i) to seek civil or criminal penalties under section 16 

for any violation of this Act, as described in sections 15 

and 409; 

(ii) to enjoin any violation of this Act, or of a rule or 

order promulgated or issued under this Act, as described in sections 15 and 409; 

(iii) to order the compliance of any person with any 

provision of this Act, or with any rule or order promulgated or issued under this Act, through an administrative proceeding (which may proceed concurrently with 

action under this section), in which the Administrator 

may levy penalties under section 16 

ø(D) direct any manufacturer¿ 

(iv) to order any manufacturer;or processor of a 

chemical substance, mixture, or øproduct subject to 

title IV¿ article subject to this Act manufactured or 

processed in violation øof section 5, 6, or title IV¿ this 

Act, or a rule or order øunder section 5, 6, or title IV¿ 

promulgated and issued under this Act, as described in 

section 15 or 409, and distributed in commerce,ø(i)¿ 

(I) to give notice of such fact to distributors in 

commerce of such substance, mixture, or 

øproduct¿ article and, to the extent reasonably ascertainable, to other persons in possession of such 

substance, mixture, or øproduct¿ article or exposed to such substance, mixture, or øproduct¿ article, ø(ii)¿ 

(II) to give public notice of such risk of injury, 

and ø(iii)¿ 

(III) to either replace or repurchase such substance, mixture, or øproduct¿ article, whichever 

the person to which the requirement is directed 

elects. 

ø(2) A civil action described in paragraph (1) may be brought— 

ø(A) in the case of a civil action described in subparagraph 

(A) of such paragraph¿ 

(2) CIVIL ACTIONS.— 

(A) IN GENERAL.—The district courts of the United States 

shall have jurisdiction over a civil action described in paragraph (1). 

(B) REQUIREMENTS.—A civil action described in paragraph (1) may be brought— 

(i) in the case of a civil action described in subparagraphs (A) and (B) of paragraph (1), in the United 

States district court for the judicial district wherein 

any act, omission, or transaction constituting a violation øof section 15¿of this Act, as described in section 

15 or 409 occurred or wherein the defendant is found 

or transacts business, or 

ø(B)¿ 


tjames on DSK6SPTVN1PROD with 
135 

(ii) in the case of any other civil action described in 

øsuch paragraph¿ paragraph (1), in the United States 

district court for the judicial district wherein the defendant is found or transacts business. 

(3) SERVING OF PROCESS AND SUBPOENAS.—In any 

øIn any¿ such civil action process may be served on a defendant 

in any judicial district in which a defendant resides or may be 

found. Subpoenas requiring attendance of witnesses in any such action may be served in any judicial district. 

(b) SEIZURE.—Any chemical substance, mixture, or øproduct¿ article subject to øtitle IV¿ this Act which was manufactured, processed, or distributed in commerce in violation of this Act or any 

rule promulgated or order issued under this Act or any article containing such a substance or mixture shall be liable to be proceeded 

against, by process of libel for the seizure and condemnation of 

such substance, mixture, øproduct,¿ or article, in any district court 

of the United States within the jurisdiction of which such substance, mixture, øproduct,¿ or article is found. Such proceeding 

shall conform as nearly as possible to proceedings in rem in admiralty. 

øSEC. 18. PREEMPTION. 

ø(a) EFFECT ON STATE LAW.—(1) Except as provided in paragraph (2), nothing in this Act shall affect the authority of any State 

or political subdivision of a State to establish or continue in effect 

regulation of any chemical substance, mixture, or article containing 

a chemical substance or mixture. 

ø(2) Except as provided in subsection (b)— 

ø(A) if the Administrator requires by a rule promulgated 

under section 4 the testing of a chemical substance or mixture, 

no State or political subdivision may, after the effective date of 

such rule, establish or continue in effect a requirement for the 

testing of such substance or mixture for purposes similar to 

those for which testing is required under such rule; and 

ø(B) if the Administrator prescribes a rule or order under 

section 5 or 6 (other than a rule imposing a requirement described in subsection (a)(6) of section 6) which is applicable to 

a chemical substance or mixture, and which is designed to protect against a risk of injury to health or the environment associated with such substance or mixture, no State or political 

subdivision of a State may, after the effective date of such requirement, establish or continue in effect, any requirement 

which is applicable to such substance or mixture, or an article 

containing such substance or mixture, and which is designed 

to protect against such risk unless such requirement (i) is identical to the requirement prescribed by the Administrator, (ii) is 

adopted under the authority of the Clean Air Act or any other 

Federal law, or (iii) prohibits the use of such substance or mixture in such State or political subdivision (other than its use 

in the manufacture or processing of other substances or mixtures). 

ø(b) EXEMPTION.—Upon application of a State or political subdivision of a State the Administrator may by rule exempt from subsection (a)(2), under such conditions as may be prescribed in such 

rule, a requirement of such State or political subdivision designed 


tjames on DSK6SPTVN1PROD with 
136 

to protect against a risk of injury to health or the environment associated with a chemical substance, mixture, or article containing 

a chemical substance or mixture if— 

ø(1) compliance with the requirement would not cause the 

manufacturing, processing, distribution in commerce, or use of 

the substance, mixture, or article to be in violation of the applicable requirement under this Act described in subsection (a)(2), 

and 

ø(2) the State or political subdivision requirement (A) provides a significantly higher degree of protection from such risk 

than the requirement under this Act described in subsection 

(a)(2) and (B) does not, through difficulties in marketing, distribution, or other factors, unduly burden interstate commerce.¿ 

Nothing in this Act affects the right of a State or a political subdivision of a State to adopt or enforce any regulation, requirement, 

or standard of performance that is different from, or in addition to, 

a regulation, requirement, liability, or standard of performance established pursuant to this Act unless compliance with both this Act 

and the State or political subdivision of a State regulation, requirement, or standard of performance is impossible, in which case the 

applicable provisions of this Act shall control. 

SEC. 19. JUDICIAL REVIEW. 

(a) IN GENERAL.—ø(1)(A) Not later than 60 days after the date 

of the promulgation of a rule or order under section 4(a), 5(a)(2), 

5(b)(4), 6(a), 6(e), or 8, or under title II or IV,¿ 

(1) JUDICIAL REVIEW.—Not later than 60 days after the date 

of the promulgation or issuance of a rule under of this Act,any 

person may file a petition for judicial review of such rule or 

order 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 

ø(other than in an enforcement proceeding)¿ of such a rule or 

order if any district court of the United States would have had 

jurisdiction of such action but for this subparagraph. 

