II 

Calendar No. 578 

112TH CONGRESS 

2D SESSION S. 847 

[Report No. 112–264] 

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, 

Mr. FRANKEN, Mr. WHITEHOUSE, Mr. SANDERS, Mrs. GILLIBRAND, Mr. 

DURBIN, Mr. MENENDEZ, Mr. LEAHY, Mr. BLUMENTHAL, Mr. 

MERKLEY, Mrs. FEINSTEIN, Mr. BEGICH, Mr. TESTER, Mr. KERRY, Mrs. 

MURRAY, Mr. CARDIN, Mr. HARKIN, Ms. CANTWELL, Mr. WYDEN, Mr. 

BAUCUS, Mr. UDALL of New Mexico, Mr. AKAKA, Mr. NELSON of Florida, Mr. LIEBERMAN, Ms. MIKULSKI, Mr. INOUYE, and Mr. BENNET) introduced the following bill; which was read twice and referred to the Committee on Environment and Public Works 

DECEMBER 27, 2012 

Reported by Mrs. BOXER, with amendments 

[Omit the part struck through and insert the part printed in italic] 

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, 


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1 SECTION 1. SHORT TITLE. 

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

3 of 2011’’. 

4 SEC. 2. PURPOSES. 

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

6 chemicals are adequately understood and managed. 

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

8 Section 2 of the Toxic Substances Control Act (15 

9 U.S.C. 2601) is amended— 

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

11 inserting ‘‘GOAL’’; and 

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

13 inserting the following: 

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

15 ‘‘(1) each year human beings and the environ16 ment are exposed to a large number of chemical sub17 stances; 

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

19 of the United States economy, provides valuable 

20 products that are used in diverse manufacturing in21 dustries and other commercial, institutional, and 

22 consumer applications; 

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

24 of this Act, people and the environment in the 

25 United States are still exposed to thousands of 


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1 chemicals whose safety has not been adequately re2 viewed and may harm health and the environment; 

3 ‘‘(4) the incidence of some diseases and dis4 orders linked to chemical substance exposures is on 

5 the rise; 

6 ‘‘(5) biomonitoring of chemical substances in 

7 humans reveals that people in the United States 

8 carry hundreds of hazardous chemicals in their bod9 ies; 

10 ‘‘(6) the concentrations of certain chemical sub11 stances that persist and accumulate are increasing 

12 in the environment and in human bodies and are 

13 found across the world, including in the remote Arc14 tic in which Native Americans face increasing con15 tamination of traditional foods; 

16 ‘‘(7) differences in metabolism and physiology 

17 at certain stages of development can make infants 

18 and children more vulnerable than adults to the ef19 fects of chemical exposure, especially exposure that 

20 occurs in utero, during infancy, and during other 

21 critical periods of development; 

22 ‘‘(8) manufacturers and processors of chemicals 

23 should supply sufficient health and environmental 

24 information before distributing products in com25 merce; 


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

2 the authority to develop sufficient information to as3 sess chemical safety, and to act effectively when the 

4 Administrator obtains information that indicates 

5 there are risks of harmful exposure to chemical sub6 stances; 

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

8 chemical sector and many of the companies that con9 duct business in the United States must also comply 

10 with chemical safety regulatory programs in other 

11 countries, and the data that is generated to comply 

12 with those other regulatory programs may be useful 

13 in understanding hazards and exposures of chemical 

14 substances presented in the United States; and 

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

16 substances will assist in renewing the manufacturing 

17 sector of the United States, create new and safer 

18 jobs, spur innovations in green chemistry, restore 

19 confidence domestically and internationally in the 

20 safety of products of the United States, and ensure 

21 that products of the United States remain competi22 tive in the global market. 

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

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

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1 ronment from harmful exposures to chemical sub2 stances; 

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

4 and other actions that reduce the use of and expo5 sure to hazardous chemical substances and reward 

6 innovation toward safer chemicals, processes, and 

7 products; 

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

9 meet a risk-based safety standard that protects vul10 nerable and affected populations and the environ11 ment; 

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

13 health and environmental information for the chem14 ical substances that the companies manufacture, 

15 process, or import as a condition of allowing those 

16 companies to distribute chemical substances in com17 merce; 

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

19 chemical safety and use; 

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

21 workers to know about the hazards and uses of 

22 chemical substances that the public and workers 

23 may be exposed to by maximizing public access to 

24 information on chemical safety and use; and 


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1 ‘‘(7) to strengthen cooperation between and 

2 among the Federal Government and State, munic3 ipal, tribal, and foreign governments. 

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

5 address the harmful exposure of vulnerable or affected 

6 populations to chemical substances caused by the distribu7 tion of chemical substances in commerce by— 

8 ‘‘(1) reviewing all chemical substances for safe9 ty and identifying the highest priority chemical sub10 stances for expedited review; 

11 ‘‘(2) determining whether chemical substances 

12 in commerce meet the safety standard under this 

13 title; 

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

15 of a chemical substance, where warranted; and 

16 ‘‘(4) encouraging the replacement of harmful 

17 chemicals and processes with safer alternatives.’’. 

18 SEC. 4. DEFINITIONS. 

19 Section 3 of the Toxic Substances Control Act (15 

20 U.S.C. 2602) is amended— 

21 (1) by striking paragraph (12); 

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

23 (5), (6), (7), (8), (9), (10), (11), (13), and (14), as 

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

25 (18), (19), (21), and (24), respectively; 


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1 (3) by inserting after paragraph (1) the fol2 lowing: 

3 ‘‘(2) AGGREGATE EXPOSURE.— 

4 ‘‘(A) IN GENERAL.—Subject to subpara5 graph (B), the term ‘aggregate exposure’ means 

6 exposure from all sources of a chemical sub7 stance, including exposure from— 

8 ‘‘(i) the manufacture, processing, dis9 tribution, use, and disposal of that chem10 ical substance; and 

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

12 substance, including— 

13 ‘‘(I) contamination of food, air, 

14 water, soil, and house dust from cur15 rent or prior uses or activity; 

16 ‘‘(II) accidental releases; 

17 ‘‘(III) permitted sources of pollu18 tion; 

19 ‘‘(IV) nonpoint sources of pollu20 tion; 

21 ‘‘(V) documented background lev22 els from natural and anthropogenic 

23 sources; and 

24 ‘‘(VI) a mixture or article con25 taining that chemical substance. 


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

2 exposure’ includes exposure from a chemical 

3 substance that is not considered to be a chem4 ical substance under this Act solely because of 

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

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

7 defined in section 201 of the Federal Food, 

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

9 ‘‘(3) BIOACCUMULATIVE.— 

10 ‘‘(A) IN GENERAL.—The term ‘bioaccumu11 lative’ means, with respect to a chemical sub12 stance or mixture, that the chemical substance 

13 or mixture, as determined by the Administrator, 

14 can significantly accumulate in biota, as indi15 cated through monitoring data, or is highly 

16 likely to accumulate in biota, as indicated by 

17 other evidence. 

18 ‘‘(B) UPDATE.—To reflect the best avail19 able science, the Administrator may, by rule, 

20 revise the definition of the term ‘bioaccumula21 tive’ in such a way that reflects the state of the 

22 science and provides for equal or greater protec23 tion of human health and the environment. 

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

25 identity’ includes— 


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

2 chemical substance; 

3 ‘‘(B) the name of a chemical substance ap4 pearing in International Union of Pure and Ap5 plied Chemistry nomenclature and the most 

6 current Collective Index format; 

7 ‘‘(C) each Chemical Abstracts Service reg8 istration number of a chemical substance; and 

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

10 substance.’’; 

11 (4) in paragraph (5) (as redesignated by para12 graph (2))— 

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

14 in subparagraph (B)’’ and inserting the fol15 lowing: 

16 ‘‘(5) CHEMICAL SUBSTANCE.— 

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

18 subparagraphs (B) and (C)’’; 

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

20 Such term’’ and inserting the following: 

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

22 substance’ ’’; and 

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

24 ‘‘(C) INCLUSIONS.—Notwithstanding mo25 lecular identity, the Administrator may deterVerDate Mar 15 2010 23:53 Dec 27, 2012 Jkt 029200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S847.RS S847

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1 mine that a variant of a chemical substance is 

2 a new chemical substance under section 

3 5(a)(6).’’; 

4 (5) by inserting after paragraph (6) (as redesig5 nated by paragraph (2)) the following: 

6 ‘‘(7) CUMULATIVE EXPOSURE.—The term ‘cu7 mulative exposure’ means the sum of aggregate ex8 posure to each of the chemical substances that are 

9 known or suspected to contribute appreciably to the 

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

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

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

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

14 ‘distribute in commerce’ and ‘distribution in com15 merce’, when used to describe an action taken with 

16 respect to a chemical substance (or mixture or arti17 cle containing that chemical substance), mean— 

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

19 mixture, or article in commerce; 

20 ‘‘(B) to introduce or deliver for introduc21 tion into commerce, or the introduction or deliv22 ery for introduction into commerce of, the sub23 stance, mixture, or article; 


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1 ‘‘(C) to hold, or the holding of, the sub2 stance, mixture, or article after its introduction 

3 into commerce; or 

4 ‘‘(D) to export or offer for export the sub5 stance, mixture, or article.’’; 

6 (7) by inserting after paragraph (8) (as redesig7 nated by paragraph (2)) the following: 

8 ‘‘(9) END CONSUMER.—The term ‘end con9 sumer’ means an individual or other entity that pur10 chases and uses or consumes a chemical substance 

11 (or mixture or article containing that chemical sub12 stance).’’; 

13 (8) in paragraph (10) (as redesignated by para14 graph (2)), by inserting ‘‘ambient and indoor’’ after 

15 ‘‘includes water,’’; 

16 (9) by inserting after paragraph (10) (as redes17 ignated by paragraph (2)) the following: 

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

19 agency’ means any department, agency, or other in20 strumentality of the Federal Government, any inde21 pendent agency or establishment of the Federal Gov22 ernment including any Government corporation, and 

23 the Government Printing Office.’’; 

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

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


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1 the chemical substance list compiled and published 

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

3 manufacturer or processor of the chemical substance 

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

5 (11) by inserting after paragraph (15) (as re6 designated by paragraph (2)) the following: 

7 ‘‘(16) PERSISTENT.— 

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

9 means, with respect to a chemical substance or 

10 mixture, that the chemical substance or mix11 ture, as determined by the Administrator, sig12 nificantly persists in 1 or more environmental 

13 media, as indicated by monitoring data or other 

14 evidence. 

15 ‘‘(B) UPDATE.—To reflect the best avail16 able science, the Administrator may, by rule, 

17 revise the definition of the term ‘persistent’ in 

18 such a way that reflects the state of the science 

19 and provides for equal or greater protection of 

20 human health and the environment. 

21 ‘‘(17) PERSON.— 

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

23 means an individual, trust, firm, joint stock 

24 company, corporation (including a Government 

25 corporation), partnership, association, State, 


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1 municipality, commission, political subdivision 

2 of a State, or any interstate body. 

3 ‘‘(B) INCLUSIONS.—The term ‘person’ in4 cludes each Federal agency and any officer, 

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

6 (12) by inserting after paragraph (19) (as re7 designated by paragraph (2)) the following: 

8 ‘‘(20) SPECIAL SUBSTANCE CHARACTERISTIC.— 

9 ‘‘(A) IN GENERAL.—The term ‘special sub10 stance characteristic’ means a physical, chem11 ical, or biological characteristic, other than mo12 lecular identity, that the Administrator deter13 mines, by order or rule, may significantly affect 

14 the risks posed by substances exhibiting that 

15 characteristic. 

16 ‘‘(B) CONSIDERATIONS.—In determining 

17 the existence of special substance characteris18 tics, the Administrator may consider— 

19 ‘‘(i) size or size distribution; 

20 ‘‘(ii) shape and surface structure; 

21 ‘‘(iii) reactivity; and 

22 ‘‘(iv) any other properties that may 

23 significantly affect the risks posed.’’; 

24 (13) by inserting after paragraph (21) (as re25 designated by paragraph (2)) the following: 


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

2 a chemical substance or mixture, means that the 

3 chemical substance or mixture has a toxicological 

4 property— 

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

6 Category 2 for any of the toxicity endpoints es7 tablished by the Globally Harmonized System 

8 for the Classification and Labeling of Haz9 ardous Substances; 

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

11 been demonstrated in humans or other exposed 

12 organisms; or 

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

14 (such as demonstration of an adverse effect de15 scribed in subparagraph (B), laboratory studies, 

16 or data for a chemical from the same chemical 

17 class that exhibits that adverse effect) dem18 onstrates the potential for an adverse effect in 

19 humans or other exposed organisms. 

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

21 ‘toxicological property’ means actual or potential 

22 toxicity or other adverse effects of a chemical sub23 stance or mixture, including actual or potential ef24 fects of exposure to a chemical substance or mixture 

25 on— 


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1 ‘‘(A) mortality; 

2 ‘‘(B) morbidity, including carcinogenesis; 

3 ‘‘(C) reproduction; 

4 ‘‘(D) growth and development; 

5 ‘‘(E) the immune system; 

6 ‘‘(F) the endocrine system; 

7 ‘‘(G) the brain or nervous system; 

8 ‘‘(H) other organ systems; or 

9 ‘‘(I) any other biological functions in hu10 mans or nonhuman organisms.’’; and 

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

12 ‘‘(25) VULNERABLE HUMAN POPULATION.— 

13 The term ‘vulnerable human population’ means a 

14 human population that is subject to disproportionate 

15 exposure to, or the potential for disproportionate ad16 verse effect from exposure to, a chemical substance 

17 or mixture, including— 

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

19 ‘‘(B) pregnant women; 

20 ‘‘(C) elderly; 

21 ‘‘(D) individuals with preexisting medical 

22 conditions; 

23 ‘‘(E) workers that work with chemical sub24 stances and mixtures; and 


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1 ‘‘(F) members of any other appropriate 

2 population identified by the Administrator.’’. 

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

4 SUBSTANCES. 

5 Section 4 of the Toxic Substances Control Act (15 

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

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

8 SUBSTANCES. 

9 ‘‘(a) MINIMUM DATA SETS.— 

10 ‘‘(1) MINIMUM DATA SETS RULES.— 

11 ‘‘(A) IN GENERAL.—Subject to subpara12 graph (B), and not later than 1 year after the 

13 date of enactment of the Safe Chemicals Act of 

14 2011, the Administrator shall establish, by rule, 

15 the data that constitute the minimum data sets 

16 for chemical substances. 

17 ‘‘(B) REQUIREMENTS.—Any rule promul18 gated under subparagraph (A) shall— 

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

20 to be provided for different chemical sub21 stances or categories of chemical sub22 stances; 

23 ‘‘(ii) identify the particular minimum 

24 data set that applies to a chemical sub25 stance or category of chemical substances; 


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1 ‘‘(iii) require each minimum data set 

2 to include the minimum amount of infor3 mation necessary for the Administrator to 

4 conduct a screening-level risk assessment 

5 of the chemical substance or category of 

6 chemical substances, including information 

7 on the characteristics, toxicological prop8 erties, exposure, and use of a chemical sub9 stance; and 

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

11 encourage and facilitate the use of alter12 native testing methods and testing strate13 gies to generate information quickly, at low 

14 cost, and without the use of animal-based 

15 testing, including toxicity pathway-based 

16 risk assessment, in vitro studies, systems 

17 biology, computational toxicology, 

18 bioinformatics, and high-throughput 

19 screening. 

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

21 Each manufacturer and processor of a chemical sub22 stance shall submit the minimum data set for the 

23 chemical substance to the Administrator— 


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1 ‘‘(A) for new chemical substances, concur2 rent with the notice required under section 

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

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

5 the earlier of— 

6 ‘‘(i) 18 months after the date on 

7 which the chemical substance is assigned 

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

9 ‘‘(ii) 5 years after the date of enact10 ment of the Safe Chemicals Act of 2011. 

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

12 by order, take any action authorized under section 

13 6(c) if a manufacturer or processor is in violation of 

14 paragraph (2), except as authorized under section 

15 6(e). 

16 ‘‘(b) TESTING.— 

17 ‘‘(1) GENERAL SUBMISSIONS.— 

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

19 may, by rule or order, require testing with re20 spect to any chemical substance, and the sub21 mission of test results by a specified date, as 

22 necessary for making any determination or car23 rying out any provision of this Act. 


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1 ‘‘(B) EFFECT ON OTHER AUTHORITY.— 

2 Nothing in this paragraph limits the authority 

3 of the Administrator under paragraph (2). 

4 ‘‘(2) SAMPLE SUBMISSIONS.— 

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

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

7 a sample of any chemical substance in such 

8 manner as the Administrator determines en9 ables the Administrator to conduct any tests 

10 necessary for making any determination or car11 rying out any provision of this Act. 

12 ‘‘(B) EFFECT ON OTHER AUTHORITY.— 

13 Nothing in this paragraph limits the authority 

14 of the Administrator under paragraph (1). 

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

16 by order, take any action authorized under section 

17 6(c) if a manufacturer or processor is in violation of 

18 a rule or order under paragraph (1), except as au19 thorized under section 6(e). 

20 ‘‘(4) EXEMPTION.—If a manufacturer or proc21 essor has submitted a declaration of cessation of 

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

23 a chemical substance, the manufacturer or processor 

24 shall be exempted from the requirements of this sub25 section. 


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1 ‘‘(c) TEST RULES OR ORDERS.— 

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

3 under subsection (b) shall include— 

4 ‘‘(A) identification of the chemical sub5 stance for which testing is required under the 

6 rule or order; 

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

8 data for that substance; and 

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

10 may not be of unreasonable duration) within 

11 which the persons required to conduct the test12 ing shall submit to the Administrator data de13 veloped in accordance with the standards re14 ferred to in subparagraph (B). 

15 ‘‘(2) CONSIDERATIONS.— 

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

17 standards and period to be required under sub18 paragraphs (B) and (C) of paragraph (1), the 

19 Administrator shall consider— 

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

21 test protocols and methodologies that may 

22 be required under the rule or order; and 

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1 ed to perform the testing required under 

2 the rule. 

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

4 order issued by the Administrator under this 

5 subsection may require a manufacturer or proc6 essor to submit preliminary data during the pe7 riod described in paragraph (1)(C). 

8 ‘‘(3) TYPES OF HEALTH AND ENVIRONMENTAL

9 INFORMATION.— 

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

11 may prescribe standards for the development of 

12 test data under this subsection for health and 

13 environmental information, including— 

14 ‘‘(i) information pertaining to carcino15 genesis, mutagenesis, teratogenesis, behav16 ioral disorders, cumulative, synergistic, or 

17 any other effect that may be considered in 

18 a safety standard determination; 

19 ‘‘(ii) information pertaining to expo20 sure to the chemical substance, including 

21 information regarding the presence of the 

22 chemical substance in human blood, fluids, 

23 or tissue; and 

24 ‘‘(iii) information pertaining to— 

25 ‘‘(I) bioaccumulation; 


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1 ‘‘(II) persistence; 

2 ‘‘(III) acute toxicity; 

3 ‘‘(IV) subacute toxicity; 

4 ‘‘(V) chronic toxicity; and 

5 ‘‘(VI) any other characteristic 

6 that may present an adverse effect. 

7 ‘‘(B) METHODOLOGIES.— 

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

9 may prescribe methodologies in standards 

10 for the development of test data, includ11 ing— 

12 ‘‘(I) epidemiologic studies; 

13 ‘‘(II) biomonitoring studies; 

14 ‘‘(III) serial or hierarchical tests; 

15 ‘‘(IV) in vitro tests; and 

16 ‘‘(V) whole animal tests, con17 sistent with section 30. 

18 ‘‘(ii) REQUIREMENT.—Prior to pre19 scribing epidemiologic studies of employ20 ees, the Administrator shall consult with 

21 the Director of the National Institute for 

22 Occupational Safety and Health. 

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

24 frequently than once every 3 years, the Admin25 istrator shall— 


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1 ‘‘(i) review the adequacy of the stand2 ards for development of data prescribed 

3 under subparagraph (A); and 

4 ‘‘(ii) if necessary, institute pro5 ceedings to make appropriate revisions of 

6 those standards. 

7 ‘‘(4) PERSONS REQUIRED TO CONDUCT TESTS

8 AND SUBMIT DATA.— 

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

10 subparagraph (B), a rule or order under sub11 section (b) respecting a chemical substance 

12 shall specify the persons required to conduct 

13 tests and submit data to the Administrator on 

14 the substance. 

15 ‘‘(B) EXCEPTION.—The Administrator 

16 may permit 2 or more of the persons described 

17 in subparagraph (A) to designate 1 of the per18 sons or a qualified third party to conduct the 

19 tests and submit the data on behalf of the per20 sons making the designation. 

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

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

23 for compliance with any requirements subject to 

24 the designation. 

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


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

2 under subsection (b) that requires the testing 

3 and submission of data for a particular chem4 ical substance shall expire at the end of the ap5 plicable reimbursement period (as defined in 

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

7 Administrator withdraws the rule or order. 

8 ‘‘(B) CATEGORY OF CHEMICAL SUB9 STANCES.—A rule or order under subsection (b) 

10 that requires the testing and submission of data 

11 for a category of chemical substances shall ex12 pire with respect to a chemical substance in13 cluded in the category at the end of the applica14 ble reimbursement period (as defined in sub15 section (d)(3)) unless, prior to that date, the 

16 Administrator withdraws the rule or order with 

17 respect to the substance entirely. 

18 ‘‘(d) EXEMPTIONS.— 

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

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

21 tests and submit data for a chemical substance may 

22 apply to the Administrator (in such form and man23 ner as the Administrator determines necessary) for 

24 an exemption from the requirement. 


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1 ‘‘(2) ACTION BY ADMINISTRATOR.—In accord2 ance with paragraph (3) or (4), the Administrator 

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

4 on receipt of the application, the Administrator de5 termines that— 

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

7 application was submitted is equivalent to a 

8 chemical substance for which— 

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

10 Administrator in accordance with a rule or 

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

12 ‘‘(ii) data is being developed in ac13 cordance with the rule or order; and 

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

15 for the substance would be duplicative of data 

16 that— 

17 ‘‘(i) has been submitted to the Admin18 istrator in accordance with the rule or 

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

20 ‘‘(ii) is being developed in accordance 

21 with the rule or order. 

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

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1 ment period’, with respect to any test data for 

2 a chemical substance, means a period that— 

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

4 test data is submitted in accordance with 

5 a rule or order issued under subsection (a) 

6 or (b); and 

7 ‘‘(ii) ends on the later of— 

8 ‘‘(I) 5 years after the date re9 ferred to in clause (i); or 

10 ‘‘(II) the date which, as deter11 mined by the Administrator, provides 

12 the applicant with a time period which 

13 is sufficient to develop the test data. 

14 ‘‘(B) REIMBURSEMENT FOR PREVIOUSLY

15 SUBMITTED TEST DATA.— 

16 ‘‘(i) IN GENERAL.—Except as pro17 vided in clause (ii), for an exemption under 

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

19 granted during the reimbursement period 

20 for the test data, the Administrator shall 

21 order the person granted the exemption to 

22 provide fair and equitable reimbursement 

23 (in an amount determined by the Adminis24 trator) to— 


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1 ‘‘(I) the person who previously 

2 submitted the test data, for a portion 

3 of the costs incurred by the person in 

4 complying with the data submission 

5 requirement; and 

6 ‘‘(II) any other person who has 

7 been required under this subsection to 

8 contribute with respect to the costs, 

9 for a portion of the amount the per10 son was required to contribute. 

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

12 not apply if there is agreement on the 

13 amount and method of reimbursement be14 tween an exempted person described in 

15 clause (i) and the persons described in sub16 clauses (I) and (II) of that clause. 

17 ‘‘(iii) CONSIDERATIONS.—In promul18 gating rules for the determination of fair 

19 and equitable reimbursement to the per20 sons described in subclauses (I) and (II) of 

21 clause (i) for costs incurred with respect to 

22 a chemical substance, the Administrator 

23 shall, after consultation with the Attorney 

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1 sion, consider all relevant factors, includ2 ing— 

3 ‘‘(I) the effect on the competitive 

4 position of the person required to pro5 vide reimbursement in relation to the 

6 person to be reimbursed; and 

7 ‘‘(II) the share of the market for 

8 the substance of the person required 

9 to provide reimbursement in relation 

10 to the share of the market of the per11 sons to be reimbursed. 

12 ‘‘(C) REIMBURSEMENT DUE TO EXEMP13 TION FOR TEST DATA BEING DEVELOPED IN

14 ACCORDANCE WITH A RULE OR ORDER.— 

15 ‘‘(i) IN GENERAL.—Except as pro16 vided in clause (ii), for an exemption under 

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

18 shall order the person granted the exemp19 tion to provide fair and equitable reim20 bursement (in an amount determined by 

21 the Administrator) to— 

22 ‘‘(I) each person who is devel23 oping the test data, for the portion of 

24 the costs incurred by each person in 

25 complying with the rule or order; and 


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1 ‘‘(II) any other person who has 

2 been required under this subsection to 

3 contribute with respect to the costs of 

4 complying with the rule or order, for 

5 a portion of the amount the person 

6 was required to contribute. 

7 ‘‘(ii) EXCEPTION.—Clause (i) shall 

8 not apply if there is agreement on the 

9 amount and method of reimbursement be10 tween an exempted person described in 

11 clause (i) and the persons described in sub12 clauses (I) and (II) of that clause. 

13 ‘‘(iii) CONSIDERATIONS.—In promul14 gating rules for the determination of fair 

15 and equitable reimbursement to the per16 sons described in subclauses (I) and (II) of 

17 clause (i) for costs incurred with respect to 

18 a chemical substance, the Administrator 

19 shall, after consultation with the Attorney 

20 General and the Federal Trade Commis21 sion, consider the factors described in sub22 paragraph (B)(iii). 

23 ‘‘(iv) LACK OF COMPLIANCE.—If any 

24 exemption is granted under paragraph (2) 

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1 veloping test data pursuant to a rule or 

2 order promulgated or issued under sub3 section (a) or (b), and after the exemption 

4 is granted, the Administrator determines 

5 that no person has complied with the rule 

6 or order, the Administrator shall— 

7 ‘‘(I) after providing written no8 tice and an opportunity for a hearing 

9 to the person who holds the exemp10 tion, by order, terminate the exemp11 tion; and 

12 ‘‘(II) notify in writing the person 

13 of the requirements of the rule or 

14 order with respect to which the ex15 emption was granted. 

16 ‘‘(e) NOTICE.— 

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

18 after the date of receipt of any test data pursuant 

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

20 Administrator shall publish in the Federal Register 

21 a notice of the receipt of the test data. 

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

23 each notice shall— 

24 ‘‘(A) identify the chemical substance for 

25 which data have been received; 


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1 ‘‘(B) list— 

2 ‘‘(i) the commercial and consumer 

3 uses or intended commercial and consumer 

4 uses of the substance known to the Admin5 istrator; and 

6 ‘‘(ii) the information required by the 

7 applicable standards for the development 

8 of test data; and 

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

10 developed. 

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

12 Administrator shall make the test data described in 

13 this subsection available on a publicly accessible 

14 Internet site. 

15 ‘‘(f) REQUESTS FROM OTHER AGENCIES FOR ADDI16 TIONAL INFORMATION OR TESTING.— 

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

18 agency may request the Administrator to seek the 

19 information on behalf of that agency if the head of 

20 that Federal agency determines that— 

21 ‘‘(A) information relating to a chemical 

22 substance, including data derived from new 

23 testing or monitoring, would assist that Federal 

24 agency in carrying out the duties or exercising 

25 the authority of that agency; but 


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1 ‘‘(B) the requested information is not 

2 available to that agency. 

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

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

5 under paragraph (1), the Administrator shall— 

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

7 available to the requesting agency; 

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

9 require— 

10 ‘‘(i) the submission of existing perti11 nent data to the Administrator; and 

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

13 be furnished to the requesting agency; 

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

15 (b)— 

16 ‘‘(i) to develop the data; and 

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

18 be furnished to the requesting agency; or 

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

20 reason for which none of the actions described 

21 in this paragraph were taken. 

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

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

24 or issued by the Administrator under this section shall be 

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1 cial of the manufacturer or processor that each statement 

2 contained in the submission— 

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

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

5 possession or control of, or reasonably ascertainable 

6 by, the manufacturer or processor.’’. 

7 SEC. 6. MANUFACTURING AND PROCESSING NOTICES. 

8 Section 5 of the Toxic Substances Control Act (15 

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

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

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

12 OF CHEMICAL SUBSTANCES.— 

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

14 provided in subsection (d), no person may manufac15 ture or process a new chemical substance unless— 

16 ‘‘(A) the person submits to the Adminis17 trator a notice, in accordance with subsection 

18 (c), of the intention of the person to manufac19 ture or process the substance; 

20 ‘‘(B) the person complies with subsection 

21 (b); and 

22 ‘‘(C) the Administrator finds that— 

23 ‘‘(i) the manufacturers and processors 

24 have established that the chemical subVerDate Mar 15 2010 23:53 Dec 27, 2012 Jkt 029200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6401 E:\BILLS\S847.RS S847

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1 stance meets the safety standard under 

2 section 6(b); or 

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

4 metabolite or degradation product of the 

5 chemical substance, as applicable, is not, 

6 and is not expected to be— 

7 ‘‘(I)(aa) manufactured in a vol8 ume of more than 1,000,000 pounds 

9 annually; or 

10 ‘‘(bb) released into the environ11 ment in a volume of more than 

12 100,000 pounds annually; 

13 ‘‘(II) a known, probable, or sus14 pected reproductive, developmental, 

15 neurological, or immunological toxi16 cant, carcinogen, mutagen, or endo17 crine disruptor; 

18 ‘‘(III) persistent and bioaccumu19 lative; 

20 ‘‘(IV) found in human cord 

21 blood, or otherwise found in human 

22 blood, fluids, or tissue, unless the 

23 chemical substance, metabolite, or 

24 degradation product is naturally 


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1 present at the level commonly found 

2 in that medium; or 

3 ‘‘(V) found in food, drinking 

4 water, ambient or indoor air, residen5 tial soil, or house dust, unless the 

6 chemical substance, metabolite, or 

7 degradation product is naturally 

8 present at the level commonly found 

9 in that medium. 

