II 

112TH CONGRESS 

1ST SESSION S. 847 

To amend the Toxic Substances Control Act to ensure that risks from 

chemicals are adequately understood and managed, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

APRIL 14, 2011 

Mr. LAUTENBERG (for himself, Ms. KLOBUCHAR, Mr. SCHUMER, Mrs. BOXER, 

and Mr. FRANKEN) introduced the following bill; which was read twice 

and referred to the Committee on Environment and Public Works 

A BILL 

To amend the Toxic Substances Control Act to ensure that 

risks from chemicals are adequately understood and managed, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Safe Chemicals Act 

5 of 2011’’. 

6 SEC. 2. PURPOSES. 

7 The purpose of this Act is to ensure that risks from 

8 chemicals are adequately understood and managed. 


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1 SEC. 3. FINDINGS, POLICY, AND GOAL. 

2 Section 2 of the Toxic Substances Control Act (15 

3 U.S.C. 2601) is amended— 

4 (1) in the heading, by striking ‘‘INTENT’’ and 

5 inserting ‘‘GOAL’’; and 

6 (2) by striking subsections (a) through (c) and 

7 inserting the following: 

8 ‘‘(a) FINDINGS.—Congress finds that— 

9 ‘‘(1) each year human beings and the environ10 ment are exposed to a large number of chemical sub11 stances; 

12 ‘‘(2) the chemical industry, an important part 

13 of the United States economy, provides valuable 

14 products that are used in diverse manufacturing in15 dustries and other commercial, institutional, and 

16 consumer applications; 

17 ‘‘(3) more than 3 decades after the enactment 

18 of this Act, people and the environment in the 

19 United States are still exposed to thousands of 

20 chemicals whose safety has not been adequately re21 viewed and may harm health and the environment; 

22 ‘‘(4) the incidence of some diseases and dis23 orders linked to chemical substance exposures is on 

24 the rise; 

25 ‘‘(5) biomonitoring of chemical substances in 

26 humans reveals that people in the United States 


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1 carry hundreds of hazardous chemicals in their bod2 ies; 

3 ‘‘(6) the concentrations of certain chemical sub4 stances that persist and accumulate are increasing 

5 in the environment and in human bodies and are 

6 found across the world, including in the remote Arc7 tic in which Native Americans face increasing con8 tamination of traditional foods; 

9 ‘‘(7) differences in metabolism and physiology 

10 at certain stages of development can make infants 

11 and children more vulnerable than adults to the ef12 fects of chemical exposure, especially exposure that 

13 occurs in utero, during infancy, and during other 

14 critical periods of development; 

15 ‘‘(8) manufacturers and processors of chemicals 

16 should supply sufficient health and environmental 

17 information before distributing products in com18 merce; 

19 ‘‘(9) the Administrator must have and exercise 

20 the authority to develop sufficient information to as21 sess chemical safety, and to act effectively when the 

22 Administrator obtains information that indicates 

23 there are risks of harmful exposure to chemical sub24 stances; 


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1 ‘‘(10) there is significant global trade in the 

2 chemical sector and many of the companies that con3 duct business in the United States must also comply 

4 with chemical safety regulatory programs in other 

5 countries, and the data that is generated to comply 

6 with those other regulatory programs may be useful 

7 in understanding hazards and exposures of chemical 

8 substances presented in the United States; and 

9 ‘‘(11) a revised policy on the safety of chemical 

10 substances will assist in renewing the manufacturing 

11 sector of the United States, create new and safer 

12 jobs, spur innovations in green chemistry, restore 

13 confidence domestically and internationally in the 

14 safety of products of the United States, and ensure 

15 that products of the United States remain competi16 tive in the global market. 

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

18 ‘‘(1) to protect the health of children, workers, 

19 consumers, and the public, and to protect the envi20 ronment from harmful exposures to chemical sub21 stances; 

22 ‘‘(2) to promote the use of safer alternatives 

23 and other actions that reduce the use of and expo24 sure to hazardous chemical substances and reward 


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1 innovation toward safer chemicals, processes, and 

2 products; 

3 ‘‘(3) to require that chemicals in commerce 

4 meet a risk-based safety standard that protects vul5 nerable and affected populations and the environ6 ment; 

7 ‘‘(4) to require companies to provide sufficient 

8 health and environmental information for the chem9 ical substances that the companies manufacture, 

10 process, or import as a condition of allowing those 

11 companies to distribute chemical substances in com12 merce; 

13 ‘‘(5) to improve the quality of information on 

14 chemical safety and use; 

15 ‘‘(6) to guarantee the right of the public and 

16 workers to know about the hazards and uses of 

17 chemical substances that the public and workers 

18 may be exposed to by maximizing public access to 

19 information on chemical safety and use; and 

20 ‘‘(7) to strengthen cooperation between and 

21 among the Federal Government and State, munic22 ipal, tribal, and foreign governments. 

23 ‘‘(c) GOAL.—It is the goal of the United States to 

24 address the harmful exposure of vulnerable or affected 


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1 populations to chemical substances caused by the distribu2 tion of chemical substances in commerce by— 

3 ‘‘(1) reviewing all chemical substances for safe4 ty and identifying the highest priority chemical sub5 stances for expedited review; 

6 ‘‘(2) determining whether chemical substances 

7 in commerce meet the safety standard under this 

8 title; 

9 ‘‘(3) applying appropriate restrictions to the use 

10 of a chemical substance, where warranted; and 

11 ‘‘(4) encouraging the replacement of harmful 

12 chemicals and processes with safer alternatives.’’. 

13 SEC. 4. DEFINITIONS. 

14 Section 3 of the Toxic Substances Control Act (15 

15 U.S.C. 2602) is amended— 

16 (1) by striking paragraph (12); 

17 (2) by redesignating paragraphs (2), (3), (4), 

18 (5), (6), (7), (8), (9), (10), (11), (13), and (14), as 

19 paragraphs (5), (6), (8), (10), (12), (13), (14), (15), 

20 (18), (19), (21), and (24), respectively; 

21 (3) by inserting after paragraph (1) the fol22 lowing: 

23 ‘‘(2) AGGREGATE EXPOSURE.— 

24 ‘‘(A) IN GENERAL.—Subject to subpara25 graph (B), the term ‘aggregate exposure’ means 


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1 exposure from all sources of a chemical sub2 stance, including exposure from— 

3 ‘‘(i) the manufacture, processing, dis4 tribution, use, and disposal of that chem5 ical substance; and 

6 ‘‘(ii) all other sources of that chemical 

7 substance, including— 

8 ‘‘(I) contamination of food, air, 

9 water, soil, and house dust from cur10 rent or prior uses or activity; 

11 ‘‘(II) accidental releases; 

12 ‘‘(III) permitted sources of pollu13 tion; 

14 ‘‘(IV) nonpoint sources of pollu15 tion; 

16 ‘‘(V) documented background lev17 els from natural and anthropogenic 

18 sources; and 

19 ‘‘(VI) a mixture or article con20 taining that chemical substance. 

21 ‘‘(B) INCLUSIONS.—The term ‘aggregate 

22 exposure’ includes exposure from a chemical 

23 substance that is not considered to be a chem24 ical substance under this Act solely because of 

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


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1 additive, cosmetic, or device (as those terms are 

2 defined in section 201 of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 321)). 

4 ‘‘(3) BIOACCUMULATIVE.— 

5 ‘‘(A) IN GENERAL.—The term ‘bioaccumu6 lative’ means, with respect to a chemical sub7 stance or mixture, that the chemical substance 

8 or mixture, as determined by the Administrator, 

9 can significantly accumulate in biota, as indi10 cated through monitoring data, or is highly 

11 likely to accumulate in biota, as indicated by 

12 other evidence. 

13 ‘‘(B) UPDATE.—To reflect the best avail14 able science, the Administrator may, by rule, 

15 revise the definition of the term ‘bioaccumula16 tive’ in such a way that reflects the state of the 

17 science and provides for equal or greater protec18 tion of human health and the environment. 

19 ‘‘(4) CHEMICAL IDENTITY.—The term ‘chemical 

20 identity’ includes— 

21 ‘‘(A) each common and trade name of a 

22 chemical substance; 

23 ‘‘(B) the name of a chemical substance ap24 pearing in International Union of Pure and ApVerDate Mar 15 2010 21:55 Apr 18, 2011 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S847.IS S847

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1 plied Chemistry nomenclature and the most 

2 current Collective Index format; 

3 ‘‘(C) each Chemical Abstracts Service reg4 istration number of a chemical substance; and 

5 ‘‘(D) the molecular structure of a chemical 

6 substance.’’; 

7 (4) in paragraph (5) (as redesignated by para8 graph (2))— 

9 (A) by striking ‘‘(2)(A) Except as provided 

10 in subparagraph (B)’’ and inserting the fol11 lowing: 

12 ‘‘(5) CHEMICAL SUBSTANCE.— 

13 ‘‘(A) IN GENERAL.—Except as provided in 

14 subparagraphs (B) and (C)’’; 

15 (B) in subparagraph (B), by striking ‘‘(B) 

16 Such term’’ and inserting the following: 

17 ‘‘(B) EXCLUSIONS.—The term ‘chemical 

18 substance’ ’’; and 

19 (C) by adding at the end the following: 

20 ‘‘(C) INCLUSIONS.—Notwithstanding mo21 lecular identity, the Administrator may deter22 mine that a variant of a chemical substance is 

23 a new chemical substance under section 

24 5(a)(6).’’; 


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1 (5) by inserting after paragraph (6) (as redesig2 nated by paragraph (2)) the following: 

3 ‘‘(7) CUMULATIVE EXPOSURE.—The term ‘cu4 mulative exposure’ means the sum of aggregate ex5 posure to each of the chemical substances that are 

6 known or suspected to contribute appreciably to the 

7 risk of the same or a similar adverse effect.’’; 

8 (6) by striking paragraph (8) (as redesignated 

9 by paragraph (2)) and inserting the following: 

10 ‘‘(8) DISTRIBUTE IN COMMERCE.—The terms 

11 ‘distribute in commerce’ and ‘distribution in com12 merce’, when used to describe an action taken with 

13 respect to a chemical substance (or mixture or arti14 cle containing that chemical substance), mean— 

15 ‘‘(A) to sell, or the sale of, the substance, 

16 mixture, or article in commerce; 

17 ‘‘(B) to introduce or deliver for introduc18 tion into commerce, or the introduction or deliv19 ery for introduction into commerce of, the sub20 stance, mixture, or article; 

21 ‘‘(C) to hold, or the holding of, the sub22 stance, mixture, or article after its introduction 

23 into commerce; or 

24 ‘‘(D) to export or offer for export the sub25 stance, mixture, or article.’’; 


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1 (7) by inserting after paragraph (8) (as redesig2 nated by paragraph (2)) the following: 

3 ‘‘(9) END CONSUMER.—The term ‘end con4 sumer’ means an individual or other entity that pur5 chases and uses or consumes a chemical substance 

6 (or mixture or article containing that chemical sub7 stance).’’; 

8 (8) in paragraph (10) (as redesignated by para9 graph (2)), by inserting ‘‘ambient and indoor’’ after 

10 ‘‘includes water,’’; 

11 (9) by inserting after paragraph (10) (as redes12 ignated by paragraph (2)) the following: 

13 ‘‘(11) FEDERAL AGENCY.—The term ‘Federal 

14 agency’ means any department, agency, or other in15 strumentality of the Federal Government, any inde16 pendent agency or establishment of the Federal Gov17 ernment including any Government corporation, and 

18 the Government Printing Office.’’; 

19 (10) in paragraph (15) (as redesignated by 

20 paragraph (2)), by striking ‘‘which is not included in 

21 the chemical substance list compiled and published 

22 under section 8(b)’’ and inserting ‘‘for which the 

23 manufacturer or processor of the chemical substance 

24 has not submitted a declaration under section 8(a)’’; 


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1 (11) by inserting after paragraph (15) (as re2 designated by paragraph (2)) the following: 

3 ‘‘(16) PERSISTENT.— 

4 ‘‘(A) IN GENERAL.—The term ‘persistent’ 

5 means, with respect to a chemical substance or 

6 mixture, that the chemical substance or mix7 ture, as determined by the Administrator, sig8 nificantly persists in 1 or more environmental 

9 media, as indicated by monitoring data or other 

10 evidence. 

11 ‘‘(B) UPDATE.—To reflect the best avail12 able science, the Administrator may, by rule, 

13 revise the definition of the term ‘persistent’ in 

14 such a way that reflects the state of the science 

15 and provides for equal or greater protection of 

16 human health and the environment. 

17 ‘‘(17) PERSON.— 

18 ‘‘(A) IN GENERAL.—The term ‘person’ 

19 means an individual, trust, firm, joint stock 

20 company, corporation (including a Government 

21 corporation), partnership, association, State, 

22 municipality, commission, political subdivision 

23 of a State, or any interstate body. 


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1 ‘‘(B) INCLUSIONS.—The term ‘person’ in2 cludes each Federal agency and any officer, 

3 agent, or employee of a Federal agency.’’; 

4 (12) by inserting after paragraph (19) (as re5 designated by paragraph (2)) the following: 

6 ‘‘(20) SPECIAL SUBSTANCE CHARACTERISTIC.— 

7 ‘‘(A) IN GENERAL.—The term ‘special sub8 stance characteristic’ means a physical, chem9 ical, or biological characteristic, other than mo10 lecular identity, that the Administrator deter11 mines, by order or rule, may significantly affect 

12 the risks posed by substances exhibiting that 

13 characteristic. 

14 ‘‘(B) CONSIDERATIONS.—In determining 

15 the existence of special substance characteris16 tics, the Administrator may consider— 

17 ‘‘(i) size or size distribution; 

18 ‘‘(ii) shape and surface structure; 

19 ‘‘(iii) reactivity; and 

20 ‘‘(iv) any other properties that may 

21 significantly affect the risks posed.’’; 

22 (13) by inserting after paragraph (21) (as re23 designated by paragraph (2)) the following: 

24 ‘‘(22) TOXIC.—The term ‘toxic’, with respect to 

25 a chemical substance or mixture, means that the 


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1 chemical substance or mixture has a toxicological 

2 property— 

3 ‘‘(A) meeting the criteria for Category 1 or 

4 Category 2 for any of the toxicity endpoints es5 tablished by the Globally Harmonized System 

6 for the Classification and Labeling of Haz7 ardous Substances; 

8 ‘‘(B) that causes an adverse effect that has 

9 been demonstrated in humans or other exposed 

10 organisms; or 

11 ‘‘(C) for which the weight of evidence 

12 (such as demonstration of an adverse effect de13 scribed in subparagraph (B), laboratory studies, 

14 or data for a chemical from the same chemical 

15 class that exhibits that adverse effect) dem16 onstrates the potential for an adverse effect in 

17 humans or other exposed organisms. 

18 ‘‘(23) TOXICOLOGICAL PROPERTY.—The term 

19 ‘toxicological property’ means actual or potential 

20 toxicity or other adverse effects of a chemical sub21 stance or mixture, including actual or potential ef22 fects of exposure to a chemical substance or mixture 

23 on— 

24 ‘‘(A) mortality; 

25 ‘‘(B) morbidity, including carcinogenesis; 


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1 ‘‘(C) reproduction; 

2 ‘‘(D) growth and development; 

3 ‘‘(E) the immune system; 

4 ‘‘(F) the endocrine system; 

5 ‘‘(G) the brain or nervous system; 

6 ‘‘(H) other organ systems; or 

7 ‘‘(I) any other biological functions in hu8 mans or nonhuman organisms.’’; and 

9 (14) by adding at the end the following: 

10 ‘‘(25) VULNERABLE HUMAN POPULATION.— 

11 The term ‘vulnerable human population’ means a 

12 human population that is subject to disproportionate 

13 exposure to, or the potential for disproportionate ad14 verse effect from exposure to, a chemical substance 

15 or mixture, including— 

16 ‘‘(A) infants, children, and adolescents; 

17 ‘‘(B) pregnant women; 

18 ‘‘(C) elderly; 

19 ‘‘(D) individuals with preexisting medical 

20 conditions; 

21 ‘‘(E) workers that work with chemical sub22 stances and mixtures; and 

23 ‘‘(F) members of any other appropriate 

24 population identified by the Administrator.’’. 


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1 SEC. 5. MINIMUM DATA SETS AND TESTING OF CHEMICAL 

2 SUBSTANCES. 

3 Section 4 of the Toxic Substances Control Act (15 

4 U.S.C. 2603) is amended to read as follows: 

5 ‘‘SEC. 4. MINIMUM DATA SETS AND TESTING OF CHEMICAL 

6 SUBSTANCES. 

7 ‘‘(a) MINIMUM DATA SETS.— 

8 ‘‘(1) MINIMUM DATA SETS RULES.— 

9 ‘‘(A) IN GENERAL.—Subject to subpara10 graph (B), and not later than 1 year after the 

11 date of enactment of the Safe Chemicals Act of 

12 2011, the Administrator shall establish, by rule, 

13 the data that constitute the minimum data sets 

14 for chemical substances. 

15 ‘‘(B) REQUIREMENTS.—Any rule promul16 gated under subparagraph (A) shall— 

17 ‘‘(i) provide for varied or tiered data 

18 to be provided for different chemical sub19 stances or categories of chemical sub20 stances; 

21 ‘‘(ii) identify the particular minimum 

22 data set that applies to a chemical sub23 stance or category of chemical substances; 

24 ‘‘(iii) require each minimum data set 

25 to include the minimum amount of infor26 mation necessary for the Administrator to 


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1 conduct a screening-level risk assessment 

2 of the chemical substance or category of 

3 chemical substances, including information 

4 on the characteristics, toxicological prop5 erties, exposure, and use of a chemical sub6 stance; and 

7 ‘‘(iv) in accordance with section 30, 

8 encourage and facilitate the use of alter9 native testing methods and testing strate10 gies to generate information quickly, at low 

11 cost, and without the use of animal-based 

12 testing, including toxicity pathway-based 

13 risk assessment, in vitro studies, systems 

14 biology, computational toxicology, 

15 bioinformatics, and high-throughput 

16 screening. 

17 ‘‘(2) SUBMISSION OF MINIMUM DATA SET.— 

18 Each manufacturer and processor of a chemical sub19 stance shall submit the minimum data set for the 

20 chemical substance to the Administrator— 

21 ‘‘(A) for new chemical substances, concur22 rent with the notice required under section 

23 (5)(a)(1)(A); and 

24 ‘‘(B) for existing chemical substances, on 

25 the earlier of— 


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1 ‘‘(i) 18 months after the date on 

2 which the chemical substance is assigned 

3 to a priority class under section 6(a); and 

4 ‘‘(ii) 5 years after the date of enact5 ment of the Safe Chemicals Act of 2011. 

6 ‘‘(3) PROHIBITION.—The Administrator may, 

7 by order, take any action authorized under section 

8 6(c) if a manufacturer or processor is in violation of 

9 paragraph (2), except as authorized under section 

10 6(e). 

11 ‘‘(b) TESTING.— 

12 ‘‘(1) GENERAL SUBMISSIONS.— 

13 ‘‘(A) IN GENERAL.—The Administrator 

14 may, by rule or order, require testing with re15 spect to any chemical substance, and the sub16 mission of test results by a specified date, as 

17 necessary for making any determination or car18 rying out any provision of this Act. 

19 ‘‘(B) EFFECT ON OTHER AUTHORITY.— 

20 Nothing in this paragraph limits the authority 

21 of the Administrator under paragraph (2). 

22 ‘‘(2) SAMPLE SUBMISSIONS.— 

23 ‘‘(A) IN GENERAL.—The Administrator 

24 may, by rule or order, require the submission of 

25 a sample of any chemical substance in such 


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1 manner as the Administrator determines en2 ables the Administrator to conduct any tests 

3 necessary for making any determination or car4 rying out any provision of this Act. 

5 ‘‘(B) EFFECT ON OTHER AUTHORITY.— 

6 Nothing in this paragraph limits the authority 

7 of the Administrator under paragraph (1). 

8 ‘‘(3) PROHIBITION.—The Administrator may, 

9 by order, take any action authorized under section 

10 6(c) if a manufacturer or processor is in violation of 

11 a rule or order under paragraph (1), except as au12 thorized under section 6(e). 

13 ‘‘(4) EXEMPTION.—If a manufacturer or proc14 essor has submitted a declaration of cessation of 

15 manufacture or processing under section 8(a)(3) for 

16 a chemical substance, the manufacturer or processor 

17 shall be exempted from the requirements of this sub18 section. 

19 ‘‘(c) TEST RULES OR ORDERS.— 

20 ‘‘(1) IN GENERAL.—A rule or order issued 

21 under subsection (b) shall include— 

22 ‘‘(A) identification of the chemical sub23 stance for which testing is required under the 

24 rule or order; 


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1 ‘‘(B) standards for the development of test 

2 data for that substance; and 

3 ‘‘(C) a specification of the period (which 

4 may not be of unreasonable duration) within 

5 which the persons required to conduct the test6 ing shall submit to the Administrator data de7 veloped in accordance with the standards re8 ferred to in subparagraph (B). 

9 ‘‘(2) CONSIDERATIONS.— 

10 ‘‘(A) IN GENERAL.—In determining the 

11 standards and period to be required under sub12 paragraphs (B) and (C) of paragraph (1), the 

13 Administrator shall consider— 

14 ‘‘(i) the relative costs of the various 

15 test protocols and methodologies that may 

16 be required under the rule or order; and 

17 ‘‘(ii) the reasonably foreseeable avail18 ability of the facilities and personnel need19 ed to perform the testing required under 

20 the rule. 

21 ‘‘(B) PRELIMINARY DATA.—Any rule or 

22 order issued by the Administrator under this 

23 subsection may require a manufacturer or proc24 essor to submit preliminary data during the pe25 riod described in paragraph (1)(C). 


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1 ‘‘(3) TYPES OF HEALTH AND ENVIRONMENTAL

2 INFORMATION.— 

3 ‘‘(A) IN GENERAL.—The Administrator 

4 may prescribe standards for the development of 

5 test data under this subsection for health and 

6 environmental information, including— 

7 ‘‘(i) information pertaining to carcino8 genesis, mutagenesis, teratogenesis, behav9 ioral disorders, cumulative, synergistic, or 

10 any other effect that may be considered in 

11 a safety standard determination; 

12 ‘‘(ii) information pertaining to expo13 sure to the chemical substance, including 

14 information regarding the presence of the 

15 chemical substance in human blood, fluids, 

16 or tissue; and 

17 ‘‘(iii) information pertaining to— 

18 ‘‘(I) bioaccumulation; 

19 ‘‘(II) persistence; 

20 ‘‘(III) acute toxicity; 

21 ‘‘(IV) subacute toxicity; 

22 ‘‘(V) chronic toxicity; and 

23 ‘‘(VI) any other characteristic 

24 that may present an adverse effect. 

25 ‘‘(B) METHODOLOGIES.— 


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1 ‘‘(i) IN GENERAL.—The Administrator 

2 may prescribe methodologies in standards 

3 for the development of test data, includ4 ing— 

5 ‘‘(I) epidemiologic studies; 

6 ‘‘(II) biomonitoring studies; 

7 ‘‘(III) serial or hierarchical tests; 

8 ‘‘(IV) in vitro tests; and 

9 ‘‘(V) whole animal tests, con10 sistent with section 30. 

11 ‘‘(ii) REQUIREMENT.—Prior to pre12 scribing epidemiologic studies of employ13 ees, the Administrator shall consult with 

14 the Director of the National Institute for 

15 Occupational Safety and Health. 

16 ‘‘(C) REVIEW.—Periodically, but not less 

17 frequently than once every 3 years, the Admin18 istrator shall— 

19 ‘‘(i) review the adequacy of the stand20 ards for development of data prescribed 

21 under subparagraph (A); and 

22 ‘‘(ii) if necessary, institute pro23 ceedings to make appropriate revisions of 

24 those standards. 


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1 ‘‘(4) PERSONS REQUIRED TO CONDUCT TESTS

2 AND SUBMIT DATA.— 

3 ‘‘(A) IN GENERAL.—Except as provided in 

4 subparagraph (B), a rule or order under sub5 section (b) respecting a chemical substance 

6 shall specify the persons required to conduct 

7 tests and submit data to the Administrator on 

8 the substance. 