ø(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) if any district court of the United States 

would have had jurisdiction of such action but for this subparagraph.¿ 

(2) Copies of any petition filed under øparagraph (1)(A)¿ paragraph (1) shall be transmitted forthwith to the Administrator and 

to the Attorney General by the clerk of the court with which such 

petition was filed. The provisions of section 2112 of title 28, United 

States Code, shall apply to the filing of the rulemaking record of 

proceedings on which the Administrator based the rule or order 

being reviewed under this section and to the transfer of proceedings between United States courts of appeals. 

ø(3) For purposes of this section, the term ‘‘rulemaking record’’ 

means— 

ø(A) the rule being reviewed under this section; 


tjames on DSK6SPTVN1PROD with 
137 

1So in law. Probably should be followed by a comma. 

ø(B) in the case of a rule under section 4(a), the finding required by such section, in the case of a rule under section 

5(b)(4), the finding required by such section, in the case of a 

rule under section 6(a) the finding required by section 5(f) or 

6(a), as the case may be, in the case of a rule under section 

6(a), the statement required by section 6(c)(1), and in the case 

of a rule under section 6(e), the findings required by paragraph 

(2)(B) or (3)(B) of such section, as the case may be 1 and in the 

case of a rule under title IV, the finding required for the 

issuance of such a rule; 

ø(C) any transcript required to be made of oral presentations 

made in proceedings for the promulgation of such rule; 

ø(D) any written submission of interested parties respecting 

the promulgation of such rule; and 

ø(E) any other information which the Administrator considers to be relevant to such rule and which the Administrator 

identified, on or before the date of the promulgation of such 

rule, in a notice published in the Federal Register.¿ 

(b) ADDITIONAL SUBMISSIONS AND PRESENTATIONS; MODIFICATIONS.—If in an action under this section to review a rule or order 

the petitioner or the Administrator applies to the court for leave to 

make additional oral submissions or written presentations respecting such rule or order 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 or 

order being reviewed or make a new rule or order by reason of the 

additional submissions and presentations and shall file such modified or new rule or order with the return of such submissions and 

presentations. The court shall thereafter review such new or modified rule or order. 

(c) STANDARD OF REVIEW.—ø(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. 

ø(B) Section 706 of title 5, United States Code, shall apply to review of a rule under this section, except that— 

ø(i) in the case of review of a rule under section 4(a), 5(b)(4), 

6(a), or 6(e), 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; 


tjames on DSK6SPTVN1PROD with 
138 

ø(ii) in the case of review of a rule under section 6(a), the 

court shall hold unlawful and set aside such rule if it finds 

that— 

ø(I) a determination by the Administrator under section 

6(c)(3) that the petitioner seeking review of such rule is 

not entitled to conduct (or have conducted) cross-examination or to present rebuttal submissions, or 

ø(II) a rule of, or ruling by, the Administrator under section 6(c)(3) limiting such petitioner’s cross-examination or 

oral presentations, 

has precluded disclosure of disputed material facts which was 

necessary to a fair determination by the Administrator of the 

rulemaking proceeding taken as a whole; and section 706(2)(D) 

shall not apply with respect to a determination, rule, or ruling 

referred to in subclause (I) or (II); and 

ø(iii) the court may not review the contents and adequacy 

of— 

ø(I) any statement required to be made pursuant to section 6(c)(1), or 

ø(II) any statement of basis and purpose required by section 553(c) of title 5, United States Code, to be incorporated in the rule 

øexcept as part of a review of the rulemaking record taken as 

a whole. 

The term ‘‘evidence’’ as used in clause (i) means any matter in the 

rulemaking record. 

ø(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.¿ 

(1) IN GENERAL.—Upon the filing of a petition under subsection (a)(1) for judicial review of a rule or order, the court 

shall have jurisdiction— 

(A) to grant appropriate relief, including interim relief, 

as provided in chapter 7 of title 5, United States Code; and 

(B) to review the rule or order in accordance with that 

chapter. 

(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. 20. CITIZENS’ CIVIL ACTIONS. 

(a) IN GENERAL.—Except as provided in subsection (b), any person may commence a civil action— 


tjames on DSK6SPTVN1PROD with 
139 

(1) against any person (including (A) the United States, and 

(B) any other governmental instrumentality or agency to the 

extent permitted by the eleventh amendment to the Constitution) who is alleged to be in violation of this Act or any rule 

promulgated øunder section 4, 5, or 6, or title II or IV, or order 

issued under section 5 or title II or IV to restrain such violation,¿ or order issued under this Act; 

(2) against the Administrator to compel the Administrator to 

perform any act or duty under this Act which is not discretionary. 

Any civil action under paragraph (1) shall be brought in the United 

States district court for the district in which the alleged violation 

occurred or in which the defendant resides or in which the defendant’s principal place of business is located. Any action brought 

under paragraph (2) shall be brought in the United States District 

Court for the District of Columbia, or the United States district 

court for the judicial district in which the plaintiff is domiciled. The 

district courts of the United States shall have jurisdiction over 

suits brought under this section, without regard to the amount in 

controversy or the citizenship of the parties , to enforce this Act or 

any rule promulgated or order issued under this Act, or to order the 

Administrator to perform an act or duty described in this Act, as 

the case may be. In any civil action under this subsection process 

may be served on a defendant in any judicial district in which the 

defendant resides or may be found and subpoenas for witnesses 

may be served in any judicial district. 

(b) LIMITATION.—No civil action may be commenced— 

(1) under subsection (a)(1) øto restrain¿ respecting a violation of this Act or rule or order under this Act— 

(A) before the expiration of 60 days after the plaintiff 

has given notice of such violation (i) to the Administrator, 

and (ii) to the person who is alleged to have committed 

such violation, or 

(B) if the Administrator has commenced and is diligently 

prosecuting a proceeding for the issuance of an order 

under section 16(a)(2) to require compliance with this Act 

or with such rule or order or if the Attorney General has 

commenced and is diligently prosecuting a civil action in 

a court of the United States to require compliance with 

this Act or with such rule or order, but if such proceeding 

or civil action is commenced after the giving of notice, any 

person giving such notice may intervene as a matter of 

right in such proceeding or action; or 

(2) under subsection (a)(2) before the expiration of 60 days 

after the plaintiff has given notice to the Administrator of the 

alleged failure of the Administrator to perform an act or duty 

which is the basis for such action or, in the case of an action 

under such subsection for the failure of the Administrator to 

file an action under section 7, before the expiration of ten days 

after such notification. 