10 ‘‘(2) NEW USES OF EXISTING CHEMICAL SUB11 STANCES PRIOR TO SAFETY STANDARD DETERMINA12 TION.— 

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

14 subparagraph (B), with respect to an existing 

15 chemical substance for which the Administrator 

16 has not made a safety standard determination 

17 under section 6, no person may manufacture or 

18 process the chemical substance— 

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

20 the date of enactment of the Safe Chemi21 cals Act of 2011; or 

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

23 increased from the volume as of the date 

24 of enactment of the Safe Chemicals Act of 

25 2011. 


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1 ‘‘(B) EXCEPTION.—A person may manu2 facture or process a chemical substance in a 

3 manner prohibited by subparagraph (A), if the 

4 person— 

5 ‘‘(i) submits to the Administrator a 

6 new or updated declaration under section 

7 8(a); and 

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

9 ‘‘(3) NEW USES OF EXISTING CHEMICAL SUB10 STANCES THAT MEET THE SAFETY STANDARD.— 

11 ‘‘(A) IN GENERAL.—For an existing chem12 ical substance for which the Administrator has 

13 determined under section 6(b) that the manu14 facturers and processors of the chemical sub15 stance have established that the substance 

16 meets the applicable safety standard, no person 

17 may manufacture or process the chemical sub18 stance for uses, at production volumes, or in 

19 manners other than those the Administrator 

20 specified in the safety standard determination, 

21 unless— 

22 ‘‘(i) the manufacturer or processor 

23 submits to the Administrator— 

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

25 the manufacturer or processor to 


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1 manufacture or process the substance 

2 for a new use, at a new production 

3 volume, or in such other manner as is 

4 inconsistent with a specified condition 

5 or term for that substance; and 

6 ‘‘(II) all updates to the minimum 

7 data set relevant to the new use, new 

8 production volume, or other new man9 ner of manufacturing or processing; 

10 ‘‘(ii) the notice under clause (i)(I) in11 dicates that the chemical substance will 

12 continue to meet the safety standard if the 

13 allowed uses, production volumes, or other 

14 specified conditions or terms for that 

15 chemical substance are revised to encom16 pass the new use, production volume, or 

17 other manner of manufacturing or proc18 essing; and 

19 ‘‘(iii) the Administrator determines 

20 that the manufacturer or processor submit21 ting the notice has established that the 

22 chemical substance will continue to meet 

23 the safety standard if the allowed uses, 

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1 vised to encompass the new use, produc2 tion volume, or other manner of manufac3 turing or processing. 

4 ‘‘(B) AMENDMENT TO SAFETY STANDARD

5 DETERMINATION.—If the conditions described 

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

7 are satisfied, the Administrator shall, by order, 

8 amend the safety standard determination for 

9 the chemical substance to include the new use, 

10 production volume, or other manner of manu11 facturing or processing among the allowed uses, 

12 production volumes, or manners of manufac13 turing or processing of the chemical substance. 

14 ‘‘(4) SAFETY STANDARD DETERMINATION.— 

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

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

17 days after the date of receipt of a notice and 

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

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

20 determine whether the person submitting the 

21 notice has established that the chemical sub22 stance will meet, or will continue to meet, the 

23 safety standard under section 6(b). 

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

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


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1 shall not be subject to the deadline described in 

2 subparagraph (A) if the Administrator first 

3 makes the finding specified under paragraph 

4 (1)(C)(ii). 

5 ‘‘(C) EXTENSION.—The Administrator 

6 may extend the determination deadline under 

7 subparagraph (A) by 1 or more additional peri8 ods not to exceed 1 year in the aggregate, in 

9 such manner as the Administrator determines 

10 necessary. 

11 ‘‘(D) FAILURE TO MAKE A TIMELY DETER12 MINATION.—The failure of the Administrator to 

13 make a timely determination in accordance with 

14 this paragraph shall not be sufficient to satisfy 

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

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

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

18 than 30 days after the date on which a manufac19 turer or processor commences the manufacturing or 

20 processing of a new chemical substance, the manu21 facturer or processor shall submit to the Adminis22 trator a notice of commencement of manufacture or 

23 processing. 

24 ‘‘(6) CHEMICAL SUBSTANCES EXHIBITING SPE25 CIAL SUBSTANCE CHARACTERISTICS.— 


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1 ‘‘(A) DETERMINATION.—The Adminis2 trator shall determine by order or rule that a 

3 variant of a chemical substance exhibiting 1 or 

4 more special substance characteristics— 

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

6 use of the chemical substance that does 

7 not exhibit the special substance character8 istics; or 

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

10 ‘‘(B) REQUIREMENTS FOR VARIANTS THAT

11 ARE SEPARATE USES.—In the case of a chem12 ical substance that the Administrator deter13 mines to be a separate use based on the special 

14 substance characteristics of the chemical sub15 stance, the manufacturer or processor shall sat16 isfy such further conditions as the Adminis17 trator establishes, by order or rule. 

18 ‘‘(b) SUBMISSION OF DATA.— 

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

20 the Administrator data in accordance with the rule 

21 or order at the time that notice is submitted under 

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

23 the Administrator— 


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

2 beginning the manufacture or processing of a 

3 chemical substance; and 

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

5 chemical substance prior to the submission of 

6 the notice. 

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

8 Administrator shall make any test data submitted 

9 under paragraph (1) available on a publicly acces10 sible Internet site. 

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

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

13 (a)(1) shall include— 

14 ‘‘(A) the declaration described in section 

15 8(a)(2); 

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

17 section 4(a); and 

18 ‘‘(C) a statement that the chemical sub19 stance will meet the applicable safety standard. 

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

21 Administrator shall make the notice under para22 graph (1) available on a publicly accessible Internet 

23 site. 

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

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1 days, and legal holidays) after the date of the receipt 

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

3 subsection (b), the Administrator shall make avail4 able on a publicly accessible Internet site informa5 tion that— 

6 ‘‘(A) identifies the chemical substance for 

7 which notice or data has been received; 

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

9 chemical substance; 

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

11 under subsection (b), describes— 

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

13 with respect to the chemical substance; and 

14 ‘‘(ii) any data that were received 

15 under subsection (b) or a rule or order 

16 under section 4; and 

17 ‘‘(D) references the availability of the min18 imum data set. 

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

20 each month, the Administrator shall make available 

21 on a publicly accessible Internet site a list of each 

22 chemical substance for which notice has been re23 ceived under subsection (a). 

24 ‘‘(d) EXEMPTIONS.— 


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1 ‘‘(1) TEST MARKETING PURPOSES.—The Ad2 ministrator may, upon application, exempt any per3 son from any requirement of subsection (a) or (b) to 

4 permit the person to manufacture or process a 

5 chemical substance for test marketing purposes— 

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

7 manner that the Administrator determines, that 

8 the manufacture, processing, distribution in 

9 commerce, use, and disposal of the chemical 

10 substance (including any combination of those 

11 activities) will not endanger human health or 

12 the environment; and 

13 ‘‘(B) under such restrictions as the Admin14 istrator considers appropriate. 

15 ‘‘(2) EQUIVALENT CHEMICAL SUBSTANCES.— 

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

17 shall, upon application, fully or partially exempt 

18 any person from the requirement to submit 

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

20 application, the Administrator determines 

21 that— 

22 ‘‘(i) the chemical substance for which 

23 the application was submitted is equivalent 

24 to a chemical substance for which data has 


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1 been submitted to the Administrator as re2 quired by this Act; and 

3 ‘‘(ii) submission of data by the appli4 cant on the chemical substance would be 

5 duplicative of data which has been sub6 mitted to the Administrator in accordance 

7 with this Act. 

8 ‘‘(B) EFFECTIVE DATE.—No exemption 

9 under this paragraph may take effect before the 

10 beginning of the reimbursement period applica11 ble to the data. 

12 ‘‘(C) FAIR AND EQUITABLE REIMBURSE13 MENT.— 

14 ‘‘(i) DEFINITION OF REIMBURSEMENT

15 PERIOD.—In this subparagraph, the term 

16 ‘reimbursement period’, with respect to 

17 any previously submitted data for a chem18 ical substance, means the period that— 

19 ‘‘(I) begins on the date of the 

20 termination of the prohibition, im21 posed under this section, on the man22 ufacture or processing of the chemical 

23 substance by the person who sub24 mitted the data to the Administrator; 

25 and 


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1 ‘‘(II) ends on the later of— 

2 ‘‘(aa) the date that is 5 

3 years after the date referred to in 

4 subclause (I); or 

5 ‘‘(bb) at the expiration of a 

6 period that begins on the date re7 ferred to in subclause (I) and 

8 ends on the date that the Admin9 istrator determines to be nec10 essary to develop the data. 

11 ‘‘(ii) REIMBURSEMENT.—Except as 

12 provided in clause (iii), if the Adminis13 trator exempts any person under subpara14 graph (A)(i) and the exemption is granted 

15 during the reimbursement period for that 

16 data, the Administrator shall order the 

17 person granted the exemption to provide 

18 fair and equitable reimbursement (in an 

19 amount determined by the Adminis20 trator)— 

21 ‘‘(I) to the person who previously 

22 submitted the data on which the ex23 emption was based, for a portion of 

24 the costs incurred by the person in 


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1 complying with the requirement under 

2 this title to submit the data; and 

3 ‘‘(II) to any other person who 

4 has been required under this subpara5 graph to contribute with respect to 

6 the costs, for a portion of the amount 

7 the person was required to contribute. 

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

9 not apply if the person exempted under 

10 that clause and the persons described in 

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

12 on the amount and method of reimburse13 ment. 

14 ‘‘(iv) CONSIDERATIONS.—In promul15 gating rules for the determination of fair 

16 and equitable reimbursement to the per17 sons described in subclauses (I) and (II) of 

18 clause (ii) for costs incurred with respect 

19 to a chemical substance, the Administrator 

20 shall, after consultation with the Attorney 

21 General and the Federal Trade Commis22 sion, consider all relevant factors, includ23 ing— 

24 ‘‘(I) the effect on the competitive 

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1 vide reimbursement in relation to the 

2 persons to be reimbursed; and 

3 ‘‘(II) the share of the market for 

4 the chemical substance of the person 

5 required to provide reimbursement in 

6 relation to the share of the market of 

7 the persons to be reimbursed. 

8 ‘‘(3) SMALL QUANTITIES.— 

9 ‘‘(A) IN GENERAL.—If the conditions de10 scribed in subparagraph (B) are met, sub11 sections (a) and (b) shall not apply with respect 

12 to the manufacturing or processing of any 

13 chemical substance that is manufactured or 

14 processed, or proposed to be manufactured or 

15 processed, only in small quantities (as defined 

16 by the Administrator by rule) solely for pur17 poses of— 

18 ‘‘(i) scientific experimentation or anal19 ysis; or 

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

21 of, the substance or another substance, in22 cluding research or analysis for the devel23 opment of a product. 

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

25 in the experimentation, research, or analysis 


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1 carried out in accordance with subparagraph 

2 (A) for a manufacturer or processor shall be 

3 notified (in such form and manner as the Ad4 ministrator may prescribe) of any risk to 

5 human health that the manufacturer, processor, 

6 or the Administrator has reason to believe may 

7 be associated with that chemical substance. 

8 ‘‘(4) TEMPORARY EXISTENCE.—The Adminis9 trator may, upon application, exempt from sub10 sections (a) and (b) the manufacturing or processing 

11 of any chemical substance— 

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

13 a chemical reaction in the manufacturing or 

14 processing of a mixture or another chemical 

15 substance; and 

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

17 any human or environmental exposure. 

18 ‘‘(5) PUBLICATION.— 

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

20 after the date of receipt of an application under 

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

22 publish in the Federal Register notice of the re23 ceipt of the application. 

24 ‘‘(B) REQUIREMENTS.—The Administrator 

25 shall— 


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1 ‘‘(i) give interested persons an oppor2 tunity to comment upon any application 

3 described in subparagraph (A); 

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

5 date of receipt of an application, approve 

6 or deny the application; and 

7 ‘‘(iii) publish in the Federal Register 

8 notice of the approval or denial of the ap9 plication. 

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

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

12 or issued by the Administrator under this section shall be 

13 accompanied by a certification signed by a responsible offi14 cial of the manufacturer or processor that each statement 

15 contained in the submission— 

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

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

18 possession or control of, or reasonably ascertainable 

19 by, the manufacturer or processor. 

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

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

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

23 process, respectively, for commercial purposes. 

24 ‘‘(2) TEST MARKETING.—The term ‘test mar25 keting’ does not include any provision of a chemical 


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1 substance, or a mixture or article containing that 

2 chemical substance, to an end consumer of the 

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

4 SEC. 7. PRIORITIZATION, SAFETY STANDARD DETERMINA5 TION, AND RISK MANAGEMENT. 

6 Section 6 of the Toxic Substances Control Act (15 

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

8 ‘‘SEC. 6. PRIORITIZATION, SAFETY STANDARD DETERMINA9 TION, AND RISK MANAGEMENT. 

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

11 ‘‘(1) PRIORITIZATION LIST.— 

12 ‘‘(A) IN GENERAL.—Subject to subpara13 graph (B), the Administrator shall, by order, 

14 develop and publish a list that— 

15 ‘‘(i) contains the names of the chem16 ical substances or categories of chemical 

17 substances that the Administrator deter18 mines warrant placement within 1 of the 3 

19 priority classes described in paragraphs (2) 

20 through (4); and 

21 ‘‘(ii) identifies the priority class to 

22 which each listed chemical substance or 

23 category of chemical substance has been 

24 assigned by the Administrator. 


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1 ‘‘(B) CONSIDERATIONS.—In determining 

2 which chemical substances to include in each 

3 priority class, the Administrator shall give due 

4 consideration to any prioritization recommenda5 tion that is provided by the committee estab6 lished under paragraph (5). 

7 ‘‘(2) CHEMICAL SUBSTANCES REQUIRING IMME8 DIATE RISK MANAGEMENT (PRIORITY CLASS 1).— 

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

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

11 a priority class that contains chemical sub12 stances that the Administrator determines re13 quire immediate risk management. 

14 ‘‘(B) ASSIGNMENT TO PRIORITY CLASS

15 1.—The Administrator shall assign a chemical 

16 substance to priority class 1 if the Adminis17 trator determines that the chemical substance 

18 is, or is degraded and metabolized into, a per19 sistent, bioaccumulative, and toxic substance 

20 with the potential for widespread exposure to 

21 humans or other organisms. 

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

23 than 1 year after the date of enactment of the 

24 Safe Chemicals Act of 2011, the Administrator 

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


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1 30, chemical substances to the initial priority 

2 class 1. 

3 ‘‘(D) RISK MANAGEMENT.— 

4 ‘‘(i) EXPEDITED EXPOSURE REDUC5 TION.—As soon as practicable, but not 

6 later than 18 months after the date on 

7 which a chemical substance is assigned to 

8 priority class 1 under this paragraph, the 

9 Administrator shall impose conditions in 

10 accordance with subsection (c) on the man11 ufacturing, processing, use, distribution in 

12 commerce, and disposal of a chemical sub13 stance assigned to priority class 1 that the 

14 Administrator determines necessary to 

15 achieve the greatest practicable reductions 

16 in human or environmental exposure to the 

17 chemical substance. 

18 ‘‘(ii) RESIDUAL RISK ASSESSMENT.— 

19 Not later than 1 year after the effective 

20 date of any conditions established under 

21 clause (i), the Administrator shall— 

22 ‘‘(I) determine whether the chem23 ical substance meets the applicable 

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1 ual risk posed by continued exposure 

2 to the chemical substance; and 

3 ‘‘(II) impose any further condi4 tions under subsection (c) that the 

5 Administrator determines necessary to 

6 ensure that the chemical substance 

7 meets the applicable safety standard. 

8 ‘‘(E) UPDATES.— 

9 ‘‘(i) REVISIONS.—The Administrator 

10 shall promptly revise the list under para11 graph (1) whenever the Administrator de12 termines that the addition or removal of a 

13 chemical substance from priority class 1 is 

14 warranted. 

15 ‘‘(ii) REMOVAL PROCEDURE.—A 

16 chemical substance may be removed from 

17 the list under paragraph (1) only if the 

18 Administrator finds that such substance 

19 meets the safety standard under subsection 

20 (b). 

21 ‘‘(3) CHEMICAL SUBSTANCES REQUIRING SAFE22 TY STANDARD DETERMINATIONS (PRIORITY CLASS

23 2).— 

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

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


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1 a priority class that contains chemical sub2 stances that Administrator determines require 

3 safety standard determinations. 

4 ‘‘(B) ASSIGNMENT TO PRIORITY CLASS

5 2.— 

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

7 (ii), if the Administrator determines, based 

8 on any more-than-theoretical concern, that 

9 there is uncertainty as to whether a chem10 ical substance would satisfy the safety 

11 standard in a determination made under 

12 subsection (b), the Administrator shall as13 sign that chemical substance priority class 

14 2. 

15 ‘‘(ii) CONDITIONS.—The Adminis16 trator shall assign chemical substances to 

17 priority class 2 subject to the conditions 

18 that— 

19 ‘‘(I) the rate at which chemical 

20 substances are added to priority class 

21 2 shall be expeditious, but shall not 

22 exceed the rate at which the Adminis23 trator reasonably anticipates com24 pleting safety standard determinations 

25 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 23:53 Dec 27, 2012 Jkt 029200 PO 00000 Frm 00071 Fmt 6652 Sfmt 6401 E:\BILLS\S847.RS 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. 5. MINIMUM INFORMATION SETS AND TESTING OF 

16 CHEMICAL SUBSTANCES. 

17 Section 4 of the Toxic Substances Control Act (15 

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

19 ‘‘SEC. 4. MINIMUM INFORMATION SETS AND TESTING OF 

20 CHEMICAL SUBSTANCES. 

21 ‘‘(a) MINIMUM INFORMATION SETS.— 

22 ‘‘(1) RULE.— 

23 ‘‘(A) IN GENERAL.—Subject to subpara24 graphs (B) and (C), and not later than 1 year 

25 after the date of enactment of the Safe Chemicals 


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1 Act of 2011, the Administrator shall establish, by 

2 rule, such minimum information sets as the Ad3 ministrator determines to be appropriate to 

4 evaluate chemical substances under sections 5 

5 and 6. 

6 ‘‘(B) GENERAL REQUIREMENTS.—The rule 

7 promulgated pursuant to subparagraph (A) 

8 shall— 

9 ‘‘(i) provide for varied or tiered infor10 mation to be provided for different chemical 

11 substances; 

12 ‘‘(ii) identify the particular minimum 

13 information set that applies to a chemical 

14 substance; 

15 ‘‘(iii) require each minimum informa16 tion set to include sufficient information for 

17 the Administrator to conduct a screening18 level risk assessment of the chemical sub19 stance, including information on the char20 acteristics, toxicological properties, environ21 mental and biological fate and behavior, ex22 posure, and use of a chemical substance; 

23 ‘‘(iv) specify information quality and 

24 reliability requirements applicable to the 


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1 information submitted in the minimum in2 formation sets; and 

3 ‘‘(v) accommodate the use of alter4 native testing methods and testing strategies 

5 to generate information quickly, at low cost, 

6 and with reduced use of animal-based test7 ing, including toxicity pathway-based risk 

8 assessment, in vitro studies, systems biology, 

9 computational toxicology, bioinformatics, 

10 and high-throughput screening, to the extent 

11 such methods and strategies would yield in12 formation of equivalent quality and reli13 ability. 

14 ‘‘(C) SPECIFIC REQUIREMENTS.—The rule 

15 promulgated pursuant to subparagraph (A) shall 

16 establish minimum information sets sufficient 

17 for the Administrator to administer this Act, in18 cluding to carry out— 

19 ‘‘(i) categorization of new chemical 

20 substances under section 5(b)(2), including 

21 the identification of information— 

22 ‘‘(I) sufficiently robust to gen23 erally support the categorization of a 

24 new chemical substance as a substance 


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1 of very low concern under section 

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

3 ‘‘(II) in the absence of which the 

4 Administrator shall designate a new 

5 chemical substance to be a substance 

6 with insufficient information under 

7 section 5(b)(2)(D)(iv); 

8 ‘‘(ii) categorization of existing chem9 ical substances under section 6(b)(3), in10 cluding the identification of information— 

11 ‘‘(I) sufficiently robust to gen12 erally support the categorization of an 

13 existing chemical substance as a sub14 stance of very low concern under sec15 tion 6(b)(3)(B)(ii); and 

16 ‘‘(II) in the absence of which the 

17 Administrator shall designate an exist18 ing chemical substance to be a sub19 stance with insufficient information 

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

21 ‘‘(iii) assignment of chemical sub22 stances to priority classes under section 

23 6(b)(4); 

24 ‘‘(iv) safety standard determinations— 


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1 ‘‘(I) for new uses of existing chem2 ical substances under section 5(b)(2); 

3 and 

4 ‘‘(II) for chemical substances 

5 under section 6(d); and 

6 ‘‘(v) safety standard redeterminations 

7 under section 6(d)(5)(E). 

8 ‘‘(2) SUBMISSION OF MINIMUM INFORMATION

9 SET.—Each manufacturer and processor of a chem10 ical substance shall submit the minimum information 

11 set for the chemical substance to the Administrator— 

12 ‘‘(A) for new chemical substances, concur13 rent with the notice required under section 

14 (5)(b)(1)(A); and 

15 ‘‘(B) for existing chemical substances, as 

16 specified in section 6 or otherwise specified by 

17 the Administrator in the rule promulgated pur18 suant to paragraph (1)(A). 

19 ‘‘(3) PROHIBITION.—In addition to any other 

20 authorities available under this Act, the Adminis21 trator may, by order, take any action authorized 

22 under section 6(f) if a manufacturer or processor is 

23 in violation of paragraph (2). 

24 ‘‘(b) TESTING.— 

25 ‘‘(1) GENERAL SUBMISSIONS.— 


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

2 may, by rule or order, require testing with re3 spect to any chemical substance, and the submis4 sion of test results by a specified date, as appro5 priate for making any determination or car6 rying out any provision of this Act. Such testing 

7 may be required— 

8 ‘‘(i) to provide information in addition 

9 to the information specified in any applica10 ble minimum information set under sub11 section (a); and 

12 ‘‘(ii) of persons to whom the Adminis13 trator decides not to apply a requirement to 

14 submit a minimum information set under 

15 subsection (a). 

16 ‘‘(B) EFFECT ON OTHER AUTHORITY.— 

17 Nothing in this paragraph limits the authority 

18 of the Administrator under paragraph (2). 

19 ‘‘(2) SAMPLE SUBMISSIONS.— 

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

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

22 a sample of any chemical substance in such 

23 manner as the Administrator determines enables 

24 the Administrator to conduct any tests necessary 


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1 for making any determination or carrying out 

2 any provision of this Act. 

3 ‘‘(B) EFFECT ON OTHER AUTHORITY.— 

4 Nothing in this paragraph limits the authority 

5 of the Administrator under paragraph (1). 

6 ‘‘(3) PROHIBITION.—In addition to any other 

7 authorities available under this Act, the Adminis8 trator may, by order, take any action authorized 

9 under section 6(f) if a manufacturer or processor is 

10 in violation of a rule or order under paragraph (1). 

11 ‘‘(4) EXEMPTION.—If a manufacturer or proc12 essor ceases all manufacture or processing of a chem13 ical substance pursuant to its submission of a dec14 laration of cessation of manufacture or processing 

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

16 manufacturer or processor shall be exempted from the 

17 requirements of this subsection. 

18 ‘‘(c) TEST RULES OR ORDERS.— 

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

20 subsection (b) shall include— 

21 ‘‘(A) identification of the chemical sub22 stance for which testing is required under the 

23 rule or order; 

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

25 information for that substance; and 


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

2 may not be of unreasonable duration) within 

3 which the persons required to conduct the testing 

4 shall submit to the Administrator information 

5 developed in accordance with the standards re6 ferred to in subparagraph (B). 

7 ‘‘(2) CONSIDERATIONS.— 

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

9 standards and period to be required under sub10 paragraphs (B) and (C) of paragraph (1), the 

11 Administrator shall consider— 

12 ‘‘(i) the relative costs of the various test 

13 protocols and methodologies that may be re14 quired under the rule or order; and 

15 ‘‘(ii) the reasonably foreseeable avail16 ability of the facilities and personnel needed 

17 to perform the testing required under the 

18 rule. 

19 ‘‘(B) PRELIMINARY INFORMATION.—Any 

20 rule or order issued by the Administrator under 

21 this subsection may require a manufacturer or 

22 processor to submit preliminary information 

23 during the period described in paragraph (1)(C). 

24 ‘‘(3) TYPES OF HEALTH AND ENVIRONMENTAL

25 INFORMATION.— 


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

2 may prescribe standards for the development of 

3 test information under this subsection for health 

4 and environmental information, including— 

5 ‘‘(i) information pertaining to carcino6 genesis, mutagenesis, teratogenesis, behav7 ioral disorders, or cumulative, synergistic, 

8 or any other effect that may be considered 

9 in a safety standard determination; 

10 ‘‘(ii) information pertaining to expo11 sure to the chemical substance, including 

12 information regarding the presence of the 

13 chemical substance in human blood, fluids, 

14 or tissue; and 

15 ‘‘(iii) information pertaining to— 

16 ‘‘(I) bioaccumulation; 

17 ‘‘(II) persistence; 

18 ‘‘(III) acute toxicity; 

19 ‘‘(IV) subacute toxicity; 

20 ‘‘(V) chronic toxicity; and 

21 ‘‘(VI) any other characteristic 

22 that may present an adverse effect. 

23 ‘‘(B) METHODOLOGIES.— 

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

25 may prescribe methodologies in standards 


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1 for the development of test information, in2 cluding— 

3 ‘‘(I) epidemiologic studies; 

4 ‘‘(II) biomonitoring or environ5 mental monitoring studies; 

6 ‘‘(III) serial or hierarchical tests; 

7 ‘‘(IV) in vitro tests; 

8 ‘‘(V) whole animal tests, con9 sistent with section 30; and 

10 ‘‘(VI) any other methodology 

11 deemed appropriate by the Adminis12 trator. 

13 ‘‘(ii) REQUIREMENT.—Prior to pre14 scribing epidemiologic studies of employees, 

15 the Administrator shall consult with the Di16 rector of the National Institute for Occupa17 tional Safety and Health. 

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

19 frequently than once every 3 years, the Adminis20 trator shall— 

21 ‘‘(i) review the adequacy of the stand22 ards for development of information pre23 scribed under subparagraph (A); and 


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1 ‘‘(ii) if necessary, institute proceedings 

2 to make appropriate revisions of those 

3 standards. 

4 ‘‘(4) PERSONS REQUIRED TO CONDUCT TESTS

5 AND SUBMIT INFORMATION.— 

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

7 subparagraph (B), a rule or order under sub8 section (b) respecting a chemical substance shall 

9 specify the persons required to conduct tests and 

10 submit information to the Administrator on the 

11 substance. 

12 ‘‘(B) EXCEPTION.—The Administrator may 

13 permit 2 or more of the persons described in sub14 paragraph (A) to designate 1 of the persons or 

15 a qualified third party to conduct the tests and 

16 submit the information on behalf of the persons 

17 making the designation. 

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

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

20 for compliance with any requirements subject to 

21 the designation. 

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

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

24 under subsection (b) that requires the testing and 

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1 ical substance shall expire at the end of the ap2 plicable reimbursement period (as defined in 

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

4 Administrator withdraws the rule or order. 

5 ‘‘(B) CATEGORY OF CHEMICAL SUB6 STANCES.—A rule or order under subsection (b) 

7 that requires the testing and submission of infor8 mation for a category of chemical substances 

9 shall expire with respect to a chemical substance 

10 included in the category at the end of the appli11 cable reimbursement period (as defined in sub12 section (d)(3)) unless, prior to that date, the Ad13 ministrator withdraws the rule or order with re14 spect to the substance entirely. 

15 ‘‘(d) EXEMPTIONS.— 

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

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

18 tests and submit information for a chemical substance 

19 may apply to the Administrator (in such form and 

20 manner as the Administrator determines necessary) 

21 for an exemption from the requirement. 

22 ‘‘(2) ACTION BY ADMINISTRATOR.—In accordance 

23 with paragraph (3) or (4), the Administrator shall 

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1 ceipt of the application, the Administrator determines 

2 that— 

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

4 application was submitted is equivalent to a 

5 chemical substance for which— 

6 ‘‘(i) information has been submitted to 

7 the Administrator in accordance with a rule 

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

9 ‘‘(ii) information is being developed in 

10 accordance with the rule or order; and 

11 ‘‘(B) submission of information by the ap12 plicant for the substance would be duplicative of 

13 information that— 

14 ‘‘(i) has been submitted to the Admin15 istrator in accordance with the rule or order 

16 under subsection (a) or (b); or 

17 ‘‘(ii) is being developed in accordance 

18 with the rule or order. 

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

20 ‘‘(A) DEFINITION OF REIMBURSEMENT PE21 RIOD.—In this paragraph, the term ‘reimburse22 ment period’, with respect to any test informa23 tion for a chemical substance, means a period 

24 that— 


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

2 test information is submitted in accordance 

3 with a rule or order issued under subsection 

4 (a) or (b); and 

5 ‘‘(ii) ends on the later of— 

6 ‘‘(I) 5 years after the date referred 

7 to in clause (i); and 

8 ‘‘(II) the date which, as deter9 mined by the Administrator, provides 

10 the applicant with a time period which 

11 is sufficient to develop the test infor12 mation. 

13 ‘‘(B) REIMBURSEMENT FOR PREVIOUSLY

14 SUBMITTED TEST INFORMATION.— 

15 ‘‘(i) IN GENERAL.—Except as provided 

16 in clause (ii), for an exemption under para17 graph (2)(B)(i), if the exemption is granted 

18 during the reimbursement period for the test 

19 information, the Administrator shall order 

20 the person granted the exemption to provide 

21 fair and equitable reimbursement (in an 

22 amount determined by the Administrator) 

23 to— 

24 ‘‘(I) the person who previously 

25 submitted the test information, for a 


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1 portion of the costs incurred by the 

2 person in complying with the informa3 tion submission requirement; and 

4 ‘‘(II) any other person who has 

5 been required under this subsection to 

6 contribute with respect to the costs, for 

7 a portion of the amount the person was 

8 required to contribute. 