9 ‘‘(B) EXCEPTION.—The Administrator 

10 may permit 2 or more of the persons described 

11 in subparagraph (A) to designate 1 of the per12 sons or a qualified third party to conduct the 

13 tests and submit the data on behalf of the per14 sons making the designation. 

15 ‘‘(C) LIABILITY.—All persons described in 

16 subparagraphs (A) and (B) shall remain liable 

17 for compliance with any requirements subject to 

18 the designation. 

19 ‘‘(5) EXPIRATION OF RULES AND ORDERS.— 

20 ‘‘(A) IN GENERAL.—Any rule or order 

21 under subsection (b) that requires the testing 

22 and submission of data for a particular chem23 ical substance shall expire at the end of the ap24 plicable reimbursement period (as defined in 


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1 subsection (d)(3)) unless, prior to that date, the 

2 Administrator withdraws the rule or order. 

3 ‘‘(B) CATEGORY OF CHEMICAL SUB4 STANCES.—A rule or order under subsection (b) 

5 that requires the testing and submission of data 

6 for a category of chemical substances shall ex7 pire with respect to a chemical substance in8 cluded in the category at the end of the applica9 ble reimbursement period (as defined in sub10 section (d)(3)) unless, prior to that date, the 

11 Administrator withdraws the rule or order with 

12 respect to the substance entirely. 

13 ‘‘(d) EXEMPTIONS.— 

14 ‘‘(1) IN GENERAL.—Any person required by a 

15 rule or order under subsections (a) or (b) to conduct 

16 tests and submit data for a chemical substance may 

17 apply to the Administrator (in such form and man18 ner as the Administrator determines necessary) for 

19 an exemption from the requirement. 

20 ‘‘(2) ACTION BY ADMINISTRATOR.—In accord21 ance with paragraph (3) or (4), the Administrator 

22 shall exempt an applicant under paragraph (1), if, 

23 on receipt of the application, the Administrator de24 termines that— 


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1 ‘‘(A) the chemical substance for which the 

2 application was submitted is equivalent to a 

3 chemical substance for which— 

4 ‘‘(i) data has been submitted to the 

5 Administrator in accordance with a rule or 

6 order under subsection (a) or (b); or 

7 ‘‘(ii) data is being developed in ac8 cordance with the rule or order; and 

9 ‘‘(B) submission of data by the applicant 

10 for the substance would be duplicative of data 

11 that— 

12 ‘‘(i) has been submitted to the Admin13 istrator in accordance with the rule or 

14 order under subsection (a) or (b); or 

15 ‘‘(ii) is being developed in accordance 

16 with the rule or order. 

17 ‘‘(3) REIMBURSEMENT DUE TO EXEMPTION.— 

18 ‘‘(A) DEFINITION OF REIMBURSEMENT PE19 RIOD.—In this paragraph, the term ‘reimburse20 ment period’, with respect to any test data for 

21 a chemical substance, means a period that— 

22 ‘‘(i) begins on the date on which the 

23 test data is submitted in accordance with 

24 a rule or order issued under subsection (a) 

25 or (b); and 


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1 ‘‘(ii) ends on the later of— 

2 ‘‘(I) 5 years after the date re3 ferred to in clause (i); or 

4 ‘‘(II) the date which, as deter5 mined by the Administrator, provides 

6 the applicant with a time period which 

7 is sufficient to develop the test data. 

8 ‘‘(B) REIMBURSEMENT FOR PREVIOUSLY

9 SUBMITTED TEST DATA.— 

10 ‘‘(i) IN GENERAL.—Except as pro11 vided in clause (ii), for an exemption under 

12 paragraph (2)(B)(i), if the exemption is 

13 granted during the reimbursement period 

14 for the test data, the Administrator shall 

15 order the person granted the exemption to 

16 provide fair and equitable reimbursement 

17 (in an amount determined by the Adminis18 trator) to— 

19 ‘‘(I) the person who previously 

20 submitted the test data, for a portion 

21 of the costs incurred by the person in 

22 complying with the data submission 

23 requirement; and 

24 ‘‘(II) any other person who has 

25 been required under this subsection to 


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1 contribute with respect to the costs, 

2 for a portion of the amount the per3 son was required to contribute. 

4 ‘‘(ii) EXCEPTION.—Clause (i) shall 

5 not apply if there is agreement on the 

6 amount and method of reimbursement be7 tween an exempted person described in 

8 clause (i) and the persons described in sub9 clauses (I) and (II) of that clause. 

10 ‘‘(iii) CONSIDERATIONS.—In promul11 gating rules for the determination of fair 

12 and equitable reimbursement to the per13 sons described in subclauses (I) and (II) of 

14 clause (i) for costs incurred with respect to 

15 a chemical substance, the Administrator 

16 shall, after consultation with the Attorney 

17 General and the Federal Trade Commis18 sion, consider all relevant factors, includ19 ing— 

20 ‘‘(I) the effect on the competitive 

21 position of the person required to pro22 vide reimbursement in relation to the 

23 person to be reimbursed; and 

24 ‘‘(II) the share of the market for 

25 the substance of the person required 


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1 to provide reimbursement in relation 

2 to the share of the market of the per3 sons to be reimbursed. 

4 ‘‘(C) REIMBURSEMENT DUE TO EXEMP5 TION FOR TEST DATA BEING DEVELOPED IN

6 ACCORDANCE WITH A RULE OR ORDER.— 

7 ‘‘(i) IN GENERAL.—Except as pro8 vided in clause (ii), for an exemption under 

9 paragraph (2)(B)(ii), the Administrator 

10 shall order the person granted the exemp11 tion to provide fair and equitable reim12 bursement (in an amount determined by 

13 the Administrator) to— 

14 ‘‘(I) each person who is devel15 oping the test data, for the portion of 

16 the costs incurred by each person in 

17 complying with the rule or order; and 

18 ‘‘(II) any other person who has 

19 been required under this subsection to 

20 contribute with respect to the costs of 

21 complying with the rule or order, for 

22 a portion of the amount the person 

23 was required to contribute. 

24 ‘‘(ii) EXCEPTION.—Clause (i) shall 

25 not apply if there is agreement on the 


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1 amount and method of reimbursement be2 tween an exempted person described in 

3 clause (i) and the persons described in sub4 clauses (I) and (II) of that clause. 

5 ‘‘(iii) CONSIDERATIONS.—In promul6 gating rules for the determination of fair 

7 and equitable reimbursement to the per8 sons described in subclauses (I) and (II) of 

9 clause (i) for costs incurred with respect to 

10 a chemical substance, the Administrator 

11 shall, after consultation with the Attorney 

12 General and the Federal Trade Commis13 sion, consider the factors described in sub14 paragraph (B)(iii). 

15 ‘‘(iv) LACK OF COMPLIANCE.—If any 

16 exemption is granted under paragraph (2) 

17 on the basis that 1 or more persons are de18 veloping test data pursuant to a rule or 

19 order promulgated or issued under sub20 section (a) or (b), and after the exemption 

21 is granted, the Administrator determines 

22 that no person has complied with the rule 

23 or order, the Administrator shall— 

24 ‘‘(I) after providing written no25 tice and an opportunity for a hearing 


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1 to the person who holds the exemp2 tion, by order, terminate the exemp3 tion; and 

4 ‘‘(II) notify in writing the person 

5 of the requirements of the rule or 

6 order with respect to which the ex7 emption was granted. 

8 ‘‘(e) NOTICE.— 

9 ‘‘(1) IN GENERAL.—Not later than 15 days 

10 after the date of receipt of any test data pursuant 

11 to a rule or order under subsection (a) or (b), the 

12 Administrator shall publish in the Federal Register 

13 a notice of the receipt of the test data. 

14 ‘‘(2) REQUIREMENTS.—Subject to section 14, 

15 each notice shall— 

16 ‘‘(A) identify the chemical substance for 

17 which data have been received; 

18 ‘‘(B) list— 

19 ‘‘(i) the commercial and consumer 

20 uses or intended commercial and consumer 

21 uses of the substance known to the Admin22 istrator; and 

23 ‘‘(ii) the information required by the 

24 applicable standards for the development 

25 of test data; and 


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1 ‘‘(C) describe the nature of the test data 

2 developed. 

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

4 Administrator shall make the test data described in 

5 this subsection available on a publicly accessible 

6 Internet site. 

7 ‘‘(f) REQUESTS FROM OTHER AGENCIES FOR ADDI8 TIONAL INFORMATION OR TESTING.— 

9 ‘‘(1) IN GENERAL.—The head of a Federal 

10 agency may request the Administrator to seek the 

11 information on behalf of that agency if the head of 

12 that Federal agency determines that— 

13 ‘‘(A) information relating to a chemical 

14 substance, including data derived from new 

15 testing or monitoring, would assist that Federal 

16 agency in carrying out the duties or exercising 

17 the authority of that agency; but 

18 ‘‘(B) the requested information is not 

19 available to that agency. 

20 ‘‘(2) DUTY OF ADMINISTRATOR.—Not later 

21 than 60 days after the date of receipt of a request 

22 under paragraph (1), the Administrator shall— 

23 ‘‘(A) subject to section 14, make the data 

24 available to the requesting agency; 


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1 ‘‘(B) issue a request under section 8(f) to 

2 require— 

3 ‘‘(i) the submission of existing perti4 nent data to the Administrator; and 

5 ‘‘(ii) a copy of any such submission to 

6 be furnished to the requesting agency; 

7 ‘‘(C) issue a rule or order under subsection 

8 (b)— 

9 ‘‘(i) to develop the data; and 

10 ‘‘(ii) to require the developed data to 

11 be furnished to the requesting agency; or 

12 ‘‘(D) publish in the Federal Register the 

13 reason for which none of the actions described 

14 in this paragraph were taken. 

15 ‘‘(g) CERTIFICATION.—Each submission required 

16 under this section or under a rule or an order promulgated 

17 or issued by the Administrator under this section shall be 

18 accompanied by a certification signed by a responsible offi19 cial of the manufacturer or processor that each statement 

20 contained in the submission— 

21 ‘‘(1) is accurate and reliable; and 

22 ‘‘(2) includes all material facts known to, in the 

23 possession or control of, or reasonably ascertainable 

24 by, the manufacturer or processor.’’. 


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1 SEC. 6. MANUFACTURING AND PROCESSING NOTICES. 

2 Section 5 of the Toxic Substances Control Act (15 

3 U.S.C. 2604) is amended to read as follows: 

4 ‘‘SEC. 5. MANUFACTURING AND PROCESSING NOTICES. 

5 ‘‘(a) NEW CHEMICAL SUBSTANCES AND NEW USES

6 OF CHEMICAL SUBSTANCES.— 

7 ‘‘(1) NEW CHEMICAL SUBSTANCES.—Except as 

8 provided in subsection (d), no person may manufac9 ture or process a new chemical substance unless— 

10 ‘‘(A) the person submits to the Adminis11 trator a notice, in accordance with subsection 

12 (c), of the intention of the person to manufac13 ture or process the substance; 

14 ‘‘(B) the person complies with subsection 

15 (b); and 

16 ‘‘(C) the Administrator finds that— 

17 ‘‘(i) the manufacturers and processors 

18 have established that the chemical sub19 stance meets the safety standard under 

20 section 6(b); or 

21 ‘‘(ii) the new chemical substance, or a 

22 metabolite or degradation product of the 

23 chemical substance, as applicable, is not, 

24 and is not expected to be— 


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1 ‘‘(I)(aa) manufactured in a vol2 ume of more than 1,000,000 pounds 

3 annually; or 

4 ‘‘(bb) released into the environ5 ment in a volume of more than 

6 100,000 pounds annually; 

7 ‘‘(II) a known, probable, or sus8 pected reproductive, developmental, 

9 neurological, or immunological toxi10 cant, carcinogen, mutagen, or endo11 crine disruptor; 

12 ‘‘(III) persistent and bioaccumu13 lative; 

14 ‘‘(IV) found in human cord 

15 blood, or otherwise found in human 

16 blood, fluids, or tissue, unless the 

17 chemical substance, metabolite, or 

18 degradation product is naturally 

19 present at the level commonly found 

20 in that medium; or 

21 ‘‘(V) found in food, drinking 

22 water, ambient or indoor air, residen23 tial soil, or house dust, unless the 

24 chemical substance, metabolite, or 

25 degradation product is naturally 


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1 present at the level commonly found 

2 in that medium. 

3 ‘‘(2) NEW USES OF EXISTING CHEMICAL SUB4 STANCES PRIOR TO SAFETY STANDARD DETERMINA5 TION.— 

6 ‘‘(A) IN GENERAL.—Except as provided in 

7 subparagraph (B), with respect to an existing 

8 chemical substance for which the Administrator 

9 has not made a safety standard determination 

10 under section 6, no person may manufacture or 

11 process the chemical substance— 

12 ‘‘(i) for a use that was not ongoing on 

13 the date of enactment of the Safe Chemi14 cals Act of 2011; or 

15 ‘‘(ii) at a volume that is significantly 

16 increased from the volume as of the date 

17 of enactment of the Safe Chemicals Act of 

18 2011. 

19 ‘‘(B) EXCEPTION.—A person may manu20 facture or process a chemical substance in a 

21 manner prohibited by subparagraph (A), if the 

22 person— 

23 ‘‘(i) submits to the Administrator a 

24 new or updated declaration under section 

25 8(a); and 


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1 ‘‘(ii) complies with subsection (b). 

2 ‘‘(3) NEW USES OF EXISTING CHEMICAL SUB3 STANCES THAT MEET THE SAFETY STANDARD.— 

4 ‘‘(A) IN GENERAL.—For an existing chem5 ical substance for which the Administrator has 

6 determined under section 6(b) that the manu7 facturers and processors of the chemical sub8 stance have established that the substance 

9 meets the applicable safety standard, no person 

10 may manufacture or process the chemical sub11 stance for uses, at production volumes, or in 

12 manners other than those the Administrator 

13 specified in the safety standard determination, 

14 unless— 

15 ‘‘(i) the manufacturer or processor 

16 submits to the Administrator— 

17 ‘‘(I) a notice of the intention of 

18 the manufacturer or processor to 

19 manufacture or process the substance 

20 for a new use, at a new production 

21 volume, or in such other manner as is 

22 inconsistent with a specified condition 

23 or term for that substance; and 

24 ‘‘(II) all updates to the minimum 

25 data set relevant to the new use, new 


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1 production volume, or other new man2 ner of manufacturing or processing; 

3 ‘‘(ii) the notice under clause (i)(I) in4 dicates that the chemical substance will 

5 continue to meet the safety standard if the 

6 allowed uses, production volumes, or other 

7 specified conditions or terms for that 

8 chemical substance are revised to encom9 pass the new use, production volume, or 

10 other manner of manufacturing or proc11 essing; and 

12 ‘‘(iii) the Administrator determines 

13 that the manufacturer or processor submit14 ting the notice has established that the 

15 chemical substance will continue to meet 

16 the safety standard if the allowed uses, 

17 production volumes, or other specified con18 ditions or terms for that substance, are re19 vised to encompass the new use, produc20 tion volume, or other manner of manufac21 turing or processing. 

22 ‘‘(B) AMENDMENT TO SAFETY STANDARD

23 DETERMINATION.—If the conditions described 

24 in clauses (i) through (iii) of subparagraph (A) 

25 are satisfied, the Administrator shall, by order, 


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1 amend the safety standard determination for 

2 the chemical substance to include the new use, 

3 production volume, or other manner of manu4 facturing or processing among the allowed uses, 

5 production volumes, or manners of manufac6 turing or processing of the chemical substance. 

7 ‘‘(4) SAFETY STANDARD DETERMINATION.— 

8 ‘‘(A) IN GENERAL.—Except as provided in 

9 subparagraphs (B) and (C), not later than 180 

10 days after the date of receipt of a notice and 

11 supporting data that satisfies paragraph (1)(A) 

12 or paragraph (3)(A), the Administrator shall 

13 determine whether the person submitting the 

14 notice has established that the chemical sub15 stance will meet, or will continue to meet, the 

16 safety standard under section 6(b). 

17 ‘‘(B) EXCEPTION.—In the case of a notice 

18 under paragraph (1)(A), the Administrator 

19 shall not be subject to the deadline described in 

20 subparagraph (A) if the Administrator first 

21 makes the finding specified under paragraph 

22 (1)(C)(ii). 

23 ‘‘(C) EXTENSION.—The Administrator 

24 may extend the determination deadline under 

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1 ods not to exceed 1 year in the aggregate, in 

2 such manner as the Administrator determines 

3 necessary. 

4 ‘‘(D) FAILURE TO MAKE A TIMELY DETER5 MINATION.—The failure of the Administrator to 

6 make a timely determination in accordance with 

7 this paragraph shall not be sufficient to satisfy 

8 the conditions described in paragraph (1)(C)(i) 

9 or paragraph (3)(A)(iii). 

10 ‘‘(5) NOTICE OF COMMENCEMENT.—Not later 

11 than 30 days after the date on which a manufac12 turer or processor commences the manufacturing or 

13 processing of a new chemical substance, the manu14 facturer or processor shall submit to the Adminis15 trator a notice of commencement of manufacture or 

16 processing. 

17 ‘‘(6) CHEMICAL SUBSTANCES EXHIBITING SPE18 CIAL SUBSTANCE CHARACTERISTICS.— 

19 ‘‘(A) DETERMINATION.—The Adminis20 trator shall determine by order or rule that a 

21 variant of a chemical substance exhibiting 1 or 

22 more special substance characteristics— 

23 ‘‘(i) is a use that is separate from any 

24 use of the chemical substance that does 


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1 not exhibit the special substance character2 istics; or 

3 ‘‘(ii) is a new chemical substance. 

4 ‘‘(B) REQUIREMENTS FOR VARIANTS THAT

5 ARE SEPARATE USES.—In the case of a chem6 ical substance that the Administrator deter7 mines to be a separate use based on the special 

8 substance characteristics of the chemical sub9 stance, the manufacturer or processor shall sat10 isfy such further conditions as the Adminis11 trator establishes, by order or rule. 

12 ‘‘(b) SUBMISSION OF DATA.— 

13 ‘‘(1) IN GENERAL.—A person shall submit to 

14 the Administrator data in accordance with the rule 

15 or order at the time that notice is submitted under 

16 subsection (a) if the person is required to submit to 

17 the Administrator— 

18 ‘‘(A) under subsection (a), a notice prior to 

19 beginning the manufacture or processing of a 

20 chemical substance; and 

21 ‘‘(B) under section 4(b), test data for the 

22 chemical substance prior to the submission of 

23 the notice. 

24 ‘‘(2) AVAILABILITY.—Subject to section 14, the 

25 Administrator shall make any test data submitted 


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1 under paragraph (1) available on a publicly acces2 sible Internet site. 

3 ‘‘(c) CONTENT AND AVAILABILITY OF NOTICE.— 

4 ‘‘(1) CONTENT.—Notice under subsection 

5 (a)(1) shall include— 

6 ‘‘(A) the declaration described in section 

7 8(a)(2); 

8 ‘‘(B) the minimum data set described in 

9 section 4(a); and 

10 ‘‘(C) a statement that the chemical sub11 stance will meet the applicable safety standard. 

12 ‘‘(2) AVAILABILITY.—Subject to section 14, the 

13 Administrator shall make the notice under para14 graph (1) available on a publicly accessible Internet 

15 site. 

16 ‘‘(3) PUBLIC INFORMATION.—Subject to section 

17 14, not later than 5 days (excluding Saturdays, Sun18 days, and legal holidays) after the date of the receipt 

19 of a notice under subsection (a) or of data under 

20 subsection (b), the Administrator shall make avail21 able on a publicly accessible Internet site informa22 tion that— 

23 ‘‘(A) identifies the chemical substance for 

24 which notice or data has been received; 


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1 ‘‘(B) lists the uses or intended uses of the 

2 chemical substance; 

3 ‘‘(C) in the case of the receipt of data 

4 under subsection (b), describes— 

5 ‘‘(i) the nature of the tests performed 

6 with respect to the chemical substance; and 

7 ‘‘(ii) any data that were received 

8 under subsection (b) or a rule or order 

9 under section 4; and 

10 ‘‘(D) references the availability of the min11 imum data set. 

12 ‘‘(4) LIST OF NOTICES.—At the beginning of 

13 each month, the Administrator shall make available 

14 on a publicly accessible Internet site a list of each 

15 chemical substance for which notice has been re16 ceived under subsection (a). 

17 ‘‘(d) EXEMPTIONS.— 

18 ‘‘(1) TEST MARKETING PURPOSES.—The Ad19 ministrator may, upon application, exempt any per20 son from any requirement of subsection (a) or (b) to 

21 permit the person to manufacture or process a 

22 chemical substance for test marketing purposes— 

23 ‘‘(A) upon a showing by the person, in a 

24 manner that the Administrator determines, that 

25 the manufacture, processing, distribution in 


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1 commerce, use, and disposal of the chemical 

2 substance (including any combination of those 

3 activities) will not endanger human health or 

4 the environment; and 

5 ‘‘(B) under such restrictions as the Admin6 istrator considers appropriate. 

7 ‘‘(2) EQUIVALENT CHEMICAL SUBSTANCES.— 

8 ‘‘(A) IN GENERAL.—The Administrator 

9 shall, upon application, fully or partially exempt 

10 any person from the requirement to submit 

11 data under subsection (a) if, on receipt of an 

12 application, the Administrator determines 

13 that— 

14 ‘‘(i) the chemical substance for which 

15 the application was submitted is equivalent 

16 to a chemical substance for which data has 

17 been submitted to the Administrator as re18 quired by this Act; and 

19 ‘‘(ii) submission of data by the appli20 cant on the chemical substance would be 

21 duplicative of data which has been sub22 mitted to the Administrator in accordance 

23 with this Act. 

24 ‘‘(B) EFFECTIVE DATE.—No exemption 

25 under this paragraph may take effect before the 


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1 beginning of the reimbursement period applica2 ble to the data. 

3 ‘‘(C) FAIR AND EQUITABLE REIMBURSE4 MENT.— 

5 ‘‘(i) DEFINITION OF REIMBURSEMENT

6 PERIOD.—In this subparagraph, the term 

7 ‘reimbursement period’, with respect to 

8 any previously submitted data for a chem9 ical substance, means the period that— 

10 ‘‘(I) begins on the date of the 

11 termination of the prohibition, im12 posed under this section, on the man13 ufacture or processing of the chemical 

14 substance by the person who sub15 mitted the data to the Administrator; 

16 and 

17 ‘‘(II) ends on the later of— 

18 ‘‘(aa) the date that is 5 

19 years after the date referred to in 

20 subclause (I); or 

21 ‘‘(bb) at the expiration of a 

22 period that begins on the date re23 ferred to in subclause (I) and 

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1 istrator determines to be nec2 essary to develop the data. 

3 ‘‘(ii) REIMBURSEMENT.—Except as 

4 provided in clause (iii), if the Adminis5 trator exempts any person under subpara6 graph (A)(i) and the exemption is granted 

7 during the reimbursement period for that 

8 data, the Administrator shall order the 

9 person granted the exemption to provide 

10 fair and equitable reimbursement (in an 

11 amount determined by the Adminis12 trator)— 

13 ‘‘(I) to the person who previously 

14 submitted the data on which the ex15 emption was based, for a portion of 

16 the costs incurred by the person in 

17 complying with the requirement under 

18 this title to submit the data; and 

19 ‘‘(II) to any other person who 

20 has been required under this subpara21 graph to contribute with respect to 

22 the costs, for a portion of the amount 

23 the person was required to contribute. 

24 ‘‘(iii) EXCEPTION.—Clause (ii) shall 

25 not apply if the person exempted under 


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1 that clause and the persons described in 

2 subclauses (I) and (II) of that clause agree 

3 on the amount and method of reimburse4 ment. 

5 ‘‘(iv) CONSIDERATIONS.—In promul6 gating rules for the determination of fair 

7 and equitable reimbursement to the per8 sons described in subclauses (I) and (II) of 

9 clause (ii) for costs incurred with respect 

10 to a chemical substance, the Administrator 

11 shall, after consultation with the Attorney 

12 General and the Federal Trade Commis13 sion, consider all relevant factors, includ14 ing— 

15 ‘‘(I) the effect on the competitive 

16 position of the person required to pro17 vide reimbursement in relation to the 

18 persons to be reimbursed; and 

19 ‘‘(II) the share of the market for 

20 the chemical substance of the person 

21 required to provide reimbursement in 

22 relation to the share of the market of 

23 the persons to be reimbursed. 