Notice under this subsection shall be given in such manner as the 

Administrator shall prescribe by rule. 

(c) GENERAL.—(1) In any action under this section, the Administrator, if not a party, may intervene as a matter of right. 


tjames on DSK6SPTVN1PROD with 
140 

(2) The court, in issuing any final order in any action brought 

pursuant to subsection (a), may award costs of suit and reasonable 

fees for attorneys and expert witnesses if the court determines that 

such an award is appropriate. Any court, in issuing its decision in 

an action brought to review such an order, may award costs of suit 

and reasonable fees for attorneys if the court determines that such 

an award is appropriate. 

(3) Nothing in this section shall restrict any right which any person (or class of persons) may have under any statute or common 

law to seek enforcement of this Act or any rule or order under this 

Act or to seek any other relief. 

(d) CONSOLIDATION.—When two or more civil actions brought 

under subsection (a) involving the same defendant and the same 

issues or violations are pending in two or more judicial districts, 

such pending actions, upon application of such defendants to such 

actions which is made to a court in which any such action is 

brought, may, if such court in its discretion so decides, be consolidated for trial by order (issued after giving all parties reasonable 

notice and opportunity to be heard) of such court and tried in— 

(1) any district which is selected by such defendant and in 

which one of such actions is pending, 

(2) a district which is agreed upon by stipulation between all 

the parties to such actions and in which one of such actions is 

pending, or 

(3) a district which is selected by the court and in which one 

of such actions is pending. 

The court issuing such an order shall give prompt notification of 

the order to the other courts in which the civil actions consolidated 

under the order are pending. 

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 øunder section 4, 6, or 8 or an order under section 5(e) or 

(6)(b)(2)¿ , order, or any other action authorized under this Act. (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 øunder section 4, 6, or 8 or an order under section 5(e), 

6(b)(1)(A), or 6(b)(1)(B)¿ or order or to initiate other action authorized under this Act. (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 

øsection 4, 5, 6, or 8¿ the applicable provisions of this Act. 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 acVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00140 Fmt 6602 Sfmt 9001 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
141 

1 In Public Law 94–469, a period appears after ‘‘environment’’. The semicolon is shown in this 

print to reflect the probable intent of Congress. 

tion in a district court of the United States to compel the Administrator to initiate øa rulemaking proceeding¿ proceedings authorized 

under this Act 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 øa proceeding to issue a rule under section 4, 6, or 8 or an 

order under section 5(e) or 6(b)(2)¿ proceedings authorized under 

this Act, the petitioner shall be provided an opportunity to have 

such petition considered by the court in a de novo proceeding. Notwithstanding the preceding sentence, in the case of a petition to 

delist a chemical substance under section 6(a), the delisting may not 

proceed except as authorized under that subsection. If the petitioner 

demonstrates to the satisfaction of the court by a preponderance of 

the evidence that— 

(i) øin the case of a petition to initiate a proceeding for the 

issuance of a rule under section 4 or an order under section 

5(e)¿ except as provided in clause (ii), in the case of a petition 

to initiate a proceeding for the issuance of a rule or an order 

under this Act— 

(I) information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of the chemical substance to be subject 

to such rule or order; and 

(II) in the absence of such information, the substance 

may present øan unreasonable risk to¿ substantial 

endangerment health or the environment, or the substance 

is or will be produced in substantial quantities and it 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 it; or 

(ii) in the case of a petition to initiate a proceeding for the 

øissuance of a rule under section 6 or 8 or an order under section 6(b)(2)¿ imposition or issuance of a restriction, use condition, or order under this chapter, there is a reasonable basis to 

conclude that the issuance of such a rule or order is necessary 

to protect health or the environment against øan unreasonable 

risk of injury¿ a substantial endangerment to health or the environment; 1

the court shall order the Administrator to initiate the action requested by the petitioner. If the court finds that 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 

there are insufficient resources available to the Administrator to 

take the action requested by the petitioner, the court may permit 

the Administrator to defer initiating the action requested by the 

petitioner until such time as the court prescribesø.¿ ; 


tjames on DSK6SPTVN1PROD with 
142 

(C) The court in issuing any final order in any action brought 

pursuant to subparagraph (A) may award costs of suit and reasonable fees for attorneys and expert witnesses if the court determines 

that such an award is appropriate. Any court, in issuing its decision in an action brought to review such an order, may award costs 

of suit and reasonable fees for attorneys if the court determines 

that such an award is appropriate. 

(5) The remedies under this section shall be in addition to, and 

not in lieu of, other remedies provided by law. 

* * * * * * * 

SEC. 24. EMPLOYMENT EFFECTS. 

(a) IN GENERAL.—The Administrator shall evaluate on a 

øcontinuing¿ periodic basis the potential effects on employment (including reductions in employment or loss of employment from 

threatened øplant 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.¿ plant closures) of the implementation of this Act. 

(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 øsection 4, 5, or 6 

or a requirement of section 5 or 6¿ this Act. 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, øby order issued¿ in writing, 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 requestø,¿ ;and 

ø(ii) such hearings shall be held in accordance with section 

6(c)(3), and¿ 

ø(iii)¿ (ii) 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 applicaVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00142 Fmt 6602 Sfmt 9001 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
143 

ble 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. 

ø(4) This section shall not be construed to require the Administrator to amend or repeal any rule or order in effect under this 

Act.¿ 

(c) EFFECT.—Nothing in this section— 

(1) requires the Administrator to amend or repeal any rule or 

order in effect under this Act; or 

(2) conditions the authority of the Administrator to issue orders or promulgate rules under this Act. 

SEC. 26. ADMINISTRATION OF THE ACT. 

(a) COOPERATION OF FEDERAL AGENCIES.—Upon request by the 

Administrator, each Federal department and agency is authorized— 

(1) to make its services, personnel, and facilities available 

(with or without reimbursement) to the Administrator to assist 

the Administrator in the administration of this Act; and 

(2) to furnish to the Administrator such information, data, 

estimates, and statistics, and to allow the Administrator access 

to all information in its possession as the Administrator may 

reasonably determine to be necessary for the administration of 

this Act. 

ø(b) FEES.—(1) The Administrator may, by rule, require the payment of a reasonable fee from any person required to submit data 

under section 4 or 5 to defray the cost of administering this Act. 

Such rules shall not provide for any fee in excess of $2,500 or, in 

the case of a small business concern, any fee in excess of $100. In 

setting a fee under this paragraph, the Administrator shall take 

into account the ability to pay of the person required to submit the 

data and the cost to the Administrator of reviewing such data. 