9 ‘‘(ii) EXCEPTION.—Clause (i) shall not 

10 apply if there is agreement on the amount 

11 and method of reimbursement between an 

12 exempted person described in clause (i) and 

13 the persons described in subclauses (I) and 

14 (II) of that clause. 

15 ‘‘(iii) CONSIDERATIONS.—In promul16 gating rules for the determination of fair 

17 and equitable reimbursement to the persons 

18 described in subclauses (I) and (II) of 

19 clause (i) for costs incurred with respect to 

20 a chemical substance, the Administrator 

21 shall, after consultation with the Attorney 

22 General and the Federal Trade Commission, 

23 consider all relevant factors, including— 

24 ‘‘(I) the effect on the competitive 

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1 vide reimbursement in relation to the 

2 person to be reimbursed; and 

3 ‘‘(II) the share of the market for 

4 the substance of the person required to 

5 provide reimbursement in relation to 

6 the share of the market of the persons 

7 to be reimbursed. 

8 ‘‘(C) REIMBURSEMENT DUE TO EXEMPTION

9 FOR TEST INFORMATION BEING DEVELOPED IN

10 ACCORDANCE WITH RULE OR ORDER.— 

11 ‘‘(i) IN GENERAL.—Except as provided 

12 in clause (ii), for an exemption under para13 graph (2)(B)(ii), the Administrator shall 

14 order the person granted the exemption to 

15 provide fair and equitable reimbursement 

16 (in an amount determined by the Adminis17 trator) to— 

18 ‘‘(I) each person who is developing 

19 the test information, for the portion of 

20 the costs incurred by each person in 

21 complying with the rule or order; and 

22 ‘‘(II) any other person who has 

23 been required under this subsection to 

24 contribute with respect to the costs of 

25 complying with the rule or order, for a 


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1 portion of the amount the person was 

2 required to contribute. 

3 ‘‘(ii) EXCEPTION.—Clause (i) shall not 

4 apply if there is agreement on the amount 

5 and method of reimbursement between an 

6 exempted person described in clause (i) and 

7 the persons described in subclauses (I) and 

8 (II) of that clause. 

9 ‘‘(iii) CONSIDERATIONS.—In promul10 gating rules for the determination of fair 

11 and equitable reimbursement to the persons 

12 described in subclauses (I) and (II) of 

13 clause (i) for costs incurred with respect to 

14 a chemical substance, the Administrator 

15 shall, after consultation with the Attorney 

16 General and the Federal Trade Commission, 

17 consider the factors described in subpara18 graph (B)(iii). 

19 ‘‘(iv) LACK OF COMPLIANCE.—If any 

20 exemption is granted under paragraph (2) 

21 on the basis that 1 or more persons are de22 veloping test information pursuant to a rule 

23 or order promulgated or issued under sub24 section (a) or (b), and after the exemption 

25 is granted, the Administrator determines 


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1 that no person has complied with the rule 

2 or order, the Administrator shall— 

3 ‘‘(I) after providing written notice 

4 and an opportunity for a hearing to 

5 the person who holds the exemption, by 

6 order, terminate the exemption; and 

7 ‘‘(II) notify in writing the person 

8 of the requirements of the rule or order 

9 with respect to which the exemption 

10 was granted. 

11 ‘‘(e) NOTICE.— 

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

13 the date of receipt of any test information pursuant 

14 to a rule or order under subsection (a) or (b), the Ad15 ministrator shall publish in the Federal Register a 

16 notice of the receipt of the test information. 

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

18 each notice shall— 

19 ‘‘(A) identify the chemical substance for 

20 which information has been received; 

21 ‘‘(B) list— 

22 ‘‘(i) the commercial and consumer uses 

23 or intended commercial and consumer uses 

24 of the substance known to the Adminis25 trator; and 


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1 ‘‘(ii) the information required by the 

2 applicable standards for the development of 

3 test information; and 

4 ‘‘(C) describe the nature of the test informa5 tion developed. 

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

7 Administrator shall make the test information de8 scribed in this subsection available on a publicly ac9 cessible Internet site. 

10 ‘‘(f) REQUESTS FROM OTHER AGENCIES FOR ADDI11 TIONAL INFORMATION OR TESTING.— 

12 ‘‘(1) IN GENERAL.—The head of a Federal agen13 cy may request the Administrator to seek the informa14 tion on behalf of that agency if the head of that Fed15 eral agency determines that— 

16 ‘‘(A) information relating to a chemical 

17 substance, including information derived from 

18 new testing or monitoring, would assist that 

19 Federal agency in carrying out the duties or ex20 ercising the authority of that agency; but 

21 ‘‘(B) the requested information is not avail22 able to that agency. 

23 ‘‘(2) DUTY OF ADMINISTRATOR.—Not later than 

24 60 days after the date of receipt of a request under 

25 paragraph (1), the Administrator shall— 


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1 ‘‘(A) subject to section 14, make the infor2 mation available to the requesting agency or in3 stitution; 

4 ‘‘(B) issue a request under section 8(k) to 

5 require— 

6 ‘‘(i) the submission of existing perti7 nent information to the Administrator; and 

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

9 be furnished to the requesting agency or in10 stitution; 

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

12 (b)— 

13 ‘‘(i) to develop the information; and 

14 ‘‘(ii) to require the developed informa15 tion to be furnished to the requesting agency 

16 or institution; or 

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

18 reason for which none of the actions described in 

19 this paragraph were taken. 

20 ‘‘(g) CERTIFICATION.—Each person who submits infor21 mation under this section or under a rule or an order pro22 mulgated or issued by the Administrator under this section 

23 shall accompany the information with a certification signed 

24 by a responsible official that each statement contained in 

25 the submission— 


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

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

3 possession or control of, or reasonably ascertainable 

4 by, the person.’’. 

5 SEC. 6. NEW CHEMICAL SUBSTANCES AND NEW USES OF 

6 CHEMICAL SUBSTANCES. 

7 Section 5 of the Toxic Substances Control Act (15 

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

9 ‘‘SEC. 5. NEW CHEMICAL SUBSTANCES AND NEW USES OF 

10 CHEMICAL SUBSTANCES. 

11 ‘‘(a) DEFINITIONS.—In this section: 

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

13 ‘manufacture’ and ‘process’ mean manufacture or 

14 process, respectively, for commercial purposes. 

15 ‘‘(2) TEST MARKETING.—The term ‘test mar16 keting’ does not include any provision of a chemical 

17 substance or mixture, or an article containing a 

18 chemical substance or mixture, to an end consumer of 

19 the chemical substance, mixture, or article. 

20 ‘‘(b) NEW CHEMICAL SUBSTANCES.— 

21 ‘‘(1) NOTICES.—Except as provided in subsection 

22 (h), no person may manufacture a new chemical sub23 stance, or process the chemical substance for a use 

24 that is proposed to meet the criteria described in sec25 tion 6(h)(2)(B), unless— 


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1 ‘‘(A) the person submits to the Adminis2 trator a notice, in accordance with subsection 

3 (g)(1)(A), of the intention of the person to manu4 facture or process the substance; 

5 ‘‘(B) the person complies with subsection 

6 (f); and 

7 ‘‘(C) the Administrator finds that— 

8 ‘‘(i) the new chemical substance is like9 ly to meet the safety standard under section 

10 6(d), which shall be limited to substances 

11 assigned by the Administrator to 1 of the 

12 categories described in paragraph 

13 (2)(D)(iii); or 

14 ‘‘(ii) the person has established by 

15 clear and convincing evidence that 1 or 

16 more uses of the new chemical substance 

17 meet the criteria described in section 

18 6(h)(2)(B), in which case— 

19 ‘‘(I) the Administrator may by 

20 order allow the person to manufacture 

21 or process the substance only for such 

22 use or uses in accordance with sub23 paragraph (A) of section 6(h)(2); 

24 ‘‘(II) the procedures and require25 ments specified in subparagraphs (A), 


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1 (C), (D), and (E) of section 6(h)(2) 

2 shall apply; and 

3 ‘‘(III) the Administrator shall 

4 not, upon receipt of a notice of com5 mencement for the chemical substance 

6 under subsection (d), add the chemical 

7 substance to the active inventory estab8 lished under section 8(h)(1). 

9 ‘‘(2) CATEGORIZATION OF NEW CHEMICAL SUB10 STANCES.— 

11 ‘‘(A) RULE.—Not later than 1 year after 

12 the date of enactment of the Safe Chemicals Act 

13 of 2011, the Administrator shall promulgate a 

14 rule that— 

15 ‘‘(i) designates the categories in accord16 ance with subparagraph (D) and specifies 

17 the process and criteria the Administrator 

18 will use to categorize new chemical sub19 stances; and 

20 ‘‘(ii) describes criteria and factors the 

21 Administrator will use to assess weight of 

22 evidence and the quality and reliability of 

23 information used to inform categorization 

24 decisions. 


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1 ‘‘(B) INFORMATION SOURCES.—In catego2 rizing a new chemical substance, the Adminis3 trator shall consider information on the sub4 stance available to the Administrator at the time 

5 the categorization decision is to be made, includ6 ing information— 

7 ‘‘(i) received by the Administrator 

8 from the manufacturer or processor of the 

9 substance in accordance with subsection (f); 

10 ‘‘(ii) submitted to a governmental body 

11 in another jurisdiction, to the extent that 

12 the information is accessible to the Admin13 istrator; 

14 ‘‘(iii) derived through application of 

15 validated structure-activity relationship or 

16 other models developed by the Administrator 

17 to estimate the environmental and human 

18 health effects, environmental and biological 

19 fate and behavior, and exposure potential of 

20 chemical substances; 

21 ‘‘(iv) inferred based on the degree of 

22 similarity of the structure or properties of 

23 the new chemical substance to those of 1 or 

24 more other chemical substances for which 

25 reliable information exists that is relevant 


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1 to predicting the potential environmental or 

2 human health effects, environmental or bio3 logical fate and behavior, or exposure poten4 tial of the new chemical substance; and 

5 ‘‘(v) any additional information the 

6 Administrator determines is needed to cat7 egorize the substance, including information 

8 identified as needed based on the analysis 

9 by the Administrator of estimated or in10 ferred information described in clauses (iii) 

11 and (iv). 

12 ‘‘(C) TIMING.—Not later than 90 days after 

13 the date of receipt of a notice under paragraph 

14 (1)(A), the Administrator shall assign the new 

15 chemical substance for which the notice was sub16 mitted to 1 of the categories described in sub17 paragraph (D). 

18 ‘‘(D) CATEGORIES.— 

19 ‘‘(i) IN GENERAL.—The rule promul20 gated pursuant to subparagraph (A) shall 

21 incorporate, establish criteria for, and fur22 ther specify as needed, the categories de23 scribed in this subparagraph, to 1 of which 

24 each new chemical substance for which a 


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1 notice is submitted pursuant to paragraph 

2 (1) shall be assigned. 

3 ‘‘(ii) SUBSTANCES OF VERY HIGH CON4 CERN.— 

5 ‘‘(I) IN GENERAL.—The Adminis6 trator shall designate as a substance of 

7 very high concern any new chemical 

8 substance that— 

9 ‘‘(aa) is toxic, persists in the 

10 environment, and is bioaccumula11 tive; or 

12 ‘‘(bb) is highly hazardous. 

13 ‘‘(II) REQUIREMENTS.— 

14 ‘‘(aa) IN GENERAL.—The Ad15 ministrator shall allow the sub16 mitter of a notice under para17 graph (1)(A) for a new chemical 

18 substance assigned to the category 

19 described in this clause to manu20 facture or process the new chem21 ical substance only in accordance 

22 with paragraph (1)(C)(ii). 

23 ‘‘(bb) PROHIBITION.—No 

24 other person may manufacture or 

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1 less the person has submitted a 

2 notice pursuant to paragraph (1) 

3 and the requirements of para4 graph (1)(C)(ii) have been met 

5 with respect to that notice. 

6 ‘‘(iii) SUBSTANCES LIKELY TO MEET

7 THE SAFETY STANDARD.— 

8 ‘‘(I) IN GENERAL.— 

9 ‘‘(aa) The Administrator 

10 shall designate as a substance 

11 likely to meet the safety standard 

12 any new chemical substance that 

13 the Administrator determines, 

14 based on available information, 

15 would likely meet the safety 

16 standard under section 6(d)— 

17 ‘‘(AA) for uses and 

18 under conditions specified by 

19 the submitter of the notice for 

20 the new chemical substance 

21 pursuant to paragraph (1); 

22 or 

23 ‘‘(BB) for uses and 

24 under additional conditions 

25 that could be specified by the 


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1 Administrator in making a 

2 safety standard determina3 tion for the substance. 

4 ‘‘(bb) The Administrator 

5 shall assign to the category de6 scribed in item (aa) any new 

7 chemical substance that meets the 

8 criteria specified in subclause (II) 

9 or (III). 

10 ‘‘(II) SUBSTANCES OF VERY LOW

11 CONCERN.— 

12 ‘‘(aa) IN GENERAL.—Within 

13 the category described in subclause 

14 (I), the Administrator shall des15 ignate as a substance of very low 

16 concern any new chemical sub17 stance that, based on robust infor18 mation, the Administrator deter19 mines possesses intrinsic low-haz20 ard properties so that no further 

21 action by the Administrator is 

22 warranted unless and until the 

23 Administrator receives new infor24 mation that warrants a different 


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1 categorization of the chemical sub2 stance. 

3 ‘‘(bb) BASIS OF DESIGNA4 TION.—In identifying new chem5 ical substances to be placed in the 

6 category described in this sub7 clause, the Administrator shall 

8 base the designation of a new 

9 chemical substance as a substance 

10 of very low concern on the appli11 cable minimum information set 

12 required under section 4, unless 

13 the Administrator determines that 

14 such designation of a particular 

15 new chemical substance— 

16 ‘‘(AA) can be made to a 

17 high degree of confidence 

18 based on less information; or 

19 ‘‘(BB) requires informa20 tion in addition to the full 

21 minimum information set to 

22 address conflicting or ambig23 uous findings, in which case 

24 the Administrator may re25 quire the development and 


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1 submission of the additional 

2 information. 

3 ‘‘(III) SUBSTANCES TO UNDERGO

4 SAFETY STANDARD DETERMINA5 TIONS.—Within the category described 

6 in subclause (I), the Administrator 

7 shall designate as a substance to un8 dergo a safety standard determination 

9 any new chemical substance that the 

10 Administrator determines, based on a 

11 screening of available use, hazard, and 

12 exposure information, has information 

13 available for the chemical substance 

14 that is sufficiently robust to determine 

15 that the chemical substance does not 

16 meet the criteria for the categories de17 scribed in subclause (II) or clause (ii) 

18 or (iv). 

19 ‘‘(IV) REQUIREMENT.—For a new 

20 chemical substance designated as likely 

21 to meet the safety standard pursuant 

22 to subclause (II) or (III), the Adminis23 trator shall, upon submission of a no24 tice of commencement described in sub25 section (d)— 


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1 ‘‘(aa) add the chemical sub2 stance to the active inventory de3 scribed in section 8(h)(1); and 

4 ‘‘(bb) for a chemical sub5 stance designated to undergo a 

6 safety standard determination, at 

7 the discretion of the Adminis8 trator accounting for timing of 

9 the submission and workload con10 siderations, add the chemical sub11 stance to the current batch or hold 

12 the substance until the next batch 

13 of substances to be prioritized in 

14 accordance with section 6(b)(4). 

15 ‘‘(V) MANUFACTURING AND PROC16 ESSING.—Pending the completion of a 

17 safety standard determination under 

18 section 6(d), a chemical substance des19 ignated as a substance likely to meet 

20 the safety standard may be manufac21 tured or processed for uses and under 

22 conditions specified by the Adminis23 trator in determining that the chemical 

24 substance is likely to meet the safety 

25 standard— 


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1 ‘‘(aa) by the submitter of the 

2 notice for the chemical substance 

3 submitted pursuant to paragraph 

4 (1)(A), upon submission of a no5 tice for the chemical substance 

6 pursuant to subsection (d); 

7 ‘‘(bb) by other manufacturers 

8 of the chemical substance, once the 

9 chemical substance has been 

10 placed on the active inventory de11 scribed in section 8(h)(1), upon 

12 submission of a declaration for 

13 the chemical substance pursuant 

14 to section 8(b)(1)(B); or 

15 ‘‘(cc) by processors of the sub16 stance, upon compliance with the 

17 requirements of section 8(e). 

18 ‘‘(iv) SUBSTANCES WITH INSUFFICIENT

19 INFORMATION.— 

20 ‘‘(I) IN GENERAL.—The Adminis21 trator shall designate as a substance 

22 with insufficient information any new 

23 chemical substance for which the Ad24 ministrator concludes, after gathering 

25 and screening available use, hazard, 


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1 and exposure information, that needed 

2 information for the chemical substance 

3 is not available, is insufficient, or is 

4 not of sufficient quality and reliability 

5 to allow for an informed categorization 

6 decision. 

7 ‘‘(II) REQUIRED SUBMISSION.— 

8 For substances designated under this 

9 clause, the Administrator shall require 

10 submission of the applicable minimum 

11 information set specified under section 

12 4 as needed to inform categorization 

13 decisionmaking for new chemical sub14 stances. 

15 ‘‘(III) RECATEGORIZATION.—Fol16 lowing submission of the applicable 

17 minimum information set for the 

18 chemical substance pursuant to sub19 clause (II), the Administrator shall re20 categorize the chemical substance using 

21 the categories and process described in 

22 this paragraph. 

23 ‘‘(IV) PROHIBITION.—Notwith24 standing paragraph (1)(C)(ii), no per25 son may manufacture or process a 


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1 chemical substance designated under 

2 this clause until and unless the infor3 mation described in subclause (II) has 

4 been submitted and the Administrator 

5 has recategorized the substance, at 

6 which time the provisions applicable to 

7 the category to which the substance has 

8 been assigned shall apply. 

9 ‘‘(v) SUBSTANCES UNLIKELY TO MEET

10 THE SAFETY STANDARD.— 

11 ‘‘(I) IN GENERAL.—The Adminis12 trator shall designate as a substance 

13 unlikely to meet the safety standard 

14 any new chemical substance that the 

15 Administrator determines, based on 

16 available information, would be un17 likely to meet the safety standard 

18 under section 6(d)— 

19 ‘‘(aa) for uses and under 

20 conditions specified by the sub21 mitter of the notice for the chem22 ical substance pursuant to para23 graph (1); or 

24 ‘‘(bb) for other uses or under 

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1 ministrator may evaluate in mak2 ing a safety standard determina3 tion for the chemical substance. 

4 ‘‘(II) PROHIBITION.—Except as 

5 provided under clause (ii), no person 

6 may manufacture or process a chem7 ical substance designated under this 

8 clause. 

9 ‘‘(c) NEW USES OF EXISTING CHEMICAL SUB10 STANCES.— 

11 ‘‘(1) NEW USES OF EXISTING CHEMICAL SUB12 STANCES PRIOR TO SAFETY STANDARD DETERMINA13 TION.— 

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

15 subparagraph (B), with respect to an existing 

16 chemical substance for which the Administrator 

17 has not made a safety standard determination 

18 under section 6(d), no person may manufacture 

19 or process the chemical substance— 

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

21 the date of enactment of the Safe Chemicals 

22 Act of 2011; or 

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

24 increased from the volume as of the date of 


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1 enactment of the Safe Chemicals Act of 

2 2011. 

3 ‘‘(B) EXCEPTION.—A person may manufac4 ture or process a chemical substance in a man5 ner prohibited by subparagraph (A) if— 

6 ‘‘(i) the person submits to the Adminis7 trator the notice specified in subsection 

8 (g)(1)(B); 

9 ‘‘(ii) the person complies with sub10 section (f); and 

11 ‘‘(iii) such manufacturing or proc12 essing is consistent with subsection 

13 (b)(2)(D)(iii)(V). 

14 ‘‘(C) GUIDANCE.—Not later than 90 days 

15 after the date of enactment of the Safe Chemicals 

16 Act of 2011, the Administrator shall issue guid17 ance for the purpose of identifying what con18 stitute new uses and significantly increased pro19 duction volumes under this paragraph. 

20 ‘‘(2) NEW USES OF EXISTING CHEMICAL SUB21 STANCES THAT MEET THE SAFETY STANDARD.— 

22 ‘‘(A) IN GENERAL.—For an existing chem23 ical substance for which the Administrator has 

24 determined under section 6(d) that the manufac25 turers and processors of the chemical substance 


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1 have established that the substance meets the ap2 plicable safety standard, no person may manu3 facture, process, distribute in commerce, use, or 

4 dispose of the chemical substance, or a mixture 

5 or article containing the chemical substance for 

6 uses, at production volumes, or in manners other 

7 than those the Administrator specified in the 

8 safety standard determination, unless— 

9 ‘‘(i) the person submits to the Adminis10 trator a notice in accordance with sub11 section (g)(1)(C) of the intention of the per12 son to manufacture, process, distribute in 

13 commerce, use, or dispose of the chemical 

14 substance, or a mixture or article con15 taining the chemical substance, for the new 

16 use or at a new production volume, or in 

17 such other manner that is inconsistent with 

18 a specified condition or term in the safety 

19 standard determination made by the Ad20 ministrator for that substance; and 

21 ‘‘(ii) the Administrator determines that 

22 the person submitting the notice has estab23 lished that the chemical substance will con24 tinue to meet the safety standard if the al25 lowed uses, production volumes, or other 


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1 specified conditions or terms for that sub2 stance, are revised to encompass the new 

3 use, new production volume, or other man4 ner of manufacturing, processing, distribu5 tion in commerce, use, or disposal. 

6 ‘‘(B) AMENDMENT TO SAFETY STANDARD

7 DETERMINATION.—If the conditions described in 

8 clauses (i) and (ii) of subparagraph (A) are sat9 isfied, the Administrator shall, by order, amend 

10 the safety standard determination for the chem11 ical substance to include the new use, production 

12 volume, or other manner of manufacturing or 

13 processing among the allowed uses, production 

14 volumes, or manners of manufacturing, proc15 essing, distribution in commerce, use, or disposal 

16 of the chemical substance. 

17 ‘‘(C) SAFETY STANDARD DETERMINATION.— 

18 ‘‘(i) IN GENERAL.—Except as provided 

19 in clauses (ii) and (iii), not later than 180 

20 days after the date of receipt of a notice 

21 pursuant to subparagraph (A)(i), the Ad22 ministrator shall determine whether the per23 son submitting the notice has established 

24 that the chemical substance will continue to 

25 meet the safety standard under section 6(d). 


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1 ‘‘(ii) EXTENSION.—The Administrator 

2 may extend the determination deadline 

3 under clause (i) by 1 or more additional pe4 riods not to exceed 1 year in the aggregate, 

5 in such manner as the Administrator deter6 mines necessary. 

7 ‘‘(iii) FAILURE TO MAKE A TIMELY DE8 TERMINATION.—The failure of the Adminis9 trator to make a timely determination in 

10 accordance with this paragraph shall not be 

11 sufficient to satisfy subparagraph (A)(ii). 

12 ‘‘(d) NOTICE OF COMMENCEMENT.— 

13 ‘‘(1) IN GENERAL.—Not later than 30 days after 

14 the date on which a manufacturer or processor com15 mences manufacturing or processing of a new chem16 ical substance, the manufacturer or processor shall 

17 submit to the Administrator a notice of commence18 ment of manufacture or processing. 

19 ‘‘(2) REQUIREMENTS.—The notice of commence20 ment shall— 

21 ‘‘(A) be considered equivalent to the declara22 tion required under subparagraph (A) or (C) of 

23 section 8(b)(2); and 

24 ‘‘(B) include the information described in 

25 section 8(b)(5). 


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1 ‘‘(3) WITHDRAWAL.—A person who has sub2 mitted a notice for a chemical substance under sub3 section (b) or (c), and has not commenced with manu4 facture or processing of the substance, may withdraw 

5 the notice. 

6 ‘‘(e) CHEMICAL SUBSTANCES EXHIBITING SPECIAL

7 SUBSTANCE CHARACTERISTICS.— 

8 ‘‘(1) DETERMINATION.—The Administrator shall 

9 determine by order or rule that a variant of a chem10 ical substance exhibiting 1 or more special substance 

11 characteristics— 

12 ‘‘(A) is a use that is separate from any use 

13 of the chemical substance that does not exhibit 

14 the special substance characteristics; or 

15 ‘‘(B) is a distinct chemical substance. 

16 ‘‘(2) REQUIREMENTS FOR VARIANTS THAT ARE

17 SEPARATE USES.—In the case of a chemical substance 

18 that the Administrator determines to be a separate 

19 use based on the special substance characteristics of 

20 the chemical substance, the manufacturer or processor 

21 shall satisfy such further conditions as the Adminis22 trator establishes, by order or rule. 

23 ‘‘(3) REQUIREMENTS FOR VARIANTS THAT ARE

24 DISTINCT CHEMICAL SUBSTANCES.—In the case of a 

25 chemical substance that the Administrator determines 


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1 to be a distinct chemical substance based on the spe2 cial substance characteristics of the chemical sub3 stance, and that is not listed on the active inventory 

4 established under section 8(h)(1), the manufacturer or 

5 processor shall comply with the requirements of sub6 section (b). 

7 ‘‘(f) SUBMISSION OF DATA.— 

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

9 Administrator data in accordance with the rule or 

10 order at the time that notice is submitted under sub11 section (b) or (c) if the person is required to submit 

12 to the Administrator— 

13 ‘‘(A) under subsection (b) or (c), a notice 

14 prior to beginning the manufacture or processing 

15 of a chemical substance; and 

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

17 chemical substance prior to the submission of the 

18 notice. 

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

20 Administrator shall make any test data submitted 

21 under paragraph (1) available on a publicly acces22 sible Internet site. 

23 ‘‘(3) TIMING.—Except as provided under sub24 section (b)(2)(D)(iv), the Administrator may require 

25 a person subject to an information requirement for a 


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1 chemical substance under this subsection or section 4 

2 to submit the information— 

3 ‘‘(A) prior to and as a condition of the Ad4 ministrator assigning the substance to a cat5 egory; 

6 ‘‘(B) as a condition of commencement of 

7 manufacture or processing; or 

8 ‘‘(C) as a condition of exceeding a specified 

9 manufacturing volume or expanding use of the 

10 substance. 

11 ‘‘(g) CONTENT AND AVAILABILITY OF NOTICE.— 

12 ‘‘(1) CONTENT.— 

13 ‘‘(A) NEW CHEMICAL SUBSTANCES.—A no14 tice under subsection (b)(1) shall include— 

15 ‘‘(i) the chemical identity and any spe16 cial substance characteristics of the chemical 

17 substance; 

18 ‘‘(ii) the identity and primary business 

19 location of the manufacturer; 

20 ‘‘(iii) the information described in sec21 tion 8(h)(5)(B)(ii); 

22 ‘‘(iv) the minimum information set de23 scribed in section 4(a), where applicable; 

24 and 

25 ‘‘(v) a statement that— 


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1 ‘‘(I) the new chemical substance is 

2 likely to meet the safety standard 

3 under section 6(d); or 

4 ‘‘(II) the 1 or more uses proposed 

5 for the new chemical substance meet 

6 the criteria described in section 

7 6(h)(2)(B). 

8 ‘‘(B) NEW USES OF EXISTING CHEMICAL

9 SUBSTANCES PRIOR TO SAFETY STANDARD DE10 TERMINATION.—A notice under subsection (c)(1) 

11 shall include all updates to the declaration de12 scribed in section 8(b)(2) and information de13 scribed in section 8(h)(5)(B)(ii) that is relevant 

14 to the new use, new production volume, or other 

15 new manner of manufacturing or processing. 

16 ‘‘(C) NEW USES OF EXISTING CHEMICAL

17 SUBSTANCES THAT MEET THE SAFETY STAND18 ARD.—A notice under subsection (c)(2) shall in19 clude— 

20 ‘‘(i) all updates to the declaration de21 scribed in section 8(b)(2); 

22 ‘‘(ii) information described in section 

23 8(h)(5)(B)(ii) that is relevant to the new 

24 use, new production volume, or other new 

25 manner of manufacturing or processing; 


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1 ‘‘(iii) all updates to the minimum in2 formation set described in section 4(a) rel3 evant to the new use, new production vol4 ume, or other new manner of manufac5 turing or processing; and 

6 ‘‘(iv) a statement that the chemical 

7 substance will continue to meet the safety 

8 standard if the allowed uses, production vol9 umes, or other specified conditions or terms 

10 for that chemical substance are revised to 

11 encompass the new use, production volume, 

12 or other manner of manufacturing or proc13 essing. 

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

15 Administrator shall make the notices under para16 graph (1) available on a publicly accessible Internet 

17 site. 

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

19 14, not later than 5 days (excluding Saturdays, Sun20 days, and legal holidays) after the date of the receipt 

21 of a notice under subsection (b), (c), or (d), or of data 

22 under subsection (f), the Administrator shall make 

23 available on a publicly accessible Internet site a no24 tice that— 


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1 ‘‘(A) identifies the chemical substance for 

2 which notice or information has been received; 

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

4 chemical substance; 

5 ‘‘(C) for substances for which a notice is 

6 submitted under subsection (b)(1), is promptly 

7 updated to specify the category to which the Ad8 ministrator has assigned the substance pursuant 

9 to subsection (b)(2) once the assignment has been 

10 made; 

11 ‘‘(D) in the case of the receipt of data under 

12 subsection (f), describes— 

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

14 with respect to the chemical substance; and 

15 ‘‘(ii) any data that were received 

16 under subsection (f) or a rule or order 

17 under section 4; and 

18 ‘‘(E) references the availability of the min19 imum information set, where applicable. 

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

21 each month, the Administrator shall make available 

22 on a publicly accessible Internet site a list of each 

23 chemical substance for which a notice has been re24 ceived under subsection (b), (c), or (d). 