24 ‘‘(3) SMALL QUANTITIES.— 


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1 ‘‘(A) IN GENERAL.—If the conditions de2 scribed in subparagraph (B) are met, sub3 sections (a) and (b) shall not apply with respect 

4 to the manufacturing or processing of any 

5 chemical substance that is manufactured or 

6 processed, or proposed to be manufactured or 

7 processed, only in small quantities (as defined 

8 by the Administrator by rule) solely for pur9 poses of— 

10 ‘‘(i) scientific experimentation or anal11 ysis; or 

12 ‘‘(ii) chemical research on, or analysis 

13 of, the substance or another substance, in14 cluding research or analysis for the devel15 opment of a product. 

16 ‘‘(B) CONDITIONS.—All persons engaged 

17 in the experimentation, research, or analysis 

18 carried out in accordance with subparagraph 

19 (A) for a manufacturer or processor shall be 

20 notified (in such form and manner as the Ad21 ministrator may prescribe) of any risk to 

22 human health that the manufacturer, processor, 

23 or the Administrator has reason to believe may 

24 be associated with that chemical substance. 


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1 ‘‘(4) TEMPORARY EXISTENCE.—The Adminis2 trator may, upon application, exempt from sub3 sections (a) and (b) the manufacturing or processing 

4 of any chemical substance— 

5 ‘‘(A) that exists temporarily as a result of 

6 a chemical reaction in the manufacturing or 

7 processing of a mixture or another chemical 

8 substance; and 

9 ‘‘(B) to which there is no, and will not be, 

10 any human or environmental exposure. 

11 ‘‘(5) PUBLICATION.— 

12 ‘‘(A) IN GENERAL.—As soon as practicable 

13 after the date of receipt of an application under 

14 paragraph (1) or (4), the Administrator shall 

15 publish in the Federal Register notice of the re16 ceipt of the application. 

17 ‘‘(B) REQUIREMENTS.—The Administrator 

18 shall— 

19 ‘‘(i) give interested persons an oppor20 tunity to comment upon any application 

21 described in subparagraph (A); 

22 ‘‘(ii) not later than 45 days after the 

23 date of receipt of an application, approve 

24 or deny the application; and 


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1 ‘‘(iii) publish in the Federal Register 

2 notice of the approval or denial of the ap3 plication. 

4 ‘‘(e) CERTIFICATION.—Each submission required 

5 under this section or under a rule or an order promulgated 

6 or issued by the Administrator under this section shall be 

7 accompanied by a certification signed by a responsible offi8 cial of the manufacturer or processor that each statement 

9 contained in the submission— 

10 ‘‘(1) is accurate and reliable; and 

11 ‘‘(2) includes all material facts known to, in the 

12 possession or control of, or reasonably ascertainable 

13 by, the manufacturer or processor. 

14 ‘‘(f) DEFINITIONS.—In this section: 

15 ‘‘(1) MANUFACTURE AND PROCESS.—The terms 

16 ‘manufacture’ and ‘process’ mean to manufacture or 

17 process, respectively, for commercial purposes. 

18 ‘‘(2) TEST MARKETING.—The term ‘test mar19 keting’ does not include any provision of a chemical 

20 substance, or a mixture or article containing that 

21 chemical substance, to an end consumer of the 

22 chemical substance, mixture, or article.’’. 


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1 SEC. 7. PRIORITIZATION, SAFETY STANDARD DETERMINA2 TION, AND RISK MANAGEMENT. 

3 Section 6 of the Toxic Substances Control Act (15 

4 U.S.C. 2605) is amended to read as follows: 

5 ‘‘SEC. 6. PRIORITIZATION, SAFETY STANDARD DETERMINA6 TION, AND RISK MANAGEMENT. 

7 ‘‘(a) PRIORITIZATION OF CHEMICAL SUBSTANCES.— 

8 ‘‘(1) PRIORITIZATION LIST.— 

9 ‘‘(A) IN GENERAL.—Subject to subpara10 graph (B), the Administrator shall, by order, 

11 develop and publish a list that— 

12 ‘‘(i) contains the names of the chem13 ical substances or categories of chemical 

14 substances that the Administrator deter15 mines warrant placement within 1 of the 3 

16 priority classes described in paragraphs (2) 

17 through (4); and 

18 ‘‘(ii) identifies the priority class to 

19 which each listed chemical substance or 

20 category of chemical substance has been 

21 assigned by the Administrator. 

22 ‘‘(B) CONSIDERATIONS.—In determining 

23 which chemical substances to include in each 

24 priority class, the Administrator shall give due 

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1 tion that is provided by the committee estab2 lished under paragraph (5). 

3 ‘‘(2) CHEMICAL SUBSTANCES REQUIRING IMME4 DIATE RISK MANAGEMENT (PRIORITY CLASS 1).— 

5 ‘‘(A) DEFINITION OF PRIORITY CLASS 1.— 

6 In this section, the term ‘priority class 1’ means 

7 a priority class that contains chemical sub8 stances that the Administrator determines re9 quire immediate risk management. 

10 ‘‘(B) ASSIGNMENT TO PRIORITY CLASS

11 1.—The Administrator shall assign a chemical 

12 substance to priority class 1 if the Adminis13 trator determines that the chemical substance 

14 is, or is degraded and metabolized into, a per15 sistent, bioaccumulative, and toxic substance 

16 with the potential for widespread exposure to 

17 humans or other organisms. 

18 ‘‘(C) INITIAL ASSIGNMENT.—Not later 

19 than 1 year after the date of enactment of the 

20 Safe Chemicals Act of 2011, the Administrator 

21 shall assign not less than 20, but not more than 

22 30, chemical substances to the initial priority 

23 class 1. 

24 ‘‘(D) RISK MANAGEMENT.— 


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1 ‘‘(i) EXPEDITED EXPOSURE REDUC2 TION.—As soon as practicable, but not 

3 later than 18 months after the date on 

4 which a chemical substance is assigned to 

5 priority class 1 under this paragraph, the 

6 Administrator shall impose conditions in 

7 accordance with subsection (c) on the man8 ufacturing, processing, use, distribution in 

9 commerce, and disposal of a chemical sub10 stance assigned to priority class 1 that the 

11 Administrator determines necessary to 

12 achieve the greatest practicable reductions 

13 in human or environmental exposure to the 

14 chemical substance. 

15 ‘‘(ii) RESIDUAL RISK ASSESSMENT.— 

16 Not later than 1 year after the effective 

17 date of any conditions established under 

18 clause (i), the Administrator shall— 

19 ‘‘(I) determine whether the chem20 ical substance meets the applicable 

21 safety standard for the chemical sub22 stance, taking into account the resid23 ual risk posed by continued exposure 

24 to the chemical substance; and 


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1 ‘‘(II) impose any further condi2 tions under subsection (c) that the 

3 Administrator determines necessary to 

4 ensure that the chemical substance 

5 meets the applicable safety standard. 

6 ‘‘(E) UPDATES.— 

7 ‘‘(i) REVISIONS.—The Administrator 

8 shall promptly revise the list under para9 graph (1) whenever the Administrator de10 termines that the addition or removal of a 

11 chemical substance from priority class 1 is 

12 warranted. 

13 ‘‘(ii) REMOVAL PROCEDURE.—A 

14 chemical substance may be removed from 

15 the list under paragraph (1) only if the 

16 Administrator finds that such substance 

17 meets the safety standard under subsection 

18 (b). 

19 ‘‘(3) CHEMICAL SUBSTANCES REQUIRING SAFE20 TY STANDARD DETERMINATIONS (PRIORITY CLASS

21 2).— 

22 ‘‘(A) DEFINITION OF PRIORITY CLASS 2.— 

23 In this section, the term ‘priority class 2’ means 

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1 stances that Administrator determines require 

2 safety standard determinations. 

3 ‘‘(B) ASSIGNMENT TO PRIORITY CLASS

4 2.— 

5 ‘‘(i) IN GENERAL.—Subject to clause 

6 (ii), if the Administrator determines, based 

7 on any more-than-theoretical concern, that 

8 there is uncertainty as to whether a chem9 ical substance would satisfy the safety 

10 standard in a determination made under 

11 subsection (b), the Administrator shall as12 sign that chemical substance priority class 

13 2. 

14 ‘‘(ii) CONDITIONS.—The Adminis15 trator shall assign chemical substances to 

16 priority class 2 subject to the conditions 

17 that— 

18 ‘‘(I) the rate at which chemical 

19 substances are added to priority class 

20 2 shall be expeditious, but shall not 

21 exceed the rate at which the Adminis22 trator reasonably anticipates com23 pleting safety standard determinations 

24 under subsection (b); and 


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1 ‘‘(II) the Administrator shall 

2 first assign to priority class 2 those 

3 chemical substances that present the 

4 greater risks to human health or the 

5 environment, as determined by the 

6 Administrator. 

7 ‘‘(C) REMOVAL PROCEDURE.—The Admin8 istrator shall not remove a chemical substance 

9 from priority class 2 until the Administrator 

10 has made a safety standard determination for 

11 that chemical substance under subsection (b). 

12 ‘‘(4) CHEMICAL SUBSTANCES REQUIRING NO

13 IMMEDIATE ACTION (PRIORITY CLASS 3).— 

14 ‘‘(A) DEFINITION OF PRIORITY CLASS 3.— 

15 In this section, the term ‘priority class 3’ means 

16 a priority class that contains chemical sub17 stances that the Administrator determines re18 quire no immediate action. 

19 ‘‘(B) ASSIGNMENT TO PRIORITY CLASS

20 3.—The Administrator shall assign a chemical 

21 substance to priority class 3 if the chemical 

22 substance has intrinsic properties such that the 

23 chemical substance, as determined by the Ad24 ministrator, does not and would not, at any 

25 stage of the lifecycle of the chemical substance, 


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1 pose any risk of adverse effects to human 

2 health or the environment under existing, pro3 posed, or anticipated levels of exposure to, or 

4 production or patterns of use of, that chemical 

5 substance. 

6 ‘‘(C) UPDATES.—The Administrator shall 

7 promptly revise the list under paragraph (1) 

8 whenever the Administrator determines that the 

9 addition or removal of a chemical substance 

10 from priority class 3 is warranted. 

11 ‘‘(5) INTERAGENCY PRIORITIZATION AND TEST12 ING COMMITTEE.— 

13 ‘‘(A) ESTABLISHMENT.—There is estab14 lished an interagency committee (referred to in 

15 this section as the ‘committee’) to make rec16 ommendations to the Administrator con17 cerning— 

18 ‘‘(i) the issuance of test rules or or19 ders for chemical substances and mixtures 

20 under section 4(c); and 

21 ‘‘(ii) the prioritization of chemical 

22 substances under this subsection. 

23 ‘‘(B) RECOMMENDATIONS.— 

24 ‘‘(i) FACTORS.—In making a rec25 ommendation concerning— 


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1 ‘‘(I) the issuance of test rules or 

2 orders under section 4(c), the com3 mittee shall consider all factors rel4 evant to risk; and 

5 ‘‘(II) prioritization of chemical 

6 substances or categories of chemical 

7 substances under this subsection, the 

8 committee shall consider the criteria 

9 described in paragraphs (2)(B), 

10 (3)(B), and (4)(B). 

11 ‘‘(ii) FORM.—The recommendations of 

12 the committee shall be in the form of 1 or 

13 more lists of chemical substances and mix14 tures that shall specify, either by individual 

15 substance or mixture or by categories of 

16 substances or mixtures— 

17 ‘‘(I) the recommendations of the 

18 committee that particular chemical 

19 substances, mixtures, or categories of 

20 chemical substances or mixtures be 

21 the subject of a test rule or order 

22 under section 4(c); or 

23 ‘‘(II) the recommendations of the 

24 committee that particular chemical 

25 substances, or categories of chemical 


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1 substances, be prioritized under this 

2 subsection. 

3 ‘‘(iii) ADDITIONS OR REVISIONS.— 

4 ‘‘(I) IN GENERAL.—Not less fre5 quently than once every year, the 

6 committee shall— 

7 ‘‘(aa) make such additions 

8 or revisions to the recommenda9 tions of the committee as the 

10 committee determines to be nec11 essary; and 

12 ‘‘(bb) submit to the Admin13 istrator the recommendations and 

14 a statement of the reasons of the 

15 committee for any additions or 

16 revisions. 

17 ‘‘(II) PUBLICATION.—On receipt 

18 of any new or revised recommenda19 tions, the Administrator shall publish 

20 in the Federal Register the rec21 ommendations and the statement of 

22 the reasons for the additions or revi23 sions. 

24 ‘‘(III) COMMENTS.—The Admin25 istrator shall— 


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1 ‘‘(aa) provide reasonable op2 portunity to any interested per3 son to file with the Administrator 

4 written comments on the rec5 ommendations of the committee, 

6 and any additions or revisions to 

7 the recommendations by the com8 mittee; 

9 ‘‘(bb) consider any com10 ments received under item (aa); 

11 and 

12 ‘‘(cc) make any comments 

13 received under item (aa) available 

14 to the public. 

15 ‘‘(C) COMPOSITION.—The committee shall 

16 consist of the following 8 members: 

17 ‘‘(i) One member appointed by the 

18 Administrator from among officers or em19 ployees of the Environmental Protection 

20 Agency. 

21 ‘‘(ii) One member appointed by the 

22 Secretary of Labor from among officers or 

23 employees of the Department of Labor who 

24 are engaged in the activities of the Sec25 retary of Labor under the Occupational 


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1 Safety and Health Act of 1970 (29 U.S.C. 

2 651 et seq.). 

3 ‘‘(iii) One member appointed by the 

4 Chairman of the Council on Environmental 

5 Quality from among the Council or the of6 ficers or employees of the Council. 

7 ‘‘(iv) One member appointed by the 

8 Director of the National Institute for Oc9 cupational Safety and Health from among 

10 officers or employees of the Institute. 

11 ‘‘(v) One member appointed by the 

12 Director of the National Institute of Envi13 ronmental Health Sciences from among of14 ficers or employees of the Institute. 

15 ‘‘(vi) One member appointed by the 

16 Director of the National Cancer Institute 

17 from among officers or employees of the 

18 Institute. 

19 ‘‘(vii) One member appointed by the 

20 Director of the National Science Founda21 tion from among officers or employees of 

22 the Foundation. 

23 ‘‘(viii) One member appointed by the 

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1 cers or employees of the Department of 

2 Commerce. 

3 ‘‘(D) APPOINTMENT OF MEMBERS.— 

4 ‘‘(i) DESIGNEES.— 

5 ‘‘(I) IN GENERAL.—An appointed 

6 member may designate an individual 

7 to serve on the committee on behalf of 

8 the member. 

9 ‘‘(II) PREREQUISITES.—A des10 ignation may be made only— 

11 ‘‘(aa) with the approval of 

12 the applicable appointing author13 ity; and 

14 ‘‘(bb) if the individual is an 

15 officer or employee of the entity 

16 from which the member was ap17 pointed. 

18 ‘‘(ii) TERMS.— 

19 ‘‘(I) IN GENERAL.—No individual 

20 may serve as a member of the com21 mittee for more than an aggregate pe22 riod of 4 years. 

23 ‘‘(II) MEMBERS LEAVING AP24 POINTING ENTITIES.—If any member 

25 of the committee leaves the entity 


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1 from which the member was ap2 pointed— 

3 ‘‘(aa) the member may not 

4 continue as a member of the 

5 committee; and 

6 ‘‘(bb) the position of the 

7 member shall be considered va8 cant. 

9 ‘‘(III) VACANCIES.—A vacancy 

10 on the committee shall be filled in the 

11 same manner in which the original ap12 pointment was made. 

13 ‘‘(E) CONFLICTS OF INTEREST.— 

14 ‘‘(i) POST-TERMINATION EMPLOY15 MENT OR COMPENSATION.—No member of 

16 the committee, or designee of a member, 

17 shall accept employment or compensation 

18 from any person subject to any require19 ment of this Act or any rule promulgated 

20 or order issued under this Act, for a period 

21 of at least 1 year beginning after the date 

22 of termination of service on the committee. 

23 ‘‘(ii) FINANCIAL INTERESTS.—No per24 son, while serving as a member of the com25 mittee or designee of a member, may own 


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1 any stocks or bonds of, or have any pecu2 niary interest of substantial value in, any 

3 person engaged in the manufacture, proc4 essing, or distribution in commerce of any 

5 chemical substance or mixture subject to 

6 this Act or of any rule promulgated or 

7 order issued under this Act. 

8 ‘‘(iii) VIOLATIONS.—The Adminis9 trator, acting through the Attorney Gen10 eral, may bring an action in the appro11 priate district court of the United States 

12 for any violation of this subparagraph. 

13 ‘‘(F) ADMINISTRATIVE SUPPORT.—The 

14 Administrator shall provide the committee such 

15 administrative support services as may be nec16 essary to enable the committee to carry out the 

17 functions of the committee under this sub18 section. 

19 ‘‘(6) NO JUDICIAL REVIEW.—The following ac20 tions shall not be subject to judicial review: 

21 ‘‘(A) The assignment of a particular chem22 ical substance under this subsection. 

23 ‘‘(B) A determination by the Administrator 

24 of whether a particular assignment under this 

25 subsection is warranted. 


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1 ‘‘(C) A response to a petition to include a 

2 particular chemical substance on the list under 

3 this subsection. 

4 ‘‘(D) The issuance of a recommendation to 

5 list a chemical substance under this subsection. 

6 ‘‘(b) SAFETY STANDARD DETERMINATIONS FOR

7 CHEMICAL SUBSTANCES.— 

8 ‘‘(1) IN GENERAL.— 

9 ‘‘(A) APPLICATION.—This paragraph ap10 plies to the determination, or redetermination, 

11 of whether a chemical substance meets the ap12 plicable safety standard of this title. 

13 ‘‘(B) BURDEN OF PROOF.— 

14 ‘‘(i) IN GENERAL.—Under this title, 

15 the manufacturers and processors of a 

16 chemical substance, at all times, bear the 

17 burden of proving that the chemical sub18 stance meets the applicable safety stand19 ard. 

20 ‘‘(ii) DUTIES.—Under this title, it 

21 shall be the duty of— 

22 ‘‘(I) the manufacturers and proc23 essors of a chemical substance to pro24 vide sufficient information for the Ad25 ministrator to determine whether the 


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1 chemical substance meets the applica2 ble safety standard; and 

3 ‘‘(II) the Administrator to deter4 mine whether the chemical substance 

5 meets the applicable safety standard. 

6 ‘‘(C) ASSESSMENT OF RISK.— 

7 ‘‘(i) IN GENERAL.—Any determination 

8 that a chemical substance meets the appli9 cable safety standard under subparagraph 

10 (B)(ii) shall be supported by an assess11 ment of risk conducted by an employee of 

12 the Environmental Protection Agency. 

13 ‘‘(ii) SAFETY STANDARD.— 

14 ‘‘(I) IN GENERAL.—The Admin15 istrator shall base the determination 

16 of whether the safety standard for a 

17 chemical substance has been met 

18 under this title solely on consider19 ations of human health and the envi20 ronment, including the health of vul21 nerable human populations. 

22 ‘‘(II) CONSIDERATIONS.—In 

23 making a safety standard determina24 tion under this title, for each chemical 

25 substance, the Administrator shall— 


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1 ‘‘(aa) to the extent prac2 ticable, review and incorporate 

3 any available scientific informa4 tion relating to the effect of cu5 mulative exposure to that chem6 ical substance on human health 

7 and the environment; and 

8 ‘‘(bb) find that a chemical 

9 substance meets the safety stand10 ard only if the Administrator 

11 finds that there is a reasonable 

12 certainty that no harm will result 

13 to human health or the environ14 ment from aggregate exposure to 

15 the chemical substance. 

16 ‘‘(iii) FINANCIAL INTERESTS.—No 

17 participant or peer reviewer in an assess18 ment described in clause (i) shall have a 

19 direct or indirect financial interest in the 

20 outcome of the assessment. 

21 ‘‘(iv) METHODOLOGY.— 

22 ‘‘(I) IN GENERAL.—Subject to 

23 subclause (II), the Administrator shall 

24 use the best available science when 


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1 conducting an assessment described in 

2 clause (i). 

3 ‘‘(II) CONSIDERATIONS.—For the 

4 purpose of determining the current 

5 best available science, the Adminis6 trator shall base the determination on 

7 the recommendations of the National 

8 Academy of Sciences in the report en9 titled ‘Science and Decisions’. 

10 ‘‘(III) REVIEW.—Not later than 

11 5 years after the date of enactment of 

12 the Safe Chemicals Act of 2011, and 

13 not less frequently than once every 5 

14 years thereafter, the Administrator 

15 shall review the methodology under 

16 this paragraph and may revise the 

17 methodology to reflect new scientific 

18 developments or understandings. 

19 ‘‘(v) SCOPE.—An assessment de20 scribed in clause (i) shall address human 

21 health or environmental impacts, including 

22 potential or demonstrated cancer and non23 cancer endpoints. 

24 ‘‘(vi) TRANSPARENCY.—In carrying 

25 out this subsection, the Administrator shall 


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1 ensure that the approaches and resulting 

2 assessments are communicated in a man3 ner that is transparent and understandable 

4 to the public and to risk managers. 

5 ‘‘(vii) MANUFACTURE OR PROCESSING

6 FOR EXPORT.—In the case of a chemical 

7 substance that is manufactured or proc8 essed in whole or in part for export, in de9 termining whether the chemical substance 

10 meets the applicable safety standard under 

11 subparagraph (B)(ii), the Administrator 

12 shall take into account any risks that the 

13 chemical substance may pose in the United 

14 States, including risks involving long-range 

15 transport of the chemical substance in the 

16 environment and risks involving the import 

17 of articles and mixtures containing the 

18 chemical substance. 

19 ‘‘(viii) RISK ASSESSMENT NOT RE20 QUIRED.—The Administrator shall not be 

21 required to conduct a risk assessment to 

22 determine that a manufacturer or proc23 essor has not met the burden of proof 

24 under subparagraph (B). 


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1 ‘‘(D) NO JUDICIAL REVIEW.—A determina2 tion by the Administrator that a manufacturer 

3 or processor has not established that the chem4 ical substance meets the applicable safety 

5 standard under this subsection shall not be sub6 ject to judicial review. 

7 ‘‘(2) DUTIES.— 

8 ‘‘(A) MANUFACTURER AND PROCESSOR

9 DUTIES.— 

10 ‘‘(i) INITIAL SAFETY STANDARD DE11 TERMINATION SUBMISSION.— 

12 ‘‘(I) IN GENERAL.—By the date 

13 that is 30 months after the date on 

14 which a chemical substance is as15 signed to priority class 2 under sub16 section (a), the manufacturers and 

17 processors of a chemical substance 

18 shall— 

19 ‘‘(aa) update the minimum 

20 dataset, if the data set was sub21 mitted prior to the assignment of 

22 the chemical substance to priority 

23 class 2 under subsection (a); 

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1 tion the Administrator may re2 quire to make a safety standard 

3 determination, including any in4 formation the Administrator de5 termines is necessary to be devel6 oped by testing; and 

7 ‘‘(cc) indicate whether the 

8 chemical substance, including 

9 specified uses to be evaluated and 

10 any proposed conditions on the 

11 specified uses, meets the safety 

12 standard. 

13 ‘‘(II) SUBMITTING MANUFACTUR14 ERS AND PROCESSORS.—The Admin15 istrator may permit the manufactur16 ers and processors of a chemical sub17 stance to designate 1 or more manu18 facturers or processors to submit the 

19 information required under subclause 

20 (I) on behalf of the manufacturers 

21 and processors making the designa22 tion. 

23 ‘‘(III) LIABILITY.—All manufac24 turers and processors described in 

25 subclause (II) shall remain liable for 


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1 compliance with any requirements 

2 subject to the designation. 

3 ‘‘(ii) RENEWAL OF SAFETY STANDARD

4 DETERMINATION SUBMISSION.— 

5 ‘‘(I) IN GENERAL.—Not later 

6 than 15 years after the date of the 

7 previous submission under clause (i), 

8 this clause, or section 5(c)(1), the 

9 manufacturers and processors of each 

10 chemical substance shall— 

11 ‘‘(aa) submit to the Admin12 istrator an updated minimum 

13 data set for the chemical sub14 stance, as established under sec15 tion 4(a); and 

16 ‘‘(bb) indicate whether the 

17 chemical substance, including 

18 specified uses to be evaluated and 

19 any proposed conditions on the 

20 specified use meets the safety 

21 standard. 