Such rules may provide for sharing such a fee in any case in which 

the expenses of testing are shared under section 4 or 5. 

ø(2) The Administrator, after consultation with the Administrator of the Small Business Administration, shall by rule prescribe 

standards for determining the persons which qualify as small business concerns for purposes of paragraph (1).¿ 

(b) FEES.— 

(1) IN GENERAL.—The Administrator may, by rule, require the 

payment of a reasonable fee from any person required to submit 

data to defray the cost of administering this Act. 

(2) CONSIDERATIONS.—In setting a fee under this subsection, 

the Administrator shall take into account— 

(A) the ability to pay of the person required to submit the 

data; and 

(B) the cost to the Administrator of reviewing the data. 

(3) FEE SHARING.—Rules described in paragraph (1) may provide for sharing a fee in any case in which the expenses of testing are shared under this Act. 

(c) ACTION WITH RESPECT TO CATEGORIES and Mixtures.—(1) Any 

action authorized or required to be taken by the Administrator 


tjames on DSK6SPTVN1PROD with 
144 

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. 

(3) MIXTURES.—Any action authorized or required to be taken 

by the Administrator or any other person under any provision 

of this Act with respect to a chemical substance is likewise also 

authorized or required with respect to a mixture, if the Administrator determines that such extension is reasonable and efficient. 

(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 

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 (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 preVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00144 Fmt 6602 Sfmt 6602 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
145 

ceding 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, which are of a nonregulatory or nonpolicymaking 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) RULEMAKING OR ORDERS.—In carrying out this Act, the Administrator may issue such orders and prescribe such regulations as 

are necessary to carry out this Act. 

* * * * * * * 


tjames on DSK6SPTVN1PROD with 
146 

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 øunreasonable¿ 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 øis unable or is 

not likely to take¿ has not taken 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) COORDINATION.—The Administrator shall establish a process 

to coordinate with States, on an on-going basis, to share data and 

priorities relating to the management of chemical substances under 

this title and under programs operated by States, in accordance 

with section 14. 

ø(b)¿ (c) 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, øincluding cancer, birth defects, and gene mutations,¿ the extent of the exposure 

in a state of human beings and the environment to chemical substances and mixtures, and the extent to which chemical substances 

and mixtures are manufactured, processed, used, and disposed of 

in a State. 

ø(c)¿ (d) ANNUAL REPORTS.—Not later than six months after the 

end of each of the fiscal years 1979, 1980, and 1981, the AdminisVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00146 Fmt 6602 Sfmt 6602 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
147 

trator shall submit to the Congress a report respecting the programs assisted by grants under subsection (a) in the preceding fiscal year and the extent to which the Administrator has disseminated information respecting such programs. 

ø(d)¿ (e) 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. CHILDREN’S ENVIRONMENTAL HEALTH RESEARCH PROGRAM. 

(a) CHILDREN’S ENVIRONMENTAL HEALTH RESEARCH PROGRAM.— (1) ESTABLISHMENT.—Not later than 90 days after the date of 

enactment of the Safe Chemicals Act of 2011, the Administrator 

shall establish within the Environmental Protection Agency a 

program to be known as the ‘Children’s Environmental Health 

Research Program’ (referred to in this subsection as the ‘Program’). 

(2) PURPOSE.—Subject to amounts made available in advance 

in appropriations Acts, the Administrator may enter into contracts and make grants under the Program to further understanding of the vulnerability of children to chemical substances 

and mixtures. 

(3) CONSULTATION.—Contracts and grants under this section 

shall be provided in consultation with the Interagency Science 

Advisory Board on Children’s Health Research established 

under subsection (b)(1). 

(b) INTERAGENCY SCIENCE ADVISORY BOARD ON CHILDREN’S

HEALTH RESEARCH.— (1) ESTABLISHMENT.—Not later than 90 days after the date of 

enactment of the Safe Chemicals Act of 2011, the Administrator 

shall establish an advisory board to be known as the ‘Interagency Science Advisory Board on Children’s Health Research’ 

(referred to in this subsection as the ‘Board’). 

(2) PURPOSE.—The purpose of the Board shall be to provide 

independent advice, expert consultation, and peer review, on request of the Administrator or Congress, with respect to the scientific and technical aspects of issues relating to the implementation of this title with respect to research on protecting children’s health. 

(3) COMPOSITION.—The Administrator shall— 

(A) appoint the members of the Board, including, at a 

minimum, representatives of— 

(i) the National Institute of Environmental Health 

Sciences; 

(ii) the Centers for Disease Control and Prevention; 

(iii) the National Toxicology Program; 

(iv) the National Cancer Institute; 

(v) the National EPA-Tribal Science Council; and 

(vi) not fewer than 3 centers of children’s health at 

leading institutions of higher education; 

(B) ensure that at least 1⁄3 of the members of the Board 

have specific scientific expertise in the relationship of chemical exposures to prenatal, infant, and children’s health; 

and 


tjames on DSK6SPTVN1PROD with 
148 

(C) ensure that no individual appointed to serve on the 

Board has a conflict of interest that is relevant to the functions performed by the Board, unless— 

(i) the individual promptly and publicly discloses the 

conflict; and 

(ii) the Administrator determines that the conflict is 

unavoidable. 

(4) APPLICABLE LAW.—The Board shall be subject to subchapter II of chapter 5, and chapter 7, of title 5, United States 

Code (commonly known as the ‘Administrative Procedure Act’). 

(c) PRENATAL AND INFANT EXPOSURES.— 

(1) MONITORING.—If, through studies performed under subsection (a) or section 4 or in any other available research, the 

Administrator identifies a chemical substance that may be 

present in human biological media that may have adverse effects on early childhood development, the Administrator shall 

coordinate with the Secretary of Health and Human Services to 

conduct, not later than 2 years after the date on which the Administrator identifies the chemical substance, a biomonitoring 

study to determine the presence of the chemical substance in 

human biological media in, at a minimum, pregnant women 

and infants. 

(2) PUBLICATION.—On completion of any study conducted 

under paragraph (1), the Secretary of Health and Human Services shall— 

(A) notify the Administrator of the results of the study; 

and 

(B) publish the results of the study in a publicly available electronic format. 

(3) POSITIVE RESULTS.— 

(A) MANUFACTURE DISCLOSURE.—If a chemical substance 

or mixture is determined to be present in a study conducted 

under paragraph (1), the manufacturers and processors of 

the chemical substance or mixture shall, not later than 180 

days after the date of publication of the study, disclose to 

the Administrator, commercial customers of the manufacturers and processors, consumers, and the public— 

(i) all known uses of the chemical substance or mixture; and 

(ii) all articles in which the chemical substance or 

mixture is, or is expected to be, present. 