25 ‘‘(h) EXEMPTIONS.— 


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1 ‘‘(1) INTRINSICALLY SAFE SUBSTANCES.— 

2 ‘‘(A) EXEMPTION.— 

3 ‘‘(i) IN GENERAL.—If the Adminis4 trator determines that scientific consensus 

5 exists that the intrinsic properties of a new 

6 chemical substance are such that the chem7 ical substance does not and would not pose 

8 any risk of injury to human health or the 

9 environment under any intended or reason10 ably anticipated levels of production, pat11 terns of use, or exposures arising at any 

12 stage across the lifecycle of the chemical sub13 stance, the Administrator may, by order, 

14 exempt the chemical substance, or par15 ticular uses of such substances, from 1 or 

16 more of the requirements of this section. 

17 ‘‘(ii) BASIS OF DETERMINATION.—A 

18 determination under clause (i)— 

19 ‘‘(I) shall be based on consider20 ation of the intrinsic properties of the 

21 chemical substance; and 

22 ‘‘(II) shall not be based on find23 ings or assumptions of low human or 

24 environmental exposure to such sub25 stances. 


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1 ‘‘(B) NOTICE OF DETERMINATION AND EX2 EMPTION.—Not later than 30 days after pro3 viding an exemption pursuant to subparagraph 

4 (A), the Administrator shall publish in the Fed5 eral Register a notice that— 

6 ‘‘(i) subject to section 14, provides the 

7 specific identity of the chemical substance 

8 or category; 

9 ‘‘(ii) if a particular use of the chemical 

10 substance is exempted under subparagraph 

11 (A), describes the particular use of the 

12 chemical substance that the Administrator 

13 has exempted; and 

14 ‘‘(iii) explains and documents the basis 

15 for the determination and exemption of the 

16 Administrator. 

17 ‘‘(C) RECONSIDERATION OF EXEMPTION.— 

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

19 may reconsider and revoke or modify any 

20 exemption provided under subparagraph 

21 (A) at any time if the Administrator deter22 mines that— 

23 ‘‘(I) the conditions specified in 

24 subparagraph (A) are no longer met; 

25 or 


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1 ‘‘(II) such action is necessary to 

2 protect human health or the environ3 ment or is otherwise in the public in4 terest. 

5 ‘‘(ii) PUBLICATION.—In the event of a 

6 revocation or modification under clause (i), 

7 the Administrator shall publish a notice of 

8 the grounds for the revocation. 

9 ‘‘(D) PRIOR REGULATORY EXEMPTIONS.— 

10 ‘‘(i) REVIEW.— 

11 ‘‘(I) IN GENERAL.—Not later than 

12 180 days after the date of enactment of 

13 the Safe Chemicals Act of 2011, the 

14 Administrator shall review exemptions 

15 that were granted pursuant to sub16 section (h)(4) of this section as in effect 

17 on the day before that date of enact18 ment. 

19 ‘‘(II) EFFECT OF EXEMPTION.— 

20 An exemption described in subclause 

21 (I) shall continue to be in effect until 

22 the date on which the Administrator 

23 determines, by order, that— 

24 ‘‘(aa) the exemption is not 

25 appropriate under this section, at 


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1 which time the exemption shall 

2 cease to be in effect; or 

3 ‘‘(bb) the exemption is appro4 priate under this section, at which 

5 time the Administrator may issue 

6 an order to modify or continue in 

7 effect the exemption pursuant to 

8 subparagraph (A). 

9 ‘‘(ii) POLYMERIC CHEMICAL SUB10 STANCES.—Notwithstanding subparagraph 

11 (A) and any previously issued exemption 

12 applicable to polymeric chemical sub13 stances— 

14 ‘‘(I) subsection (d) shall apply to 

15 new polymeric chemical substances eli16 gible for the previously issued exemp17 tion— 

18 ‘‘(aa) during the period prior 

19 to a determination by the Admin20 istrator pursuant to clause (i) ap21 plicable to such substances; and 

22 ‘‘(bb) after a determination 

23 by the Administrator pursuant to 

24 clause (i)(II)(bb) that continu25 ation of the prior exemption is 


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1 appropriate for some or all such 

2 substances, for such substances to 

3 which the continuation applies; 

4 and 

5 ‘‘(II) all of this section shall 

6 apply to new polymeric chemical sub7 stances eligible for the previously 

8 issued exemption after a determination 

9 by the Administrator pursuant to 

10 clause (i)(II)(aa) that continuation of 

11 the prior exemption is not appropriate 

12 for some or all such substances, for 

13 such substances to which the deter14 mination applies. 

15 ‘‘(E) NO LIMITATION ON AUTHORITY.— 

16 Nothing in this paragraph limits or otherwise 

17 affects the authority of the Administrator under 

18 any other provision of this Act. 

19 ‘‘(2) TEST MARKETING PURPOSES.—Subject to 

20 paragraph (6), the Administrator may, upon applica21 tion, exempt any person from any requirement of sub22 section (b), (c), or (f) to permit the person to manu23 facture or process a chemical substance for test mar24 keting purposes— 


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

2 manner that the Administrator determines, that 

3 the manufacture, processing, distribution in 

4 commerce, use, and disposal of the chemical sub5 stance (including any combination of those ac6 tivities) will not endanger human health or the 

7 environment; and 

8 ‘‘(B) under such restrictions as the Admin9 istrator considers appropriate. 

10 ‘‘(3) EQUIVALENT CHEMICAL SUBSTANCES.— 

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

12 shall, upon application, fully or partially ex13 empt any person from the requirement to submit 

14 any data under subsection (b) or (f) if, on re15 ceipt of an application, the Administrator deter16 mines that— 

17 ‘‘(i) the chemical substance for which 

18 the application was submitted is equivalent 

19 to a chemical substance for which data has 

20 been submitted to the Administrator as re21 quired by this Act; and 

22 ‘‘(ii) submission of data by the appli23 cant on the chemical substance would be du24 plicative of data which has been submitted 


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1 to the Administrator in accordance with 

2 this Act. 

3 ‘‘(B) EFFECTIVE DATE.—No exemption 

4 under this paragraph may take effect before the 

5 beginning of the reimbursement period applica6 ble to the data. 

7 ‘‘(C) FAIR AND EQUITABLE REIMBURSE8 MENT.— 

9 ‘‘(i) DEFINITION OF REIMBURSEMENT

10 PERIOD.—In this subparagraph, the term 

11 ‘reimbursement period’, with respect to any 

12 previously submitted data for a chemical 

13 substance, means a period— 

14 ‘‘(I) beginning on the date of the 

15 termination of the prohibition, im16 posed under this section, on the manu17 facture or processing of the chemical 

18 substance by the person who submitted 

19 the data to the Administrator; and 

20 ‘‘(II) ending on the later of— 

21 ‘‘(aa) the date that is 5 years 

22 after the date referred to in sub23 clause (I); or 

24 ‘‘(bb) the expiration of the 

25 period, which begins on the date 


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1 referred to in subclause (I) and is 

2 equal to the period that the Ad3 ministrator determines to be nec4 essary to develop the data. 

5 ‘‘(ii) REIMBURSEMENT.—Except as 

6 provided in clause (iii), if the Adminis7 trator exempts any person, under subpara8 graph (A), and the exemption is granted 

9 during the reimbursement period for that 

10 data, the Administrator shall order the per11 son granted the exemption to provide fair 

12 and equitable reimbursement (in an amount 

13 determined by the Administrator)— 

14 ‘‘(I) to the person who previously 

15 submitted the data on which the ex16 emption was based, for a portion of the 

17 costs incurred by the person in com18 plying with the requirement under this 

19 title to submit the data; and 

20 ‘‘(II) to any other person who has 

21 been required under this subparagraph 

22 to contribute with respect to the costs, 

23 for a portion of the amount the person 

24 was required to contribute. 


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

2 not apply if the person exempted under that 

3 clause and the persons described in sub4 clauses (I) and (II) of that clause agree on 

5 the amount and method of reimbursement. 

6 ‘‘(iv) CONSIDERATIONS.—In promul7 gating rules for the determination of fair 

8 and equitable reimbursement to the persons 

9 described in subclauses (I) and (II) of 

10 clause (ii) for costs incurred with respect to 

11 a chemical substance, the Administrator 

12 shall, after consultation with the Attorney 

13 General and the Federal Trade Commission, 

14 consider all relevant factors, including— 

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 re21 quired to provide reimbursement to the 

22 share of the market of the persons to be 

23 reimbursed. 

24 ‘‘(4) SMALL QUANTITIES SOLELY FOR EXPERI25 MENTATION, RESEARCH, AND ANALYSIS.— 


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1 ‘‘(A) IN GENERAL.—If the conditions de2 scribed in subparagraph (B) are met, subsections 

3 (b), (c), and (f) shall not apply with respect to 

4 the manufacturing or processing of any chemical 

5 substance that is manufactured or processed, or 

6 proposed to be manufactured or processed, only 

7 in small quantities (as defined by the Adminis8 trator by rule) solely for purposes of— 

9 ‘‘(i) scientific experimentation or anal10 ysis; or 

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

12 of the chemical substance or another chem13 ical substance, including such research or 

14 analysis for the development of a product. 

15 ‘‘(B) CONDITIONS.—All persons engaged in 

16 the experimentation, research, or analysis for a 

17 manufacturer or processor shall be notified (in 

18 such form and manner as the Administrator 

19 may prescribe) of any risk to human health that 

20 the manufacturer, processor, or the Adminis21 trator has reason to believe may be associated 

22 with that chemical substance. 

23 ‘‘(5) TEMPORARY EXISTENCE.—Subject to para24 graph (6), the Administrator may, upon application, 


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1 exempt from subsections (b), (c), and (f) the manufac2 turing or processing of any chemical substance— 

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

4 a chemical reaction in the manufacturing or 

5 processing of a mixture or another chemical sub6 stance; and 

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

8 human or environmental exposure. 

9 ‘‘(6) PUBLICATION.— 

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

11 after the date of receipt of an application under 

12 paragraph (2) or (5), the Administrator shall 

13 publish in the Federal Register notice of the re14 ceipt of the application. 

15 ‘‘(B) REQUIREMENTS.—The Administrator 

16 shall— 

17 ‘‘(i) give interested persons an oppor18 tunity to comment upon any application 

19 described in subparagraph (A); 

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

21 date of receipt of an application, approve or 

22 deny the application; and 

23 ‘‘(iii) publish in the Federal Register 

24 notice of the approval or denial of the ap25 plication. 


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

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

3 or issued by the Administrator under this section shall be 

4 accompanied by a certification signed by a responsible offi5 cial of the manufacturer or processor that each statement 

6 contained in the submission— 

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

8 ‘‘(2) includes all material facts required by the 

9 applicable provision of this section or rule or order 

10 under this section.’’. 

11 SEC. 7. BATCHING, CATEGORIZATION, PRIORITIZATION, 

12 SAFETY STANDARD DETERMINATION, AND 

13 RISK MANAGEMENT. 

14 (a) IN GENERAL.—Section 6 of the Toxic Substances 

15 Control Act (15 U.S.C. 2605) is amended— 

16 (1) by striking subsection (f); 

17 (2) by redesignating subsection (e) as subsection 

18 (i); 

19 (3) by striking the section heading and designa20 tion and all that follows through subsection (d) and 

21 inserting the following: 

22 ‘‘SEC. 6. BATCHING, CATEGORIZATION, PRIORITIZATION, 

23 SAFETY STANDARD DETERMINATION, AND 

24 RISK MANAGEMENT. 

25 ‘‘(a) BATCHING.— 


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1 ‘‘(1) IN GENERAL.—To ensure that an efficient 

2 and orderly process and pace is established for the de3 termination of safety of chemical substances in com4 merce and the application of risk management meas5 ures as needed, the Administrator shall establish a 

6 system for assigning chemical substances into batches 

7 in accordance with this subsection. 

8 ‘‘(2) REQUIREMENTS.— 

9 ‘‘(A) TIMING.—Not later than 270 days 

10 after the date of enactment of the Safe Chemicals 

11 Act of 2011, and not less frequently than once 

12 every 5 years thereafter until all chemical sub13 stances listed on the active portion of the inven14 tory established under section 8(h)(1) have been 

15 assigned to a batch, the Administrator shall as16 sign chemical substances on the active portion of 

17 the inventory to batches of chemical substances 

18 under this subsection. 

19 ‘‘(B) NUMBER.—Each batch established 

20 under this subsection shall include a number of 

21 chemical substances approximately equal to the 

22 number of chemical substances for which reports 

23 are submitted to the Administrator under the 

24 chemical data reporting rule as of the date of en25 actment of the Safe Chemicals Act of 2011. 


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1 ‘‘(C) PUBLICATION.—The Administrator 

2 shall publish, subject to section 14, the list of 

3 chemical substances assigned to each batch 

4 promptly on designation of the chemical sub5 stances to the batch. 

6 ‘‘(3) INITIAL BATCH.— 

7 ‘‘(A) IN GENERAL.—Subject to subpara8 graph (B), the initial batch of chemical sub9 stances designated under paragraph (2)(A) shall 

10 include the chemical substances for which reports 

11 are submitted to the Administrator under the 

12 chemical data reporting rule as of the date of en13 actment of the Safe Chemicals Act of 2011. 

14 ‘‘(B) INCLUSIONS AND EXCLUSIONS.—Not15 withstanding subparagraph (A), the Adminis16 trator may— 

17 ‘‘(i) include in the initial batch chem18 ical substances that— 

19 ‘‘(I) are manufactured at volumes 

20 below the threshold used under the 

21 chemical data reporting rule to des22 ignate chemical substances subject to 

23 basic reporting under that rule; but 

24 ‘‘(II) are used or released into the 

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1 ministrator determines warrants early 

2 evaluation; and 

3 ‘‘(ii) exclude from the initial batch 

4 chemical substances that— 

5 ‘‘(I) are reported to the Adminis6 trator under the chemical data report7 ing rule; but 

8 ‘‘(II) are used or released into the 

9 environment in a manner that the Ad10 ministrator determines does not war11 rant early evaluation. 

12 ‘‘(4) SUBSEQUENT BATCHES.—The Adminis13 trator shall assign chemical substances to subsequent 

14 batches in a manner that the Administrator deter15 mines reflects the extent to which the chemical sub16 stances warrant earlier or later evaluation. 

17 ‘‘(b) CATEGORIZATION AND PRIORITIZATION.— 

18 ‘‘(1) REGULATIONS.—Not later than 1 year after 

19 the date of enactment of the Safe Chemicals Act of 

20 2011, the Administrator shall promulgate regulations 

21 that— 

22 ‘‘(A) establish the categories and specify the 

23 process and criteria the Administrator will use 

24 to categorize chemical substances, which shall be 

25 consistent with paragraph (3)(B), beginning 


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1 with those chemical substances assigned to the 

2 initial batch described in subsection (a)(3); 

3 ‘‘(B) designate the process and criteria the 

4 Administrator will use to prioritize chemical 

5 substances that are placed in the category of 

6 chemical substances to undergo safety standard 

7 determinations, which shall be consistent with 

8 the priorities described in paragraph (4); 

9 ‘‘(C) describe how the categorization and 

10 prioritization process and criteria relate to, and 

11 take into account, the categorization and 

12 prioritization decisions made in other jurisdic13 tions, including States and foreign governments; 

14 and 

15 ‘‘(D) describe criteria and factors the Ad16 ministrator will use to weigh evidence and assess 

17 the quality and reliability of information used to 

18 inform categorization and prioritization deci19 sions. 

20 ‘‘(2) INFORMATION SOURCES.— 

21 ‘‘(A) IN GENERAL.—In making categoriza22 tion and prioritization decisions, the Adminis23 trator shall take into consideration information 

24 regarding chemical substances that is available 


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1 to the Administrator at the time the decisions 

2 are made, including information that is— 

3 ‘‘(i) received by the Administrator 

4 from manufacturers or processors pursuant 

5 to requirements under section 8(b) and (c); 

6 ‘‘(ii) included in any minimum infor7 mation set required under section 4; 

8 ‘‘(iii) submitted to the Administrator 

9 that is relevant to the categorization or 

10 prioritization of the chemical substance; 

11 and 

12 ‘‘(iv) identified through an active 

13 search by the Administrator of information 

14 sources that are publicly available or other15 wise accessible to the Administrator. 

16 ‘‘(B) INFORMATION FROM MANUFACTURERS

17 AND PROCESSORS.— 

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

19 (ii), on designation by the Administrator 

20 under paragraph (3)(B)(iii) of a chemical 

21 substance safety standard determination, 

22 any manufacturer or processor of a des23 ignated chemical substance and any trade 

24 association or voluntary consortium that 

25 represents a manufacturer or processor of a 


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1 designated chemical substance may provide 

2 to the Administrator information that— 

3 ‘‘(I) relates to the chemical sub4 stances manufactured or processed by 

5 the applicable manufacturer or proc6 essor; 

7 ‘‘(II) is in the possession of, or 

8 known to, the manufacturer, processor, 

9 trade association, or consortium; and 

10 ‘‘(III) is not already available to 

11 the Administrator. 

12 ‘‘(ii) REQUIREMENT.—If a manufac13 turer, processor, trade association, or con14 sortium elects to provide information to the 

15 Administrator under clause (i), the manu16 facturer, processor, trade association, or 

17 consortium shall provide all relevant infor18 mation in the possession of, or known to, 

19 the manufacturer, processor, trade associa20 tion, or consortium for each chemical sub21 stance designated by the Administrator that 

22 is manufactured or processed by the appli23 cable manufacturer or processor. 

24 ‘‘(iii) METHOD OF SUBMISSION.—In25 formation described in this subparagraph 


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1 may be submitted to the Administrator 

2 by— 

3 ‘‘(I) a manufacturer or proc4 essor— 

5 ‘‘(aa) on an individual basis; 

6 or 

7 ‘‘(bb) through a trade asso8 ciation or voluntary consortium; 

9 and 

10 ‘‘(II) a trade association or vol11 untary consortium that has developed 

12 relevant information on behalf of the 

13 manufacturers or processors of des14 ignated chemical substances rep15 resented by the trade association or 

16 voluntary consortium. 

17 ‘‘(3) CATEGORIZATION OF CHEMICAL SUB18 STANCES.— 

19 ‘‘(A) TIMING.— 

20 ‘‘(i) INITIAL BATCH.—Not later than 

21 180 days after the date of promulgation of 

22 regulations pursuant to paragraph (1), the 

23 Administrator shall publish, subject to sec24 tion 14, the category assignments for the 

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1 fied under subsection (a)(3), using the cat2 egories described in subparagraph (B). 

3 ‘‘(ii) SUBSEQUENT BATCHES.—Not 

4 later than 180 days after the date on which 

5 the Administrator designates each subse6 quent batch of chemical substances under 

7 subsection (a)(2)(A), the Administrator 

8 shall publish the category assignments for 

9 the chemical substances in the batch. 

10 ‘‘(B) CATEGORIES.—The regulation promul11 gated pursuant to paragraph (1) shall incor12 porate, establish criteria for, and further specify 

13 as needed, the following categories into which 

14 chemical substances in each batch shall be 

15 placed: 

16 ‘‘(i) SUBSTANCES OF VERY HIGH CON17 CERN.— 

18 ‘‘(I) IN GENERAL.—The Adminis19 trator shall designate as substances of 

20 very high concern those chemical sub21 stances— 

22 ‘‘(aa) for which there is evi23 dence of widespread exposure and 

24 that— 


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1 ‘‘(AA) are toxic, persist 

2 in the environment, and are 

3 bioaccumulative; or 

4 ‘‘(BB) are highly haz5 ardous; 

6 ‘‘(bb) that are subject to reg7 ulation under section 6 or 7 of 

8 this Act (as in effect on the day 

9 before the date of enactment of the 

10 Safe Chemicals Act of 2011); or 

11 ‘‘(cc) that are subject to a 

12 voluntary phase-out, administered 

13 by the Administrator, that has 

14 been completed or is underway at 

15 the time the category designation 

16 is made. 

17 ‘‘(II) INFORMATION SET.—A min18 imum information set, as specified 

19 under section 4, need not be submitted 

20 or otherwise available for a chemical 

21 substance to be designated a substance 

22 of very high concern under this clause. 

23 ‘‘(ii) SUBSTANCES OF VERY LOW CON24 CERN.— 


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1 ‘‘(I) IN GENERAL.—The Adminis2 trator shall designate as substances of 

3 very low concern those chemical sub4 stances that, based on robust informa5 tion, the Administrator determines 

6 possess intrinsic low-hazard properties 

7 such that no further action by the Ad8 ministrator is warranted, unless the 

9 Administrator receives new informa10 tion that warrants a different cat11 egorization of the chemical substance. 

12 ‘‘(II) FACTORS FOR CONSIDER13 ATION.—In designating chemical sub14 stances to be placed in the very low 

15 concern category under this clause, the 

16 Administrator shall— 

17 ‘‘(aa) take into consideration 

18 whether chemical substances in 

19 commerce have received, as of the 

20 date of enactment of the Safe 

21 Chemicals Act of 2011, exemptions 

22 under section 5 of this Act (as in 

23 effect on the day before the date of 

24 enactment of the Safe Chemicals 


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1 Act of 2011) based on anticipated 

2 low intrinsic hazard; and 

3 ‘‘(bb) in general, base the 

4 designation on a minimum infor5 mation set as required under sec6 tion 4, unless the Administrator 

7 determines that such designation 

8 of a particular chemical sub9 stance— 

10 ‘‘(AA) can be made to a 

11 high degree of confidence 

12 based on less information; or 

13 ‘‘(BB) requires informa14 tion in addition to the full 

15 minimum information set to 

16 address conflicting or ambig17 uous findings, in which case 

18 the Administrator may re19 quire the development and 

20 submission of the additional 

21 information. 

22 ‘‘(iii) SUBSTANCES TO UNDERGO SAFE23 TY STANDARD DETERMINATIONS.—The Ad24 ministrator shall designate as substances to 

25 undergo safety standard determinations 


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1 those chemical substances that the Adminis2 trator determines— 

3 ‘‘(I) based on a screening of avail4 able use, hazard, and exposure infor5 mation, do not meet the criteria for the 

6 categories described in clauses (i) and 

7 (ii); and 

8 ‘‘(II) are the subject of available 

9 information that is sufficiently robust 

10 to inform prioritization decisions to be 

11 made for the chemical substances under 

12 paragraph (4). 

13 ‘‘(iv) SUBSTANCES WITH INSUFFICIENT

14 INFORMATION.— 

15 ‘‘(I) IN GENERAL.—The Adminis16 trator shall designate as substances 

17 with insufficient information those 

18 chemical substances for which the Ad19 ministrator determines, after gathering 

20 and screening available use, hazard, 

21 and exposure information, that infor22 mation is not available, is insufficient, 

23 or is not of sufficient quality and reli24 ability to allow for an informed cat25 egorization decision. 


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1 ‘‘(II) MINIMUM INFORMATION

2 SET.— 

3 ‘‘(aa) IN GENERAL.—For 

4 chemical substances designated 

5 under this clause, the Adminis6 trator shall require submission of 

7 the applicable minimum informa8 tion set specified under section 4 

9 as needed to inform categorization 

10 decisionmaking. 

11 ‘‘(bb) TIMING.—The min12 imum information set shall be 

13 submitted to the Administrator— 

14 ‘‘(AA) not later than 5 

15 years after the date of enact16 ment of the Safe Chemicals 

17 Act of 2011 for the initial 

18 batch of chemical substances 

19 identified under subsection 

20 (a)(3); and 

21 ‘‘(BB) not later than 5 

22 years after the assignment of 

23 a chemical substance to the 

24 category under this clause for 

25 subsequent batches. 


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1 ‘‘(III) RECATEGORIZATION.— 

2 ‘‘(aa) IN GENERAL.—After 

3 submission of the minimum infor4 mation set for a chemical sub5 stance pursuant to subclause (I), 

6 the Administrator shall recat7 egorize the chemical substance 

8 using the categories and process 

9 described in this paragraph. 

10 ‘‘(bb) DISCRETION OF ADMIN11 ISTRATOR.—The Administrator, 

12 taking into account the timing of 

13 the submission and workload con14 siderations, may— 

15 ‘‘(AA) add a chemical 

16 substance to a current batch; 

17 or 

18 ‘‘(BB) hold the chemical 

19 substance until the next 

20 batch of chemical substances 

21 for recategorization. 

22 ‘‘(4) PRIORITIZATION OF CHEMICAL SUB23 STANCES.— 

24 ‘‘(A) TIMING.— 


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1 ‘‘(i) INITIAL BATCH.—Not later than 

2 270 days after the date of promulgation of 

3 regulations pursuant to paragraph (1), the 

4 Administrator shall publish, subject to sec5 tion 14, the priority class assignments, 

6 using the priority classes described in sub7 paragraph (B), for the chemical substances 

8 in the initial batch of chemical substances 

9 identified under subsection (a)(3) that the 

10 Administrator has assigned to the category 

11 of chemical substances to undergo safety 

12 standard determinations. 

13 ‘‘(ii) SUBSEQUENT BATCHES.—Not 

14 later than 270 days after the date on which 

15 the Administrator designates each subse16 quent batch of chemical substances under 

17 subsection (a)(2)(A), the Administrator 

18 shall publish the priority class assignments 

19 for the chemical substances in the batch that 

20 the Administrator has assigned to the cat21 egory of chemical substances to undergo 

22 safety standard determinations. 

23 ‘‘(B) CRITERIA.—The criteria used by the 

24 Administrator to assign chemical substances to 

25 priority classes shall take into account— 


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1 ‘‘(i) potential impacts of the chemical 

2 substance on human health and the environ3 ment; 

4 ‘‘(ii) the hazard potential of the chem5 ical substance, including classifications and 

6 designations of hazard characteristics by 

7 other authoritative entities; 

8 ‘‘(iii) the potential for exposure to the 

9 chemical substance; and 

10 ‘‘(iv) measurements of exposure for a 

11 given pathway of exposure, if available and 

12 reliable, in preference to less direct indica13 tors of, or surrogates for, exposure potential 

14 for the same pathway. 

15 ‘‘(C) PRIORITY CLASSES.—The regulations 

16 promulgated pursuant to paragraph (1) shall es17 tablish the following priority classes and cri18 teria, and further specify the process the Admin19 istrator will use to assign to the priority classes 

20 the chemical substances in each batch that the 

21 Administrator has assigned to the category of 

22 chemical substances to undergo safety standard 

23 determinations: 

24 ‘‘(i) PRIORITY CLASS 1.— 


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1 ‘‘(I) IN GENERAL.—In each batch, 

2 the Administrator shall designate as 

3 Priority Class 1 those chemical sub4 stances that the Administrator deter5 mines warrant safety standard deter6 minations in the near term. 

7 ‘‘(II) INITIAL ASSIGNMENT.—The 

8 Administrator shall in each batch ini9 tially designate as Priority Class 1 

10 chemical substances that possess rel11 atively greater hazard potential and 

12 for which there is evidence of more sig13 nificant or widespread exposure. 

14 ‘‘(III) REASSIGNMENT.—As safety 

15 standard determinations for the chem16 ical substance are completed, the Ad17 ministrator may designate as Priority 

18 Class 1 any chemical substance ini19 tially assigned to a lower priority 

20 class, including chemical substances— 

21 ‘‘(aa) posing significant haz22 ard concerns but of less or un23 known exposure concern; 


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1 ‘‘(bb) posing significant ex2 posure concern but of less or un3 known hazard concern; or 

4 ‘‘(cc) posing less hazard and 

5 exposure concerns. 

6 ‘‘(IV) FACTORS FOR CONSIDER7 ATION.—In determining the number of 

8 chemical substances to be placed in 

9 Priority Class 1, the Administrator 

10 shall seek to balance considerations re11 lating to— 

12 ‘‘(aa) the number of chemical 

13 substances for which safety stand14 ard determinations need to be 

15 conducted; 

16 ‘‘(bb) the resources available 

17 to the Administrator for con18 ducting safety standard deter19 minations; and 

20 ‘‘(cc) the deadlines for com21 pletion of safety standard deter22 minations specified in subsection 

23 (d)(4). 

24 ‘‘(ii) PRIORITY CLASS 2.— 


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1 ‘‘(I) IN GENERAL.—The Adminis2 trator shall designate as Priority Class 

3 2 those chemical substances that the 

4 Administrator determines are of lower 

5 priority than Priority Class 1 sub6 stances with respect to the timing for 

7 conducting safety standard determina8 tions. 

9 ‘‘(II) MINIMUM INFORMATION

10 SET.— 

11 ‘‘(aa) IN GENERAL.—For 

12 chemical substances designated 

13 under this clause, the Adminis14 trator shall require submission of 

15 the applicable minimum informa16 tion set specified under section 4 

17 as needed to inform prioritization 

18 decisionmaking. 

19 ‘‘(bb) TIMING.—The min20 imum information set shall be 

21 submitted to the Administrator— 

22 ‘‘(AA) not later than 5 

23 years after the date of enact24 ment of the Safe Chemicals 

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1 stances in the initial batch 

2 identified under subsection 

3 (a)(3) that are assigned to 

4 Priority Class 2; and 

5 ‘‘(BB) not later than 5 

6 years after the assignment of 

7 a chemical substance to Pri8 ority Class 2 under this 

9 clause for subsequent batches. 

10 ‘‘(III) REPRIORITIZATION.—After 

11 submission of the minimum informa12 tion set for a chemical substance under 

13 subclause (II), the Administrator shall, 

14 if warranted, recategorize or otherwise 

15 reprioritize the chemical substance 

16 using the priority classes and process 

17 described in this paragraph, together 

18 with other chemical substances in the 

19 batch undergoing prioritization at the 

20 time of the submission. 

21 ‘‘(IV) REPRIORITIZATION TO PRI22 ORITY CLASS 1.—As safety standard 

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1 trator shall reprioritize Priority Class 

2 2 substances as Priority Class 1 at a 

3 pace consistent with— 

4 ‘‘(aa) the resources available 

5 to the Administrator for con6 ducting safety standard deter7 minations; and 

8 ‘‘(bb) the deadlines for com9 pletion of safety standard deter10 minations specified in subsection 

11 (d)(4). 