22 ‘‘(II) SUBMITTING MANUFACTUR23 ERS AND PROCESSORS.—The Admin24 istrator may permit the manufactur25 ers and processors of a chemical subVerDate Mar 15 2010 21:55 Apr 18, 2011 Jkt 099200 PO 00000 Frm 00071 Fmt 6652 Sfmt 6201 E:\BILLS\S847.IS S847

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1 stance to designate 1 or more manu2 facturers or processors to submit the 

3 information required under subclause 

4 (I) on behalf of the manufacturers 

5 and processors making the designa6 tion. 

7 ‘‘(III) LIABILITY.—All manufac8 turers and processors described in 

9 subclause (II) shall remain liable for 

10 compliance with any requirements 

11 subject to the designation. 

12 ‘‘(iii) NOTICE OF PENDING DETER13 MINATION.—If the Administrator fails to 

14 act by an applicable deadline under sub15 paragraph (B)(i), each manufacturer and 

16 processor of a chemical substance for 

17 which the Administrator has failed to act 

18 shall provide to the Administrator, the 

19 public, the employees and recognized bar20 gaining agents of any employees who are 

21 represented by bargaining agents of the 

22 manufacturer or processor, and each 

23 known customer who has purchased the 

24 chemical substance within a reasonable 

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1 trator by rule or order, a written notice 

2 that a determination by the Administrator 

3 of the safety of the chemical substance is 

4 pending. 

5 ‘‘(iv) FAILURE OF MANUFACTURER OR

6 PROCESSOR TO MEET DUTIES.—If a manu7 facturer or processor fails to meet any 

8 duty under this subparagraph for a chem9 ical substance, the Administrator may, by 

10 order, take any action authorized under 

11 subsection (c) if a manufacturer or proc12 essor is in violation of a duty under this 

13 subparagraph, except as authorized sub14 section (e). 

15 ‘‘(B) ADMINISTRATOR DUTIES.— 

16 ‘‘(i) SAFETY STANDARD DETERMINA17 TION.—Not later than 1 year after the ear18 lier of the date of receipt of a complete 

19 submission or the applicable submission 

20 deadline under clause (i) or (ii) of subpara21 graph (A), or after initiating a redeter22 mination under clause (iii) of this subpara23 graph, with respect to a chemical sub24 stance, the Administrator shall by order 

25 determine, or redetermine, as appropriate, 


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1 whether the manufacturers and processors 

2 of the chemical substance have established 

3 that the chemical substance meets the 

4 safety standard. 

5 ‘‘(ii) USES AND CONDITIONS.—If the 

6 Administrator determines that the chem7 ical substance meets the safety standard, 

8 the Administrator shall specify in the 

9 order— 

10 ‘‘(I) the allowed uses of the sub11 stance, which shall be limited to the 

12 uses evaluated in the determination; 

13 and 

14 ‘‘(II) any conditions on the speci15 fied uses to ensure the safety stand16 ard is met, including conditions that 

17 relate to the manufacture, processing, 

18 use, distribution in commerce, or dis19 posal of a chemical substance, or mix20 ture or article containing such chem21 ical substance, and any conditions de22 scribed in subsection (c). 

23 ‘‘(iii) REDETERMINATION.—The Ad24 ministrator shall initiate a redetermination 

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1 essors of a chemical substance distributed 

2 in commerce have established that the 

3 chemical substance meets the safety stand4 ard— 

5 ‘‘(I) if new information raises a 

6 credible question as to whether the 

7 chemical substance continues to meet 

8 the safety standard; 

9 ‘‘(II) on the receipt of a renewal 

10 submission under subparagraph 

11 (A)(ii); or 

12 ‘‘(III) after the 15-year period 

13 beginning on the date of the previous 

14 applicable determination of the Ad15 ministrator under this subparagraph, 

16 if a redetermination has not already 

17 been initiated subsequent to the deter18 mination. 

19 ‘‘(iv) PETITION FOR REDETERMINA20 TION.— 

21 ‘‘(I) IN GENERAL.—Any person 

22 may petition the Administrator for a 

23 redetermination of whether a chemical 

24 substance continues to meet the appli25 cable safety standard. 


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1 ‘‘(II) BASIS.—The person shall 

2 include in the petition a description of 

3 the basis for requesting the redeter4 mination. 

5 ‘‘(III) ACTION BY ADMINIS6 TRATOR.—On receipt of the petition, 

7 the Administrator shall— 

8 ‘‘(aa) not later than 30 days 

9 after the date of receipt, publish 

10 in the Federal Register a notice 

11 of receipt of the petition that 

12 specifies the chemical identity of 

13 the chemical substance to which 

14 the petition pertains; 

15 ‘‘(bb) make the petition 

16 available on request; 

17 ‘‘(cc) provide a reasonable 

18 opportunity for public review and 

19 comment on the petition and give 

20 due consideration to any com21 ments received; 

22 ‘‘(dd) decide whether to 

23 make the requested redetermina24 tion; and 


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1 ‘‘(ee) not later than 180 

2 days after the date of receipt, 

3 publish in the Federal Register 

4 the decision and the basis for the 

5 decision. 

6 ‘‘(3) RISK REDUCTION.— 

7 ‘‘(A) IN GENERAL.—Except as provided 

8 under subsection (e), the risk reduction meas9 ures described in this paragraph shall apply to 

10 a chemical substance in accordance with this 

11 paragraph. 

12 ‘‘(B) NEGATIVE SAFETY STANDARD DE13 TERMINATION.—No person shall manufacture, 

14 process, or distribute in commerce a chemical 

15 substance, or any mixture or article containing 

16 the chemical substance, for— 

17 ‘‘(i) any new chemical substance for 

18 which notice is required under section 5(a), 

19 effective immediately after the Adminis20 trator makes a safety standard determina21 tion for a chemical substance under para22 graph (2)(B)(i) and does not determine 

23 that the manufacturer or processor has es24 tablished that the chemical substance 

25 meets the applicable safety standard; or 


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1 ‘‘(ii) any other chemical substance, ef2 fective 1 year after the Administrator 

3 makes a safety standard determination for 

4 a chemical substance under paragraph 

5 (2)(B)(i) and does not determine that the 

6 chemical substance meets the applicable 

7 safety standard. 

8 ‘‘(C) POSITIVE SAFETY STANDARD DETER9 MINATION.—Effective beginning 1 year after 

10 the date on which the Administrator determines 

11 under paragraph (2)(B)(i) that a chemical sub12 stance meets the safety standard or imme13 diately after such a determination is made for 

14 a new chemical substance for which notice is re15 quired under section 5(a), no person shall man16 ufacture, process, or distribute in commerce the 

17 chemical substance, or any mixture or article 

18 containing the chemical substance, for any use 

19 other than those specified in the determination 

20 established under paragraph (2)(B)(ii). 

21 ‘‘(c) RISK MANAGEMENT.—The Administrator, in 

22 making a safety standard determination, may impose con23 ditions on the manufacture, processing, use, distribution 

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1 ture or article containing that chemical substance, in ac2 cordance with subsection (b)(2)(B)(ii)(II), including— 

3 ‘‘(1) a requirement limiting the quantity of the 

4 substance that may be manufactured, processed, or 

5 distributed in commerce; 

6 ‘‘(2) a requirement— 

7 ‘‘(A) prohibiting the manufacture, proc8 essing, or distribution in commerce of the sub9 stance for a particular use in a concentration in 

10 excess of a level specified by the Administrator 

11 in conditions under subsection (b)(2)(B)(ii)(II); 

12 or 

13 ‘‘(B) limiting the quantity of the substance 

14 that may be manufactured, processed, or dis15 tributed in commerce for— 

16 ‘‘(i) a particular use; or 

17 ‘‘(ii) a particular use in a concentra18 tion in excess of a level specified by the 

19 Administrator in conditions established 

20 under subsection (b)(2)(B)(ii)(II); 

21 ‘‘(3) a requirement that the substance be 

22 marked with or accompanied by clear and adequate 

23 warnings and instructions with respect to use, dis24 tribution in commerce, or disposal, or any combina25 tion of such activities, with the form and content of 


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1 the warnings and instructions prescribed by the Ad2 ministrator; 

3 ‘‘(4) a requirement that manufacturers and 

4 processors of the substance— 

5 ‘‘(A) make and retain records of the proc6 esses used to manufacture or process the sub7 stance; and 

8 ‘‘(B) monitor or conduct tests that are rea9 sonable and necessary to ensure compliance 

10 with this Act; 

11 ‘‘(5) a requirement prohibiting or otherwise reg12 ulating any manner or method of commercial use of 

13 the substance; 

14 ‘‘(6) a requirement prohibiting or otherwise reg15 ulating any manner or method of disposal of the 

16 substance by— 

17 ‘‘(A) the manufacturer or processor of the 

18 substance; or 

19 ‘‘(B) any other person that uses, or dis20 poses of, the substance for commercial pur21 poses; and 

22 ‘‘(7) a requirement that the manufacturers and 

23 processors of the substance, mixture, or article de24 velop a risk reduction management plan to achieve 

25 a risk reduction specified by the Administrator. 


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1 ‘‘(d) QUALITY CONTROL ORDERS.— 

2 ‘‘(1) IN GENERAL.—If the Administrator has a 

3 reasonable basis to conclude that a particular manu4 facturer or processor is manufacturing or processing 

5 a chemical substance in a manner that may present 

6 a substantial endangerment to human health or the 

7 environment, the Administrator may, by order, re8 quire the manufacturer or processor to submit a de9 scription of the quality control procedures followed 

10 in the manufacturing or processing of the chemical 

11 substance. 

12 ‘‘(2) ORDERS.— 

13 ‘‘(A) IN GENERAL.—If the Administrator 

14 determines that quality control procedures de15 scribed in paragraph (1) are inadequate to pre16 vent the chemical substance from presenting a 

17 risk of injury to human health or the environ18 ment, the Administrator may order the manu19 facturer or processor to revise the quality con20 trol procedures to the extent necessary to rem21 edy the inadequacy. 

22 ‘‘(B) SUBSTANTIAL ENDANGERMENT.—If 

23 the Administrator determines that quality con24 trol procedures described in paragraph (1) have 

25 resulted in the distribution in commerce of a 


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1 chemical substance that may present a substan2 tial endangerment to human health or the envi3 ronment, the Administrator may order the man4 ufacturer or processor— 

5 ‘‘(i) to give notice of the 

6 endangerment to— 

7 ‘‘(I) processors or distributors (or 

8 both) in commerce of the substance; 

9 and 

10 ‘‘(II) to the extent reasonably as11 certainable, any other person in pos12 session of or exposed to the substance; 

13 ‘‘(ii) to give public notice of the 

14 endangerment; and 

15 ‘‘(iii) to provide for the replacement 

16 or repurchase, as prescribed by the Admin17 istrator, of the substance as the Adminis18 trator determines necessary to adequately 

19 protect human health or the environment. 

20 ‘‘(e) EXEMPTIONS TO RESTRICTIONS.— 

21 ‘‘(1) APPLICATION.—This subsection applies to 

22 the restrictions established under sections 4(a)(3), 

23 4(b)(3), 8(b)(6), and 8(c)(3), and paragraphs 

24 (2)(A)(iv) and (3) of subsection (b). 

25 ‘‘(2) EXEMPTIONS.— 


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1 ‘‘(A) IN GENERAL.— 

2 ‘‘(i) REQUEST.—The manufacturers 

3 and processors of a chemical substance 

4 may request an exemption from any re5 striction described in paragraph (1) for a 

6 specified use of the chemical substance. 

7 ‘‘(ii) ORDER.—The Administrator 

8 may, by order, grant an exemption from 

9 any restriction described in paragraph (1) 

10 for a period of not to exceed 5 years if the 

11 manufacturers and processors of the chem12 ical substance have established by clear 

13 and convincing evidence that the uses to be 

14 exempted meet the exemption criteria de15 scribed in subparagraph (B). 

16 ‘‘(B) CRITERIA.—The Administrator may 

17 grant an exemption for the use of a chemical 

18 substance under subparagraph (A)(ii) if— 

19 ‘‘(i) the exemption is in the para20 mount interest of national security; 

21 ‘‘(ii) the lack of availability of the 

22 chemical substance would cause significant 

23 disruption in the national economy; or 


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1 ‘‘(iii) the use for which the exemption 

2 is sought is a critical or essential use for 

3 which— 

4 ‘‘(I) no feasible safer alternative 

5 for the specified use of the chemical 

6 substance is available; or 

7 ‘‘(II) the specified use of the 

8 chemical substance when compared to 

9 all available alternatives, provides a 

10 net benefit to human health, the envi11 ronment, or public safety. 

12 ‘‘(C) PUBLIC NOTICE.—If the Adminis13 trator grants an exemption for a chemical sub14 stance under this paragraph— 

15 ‘‘(i) the manufacturers and processors 

16 of the chemical substance shall, for the ex17 empted use, provide notice of the exemp18 tion to each known purchaser of— 

19 ‘‘(I) the chemical substance; and 

20 ‘‘(II) a mixture or article con21 taining the chemical substance; and 

22 ‘‘(ii) the Administrator shall provide 

23 the public with a notice of the exemption. 

24 ‘‘(D) RENEWAL.—The Administrator may, 

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1 graph for 1 or more additional 5-year periods 

2 if the Administrator concludes, after providing 

3 public notice and an opportunity for comment, 

4 that the use of the chemical substance con5 tinues to meet the criteria described in subpara6 graph (B). 

7 ‘‘(E) CONDITIONS.— 

8 ‘‘(i) IN GENERAL.—The Administrator 

9 shall, by order, impose any condition on an 

10 exemption issued under this paragraph 

11 that the Administrator determines to be 

12 necessary to ensure the protection of 

13 human health and the environment. 

14 ‘‘(ii) COMPLIANCE.—Effective imme15 diately after the date on which the Admin16 istrator establishes conditions on exempted 

17 use under clause (i), the manufacturing, 

18 processing, or distribution in commerce of 

19 the chemical substance, or any mixture or 

20 article containing the chemical substance, 

21 shall be prohibited except to the extent 

22 that the conditions are satisfied. 

23 ‘‘(3) RESALE OF USED ARTICLES.—The restric24 tions described in paragraph (1) shall not apply to 

25 the resale of an article subject to a restriction under 


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1 subsection (b) if the article has previously been used 

2 by an end consumer. 

3 ‘‘(4) EXTENSIONS OF EFFECTIVE DATES FOR

4 RETAIL SALE OF ARTICLES TO END CONSUMERS.— 

5 ‘‘(A) IN GENERAL.—Except as provided in 

6 subparagraph (B), in the case of the retail sale 

7 to an end consumer of a chemical substance (or 

8 mixture or article containing that chemical sub9 stance) that is subject to a restriction described 

10 in paragraph (1), the Administrator may, by 

11 order, extend the effective date of the restric12 tion by a period not to exceed 3 years, if the 

13 Administrator determines that the extension— 

14 ‘‘(i) is necessary and appropriate to 

15 allow for depletion of the existing retail in16 ventory; and 

17 ‘‘(ii) will not present a substantial 

18 endangerment to human health or the en19 vironment. 

20 ‘‘(B) EXCEPTION.—An extension under 

21 subparagraph (A) shall not apply to any retailer 

22 that the Administrator determines has failed to 

23 comply with an order requesting information 

24 issued by the Administrator pursuant to section 

25 8. 


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1 ‘‘(f) POLYCHLORINATED BIPHENYLS.— 

2 ‘‘(1) IN GENERAL.—The Administrator shall 

3 act by order or rule consistent with paragraphs (2) 

4 and (3)— 

5 ‘‘(A) to prescribe methods for the disposal 

6 of polychlorinated biphenyls; and 

7 ‘‘(B) to require polychlorinated biphenyls 

8 to be marked with clear and adequate warnings 

9 and instructions with respect to the processing, 

10 distribution in commerce, use, or disposal (or 

11 any combination of such activities) of poly12 chlorinated biphenyls. 

13 ‘‘(2) MANUFACTURE, PROCESS, OR DISTRIBU14 TION IN TOTALLY ENCLOSED MANNER.— 

15 ‘‘(A) DEFINITION OF TOTALLY ENCLOSED

16 MANNER.—In this paragraph, the term ‘totally 

17 enclosed manner’ means any manner that en18 sures that any exposure of human beings or the 

19 environment to the polychlorinated biphenyl will 

20 be insignificant, as determined by the Adminis21 trator by order or rule. 

22 ‘‘(B) PROHIBITION.—Except as provided 

23 in subparagraph (C), no person may manufac24 ture, process, distribute in commerce, or use 


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1 any polychlorinated biphenyl in any manner 

2 other than in a totally enclosed manner. 

3 ‘‘(C) ALTERNATIVE MANNER.—The Ad4 ministrator may, by order or rule, authorize the 

5 manufacture, processing, distribution in com6 merce, or use (or any combination of such ac7 tivities) of any polychlorinated biphenyl in a 

8 manner other than in a totally enclosed manner 

9 if the Administrator finds that the manufac10 ture, processing, distribution in commerce, or 

11 use (or combination of such activities) will not 

12 present a substantial endangerment to human 

13 health or the environment. 

14 ‘‘(3) PROHIBITION ON MANUFACTURE, PROC15 ESS, OR DISTRIBUTION.— 

16 ‘‘(A) IN GENERAL.—Except as provided in 

17 subparagraphs (B), (C), and (D)— 

18 ‘‘(i) no person may manufacture any 

19 polychlorinated biphenyl; and 

20 ‘‘(ii) no person may process or dis21 tribute in commerce any polychlorinated 

22 biphenyl. 

23 ‘‘(B) EXEMPTIONS.— 

24 ‘‘(i) IN GENERAL.—Any person may 

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1 tion from the requirements of subpara2 graph (A), and the Administrator may 

3 grant by rule the exemption, if the Admin4 istrator finds that— 

5 ‘‘(I) a substantial endangerment 

6 to human health or environment 

7 would not result; and 

8 ‘‘(II) good faith efforts have been 

9 made to develop a chemical substance 

10 that meets the safety standard and 

11 that may be substituted for such poly12 chlorinated biphenyl. 

13 ‘‘(ii) ADMINISTRATION.—An exemp14 tion granted under this subparagraph shall 

15 be— 

16 ‘‘(I) subject to such terms and 

17 conditions as the Administrator may 

18 prescribe; and 

19 ‘‘(II) be in effect for such period 

20 (but not more than 1 year after the 

21 date on which the exemption is grant22 ed, except as provided in subpara23 graph (D)) as the Administrator may 

24 prescribe. 


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1 ‘‘(C) PRIOR SALES.—Subparagraph (A) 

2 shall not apply to the distribution in commerce 

3 of any polychlorinated biphenyl if the poly4 chlorinated biphenyl was sold for purposes other 

than resale before the expiration of the 21 5 ⁄2- 

6 year period beginning on the date of enactment 

7 of this Act. 

8 ‘‘(D) EXTENSION OF EXEMPTIONS.— 

9 ‘‘(i) IN GENERAL.—The Administrator 

10 may, by order or rule, extend an exemption 

11 granted under subparagraph (B) that has 

12 not yet expired for a period not to exceed 

13 60 days for the purpose of authorizing the 

14 Secretary of Defense and the Secretaries 

15 of the military departments to provide for 

16 the transportation into the customs terri17 tory of the United States of poly18 chlorinated biphenyls generated by or 

19 under the control of the Department of 

20 Defense for purposes of the disposal, treat21 ment, or storage of the polychlorinated 

22 biphenyls in the customs territory of the 

23 United States if the polychlorinated 

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1 mines, in the sole discretion of the Admin2 istrator, the polychlorinated biphenyls 

3 would not otherwise arrive in the customs 

4 territory of the United States within the 

5 period of the original exemption. 

6 ‘‘(ii) NOTICE.—The Administrator 

7 shall promptly publish in the Federal Reg8 ister notice of the extension. 

9 ‘‘(g) MERCURY.— 

10 ‘‘(1) IN GENERAL.—Except as provided in para11 graph (2), no Federal agency shall convey, sell, or 

12 distribute to any other Federal agency, any State or 

13 local government agency, or any private individual or 

14 entity any elemental mercury under the control or 

15 jurisdiction of the Federal agency. 

16 ‘‘(2) EXCEPTIONS.—Paragraph (1) shall not 

17 apply to— 

18 ‘‘(A) a transfer between Federal agencies 

19 of elemental mercury for the sole purpose of fa20 cilitating storage of mercury to carry out this 

21 Act; or 

22 ‘‘(B) a conveyance, sale, distribution, or 

23 transfer of coal. 

24 ‘‘(3) LEASES OF FEDERAL COAL.—Nothing in 

25 this subsection prohibits the leasing of coal. 


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1 ‘‘(h) CERTIFICATION.—Each submission required 

2 pursuant to this section or pursuant to a rule or an order 

3 promulgated or issued by the Administrator under this 

4 section shall be accompanied by a certification signed by 

5 a responsible official of the manufacturer or processor that 

6 each statement contained in the submission— 

7 ‘‘(1) is accurate and reliable; and 

8 ‘‘(2) includes all material facts known to, in the 

9 possession or control of, or reasonably ascertainable 

10 by, the manufacturer or processor. 

11 ‘‘(i) EFFECTIVE DATE.—In any rule or order under 

12 this section, the Administrator shall specify the date on 

13 which the rule or order shall take effect, which shall be 

14 as soon as practicable.’’. 

15 SEC. 8. IMMINENT HAZARDS. 

16 Section 7 of the Toxic Substances Control Act (15 

17 U.S.C. 2606) is amended to read as follows: 

18 ‘‘SEC. 7. IMMINENT HAZARDS. 

19 ‘‘(a) ACTIONS AUTHORIZED AND REQUIRED.— 

20 ‘‘(1) IN GENERAL.—The Administrator may 

21 commence a civil action in an appropriate district 

22 court of the United States for— 

23 ‘‘(A) seizure of a chemical substance or 

24 mixture, or any article containing a chemical 

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1 minent and substantial endangerment to health 

2 or the environment; 

3 ‘‘(B) relief authorized under subsection (b) 

4 against any person that— 

5 ‘‘(i) manufactures, processes, distrib6 utes in commerce, uses, or disposes of a 

7 chemical substance or mixture, or any arti8 cle containing a chemical substance or mix9 ture, if the manufacture, processing, dis10 tribution in commerce, use, or disposal 

11 may present an imminent and substantial 

12 endangerment to health or the environ13 ment; or 

14 ‘‘(ii) contributes to an activity de15 scribed in clause (i); or 

16 ‘‘(C) both seizure and relief described in 

17 subparagraphs (A) and (B), respectively. 

18 ‘‘(2) OTHER ACTIONS.— 

19 ‘‘(A) IN GENERAL.—The Administrator 

20 may issue such orders as are necessary to pro21 tect health or the environment from any manu22 facturing, processing, distribution in commerce, 

23 use, or disposal of a chemical substance or mix24 ture, or any article containing such a substance 

25 or mixture, that may present an imminent and 


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1 substantial endangerment to health or the envi2 ronment, as determined by the Administrator. 

3 ‘‘(B) REQUIREMENT.—An order under 

4 subparagraph (A) may include such require5 ments imposed on the manufacture, processing, 

6 distribution in commerce, use, or disposal of a 

7 chemical substance or mixture, or article con8 taining the chemical substance or mixture, as 

9 the Administrator determines are necessary to 

10 protect health or the environment, including— 

11 ‘‘(i) the requirements described in sec12 tion 6(c); and 

13 ‘‘(ii) the relief authorized under sub14 section (b). 

15 ‘‘(3) RELATIONSHIP TO EXISTING RULES, OR16 DERS, AND PROCEEDINGS.—A civil action may be 

17 commenced under paragraph (1), or other action 

18 may be taken under paragraph (2), notwith19 standing— 

20 ‘‘(A) the existence of a rule or order under 

21 this Act; and 

22 ‘‘(B) the pendency of any administrative or 

23 judicial proceeding under this Act. 

24 ‘‘(b) RELIEF AUTHORIZED.— 


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1 ‘‘(1) IN GENERAL.—The district court of the 

2 United States in which a civil action under sub3 section (a)(1) is brought shall have jurisdiction to 

4 grant such temporary or permanent relief as are 

5 necessary to protect health or the environment from 

6 the risk associated with the activity involved in the 

7 civil action. 