(B) COST AND FORM OF DISCLOSURE.—Information under 

clauses (i) and (ii) of subparagraph (A) shall be— 

(i) made available by the Administrator in electronic 

format; and 

(ii) made readily accessible and free of charge by 

each applicable manufacturer and processor in electronic format to the commercial customers of such 

manufacturer or processor, consumers, and the public. 

SEC. 30. REDUCTION OF ANIMAL-BASED TESTING. 

(a) ADMINISTRATION.—The Administrator shall take action to 

minimize the use of animals in testing of chemical substances or 

mixtures, including— 


tjames on DSK6SPTVN1PROD with 
149 

(1) encouraging and facilitating, to the maximum extent practicable— 

(A) the use of existing data of sufficient scientific quality; 

(B) the use of test methods that eliminate or reduce the 

use of animals while providing data of high scientific quality; 

(C) the grouping of 2 or more chemical substances into 

scientifically appropriate categories in cases in which testing of 1 chemical substance would provide reliable and useful data on others in the category; 

(D) the formation of industry consortia to jointly conduct 

testing to avoid unnecessary duplication of tests; and 

(E) the parallel submission of data from animal-based 

studies and from emerging methods and models; and 

(2) funding research and validation studies to reduce, refine, 

and replace the use of animal tests in accordance with this subsection. 

(b) INTERAGENCY SCIENCE ADVISORY BOARD ON ALTERNATIVE

TESTING METHODS.— (1) ESTABLISHMENT.—Not later than 90 days after the date of 

enactment of the Safe Chemicals Act of 2011, the Administrator 

shall establish an advisory board to be known as the ‘Interagency Science Advisory Board on Alternative Testing Methods’ 

(referred to in this subsection and subsection (c) as the ‘Board’). 

(2) COMPOSITION.—The Administrator shall— 

(A) appoint the members of the Board, including, at a 

minimum, representatives of— 

(i) the National Institute of Environmental Health 

Sciences; 

(ii) the Centers for Disease Control and Prevention; 

(iii) the National Toxicology Program; 

(iv) the National Cancer Institute; and 

(v) the National EPA-Tribal Science Council; and 

(B) ensure that no individual appointed to serve on the 

Board has a conflict of interest that is relevant to the functions to be performed, unless— 

(i) the individual promptly and publicly discloses the 

conflict; and 

(ii) the Administrator determines that the conflict is 

unavoidable. 

(3) PURPOSE.—The purpose of the Board shall be to provide 

independent advice and peer review to Congress and the Administrator on the scientific and technical aspects of issues relating to the implementation of this title with respect to minimizing the use of animals in testing chemical substances or 

mixtures. 

(4) APPLICABLE LAW.—The Board shall be subject to subchapter II of chapter 5, and chapter 7, of title 5, United States 

Code (commonly known as the ‘Administrative Procedure Act’). 

(5) REPORT.—Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, and every 3 years 

thereafter, the Administrator, in consultation with the Board, 

shall publish in the Federal Register a list of testing methods 

that reduce the use of animals in testing under section 4. 


tjames on DSK6SPTVN1PROD with 
150 

(c) IMPLEMENTATION OF ALTERNATIVE TESTING METHODS.—To 

promote the development and timely incorporation of new testing 

methods that are not animal-based, the Administrator shall— 

(1) in consultation with the Board, and after providing an opportunity for public comment, develop a strategic plan to promote the development and implementation of alternative test 

methods and testing strategies to generate information used for 

safety standard determinations under section 6(b) that do not 

use animals, including toxicity pathway-based risk assessment, 

in vitro studies, systems biology, computational toxicology, 

bioinformatics, and high-throughput screening; 

(2) beginning on the date that is 2 years after the date of enactment of the Safe Chemicals Act of 2011 and every 2 years 

thereafter, submit to Congress a report that describes the 

progress made in implementing this section; and 

(3) fund and carry out research, development, performance 

assessment, and translational studies to accelerate the development of test methods and testing strategies that are not animalbased for use in safety standard determinations under section 

6(b). 

(d) CRITERIA FOR ADAPTING OR WAIVING ANIMAL TESTING REQUIREMENTS.—On request from a manufacturer or processor that is 

required to conduct animal-based testing of a chemical substance or 

mixture under this title, the Administrator may adapt or waive the 

animal testing requirement if the Administrator determines that— 

(1) there is a sufficient weight of 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, in any case in which the information from 

each individual source alone is regarded as insufficient to support the conclusion; 

(2) because of 1 or more physical or chemical properties of the 

chemical substance or mixture, testing for a specific endpoint is 

technically not practicable to conduct; or 

(3) a chemical substance or mixture cannot be tested in 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 potential to cause severe corrosion or severe irritation to tissues. 

SEC. 31. SAFER ALTERNATIVES AND GREEN CHEMISTRY AND ENGINEERING. 

(a) SAFER ALTERNATIVES PROGRAM.— 

(1) IN GENERAL.—Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator 

shall establish a program to create market incentives for the development of safer alternatives to existing chemical substances 

that reduce or avoid the use and generation of hazardous substances. 

(2) REQUIREMENTS.—The program established under paragraph (1) shall include— 

(A) expedited review of new chemical substances for 

which the manufacturer or processor submits an alternatives analysis indicating that the new chemical subVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00150 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
151 

stance is the safer alternative for a particular use than existing chemical substances used for the same purpose; 

(B) recognition for a chemical substance or product determined by the Administrator to be a safer alternative for a 

particular use by means of a special designation intended 

for use in marketing the safer alternative, and periodic 

public awards or rewards; and 

(C) such other incentives, as the Administrator considers 

to be appropriate to encourage the development, marketing, 

and use of chemical substances or products determined by 

the Administrator to be safer alternatives for the particular 

uses, such as job training and worker assistance. 

(b) GREEN CHEMISTRY RESEARCH NETWORK.—The Administrator 

shall establish a network of not less than 4 green chemistry and engineering centers, located in various regions of the United States, to 

support the development and adoption of safer alternatives to chemical substances, particularly chemical substances listed under section 6(a). 

(c) GREEN CHEMISTRY AND ENGINEERING RESEARCH GRANTS.— 

The Administrator shall make grants to promote and support the 

research, development, and adoption of safer alternatives to hazardous substances. 