12 ‘‘(iii) PRIORITY CLASS 3.— 

13 ‘‘(I) IN GENERAL.—The Adminis14 trator shall designate as Priority Class 

15 3 those chemical substances that the 

16 Administrator determines may be set 

17 aside for further assessment until such 

18 time as— 

19 ‘‘(aa) safety standard deter20 minations are completed on all 

21 Priority Class 1 and 2 substances; 

22 or 

23 ‘‘(bb) new information arises 

24 that warrants reprioritization of 


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1 such a substance to a higher pri2 ority class. 

3 ‘‘(II) MINIMUM INFORMATION

4 SET.— 

5 ‘‘(aa) IN GENERAL.—For a 

6 chemical substance designated 

7 under this clause, the Adminis8 trator shall not require submis9 sion of the applicable minimum 

10 information set specified under 

11 section 4 until such time as the 

12 chemical substance is reassigned 

13 to Priority Class 1 or 2. 

14 ‘‘(bb) SUBMISSION.—On re15 assignment of a chemical sub16 stance to Priority Class 1 or 2 

17 under item (aa), the minimum 

18 information set shall be submitted 

19 to the Administrator not later 

20 than 5 years after the date of the 

21 reassignment. 

22 ‘‘(III) REPRIORITIZATION.—After 

23 submission of the minimum informa24 tion set for a chemical substance pur25 suant to subclause (II), the AdminisVerDate Mar 15 2010 23:53 Dec 27, 2012 Jkt 029200 PO 00000 Frm 00170 Fmt 6652 Sfmt 6203 E:\BILLS\S847.RS S847

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1 trator shall reprioritize the chemical 

2 substance using the priority classes 

3 and process described in this para4 graph, together with chemical sub5 stances in the batch undergoing 

6 prioritization at the time of the sub7 mission. 

8 ‘‘(IV) REPRIORITIZATION TO PRI9 ORITY CLASSES 1 AND 2.—In conjunc10 tion with the reprioritization by the 

11 Administrator of Priority Class 2 sub12 stances as Priority Class 1, the Admin13 istrator shall reprioritize Priority 

14 Class 3 substances as Priority Class 1 

15 or 2, at a pace consistent with— 

16 ‘‘(aa) the resources available 

17 to the Administrator for con18 ducting safety standard deter19 minations; and 

20 ‘‘(bb) the deadlines for com21 pletion of safety standard deter22 minations specified in subsection 

23 (d)(4). 

24 ‘‘(c) TREATMENT AS FINAL AGENCY ACTION; NO JUDI25 CIAL REVIEW; NONDISCRETIONARY DUTY.— 


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1 ‘‘(1) IN GENERAL.—The designation by the Ad2 ministrator of batches of chemical substances pursu3 ant to subsection (a), the assignment of chemical sub4 stances to categories pursuant to subsection (b)(3), 

5 and the assignment of chemical substances to priority 

6 classes pursuant to subsection (b)(4), including any 

7 determination of the Administrator to include a spe8 cific chemical substance in, or exclude a specific 

9 chemical substance from, a designated batch, category, 

10 or priority class under this section, shall not be— 

11 ‘‘(A) considered to be a final agency action 

12 for the purpose of subchapter II of chapter 5, 

13 and chapter 7, of title 5, United States Code 

14 (commonly known as ‘the Administrative Proce15 dure Act’); or 

16 ‘‘(B) subject to judicial review. 

17 ‘‘(2) FAILURE TO ACT.—A failure by the Admin18 istrator to designate or publish a list of chemical sub19 stances assigned to a batch, category, or priority class 

20 in accordance with this subsection shall be— 

21 ‘‘(A) considered to be a failure to perform 

22 a nondiscretionary duty; and 

23 ‘‘(B) subject to judicial review. 

24 ‘‘(d) SAFETY STANDARD DETERMINATIONS FOR CHEM25 ICAL SUBSTANCES.— 


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1 ‘‘(1) IN GENERAL.— 

2 ‘‘(A) APPLICATION.—This paragraph ap3 plies to any determination or redetermination 

4 regarding whether a chemical substance meets 

5 the safety standards of this Act. 

6 ‘‘(B) RESPONSIBILITIES.— 

7 ‘‘(i) IN GENERAL.—For purposes of 

8 this Act, each manufacturer and processor 

9 of a chemical substance shall at all times 

10 bear the burden of proof in any legal pro11 ceeding relating to a decision of the Admin12 istrator regarding whether the chemical sub13 stance meets the safety standard. 

14 ‘‘(ii) DUTIES.—For purposes of this 

15 Act— 

16 ‘‘(I) it shall be the duty of the 

17 manufacturer or processor of a chem18 ical substance to provide sufficient in19 formation for the Administrator to de20 termine whether the chemical substance 

21 meets the safety standard; and 

22 ‘‘(II) it shall be the duty of the 

23 Administrator to determine whether a 

24 chemical substance meets the safety 

25 standard. 


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1 ‘‘(2) ASSESSMENT OF RISK.— 

2 ‘‘(A) ASSESSMENT.— 

3 ‘‘(i) IN GENERAL.—A chemical sub4 stance that undergoes a safety standard de5 termination under this section may be man6 ufactured, processed, or distributed in com7 merce only if the Administrator determines 

8 that the chemical substance— 

9 ‘‘(I) meets the safety standard, 

10 taking into account any existing condi11 tions or controls already in effect; or 

12 ‘‘(II) can meet the safety standard 

13 for all or some uses through the impo14 sition of additional conditions. 

15 ‘‘(ii) REQUIREMENT.—Any assessment 

16 of risk used to support a determination that 

17 a chemical substance meets the safety stand18 ard under clause (i) shall be conducted by 

19 employees of the Environmental Protection 

20 Agency who are competent to conduct such 

21 assessments. 

22 ‘‘(B) SAFETY STANDARD.— 

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

24 shall base a determination of whether a 

25 safety standard for a chemical substance 


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1 has been met under subparagraph (A) solely 

2 on considerations of human health and the 

3 environment, including the health of vulner4 able populations. 

5 ‘‘(ii) CONSIDERATIONS.—In making a 

6 safety standard determination under this 

7 subsection, for each chemical substance, the 

8 Administrator shall— 

9 ‘‘(I) to the extent practicable, re10 view and incorporate any available 

11 scientific information relating to the 

12 effect of cumulative exposure relevant 

13 to that chemical substance on human 

14 health and the environment; and 

15 ‘‘(II) find that a chemical sub16 stance meets the safety standard only if 

17 the Administrator finds that there is a 

18 reasonable certainty that no harm will 

19 result to human health or the environ20 ment from aggregate exposure to the 

21 chemical substance. 

22 ‘‘(C) FINANCIAL INTERESTS.—No person 

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1 ment, may have a direct or indirect financial in2 terest in the outcome of the assessment. 

3 ‘‘(D) METHODOLOGY.— 

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

5 (ii), the Administrator shall use the best 

6 available science when conducting an assess7 ment described in subparagraph (A). 

8 ‘‘(ii) CONSIDERATIONS.—For the pur9 pose of determining the current best avail10 able science the Administrator shall base the 

11 determination on the recommendations of 

12 the National Academy of Sciences in the re13 port entitled ‘Science and Decisions’. 

14 ‘‘(iii) REVIEW.—Not later than 5 years 

15 after the date of enactment of the Safe 

16 Chemicals Act of 2011, and not less fre17 quently than once every 5 years thereafter, 

18 the Administrator shall review the method19 ology under this paragraph and may revise 

20 the methodology to reflect new scientific de21 velopments or understandings. 

22 ‘‘(E) SCOPE.—An assessment described in 

23 subparagraph (A) shall address health or envi24 ronmental impacts including potential or dem25 onstrated cancer and noncancer endpoints. 


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1 ‘‘(F) TRANSPARENCY.—In carrying out this 

2 subsection, the Administrator shall ensure that 

3 the approaches and resulting assessments are 

4 communicated in a manner that is transparent 

5 and understandable to— 

6 ‘‘(i) the public; and 

7 ‘‘(ii) risk managers. 

8 ‘‘(G) MANUFACTURE OR PROCESSING FOR

9 EXPORT.—In the case of a chemical substance 

10 that is manufactured or processed in whole or in 

11 part for export, in determining whether the 

12 chemical substance meets the safety standard 

13 under subparagraph (A)(i), the Administrator 

14 shall take into account any risk— 

15 ‘‘(i) that the chemical substance may 

16 pose in the United States, including risks 

17 involving long-range transport of the chem18 ical substance in the environment; or 

19 ‘‘(ii) involving the import of articles 

20 and mixtures containing the chemical sub21 stance. 

22 ‘‘(H) RISK ASSESSMENT NOT REQUIRED.— 

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1 ufacturer or processor has not met the burden of 

2 proof under paragraph (1)(B). 

3 ‘‘(I) NO JUDICIAL REVIEW.—A determina4 tion by the Administrator that a manufacturer 

5 or processor has not established that the chemical 

6 substance meets the applicable safety standard 

7 under this subsection shall not be subject to judi8 cial review. 

9 ‘‘(3) INFORMATION FOR SAFETY STANDARD DE10 TERMINATIONS.— 

11 ‘‘(A) IN GENERAL.—In making a safety 

12 standard determination with respect to a chem13 ical substance, the Administrator— 

14 ‘‘(i) shall take into consideration infor15 mation regarding the chemical substance 

16 that is already available to the Adminis17 trator at the time the determination is to be 

18 made, including information— 

19 ‘‘(I) received by the Administrator 

20 from manufacturers or processors 

21 under this section or section 8; 

22 ‘‘(II) contained in any minimum 

23 information sets previously required 

24 under section 4; 


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1 ‘‘(III) voluntarily submitted by 

2 manufacturers and processors in ac3 cordance with subsection (b)(2)(B); 

4 ‘‘(IV) submitted by any other 

5 party to the Administrator that is rel6 evant to the conduct of a safety stand7 ard determination of the chemical sub8 stance; or 

9 ‘‘(V) identified through an active 

10 search by the Administrator of infor11 mation sources that are publicly avail12 able or otherwise accessible to the Ad13 ministrator; 

14 ‘‘(ii) shall require information needed 

15 to complete the applicable minimum infor16 mation set for the chemical substance re17 quired under section 4(a); 

18 ‘‘(iii) may require, by regulation or 

19 order pursuant to section 4(b) or 8(e), man20 ufacturers or processors of the chemical sub21 stance to develop and submit any addi22 tional information the Administrator deter23 mines is needed to conduct the safety stand24 ard determination of the chemical sub25 stance; and 


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1 ‘‘(iv) shall take into consideration, but 

2 not rely on, assessments of safety or anal3 yses of the effectiveness of existing control 

4 measures— 

5 ‘‘(I) submitted to the Adminis6 trator by any party; or 

7 ‘‘(II) conducted by a govern8 mental entity in another jurisdiction. 

9 ‘‘(4) TIMING OF SAFETY STANDARD DETERMINA10 TIONS.— 

11 ‘‘(A) PRIORITY CLASS 1.— 

12 ‘‘(i) IN GENERAL.—Beginning with 

13 chemical substances initially designated as 

14 Priority Class 1 under subsection 

15 (b)(4)(C)(i), the Administrator shall con16 duct safety standard determinations of all 

17 chemical substances assigned to the category 

18 of substances to undergo safety standard de19 terminations pursuant to subsection 

20 (b)(3)(B)(iii). 

21 ‘‘(ii) INITIAL BATCH.—Not later than 5 

22 years after the date of enactment of the Safe 

23 Chemicals Act of 2011, the Administrator 

24 shall complete and publish safety standard 

25 determinations for all chemical substances 


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1 designated as Priority Class 1 substances in 

2 the initial batch of chemical substances 

3 identified under subsection (a)(3). 

4 ‘‘(iii) SUBSEQUENT BATCHES.—Not 

5 later than 5 years after the date on which 

6 the Administrator designates chemical sub7 stances as Priority Class 1 in each subse8 quent batch of chemical substances under 

9 subsection (a)(2)(A), the Administrator 

10 shall complete and publish safety standard 

11 determinations for those Priority Class 1 

12 substances in the batch. 

13 ‘‘(B) PRIORITY CLASSES 2 AND 3.— 

14 ‘‘(i) IN GENERAL.—Each chemical sub15 stance initially designated as Priority Class 

16 2 or 3 shall become subject to 

17 reprioritization and safety standard deter18 minations in accordance with subsection 

19 (b)(4). 

20 ‘‘(ii) REPRIORITIZATION.—Not later 

21 than 5 years after the date on which the Ad22 ministrator designates a Priority Class 2 or 

23 3 substance to be Priority Class 1, the Ad24 ministrator shall complete and publish the 


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1 safety standard determination on the chem2 ical substance. 

3 ‘‘(C) NOTICE OF OVERDUE DETERMINA4 TION.—If the Administrator fails to act by an 

5 applicable deadline under subparagraph (A) or 

6 (B), each manufacturer and processor of a chem7 ical substance for which the Administrator has 

8 failed to act shall provide to the Administrator, 

9 the public, employees and recognized bargaining 

10 agents of any employees who are represented by 

11 bargaining agents of the manufacturer or proc12 essor, and each known customer who has pur13 chased the chemical substance within a reason14 able timeframe, as determined by the Adminis15 trator by regulation or order, a written notice 

16 that a determination by the Administrator of the 

17 safety of the chemical substance is pending. 

18 ‘‘(D) FAILURE OF MANUFACTURER OR

19 PROCESSOR TO MEET DUTIES.—If a manufac20 turer or processor fails to meet any duty under 

21 this paragraph for a chemical substance, the Ad22 ministrator, by order, may take any action au23 thorized under subsection (f). 

24 ‘‘(5) OUTCOME OF SAFETY STANDARD DETER25 MINATIONS.— 


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1 ‘‘(A) DETERMINATION.— 

2 ‘‘(i) IN GENERAL.—In making a safety 

3 standard determination for a chemical sub4 stance, the Administrator, by order, shall 

5 determine or redetermine, as appropriate, 

6 whether the manufacturers and processors of 

7 the chemical substance have established that 

8 the chemical substance meets the safety 

9 standard. 

10 ‘‘(ii) CONCURRENT PUBLICATION.—The 

11 Administrator— 

12 ‘‘(I) shall seek to publish safety 

13 standard determination and risk man14 agement decisions concurrently, to the 

15 maximum extent practicable; but 

16 ‘‘(II) shall not unduly delay the 

17 issuance of any safety standard deter18 mination if more information or anal19 ysis is required to make a determina20 tion regarding risk management. 

21 ‘‘(iii) OTHER REQUIREMENTS.—The 

22 Administrator— 

23 ‘‘(I) may publish safety standard 

24 determinations for chemical substances 

25 individually or in groups; but 


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1 ‘‘(II) shall publish completed de2 terminations— 

3 ‘‘(aa) not less frequently than 

4 annually; and 

5 ‘‘(bb) at a pace sufficient to 

6 demonstrate steady progress to7 ward completing all such safety 

8 standard determinations within 

9 the required timeframe. 

10 ‘‘(iv) PUBLIC NOTICE AND COMMENT.— 

11 The Administrator shall provide reasonable 

12 public notice and opportunity for comment 

13 on all published safety standard determina14 tions through any reasonable means of pub15 lication and solicitation of comments, in16 cluding electronic means. 

17 ‘‘(B) POSITIVE SAFETY STANDARD DETER18 MINATION WITHOUT NEW CONDITIONS.—If the 

19 Administrator determines that a chemical sub20 stance meets the safety standard for all current 

21 uses and under conditions currently used, the 

22 Administrator shall specify in the order— 

23 ‘‘(i) the allowed uses of the chemical 

24 substance, which shall be limited to the uses 

25 evaluated in the determination; and 


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1 ‘‘(ii) conditions on the specified uses 

2 that are currently used and are to be fol3 lowed to ensure the safety standard is met, 

4 including conditions relating to the manu5 facture, processing, use, distribution in com6 merce, or disposal of a chemical substance 

7 or mixture or article containing the chem8 ical substance. 

9 ‘‘(C) POSITIVE SAFETY STANDARD DETER10 MINATION WITH NEW CONDITIONS.—If the Ad11 ministrator determines that a chemical substance 

12 can only meet the safety standard for a subset of 

13 all current uses or only under conditions beyond 

14 those currently used, the Administrator shall 

15 specify in the order— 

16 ‘‘(i) the allowed uses of the chemical 

17 substance, which shall be limited to the uses 

18 evaluated in the determination that the Ad19 ministrator determines meet the safety 

20 standard; and 

21 ‘‘(ii) all current and all newly required 

22 conditions on the specified uses needed to 

23 ensure the safety standard is met, including 

24 conditions relating to the manufacture, 

25 processing, use, distribution in commerce, 


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1 or disposal of a chemical substance or mix2 ture or article containing the chemical sub3 stance, and any conditions described in sub4 section (f). 

5 ‘‘(D) EFFECTIVE DATE FOR POSITIVE SAFE6 TY STANDARD DETERMINATION.— 

7 ‘‘(i) WITHOUT NEW CONDITIONS.—Ef8 fective beginning on the date that is 90 days 

9 after the date of a determination by the Ad10 ministrator under subparagraph (B), no 

11 person shall manufacture, process, or dis12 tribute in commerce the chemical substance 

13 subject to the determination, or any mixture 

14 or article containing the chemical substance, 

15 for any use or under any condition other 

16 than those specified in the determination 

17 order. 

18 ‘‘(ii) WITH NEW CONDITIONS.—Effec19 tive beginning on the date that is 18 months 

20 after the date of a determination by the Ad21 ministrator under subparagraph (C), except 

22 as provided in clause (iii), no person shall 

23 manufacture, process, or distribute in com24 merce the chemical substance subject to the 

25 determination, or any mixture or article 


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1 containing the chemical substance, for any 

2 use or under any condition other than those 

3 specified in the determination order. 

4 ‘‘(iii) EXCEPTIONAL CIRCUMSTANCE.— 

5 The Administrator may grant a manufac6 turer or processor of a chemical substance a 

7 1-time extension of the deadline for com8 plying with a restriction under clause (ii), 

9 for a period of not longer than 5 years after 

10 the date of the determination by the Admin11 istrator under subparagraph (C), if the 

12 manufacturer or processor demonstrates— 

13 ‘‘(I) a compelling technological 

14 need to continue a restricted activity 

15 beyond the applicable 18-month time 

16 period; or 

17 ‘‘(II) that a factor wholly beyond 

18 the control of the manufacturer or 

19 processor prevents compliance with the 

20 restriction within that 18-month time 

21 period. 

22 ‘‘(E) REDETERMINATION.— 

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

24 shall initiate a redetermination of whether 

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1 ard if new information or significant 

2 changes in manufacture, processing, use, or 

3 distribution in commerce of the chemical 

4 substance, or mixtures or articles con5 taining the chemical substance, raise a cred6 ible question as to whether the chemical sub7 stance continues to meet the safety stand8 ard. 

9 ‘‘(ii) NEW METHODOLOGIES.—The Ad10 ministrator may initiate a redetermination 

11 of whether a chemical substance meets the 

12 safety standard if significant changes have 

13 occurred in the methodologies used in the 

14 initial safety standard determination such 

15 that a redetermination using the newer 

16 methodologies would provide a significantly 

17 improved determination of the safety of the 

18 chemical substance. 

19 ‘‘(iii) NEW INFORMATION.—For a 

20 chemical substance for which a safety stand21 ard determination has been completed, the 

22 Administrator shall assess, on an ongoing 

23 basis, new information, including that ob24 tained from reporting under section 8, to 

25 decide whether such information raises a 


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1 credible question as to whether a chemical 

2 substance continues to meet the safety 

3 standard 

4 ‘‘(iv) PETITION FOR REDETERMINA5 TION.— 

6 ‘‘(I) IN GENERAL.—Any person 

7 may petition the Administrator for a 

8 redetermination of whether a chemical 

9 substance continues to meet the safety 

10 standard. 

11 ‘‘(II) BASIS.—A person shall in12 clude in a petition under this clause a 

13 description of the basis for requesting 

14 the redetermination. 

15 ‘‘(III) ACTION BY ADMINIS16 TRATOR.—On receipt of a petition 

17 under this clause, the Administrator 

18 shall— 

19 ‘‘(aa) not later than 30 days 

20 after the date of receipt, publish 

21 in the Federal Register a notice of 

22 receipt of the petition that speci23 fies the chemical identity of the 

24 chemical substance to which the 

25 petition pertains; 


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1 ‘‘(bb) make the petition 

2 available on request; 

3 ‘‘(cc) provide a reasonable 

4 opportunity for public review and 

5 comment on the petition and give 

6 due consideration to any com7 ments received; 

8 ‘‘(dd) decide whether to make 

9 the requested redetermination; 

10 and 

11 ‘‘(ee) not later than 180 days 

12 after the date of receipt, publish 

13 in the Federal Register the deci14 sion and the basis for the decision. 

15 ‘‘(v) DEADLINE FOR COMPLETION.— 

16 Each redetermination carried out under 

17 this subparagraph shall be completed by not 

18 later than 3 years after the date of the deci19 sion to make the redetermination. 

20 ‘‘(F) NEGATIVE SAFETY STANDARD DETER21 MINATION.— 

22 ‘‘(i) RESTRICTION.—Except as pro23 vided in clause (ii) and subsection (h), effec24 tive beginning on the date that is 18 months 

25 after the date on which the Administrator 


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1 makes a determination under this sub2 section that a chemical substance fails to 

3 meet the safety standard, regardless of 

4 whether additional restrictions on use or 

5 risk management conditions are imposed, 

6 no person shall manufacture, process, or 

7 distribute in commerce that chemical sub8 stance or any mixture or article containing 

9 the chemical substance. 

10 ‘‘(ii) EXCEPTIONAL CIRCUMSTANCE.— 

11 The Administrator may grant a manufac12 turer or processor of a chemical substance a 

13 1-time extension of the deadline for com14 plying with the restriction under clause (i), 

15 for a period of not longer than 5 years after 

16 the date of the determination by the Admin17 istrator under this subparagraph, if the 

18 manufacturer or processor demonstrates— 

19 ‘‘(I) a compelling technological 

20 need to continue a restricted activity 

21 beyond the applicable 18-month time 

22 period; or 

23 ‘‘(II) that a factor wholly beyond 

24 the control of the manufacturer or 

25 processor prevents compliance with the 


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1 restriction within that 18-month time 

2 period. 

3 ‘‘(e) EXPEDITED ACTION FOR SUBSTANCES OF VERY

4 HIGH CONCERN.— 

5 ‘‘(1) USE AND EXPOSURE ASSESSMENT.— 

6 ‘‘(A) IN GENERAL.—Not later than 180 

7 days after the date on which a chemical sub8 stance is assigned to the category of substances of 

9 very high concern under subsection (b)(3)(B)(i), 

10 the Administrator may require, by order pursu11 ant to section 8(g), the submission by manufac12 turers or processors of the chemical substance of 

13 any additional information the Administrator 

14 determines to be necessary to conduct an expe15 dited assessment of the known uses of, and expo16 sures to, the chemical substance. 

17 ‘‘(B) PUBLICATION.—Not later than 1 year 

18 after the date on which a chemical substance is 

19 assigned to the category of substances of very 

20 high concern under subsection (b)(3)(B)(i), the 

21 Administrator shall complete and publish an 

22 identification and assessment of the known uses 

23 of, and exposures to, the chemical substance. 

24 ‘‘(2) EXPOSURE REDUCTION.— 


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1 ‘‘(A) USE RESTRICTIONS AND OTHER CON2 DITIONS.—As soon as practicable, but not later 

3 than 18 months, after the date on which a chem4 ical substance is assigned to the category of sub5 stances of very high concern under subsection 

6 (b)(3)(B)(i), the Administrator shall impose, by 

7 order, use restrictions and other conditions, in8 cluding the conditions specified in subsection (f), 

9 on the manufacturing, processing, use, distribu10 tion in commerce, and disposal of the chemical 

11 substance that the Administrator determines to 

12 be necessary to achieve the maximum practicable 

13 reduction in human or environmental exposure 

14 to the chemical substance. 

15 ‘‘(B) TIMING.—Except as provided in sub16 paragraph (C) and subsection (h), effective be17 ginning on the date that is 18 months after the 

18 date of issuance by the Administrator of the 

19 order described in subparagraph (A), no person 

20 shall manufacture, process, or distribute in com21 merce the chemical substance subject to the deter22 mination, or any mixture or article containing 

23 the chemical substance, for any use or under any 

24 condition other than those specified in the order 

25 issued under subparagraph (A). 


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1 ‘‘(C) EXCEPTIONAL CIRCUMSTANCE.—The 

2 Administrator may grant a manufacturer or 

3 processor of a chemical substance a 1-time exten4 sion of the deadline for complying with the re5 striction under subparagraph (B), for a period of 

6 not longer than 5 years after the date of the de7 termination by the Administrator under this 

8 paragraph, if the manufacturer or processor 

9 demonstrates— 

10 ‘‘(i) a compelling technological need to 

11 continue a restricted activity beyond the ap12 plicable 18-month time period; or 

13 ‘‘(ii) that a factor wholly beyond the 

14 control of the manufacturer or processor 

15 prevents compliance with the restriction 

16 within that 18-month time period. 

17 ‘‘(3) RESIDUAL RISK ASSESSMENT.—Not later 

18 than 1 year after the deadline specified in paragraph 

19 (2)(B), or of an alternative deadline provided under 

20 paragraph (2)(C), the Administrator shall— 

21 ‘‘(A) determine whether the chemical sub22 stance meets the safety standard for the chemical 

23 substance, taking into account the residual risk 

24 posed by continued exposure to the chemical sub25 stance; and 


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1 ‘‘(B) impose any additional restrictions on 

2 use or other conditions under subsection (f) that 

3 the Administrator determines to be necessary to 

4 ensure that the chemical substance meets the 

5 safety standard. 

6 ‘‘(f) RISK MANAGEMENT.—In issuing an order under 

7 subsection (d) or (e), the Administrator may impose condi8 tions on the manufacture, processing, use, distribution in 

9 commerce, or disposal of a chemical substance, or mixture 

10 or article containing a chemical substance, including a re11 quirement— 

12 ‘‘(1) limiting the quantity of the chemical sub13 stance (or mixture or article containing that chemical 

14 substance) that may be manufactured, processed, or 

15 distributed in commerce; 

16 ‘‘(2)(A) prohibiting the manufacturing, proc17 essing, or distribution in commerce of the chemical 

18 substance (or mixture or article containing that 

19 chemical substance) for a particular use in a con20 centration in excess of a level specified by the Admin21 istrator; or 

22 ‘‘(B) limiting the quantity of the chemical sub23 stance (or mixture or article containing that chemical 

24 substance) that may be manufactured, processed, or 

25 distributed in commerce for— 


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1 ‘‘(i) a particular use; or 

2 ‘‘(ii) a particular use in a concentration in 

3 excess of a level specified by the Administrator; 

4 ‘‘(3) that the chemical substance (or mixture, or 

5 article containing that chemical substance) be marked 

6 with, or accompanied by, clear and adequate warn7 ings and instructions with respect to use, distribution 

8 in commerce, or disposal, or any combination of such 

9 activities, with the form and content of the warnings 

10 and instructions prescribed by the Administrator; 

11 ‘‘(4) that manufacturers and processors of the 

12 chemical substance (or mixture or article containing 

13 that chemical substance)— 

14 ‘‘(A) make and retain records of the proc15 esses used to manufacture or process the chemical 

16 substance (or mixture or article containing that 

17 chemical substance); and 

18 ‘‘(B) monitor or conduct tests that are rea19 sonable and necessary to ensure compliance with 

20 this Act; 

21 ‘‘(5) prohibiting or otherwise regulating any 

22 manner or method of commercial use of the chemical 

23 substance (or mixture or article containing that 

24 chemical substance); 


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1 ‘‘(6) prohibiting or otherwise regulating any 

2 manner or method of disposal of the chemical sub3 stance, mixture, or article, by— 

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

5 chemical substance (or mixture or article con6 taining that chemical substance); or 

7 ‘‘(B) any other person that uses or disposes 

8 of the chemical substance (or mixture or article 

9 containing that chemical substance) for commer10 cial purposes; 

11 ‘‘(7) that the manufacturers and processors of the 

12 chemical substance, mixture, or article develop a risk 

13 reduction management plan, under subsection (h) or 

14 (e) of this section, to achieve a risk reduction specified 

15 by the Administrator; or 

16 ‘‘(8) that the Administrator otherwise determines 

17 is appropriate. 

18 ‘‘(g) QUALITY CONTROL ORDERS.— 

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

20 reasonable basis to conclude that a particular manu21 facturer or processor is manufacturing or processing 

22 a chemical substance in a manner that may present 

23 a substantial endangerment to health or the environ24 ment, the Administrator may require, by order, that 

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1 trator a description of the quality control procedures 

2 followed in the manufacturing or processing of the 

3 chemical substance or mixture. 

4 ‘‘(2) ORDERS.— 

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

6 determines that quality control procedures de7 scribed in paragraph (1) are inadequate to pre8 vent a chemical substance from presenting a risk 

9 of injury to human health or the environment, 

10 the Administrator may order the manufacturer 

11 or processor to revise the quality control proce12 dures to the extent necessary to remedy the inad13 equacy. 

14 ‘‘(B) SUBSTANTIAL ENDANGERMENT.—If the 

15 Administrator determines that quality control 

16 procedures described in paragraph (1) have re17 sulted in the distribution in commerce of a chem18 ical substance that may present a substantial 

19 endangerment to human health or the environ20 ment, the Administrator may order the manufac21 turer or processor— 

22 ‘‘(i) to give notice of the endangerment 

23 to— 


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1 ‘‘(I) processors or distributors (or 

2 both) in commerce of the chemical sub3 stance or mixture; and 

4 ‘‘(II) to the extent reasonably as5 certainable, any other person in posses6 sion of or exposed to the chemical sub7 stance or mixture; 

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

9 endangerment; and 

10 ‘‘(iii) to provide for the replacement or 

11 repurchase, as prescribed by the Adminis12 trator, of the chemical substance as the Ad13 ministrator determines to be necessary to 

14 adequately protect human health or the en15 vironment. 

16 ‘‘(h) EXEMPTIONS TO RESTRICTIONS.— 

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

18 the restrictions established under section 

19 5(b)(1)(C)(ii)(I), subsection (d)(5), and subsection (e). 