8 ‘‘(2) TYPES OF RELIEF.—In the case of a civil 

9 action under subsection (a)(1) brought against a 

10 person that manufactures, processes, distributes in 

11 commerce, uses, or disposes of a chemical substance 

12 or mixture or an article containing a chemical sub13 stance or mixture, the relief authorized by para14 graph (1) may include— 

15 ‘‘(A) the issuance of a mandatory order 

16 imposing any of the requirements described in 

17 section 6(c); and 

18 ‘‘(B) in the case of purchasers of the sub19 stance, mixture, or article known to the defend20 ant— 

21 ‘‘(i) notification to the purchasers of 

22 the risk associated with the substance, 

23 mixture, or article; 

24 ‘‘(ii) public notice of the risk; 

25 ‘‘(iii) recall; 


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1 ‘‘(iv) the replacement or repurchase of 

2 the substance, mixture, or article; or 

3 ‘‘(v) any combination of the actions 

4 described in section 6(c) or in clauses (i) 

5 through (iv) of this subparagraph; or 

6 ‘‘(C) such other relief as is necessary to 

7 protect health or the environment from the risk 

8 associated with the activity involved in the civil 

9 action. 

10 ‘‘(3) SEIZURE AND CONDEMNATION.— 

11 ‘‘(A) IN GENERAL.—A civil action under 

12 subsection (a)(1) against a chemical substance, 

13 mixture, or article may be proceeded against by 

14 process of libel for seizure and condemnation of 

15 the chemical substance, mixture, or article. 

16 ‘‘(B) PROCEEDINGS.—Proceedings in a 

17 civil action described in subparagraph (A) shall 

18 conform, to the maximum extent practicable, to 

19 proceedings in rem in admiralty. 

20 ‘‘(c) VENUE AND CONSOLIDATION.— 

21 ‘‘(1) VENUE.— 

22 ‘‘(A) IN GENERAL.—A civil action under 

23 subsection (a)(1) against a person that manu24 factures, processes, or distributes a chemical 

25 substance or mixture or an article containing a 


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1 chemical substance or mixture may be brought 

2 in the United States District Court for the Dis3 trict of Columbia, or in any judicial district in 

4 which any of the defendants is found, resides, 

5 or transacts business. 

6 ‘‘(B) PROCESS.—Process in an action de7 scribed in subparagraph (A) may be served on 

8 a defendant in any other district in which the 

9 defendant resides or may be found. 

10 ‘‘(C) CHEMICAL SUBSTANCES, MIXTURES, 

11 OR ARTICLES.—A civil action under subsection 

12 (a)(1) against a chemical substance, mixture, or 

13 article may be brought in any United States 

14 district court within the jurisdiction of which 

15 the chemical substance, mixture, or article is 

16 found. 

17 ‘‘(D) MULTIPLE JUDICIAL DISTRICTS.—In 

18 determining the judicial district in which a civil 

19 action may be brought under subsection (a)(1) 

20 in instances in which the action may be brought 

21 in more than 1 judicial district, the Adminis22 trator shall take into account the convenience of 

23 the parties. 

24 ‘‘(E) SUBPOENAS.—Subpoenas requiring 

25 attendance of witnesses in a civil action brought 


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1 under subsection (a)(1) may be served in any 

2 judicial district. 

3 ‘‘(2) CONSOLIDATION.—If proceedings under 

4 subsection (a)(1) involving identical chemical sub5 stances, mixtures, or articles are pending in courts 

6 in 2 or more judicial districts, the proceedings shall 

7 be consolidated for trial by order of any such court 

8 on application reasonably made by any party in in9 terest, on notice to all parties in interest.’’. 

10 SEC. 9. REPORTING AND RETENTION OF INFORMATION. 

11 Section 8 of the Toxic Substances Control Act (15 

12 U.S.C. 2607) is amended to read as follows: 

13 ‘‘SEC. 8. REPORTING AND RETENTION OF INFORMATION. 

14 ‘‘(a) SUBSTANCE IDENTIFICATION, DECLARATION, 

15 AND INFORMATION.— 

16 ‘‘(1) IN GENERAL.—Not later than 1 year after 

17 the date of enactment of the Safe Chemicals Act of 

18 2011, each manufacturer or processor of a chemical 

19 substance distributed in commerce shall submit to 

20 the Administrator the declaration described in para21 graph (2) or (3), accompanied by the certification 

22 described in subsection (h). 

23 ‘‘(2) DECLARATION OF CURRENT MANUFAC24 TURE OR PROCESSING.—A declaration described in 

25 this paragraph is a statement that includes, for each 


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1 chemical substance manufactured or processed by a 

2 manufacturer or processor— 

3 ‘‘(A) the chemical identity and any special 

4 substance characteristics of the chemical sub5 stance; 

6 ‘‘(B) the name and location of each facility 

7 under the control of the manufacturer or proc8 essor at which the chemical substance is manu9 factured or processed or from which the chem10 ical substance is distributed in commerce; 

11 ‘‘(C) a list of health and safety studies 

12 conducted or initiated by or for, known to, or 

13 reasonably ascertainable by the manufacturer 

14 or processor with respect to the chemical sub15 stance, and copies of any such studies that have 

16 not previously been submitted to the Adminis17 trator; and 

18 ‘‘(D) all other information known to, in the 

19 possession or control of, or reasonably ascer20 tainable by the manufacturer or processor that 

21 has not previously been submitted to the Ad22 ministrator regarding— 

23 ‘‘(i) the physical, chemical, and toxi24 cological properties of the chemical sub25 stance; 


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1 ‘‘(ii) the annual production volume 

2 and known uses of, and exposure and fate 

3 information relating to, the chemical sub4 stance; and 

5 ‘‘(iii) the name and location of each 

6 facility to which the chemical substance is 

7 sent, after manufacture and processing, for 

8 subsequent processing, distribution, or use. 

9 ‘‘(3) DECLARATION OF CESSATION OF MANU10 FACTURING OR PROCESSING.—A declaration de11 scribed in this paragraph is a statement certifying 

12 that the manufacturer or processor has ceased, or 

13 will cease not later than 180 days after the date of 

14 submission of the declaration, all production, impor15 tation, processing, and export of the chemical sub16 stance. 

17 ‘‘(4) UPDATING OF INFORMATION.—Each man18 ufacturer or processor of a chemical substance that 

19 submits to the Administrator a declaration described 

20 in paragraph (2) shall update and submit to the Ad21 ministrator a new declaration— 

22 ‘‘(A) at a minimum every 3 years; and 

23 ‘‘(B) immediately, at any time at which 

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1 able by the manufacturer or processor signifi2 cant new information regarding a physical, 

3 chemical, toxicological property or use of, or ex4 posure to, the chemical substance, including 

5 any information that— 

6 ‘‘(i) demonstrates a new potential 

7 toxic effect of the chemical substance; 

8 ‘‘(ii) corroborates previous informa9 tion demonstrating or suggesting a toxic 

10 effect; or 

11 ‘‘(iii) suggests a toxic effect at a lower 

12 dose than previously demonstrated. 

13 ‘‘(5) RECORDS TO SUPPORT DECLARATIONS.— 

14 Each manufacturer or processor of a chemical sub15 stance distributed in commerce shall maintain 

16 records of the information described in subpara17 graphs (A) through (D) of paragraph (2). 

18 ‘‘(6) PROHIBITION ON MANUFACTURING, PROC19 ESSING, OR DISTRIBUTION.—The Administrator 

20 may, by order, prohibit a manufacturer or processor 

21 in violation of this subsection from manufacturing, 

22 processing, or distributing in commerce the chemical 

23 substance or any article containing the chemical sub24 stance, except as authorized under section 6(e). 

25 ‘‘(b) REPORTS.— 


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1 ‘‘(1) REQUIREMENT.— 

2 ‘‘(A) IN GENERAL.—Except as provided in 

3 paragraph (2), the Administrator may by rule 

4 or order require any person who manufactures, 

5 processes, distributes in commerce, uses, or dis6 poses of a chemical substance to maintain 

7 records of and report by a specified date any in8 formation concerning the substance that, in the 

9 judgment of the Administrator, would assist the 

10 Administrator in— 

11 ‘‘(i) making a safety standard deter12 mination with respect to a chemical sub13 stance under this title; or 

14 ‘‘(ii) any other aspect of administering 

15 this Act. 

16 ‘‘(B) CHARACTERISTICS.—The Adminis17 trator may by rule or order require that any re18 port or information submitted pursuant to this 

19 Act include chemical identity and special sub20 stance characteristics, as appropriate to the 

21 chemical substance that is the subject of the re22 port or information. 

23 ‘‘(C) REQUIRED INFORMATION.—The Ad24 ministrator shall by rule or order specify or 

25 modify the information that is required to be 


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1 submitted with a particular report or informa2 tion submission to establish the chemical iden3 tity and special substance characteristics of the 

4 subject chemical substance (or mixture or arti5 cle containing that chemical substance) for the 

6 purposes of the report or information submis7 sion. 

8 ‘‘(2) SMALL QUANTITIES FOR RESEARCH OR

9 ANALYSIS.—In the case of the manufacture, proc10 essing, distribution in commerce, use, or disposal of 

11 a chemical substance in small quantities (as defined 

12 by the Administrator by rule) solely for purposes of 

13 scientific experimentation or analysis or chemical re14 search (including any such research or analysis for 

15 the development of a product), the Administrator 

16 may promulgate or issue a rule or order under para17 graph (1) only to the extent that the Administrator 

18 determines the maintenance of records or submission 

19 of reports, or both, are necessary for the effective 

20 enforcement of this Act. 

21 ‘‘(3) PROHIBITION ON MANUFACTURING, PROC22 ESSING, OR DISTRIBUTION.—The Administrator 

23 may, by order, prohibit a manufacturer or processor 

24 in violation of a requirement of a rule or order 

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1 essing, or distributing in commerce the chemical 

2 substance or any article containing the chemical sub3 stance, except as authorized under section 6(e). 

4 ‘‘(c) INVENTORY.— 

5 ‘‘(1) IN GENERAL.—The Administrator shall 

6 compile, keep current, and publish a list of each 

7 chemical substance that is manufactured or proc8 essed in the United States. 

9 ‘‘(2) CONTENTS.—The list shall at least include 

10 the name of each chemical substance that any per11 son reports, under section 5 or subsection (b) of this 

12 section, is manufactured or processed in the United 

13 States. 

14 ‘‘(3) TIMING.— 

15 ‘‘(A) IN GENERAL.—In the case of a chem16 ical substance for which a notice is submitted in 

17 accordance with section 5, the chemical sub18 stance shall be included on the list as of the 

19 earliest date (as determined by the Adminis20 trator) on which the substance was manufac21 tured or processed in the United States. 

22 ‘‘(B) PUBLICATION.—The Administrator 

23 shall first publish a list under subparagraph (A) 

24 not later than 18 months after the effective 

25 date of this Act. 


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1 ‘‘(4) SMALL QUANTITIES FOR RESEARCH OR

2 ANALYSIS.—The Administrator shall not include in 

3 the list any chemical substance that is manufactured 

4 or processed only in small quantities (as defined by 

5 the Administrator by rule) solely for purposes of sci6 entific experimentation or analysis or chemical re7 search on, or analysis of, the substance or another 

8 substance, including such research or analysis for 

9 the development of a product. 

10 ‘‘(d) PUBLIC ACCESS TO SIGNIFICANT INFORMA11 TION.— 

12 ‘‘(1) ELECTRONIC DATABASE.—Not later than 

13 1 year after the date of enactment of the Safe 

14 Chemicals Act of 2011, the Administrator, through 

15 collaboration, as appropriate, shall establish— 

16 ‘‘(A) an electronic, Internet-accessible 

17 database for storing and sharing of information 

18 relating to the toxicity and use of, and exposure 

19 to, chemical substances; and 

20 ‘‘(B) procedures for use in maintaining 

21 and updating the database. 

22 ‘‘(2) PUBLIC ACCESS.—Not later than 18 

23 months after the date of enactment of the Safe 

24 Chemicals Act of 2011, or not later than 90 days 

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1 trator or receipt by the Administrator of information 

2 submitted pursuant to this title (for decisions made 

3 or information submitted after that 18-month pe4 riod), the Administrator shall, subject to section 14, 

5 make available to the public via the Internet-acces6 sible database described in paragraph (1) a descrip7 tion of all significant— 

8 ‘‘(A) decisions made by the Administrator 

9 under this title; and 

10 ‘‘(B) information submitted pursuant to 

11 this title. 

12 ‘‘(e) RECORDS.— 

13 ‘‘(1) IN GENERAL.—Any person that manufac14 tures, processes, or distributes in commerce any 

15 chemical substance shall maintain and submit to the 

16 Administrator records of significant adverse reac17 tions to health or the environment, as determined by 

18 the Administrator by rule, that are alleged to have 

19 been caused by the substance. 

20 ‘‘(2) DURATION.— 

21 ‘‘(A) IN GENERAL.—Records of the ad22 verse reactions to the health of employees shall 

23 be retained for a period of at least 30 years 

24 after the date on which the reactions were first 


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1 reported to or known by the person maintaining 

2 the records. 

3 ‘‘(B) OTHER RECORDS.—Any other record 

4 of the adverse reactions shall be retained for a 

5 period of at least 5 years after the date on 

6 which information contained in the record was 

7 first reported to or known by the person main8 taining the record. 

9 ‘‘(3) CONTENTS.—Records required to be main10 tained under this subsection shall include— 

11 ‘‘(A) records of consumer allegations of 

12 personal injury or harm to health; 

13 ‘‘(B) reports of occupational disease or in14 jury; and 

15 ‘‘(C) reports or complaints of injury to the 

16 environment submitted to the manufacturer, 

17 processor, or distributor in commerce from any 

18 source. 

19 ‘‘(f) INFORMATION IN THE POSSESSION OF OTHER

20 FEDERAL AGENCIES.— 

21 ‘‘(1) SYNOPSES.— 

22 ‘‘(A) IN GENERAL.—From time to time, 

23 each Federal agency and Federal institution 

24 shall submit to the Administrator a synopsis of 

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1 trol of the agency or institution, respectively, 

2 that may be useful to the Administrator in car3 rying out this Act. 

4 ‘‘(B) FORMAT AND CONTENT.—Not later 

5 than 1 year after the date of enactment of the 

6 Safe Chemicals Act of 2011, the Administrator 

7 shall prescribe, by order, the format, content, 

8 and level of detail of the synopses. 

9 ‘‘(C) INITIAL SUBMISSION.—Not later than 

10 18 months after the date of enactment of the 

11 Safe Chemicals Act of 2011, each Federal agen12 cy and Federal institution shall make the initial 

13 submission of a synopsis of the agency and in14 stitution, respectively, to the Administrator. 

15 ‘‘(D) UPDATES.—At least once every 3 

16 years, each Federal agency and Federal institu17 tion shall— 

18 ‘‘(i) update the synopsis of the agency 

19 and institution, respectively; and 

20 ‘‘(ii) submit the updated synopsis to 

21 the Administrator. 

22 ‘‘(2) REQUESTS BY ADMINISTRATOR.—On the 

23 request of the Administrator, any information in the 

24 possession or control of an agency or institution re25 lating to a hazard of, use of, exposure to, or risk of 


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1 a chemical substance (or mixture or article con2 taining that chemical substance) shall be provided to 

3 the Administrator. 

4 ‘‘(g) NOTICE TO ADMINISTRATOR OF SUBSTANTIAL

5 RISKS.—Any person that manufactures, processes, or dis6 tributes in commerce a chemical substance and that ob7 tains information that reasonably supports the conclusion 

8 that the substance presents a substantial risk of injury 

9 to health or the environment shall immediately inform the 

10 Administrator of the information unless the person has ac11 tual knowledge that the Administrator has been ade12 quately informed of the information. 

13 ‘‘(h) CERTIFICATION.—Each submission required 

14 pursuant to this section or pursuant to a rule or an order 

15 promulgated or issued by the Administrator under this 

16 section, other than a submission under subsection (f), 

17 shall be accompanied by a certification signed by a respon18 sible official of the manufacturer or processor that each 

19 statement contained in the submission— 

20 ‘‘(1) is accurate and reliable; and 

21 ‘‘(2) includes all material facts known to, in the 

22 possession or control of, or reasonably ascertainable 

23 by the manufacturer or processor.’’ 

24 ‘‘(i) DEFINITION OF MANUFACTURE AND PROC25 ESS.—In this section, the terms ‘manufacture’ and ‘procVerDate Mar 15 2010 21:55 Apr 18, 2011 Jkt 099200 PO 00000 Frm 00109 Fmt 6652 Sfmt 6201 E:\BILLS\S847.IS S847

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1 ess’ mean manufacture and process, respectively, for com2 mercial purposes.’’. 

3 SEC. 10. RELATIONSHIP TO OTHER FEDERAL LAWS. 

4 Section 9 of the Toxic Substances Control Act (15 

5 U.S.C. 2608) is amended— 

6 (1) in subsection (a)— 

7 (A) by striking paragraphs (1) and (2) and 

8 inserting the following: 

9 ‘‘(1) REPORT.— 

10 ‘‘(A) IN GENERAL.—If the Administrator 

11 determines that the manufacture, processing, 

12 distribution in commerce, use, or disposal of a 

13 chemical substance, or that any combination of 

14 those activities, does not meet a safety standard 

15 under this title or requires conditions or restric16 tions in order to the meet the safety standard, 

17 and the Administrator determines that action 

18 may be taken under a Federal law not adminis19 tered by the Administrator to address the uses 

20 of, or exposure to, the chemical substance, the 

21 Administrator shall submit to the agency that 

22 administers the Federal law a report that— 

23 ‘‘(i) describes with specification the 

24 activity or combination of activities that 

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1 ing the safety standard or restrictions or 

2 conditions required to meet the safety 

3 standard under this title; 

4 ‘‘(ii) requests that the agency— 

5 ‘‘(I) determine whether the 1 or 

6 more actions may be taken under 

7 Federal law administered by the agen8 cy; 

9 ‘‘(II) if the agency determines 

10 under clause (i) that the 1 or more 

11 actions may be taken, initiate and 

12 provide a timetable for the 1 or more 

13 actions; and 

14 ‘‘(III) respond to the Adminis15 trator with respect to the matters de16 scribed in the report; and 

17 ‘‘(iii) includes a detailed statement of 

18 the information on which the report is 

19 based. 

20 ‘‘(B) PUBLICATION.—A report of the Ad21 ministrator submitted under subparagraph (A) 

22 shall be promptly published in the Federal Reg23 ister. 

24 ‘‘(C) ACTION BY RECIPIENT AGENCY.—Not 

25 later than 90 days after the date of receipt of 


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1 a report from the Administrator under subpara2 graph (A), or by such earlier date as the Ad3 ministrator may specify in such a report, an 

4 agency that receives the report shall— 

5 ‘‘(i) make all determinations requested 

6 by the Administrator in the report; 

7 ‘‘(ii) take all action necessary to en8 sure that a chemical substance meets the 

9 safety standard under this title, if appro10 priate; 

11 ‘‘(iii) include with the response of the 

12 agency a detailed statement of the findings 

13 and conclusions of the agency; and 

14 ‘‘(iv) publish that statement in the 

15 Federal Register. 

16 ‘‘(2) INITIATION OF ACTION.—If the Adminis17 trator submits a report under paragraph (1) with re18 spect to a chemical substance to an agency, and the 

19 agency that receives the report initiates, within the 

20 period specified in the request under paragraph (1), 

21 a civil action under Federal law administered by the 

22 agency to ensure that a chemical substance meets 

23 the safety standard under this title, or requires re24 strictions or conditions to meet that safety standard, 

25 the Administrator may not take action under this 


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1 Act with respect to the civil action (other than any 

2 action taken pursuant to section 7).’’; 

3 (B) by redesignating paragraph (3) as 

4 paragraph (4); 

5 (C) by inserting after paragraph (2) the 

6 following: 

7 ‘‘(3) NO ACTION.—The Administrator may, by 

8 order, initiate action or a combination of actions 

9 under this Act to ensure compliance with the safety 

10 standard for a chemical substance under this title 

11 if— 

12 ‘‘(A) the Administrator submits a report 

13 under paragraph (1) with respect to a chemical 

14 substance; and 

15 ‘‘(B) the agency to which the report was 

16 submitted— 

17 ‘‘(i) determines that action cannot be 

18 taken under the authorities of the agency; 

19 ‘‘(ii) does not initiate action, if appro20 priate, within the period specified in the 

21 request under paragraph (1); 

22 ‘‘(iii) does not complete the action 

23 within the timeframe provided by the agen24 cy; or 

25 ‘‘(iv) fails to respond.’’; and 


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1 (D) in paragraph (4) (as redesignated by 

2 subparagraph (B))— 

3 (i) by striking ‘‘(4) If the Adminis4 trator has initiated action under section 6 

5 or 7’’ and inserting the following: 

6 ‘‘(4) CONSULTATION.—If the Administrator has 

7 initiated action under this Act’’; and 

8 (ii) by striking ‘‘against such risk’’ 

9 after ‘‘Federal action’’; 

10 (2) in subsection (c)— 

11 (A) by striking ‘‘the Administrator shall 

12 not’’ and inserting ‘‘Administrator— 

13 ‘‘(1) shall not’’; and 

14 (B) by striking the period at the end and 

15 inserting ‘‘; and’’; and 

16 (C) by adding at the end the following: 

17 ‘‘(2) shall ensure that any actions to address 

18 workplace exposures that the Administrator takes or 

19 requires to be taken by manufacturers or processors 

20 of a chemical substance are consistent with the in21 dustrial hygiene hierarchy of controls.’’; and 

22 (3) in subsection (d)— 

23 (A) in the first sentence, by striking ‘‘while 

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1 quirements on those subject to the Act and for 

2 other purposes’’; and 

3 (B) in the second sentence, by striking ‘‘, 

4 in the report required by section 30,’’. 

5 SEC. 11. INSPECTIONS AND SUBPOENAS. 

6 Section 11 of the Toxic Substances Control Act (15 

7 U.S.C. 2610) is amended to read as follows: 

8 ‘‘SEC. 11. INSPECTIONS AND SUBPOENAS. 

9 ‘‘(a) INSPECTIONS.— 

10 ‘‘(1) IN GENERAL.—For purposes of admin11 istering this Act, the Administrator, and any duly 

12 designated representative of the Administrator, may 

13 inspect— 

14 ‘‘(A) any establishment, facility, or other 

15 premises in which chemical substances, mix16 tures, or articles subject to this Act are manu17 factured, processed, stored, or held before or 

18 after distribution in commerce; 

19 ‘‘(B) any conveyance being used to trans20 port such chemical substances, mixtures, or ar21 ticles in connection with distribution in com22 merce; and 

23 ‘‘(C) any place at which records relating to 

24 the chemical substances, mixtures, or articles, 


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1 or otherwise relating to compliance with this 

2 Act, are held. 

3 ‘‘(2) METHOD.—Each inspection under para4 graph (1) shall be— 

5 ‘‘(A) commenced and completed with rea6 sonable promptness; and 

7 ‘‘(B) conducted at reasonable times, within 

8 reasonable limits, and in a reasonable manner. 

9 ‘‘(3) SAMPLES.—The Administrator, and any 

10 duly designated representative of the Administrator, 

11 may inspect and obtain samples of any— 

12 ‘‘(A) chemical substance, mixture, or arti13 cle; and 

14 ‘‘(B) container or labeling of a chemical 

15 substance, mixture, or article. 

16 ‘‘(b) SCOPE.—An inspection conducted under sub17 section (a) shall extend to all things within the premises 

18 or conveyance inspected (including records, files, papers, 

19 processes, controls, and facilities) regarding whether the 

20 owner or operator of the premises, conveyance, or records 

21 has complied with provisions of this Act applicable to the 

22 chemical substances, mixtures, articles, or records. 

23 ‘‘(c) INFORMATION GATHERING.— 

24 ‘‘(1) IN GENERAL.—In carrying out this Act, 

25 the Administrator may require the attendance and 


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1 testimony of witnesses and the production of such 

2 reports, papers, documents, items, answers to ques3 tions, and other information, including the develop4 ment of analyses and other information, as the Ad5 ministrator determines to be necessary. 

6 ‘‘(2) PAYMENT OF WITNESSES.—A witness de7 scribed in paragraph (1) shall be paid the same fees 

8 and mileage that are paid witnesses in the courts of 

9 the United States. 