(d) GREEN CHEMISTRY WORKFORCE EDUCATION AND TRAINING

PROGRAM.— 

(1) IN GENERAL.—The Administrator shall establish a program to facilitate the development of a workforce, including industrial and scientific workers, that produces safer alternatives 

to existing chemical substances. 

(2) GOALS.—The goals of the program established under 

paragraph (1) are to provide workforce training on skills that 

would— 

(A) facilitate the expansion of green chemistry; 

(B) develop scientific and technical leadership in green 

chemistry; 

(C) facilitate the successful and safe integration of green 

chemistry into infrastructure projects; 

(D) inform and engage communities about green chemistry; and 

(E) promote innovation and strong public health and environmental protections. 

(3) IMPLEMENTATION.—The Administrator shall implement 

the program to achieve the goals of this Act, including by— 

(A) helping to develop a broad range of skills relevant to 

the production and use of the safer alternatives, including 

the design, manufacturing, use, and disposal of the alternatives; 

(B) offering to develop partnerships with educational institutions, training organizations, private sector companies, 

and community organizations; and 

(C) providing grants to States, units of local government, 

and the partnerships developed under subparagraph (B) to 

promote and support activities consistent with achieving 

the goals of the program established under this subsection. 


tjames on DSK6SPTVN1PROD with 
152 

SEC. 32. COOPERATION WITH INTERNATIONAL EFFORTS. 

In cooperation with the Secretary of State and the head of any 

other appropriate Federal agency (as determined by the Administrator), the Administrator shall cooperate with international efforts 

as appropriate— 

(1) to develop a common protocol or electronic database relating to chemical substances; or 

(2) to develop safer alternatives for chemical substances. 

SEC. 33. RELIABLE INFORMATION AND ADVICE. 

Not later than 18 months after the date of enactment of the Safe 

Chemicals Act of 2011, the Administrator shall, by order, establish 

and implement procedures to ensure data reliability including, at a 

minimum, requirements that the Administrator— 

(1) not less than annually randomly inspect laboratories that 

develop the data required under this title on the various properties and characteristics of a chemical substance; 

(2) annually perform a comprehensive data audit on a subset, 

as chosen by the Administrator, of the data submissions under 

this title; 

(3) establish and maintain a registry of all health- and safety-related studies initiated in response to requirements under 

this title; 

(4) have access to all records of health- and safety-related 

studies initiated in response to requirements under this title; 

and 

(5) require the submitter of any research study conducted by 

a third party in response to requirements under this title to disclose to the Administrator and the public, at the time of submission, the sources of any funding used for the conduct or publication of the study received by the researchers who conducted the 

study. 

SEC. 34. HOT SPOTS. 

(a) DEFINITIONS.—In this section: 

(1) DISPROPORTIONATE EXPOSURE.—The term ‘disproportionate exposure’ means residential population exposure to 1 or 

more toxic chemical substances or mixtures at levels that are 

significantly greater than the average exposure in the United 

States, as defined and identified by the Administrator in accordance with the criteria established under subsection (b). 

(2) LOCALITY.—The term ‘locality’ means any geographical 

area (including a county, city, town, neighborhood, census tract, 

zip code area, or other commonly understood political or geographical subdivision) in which the Administrator identifies 

disproportionate exposure. 

(b) CRITERIA.—Not later than 180 days after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall 

promulgate a rule to establish criteria consistent with this section 

that— 

(1) defines disproportionate exposure; and 

(2) identifies any locality that is disproportionately exposed. 

(c) IDENTIFICATION.— 

(1) IN GENERAL.—Not later than 120 days after the date on 

which the rule is promulgated under subsection (b), the AdminVerDate Mar 15 2010 02:10 Jan 13, 2013 Jkt 029010 PO 00000 Frm 00152 Fmt 6602 Sfmt 6603 E:\HR\OC\SR264.XXX SR264

tjames on DSK6SPTVN1PROD with 
153 

istrator shall identify localities in the United States that are 

subject to disproportionate exposure. 

(2) USE OF DATA.—In identifying localities under paragraph 

(1), the Administrator— 

(A) shall use data contained in the National Air Toxic 

Assessment Database; and 

(B) may use other data available to the Administrator, 

including data developed under— 

(i) the Safe Drinking Water Act (42 U.S.C. 300f et 

seq.); 

(ii) the Solid Waste Disposal Act (42 U.S.C. 6901 et 

seq.); 

(iii) the Comprehensive Environmental Response, 

Compensation, and Liability Act of 1980 (42 U.S.C. 

9601 et seq.); and 

(iv) the Emergency Planning and Community Rightto-Know Act of 1986 (42 U.S.C. 11001 et seq.). 

(3) PUBLIC PARTICIPATION.—The Administrator shall provide 

an opportunity for members of the public to nominate localities 

in which disproportionate exposure may be found for inclusion 

in the identification of localities under paragraph (1). 

(d) LOCALITY LIST.— (1) IN GENERAL.—Not later than 180 days after completing 

the identification of localities under subsection (c)(1), the Administrator, after notice and consultation with applicable State, 

local, county health, and environmental officials, State, local, 

and county legislators, and other elected officials, shall— 

(A) publish a list of the localities subject to disproportionate exposure identified under that subsection in the 

Federal Register; and 

(B) make the list published under subparagraph (A) 

available electronically. 

(2) UPDATED LIST.— (A) IN GENERAL.—Subject to subparagraph (B), not later 

than 5 years after the date on which the list is published 

under paragraph (1)(A), and at least once every 5 years 

thereafter, the Administrator shall update and republish 

the list. 

(B) DISCRETIONARY UPDATES.—The Administrator may 

update and republish the list under paragraph (1) more 

frequently than every 5 years— 

(i) to add new localities that meet the criteria established under subsection (b); or 

(ii) to remove localities, if the Administrator determines that the exposure reduction has been achieved 

and no further action is needed after actions are taken 

under subsection (f). 

(C) NOTIFICATION.—The Administrator shall notify all 

applicable State, local, county health, and environmental 

officials, State, local, and county legislators, and other 

elected officials of the updated listing. 

(e) NO JUDICIAL REVIEW; NONDISCRETIONARY DUTY.— (1) NO JUDICIAL REVIEW.—The following actions under this 

section shall not be subject to judicial review: 


tjames on DSK6SPTVN1PROD with 
154 

(A) A decision to include on the list published under subsection (d)(1) a locality identified under subsection (c)(1). 

(B) A decision in response to nominations submitted 

under subsection (c)(3). 

(C) A decision to list localities under subsection (d)(1) or 

update the list under subsection (d)(2). 