20 ‘‘(2) EXEMPTIONS.— 

21 ‘‘(A) IN GENERAL.— 

22 ‘‘(i) REQUEST.—A person who manu23 facturers, processes, distributes in commerce, 

24 uses, or disposes of a chemical substance, or 

25 a mixture or article containing a chemical 


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1 substance may request an exemption from 

2 any restriction referred to in paragraph (1) 

3 to which they are subject for a specified use 

4 of the chemical substance. 

5 ‘‘(ii) ORDER.—The Administrator may 

6 grant, by order, an exemption from any re7 striction referred to in paragraph (1) for a 

8 period of not longer than 5 years if the per9 son has established by clear and convincing 

10 evidence that the uses to be exempted meet 

11 the exemption criteria described in subpara12 graph (B). 

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

14 grant an exemption for the use of a chemical 

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

16 ‘‘(i) the exemption is in the paramount 

17 interest of national security; 

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

19 chemical substance would cause significant 

20 disruption in the national economy; or 

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

22 is sought is a critical or essential use for 

23 which— 


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1 ‘‘(I) no feasible safer alternative 

2 for the specified use of the chemical 

3 substance is available; or 

4 ‘‘(II) the specified use of the chem5 ical substance, as compared to all 

6 available alternatives, provides a sub7 stantial net benefit to human health, 

8 the environment, or public safety. 

9 ‘‘(C) PUBLIC NOTICE.—If the Administrator 

10 grants an exemption for a chemical substance 

11 under this paragraph— 

12 ‘‘(i) the manufacturer or processor of 

13 the chemical substance shall provide a no14 tice of the exemption to each known pur15 chaser of— 

16 ‘‘(I) the chemical substance; and 

17 ‘‘(II) a mixture or article con18 taining the chemical substance; and 

19 ‘‘(ii) the Administrator shall provide 

20 the public with a notice of the exemption. 

21 ‘‘(D) RENEWAL.—The Administrator may 

22 renew, by order, an exemption under this para23 graph for 1 or more additional 5-year periods if 

24 the Administrator concludes, after providing 

25 public notice and an opportunity for comment, 


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1 that the use of the chemical substance continues 

2 to meet the criteria described in subparagraph 

3 (B). 

4 ‘‘(E) CONDITIONS.— 

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

6 may impose, by order, any condition on an 

7 exemption issued under this paragraph that 

8 the Administrator determines to be nec9 essary to ensure the protection of human 

10 health and the environment on the use of a 

11 chemical substance exempted under this 

12 paragraph. 

13 ‘‘(ii) COMPLIANCE.—Effective imme14 diately after the Administrator establishes 

15 conditions on an exempted use under clause 

16 (i), the manufacturing, processing, or dis17 tribution in commerce of the chemical sub18 stance, or any mixture or article containing 

19 the chemical substance, shall be prohibited 

20 except to the extent that the conditions are 

21 satisfied. 

22 ‘‘(3) RESALE OF USED ARTICLES.— 

23 ‘‘(A) IN GENERAL.—The restrictions re24 ferred to in paragraph (1) shall not apply to the 

25 resale of an article subject to a restriction under 


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1 subsection (b) if the article has previously been 

2 used by an end consumer. 

3 ‘‘(B) COMPLIANCE.—The Administrator 

4 may utilize the authorities contained in section 

5 7 to address potential threats to public health 

6 and the environment from such articles. 

7 ‘‘(4) EXTENSIONS OF EFFECTIVE DATES FOR RE8 TAIL SALE OF ARTICLES TO END CONSUMERS.— 

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

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

11 to an end consumer of a chemical substance (or 

12 mixture or article containing that chemical sub13 stance) that is subject to a restriction described 

14 in paragraph (1), the Administrator may extend, 

15 by order, the effective date of the restriction by 

16 a period of not longer than 3 years, if the Ad17 ministrator determines that the extension— 

18 ‘‘(i) is necessary and appropriate to 

19 allow for depletion of the existing retail in20 ventory; and 

21 ‘‘(ii) will not present a substantial 

22 endangerment to human health or the envi23 ronment. 

24 ‘‘(B) EXCEPTION.—An extension under sub25 paragraph (A) shall not apply to any retailer 


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1 that the Administrator determines has failed to 

2 comply with an order requesting information 

3 issued by the Administrator pursuant to section 

4 8.’’; 

5 SEC. 8. IMMINENT HAZARDS. 

6 Section 7 of the Toxic Substances Control Act (15 

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

8 ‘‘SEC. 7. IMMINENT HAZARDS. 

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

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

11 commence a civil action in an appropriate district 

12 court of the United States for— 

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

14 mixture, or any article containing a chemical 

15 substance or mixture, that may present an im16 minent and substantial endangerment to health 

17 or the environment; 

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

19 against any person that— 

20 ‘‘(i) manufactures, processes, distrib21 utes in commerce, uses, or disposes of a 

22 chemical substance or mixture, or any arti23 cle containing a chemical substance or mix24 ture, if the manufacture, processing, dis25 tribution in commerce, use, or disposal 


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1 may present an imminent and substantial 

2 endangerment to health or the environ3 ment; or 

4 ‘‘(ii) contributes to an activity de5 scribed in clause (i); or 

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

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

8 ‘‘(2) OTHER ACTIONS.— 

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

10 may issue such orders as are necessary to pro11 tect health or the environment from any manu12 facturing, processing, distribution in commerce, 

13 use, or disposal of a chemical substance or mix14 ture, or any article containing such a substance 

15 or mixture, that may present an imminent and 

16 substantial endangerment to health or the envi17 ronment, as determined by the Administrator. 

18 ‘‘(B) REQUIREMENT.—An order under 

19 subparagraph (A) may include such require20 ments imposed on the manufacture, processing, 

21 distribution in commerce, use, or disposal of a 

22 chemical substance or mixture, or article con23 taining the chemical substance or mixture, as 

24 the Administrator determines are necessary to 

25 protect health or the environment, including— 


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1 ‘‘(i) the requirements described in sec2 tion 6(c); and 

3 ‘‘(ii) the relief authorized under sub4 section (b). 

5 ‘‘(3) RELATIONSHIP TO EXISTING RULES, OR6 DERS, AND PROCEEDINGS.—A civil action may be 

7 commenced under paragraph (1), or other action 

8 may be taken under paragraph (2), notwith9 standing— 

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

11 this Act; and 

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

13 judicial proceeding under this Act. 

14 ‘‘(b) RELIEF AUTHORIZED.— 

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

16 United States in which a civil action under sub17 section (a)(1) is brought shall have jurisdiction to 

18 grant such temporary or permanent relief as are 

19 necessary to protect health or the environment from 

20 the risk associated with the activity involved in the 

21 civil action. 

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

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

24 person that manufactures, processes, distributes in 

25 commerce, uses, or disposes of a chemical substance 


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1 or mixture or an article containing a chemical sub2 stance or mixture, the relief authorized by para3 graph (1) may include— 

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

5 imposing any of the requirements described in 

6 section 6(c); and 

7 ‘‘(B) in the case of purchasers of the sub8 stance, mixture, or article known to the defend9 ant— 

10 ‘‘(i) notification to the purchasers of 

11 the risk associated with the substance, 

12 mixture, or article; 

13 ‘‘(ii) public notice of the risk; 

14 ‘‘(iii) recall; 

15 ‘‘(iv) the replacement or repurchase of 

16 the substance, mixture, or article; or 

17 ‘‘(v) any combination of the actions 

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

19 through (iv) of this subparagraph; or 

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

21 protect health or the environment from the risk 

22 associated with the activity involved in the civil 

23 action. 

24 ‘‘(3) SEIZURE AND CONDEMNATION.— 


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

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

3 mixture, or article may be proceeded against by 

4 process of libel for seizure and condemnation of 

5 the chemical substance, mixture, or article. 

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

7 civil action described in subparagraph (A) shall 

8 conform, to the maximum extent practicable, to 

9 proceedings in rem in admiralty. 

10 ‘‘(c) VENUE AND CONSOLIDATION.— 

11 ‘‘(1) VENUE.— 

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

13 subsection (a)(1) against a person that manu14 factures, processes, or distributes a chemical 

15 substance or mixture or an article containing a 

16 chemical substance or mixture may be brought 

17 in the United States District Court for the Dis18 trict of Columbia, or in any judicial district in 

19 which any of the defendants is found, resides, 

20 or transacts business. 

21 ‘‘(B) PROCESS.—Process in an action de22 scribed in subparagraph (A) may be served on 

23 a defendant in any other district in which the 

24 defendant resides or may be found. 


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1 ‘‘(C) CHEMICAL SUBSTANCES, MIXTURES, 

2 OR ARTICLES.—A civil action under subsection 

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

4 article may be brought in any United States 

5 district court within the jurisdiction of which 

6 the chemical substance, mixture, or article is 

7 found. 

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

9 determining the judicial district in which a civil 

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

11 in instances in which the action may be brought 

12 in more than 1 judicial district, the Adminis13 trator shall take into account the convenience of 

14 the parties. 

15 ‘‘(E) SUBPOENAS.—Subpoenas requiring 

16 attendance of witnesses in a civil action brought 

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

18 judicial district. 

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

20 subsection (a)(1) involving identical chemical sub21 stances, mixtures, or articles are pending in courts 

22 in 2 or more judicial districts, the proceedings shall 

23 be consolidated for trial by order of any such court 

24 on application reasonably made by any party in in25 terest, on notice to all parties in interest.’’. 


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1 SEC. 9. REPORTING AND RETENTION OF INFORMATION. 

2 Section 8 of the Toxic Substances Control Act (15 

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

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

5 ‘‘(a) SUBSTANCE IDENTIFICATION, DECLARATION, 

6 AND INFORMATION.— 

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

8 the date of enactment of the Safe Chemicals Act of 

9 2011, each manufacturer or processor of a chemical 

10 substance distributed in commerce shall submit to 

11 the Administrator the declaration described in para12 graph (2) or (3), accompanied by the certification 

13 described in subsection (h). 

14 ‘‘(2) DECLARATION OF CURRENT MANUFAC15 TURE OR PROCESSING.—A declaration described in 

16 this paragraph is a statement that includes, for each 

17 chemical substance manufactured or processed by a 

18 manufacturer or processor— 

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

20 substance characteristics of the chemical sub21 stance; 

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

23 under the control of the manufacturer or proc24 essor at which the chemical substance is manu25 factured or processed or from which the chem26 ical substance is distributed in commerce; 


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

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

3 reasonably ascertainable by the manufacturer 

4 or processor with respect to the chemical sub5 stance, and copies of any such studies that have 

6 not previously been submitted to the Adminis7 trator; and 

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

9 possession or control of, or reasonably ascer10 tainable by the manufacturer or processor that 

11 has not previously been submitted to the Ad12 ministrator regarding— 

13 ‘‘(i) the physical, chemical, and toxi14 cological properties of the chemical sub15 stance; 

16 ‘‘(ii) the annual production volume 

17 and known uses of, and exposure and fate 

18 information relating to, the chemical sub19 stance; and 

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

21 facility to which the chemical substance is 

22 sent, after manufacture and processing, for 

23 subsequent processing, distribution, or use. 

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1 scribed in this paragraph is a statement certifying 

2 that the manufacturer or processor has ceased, or 

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

4 submission of the declaration, all production, impor5 tation, processing, and export of the chemical sub6 stance. 

7 ‘‘(4) UPDATING OF INFORMATION.—Each man8 ufacturer or processor of a chemical substance that 

9 submits to the Administrator a declaration described 

10 in paragraph (2) shall update and submit to the Ad11 ministrator a new declaration— 

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

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

14 there becomes known or available to, in the pos15 session or control of, or reasonably ascertain16 able by the manufacturer or processor signifi17 cant new information regarding a physical, 

18 chemical, toxicological property or use of, or ex19 posure to, the chemical substance, including 

20 any information that— 

21 ‘‘(i) demonstrates a new potential 

22 toxic effect of the chemical substance; 

23 ‘‘(ii) corroborates previous informa24 tion demonstrating or suggesting a toxic 

25 effect; or 


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

2 dose than previously demonstrated. 

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

4 Each manufacturer or processor of a chemical sub5 stance distributed in commerce shall maintain 

6 records of the information described in subpara7 graphs (A) through (D) of paragraph (2). 

8 ‘‘(6) PROHIBITION ON MANUFACTURING, PROC9 ESSING, OR DISTRIBUTION.—The Administrator 

10 may, by order, prohibit a manufacturer or processor 

11 in violation of this subsection from manufacturing, 

12 processing, or distributing in commerce the chemical 

13 substance or any article containing the chemical sub14 stance, except as authorized under section 6(e). 

15 ‘‘(b) REPORTS.— 

16 ‘‘(1) REQUIREMENT.— 

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

18 paragraph (2), the Administrator may by rule 

19 or order require any person who manufactures, 

20 processes, distributes in commerce, uses, or dis21 poses of a chemical substance to maintain 

22 records of and report by a specified date any in23 formation concerning the substance that, in the 

24 judgment of the Administrator, would assist the 

25 Administrator in— 


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1 ‘‘(i) making a safety standard deter2 mination with respect to a chemical sub3 stance under this title; or 

4 ‘‘(ii) any other aspect of administering 

5 this Act. 

6 ‘‘(B) CHARACTERISTICS.—The Adminis7 trator may by rule or order require that any re8 port or information submitted pursuant to this 

9 Act include chemical identity and special sub10 stance characteristics, as appropriate to the 

11 chemical substance that is the subject of the re12 port or information. 

13 ‘‘(C) REQUIRED INFORMATION.—The Ad14 ministrator shall by rule or order specify or 

15 modify the information that is required to be 

16 submitted with a particular report or informa17 tion submission to establish the chemical iden18 tity and special substance characteristics of the 

19 subject chemical substance (or mixture or arti20 cle containing that chemical substance) for the 

21 purposes of the report or information submis22 sion. 

23 ‘‘(2) SMALL QUANTITIES FOR RESEARCH OR

24 ANALYSIS.—In the case of the manufacture, proc25 essing, distribution in commerce, use, or disposal of 


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1 a chemical substance in small quantities (as defined 

2 by the Administrator by rule) solely for purposes of 

3 scientific experimentation or analysis or chemical re4 search (including any such research or analysis for 

5 the development of a product), the Administrator 

6 may promulgate or issue a rule or order under para7 graph (1) only to the extent that the Administrator 

8 determines the maintenance of records or submission 

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

10 enforcement of this Act. 

11 ‘‘(3) PROHIBITION ON MANUFACTURING, PROC12 ESSING, OR DISTRIBUTION.—The Administrator 

13 may, by order, prohibit a manufacturer or processor 

14 in violation of a requirement of a rule or order 

15 under paragraph (1) from manufacturing, proc16 essing, or distributing in commerce the chemical 

17 substance or any article containing the chemical sub18 stance, except as authorized under section 6(e). 

19 ‘‘(c) INVENTORY.— 

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

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

22 chemical substance that is manufactured or proc23 essed in the United States. 

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

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1 son reports, under section 5 or subsection (b) of this 

2 section, is manufactured or processed in the United 

3 States. 

4 ‘‘(3) TIMING.— 

5 ‘‘(A) IN GENERAL.—In the case of a chem6 ical substance for which a notice is submitted in 

7 accordance with section 5, the chemical sub8 stance shall be included on the list as of the 

9 earliest date (as determined by the Adminis10 trator) on which the substance was manufac11 tured or processed in the United States. 

12 ‘‘(B) PUBLICATION.—The Administrator 

13 shall first publish a list under subparagraph (A) 

14 not later than 18 months after the effective 

15 date of this Act. 

16 ‘‘(4) SMALL QUANTITIES FOR RESEARCH OR

17 ANALYSIS.—The Administrator shall not include in 

18 the list any chemical substance that is manufactured 

19 or processed only in small quantities (as defined by 

20 the Administrator by rule) solely for purposes of sci21 entific experimentation or analysis or chemical re22 search on, or analysis of, the substance or another 

23 substance, including such research or analysis for 

24 the development of a product. 


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1 ‘‘(d) PUBLIC ACCESS TO SIGNIFICANT INFORMA2 TION.— 

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

4 1 year after the date of enactment of the Safe 

5 Chemicals Act of 2011, the Administrator, through 

6 collaboration, as appropriate, shall establish— 

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

8 database for storing and sharing of information 

9 relating to the toxicity and use of, and exposure 

10 to, chemical substances; and 

11 ‘‘(B) procedures for use in maintaining 

12 and updating the database. 

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

14 months after the date of enactment of the Safe 

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

16 after the date of decisions made by the Adminis17 trator or receipt by the Administrator of information 

18 submitted pursuant to this title (for decisions made 

19 or information submitted after that 18-month pe20 riod), the Administrator shall, subject to section 14, 

21 make available to the public via the Internet-acces22 sible database described in paragraph (1) a descrip23 tion of all significant— 

24 ‘‘(A) decisions made by the Administrator 

25 under this title; and 


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1 ‘‘(B) information submitted pursuant to 

2 this title. 

3 ‘‘(e) RECORDS.— 

4 ‘‘(1) IN GENERAL.—Any person that manufac5 tures, processes, or distributes in commerce any 

6 chemical substance shall maintain and submit to the 

7 Administrator records of significant adverse reac8 tions to health or the environment, as determined by 

9 the Administrator by rule, that are alleged to have 

10 been caused by the substance. 

11 ‘‘(2) DURATION.— 

12 ‘‘(A) IN GENERAL.—Records of the ad13 verse reactions to the health of employees shall 

14 be retained for a period of at least 30 years 

15 after the date on which the reactions were first 

16 reported to or known by the person maintaining 

17 the records. 

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

19 of the adverse reactions shall be retained for a 

20 period of at least 5 years after the date on 

21 which information contained in the record was 

22 first reported to or known by the person main23 taining the record. 

24 ‘‘(3) CONTENTS.—Records required to be main25 tained under this subsection shall include— 


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1 ‘‘(A) records of consumer allegations of 

2 personal injury or harm to health; 

3 ‘‘(B) reports of occupational disease or in4 jury; and 

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

6 environment submitted to the manufacturer, 

7 processor, or distributor in commerce from any 

8 source. 

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

10 FEDERAL AGENCIES.— 

11 ‘‘(1) SYNOPSES.— 

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

13 each Federal agency and Federal institution 

14 shall submit to the Administrator a synopsis of 

15 the data and records in the possession or con16 trol of the agency or institution, respectively, 

17 that may be useful to the Administrator in car18 rying out this Act. 

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

20 than 1 year after the date of enactment of the 

21 Safe Chemicals Act of 2011, the Administrator 

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

23 and level of detail of the synopses. 

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

25 18 months after the date of enactment of the 


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1 Safe Chemicals Act of 2011, each Federal agen2 cy and Federal institution shall make the initial 

3 submission of a synopsis of the agency and in4 stitution, respectively, to the Administrator. 

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

6 years, each Federal agency and Federal institu7 tion shall— 

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

9 and institution, respectively; and 

10 ‘‘(ii) submit the updated synopsis to 

11 the Administrator. 

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

13 request of the Administrator, any information in the 

14 possession or control of an agency or institution re15 lating to a hazard of, use of, exposure to, or risk of 

16 a chemical substance (or mixture or article con17 taining that chemical substance) shall be provided to 

18 the Administrator. 

19 ‘‘(g) NOTICE TO ADMINISTRATOR OF SUBSTANTIAL

20 RISKS.—Any person that manufactures, processes, or dis21 tributes in commerce a chemical substance and that ob22 tains information that reasonably supports the conclusion 

23 that the substance presents a substantial risk of injury 

24 to health or the environment shall immediately inform the 

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1 tual knowledge that the Administrator has been ade2 quately informed of the information. 

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

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

5 promulgated or issued by the Administrator under this 

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

7 shall be accompanied by a certification signed by a respon8 sible official of the manufacturer or processor that each 

9 statement 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 ‘‘(i) DEFINITION OF MANUFACTURE AND PROC15 ESS.—In this section, the terms ‘manufacture’ and ‘proc16 ess’ mean manufacture and process, respectively, for com17 mercial purposes.’’. 

18 SEC. 9. REPORTING AND RETENTION OF INFORMATION. 

19 Section 8 of the Toxic Substances Control Act (15 

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

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

22 ‘‘(a) DEFINITIONS.—In this section: 

23 ‘‘(1) KNOWN TO, OR REASONABLY ASCERTAIN24 ABLE BY.—The term ‘known to, or reasonably ascer25 tainable by’ has the meaning given the term in secVerDate Mar 15 2010 23:53 Dec 27, 2012 Jkt 029200 PO 00000 Frm 00221 Fmt 6652 Sfmt 6203 E:\BILLS\S847.RS S847

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1 tion 704.3 of title 40, Code of Federal Regulations (or 

2 successor regulations). 

3 ‘‘(2) MANUFACTURE AND PROCESS.—The terms 

4 ‘manufacture’ and ‘process’ mean manufacture and 

5 process, respectively, for commercial purposes. 

6 ‘‘(b) DECLARATIONS OF CHEMICAL SUBSTANCES IN

7 COMMERCE.— 

8 ‘‘(1) SCOPE AND CRITERIA.— 

9 ‘‘(A) SCOPE.—The declarations described in 

10 this subsection shall apply only to chemical sub11 stances in commerce as of the date of enactment 

12 of the Safe Chemicals Act of 2011. 

13 ‘‘(B) CRITERIA.—The following criteria 

14 shall apply in identifying chemical substances to 

15 which the declarations described in this sub16 section apply: 

17 ‘‘(i) CURRENT COMMERCIAL INTER18 EST.—A chemical substance in which a 

19 manufacturer or processor has a current 

20 commercial interest shall include only 

21 chemical substances that the manufacturer 

22 or processor— 

23 ‘‘(I) is currently manufacturing 

24 or processing; or 


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1 ‘‘(II) has manufactured or proc2 essed in the recent past and expects to 

3 manufacture or process again in the 

4 near future. 

5 ‘‘(ii) POTENTIAL COMMERCIAL INTER6 EST.—A chemical substance in which a 

7 manufacturer or processor has a potential 

8 commercial interest shall include only a 

9 chemical substance that may serve as a rea10 sonable substitute for a chemical substance 

11 in which the manufacturer or processor has 

12 declared a current commercial interest. 

13 ‘‘(C) GUIDANCE.—Not later than 90 days 

14 after the date of enactment of the Safe Chemicals 

15 Act of 2011, the Administrator shall issue guid16 ance further describing the criteria described in 

17 subparagraph (B) and specifying the supporting 

18 information manufacturers and processors are to 

19 include in declarations they submit pursuant to 

20 paragraph (2) or (3) for chemical substances in 

21 which they have a current or potential commer22 cial interest. 

23 ‘‘(2) DECLARATION OF CURRENT COMMERCIAL

24 INTEREST IN A CHEMICAL SUBSTANCE.— 


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1 ‘‘(A) IN GENERAL.—Notwithstanding any 

2 other provision of law, not later than 180 days 

3 after the date of enactment of the Safe Chemicals 

4 Act of 2011, each manufacturer of a chemical 

5 substance in which the manufacturer has a cur6 rent commercial interest shall submit to the Ad7 ministrator a declaration of the interest for the 

8 chemical substance. 

9 ‘‘(B) EXCLUSIONS OR EXEMPTIONS.—Dec10 larations are required for all chemical substances 

11 in which a manufacturer has a current commer12 cial interest, notwithstanding any exclusions or 

13 exemptions from other notification or reporting 

14 requirements provided in any other provision of 

15 this Act. 

16 ‘‘(C) PROCESSORS.—A processor of a chem17 ical substance in which the processor has a cur18 rent commercial interest that meets the criteria 

19 described in paragraph (1)(B)(i) may volun20 tarily submit to the Administrator a declaration 

21 for the chemical substance. Such a declaration 

22 shall be submitted not later than 1 year after the 

23 date of enactment of the Safe Chemicals Act of 

24 2011. 


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1 ‘‘(3) DECLARATION OF POTENTIAL COMMERCIAL

2 INTEREST IN A CHEMICAL SUBSTANCE.— 

3 ‘‘(A) A manufacturer or processor may vol4 untarily submit to the Administrator, not later 

5 than 180 days after the date of enactment of the 

6 Safe Chemicals Act of 2011, a declaration for a 

7 chemical substance in which the manufacturer or 

8 processor— 

9 ‘‘(i) does not have a current commer10 cial interest; but 

11 ‘‘(ii) has a potential commercial inter12 est that meets the criteria described in 

13 paragraph (1)(B)(ii). 

14 ‘‘(B) If a manufacturer or processor com15 mences the manufacture or processing of a chem16 ical substance for which it submitted a declara17 tion under this paragraph, the manufacturer or 

18 processor shall comply with the requirements of 

19 subsection (h)(5)(B). 

20 ‘‘(4) DECLARATION OF CESSATION OF MANUFAC21 TURING OR PROCESSING.—A former or current manu22 facturer or processor of a chemical substance in which 

23 the manufacturer or processor no longer has a com24 mercial interest may voluntarily submit to the Ad25 ministrator, not later than 180 days after the date of 


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1 enactment of the Safe Chemicals Act of 2011, a dec2 laration that the manufacturer or processor has 

3 ceased, or will cease not later than 180 days after the 

4 date on which the declaration is submitted, all pro5 duction, importation, processing, and export of the 

6 chemical substance. 

7 ‘‘(5) CONTENTS.—A declaration submitted under 

8 this subsection shall include for each chemical sub9 stance— 

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

11 substance characteristics of the chemical sub12 stance; 

13 ‘‘(B) the identity and primary business lo14 cation of the manufacturer or processor; and 

15 ‘‘(C) information supporting the declarant’s 

16 basis for meeting the applicable criteria under 

17 paragraph (1)(B). 

18 ‘‘(6) REVIEW BY ADMINISTRATOR.— 

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

20 shall— 

21 ‘‘(i) review each declaration received 

22 under this subsection to determine whether 

23 the declaration conforms to the criteria and 

24 requirements of this subsection; and 


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1 ‘‘(ii)(I) for a chemical substance for 

2 which 1 or more conforming declarations 

3 are submitted under paragraph (2), add the 

4 chemical substance to the list of active 

5 chemical substances in the inventory estab6 lished under subsection (h)(1); 

7 ‘‘(II) for a chemical substance for 

8 which the only conforming declarations sub9 mitted for the substance are submitted 

10 under paragraph (3), add the chemical sub11 stance to the list of inactive chemical sub12 stances in the inventory established under 

13 subsection (h)(5); and 

14 ‘‘(III) for a chemical substance for 

15 which the only conforming declarations sub16 mitted for the substance are submitted 

17 under paragraph (4), or for which no dec18 laration has been submitted, remove the 

19 chemical substance from the inventories es20 tablished under subsection (h). 

21 ‘‘(B) REVISIONS.—The Administrator shall 

22 allow a manufacturer or processor, as applicable, 

23 to promptly revise and resubmit any declaration 

24 submitted to the Administrator under this sub25 section if the Administrator determines that any 


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1 omission or error in the original declaration was 

2 not intentional. 

3 ‘‘(c) PERIODIC REPORTING BY MANUFACTURERS.— 

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

5 ‘‘(A) maintain the periodic reporting pro6 gram of the agency applicable to manufacturers 

7 of chemical substances set forth in part 711 of 

8 title 40, Code of Federal Regulations (as in effect 

9 on the date of enactment of the Safe Chemicals 

10 Act of 2011), unless such reporting requirements 

11 are superseded pursuant to subparagraph (B); or 

12 ‘‘(B) establish a new periodic reporting pro13 gram consistent with this subsection. 

14 ‘‘(2) RULEMAKING.— 

15 ‘‘(A) IN GENERAL.—Not later than 180 

16 days after the date of enactment of the Safe 

17 Chemicals Act of 2011, the Administrator shall 

18 specify, by rule— 

19 ‘‘(i) the chemical substances for which 

20 periodic reporting is required; and 

21 ‘‘(ii) the information a chemical man22 ufacturer is required to submit to the Ad23 ministrator for the chemical substances in24 cluded under the periodic reporting pro25 gram. 


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1 ‘‘(B) EXEMPTIONS.—The rule promulgated 

2 under subparagraph (A) may exempt certain 

3 manufacturers, including small manufacturers, 

4 from— 

5 ‘‘(i) a requirement to participate in 

6 the periodic reporting program, if the Ad7 ministrator determines that the participa8 tion of those manufacturers would not assist 

9 in the administration of this Act; or 

10 ‘‘(ii) specific reporting requirements, if 

11 the Administrator determines that the value 

12 of a particular reporting requirement, for 

13 the administration of this Act, would not be 

14 commensurate with the burden of the re15 quirement on submitters. 

16 ‘‘(C) CONTENTS.—The rule promulgated 

17 under subparagraph (A) shall, at a minimum, 

18 require each manufacturer of a chemical sub19 stance included in the periodic reporting pro20 gram to submit to the Administrator— 

21 ‘‘(i) the chemical identity and any spe22 cial substance characteristics of the chemical 

23 substance, the identity and primary busi24 ness location of the manufacturer, and any 

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1 mitted by the manufacturer in any declara2 tion for an included chemical substance sub3 mitted under subsection (b); 

4 ‘‘(ii) a list of health and safety studies 

5 conducted or initiated by or for, known to, 

6 or reasonably ascertainable by, the manu7 facturer with respect to each included chem8 ical substance; 

9 ‘‘(iii) a copy of each study described in 

10 clause (ii) in the possession or control of the 

11 manufacturer that has not previously been 

12 submitted to the Administrator; and 

13 ‘‘(iv) all other information specified by 

14 the Administrator in the rules promulgated 

15 under this subsection that is known to, in 

16 the possession or control of, or reasonably 

17 ascertainable by, the manufacturer or proc18 essor that has not previously been submitted 

19 to the Administrator regarding— 

20 ‘‘(I) the physical, chemical, and 

21 toxicological properties of the chemical 

22 substance; 

23 ‘‘(II) the manufacturer’s annual 

24 production volume of the chemical sub25 stance; 


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1 ‘‘(III) the uses of, and exposure 

2 and fate information relating to the 

3 manufacturer’s production or import 

4 of the chemical substance; and 

5 ‘‘(IV) the name and location of 

6 each facility to which the manufacturer 

7 sends the chemical substance after 

8 manufacture for subsequent processing, 

9 distribution, or use. 