10 ‘‘(d) WARRANTS.—For purposes of enforcing this 

11 Act, upon a showing to an officer or court of competent 

12 jurisdiction that there is reason to believe that a provision 

13 of this Act has been violated, officers or employees duly 

14 designated by the Administrator are empowered to obtain 

15 and to execute warrants authorizing— 

16 ‘‘(1) entry, inspection, and copying of records 

17 for purposes of this Act; and 

18 ‘‘(2) the seizure of any chemical substance, mix19 ture, or article that is in violation of this Act.’’. 

20 SEC. 12. EXPORTS. 

21 Section 12 of the Toxic Substances Control Act (15 

22 U.S.C. 2611) is amended— 

23 (1) by striking subsection (a); 

24 (2) by redesignating subsections (b) and (c) as 

25 subsections (a) and (b), respectively; 


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1 (3) in subsection (a) (as redesignated by para2 graph (2))— 

3 (A) in paragraph (1)— 

4 (i) by striking ‘‘or intends to export’’; 

5 (ii) by striking ‘‘section 4 or 5(b)’’ 

6 and inserting ‘‘section 4, 5, or 6(b)’’; 

7 (iii) by striking ‘‘or intent to export’’ 

8 and inserting ‘‘, not later than 30 days 

9 after the date of exportation of the sub10 stance or mixture,’’; and 

11 (iv) by inserting ‘‘promptly there12 after’’ before ‘‘furnish’’; 

13 (B) in paragraph (2)— 

14 (i) by striking ‘‘or intends to export’’; 

15 (ii) by striking ‘‘an order has been 

16 issued under section 5 or a rule has been 

17 proposed or promulgated under section 5 

18 or 6, or with respect to which an action is 

19 pending or relief has been granted under 

20 section 5 or 7’’ and inserting ‘‘an action 

21 has been taken pursuant to section 6 or 

22 7’’; 

23 (iii) by striking ‘‘or intent to export’’ 

24 and inserting ‘‘, not later than 30 days 


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1 after the date of exportation of the sub2 stance or mixture,’’; 

3 (iv) by inserting ‘‘promptly there4 after’’ before ‘‘furnish’’; and 

5 (v) by striking ‘‘such rule, order, ac6 tion, or relief’’ and inserting ‘‘the action 

7 taken pursuant to section 6 or 7’’; and 

8 (C) by adding at the end the following: 

9 ‘‘(3) CHANGE IN EXPORT STATUS.— 

10 ‘‘(A) IN GENERAL.—Any person that has 

11 notified the Administrator of the exportation of 

12 a chemical substance or mixture under this sec13 tion shall notify the Administrator of any 

14 change in the export status of the substance or 

15 mixture by not later than 30 days after such a 

16 change in status. 

17 ‘‘(B) UPDATED NOTICE.—The Adminis18 trator shall promptly furnish an updated notice 

19 to the governments that have been notified pur20 suant to paragraphs (1) and (2) regarding the 

21 exportation of any chemical substance or mix22 ture subject to this section if— 

23 ‘‘(i) data for the substance or mixture 

24 have been received by the Administrator 

25 pursuant to section 4, 5, 6(b), or 8; 


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1 ‘‘(ii) a change has occurred in the ex2 port status of the substance or mixture; or 

3 ‘‘(iii) a change has been made in any 

4 risk management action taken pursuant to 

5 section 6 or 7 for the substance or mix6 ture.’’; 

7 (4) in subsection (b), as redesignated by para8 graph (2) of this section— 

9 (A) by striking paragraph (2); and 

10 (B) by redesignating paragraphs (3), (4), 

11 (5), and (6) as paragraphs (2), (3), (4), and 

12 (5), respectively; and 

13 (5) by adding at the end the following: 

14 ‘‘(c) PUBLIC RECORDS.—The Administrator shall— 

15 ‘‘(1) maintain copies of all current notices pro16 vided to other governments under this section; and 

17 ‘‘(2) make such copies available to the public in 

18 electronic format.’’. 

19 SEC. 13. ENTRY INTO CUSTOMS TERRITORY OF THE 

20 UNITED STATES. 

21 Section 13 of the Toxic Substances Control Act (15 

22 U.S.C. 2612) is amended— 

23 (1) by striking ‘‘Secretary of the Treasury’’ 

24 each place it appears and inserting ‘‘Secretary of 

25 Homeland Security’’; 


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1 (2) in subsection (a)— 

2 (A) in paragraph (1), by striking ‘‘if—’’ 

3 and subparagraphs (A) and (B) and inserting 

4 ‘‘if the substance, mixture, or article fails to 

5 comply with or is offered for entry in violation 

6 of any rule or order in effect under this Act.’’; 

7 and 

8 (B) by adding at the end the following: 

9 ‘‘(3) IMPORT AS PART OF AN ARTICLE.—Chem10 ical substances and mixtures imported as part of an 

11 article shall be subject to the same requirements 

12 under this Act as if the substances and mixtures had 

13 been imported in bulk, except as the Administrator 

14 may provide by rule under this Act, or as the Sec15 retary of Homeland Security may provide by rule 

16 under subsection (b).’’. 

17 SEC. 14. DISCLOSURE OF DATA. 

18 Section 14 of the Toxic Substances Control Act (15 

19 U.S.C. 2613) is amended— 

20 (1) by redesignating subsections (a) through (e) 

21 as subsections (c) through (g), respectively; 

22 (2) by inserting before subsection (c) (as redes23 ignated by paragraph (1)), the following: 

24 ‘‘(a) AGENCY RESPONSIBILITIES.—The Adminis25 trator shall ensure that— 


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1 ‘‘(1) information control designations under this 

2 section are not a determinant of public disclosure 

3 pursuant to section 552 of title 5, United States 

4 Code (commonly known as the ‘Freedom of Informa5 tion Act’); and 

6 ‘‘(2) all information in the possession of the 

7 agency that is releasable pursuant to an appropriate 

8 request under that section is made available to mem9 bers of the public. 

10 ‘‘(b) VOLUNTARY RELEASE OF UNCLASSIFIED IN11 FORMATION NOT PROHIBITED.—Nothing in this section 

12 prevents or discourages the Administrator from volun13 tarily releasing to the public any unclassified information 

14 that is not exempt from disclosure under section 552 of 

15 title 5, United States Code (commonly known as the 

16 ‘Freedom of Information Act’).’’; 

17 (3) in subsection (c) (as redesignated by para18 graph (1))— 

19 (A) in the subsection heading, by striking 

20 ‘‘IN GENERAL’’ and inserting ‘‘DISCLOSURE OF

21 CERTAIN INFORMATION’’; 

22 (B) by striking ‘‘subsection (b)’’ and in23 serting ‘‘subsection (d)’’; 

24 (C) by redesignating paragraphs (3) and 

25 (4) as paragraphs (4) and (5), respectively; 


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1 (D) by inserting after paragraph (2) the 

2 following: 

3 ‘‘(3) shall be disclosed upon request to a State, 

4 tribal, or municipal government, including identifica5 tion of the location of the manufacture, processing, 

6 or storage of a chemical substance upon the request 

7 of the government for the purpose of administration 

8 or enforcement of a law, if 1 or more applicable 

9 agreements ensure that the recipient government 

10 will take appropriate steps to maintain the confiden11 tiality of the information in accordance with this sec12 tion and section 350.19 of title 40, Code of Federal 

13 Regulations (or any successor regulation);’’; and 

14 (E) in paragraph (4) (as redesignated by 

15 subparagraph (B)), by striking ‘‘an unreason16 able risk of injury’’ and inserting ‘‘an imminent 

17 and substantial endangerment’’; 

18 (4) in subsection (d) (as redesignated by para19 graph (1))— 

20 (A) in the subsection heading, by striking 

21 ‘‘DATA FROM HEALTH AND SAFETY STUDIES’’ 

22 and inserting ‘‘INFORMATION NOT ELIGIBLE

23 FOR PROTECTION’’; 

24 (B) by striking paragraph (1) and insert25 ing the following: 


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1 ‘‘(1) INELIGIBLE INFORMATION.— 

2 ‘‘(A) IN GENERAL.—The following types of 

3 information shall not be eligible for protection 

4 under this section, and the Administrator shall 

5 not approve a request to treat information of 

6 the following types as confidential under this 

7 section: 

8 ‘‘(i) The identity of a chemical sub9 stance, except as provided in section 5. 

10 ‘‘(ii) Any safety standard determina11 tion developed under section 6, including 

12 supporting information developed by the 

13 Administrator. 

14 ‘‘(iii) Any health and safety study 

15 that is submitted under this Act with re16 spect to— 

17 ‘‘(I) any chemical substance or 

18 mixture— 

19 ‘‘(aa) which, on the date on 

20 which the study is to be disclosed 

21 has been offered for commercial 

22 distribution; or 

23 ‘‘(bb) for which testing is re24 quired under section 4 or for 


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1 which notification is required 

2 under section 5; and 

3 ‘‘(II) any data reported to, or 

4 otherwise obtained by, the Adminis5 trator from a health and safety study 

6 which relates to a chemical substance 

7 or mixture described in item (aa) or 

8 (bb) of subclause (I). 

9 ‘‘(iv) Any information indicating the 

10 presence of a chemical substance in a con11 sumer article intended for use or reason12 ably expected to be used by children or to 

13 which children can otherwise be reasonably 

14 expected to be exposed. 

15 ‘‘(B) PROHIBITION.—This paragraph does 

16 not authorize the release of any data which dis17 closes processes used in the manufacturing or 

18 processing of a chemical substance or mixture 

19 or, in the case of a mixture, the release of data 

20 disclosing the portion of the mixture comprised 

21 by any of the chemical substances in the mix22 ture.’’; and 

23 (C) in paragraph (2)— 


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1 (i) by striking ‘‘the first sentence of 

2 paragraph (1)’’ and inserting ‘‘item (aa) or 

3 (bb) of paragraph (1)(A)(iii)’’; and 

4 (ii) by striking ‘‘in the second sen5 tence of such paragraph’’ and inserting ‘‘in 

6 paragraph (1)(B)’’; 

7 (5) in subsection (e) (as redesignated by para8 graph (1))— 

9 (A) by striking paragraph (1) and insert10 ing the following: 

11 ‘‘(1) DUTIES OF MANUFACTURERS AND PROC12 ESSORS.— 

13 ‘‘(A) IN GENERAL.—In submitting data 

14 under this Act, a manufacturer, processor, or 

15 distributor in commerce may— 

16 ‘‘(i) designate the data which the 

17 manufacturer, processor, or distributor be18 lieves is entitled to confidential treatment 

19 under subsection (a); and 

20 ‘‘(ii) submit the designated data sepa21 rately from other data submitted under 

22 this Act. 

23 ‘‘(B) REQUIREMENTS.—A designation 

24 under this paragraph shall be made in writing 


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1 and in such manner as the Administrator may 

2 prescribe, and shall include— 

3 ‘‘(i) justification for each claim for 

4 confidentiality; 

5 ‘‘(ii) a certification that the informa6 tion is not otherwise publicly available; and 

7 ‘‘(iii) separate copies of all submitted 

8 information, with 1 copy containing and 1 

9 copy excluding the information to which 

10 the request applies.’’; 

11 (B) by redesignating paragraph (2) as 

12 paragraph (3); 

13 (C) by inserting after paragraph (1) the 

14 following: 

15 ‘‘(2) DUTIES OF THE ADMINISTRATOR.— 

16 ‘‘(A) IN GENERAL.—The Administrator 

17 shall— 

18 ‘‘(i)(I) not later than 1 year after the 

19 date of enactment of the Safe Chemicals 

20 Act of 2011, by order develop and make 

21 publicly available standards that specify— 

22 ‘‘(aa) the acceptable bases on 

23 which written requests to maintain 

24 confidentiality of information may be 

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1 strictive of public disclosure than sec2 tion 552 of title 5, United States 

3 Code; and 

4 ‘‘(bb) the documentation that 

5 must accompany those requests; and 

6 ‘‘(II) not later than 1 year after the 

7 date of enactment of the Safe Chemicals 

8 Act of 2011, identify by rule those types of 

9 information for which the Administrator 

10 shall not prospectively specify the term of 

11 confidentiality pursuant to this subpara12 graph; 

13 ‘‘(ii) not later than 90 days after the 

14 date of receipt of information designated 

15 under paragraph (1), review all requests to 

16 maintain confidentiality of the submitted 

17 information and decide whether to approve 

18 or deny each request based on whether the 

19 request and accompanying documentation 

20 comply with the standards that are devel21 oped under clause (i) (except that if a re22 quest for the information is received under 

23 section 552 of title 5, United States Code, 

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1 ments, procedures, and judicial review pro2 visions under that section shall apply); 

3 ‘‘(iii) in the event such a request is 

4 denied, make the information available to 

5 the public in accordance with section 

6 8(d)(2); and 

7 ‘‘(iv) if such a request is approved, 

8 specify a time period of not greater than 5 

9 years for which the submitted information 

10 shall be kept confidential, except with re11 spect to claims subject to a rule issued 

12 pursuant to clause (i)(II). 

13 ‘‘(B) AUTHORITY OF ADMINISTRATOR.— 

14 Subparagraph (A) does not limit the authority 

15 of the Administrator to determine that par16 ticular information, previously considered enti17 tled to confidential treatment, is no longer enti18 tled to such treatment.’’; and 

19 (D) in paragraph (3) (as redesignated by 

20 subparagraph (B))— 

21 (i) in subparagraph (A)— 

22 (I) in the first sentence, by strik23 ing ‘‘paragraph (1)(A)’’ and inserting 

24 ‘‘paragraph (1) and approved by the 


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1 Administrator under paragraph 

2 (2)(A)(ii)’’; and 

3 (II) by striking the last sentence 

4 and inserting ‘‘The Administrator 

5 shall release the information in ac6 cordance with the disclosure and pro7 cedural requirements of section 552 of 

8 title 5, United States Code.’’; 

9 (ii) in subparagraph (B)(i)— 

10 (I) in the first sentence— 

11 (aa) by striking ‘‘or (4)’’ 

12 and inserting ‘‘(4), or (5)’’; 

13 (bb) by striking ‘‘subsection 

14 (a)’’ each place it appears and in15 serting ‘‘subsection (c)’’; and 

16 (cc) by striking ‘‘paragraph 

17 (3)’’ and inserting ‘‘paragraph 

18 (4)’’; and 

19 (II) in the second sentence, by 

20 striking ‘‘except that’’ and all that fol21 lows through ‘‘such release is made’’ 

22 and inserting ‘‘except if the Adminis23 trator determines that the release of 

24 such data is necessary to protect 

25 against an imminent and substantial 


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1 endangerment to health or the envi2 ronment then no notice is required.’’; 

3 and 

4 (iii) in subparagraph (B)(ii), by strik5 ing ‘‘(b)(1)’’ and inserting ‘‘(d)(1)(A)(iii)’’; 

6 (6) in subsection (f) (as redesignated by para7 graph (1)), by striking ‘‘subsection (a)’’ and insert8 ing ‘‘subsection (c)’’; and 

9 (7) by adding at the end the following: 

10 ‘‘(h) RISK INFORMATION FOR WORKERS.—The Ad11 ministrator shall provide standards for, and facilitate the 

12 sharing of, chemical identity, safety standard determina13 tion, and health and safety data described in subsection 

14 (d) that pertains to chemical substances or mixtures, or 

15 articles containing chemical substances, that workers may 

16 come into contact with or otherwise be exposed to during 

17 the course of work, to and with those workers and rep18 resentatives of each certified or recognized bargaining 

19 agent representing those employees.’’. 

20 SEC. 15. PROHIBITED ACTS. 

21 Section 15 of the Toxic Substances Control Act (15 

22 U.S.C. 2614) is amended— 

23 (1) by striking paragraph (1) and inserting the 

24 following: 


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1 ‘‘(1) fail or refuse to comply with any rule, 

2 order, prohibition, restriction, or other requirement 

3 imposed by this Act or by the Administrator under 

4 this Act;’’; 

5 (2) in paragraph (2)— 

6 (A) by striking ‘‘use’’ and inserting ‘‘man7 ufacture, process, distribute in commerce, use, 

8 or dispose of’’; 

9 (B) by striking ‘‘or mixture’’ and inserting 

10 ‘‘, mixture, or article’’; and 

11 (C) by striking ‘‘section 5 or 6, a rule or 

12 order under section 5 or 6, or an order issued 

13 in action brought under section 5 or 7’’ and in14 serting ‘‘any rule, order, prohibition, restriction, 

15 or other requirement imposed by this Act or by 

16 the Administrator under this Act’’; 

17 (3) in paragraph (3)— 

18 (A) in subparagraph (A), by inserting ‘‘ac19 curate and complete’’ after ‘‘maintain’’; 

20 (B) in subparagraph (B)— 

21 (i) by inserting ‘‘or make accurate 

22 and complete’’ after ‘‘submit’’; and 

23 (ii) by inserting ‘‘information submis24 sions, disclosures, declarations, certifi25 cations,’’ after ‘‘notices,’’; and 


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1 (C) in subparagraph (C), by striking ‘‘or’’ 

2 after the semicolon; 

3 (4) in paragraph (4), by striking the period at 

4 the end and inserting a semicolon; and 

5 (5) by adding at the end the following: 

6 ‘‘(5) make or submit a statement, declaration, 

7 disclosure, certification, writing, data set, or rep8 resentation that is materially false, in whole or in 

9 part, or to falsify or conceal any material fact, in 

10 taking any action or making any communication 

11 pursuant to this Act or pursuant to any rule or 

12 order promulgated or issued under this Act; or 

13 ‘‘(6) take any action prohibited by this Act.’’. 

14 SEC. 16. PENALTIES. 

15 Section 16 of the Toxic Substances Control Act (15 

16 U.S.C. 2615) is amended— 

17 (1) in subsection (a)— 

18 (A) in paragraph (1)— 

19 (i) in the first sentence— 

20 (I) by inserting ‘‘this Act or a 

21 rule or order promulgated or issued 

22 pursuant to this Act, as described in’’ 

23 after ‘‘a provision of’’; and 

24 (II) by striking ‘‘$25,000’’ and 

25 inserting ‘‘$37,500’’; and 


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1 (ii) in the second sentence, by striking 

2 ‘‘violation of section 15 or 409’’ and in3 serting ‘‘violation of this Act’’; 

4 (B) by redesignating paragraphs (2), (3), 

5 and (4) as paragraphs (3), (4), and (5), respec6 tively; 

7 (C) by inserting after paragraph (1) the 

8 following: 

9 ‘‘(2) In the case of any violation described in 

10 paragraph (1), the Administrator may commence a 

11 civil action in the appropriate United States district 

12 court to assess penalties pursuant to that para13 graph.’’; 

14 (D) in subparagraph (A) of paragraph (3) 

15 (as redesignated by subparagraph (B))— 

16 (i) in the first sentence, by inserting 

17 ‘‘this Act, as described in’’ before ‘‘section 

18 15 or 409’’; and 

19 (ii) in the last sentence, by striking 

20 ‘‘within 15 days of’’ and inserting ‘‘not 

21 later than 15 days after’’; 

22 (E) in the first sentence of paragraph (4) 

23 (as redesignated by subparagraph (B))— 

24 (i) by striking ‘‘paragraph (2)(A)’’ 

25 and inserting ‘‘paragraph (3)(A)’’; and 


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1 (ii) by striking ‘‘the United States 

2 Court of Appeals for the District of Co3 lumbia Circuit or for any other circuit’’ 

4 and inserting ‘‘the appropriate district 

5 court of the United States for the dis6 trict’’; and 

7 (F) in paragraph (5) (as redesignated by 

8 subparagraph (B)), by striking ‘‘paragraph (3)’’ 

9 each place it appears and inserting ‘‘paragraph 

10 (4)’’; and 

11 (2) in subsection (b)— 

12 (A) by striking ‘‘Any person’’ and inserting 

13 the following: 

14 ‘‘(1) IN GENERAL.—Any person’’; 

15 (B) by striking ‘‘or willfully’’; 

16 (C) by inserting ‘‘this Act, as described in’’ 

17 after ‘‘any provision of’’; 

18 (D) by striking ‘‘$25,000’’ and inserting 

19 ‘‘$50,000’’; 

20 (E) by striking ‘‘one year’’ and inserting 

21 ‘‘5 years’’; and 

22 (F) by adding at the end the following: 

23 ‘‘(2) IMMINENT DANGER OF DEATH OR SERIOUS

24 BODILY INJURY.— 


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1 ‘‘(A) IN GENERAL.—Any individual who 

2 knowingly violates any provision of this Act and 

3 who knows at the time that the violation places 

4 another person in imminent danger of death or 

5 serious bodily injury shall upon conviction be 

6 subject to a fine of not more than $250,000, or 

7 imprisonment of not more than 15 years, or 

8 both. 

9 ‘‘(B) OTHER PERSONS.—A person that is 

10 not an individual shall, upon conviction of vio11 lating this paragraph, be subject to a fine of 

12 not more than $1,000,000.’’. 

13 SEC. 17. SPECIFIC ENFORCEMENT AND SEIZURE. 

14 Section 17 of the Toxic Substances Control Act (15 

15 U.S.C. 2616) is amended— 

16 (1) in subsection (a)— 

17 (A) in paragraph (1)— 

18 (i) by striking ‘‘(1) The district 

19 courts’’ and all that follows through the 

20 end of subparagraph (C) and inserting the 

21 following: 

22 ‘‘(1) AUTHORITY OF THE ADMINISTRATOR.— 

23 ‘‘(A) IN GENERAL.—The Administrator 

24 may commence a civil action in the appropriate 

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1 ance of any person with any provision of this 

2 Act or any rule or order promulgated pursuant 

3 to this Act. 

4 ‘‘(B) ENFORCEMENT.—The authority of 

5 the Administrator to enforce this Act includes 

6 the authority— 

7 ‘‘(i) to seek civil or criminal penalties 

8 under section 16 for any violation of this 

9 Act, as described in sections 15 and 409; 

10 ‘‘(ii) to enjoin any violation of this 

11 Act, or of a rule or order promulgated or 

12 issued under this Act, as described in sec13 tions 15 and 409; 

14 ‘‘(iii) to order the compliance of any 

15 person with any provision of this Act, or 

16 with any rule or order promulgated or 

17 issued under this Act, through an adminis18 trative proceeding (which may proceed con19 currently with action under this section), 

20 in which the Administrator may levy pen21 alties under section 16; and’’; and 

22 (ii) in subparagraph (D)— 

23 (I) by redesignating clause (i) 

24 through (iii) as subclauses (I) through 


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1 (III), respectively, and indenting ap2 propriately; 

3 (II) by striking ‘‘(D) direct any 

4 manufacturer’’ and inserting the fol5 lowing: 

6 ‘‘(iv) to order any manufacturer’’; 

7 (III) by striking ‘‘product subject 

8 to title IV’’ and inserting ‘‘article sub9 ject to this Act’’; 

10 (IV) by striking ‘‘product’’ each 

11 place it appears and inserting ‘‘arti12 cle’’; 

13 (V) by striking ‘‘of section 5, 6, 

14 or title IV’’ and inserting ‘‘this Act’’; 

15 and 

16 (VI) by striking ‘‘under section 

17 5, 6, or title IV’’ and inserting ‘‘pro18 mulgated and issued under this Act, 

19 as described in section 15 or 409,’’; 

20 (B) in paragraph (2)— 

21 (i) by striking ‘‘(2) A civil action’’ and 

22 all that follows through ‘‘described in sub23 paragraph (A) of such paragraph’’ in sub24 paragraph (A) and inserting the following: 

25 ‘‘(2) CIVIL ACTIONS.— 


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1 ‘‘(A) IN GENERAL.—The district courts of 

2 the United States shall have jurisdiction over a 

3 civil action described in paragraph (1). 

4 ‘‘(B) REQUIREMENTS.—A civil action de5 scribed in paragraph (1) may be brought— 

6 ‘‘(i) in the case of a civil action de7 scribed in subparagraphs (A) and (B) of 

8 paragraph (1)’’; 

9 (ii) in clause (i) (as so designated), by 

10 striking ‘‘of section 15’’ and inserting ‘‘of 

11 this Act, as described in section 15 or 

12 409’’; 

13 (iii) by redesignating subparagraph 

14 (B) as clause (ii) and indenting appro15 priately; and 

16 (iv) in clause (ii) (as so designated), 

17 by striking ‘‘such paragraph’’ and insert18 ing ‘‘paragraph (1)’’; and 

19 (C) in the undesignated matter following 

20 paragraph (2), by striking ‘‘In any’’ and insert21 ing the following: 

22 ‘‘(3) SERVING OF PROCESS AND SUBPOENAS.— 

23 In any’’; and 

24 (2) in the first sentence of subsection (b)— 


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1 (A) by striking ‘‘title IV’’ and inserting 

2 ‘‘this Act’’; 

3 (B) by striking ‘‘product’’ the first place it 

4 appears and inserting ‘‘article’’; and 

5 (C) by striking ‘‘product,’’ both places it 

6 appears. 