(2) NONDISCRETIONARY DUTY.—Notwithstanding paragraph 

(1), the failure of the Administrator to publish or update the list 

of localities in accordance with this section shall be— 

(A) considered to be a failure to perform a nondiscretionary duty; and 

(B) subject to judicial review. 

(f) ACTION PLANS.— (1) IN GENERAL.—Not later than 1 year after the date on 

which the list is published or updated under subsection (d), the 

Administrator shall develop and publish, for each locality identified on the list, an action plan that includes— 

(A) an identification of the chemical substances and mixtures that contribute to the disproportionate exposure (including exposure levels, sources, and pathways); and 

(B) a description of actions planned by the Administrator 

to reduce disproportionate exposure in the locality. 

(2) GOALS.—The goal of each action plan under this subsection shall be to reduce disproportionate exposure in the locality by establishing— 

(A) a percentage exposure reduction goal for each chemical substance and mixture; and 

(B) a timeline to achieve the percentage exposure reduction goal. 

(g) REPORT TO CONGRESS.—The Administrator shall— 

(1) submit to Congress an annual report that identifies— 

(A) each locality added to the list in the prior year under 

subsection (d); 

(B) each action plan developed in the prior year under 

subsection (f); and 

(C) the progress on each action plan to date; and 

(2) make the report available to the public in electronic format. 

SEC. 35. APPLICATION OF THIS ACT TO FEDERAL AGENCIES. 

(a) IN GENERAL.—Except as provided in subsection (e), each Federal agency, and any officer, agent, or employee of a Federal agency, 

shall be subject to, and comply with, all applicable requirements of 

this Act described in subsection (b), both substantive and procedural, in the same manner, and to the same extent, as any person 

subject to the requirements. 

(b) DESCRIPTION OF REQUIREMENTS.—The substantive and procedural requirements referred to in this subsection include— 

(1) any administrative order; 

(2) any civil or administrative penalty or fine, regardless of 

whether the penalty or fine is— 

(A) punitive or coercive in nature; or 

(B) imposed for isolated, intermittent, or continuing violations; 

(3) any requirement for reporting; 


tjames on DSK6SPTVN1PROD with 
155 

(4) any provision for injunctive relief and sanctions that may 

be imposed by a court to enforce such relief; and 

(5) payment of reasonable service charges. 

(c) WAIVER OF IMMUNITY.—The United States expressly waives 

any immunity otherwise applicable to the United States with respect 

to any substantive or procedural requirement referred to under subsection (a). 

(d) CIVIL PENALTIES.—No agent, employee, or officer of the United 

States shall be personally liable for any civil penalty under this title 

with respect to any act or omission within the scope of the official 

duties of the agent, employee, or officer. 

(e) CRIMINAL SANCTIONS.—An agent, employee, or officer of the 

United States shall be subject to any criminal sanction (including 

any fine or imprisonment) under this Act, but no department, agency, or instrumentality of the executive, legislative, or judicial branch 

of the Federal Government shall be subject to such sanction. 

(f) EXEMPTION.— (1) IN GENERAL.—If the President determines it is in the paramount interest of the United States, the President may grant an 

exemption for any Federal agency from compliance with any requirement of this Act. 

(2) LACK OF APPROPRIATION.—No exemption shall be granted 

under paragraph (1) due to lack of appropriation unless— 

(A) the President has specifically requested the appropriation as a part of the budgetary process; and 

(B) Congress has failed to make the requested appropriation available. 

(3) PERIOD OF EXEMPTION.—Any exemption granted under 

paragraph (1) shall be for a period of not more than 1 year, but 

additional exemptions may be granted for periods not to exceed 

1 year, if the President makes a subsequent determination that 

the exemption is in the paramount interest of the United States. 

(4) REPORT.—Each January after the date of enactment of 

this section, the President shall submit to Congress a report 

that describes— 

(A) all exemptions granted under this subsection during 

the preceding calendar year; and 

(B) the reason for granting each exemption. 

(g) ADMINISTRATIVE ENFORCEMENT ACTIONS.— (1) IN GENERAL.—The Administrator may initiate an administrative enforcement action against any Federal agency— 

(A) in accordance with the enforcement authorities of this 

Act; and 

(B) in the same manner and under the same circumstances as an action would be initiated against another 

person. 

(2) SETTLEMENT.—Any voluntary resolution or settlement of 

an administrative enforcement action initiated under this subsection shall be set forth in a consent order. 

(3) FINALITY OF ADMINISTRATIVE ORDER.—No administrative 

order issued to a Federal department, agency, or instrumentality under this subsection shall become final until the Federal 

department, agency, or instrumentality has had the opportunity 

to confer with the Administrator. 


tjames on DSK6SPTVN1PROD with 
156 

SEC. 36. IMPLEMENTATION OF STOCKHOLM CONVENTION, THE LRTAP 

POPS PROTOCOL, AND THE ROTTERDAM CONVENTION. 

(a) DEFINITIONS.—In this section: 

(1) CHEMICAL.—The term ‘chemical’ includes any substance 

or mixture of substances, including a substance that is part of 

an article. 

(2) LRTAP CONVENTION.—The term ‘LRTAP Convention’ 

means the Convention on Long-Range Transboundary Air Pollution, done at Geneva on November 13, 1979 (TIAS 10541), 

and any subsequent amendments to which the United States is 

a party. 

(3) LRTAP POPS CHEMICAL.—The term ‘LRTAP POPs chemical’ means any chemical listed on any Annex of the LRTAP 

POPs Protocol, if such listing has entered into force for the 

United States. 

(4) LRTAP POPS PROTOCOL.—The term ‘LRTAP POPs Protocol’ means the Protocol on Persistent Organic Pollutants to 

the LRTAP Convention, done at Aarhus on June 24, 1998, and 

any subsequent amendment to which the United States is a 

party. 

(5) MEETING OF THE PARTIES.—The term ‘meeting of the parties’ means— 

(A) the Conference of the Parties established by and operating under Article 19 of the Stockholm Convention; 

(B) the Executive Body established by and operating 

under Article 10 of the LRTAP POPs Convention; and 

(C) the Conference of the Parties established by and operating under Article 18 of the Rotterdam Convention. 

(6) PIC CHEMICAL.—The term ‘PIC chemical’ means any 

chemical identified by notification to the Secretariat of the Rotterdam Convention by the United States as banned or severely 

restricted in the United States, and any chemical listed on any 

Annex of the Rotterdam Convention, if such listing has entered 

into force for the United States. 