10 ‘‘(d) RECORDS TO SUPPORT DECLARATIONS AND

11 PERIODIC REPORTS.— 

12 ‘‘(1) IN GENERAL.—Each manufacturer and 

13 processor of a chemical substance that is distributed 

14 in commerce shall— 

15 ‘‘(A) maintain records of the information 

16 submitted to the Administrator under subsections 

17 (b) and (c), as well as supporting information; 

18 and 

19 ‘‘(B) submit those records or that informa20 tion to the Administrator upon request by the 

21 Administrator. 

22 ‘‘(2) BURDEN OF PROOF.—Each manufacturer 

23 and processor that submits to the Administrator a 

24 declaration under subsection (b) or a notice under 


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1 subsection (h)(5)(B) shall at all times bear the burden 

2 of proving that the manufacturer or processor— 

3 ‘‘(A) has a current or potential commercial 

4 interest in the applicable chemical substance; or 

5 ‘‘(B) has ceased the production, importa6 tion, processing, and export of, the applicable 

7 chemical substance. 

8 ‘‘(e) SUBSTANCE IDENTIFICATION AND INFORMATION

9 FOR CHEMICAL PROCESSORS.— 

10 ‘‘(1) RULEMAKING.— 

11 ‘‘(A) IN GENERAL.—Not later than 1 year 

12 after the date of enactment of the Safe Chemicals 

13 Act of 2011, the Administrator shall specify, by 

14 rule, the information that chemical processors 

15 are required to submit for chemical substances 

16 under this subsection as will assist the Adminis17 trator in the administration of this Act. 

18 ‘‘(B) EXEMPTIONS.—The rule promulgated 

19 under this paragraph may exempt certain proc20 essors, including small processors, from— 

21 ‘‘(i) a requirement to participate in 

22 the periodic reporting program, if the Ad23 ministrator determines that the participa24 tion of those processors would not assist in 

25 the administration of this Act; or 


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1 ‘‘(ii) specific reporting requirements, if 

2 the Administrator determines that the value 

3 of a particular reporting requirement, for 

4 the administration of this Act, would not be 

5 commensurate with the burden of the re6 quirement on submitters. 

7 ‘‘(2) INFORMATION REQUIREMENTS.—The rule 

8 promulgated under paragraph (1) shall— 

9 ‘‘(A) specify the information that processors 

10 are required to submit for chemical substances 

11 that are— 

12 ‘‘(i) processed for use in 1 or more con13 sumer or commercial product categories, as 

14 determined by the Administrator; and 

15 ‘‘(ii) intentionally added to 1 or more 

16 products during processing and not inci17 dental to the end uses of the products; 

18 ‘‘(B) require each processor of a chemical 

19 substance identified under subparagraph (A) to 

20 submit the information specified in clauses (i) 

21 through (iii) of subparagraph (C) for the chem22 ical substance, and to submit the information 

23 specified in clauses (iv) through (viii) of sub24 paragraph (C)— 


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1 ‘‘(i) separately for each applicable con2 sumer and commercial product category; 

3 and 

4 ‘‘(ii) in aggregate form, taking into ac5 count the use by the processor of the chem6 ical substance in all product categories; 

7 ‘‘(C) require each processor of a chemical 

8 substance identified under subparagraph (A) to 

9 identify in the submission of the processor— 

10 ‘‘(i) the corporate name and primary 

11 business location of the processor; 

12 ‘‘(ii) the chemical identity and any 

13 special substance characteristics of the 

14 chemical substance; 

15 ‘‘(iii) the applicable consumer or com16 mercial product category or categories for 

17 which the processor processes the chemical 

18 substance; 

19 ‘‘(iv) the annual volume of the chem20 ical substance processed by the submitter; 

21 ‘‘(v) any products intended for use by 

22 children aged 14 years or younger for use in 

23 which the processor processes the chemical 

24 substance; 


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1 ‘‘(vi) the concentration range within 

2 which the maximum concentration of the 

3 substance used in each consumer and com4 mercial product category falls; 

5 ‘‘(vii) the range within which the total 

6 number of commercial workers reasonably 

7 likely to be exposed to the chemical sub8 stance at the processing site falls; and 

9 ‘‘(viii) any other information regard10 ing processing activities or product 

11 descriptors relating to the processor’s proc12 essing of the chemical substance identified 

13 by the Administrator as necessary to under14 stand the potential exposure from processed 

15 chemical substances or products in which 

16 the chemical substances are used; and 

17 ‘‘(D) require each processor to periodically 

18 report the information described in subpara19 graphs (B) and (C) for the chemical substances 

20 described in subparagraph (A). 

21 ‘‘(3) RECORDS.—The rules promulgated under 

22 paragraph (1) shall require processors of chemical 

23 substances to which those rules apply— 

24 ‘‘(A) to maintain records of the information 

25 described in paragraph (2); and 


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1 ‘‘(B) to submit those records to the Admin2 istrator upon request by the Administrator. 

3 ‘‘(f) UPDATING OF INFORMATION.— 

4 ‘‘(1) IN GENERAL.—Each manufacturer or proc5 essor of a chemical substance that submits informa6 tion to the Administrator under subsection (c) or (e) 

7 shall update the information— 

8 ‘‘(A) at a minimum every 4 years; and 

9 ‘‘(B) at any time that— 

10 ‘‘(i) the manufacturer or processor ob11 tains knowledge of, comes into possession of, 

12 or generates significant new information re13 garding the production, processing, use, dis14 tribution, hazard, or exposure potential of 

15 the chemical substance; or 

16 ‘‘(ii) there is a significant change in 

17 the production, distribution in commerce, or 

18 use of the chemical substance by or known 

19 to the manufacturer or processor. 

20 ‘‘(2) GUIDANCE.—Not later than 1 year after the 

21 date of enactment of the Safe Chemicals Act of 2011, 

22 the Administrator shall issue guidance on what con23 stitutes significant new information regarding or sig24 nificant changes in the production, distribution in 

25 commerce, or use of a chemical substance. 


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1 ‘‘(g) REPORTS.— 

2 ‘‘(1) REQUIREMENT.— 

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

4 paragraph (2), the Administrator may by rule 

5 or order require any person who manufactures, 

6 processes, distributes in commerce, uses, or dis7 poses of a chemical substance, or a mixture or 

8 article containing the chemical substance to 

9 maintain records of and report by a specified 

10 date any existing information concerning the 

11 substance that, in the judgment of the Adminis12 trator, would assist the Administrator in— 

13 ‘‘(i) making a safety standard deter14 mination with respect to a chemical sub15 stance; 

16 ‘‘(ii) determining testing or informa17 tion needs for a chemical substance; 

18 ‘‘(iii) assigning a chemical substance 

19 to a batch, category, or priority class pursu20 ant to section 6; 

21 ‘‘(iv) evaluating, developing, and im22 plementing risk management conditions for 

23 a chemical substance; 

24 ‘‘(v) assessing hazards, exposures, or 

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1 tribution, processing, or disposal of a chem2 ical substance; 

3 ‘‘(vi) determining compliance with any 

4 provision of this Act; or 

5 ‘‘(vii) any other aspect of admin6 istering this Act. 

7 ‘‘(B) CHARACTERISTICS.—The Adminis8 trator may by rule or order require that any re9 port or information submitted pursuant to this 

10 Act include chemical identity and special sub11 stance characteristics, as appropriate to the 

12 chemical substance that is the subject of the re13 port or information. 

14 ‘‘(C) REQUIRED INFORMATION.—The Ad15 ministrator shall by rule or order specify or 

16 modify the information that is required to be 

17 submitted with a particular report or informa18 tion submission to establish the chemical identity 

19 and special substance characteristics of the sub20 ject chemical substance (or mixture or article 

21 containing that chemical substance) for the pur22 poses of the report or information submission. 

23 ‘‘(2) EXEMPTIONS.— 

24 ‘‘(A) SMALL QUANTITIES FOR RESEARCH OR

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1 essing, distribution in commerce, use, or disposal 

2 of a chemical substance in small quantities (as 

3 defined by the Administrator by rule) solely for 

4 purposes of scientific experimentation or anal5 ysis or chemical research (including any such re6 search or analysis for the development of a prod7 uct), the Administrator may promulgate a rule 

8 or order under paragraph (1) only to the extent 

9 that the Administrator determines that the 

10 maintenance of records, submission of reports, or 

11 both, is necessary for the effective enforcement of 

12 this Act. 

13 ‘‘(B) SMALL BUSINESS.—The rules promul14 gated under this subsection may exempt certain 

15 small businesses from the rules promulgated 

16 under this subsection, if the Administrator deter17 mines that the participation of those small busi18 nesses would not assist in the administration of 

19 this Act. 

20 ‘‘(h) INVENTORIES.— 

21 ‘‘(1) ACTIVE INVENTORY.—The Administrator 

22 shall compile, keep current, and, subject to section 14, 

23 publish a list of each chemical substance that is man24 ufactured or processed in the United States. 

25 ‘‘(2) CONTENTS.— 


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1 ‘‘(A) IN GENERAL.—The list shall consist of 

2 those chemical substances for which— 

3 ‘‘(i) a notice is submitted under section 

4 5(d), consistent with the requirements of 

5 section 5(b); or 

6 ‘‘(ii) a valid declaration is submitted 

7 under paragraph (2) of subsection (b). 

8 ‘‘(B) EXCLUSIONS.—The list shall not in9 clude— 

10 ‘‘(i) any chemical substance for which 

11 the only declarations submitted are sub12 mitted under paragraph (3) or (4) of sub13 section (b), or for which no declaration has 

14 been submitted; or 

15 ‘‘(ii) any chemical substance for which 

16 an exemption has been granted under sec17 tion 5(b)(1)(C)(ii) or section 6(h)(2). 

18 ‘‘(3) TIMING.— 

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

20 paragraph (2)(B), for a chemical substance for 

21 which a notice is submitted under section 5(d), 

22 the chemical substance shall be included in the 

23 list established under paragraph (1) as of the 

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1 trator) on which the substance was manufactured 

2 or processed in the United States. 

3 ‘‘(B) PUBLICATION.—The Administrator 

4 shall first publish a list under paragraph (1) not 

5 later than 1 year after the date of enactment of 

6 the Safe Chemicals Act of 2011. 

7 ‘‘(4) SMALL QUANTITIES FOR RESEARCH OR

8 ANALYSIS.—The Administrator shall not include in 

9 the list established under paragraph (1) any chemical 

10 substance that is manufactured or processed only in 

11 small quantities (as defined by the Administrator by 

12 rule) solely for purposes of scientific experimentation 

13 or analysis or chemical research on, or analysis of, 

14 the substance or another substance, including research 

15 or analysis for the development of a product. 

16 ‘‘(5) INACTIVE INVENTORY.— 

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

18 shall compile, keep current, and, subject to sec19 tion 14, publish an inactive list on which the 

20 Administrator shall include each chemical sub21 stance for which the only declarations submitted 

22 for the substance are submitted under subsection 

23 (b)(3). 

24 ‘‘(B) REQUIREMENTS.—If a manufacturer 

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1 essing of a chemical substance on the inactive 

2 list, the manufacturer or processor shall— 

3 ‘‘(i) not less than 30 days before recom4 mencing the manufacture or processing of 

5 the chemical substance, notify the Adminis6 trator; and 

7 ‘‘(ii) provide with the notification 

8 under clause (i)— 

9 ‘‘(I) the chemical identity and 

10 any special substance characteristics of 

11 the chemical substance; 

12 ‘‘(II) the identity and primary 

13 business location of the manufacturer; 

14 ‘‘(III) a list of health and safety 

15 studies conducted or initiated by or 

16 for, known to, or reasonably ascertain17 able by, the manufacturer or processor 

18 with respect to the chemical substance; 

19 ‘‘(IV) upon request of the Admin20 istrator, a copy of each study described 

21 in subclause (III) in the possession or 

22 control of the manufacturer that has 

23 not previously been submitted to the 

24 Administrator; 


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1 ‘‘(V) the projected annual manu2 facturing or processing volume for the 

3 chemical substance for each of the sub4 sequent 3 years; 

5 ‘‘(VI) the name and location of 

6 each facility to which the chemical sub7 stance is expected to be sent, after 

8 manufacture or processing, for subse9 quent processing, distribution in com10 merce, or use; and 

11 ‘‘(VII) all other existing informa12 tion known to, in the possession or 

13 control of, or reasonably ascertainable 

14 by the manufacturer or processor that 

15 has not previously been submitted to 

16 the Administrator regarding— 

17 ‘‘(aa) the toxicological prop18 erties of the chemical substance; 

19 and 

20 ‘‘(bb) the uses of, and expo21 sure and fate information relating 

22 to, the chemical substance. 

23 ‘‘(C) ADMINISTRATOR ACTIONS.—For any 

24 chemical substance for which the Administrator 


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1 receives a valid notification under subparagraph 

2 (B), the Administrator shall promptly— 

3 ‘‘(i) move the chemical substance to the 

4 active inventory established under para5 graph (1); and 

6 ‘‘(ii) add the chemical substance to the 

7 current batch of chemical substances identi8 fied pursuant to section 6(a), and categorize 

9 the chemical substance with other chemical 

10 substances in the batch, pursuant to section 

11 6(b). 

12 ‘‘(D) ADMINISTRATION.—Disclosure of any 

13 information provided in the notice described in 

14 subparagraph (B) shall be subject to section 14. 

15 ‘‘(6) CHEMICALS NOT LISTED ON OR REMOVED

16 FROM THE INVENTORIES.—If a manufacturer or proc17 essor seeks to commence the manufacture or processing 

18 of a chemical substance that is not listed on the in19 ventories established under paragraph (1) or (5), or 

20 that has been removed from the inventories pursuant 

21 to subsection (b)(6)(A)(ii)(III), the manufacturer or 

22 processor shall comply with section 5. 

23 ‘‘(i) PUBLIC ACCESS TO SIGNIFICANT INFORMATION.— 

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

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1 Act of 2011, the Administrator, through collaboration 

2 as appropriate, shall establish— 

3 ‘‘(A) an electronic, Internet-accessible data4 base for the storing and sharing of information 

5 relating to the toxicity and use of, and exposure 

6 to, chemical substances; and 

7 ‘‘(B) procedures for use in maintaining and 

8 updating the database. 

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

10 after the date of enactment of the Safe Chemicals Act 

11 of 2011 or for decisions made or information sub12 mitted after that 18-month period, not later than 90 

13 days after the date on which a decision is made by 

14 the Administrator or information submitted under 

15 this title is received by the Administrator, the Admin16 istrator shall, subject to section 14, make available to 

17 the public via the Internet-accessible database de18 scribed in paragraph (1) a description of all signifi19 cant— 

20 ‘‘(A) decisions made by the Administrator 

21 under this title; and 

22 ‘‘(B) information submitted pursuant to 

23 this title. 

24 ‘‘(j) RECORDS OF SIGNIFICANT ADVERSE REAC25 TIONS.— 


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1 ‘‘(1) IN GENERAL.—Any person that manufac2 tures, processes, or distributes in commerce any chem3 ical substance shall maintain, and on request submit 

4 to the Administrator, records of significant adverse 

5 reactions to human health or the environment, as de6 termined by the Administrator by rule, alleged to 

7 have been caused by the substance or mixture. 

8 ‘‘(2) DURATION.— 

9 ‘‘(A) IN GENERAL.—Records of the adverse 

10 reactions to the health of employees shall be re11 tained for a period of 30 years after the date on 

12 which the reactions were first reported to or 

13 known by the person maintaining the records. 

14 ‘‘(B) OTHER RECORDS.—Any record of 

15 other adverse reactions shall be retained for a pe16 riod of 5 years after the date on which informa17 tion contained in the record was first reported to 

18 or known by the person maintaining the record. 

19 ‘‘(3) CONTENTS.—Records required to be main20 tained under this subsection shall include— 

21 ‘‘(A) records of consumer allegations of per22 sonal injury or harm to health; 

23 ‘‘(B) reports of occupational disease or in24 jury; and 


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

2 environment submitted to the manufacturer, 

3 processor, or distributor in commerce from any 

4 source. 

5 ‘‘(k) INFORMATION IN THE POSSESSION OF OTHER

6 FEDERAL AGENCIES.— 

7 ‘‘(1) SYNOPSES.— 

8 ‘‘(A) IN GENERAL.—Notwithstanding any 

9 other provision of law, from time to time, each 

10 Federal agency and Federal institution shall 

11 submit to the Administrator a synopsis of the 

12 data and records in the possession or control of 

13 the agency or institution, respectively, that may 

14 be useful to the Administrator in carrying out 

15 this Act. 

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

17 than 1 year after the date of enactment of the 

18 Safe Chemicals Act of 2011, the Administrator 

19 shall prescribe, by order, the format, content, and 

20 level of detail of the synopses. 

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

22 18 months after the date of enactment of the Safe 

23 Chemicals Act of 2011, each Federal agency and 

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1 mission of a synopsis of the agency and institu2 tion, respectively, to the Administrator. 

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

4 years, each Federal agency and Federal institu5 tion shall— 

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

7 and institution, respectively; and 

8 ‘‘(ii) submit the updated synopsis to 

9 the Administrator. 

10 ‘‘(2) REQUESTS BY THE ADMINISTRATOR.—Not11 withstanding any other provision of law, on the re12 quest of the Administrator, any information in the 

13 possession or control of an agency or institution relat14 ing to a hazard of, use of, exposure to, or risk of, a 

15 chemical substance (or mixture or article containing 

16 that chemical substance) shall be submitted to the Ad17 ministrator. 

18 ‘‘(l) NOTICE TO ADMINISTRATOR OF SUBSTANTIAL

19 RISKS.—Any person that manufactures, processes, or dis20 tributes in commerce a chemical substance and that obtains 

21 information that reasonably supports the conclusion that 

22 the substance presents a substantial risk of injury to health 

23 or the environment shall immediately inform the Adminis24 trator of the information unless the person has actual 


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1 knowledge that the Administrator has been adequately in2 formed of the information. 

3 ‘‘(m) CERTIFICATION.—Each submission required pur4 suant to this section or pursuant to a rule or an order pro5 mulgated or issued by the Administrator under this section, 

6 other than a submission under subsection (k), shall be ac7 companied by a certification signed by a responsible official 

8 of the manufacturer, processor, distributor, user, or disposer 

9 of a chemical substance that each statement contained in 

10 the submission— 

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

12 ‘‘(2) includes all material facts required by the 

13 applicable provision of this section or rule or order 

14 under this section. 

15 ‘‘(n) ADMINISTRATION.— 

16 ‘‘(1) IN GENERAL.—Nothing in this section lim17 its the authority of the Administrator to require re18 porting under any other provision of this Act by any 

19 person who manufactures, processes, distributes in 

20 commerce, uses, or disposes of a chemical substance, 

21 or a mixture or article containing a chemical sub22 stance. 

23 ‘‘(2) VIOLATIONS.—In addition to all other au24 thorities available for the enforcement of this Act, the 

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1 ized under section 6(f) if a person who manufactures, 

2 processes, distributes in commerce, uses, or disposes of 

3 a chemical substance, or a mixture or article con4 taining a chemical substance violates any provision of 

5 this section.’’. 

6 SEC. 10. RELATIONSHIP TO OTHER FEDERAL LAWS. 

7 Section 9 of the Toxic Substances Control Act (15 

8 U.S.C. 2608) is amended— 

9 (1) in subsection (a)— 

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

11 inserting the following: 

12 ‘‘(1) REPORT.— 

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

14 determines that the manufacture, processing, 

15 distribution in commerce, use, or disposal of a 

16 chemical substance, or that any combination of 

17 those activities, does not meet a safety standard 

18 under this title or requires conditions or restric19 tions in order to the meet the safety standard, 

20 and the Administrator determines that action 

21 may be taken under a Federal law not adminis22 tered by the Administrator to address the uses 

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

24 Administrator shall submit to the agency that 

25 administers the Federal law a report that— 


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1 ‘‘(i) describes with specification the 

2 activity or combination of activities that 

3 prevent the chemical substance from meet4 ing the safety standard or restrictions or 

5 conditions required to meet the safety 

6 standard under this title; 

7 ‘‘(ii) requests that the agency— 

8 ‘‘(I) determine whether the 1 or 

9 more actions may be taken under 

10 Federal law administered by the agen11 cy; 

12 ‘‘(II) if the agency determines 

13 under clause (i) that the 1 or more 

14 actions may be taken, initiate and 

15 provide a timetable for the 1 or more 

16 actions; and 

17 ‘‘(III) respond to the Adminis18 trator with respect to the matters de19 scribed in the report; and 

20 ‘‘(iii) includes a detailed statement of 

21 the information on which the report is 

22 based. 

23 ‘‘(B) PUBLICATION.—A report of the Ad24 ministrator submitted under subparagraph (A) 


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1 shall be promptly published in the Federal Reg2 ister. 

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

4 later than 90 days after the date of receipt of 

5 a report from the Administrator under subpara6 graph (A), or by such earlier date as the Ad7 ministrator may specify in such a report, an 

8 agency that receives the report shall— 

9 ‘‘(i) make all determinations requested 

10 by the Administrator in the report; 

11 ‘‘(ii) take all action necessary to en12 sure that a chemical substance meets the 

13 safety standard under this title, if appro14 priate; 

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

16 agency a detailed statement of the findings 

17 and conclusions of the agency; and 

18 ‘‘(iv) publish that statement in the 

19 Federal Register. 

20 ‘‘(2) INITIATION OF ACTION.—If the Adminis21 trator submits a report under paragraph (1) with re22 spect to a chemical substance to an agency, and the 

23 agency that receives the report initiates, within the 

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

25 a civil action under Federal law administered by the 


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1 agency to ensure that a chemical substance meets 

2 the safety standard under this title, or requires re3 strictions or conditions to meet that safety standard, 

4 the Administrator may not take action under this 

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

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

7 (B) by redesignating paragraph (3) as 

8 paragraph (4); 

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

10 following: 

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

12 order, initiate action or a combination of actions 

13 under this Act to ensure compliance with the safety 

14 standard for a chemical substance under this title 

15 if— 

16 ‘‘(A) the Administrator submits a report 

17 under paragraph (1) with respect to a chemical 

18 substance; and 

19 ‘‘(B) the agency to which the report was 

20 submitted— 

21 ‘‘(i) determines that action cannot be 

22 taken under the authorities of the agency; 

23 ‘‘(ii) does not initiate action, if appro24 priate, within the period specified in the 

25 request under paragraph (1); 


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1 ‘‘(iii) does not complete the action 

2 within the timeframe provided by the agen3 cy; or 

4 ‘‘(iv) fails to respond.’’; and 

5 (D) in paragraph (4) (as redesignated by 

6 subparagraph (B))— 

7 (i) by striking ‘‘(4) If the Adminis8 trator has initiated action under section 6 

9 or 7’’ and inserting the following: 

10 ‘‘(4) CONSULTATION.—If the Administrator has 

11 initiated action under this Act’’; and 

12 (ii) by striking ‘‘against such risk’’ 

13 after ‘‘Federal action’’; 

14 (2) in subsection (c)— 

15 (A) by striking ‘‘the Administrator shall 

16 not’’ and inserting ‘‘Administrator— 

17 ‘‘(1) shall not’’; and 

18 (B) by striking the period at the end and 

19 inserting ‘‘; and’’; and 

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

21 ‘‘(2) shall ensure that any actions to address 

22 workplace exposures that the Administrator takes or 

23 requires to be taken by manufacturers or processors 

24 of a chemical substance are consistent with the in25 dustrial hygiene hierarchy of controls.’’; and 


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1 (3) in subsection (d)— 

2 (A) in the first sentence, by striking ‘‘while 

3 imposing the least burden of duplicative re4 quirements on those subject to the Act and for 

5 other purposes’’; and 

6 (B) in the second sentence, by striking ‘‘, 

7 in the report required by section 30,’’. 

8 SEC. 11. INSPECTIONS AND SUBPOENAS. 

9 Section 11 of the Toxic Substances Control Act (15 

10 U.S.C. 2610) is amended to read as follows: 

11 ‘‘SEC. 11. INSPECTIONS AND SUBPOENAS. 

12 ‘‘(a) INSPECTIONS.— 

13 ‘‘(1) IN GENERAL.—For purposes of admin14 istering this Act, the Administrator, and any duly 

15 designated representative of the Administrator, may 

16 inspect— 

17 ‘‘(A) any establishment, facility, or other 

18 premises in which chemical substances, mix19 tures, or articles subject to this Act are manu20 factured, processed, stored, or held before or 

21 after distribution in commerce; 

22 ‘‘(B) any conveyance being used to trans23 port such chemical substances, mixtures, or ar24 ticles in connection with distribution in com25 merce; and 


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1 ‘‘(C) any place at which records relating to 

2 the chemical substances, mixtures, or articles, 

3 or otherwise relating to compliance with this 

4 Act, are held. 

5 ‘‘(2) METHOD.—Each inspection under para6 graph (1) shall be— 

7 ‘‘(A) commenced and completed with rea8 sonable promptness; and 

9 ‘‘(B) conducted at reasonable times, within 

10 reasonable limits, and in a reasonable manner. 

11 ‘‘(3) SAMPLES.—The Administrator, and any 

12 duly designated representative of the Administrator, 

13 may inspect and obtain samples of any— 

14 ‘‘(A) chemical substance, mixture, or arti15 cle; and 

16 ‘‘(B) container or labeling of a chemical 

17 substance, mixture, or article. 

18 ‘‘(b) SCOPE.—An inspection conducted under sub19 section (a) shall extend to all things within the premises 

20 or conveyance inspected (including records, files, papers, 

21 processes, controls, and facilities) regarding whether the 

22 owner or operator of the premises, conveyance, or records 

23 has complied with provisions of this Act applicable to the 

24 chemical substances, mixtures, articles, or records. 

25 ‘‘(c) INFORMATION GATHERING.— 


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1 ‘‘(1) IN GENERAL.—In carrying out this Act, 

2 the Administrator may require the attendance and 

3 testimony of witnesses and the production of such 

4 reports, papers, documents, items, answers to ques5 tions, and other information, including the develop6 ment of analyses and other information, as the Ad7 ministrator determines to be necessary. 

8 ‘‘(2) PAYMENT OF WITNESSES.—A witness de9 scribed in paragraph (1) shall be paid the same fees 

10 and mileage that are paid witnesses in the courts of 

11 the United States. 

12 ‘‘(d) WARRANTS.—For purposes of enforcing this 

13 Act, upon a showing to an officer or court of competent 

14 jurisdiction that there is reason to believe that a provision 

15 of this Act has been violated, officers or employees duly 

16 designated by the Administrator are empowered to obtain 

17 and to execute warrants authorizing— 

18 ‘‘(1) entry, inspection, and copying of records 

19 for purposes of this Act; and 

20 ‘‘(2) the seizure of any chemical substance, mix21 ture, or article that is in violation of this Act.’’. 

22 SEC. 12. EXPORTS. 

23 Section 12 of the Toxic Substances Control Act (15 

24 U.S.C. 2611) is amended— 

25 (1) by striking subsection (a); 


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1 (2) by redesignating subsections (b) and (c) as 

2 subsections (a) and (b), respectively; 

3 (3) in subsection (a) (as redesignated by para4 graph (2))— 

5 (A) in paragraph (1)— 

6 (i) by striking ‘‘or intends to export’’; 

7 (ii) by striking ‘‘section 4 or 5(b)’’ 

8 and inserting ‘‘section 4, 5, or 6(b)’’; 

9 (iii) by striking ‘‘or intent to export’’ 

10 and inserting ‘‘, not later than 30 days 

11 after the date of exportation of the sub12 stance or mixture,’’; and 

13 (iv) by inserting ‘‘promptly there14 after’’ before ‘‘furnish’’; 

15 (B) in paragraph (2)— 

16 (i) by striking ‘‘or intends to export’’; 

17 (ii) by striking ‘‘an order has been 

18 issued under section 5 or a rule has been 

19 proposed or promulgated under section 5 

20 or 6, or with respect to which an action is 

21 pending or relief has been granted under 

22 section 5 or 7’’ and inserting ‘‘an action 

23 has been taken pursuant to section 6 or 

24 7’’; 


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1 (iii) by striking ‘‘or intent to export’’ 

2 and inserting ‘‘, not later than 30 days 

3 after the date of exportation of the sub4 stance or mixture,’’; 

5 (iv) by inserting ‘‘promptly there6 after’’ before ‘‘furnish’’; and 

7 (v) by striking ‘‘such rule, order, ac8 tion, or relief’’ and inserting ‘‘the action 

9 taken pursuant to section 6 or 7’’; and 

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

11 ‘‘(3) CHANGE IN EXPORT STATUS.— 

12 ‘‘(A) IN GENERAL.—Any person that has 

13 notified the Administrator of the exportation of 

14 a chemical substance or mixture under this sec15 tion shall notify the Administrator of any 

16 change in the export status of the substance or 

17 mixture by not later than 30 days after such a 

18 change in status. 

19 ‘‘(B) UPDATED NOTICE.—The Adminis20 trator shall promptly furnish an updated notice 

21 to the governments that have been notified pur22 suant to paragraphs (1) and (2) regarding the 

23 exportation of any chemical substance or mix24 ture subject to this section if— 


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1 ‘‘(i) data for the substance or mixture 

2 have been received by the Administrator 

3 pursuant to section 4, 5, 6(b), or 8; 

4 ‘‘(ii) a change has occurred in the ex5 port status of the substance or mixture; or 

6 ‘‘(iii) a change has been made in any 

7 risk management action taken pursuant to 

8 section 6 or 7 for the substance or mix9 ture.’’; 

10 (4) in subsection (b), as redesignated by para11 graph (2) of this section— 

12 (A) by striking paragraph (2); and 

13 (B) by redesignating paragraphs (3), (4), 

14 (5), and (6) as paragraphs (2), (3), (4), and 

15 (5), respectively; and 

16 (5) by adding at the end the following: 

17 ‘‘(c) PUBLIC RECORDS.—The Administrator shall— 

18 ‘‘(1) maintain copies of all current notices pro19 vided to other governments under this section; and 

20 ‘‘(2) make such copies available to the public in 

21 electronic format.’’. 