7 SEC. 18. PREEMPTION. 

8 Section 18 of the Toxic Substances Control Act (15 

9 U.S.C. 2617) is amended to read as follows: 

10 ‘‘SEC. 18. PREEMPTION. 

11 ‘‘Nothing in this Act affects the right of a State or 

12 a political subdivision of a State to adopt or enforce any 

13 regulation, requirement, or standard of performance that 

14 is different from, or in addition to, a regulation, require15 ment, liability, or standard of performance established 

16 pursuant to this Act unless compliance with both this Act 

17 and the State or political subdivision of a State regulation, 

18 requirement, or standard of performance is impossible, in 

19 which case the applicable provisions of this Act shall con20 trol.’’. 

21 SEC. 19. JUDICIAL REVIEW. 

22 Section 19 of the Toxic Substances Control Act (15 

23 U.S.C. 2618) is amended— 

24 (1) in subsection (a)— 

25 (A) in paragraph (1)— 


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1 (i) by striking subparagraph (B); 

2 (ii) in subparagraph (A), by striking 

3 ‘‘(1)(A) Not later’’ and all that follows 

4 through ‘‘under title II or IV,’’ and insert5 ing the following: 

6 ‘‘(1) JUDICIAL REVIEW.—Not later than 60 

7 days after the date of the promulgation or issuance 

8 of a rule under of this Act,’’; 

9 (iii) by inserting ‘‘or order’’ after 

10 ‘‘rule’’ each place it appears; and 

11 (iv) in the second sentence, by strik12 ing ‘‘(other than in an enforcement pro13 ceeding)’’; 

14 (B) in paragraph (2)— 

15 (i) in the first sentence, by striking 

16 ‘‘paragraph (1)(A)’’ and inserting ‘‘para17 graph (1)’’; and 

18 (ii) in the second sentence, by insert19 ing ‘‘or order’’ after ‘‘rule’’; and 

20 (C) by striking paragraph (3); 

21 (2) in subsection (b), by inserting ‘‘or order’’ 

22 after ‘‘rule’’ each place it appears; and 

23 (3) in subsection (c), by striking paragraph (1) 

24 and inserting the following: 


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1 ‘‘(1) IN GENERAL.—Upon the filing of a peti2 tion under subsection (a)(1) for judicial review of a 

3 rule or order, the court shall have jurisdiction— 

4 ‘‘(A) to grant appropriate relief, including 

5 interim relief, as provided in chapter 7 of title 

6 5, United States Code; and 

7 ‘‘(B) to review the rule or order in accord8 ance with that chapter.’’. 

9 SEC. 20. CITIZENS’ CIVIL ACTION. 

10 Section 20 of the Toxic Substances Control Act (15 

11 U.S.C. 2619) is amended— 

12 (1) in subsection (a)— 

13 (A) in paragraph (1), by striking ‘‘under 

14 section 4, 5, or 6, or title II or IV, or order 

15 issued under section 5 or title II or IV to re16 strain such violation,’’ and inserting ‘‘or order 

17 issued under this Act;’’; and 

18 (B) in the third sentence of the undesig19 nated language following paragraph (2), by in20 serting ‘‘, to enforce this Act or any rule pro21 mulgated or order issued under this Act, or to 

22 order the Administrator to perform an act or 

23 duty described in this Act, as the case may be’’ 

24 after ‘‘citizenship of the parties’’; and 


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1 (2) in subsection (b)(1), by striking ‘‘to re2 strain’’ and inserting ‘‘respecting’’. 

3 SEC. 21. CITIZENS’ PETITIONS. 

4 Section 21 of the Toxic Substances Control Act (15 

5 U.S.C. 2620) is amended— 

6 (1) in subsection (a), by striking ‘‘under section 

7 4, 6, or 8 or an order under section 5(e) or 

8 (6)(b)(2)’’ and inserting ‘‘, order, or any other ac9 tion authorized under this Act’’; and 

10 (2) in subsection (b)— 

11 (A) in paragraph (1), by striking ‘‘under 

12 section 4, 6, or 8 or an order under section 

13 5(e), 6(b)(1)(A), or 6(b)(1)(B)’’ and inserting 

14 ‘‘or order or to initiate other action authorized 

15 under this Act’’; 

16 (B) in the first sentence of paragraph (3), 

17 by striking ‘‘section 4, 5, 6, or 8’’ and inserting 

18 ‘‘the applicable provisions of this Act’’; and 

19 (C) in paragraph (4)— 

20 (i) in the first sentence of subpara21 graph (A), by striking ‘‘a rulemaking pro22 ceeding’’ and inserting ‘‘proceedings au23 thorized under this Act’’; and 

24 (ii) in subparagraph (B)— 


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1 (I) in the matter preceding clause 

2 (i)— 

3 (aa) in the first sentence, by 

4 striking ‘‘a proceeding to issue a 

5 rule under section 4, 6, or 8 or 

6 an order under section 5(e) or 

7 6(b)(2)’’ and inserting ‘‘pro8 ceedings authorized under this 

9 Act’’; and 

10 (bb) by inserting ‘‘Notwith11 standing the preceding sentence, 

12 in the case of a petition to delist 

13 a chemical substance under sec14 tion 6(a), the delisting may not 

15 proceed except as authorized 

16 under that subsection.’’ after the 

17 first sentence; 

18 (II) in clause (i)— 

19 (aa) in the matter preceding 

20 subclause (I), by striking ‘‘in the 

21 case of a petition to initiate a 

22 proceeding for the issuance of a 

23 rule under section 4 or an order 

24 under section 5(e)’’ and inserting 

25 ‘‘except as provided in clause (ii), 


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1 in the case of a petition to ini2 tiate a proceeding for the 

3 issuance of a rule or an order 

4 under this Act’’; and 

5 (bb) in subclause (II), by 

6 striking ‘‘an unreasonable risk 

7 to’’ and inserting ‘‘substantial 

8 endangerment’’; and 

9 (III) in clause (ii)— 

10 (aa) by striking ‘‘issuance of 

11 a rule under section 6 or 8 or an 

12 order under section 6(b)(2)’’ and 

13 inserting ‘‘imposition or issuance 

14 of a restriction, use condition, or 

15 order under this chapter’’; 

16 (bb) by striking ‘‘an unrea17 sonable risk of injury’’ and in18 serting ‘‘a substantial 

19 endangerment’’; and 

20 (cc) by striking the period at 

21 the end and inserting a semi22 colon. 

23 SEC. 22. EMPLOYMENT EFFECTS. 

24 Section 24 of the Toxic Substances Control Act (15 

25 U.S.C. 2623) is amended— 


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1 (1) in subsection (a), in the matter preceding 

2 paragraph (1)— 

3 (A) by striking ‘‘continuing’’ and inserting 

4 ‘‘periodic’’; and 

5 (B) by striking ‘‘plant closures)’’ and all 

6 that follows through the end of paragraph (2) 

7 and inserting ‘‘plant closures) of the implemen8 tation of this Act.’’; 

9 (2) in subsection (b)— 

10 (A) in paragraph (1), in the undesignated 

11 language following subparagraph (B), by strik12 ing ‘‘section 4, 5, or 6 or a requirement of sec13 tion 5 or 6’’ and inserting ‘‘this Act’’; 

14 (B) in paragraph (2)— 

15 (i) in subparagraph (A)(ii), by strik16 ing ‘‘by order issued’’ and inserting ‘‘in 

17 writing,’’; and 

18 (ii) in subparagraph (B)— 

19 (I) in clause (i), by striking the 

20 comma after ‘‘such request’’ and in21 serting ‘‘; and’’; 

22 (II) by striking clause (ii); and 

23 (III) by redesignating clause (iii) 

24 as clause (ii); and 

25 (C) by striking paragraph (4); and 


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1 (3) by adding at the end the following: 

2 ‘‘(c) EFFECT.—Nothing in this section— 

3 ‘‘(1) requires the Administrator to amend or re4 peal any rule or order in effect under this Act; or 

5 ‘‘(2) conditions the authority of the Adminis6 trator to issue orders or promulgate rules under this 

7 Act.’’. 

8 SEC. 23. ADMINISTRATION OF THE TOXIC SUBSTANCES 

9 CONTROL ACT. 

10 Section 26 of the Toxic Substances Control Act (15 

11 U.S.C. 2625) is amended— 

12 (1) by striking subsection (b) and inserting the 

13 following: 

14 ‘‘(b) FEES.— 

15 ‘‘(1) IN GENERAL.—The Administrator may, by 

16 rule, require the payment of a reasonable fee from 

17 any person required to submit data to defray the 

18 cost of administering this Act. 

19 ‘‘(2) CONSIDERATIONS.—In setting a fee under 

20 this subsection, the Administrator shall take into ac21 count— 

22 ‘‘(A) the ability to pay of the person re23 quired to submit the data; and 

24 ‘‘(B) the cost to the Administrator of re25 viewing the data. 


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1 ‘‘(3) FEE SHARING.—Rules described in para2 graph (1) may provide for sharing a fee in any case 

3 in which the expenses of testing are shared under 

4 this Act.’’; 

5 (2) in subsection (c)— 

6 (A) in the subsection heading, by adding 

7 ‘‘AND MIXTURES’’ after ‘‘CATEGORIES’’; and 

8 (B) by adding at the end the following: 

9 ‘‘(3) MIXTURES.—Any action authorized or re10 quired to be taken by the Administrator or any other 

11 person under any provision of this Act with respect 

12 to a chemical substance is likewise also authorized or 

13 required with respect to a mixture, if the Adminis14 trator determines that such extension is reasonable 

15 and efficient.’’; and 

16 (3) by adding at the end the following: 

17 ‘‘(h) RULEMAKING OR ORDERS.—In carrying out this 

18 Act, the Administrator may issue such orders and pre19 scribe such regulations as are necessary to carry out this 

20 Act.’’. 

21 SEC. 24. STATE PROGRAMS. 

22 Section 28 of the Toxic Substances Control Act (15 

23 U.S.C. 2627) is amended— 

24 (1) in the first sentence of subsection (a)— 

25 (A) by striking ‘‘unreasonable’’; and 


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1 (B) by striking ‘‘is unable or is not likely 

2 to take’’ and inserting ‘‘has not taken’’; 

3 (2) by redesignating subsections (b), (c), and 

4 (d) as subsections (c), (d), and (e), respectively; 

5 (3) by inserting after subsection (a) the fol6 lowing: 

7 ‘‘(b) COORDINATION.—The Administrator shall es8 tablish a process to coordinate with States, on an on-going 

9 basis, to share data and priorities relating to the manage10 ment of chemical substances under this title and under 

11 programs operated by States, in accordance with section 

12 14.’’; and 

13 (4) in subsection (c)(2) (as redesignated by 

14 paragraph (2)), by striking ‘‘including cancer, birth 

15 defects, and gene mutations,’’. 

16 SEC. 25. AUTHORIZATION OF APPROPRIATIONS. 

17 Title I of the Toxic Substances Control Act (15 

18 U.S.C. 2601 et seq.) is amended— 

19 (1) by redesignating section 29 (15 U.S.C. 

20 2628) as section 39; 

21 (2) by redesignating section 30 (15 U.S.C. 

22 2629) as section 38; 

23 (3) by striking section 31 (Public Law 94–469; 

24 100 Stat. 2989); and 


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1 (4) by amending section 39 (as redesignated by 

2 paragraph (1)) to read as follows: 

3 ‘‘SEC. 39. AUTHORIZATION OF APPROPRIATIONS. 

4 ‘‘There are authorized to be appropriated to the Ad5 ministrator to carry out this Act such sums as are nec6 essary for each of fiscal years 2011 through 2018.’’. 

7 SEC. 26. ADDITIONAL REQUIREMENTS. 

8 (a) RESTRICTIONS ON CERTAIN CHEMICAL SUB9 STANCES.—The Toxic Substances Control Act is amended 

10 by inserting after section 28 (15 U.S.C. 2627) the fol11 lowing: 

12 ‘‘SEC. 29. CHILDREN’S ENVIRONMENTAL HEALTH RE13 SEARCH PROGRAM. 

14 ‘‘(a) CHILDREN’S ENVIRONMENTAL HEALTH RE15 SEARCH PROGRAM.— 

16 ‘‘(1) ESTABLISHMENT.—Not later than 90 days 

17 after the date of enactment of the Safe Chemicals 

18 Act of 2011, the Administrator shall establish within 

19 the Environmental Protection Agency a program to 

20 be known as the ‘Children’s Environmental Health 

21 Research Program’ (referred to in this subsection as 

22 the ‘Program’). 

23 ‘‘(2) PURPOSE.—Subject to amounts made 

24 available in advance in appropriations Acts, the Ad25 ministrator may enter into contracts and make 


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1 grants under the Program to further understanding 

2 of the vulnerability of children to chemical sub3 stances and mixtures. 

4 ‘‘(3) CONSULTATION.—Contracts and grants 

5 under this section shall be provided in consultation 

6 with the Interagency Science Advisory Board on 

7 Children’s Health Research established under sub8 section (b)(1). 

9 ‘‘(b) INTERAGENCY SCIENCE ADVISORY BOARD ON

10 CHILDREN’S HEALTH RESEARCH.— 

11 ‘‘(1) ESTABLISHMENT.—Not later than 90 days 

12 after the date of enactment of the Safe Chemicals 

13 Act of 2011, the Administrator shall establish an ad14 visory board to be known as the ‘Interagency 

15 Science Advisory Board on Children’s Health Re16 search’ (referred to in this subsection as the 

17 ‘Board’). 

18 ‘‘(2) PURPOSE.—The purpose of the Board 

19 shall be to provide independent advice, expert con20 sultation, and peer review, on request of the Admin21 istrator or Congress, with respect to the scientific 

22 and technical aspects of issues relating to the imple23 mentation of this title with respect to research on 

24 protecting children’s health. 

25 ‘‘(3) COMPOSITION.—The Administrator shall— 


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1 ‘‘(A) appoint the members of the Board, 

2 including, at a minimum, representatives of— 

3 ‘‘(i) the National Institute of Environ4 mental Health Sciences; 

5 ‘‘(ii) the Centers for Disease Control 

6 and Prevention; 

7 ‘‘(iii) the National Toxicology Pro8 gram; 

9 ‘‘(iv) the National Cancer Institute; 

10 ‘‘(v) the National EPA-Tribal Science 

11 Council; and 

12 ‘‘(vi) not fewer than 3 centers of chil13 dren’s health at leading institutions of 

14 higher education; 

‘‘(B) ensure that at least 1 15 ⁄3 of the mem16 bers of the Board have specific scientific exper17 tise in the relationship of chemical exposures to 

18 prenatal, infant, and children’s health; and 

19 ‘‘(C) ensure that no individual appointed 

20 to serve on the Board has a conflict of interest 

21 that is relevant to the functions performed by 

22 the Board, unless— 

23 ‘‘(i) the individual promptly and pub24 licly discloses the conflict; and 


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1 ‘‘(ii) the Administrator determines 

2 that the conflict is unavoidable. 

3 ‘‘(4) APPLICABLE LAW.—The Board shall be 

4 subject to subchapter II of chapter 5, and chapter 

5 7, of title 5, United States Code (commonly known 

6 as the ‘Administrative Procedure Act’). 

7 ‘‘(c) PRENATAL AND INFANT EXPOSURES.— 

8 ‘‘(1) MONITORING.—If, through studies per9 formed under subsection (a) or section 4 or in any 

10 other available research, the Administrator identifies 

11 a chemical substance that may be present in human 

12 biological media that may have adverse effects on 

13 early childhood development, the Administrator shall 

14 coordinate with the Secretary of Health and Human 

15 Services to conduct, not later than 2 years after the 

16 date on which the Administrator identifies the chem17 ical substance, a biomonitoring study to determine 

18 the presence of the chemical substance in human bi19 ological media in, at a minimum, pregnant women 

20 and infants. 

21 ‘‘(2) PUBLICATION.—On completion of any 

22 study conducted under paragraph (1), the Secretary 

23 of Health and Human Services shall— 

24 ‘‘(A) notify the Administrator of the re25 sults of the study; and 


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1 ‘‘(B) publish the results of the study in a 

2 publicly available electronic format. 

3 ‘‘(3) POSITIVE RESULTS.— 

4 ‘‘(A) MANUFACTURE DISCLOSURE.—If a 

5 chemical substance or mixture is determined to 

6 be present in a study conducted under para7 graph (1), the manufacturers and processors of 

8 the chemical substance or mixture shall, not 

9 later than 180 days after the date of publica10 tion of the study, disclose to the Administrator, 

11 commercial customers of the manufacturers and 

12 processors, consumers, and the public— 

13 ‘‘(i) all known uses of the chemical 

14 substance or mixture; and 

15 ‘‘(ii) all articles in which the chemical 

16 substance or mixture is, or is expected to 

17 be, present. 

18 ‘‘(B) COST AND FORM OF DISCLOSURE.— 

19 Information under clauses (i) and (ii) of sub20 paragraph (A) shall be— 

21 ‘‘(i) made available by the Adminis22 trator in electronic format; and 

23 ‘‘(ii) made readily accessible and free 

24 of charge by each applicable manufacturer 

25 and processor in electronic format to the 


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1 commercial customers of such manufac2 turer or processor, consumers, and the 

3 public. 

4 ‘‘SEC. 30. REDUCTION OF ANIMAL-BASED TESTING. 

5 ‘‘(a) ADMINISTRATION.—The Administrator shall 

6 take action to minimize the use of animals in testing of 

7 chemical substances or mixtures, including— 

8 ‘‘(1) encouraging and facilitating, to the max9 imum extent practicable— 

10 ‘‘(A) the use of existing data of sufficient 

11 scientific quality; 

12 ‘‘(B) the use of test methods that eliminate 

13 or reduce the use of animals while providing 

14 data of high scientific quality; 

15 ‘‘(C) the grouping of 2 or more chemical 

16 substances into scientifically appropriate cat17 egories in cases in which testing of 1 chemical 

18 substance would provide reliable and useful 

19 data on others in the category; 

20 ‘‘(D) the formation of industry consortia to 

21 jointly conduct testing to avoid unnecessary du22 plication of tests; and 

23 ‘‘(E) the parallel submission of data from 

24 animal-based studies and from emerging meth25 ods and models; and 


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1 ‘‘(2) funding research and validation studies to 

2 reduce, refine, and replace the use of animal tests in 

3 accordance with this subsection. 

4 ‘‘(b) INTERAGENCY SCIENCE ADVISORY BOARD ON

5 ALTERNATIVE TESTING METHODS.— 

6 ‘‘(1) ESTABLISHMENT.—Not later than 90 days 

7 after the date of enactment of the Safe Chemicals 

8 Act of 2011, the Administrator shall establish an ad9 visory board to be known as the ‘Interagency 

10 Science Advisory Board on Alternative Testing 

11 Methods’ (referred to in this subsection and sub12 section (c) as the ‘Board’). 

13 ‘‘(2) COMPOSITION.—The Administrator shall— 

14 ‘‘(A) appoint the members of the Board, 

15 including, at a minimum, representatives of— 

16 ‘‘(i) the National Institute of Environ17 mental Health Sciences; 

18 ‘‘(ii) the Centers for Disease Control 

19 and Prevention; 

20 ‘‘(iii) the National Toxicology Pro21 gram; 

22 ‘‘(iv) the National Cancer Institute; 

23 and 

24 ‘‘(v) the National EPA-Tribal Science 

25 Council; and 


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1 ‘‘(B) ensure that no individual appointed 

2 to serve on the Board has a conflict of interest 

3 that is relevant to the functions to be per4 formed, unless— 

5 ‘‘(i) the individual promptly and pub6 licly discloses the conflict; and 

7 ‘‘(ii) the Administrator determines 

8 that the conflict is unavoidable. 

9 ‘‘(3) PURPOSE.—The purpose of the Board 

10 shall be to provide independent advice and peer re11 view to Congress and the Administrator on the sci12 entific and technical aspects of issues relating to the 

13 implementation of this title with respect to mini14 mizing the use of animals in testing chemical sub15 stances or mixtures. 

16 ‘‘(4) APPLICABLE LAW.—The Board shall be 

17 subject to subchapter II of chapter 5, and chapter 

18 7, of title 5, United States Code (commonly known 

19 as the ‘Administrative Procedure Act’). 

20 ‘‘(5) REPORT.—Not later than 1 year after the 

21 date of enactment of the Safe Chemicals Act of 

22 2011, and every 3 years thereafter, the Adminis23 trator, in consultation with the Board, shall publish 

24 in the Federal Register a list of testing methods that 

25 reduce the use of animals in testing under section 4. 


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1 ‘‘(c) IMPLEMENTATION OF ALTERNATIVE TESTING

2 METHODS.—To promote the development and timely in3 corporation of new testing methods that are not animal4 based, the Administrator shall— 

5 ‘‘(1) in consultation with the Board, and after 

6 providing an opportunity for public comment, de7 velop a strategic plan to promote the development 

8 and implementation of alternative test methods and 

9 testing strategies to generate information used for 

10 safety standard determinations under section 6(b) 

11 that do not use animals, including toxicity pathway12 based risk assessment, in vitro studies, systems biol13 ogy, computational toxicology, bioinformatics, and 

14 high-throughput screening; 

15 ‘‘(2) beginning on the date that is 2 years after 

16 the date of enactment of the Safe Chemicals Act of 

17 2011 and every 2 years thereafter, submit to Con18 gress a report that describes the progress made in 

19 implementing this section; and 

20 ‘‘(3) fund and carry out research, development, 

21 performance assessment, and translational studies to 

22 accelerate the development of test methods and test23 ing strategies that are not animal-based for use in 

24 safety standard determinations under section 6(b). 


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1 ‘‘(d) CRITERIA FOR ADAPTING OR WAIVING ANIMAL

2 TESTING REQUIREMENTS.—On request from a manufac3 turer or processor that is required to conduct animal4 based testing of a chemical substance or mixture under 

5 this title, the Administrator may adapt or waive the ani6 mal testing requirement if the Administrator determines 

7 that— 

8 ‘‘(1) there is a sufficient weight of evidence 

9 from several independent sources of information to 

10 support a conclusion that a chemical substance or 

11 mixture has, or does not have, a particular property, 

12 in any case in which the information from each indi13 vidual source alone is regarded as insufficient to 

14 support the conclusion; 

15 ‘‘(2) because of 1 or more physical or chemical 

16 properties of the chemical substance or mixture, 

17 testing for a specific endpoint is technically not 

18 practicable to conduct; or 

19 ‘‘(3) a chemical substance or mixture cannot be 

20 tested in animals at concentrations that do not re21 sult in significant pain or distress, because of phys22 ical or chemical properties of the chemical substance 

23 or mixture, such as potential to cause severe corro24 sion or severe irritation to tissues. 


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1 ‘‘SEC. 31. SAFER ALTERNATIVES AND GREEN CHEMISTRY 

2 AND ENGINEERING. 

3 ‘‘(a) SAFER ALTERNATIVES PROGRAM.— 

4 ‘‘(1) IN GENERAL.—Not later than 1 year after 

5 the date of enactment of the Safe Chemicals Act of 

6 2011, the Administrator shall establish a program to 

7 create market incentives for the development of safer 

8 alternatives to existing chemical substances that re9 duce or avoid the use and generation of hazardous 

10 substances. 

11 ‘‘(2) REQUIREMENTS.—The program estab12 lished under paragraph (1) shall include— 

13 ‘‘(A) expedited review of new chemical sub14 stances for which the manufacturer or proc15 essor submits an alternatives analysis indicating 

16 that the new chemical substance is the safer al17 ternative for a particular use than existing 

18 chemical substances used for the same purpose; 

19 ‘‘(B) recognition for a chemical substance 

20 or product determined by the Administrator to 

21 be a safer alternative for a particular use by 

22 means of a special designation intended for use 

23 in marketing the safer alternative, and periodic 

24 public awards or rewards; and 

25 ‘‘(C) such other incentives, as the Adminis26 trator considers to be appropriate to encourage 


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1 the development, marketing, and use of chem2 ical substances or products determined by the 

3 Administrator to be safer alternatives for the 

4 particular uses, such as job training and worker 

5 assistance. 