(7) POPS CHEMICAL.—The term ‘POPs chemical’ means any 

chemical that is listed on any Annex of the Stockholm Convention, if such listing has entered into force for the United States. 

(8) ROTTERDAM CONVENTION.—The term ‘Rotterdam Convention’ means the Rotterdam Convention on the Prior Informed 

Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, done at Rotterdam on September 

10, 1998, and any subsequent amendment to which the United 

States is a party. 

(9) STOCKHOLM CONVENTION.—The term ‘Stockholm Convention’ means the Stockholm Convention on Persistent Organic 

Pollutants, done at Stockholm on May 22, 2001, and any subsequent amendment to which the United States is a party. 

(b) IMPLEMENTATION OF INTERNATIONAL AGREEMENTS.— 

(1) IN GENERAL.—The Administrator, in cooperation with appropriate Federal agencies, shall implement and support the 

implementation by the United States of the provisions of the 

Stockholm Convention, the LRTAP POPs Protocol, and the Rotterdam Convention that have entered into effect for the United 

States. 


tjames on DSK6SPTVN1PROD with 
157 

(2) PROHIBITIONS.—Notwithstanding any other provision of 

law, no person may manufacture, process, distribute in commerce, use, dispose of, or take any other action with respect to 

a POPs chemical, LRTAP POPs chemical, or PIC chemical in 

a manner inconsistent with applicable obligations for that 

chemical under the Stockholm Convention, LRTAP POPs Protocol, or Rotterdam Convention. 

(3) PUBLIC NOTICE AND COMMENT.— (A) IN GENERAL.—The Administrator shall provide timely 

public notice and opportunity to comment on a chemical 

proposed for listing to any Annex to the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam Convention. 

(B) CONTENTS.—The Administrator shall identify in the 

notice under subparagraph (A) any relevant toxicity, exposure, and risk information on the chemical known to the 

Administrator, and any domestic activities involving the 

chemical known to the Administrator. 

(C) NOTICE AND COMMENT.— (i) IN GENERAL.—Any interested person may provide 

relevant comment and information on the chemical in 

response to the notice under subparagraph (A). 

(ii) REQUEST FOR INFORMATION.—The Administrator 

may require the provision of relevant information related to a proposed chemical from any person, as the 

Administrator determines necessary to assist the 

United States in the review. 

(iii) PUBLIC DOCKET.—The Administrator shall consider all comments and information received under 

this subparagraph in the review of the proposal and include the comments and information in an established 

public docket. 

(D) POST-RECOMMENDATION.— (i) IN GENERAL.—The Administrator shall provide 

timely public notice and opportunity to comment after 

a recommendation is made to list a chemical on any 

Annex to the Stockholm Convention, the LRTAP POPs 

Protocol, or the Rotterdam Convention. 

(ii) MEETING OF THE PARTIES.—The Administrator 

shall provide the notice under clause (i) in advance of 

the meeting of the Parties at which the recommendation is to be considered. 

(iii) REQUEST FOR INFORMATION.—The Administrator 

shall request comment and information on all aspects 

of the recommendation and may, if the Administrator 

determines it to be necessary to assist the United States 

in the review, require the provision of relevant information related to a proposed chemical from any person. 

(iv) PUBLIC DOCKET.—The Administrator shall consider all comments and information received under 

this subparagraph in the review of the proposal and include the comments and information in an established 

public docket. 

(E) DECISIONS.— 


tjames on DSK6SPTVN1PROD with 
158 

(i) IN GENERAL.—Not later than 30 days after a decision by the meeting of the parties, the Administrator 

shall provide timely public notice and opportunity to 

comment on any decision by the meeting of the parties 

to list a chemical on any Annex to the Stockholm Convention. 

(ii) CONTENTS.—The Administrator shall provide in 

the notice under clause (i) a description of the amendments to the instruments and identify the changes to 

the domestic activities that the Administrator believes, 

based on information available to the Administrator, 

would be necessary if the United States chose to be 

bound by the listing decision. 

(iii) PUBLIC COMMENT.—Any interested person may 

provide relevant comment and information in response 

to the notice under clause (i). 

(iv) PUBLIC DOCKET.—The Administrator shall consider all comments and information received under 

this subparagraph in the review of the proposal and include the comments and information in an established 

public docket. 

(F) RATIFICATION.—Not later than 30 days after the 

United States deposits the instrument of ratification for the 

Stockholm Convention, the LRTAP POPs Protocol, or the 

Rotterdam Convention, or not later than 30 days after the 

listing of any chemical subsequently added under those instruments has entered into force for the United States 

(whichever date is earlier), the Administrator— 

(i) shall provide public notice of— 

(I) the chemicals that are subject to those instruments; and 

(II) any chemical subsequently added under 

those instruments; and 

(ii) may specify the requirements that are applicable 

for individual chemicals in a public notice under this 

subparagraph. 

(4) GENERAL RULEMAKING AUTHORITY.—The Administrator 

may promulgate regulations necessary to carry out the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam 

Convention, or to ensure compliance with any obligations under 

such instruments. 

(5) OBLIGATIONS.—If a chemical is subject to obligations 

under more than 1 of the instruments that includes the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam 

Convention, the most stringent of the obligations shall apply to 

ensure compliance with each of the instruments. 

(c) ENFORCEMENT.—The prohibitions and any other requirements 

of this section shall be enforced in the same manner as final rules 

or orders under section 6. 

* * * * * * * 

TITLE I—CONTROL OF TOXIC SUBSTANCES 

* * * * * * * 


tjames on DSK6SPTVN1PROD with 
159 

SEC. ø30¿37. 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); 

(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. 

øSEC. 31. EFFECTIVE DATE. 

øExcept as provided in section 4(f), this Act shall take effect on 

January 1, 1977.¿ 

øSEC. ø29¿38. AUTHORIZATION FOR APPROPRIATIONS. 

øThere are authorized to be appropriated to the Administrator 

for purposes of carrying out this Act (other than sections 27 and 

28 and subsections (a) and (c) through (g) of section 10 thereof) 

$10,100,000 for the fiscal year ending September 30, 1977, 

$58,646,000 for the fiscal year 1982 and $62,000,000 for the fiscal 

year 1983. No part of the funds appropriated under this section 

may be used to construct any research laboratories.¿ 

SEC. 38. AUTHORIZATION OF APPROPRIATIONS. 

There are authorized to be appropriated to the Administrator to 

carry out this Act such sums as are necessary for each of fiscal years 

2011 through 2018. 

* * * * * * * 

Æ 


tjames on DSK6SPTVN1PROD with