6 ‘‘(b) GREEN CHEMISTRY RESEARCH NETWORK.— 

7 The Administrator shall establish a network of not less 

8 than 4 green chemistry and engineering centers, located 

9 in various regions of the United States, to support the 

10 development and adoption of safer alternatives to chemical 

11 substances, particularly chemical substances listed under 

12 section 6(a). 

13 ‘‘(c) GREEN CHEMISTRY AND ENGINEERING RE14 SEARCH GRANTS.—The Administrator shall make grants 

15 to promote and support the research, development, and 

16 adoption of safer alternatives to hazardous substances. 

17 ‘‘(d) GREEN CHEMISTRY WORKFORCE EDUCATION

18 AND TRAINING PROGRAM.— 

19 ‘‘(1) IN GENERAL.—The Administrator shall es20 tablish a program to facilitate the development of a 

21 workforce, including industrial and scientific work22 ers, that produces safer alternatives to existing 

23 chemical substances. 


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1 ‘‘(2) GOALS.—The goals of the program estab2 lished under paragraph (1) are to provide workforce 

3 training on skills that would— 

4 ‘‘(A) facilitate the expansion of green 

5 chemistry; 

6 ‘‘(B) develop scientific and technical lead7 ership in green chemistry; 

8 ‘‘(C) facilitate the successful and safe inte9 gration of green chemistry into infrastructure 

10 projects; 

11 ‘‘(D) inform and engage communities 

12 about green chemistry; and 

13 ‘‘(E) promote innovation and strong public 

14 health and environmental protections. 

15 ‘‘(3) IMPLEMENTATION.—The Administrator 

16 shall implement the program to achieve the goals of 

17 this Act, including by— 

18 ‘‘(A) helping to develop a broad range of 

19 skills relevant to the production and use of the 

20 safer alternatives, including the design, manu21 facturing, use, and disposal of the alternatives; 

22 ‘‘(B) offering to develop partnerships with 

23 educational institutions, training organizations, 

24 private sector companies, and community orga25 nizations; and 


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1 ‘‘(C) providing grants to States, units of 

2 local government, and the partnerships devel3 oped under subparagraph (B) to promote and 

4 support activities consistent with achieving the 

5 goals of the program established under this 

6 subsection. 

7 ‘‘SEC. 32. COOPERATION WITH INTERNATIONAL EFFORTS. 

8 ‘‘In cooperation with the Secretary of State and the 

9 head of any other appropriate Federal agency (as deter10 mined by the Administrator), the Administrator shall co11 operate with international efforts as appropriate— 

12 ‘‘(1) to develop a common protocol or electronic 

13 database relating to chemical substances; or 

14 ‘‘(2) to develop safer alternatives for chemical 

15 substances. 

16 ‘‘SEC. 33. RELIABLE INFORMATION AND ADVICE. 

17 ‘‘Not later than 18 months after the date of enact18 ment of the Safe Chemicals Act of 2011, the Adminis19 trator shall, by order, establish and implement procedures 

20 to ensure data reliability including, at a minimum, re21 quirements that the Administrator— 

22 ‘‘(1) not less than annually randomly inspect 

23 laboratories that develop the data required under 

24 this title on the various properties and characteris25 tics of a chemical substance; 


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1 ‘‘(2) annually perform a comprehensive data 

2 audit on a subset, as chosen by the Administrator, 

3 of the data submissions under this title; 

4 ‘‘(3) establish and maintain a registry of all 

5 health- and safety-related studies initiated in re6 sponse to requirements under this title; 

7 ‘‘(4) have access to all records of health- and 

8 safety-related studies initiated in response to re9 quirements under this title; and 

10 ‘‘(5) require the submitter of any research 

11 study conducted by a third party in response to re12 quirements under this title to disclose to the Admin13 istrator and the public, at the time of submission, 

14 the sources of any funding used for the conduct or 

15 publication of the study received by the researchers 

16 who conducted the study. 

17 ‘‘SEC. 34. HOT SPOTS. 

18 ‘‘(a) DEFINITIONS.—In this section: 

19 ‘‘(1) DISPROPORTIONATE EXPOSURE.—The 

20 term ‘disproportionate exposure’ means residential 

21 population exposure to 1 or more toxic chemical sub22 stances or mixtures at levels that are significantly 

23 greater than the average exposure in the United 

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1 trator in accordance with the criteria established 

2 under subsection (b). 

3 ‘‘(2) LOCALITY.—The term ‘locality’ means any 

4 geographical area (including a county, city, town, 

5 neighborhood, census tract, zip code area, or other 

6 commonly understood political or geographical sub7 division) in which the Administrator identifies dis8 proportionate exposure. 

9 ‘‘(b) CRITERIA.—Not later than 180 days after the 

10 date of enactment of the Safe Chemicals Act of 2011, the 

11 Administrator shall promulgate a rule to establish criteria 

12 consistent with this section that— 

13 ‘‘(1) defines disproportionate exposure; and 

14 ‘‘(2) identifies any locality that is disproportion15 ately exposed. 

16 ‘‘(c) IDENTIFICATION.— 

17 ‘‘(1) IN GENERAL.—Not later than 120 days 

18 after the date on which the rule is promulgated 

19 under subsection (b), the Administrator shall iden20 tify localities in the United States that are subject 

21 to disproportionate exposure. 

22 ‘‘(2) USE OF DATA.—In identifying localities 

23 under paragraph (1), the Administrator— 

24 ‘‘(A) shall use data contained in the Na25 tional Air Toxic Assessment Database; and 


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1 ‘‘(B) may use other data available to the 

2 Administrator, including data developed 

3 under— 

4 ‘‘(i) the Safe Drinking Water Act (42 

5 U.S.C. 300f et seq.); 

6 ‘‘(ii) the Solid Waste Disposal Act (42 

7 U.S.C. 6901 et seq.); 

8 ‘‘(iii) the Comprehensive Environ9 mental Response, Compensation, and Li10 ability Act of 1980 (42 U.S.C. 9601 et 

11 seq.); and 

12 ‘‘(iv) the Emergency Planning and 

13 Community Right-to-Know Act of 1986 

14 (42 U.S.C. 11001 et seq.). 

15 ‘‘(3) PUBLIC PARTICIPATION.—The Adminis16 trator shall provide an opportunity for members of 

17 the public to nominate localities in which dispropor18 tionate exposure may be found for inclusion in the 

19 identification of localities under paragraph (1). 

20 ‘‘(d) LOCALITY LIST.— 

21 ‘‘(1) IN GENERAL.—Not later than 180 days 

22 after completing the identification of localities under 

23 subsection (c)(1), the Administrator, after notice 

24 and consultation with applicable State, local, county 


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1 health, and environmental officials, State, local, and 

2 county legislators, and other elected officials, shall— 

3 ‘‘(A) publish a list of the localities subject 

4 to disproportionate exposure identified under 

5 that subsection in the Federal Register; and 

6 ‘‘(B) make the list published under sub7 paragraph (A) available electronically. 

8 ‘‘(2) UPDATED LIST.— 

9 ‘‘(A) IN GENERAL.—Subject to subpara10 graph (B), not later than 5 years after the date 

11 on which the list is published under paragraph 

12 (1)(A), and at least once every 5 years there13 after, the Administrator shall update and re14 publish the list. 

15 ‘‘(B) DISCRETIONARY UPDATES.—The Ad16 ministrator may update and republish the list 

17 under paragraph (1) more frequently than every 

18 5 years— 

19 ‘‘(i) to add new localities that meet 

20 the criteria established under subsection 

21 (b); or 

22 ‘‘(ii) to remove localities, if the Ad23 ministrator determines that the exposure 

24 reduction has been achieved and no further 


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1 action is needed after actions are taken 

2 under subsection (f). 

3 ‘‘(C) NOTIFICATION.—The Administrator 

4 shall notify all applicable State, local, county 

5 health, and environmental officials, State, local, 

6 and county legislators, and other elected offi7 cials of the updated listing. 

8 ‘‘(e) NO JUDICIAL REVIEW; NONDISCRETIONARY

9 DUTY.— 

10 ‘‘(1) NO JUDICIAL REVIEW.—The following ac11 tions under this section shall not be subject to judi12 cial review: 

13 ‘‘(A) A decision to include on the list pub14 lished under subsection (d)(1) a locality identi15 fied under subsection (c)(1). 

16 ‘‘(B) A decision in response to nominations 

17 submitted under subsection (c)(3). 

18 ‘‘(C) A decision to list localities under sub19 section (d)(1) or update the list under sub20 section (d)(2). 

21 ‘‘(2) NONDISCRETIONARY DUTY.—Notwith22 standing paragraph (1), the failure of the Adminis23 trator to publish or update the list of localities in ac24 cordance with this section shall be— 


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1 ‘‘(A) considered to be a failure to perform 

2 a nondiscretionary duty; and 

3 ‘‘(B) subject to judicial review. 

4 ‘‘(f) ACTION PLANS.— 

5 ‘‘(1) IN GENERAL.—Not later than 1 year after 

6 the date on which the list is published or updated 

7 under subsection (d), the Administrator shall de8 velop and publish, for each locality identified on the 

9 list, an action plan that includes— 

10 ‘‘(A) an identification of the chemical sub11 stances and mixtures that contribute to the dis12 proportionate exposure (including exposure lev13 els, sources, and pathways); and 

14 ‘‘(B) a description of actions planned by 

15 the Administrator to reduce disproportionate 

16 exposure in the locality. 

17 ‘‘(2) GOALS.—The goal of each action plan 

18 under this subsection shall be to reduce dispropor19 tionate exposure in the locality by establishing— 

20 ‘‘(A) a percentage exposure reduction goal 

21 for each chemical substance and mixture; and 

22 ‘‘(B) a timeline to achieve the percentage 

23 exposure reduction goal. 

24 ‘‘(g) REPORT TO CONGRESS.—The Administrator 

25 shall— 


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1 ‘‘(1) submit to Congress an annual report that 

2 identifies— 

3 ‘‘(A) each locality added to the list in the 

4 prior year under subsection (d); 

5 ‘‘(B) each action plan developed in the 

6 prior year under subsection (f); and 

7 ‘‘(C) the progress on each action plan to 

8 date; and 

9 ‘‘(2) make the report available to the public in 

10 electronic format. 

11 ‘‘SEC. 35. APPLICATION OF THIS ACT TO FEDERAL AGEN12 CIES. 

13 ‘‘(a) IN GENERAL.—Except as provided in subsection 

14 (e), each Federal agency, and any officer, agent, or em15 ployee of a Federal agency, shall be subject to, and comply 

16 with, all applicable requirements of this Act described in 

17 subsection (b), both substantive and procedural, in the 

18 same manner, and to the same extent, as any person sub19 ject to the requirements. 

20 ‘‘(b) DESCRIPTION OF REQUIREMENTS.—The sub21 stantive and procedural requirements referred to in this 

22 subsection include— 

23 ‘‘(1) any administrative order; 

24 ‘‘(2) any civil or administrative penalty or fine, 

25 regardless of whether the penalty or fine is— 


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1 ‘‘(A) punitive or coercive in nature; or 

2 ‘‘(B) imposed for isolated, intermittent, or 

3 continuing violations; 

4 ‘‘(3) any requirement for reporting; 

5 ‘‘(4) any provision for injunctive relief and 

6 sanctions that may be imposed by a court to enforce 

7 such relief; and 

8 ‘‘(5) payment of reasonable service charges. 

9 ‘‘(c) WAIVER OF IMMUNITY.—The United States ex10 pressly waives any immunity otherwise applicable to the 

11 United States with respect to any substantive or proce12 dural requirement referred to under subsection (a). 

13 ‘‘(d) CIVIL PENALTIES.—No agent, employee, or offi14 cer of the United States shall be personally liable for any 

15 civil penalty under this title with respect to any act or 

16 omission within the scope of the official duties of the 

17 agent, employee, or officer. 

18 ‘‘(e) CRIMINAL SANCTIONS.—An agent, employee, or 

19 officer of the United States shall be subject to any crimi20 nal sanction (including any fine or imprisonment) under 

21 this Act, but no department, agency, or instrumentality 

22 of the executive, legislative, or judicial branch of the Fed23 eral Government shall be subject to such sanction. 

24 ‘‘(f) EXEMPTION.— 


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1 ‘‘(1) IN GENERAL.—If the President determines 

2 it is in the paramount interest of the United States, 

3 the President may grant an exemption for any Fed4 eral agency from compliance with any requirement 

5 of this Act. 

6 ‘‘(2) LACK OF APPROPRIATION.—No exemption 

7 shall be granted under paragraph (1) due to lack of 

8 appropriation unless— 

9 ‘‘(A) the President has specifically re10 quested the appropriation as a part of the 

11 budgetary process; and 

12 ‘‘(B) Congress has failed to make the re13 quested appropriation available. 

14 ‘‘(3) PERIOD OF EXEMPTION.—Any exemption 

15 granted under paragraph (1) shall be for a period of 

16 not more than 1 year, but additional exemptions 

17 may be granted for periods not to exceed 1 year, if 

18 the President makes a subsequent determination 

19 that the exemption is in the paramount interest of 

20 the United States. 

21 ‘‘(4) REPORT.—Each January after the date of 

22 enactment of this section, the President shall submit 

23 to Congress a report that describes— 


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1 ‘‘(A) all exemptions granted under this 

2 subsection during the preceding calendar year; 

3 and 

4 ‘‘(B) the reason for granting each exemp5 tion. 

6 ‘‘(g) ADMINISTRATIVE ENFORCEMENT ACTIONS.— 

7 ‘‘(1) IN GENERAL.—The Administrator may ini8 tiate an administrative enforcement action against 

9 any Federal agency— 

10 ‘‘(A) in accordance with the enforcement 

11 authorities of this Act; and 

12 ‘‘(B) in the same manner and under the 

13 same circumstances as an action would be initi14 ated against another person. 

15 ‘‘(2) SETTLEMENT.—Any voluntary resolution 

16 or settlement of an administrative enforcement ac17 tion initiated under this subsection shall be set forth 

18 in a consent order. 

19 ‘‘(3) FINALITY OF ADMINISTRATIVE ORDER.— 

20 No administrative order issued to a Federal depart21 ment, agency, or instrumentality under this sub22 section shall become final until the Federal depart23 ment, agency, or instrumentality has had the oppor24 tunity to confer with the Administrator. 


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1 ‘‘SEC. 36. IMPLEMENTATION OF STOCKHOLM CONVENTION, 

2 THE LRTAP POPS PROTOCOL, AND THE ROT3 TERDAM CONVENTION. 

4 ‘‘(a) DEFINITIONS.—In this section: 

5 ‘‘(1) CHEMICAL.—The term ‘chemical’ includes 

6 any substance or mixture of substances, including a 

7 substance that is part of an article. 

8 ‘‘(2) LRTAP CONVENTION.—The term 

9 ‘LRTAP Convention’ means the Convention on 

10 Long-Range Transboundary Air Pollution, done at 

11 Geneva on November 13, 1979 (TIAS 10541), and 

12 any subsequent amendments to which the United 

13 States is a party. 

14 ‘‘(3) LRTAP POPS CHEMICAL.—The term 

15 ‘LRTAP POPs chemical’ means any chemical listed 

16 on any Annex of the LRTAP POPs Protocol, if such 

17 listing has entered into force for the United States. 

18 ‘‘(4) LRTAP POPS PROTOCOL.—The term 

19 ‘LRTAP POPs Protocol’ means the Protocol on Per20 sistent Organic Pollutants to the LRTAP Conven21 tion, done at Aarhus on June 24, 1998, and any 

22 subsequent amendment to which the United States 

23 is a party. 

24 ‘‘(5) MEETING OF THE PARTIES.—The term 

25 ‘meeting of the parties’ means— 


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1 ‘‘(A) the Conference of the Parties estab2 lished by and operating under Article 19 of the 

3 Stockholm Convention; 

4 ‘‘(B) the Executive Body established by 

5 and operating under Article 10 of the LRTAP 

6 POPs Convention; and 

7 ‘‘(C) the Conference of the Parties estab8 lished by and operating under Article 18 of the 

9 Rotterdam Convention. 

10 ‘‘(6) PIC CHEMICAL.—The term ‘PIC chemical’ 

11 means any chemical identified by notification to the 

12 Secretariat of the Rotterdam Convention by the 

13 United States as banned or severely restricted in the 

14 United States, and any chemical listed on any Annex 

15 of the Rotterdam Convention, if such listing has en16 tered into force for the United States. 

17 ‘‘(7) POPS CHEMICAL.—The term ‘POPs chem18 ical’ means any chemical that is listed on any Annex 

19 of the Stockholm Convention, if such listing has en20 tered into force for the United States. 

21 ‘‘(8) ROTTERDAM CONVENTION.—The term 

22 ‘Rotterdam Convention’ means the Rotterdam Con23 vention on the Prior Informed Consent Procedure 

24 for Certain Hazardous Chemicals and Pesticides in 

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1 tember 10, 1998, and any subsequent amendment to 

2 which the United States is a party. 

3 ‘‘(9) STOCKHOLM CONVENTION.—The term 

4 ‘Stockholm Convention’ means the Stockholm Con5 vention on Persistent Organic Pollutants, done at 

6 Stockholm on May 22, 2001, and any subsequent 

7 amendment to which the United States is a party. 

8 ‘‘(b) IMPLEMENTATION OF INTERNATIONAL AGREE9 MENTS.— 

10 ‘‘(1) IN GENERAL.—The Administrator, in co11 operation with appropriate Federal agencies, shall 

12 implement and support the implementation by the 

13 United States of the provisions of the Stockholm 

14 Convention, the LRTAP POPs Protocol, and the 

15 Rotterdam Convention that have entered into effect 

16 for the United States. 

17 ‘‘(2) PROHIBITIONS.—Notwithstanding any 

18 other provision of law, no person may manufacture, 

19 process, distribute in commerce, use, dispose of, or 

20 take any other action with respect to a POPs chem21 ical, LRTAP POPs chemical, or PIC chemical in a 

22 manner inconsistent with applicable obligations for 

23 that chemical under the Stockholm Convention, 

24 LRTAP POPs Protocol, or Rotterdam Convention. 

25 ‘‘(3) PUBLIC NOTICE AND COMMENT.— 


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1 ‘‘(A) IN GENERAL.—The Administrator 

2 shall provide timely public notice and oppor3 tunity to comment on a chemical proposed for 

4 listing to any Annex to the Stockholm Conven5 tion, the LRTAP POPs Protocol, or the Rot6 terdam Convention. 

7 ‘‘(B) CONTENTS.—The Administrator shall 

8 identify in the notice under subparagraph (A) 

9 any relevant toxicity, exposure, and risk infor10 mation on the chemical known to the Adminis11 trator, and any domestic activities involving the 

12 chemical known to the Administrator. 

13 ‘‘(C) NOTICE AND COMMENT.— 

14 ‘‘(i) IN GENERAL.—Any interested 

15 person may provide relevant comment and 

16 information on the chemical in response to 

17 the notice under subparagraph (A). 

18 ‘‘(ii) REQUEST FOR INFORMATION.— 

19 The Administrator may require the provi20 sion of relevant information related to a 

21 proposed chemical from any person, as the 

22 Administrator determines necessary to as23 sist the United States in the review. 

24 ‘‘(iii) PUBLIC DOCKET.—The Admin25 istrator shall consider all comments and inVerDate Mar 15 2010 21:55 Apr 18, 2011 Jkt 099200 PO 00000 Frm 00177 Fmt 6652 Sfmt 6201 E:\BILLS\S847.IS S847

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1 formation received under this subpara2 graph in the review of the proposal and in3 clude the comments and information in an 

4 established public docket. 

5 ‘‘(D) POST-RECOMMENDATION.— 

6 ‘‘(i) IN GENERAL.—The Administrator 

7 shall provide timely public notice and op8 portunity to comment after a recommenda9 tion is made to list a chemical on any 

10 Annex to the Stockholm Convention, the 

11 LRTAP POPs Protocol, or the Rotterdam 

12 Convention. 

13 ‘‘(ii) MEETING OF THE PARTIES.— 

14 The Administrator shall provide the notice 

15 under clause (i) in advance of the meeting 

16 of the Parties at which the recommenda17 tion is to be considered. 

18 ‘‘(iii) REQUEST FOR INFORMATION.— 

19 The Administrator shall request comment 

20 and information on all aspects of the rec21 ommendation and may, if the Adminis22 trator determines it to be necessary to as23 sist the United States in the review, re24 quire the provision of relevant information 


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1 related to a proposed chemical from any 

2 person. 

3 ‘‘(iv) PUBLIC DOCKET.—The Adminis4 trator shall consider all comments and in5 formation received under this subpara6 graph in the review of the proposal and in7 clude the comments and information in an 

8 established public docket. 

9 ‘‘(E) DECISIONS.— 

10 ‘‘(i) IN GENERAL.—Not later than 30 

11 days after a decision by the meeting of the 

12 parties, the Administrator shall provide 

13 timely public notice and opportunity to 

14 comment on any decision by the meeting of 

15 the parties to list a chemical on any Annex 

16 to the Stockholm Convention. 

17 ‘‘(ii) CONTENTS.—The Administrator 

18 shall provide in the notice under clause (i) 

19 a description of the amendments to the in20 struments and identify the changes to the 

21 domestic activities that the Administrator 

22 believes, based on information available to 

23 the Administrator, would be necessary if 

24 the United States chose to be bound by the 

25 listing decision. 


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1 ‘‘(iii) PUBLIC COMMENT.—Any inter2 ested person may provide relevant com3 ment and information in response to the 

4 notice under clause (i). 

5 ‘‘(iv) PUBLIC DOCKET.—The Adminis6 trator shall consider all comments and in7 formation received under this subpara8 graph in the review of the proposal and in9 clude the comments and information in an 

10 established public docket. 

11 ‘‘(F) RATIFICATION.—Not later than 30 

12 days after the United States deposits the in13 strument of ratification for the Stockholm Con14 vention, the LRTAP POPs Protocol, or the 

15 Rotterdam Convention, or not later than 30 

16 days after the listing of any chemical subse17 quently added under those instruments has en18 tered into force for the United States (which19 ever date is earlier), the Administrator— 

20 ‘‘(i) shall provide public notice of— 

21 ‘‘(I) the chemicals that are sub22 ject to those instruments; and 

23 ‘‘(II) any chemical subsequently 

24 added under those instruments; and 


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1 ‘‘(ii) may specify the requirements 

2 that are applicable for individual chemicals 

3 in a public notice under this subparagraph. 

4 ‘‘(4) GENERAL RULEMAKING AUTHORITY.—The 

5 Administrator may promulgate regulations necessary 

6 to carry out the Stockholm Convention, the LRTAP 

7 POPs Protocol, or the Rotterdam Convention, or to 

8 ensure compliance with any obligations under such 

9 instruments. 

10 ‘‘(5) OBLIGATIONS.—If a chemical is subject to 

11 obligations under more than 1 of the instruments 

12 that includes the Stockholm Convention, the LRTAP 

13 POPs Protocol, or the Rotterdam Convention, the 

14 most stringent of the obligations shall apply to en15 sure compliance with each of the instruments. 

16 ‘‘(c) ENFORCEMENT.—The prohibitions and any 

17 other requirements of this section shall be enforced in the 

18 same manner as final rules or orders under section 6.’’. 

19 (b) CONFORMING AMENDMENTS.—The table of con20 tents for the Toxic Substances Control Act (15 U.S.C. 

21 2601 et seq.) is amended— 

22 (1) by striking the item relating to section 2 

23 and inserting the following: 

‘‘Sec. 2. Findings, policy, and goal.’’; 


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1 (2) by striking the item relating to section 4 

2 and inserting the following: 

‘‘Sec. 4. Minimum data set and testing of chemical substances.’’; 

3 (3) by striking the item relating to section 6 

4 and inserting the following: 

‘‘Sec. 6. Prioritization, safety standard determination, and risk management.’’; 

5 (4) by striking the items relating to sections 29 

6 through 31; and 

7 (5) by adding after the item relating to section 

8 28 the following: 

‘‘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.’’. 

Æ 


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