22 SEC. 13. ENTRY INTO CUSTOMS TERRITORY OF THE 

23 UNITED STATES. 

24 Section 13 of the Toxic Substances Control Act (15 

25 U.S.C. 2612) is amended— 


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1 (1) by striking ‘‘Secretary of the Treasury’’ 

2 each place it appears and inserting ‘‘Secretary of 

3 Homeland Security’’; 

4 (2) in subsection (a)— 

5 (A) in paragraph (1), by striking ‘‘if—’’ 

6 and subparagraphs (A) and (B) and inserting 

7 ‘‘if the substance, mixture, or article fails to 

8 comply with or is offered for entry in violation 

9 of any rule or order in effect under this Act.’’; 

10 and 

11 (B) by adding at the end the following: 

12 ‘‘(3) IMPORT AS PART OF AN ARTICLE.—Chem13 ical substances and mixtures imported as part of an 

14 article shall be subject to the same requirements 

15 under this Act as if the substances and mixtures had 

16 been imported in bulk, except as the Administrator 

17 may provide by rule under this Act, or as the Sec18 retary of Homeland Security may provide by rule 

19 under subsection (b).’’. 

20 SEC. 14. DISCLOSURE OF DATA. 

21 Section 14 of the Toxic Substances Control Act (15 

22 U.S.C. 2613) is amended— 

23 (1) by redesignating subsections (a) through (e) 

24 as subsections (c) through (g), respectively; 


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1 (2) by inserting before subsection (c) (as redes2 ignated by paragraph (1)), the following: 

3 ‘‘(a) AGENCY RESPONSIBILITIES.—The Adminis4 trator shall ensure that— 

5 ‘‘(1) information control designations under this 

6 section are not a determinant of public disclosure 

7 pursuant to section 552 of title 5, United States 

8 Code (commonly known as the ‘Freedom of Informa9 tion Act’); and 

10 ‘‘(2) all information in the possession of the 

11 agency that is releasable pursuant to an appropriate 

12 request under that section is made available to mem13 bers of the public. 

14 ‘‘(b) VOLUNTARY RELEASE OF UNCLASSIFIED IN15 FORMATION NOT PROHIBITED.—Nothing in this section 

16 prevents or discourages the Administrator from volun17 tarily releasing to the public any unclassified information 

18 that is not exempt from disclosure under section 552 of 

19 title 5, United States Code (commonly known as the 

20 ‘Freedom of Information Act’).’’; 

21 (3) in subsection (c) (as redesignated by para22 graph (1))— 

23 (A) in the subsection heading, by striking 

24 ‘‘IN GENERAL’’ and inserting ‘‘DISCLOSURE OF

25 CERTAIN INFORMATION’’; 


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1 (B) by striking ‘‘subsection (b)’’ and in2 serting ‘‘subsection (d)’’; 

3 (C) by redesignating paragraphs (3) and 

4 (4) as paragraphs (4) and (5), respectively; 

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

6 following: 

7 ‘‘(3) shall be disclosed upon request to a State, 

8 tribal, or municipal government, including identifica9 tion of the location of the manufacture, processing, 

10 or storage of a chemical substance upon the request 

11 of the government for the purpose of administration 

12 or enforcement of a law, if 1 or more applicable 

13 agreements ensure that the recipient government 

14 will take appropriate steps to maintain the confiden15 tiality of the information in accordance with this sec16 tion and section 350.19 of title 40, Code of Federal 

17 Regulations (or any successor regulation);’’; and 

18 (E) in paragraph (4) (as redesignated by 

19 subparagraph (B)), by striking ‘‘an unreason20 able risk of injury’’ and inserting ‘‘an imminent 

21 and substantial endangerment’’; 

22 (4) in subsection (d) (as redesignated by para23 graph (1))— 

24 (A) in the subsection heading, by striking 

25 ‘‘DATA FROM HEALTH AND SAFETY STUDIES’’ 


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1 and inserting ‘‘INFORMATION NOT ELIGIBLE

2 FOR PROTECTION’’; 

3 (B) by striking paragraph (1) and insert4 ing the following: 

5 ‘‘(1) INELIGIBLE INFORMATION.— 

6 ‘‘(A) IN GENERAL.—The following types of 

7 information shall not be eligible for protection 

8 under this section, and the Administrator shall 

9 not approve a request to treat information of 

10 the following types as confidential under this 

11 section: 

12 ‘‘(i) The identity of a chemical sub13 stance, except as provided in section 5. 

14 ‘‘(ii) Any safety standard determina15 tion developed under section 6, including 

16 supporting information developed by the 

17 Administrator. 

18 ‘‘(iii) Any health and safety study 

19 that is submitted under this Act with re20 spect to— 

21 ‘‘(I) any chemical substance or 

22 mixture— 

23 ‘‘(aa) which, on the date on 

24 which the study is to be disclosed 


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1 has been offered for commercial 

2 distribution; or 

3 ‘‘(bb) for which testing is re4 quired under section 4 or for 

5 which notification is required 

6 under section 5; and 

7 ‘‘(II) any data reported to, or 

8 otherwise obtained by, the Adminis9 trator from a health and safety study 

10 which relates to a chemical substance 

11 or mixture described in item (aa) or 

12 (bb) of subclause (I). 

13 ‘‘(iv) Any information indicating the 

14 presence of a chemical substance in a con15 sumer article intended for use or reason16 ably expected to be used by children or to 

17 which children can otherwise be reasonably 

18 expected to be exposed. 

19 ‘‘(B) PROHIBITION.—This paragraph does 

20 not authorize the release of any data which dis21 closes processes used in the manufacturing or 

22 processing of a chemical substance or mixture 

23 or, in the case of a mixture, the release of data 

24 disclosing the portion of the mixture comprised 


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1 by any of the chemical substances in the mix2 ture.’’; and 

3 (C) in paragraph (2)— 

4 (i) by striking ‘‘the first sentence of 

5 paragraph (1)’’ and inserting ‘‘item (aa) or 

6 (bb) of paragraph (1)(A)(iii)’’; and 

7 (ii) by striking ‘‘in the second sen8 tence of such paragraph’’ and inserting ‘‘in 

9 paragraph (1)(B)’’; 

10 (5) in subsection (e) (as redesignated by para11 graph (1))— 

12 (A) by striking paragraph (1) and insert13 ing the following: 

14 ‘‘(1) DUTIES OF MANUFACTURERS AND PROC15 ESSORS.— 

16 ‘‘(A) IN GENERAL.—In submitting data 

17 under this Act, a manufacturer, processor, or 

18 distributor in commerce may— 

19 ‘‘(i) designate the data which the 

20 manufacturer, processor, or distributor be21 lieves is entitled to confidential treatment 

22 under subsection (a); and 

23 ‘‘(ii) submit the designated data sepa24 rately from other data submitted under 

25 this Act. 


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1 ‘‘(B) REQUIREMENTS.—A designation 

2 under this paragraph shall be made in writing 

3 and in such manner as the Administrator may 

4 prescribe, and shall include— 

5 ‘‘(i) justification for each claim for 

6 confidentiality; 

7 ‘‘(ii) a certification that the informa8 tion is not otherwise publicly available; and 

9 ‘‘(iii) separate copies of all submitted 

10 information, with 1 copy containing and 1 

11 copy excluding the information to which 

12 the request applies.’’; 

13 (B) by redesignating paragraph (2) as 

14 paragraph (3); 

15 (C) by inserting after paragraph (1) the 

16 following: 

17 ‘‘(2) DUTIES OF THE ADMINISTRATOR.— 

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

19 shall— 

20 ‘‘(i)(I) not later than 1 year after the 

21 date of enactment of the Safe Chemicals 

22 Act of 2011, by order develop and make 

23 publicly available standards that specify— 

24 ‘‘(aa) the acceptable bases on 

25 which written requests to maintain 


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1 confidentiality of information may be 

2 approved, which shall be no more re3 strictive of public disclosure than sec4 tion 552 of title 5, United States 

5 Code; and 

6 ‘‘(bb) the documentation that 

7 must accompany those requests; and 

8 ‘‘(II) not later than 1 year after the 

9 date of enactment of the Safe Chemicals 

10 Act of 2011, identify by rule those types of 

11 information for which the Administrator 

12 shall not prospectively specify the term of 

13 confidentiality pursuant to this subpara14 graph; 

15 ‘‘(ii) not later than 90 days after the 

16 date of receipt of information designated 

17 under paragraph (1), review all requests to 

18 maintain confidentiality of the submitted 

19 information and decide whether to approve 

20 or deny each request based on whether the 

21 request and accompanying documentation 

22 comply with the standards that are devel23 oped under clause (i) (except that if a re24 quest for the information is received under 

25 section 552 of title 5, United States Code, 


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1 before the 90-day review and decision pe2 riod has elapsed, the disclosure require3 ments, procedures, and judicial review pro4 visions under that section shall apply); 

5 ‘‘(iii) in the event such a request is 

6 denied, make the information available to 

7 the public in accordance with section 

8 8(d)(2); and 

9 ‘‘(iv) if such a request is approved, 

10 specify a time period of not greater than 5 

11 years for which the submitted information 

12 shall be kept confidential, except with re13 spect to claims subject to a rule issued 

14 pursuant to clause (i)(II). 

15 ‘‘(B) AUTHORITY OF ADMINISTRATOR.— 

16 Subparagraph (A) does not limit the authority 

17 of the Administrator to determine that par18 ticular information, previously considered enti19 tled to confidential treatment, is no longer enti20 tled to such treatment.’’; and 

21 (D) in paragraph (3) (as redesignated by 

22 subparagraph (B))— 

23 (i) in subparagraph (A)— 

24 (I) in the first sentence, by strik25 ing ‘‘paragraph (1)(A)’’ and inserting 


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1 ‘‘paragraph (1) and approved by the 

2 Administrator under paragraph 

3 (2)(A)(ii)’’; and 

4 (II) by striking the last sentence 

5 and inserting ‘‘The Administrator 

6 shall release the information in ac7 cordance with the disclosure and pro8 cedural requirements of section 552 of 

9 title 5, United States Code.’’; 

10 (ii) in subparagraph (B)(i)— 

11 (I) in the first sentence— 

12 (aa) by striking ‘‘or (4)’’ 

13 and inserting ‘‘(4), or (5)’’; 

14 (bb) by striking ‘‘subsection 

15 (a)’’ each place it appears and in16 serting ‘‘subsection (c)’’; and 

17 (cc) by striking ‘‘paragraph 

18 (3)’’ and inserting ‘‘paragraph 

19 (4)’’; and 

20 (II) in the second sentence, by 

21 striking ‘‘except that’’ and all that fol22 lows through ‘‘such release is made’’ 

23 and inserting ‘‘except if the Adminis24 trator determines that the release of 

25 such data is necessary to protect 


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1 against an imminent and substantial 

2 endangerment to health or the envi3 ronment then no notice is required.’’; 

4 and 

5 (iii) in subparagraph (B)(ii), by strik6 ing ‘‘(b)(1)’’ and inserting ‘‘(d)(1)(A)(iii)’’; 

7 (6) in subsection (f) (as redesignated by para8 graph (1)), by striking ‘‘subsection (a)’’ and insert9 ing ‘‘subsection (c)’’; and 

10 (7) by adding at the end the following: 

11 ‘‘(h) RISK INFORMATION FOR WORKERS.—The Ad12 ministrator shall provide standards for, and facilitate the 

13 sharing of, chemical identity, safety standard determina14 tion, and health and safety data described in subsection 

15 (d) that pertains to chemical substances or mixtures, or 

16 articles containing chemical substances, that workers may 

17 come into contact with or otherwise be exposed to during 

18 the course of work, to and with those workers and rep19 resentatives of each certified or recognized bargaining 

20 agent representing those employees.’’. 

21 SEC. 14. DISCLOSURE OF DATA. 

22 Section 14 of the Toxic Substances Control Act (15 

23 U.S.C. 2613) is amended to read as follows: 

24 ‘‘SEC. 14. DISCLOSURE OF DATA. 

25 ‘‘(a) APPLICABILITY.— 


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1 ‘‘(1) IN GENERAL.—Subject to paragraph (2) 

2 and except as provided under subsections (b) and (e), 

3 any information reported to, or otherwise obtained 

4 by, the Administrator (or any representative of the 

5 Administrator) that is exempt from disclosure under 

6 subsection (a) of section 552 of title 5, United States 

7 Code, (commonly known as the ‘Freedom of Informa8 tion Act’) under subsection (b)(4) of that section, shall 

9 not be disclosed by the Administrator or by any offi10 cer or employee of the United States, unless the des11 ignation of the information as exempt from disclosure 

12 is prohibited under Federal law. 

13 ‘‘(2) EXEMPTIONS.— 

14 ‘‘(A) MANDATORY EXEMPTIONS.—Notwith15 standing any other provision of law, the Admin16 istrator shall disclose the information described 

17 in paragraph (1)— 

18 ‘‘(i) to any officer or employee of the 

19 United States— 

20 ‘‘(I) in connection with the offi21 cial duties of that officer or employee 

22 under any law for the protection of 

23 human health or the environment; or 

24 ‘‘(II) for specific law enforcement 

25 purposes; 


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1 ‘‘(ii) to a contractor with the United 

2 States and employees of that contractor if, 

3 in the opinion of the Administrator, the dis4 closure is necessary for the satisfactory per5 formance by the contractor of a contract 

6 with the United States entered into on or 

7 after the date of enactment of the Safe 

8 Chemicals Act of 2011 for the performance 

9 of work in connection with this Act and 

10 under such conditions as the Administrator 

11 may specify; 

12 ‘‘(iii) if the Administrator determines 

13 that the disclosure is necessary to protect 

14 human health or the environment; 

15 ‘‘(iv) on request, to a State or tribal 

16 government for the purpose of development 

17 or potential development, administration, 

18 or enforcement of a law, if 1 or more appli19 cable agreements ensure that the recipient 

20 government will take appropriate steps, and 

21 has adequate authority, to maintain the 

22 confidentiality of the information in accord23 ance with procedures comparable to those 

24 which the Administrator uses to safeguard 

25 the information; 


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1 ‘‘(v) on request, to public health or en2 vironmental health professionals or medical 

3 personnel if the Administrator determines 

4 that— 

5 ‘‘(I) disclosure is in the public in6 terest; 

7 ‘‘(II) the recipient does not have a 

8 conflict of interest or competitive inter9 est with respect to the submitter of the 

10 information; and 

11 ‘‘(III) 1 or more applicable agree12 ments are in place to ensure that the 

13 recipient of the information provides 

14 comparable protections to those pro15 vided by the Administrator to main16 tain the confidentiality of the informa17 tion. 

18 ‘‘(B) OPTIONAL EXEMPTIONS.—Notwith19 standing any other provision of law, the Admin20 istrator may disclose the information described 

21 in paragraph (1) if relevant, in any proceeding 

22 under this Act, except that disclosure in such a 

23 proceeding shall be made in such manner as to 

24 preserve confidentiality to the maximum extent 

25 practicable without impairing the proceeding. 


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1 ‘‘(3) EFFECT ON OTHER LAWS.—In any pro2 ceeding under section 552(a) of title 5, United States 

3 Code (commonly referred to as the ‘Freedom of Infor4 mation Act’), to obtain information, the disclosure of 

5 which has been denied pursuant to this section, the 

6 Administrator may not rely on subsection (b)(3) of 

7 that section to sustain the action of the Adminis8 trator. 

9 ‘‘(b) CATEGORIES OF CONFIDENTIAL BUSINESS INFOR10 MATION.— 

11 ‘‘(1) INFORMATION THAT IS ALWAYS ELIGIBLE

12 FOR PROTECTION.—Subject to subsection (a)(2) and 

13 any other applicable provision of Federal law, the Ad14 ministrator shall review and approve a request that 

15 conforms to the requirements described in subsection 

16 (c)(2) to treat as confidential under this section the 

17 following information: 

18 ‘‘(A) Precise information describing the 

19 manufacture, processing, or distribution of a 

20 chemical substance or mixture. 

21 ‘‘(B) Marketing and sales information. 

22 ‘‘(C) Information identifying the customers 

23 of a manufacturer, processor, or distributor. 


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1 ‘‘(D) Details of the full composition of a 

2 mixture of a particular manufacturer or proc3 essor. 

4 ‘‘(E) Precise information about the use, 

5 function, or application of a chemical substance 

6 or mixture in a process, mixture, or product of 

7 a particular manufacturer or processor. 

8 ‘‘(F) Precise production or import volumes 

9 of a particular manufacturer, processor, or dis10 tributor. 

11 ‘‘(2) INFORMATION THAT MAY BE ELIGIBLE FOR

12 PROTECTION.— 

13 ‘‘(A) IN GENERAL.—Subject to subsection 

14 (a) and any other applicable provision of Fed15 eral law, and except as provided in paragraphs 

16 (1) and (3), information submitted by a manu17 facturer, processor, or distributor to the Admin18 istrator may be protected if the manufacturer, 

19 processor, or distributor complies with subsection 

20 (c)(2) and the Administrator determines that a 

21 request to maintain the confidentiality of the in22 formation meets the applicable requirements of 

23 this subsection and any rule promulgated by the 

24 Administrator under subsection (c)(1). 


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1 ‘‘(B) IDENTITIES OF CERTAIN CHEMICAL

2 SUBSTANCES.— 

3 ‘‘(i) IN GENERAL.—Notwithstanding 

4 subparagraph (A), the Administrator shall 

5 not disclose precise information on the iden6 tity of a chemical substance if— 

7 ‘‘(I) the manufacturer or processor 

8 of the substance has, in accordance 

9 with subsection (c)(2)— 

10 ‘‘(aa) included in a notice 

11 under section 5(b) a request, in12 cluding a justification and docu13 mentation for the request, that the 

14 identity of the substance be treat15 ed as confidential business infor16 mation; or 

17 ‘‘(bb) submitted to the Ad18 ministrator not later than 180 

19 days after the date of enactment 

20 of the Safe Chemicals Act of 2011 

21 a request, including a justifica22 tion and documentation for the 

23 request, that the identity of a sub24 stance for which a notice has been 

25 submitted under section 5(b) as of 


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1 the date of enactment of the Safe 

2 Chemicals Act of 2011 be treated 

3 as confidential business informa4 tion; and 

5 ‘‘(II) the Administrator deter6 mines that— 

7 ‘‘(aa) the request complies 

8 with all applicable requirements 

9 of this section; 

10 ‘‘(bb) the chemical identity is 

11 not readily discoverable through 

12 reverse engineering; 

13 ‘‘(cc) the manufacturer or 

14 processor takes reasonable meas15 ures to protect the confidentiality 

16 of the chemical substance; 

17 ‘‘(dd) no other Federal stat18 ute requires disclosure; 

19 ‘‘(ee) disclosure of the iden20 tity of the chemical substance 

21 would cause financial or competi22 tive harm to the manufacturer or 

23 processor; 

24 ‘‘(ff) the chemical substance 

25 is not, based on information that 


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1 is initially available or that later 

2 becomes available to the Adminis3 trator, a known or probable repro4 ductive, developmental, neuro5 logical, or immunological toxi6 cant, carcinogen, or mutagen; 

7 ‘‘(gg) the chemical substance 

8 is not persistent, bioaccumulative, 

9 and toxic; and 

10 ‘‘(hh) if a safety standard de11 termination has been made for a 

12 chemical substance, the Adminis13 trator determines that the chem14 ical substance meets the applicable 

15 safety standard either under cur16 rent conditions or under addi17 tional conditions required by the 

18 Administrator. 

19 ‘‘(ii) NOTICE.—In cases where all of 

20 the requirements specified in clause (i) are 

21 met— 

22 ‘‘(I) the notice required to be 

23 made public by the Administrator 

24 under section 5(f)(3) shall include a 

25 justification for the determination of 


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1 the Administrator and identify the 

2 chemical substance by generic class un3 less the Administrator determines that 

4 more specific identification is required 

5 in the public interest; and 

6 ‘‘(II) as part of a claim to protect 

7 the identity of a chemical substance 

8 under subsection (c)(2), a manufac9 turer or processor may provide a ‘pub10 lic name’ for the chemical substance for 

11 use by the Administrator when sharing 

12 information on the chemical substance 

13 under this subsection. The public 

14 names should disclose a maximum 

15 amount of information on the chemical 

16 structure of the substance, while pro17 tecting those features of the chemical 

18 structure that are considered confiden19 tial and the disclosure of which would 

20 potentially harm the owner of that in21 formation. 

22 ‘‘(iii) DURATION OF PROTECTION FOR

23 CHEMICAL IDENTITY.—Notwithstanding 

24 subsection (c)(1)(B)(iv), the identity of a 

25 chemical substance for which a request has 


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1 been submitted pursuant to clause (i)(I) 

2 and meets the requirements of clause (i) 

3 shall be protected as confidential business 

4 information— 

5 ‘‘(I) for such period of time as the 

6 Administrator, after reviewing the re7 quest, determines to be reasonable; and 

8 ‘‘(II) upon expiration of a time 

9 period specified under this clause, for 

10 an additional 5-year period, if the Ad11 ministrator, after reviewing the re12 quest, determines that the request for 

13 protection continues to meet the cri14 teria established in this subparagraph. 

15 ‘‘(iv) PUBLICATION REQUIREMENT.— 

16 The Administrator shall annually publish a 

17 notice that— 

18 ‘‘(I) includes an updated, cumu19 lative list of each new chemical sub20 stance for which the Administrator has 

21 approved a request to protect informa22 tion under this paragraph, identified 

23 by a unique identifier, other than the 

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1 ing the period of time for which the 

2 protection applies; and 

3 ‘‘(II) for each chemical substance 

4 for which the protection provided 

5 under this paragraph has expired, pro6 vides the precise identity of the chem7 ical substance, and provides public ac8 cess to any information that had been 

9 submitted to the Administrator which 

10 concealed the identity of the chemical 

11 substance in accordance with this 

12 paragraph. 

13 ‘‘(C) IMPURITIES.—Notwithstanding sub14 paragraph (A), the Administrator may deter15 mine not to disclose information relating to the 

16 degree of purity or the identity of impurities 

17 present in a chemical substance or mixture if the 

18 Administrator determines that knowledge of the 

19 information would reveal processes used in the 

20 manufacturing or processing of the chemical sub21 stance or mixture. 

22 ‘‘(3) INFORMATION THAT IS NEVER ELIGIBLE

23 FOR PROTECTION.— 


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

2 paragraph (2), the Administrator shall disclose 

3 the following information: 

4 ‘‘(i) The identity of a chemical sub5 stance. 

6 ‘‘(ii) Any safety standard determina7 tion developed under section 6, including 

8 supporting analysis developed by the Ad9 ministrator. 

10 ‘‘(iii) Any health and safety study 

11 data that is submitted under this Act with 

12 respect to— 

13 ‘‘(I) any chemical substance or 

14 mixture— 

15 ‘‘(aa) that has been offered 

16 for commercial distribution as of 

17 the date on which the study is to 

18 be disclosed; or 

19 ‘‘(bb) for which testing is re20 quired under section 4 or for 

21 which notification is required 

22 under section 5; and 

23 ‘‘(II) any data reported to, or oth24 erwise obtained by, the Administrator 

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1 lates to a chemical substance or mix2 ture described in subclause (I). 

3 ‘‘(iv) Health and safety data in notices 

4 of substantial risk submitted pursuant to 

5 section 8(l) and in the underlying studies. 

6 ‘‘(v) General information describing 

7 the manufacturing volumes, expressed in 

8 ranges, and industrial, commercial, or con9 sumer functions and uses of a chemical sub10 stance or mixture. 

11 ‘‘(vi) Any information indicating the 

12 presence of a chemical substance in con13 sumer products intended for use, or reason14 ably expected to be used, by children aged 

15 14 years or younger, if— 

16 ‘‘(I) the Administrator, or another 

17 authoritative body, has determined 

18 that the chemical substance— 

19 ‘‘(aa) is a known or probable 

20 reproductive, developmental, neu21 rological, or immunological toxi22 cant, carcinogen, or mutagen; or 

23 ‘‘(bb) is persistent, bio24 accumulative, and toxic; or 


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1 ‘‘(II) for a chemical substance for 

2 which a safety standard determination 

3 has been made, the Administrator has 

4 not found that the chemical substance 

5 meets the safety standard. 

6 ‘‘(B) PROHIBITION.—Nothing in this para7 graph authorizes the release of any data that dis8 closes a process used in the manufacturing or 

9 processing of a chemical substance or mixture, or 

10 in the case of a mixture, the release of data dis11 closing the portion of the mixture comprised by 

12 any of the chemical substances in the mixture. 

13 ‘‘(C) APPLICABILITY OF OTHER LAWS.—Ex14 cept as provided in paragraph (2), if the Admin15 istrator receives a request for information under 

16 section 552(a) of title 5, United States Code, 

17 (commonly known as the ‘Freedom of Informa18 tion Act’) for information described in subpara19 graph (A), which is not information described in 

20 subparagraph (B), the Administrator shall not 

21 deny the request under subsection (b)(4) of that 

22 section. 

23 ‘‘(c) DESIGNATION AND TREATMENT OF CONFIDENTIAL

24 BUSINESS INFORMATION.— 

25 ‘‘(1) DUTIES OF THE ADMINISTRATOR.— 


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1 ‘‘(A) RULES.—Not later than 1 year after 

2 the date of enactment of the Safe Chemicals Act 

3 of 2011, the Administrator shall promulgate 

4 rules that specify— 

5 ‘‘(i) the acceptable bases on which 

6 written requests to maintain confidentiality 

7 of information may be approved, which 

8 shall be consistent with the requirements of 

9 this section; 

10 ‘‘(ii) the nature of the documentation 

11 and justification that must accompany such 

12 a request; and 

13 ‘‘(iii) the types of information the Ad14 ministrator determines warrant protection 

15 for an indefinite period of time, for which 

16 the term of confidentiality specified in sub17 paragraph (B)(iv)(I) shall not apply. 

18 ‘‘(B) REVIEW OF REQUESTS.— 

19 ‘‘(i) IN GENERAL.—Not later than 90 

20 days after the date of receipt of information 

21 under paragraph (2), the Administrator 

22 shall review a request to maintain confiden23 tiality of information submitted under this 

24 Act and determine whether to approve, 

25 modify, or deny that request based on the 


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1 regulations promulgated by the Adminis2 trator under subparagraph (A). 

3 ‘‘(ii) PROCESS.—The Administrator 

4 shall, in accordance with clause (i)— 

5 ‘‘(I) review all requests received to 

6 maintain confidentiality of submitted 

7 information; or 

8 ‘‘(II) if it is not feasible for the 

9 Administrator to review all of the re10 quests— 

11 ‘‘(aa) review all requests re12 lating to information described in 

13 subsection (b)(2)(B); and 

14 ‘‘(bb) review a representative 

15 subset that includes not less than 

16 25 percent of all other requests re17 ceived; and 

18 ‘‘(III) publish in the Federal Reg19 ister on at least an annual basis a de20 scription of the number and types of 

21 requests received and reviewed by the 

22 Administrator. 

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1 graph (D), the Administrator shall prompt2 ly make the information available to the 

3 public in accordance with section 8(i)(2). 

4 ‘‘(iv) APPROVALS.—If a request to 

5 maintain confidentiality of submitted infor6 mation is approved, the Administrator 

7 shall— 

8 ‘‘(I) except with respect to re9 quests subject to a rule issued pursuant 

10 to subparagraph (A)(iii) and requests 

11 submitted pursuant to subsection 

12 (b)(2)(B)(i)(I), specify a time period 

13 not to exceed 5 years for which the sub14 mitted information shall be kept con15 fidential, unless the information other16 wise becomes available to the public 

17 during the period; and 

18 ‘‘(II) upon the expiration of the 

19 protection period, make the informa20 tion available to the public unless the 

21 manufacturer, processor, or distributor 

22 has submitted, documented, and justi23 fied to the satisfaction of the Adminis24 trator and in accordance with this sub25 section the basis for a renewal of the 


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1 protection, for a time period not to ex2 ceed 5 years. 

3 ‘‘(C) AUTHORITY OF THE ADMINIS4 TRATOR.—Nothing in subparagraph (A) or (B) 

5 limits the authority of the Administrator to de6 termine that particular information, previously 

7 treated as confidential, is no longer entitled to 

8 confidential treatment. 

9 ‘‘(D) NOTIFICATIONS.— 

10 ‘‘(i) IN GENERAL.—Except as provided 

11 in clause (ii), if the Administrator proposes 

12 to release information for which a request 

13 for confidential treatment has been ap14 proved under this section, the Administrator 

15 shall electronically notify the manufacturer, 

16 processor, or distributor in commerce who 

17 submitted the request of the intent of the 

18 Administrator to release the information 

19 not less than 15 days prior to the release of 

20 the information. 

21 ‘‘(ii) ADMINISTRATION.—The Adminis22 trator shall release the information de23 scribed in clause (i) in accordance with the 

24 disclosure and procedural requirements of 

25 section 552 of title 5, United States Code 


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1 (commonly known as the ‘Freedom of Infor2 mation Act’), except that— 

3 ‘‘(I) if the release of the informa4 tion is to be made pursuant to a re5 quest made under section 552(a) of 

6 title 5, United States Code, the notice 

7 shall be given immediately upon ap8 proval of the request by the Adminis9 trator; 

10 ‘‘(II) if the Administrator deter11 mines that the release of information 

12 pursuant to subsection (a)(2)(A)(iii) is 

13 necessary to protect against imminent 

14 and substantial harm to human health 

15 or the environment, no notice shall be 

16 required; and 

17 ‘‘(III) the requirements of this 

18 subparagraph shall not apply to the re19 lease of information under— 

20 ‘‘(aa) clauses (i) through (iii) 

21 of subsection (a)(2)(A); or 

22 ‘‘(bb) subsection (b)(3)(A). 

23 ‘‘(2) DUTIES OF MANUFACTURERS, PROCESSORS, 

24 AND DISTRIBUTORS.— 


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1 ‘‘(A) IN GENERAL.—In submitting data 

2 under this Act, a manufacturer, processor, or 

3 distributor in commerce may— 

4 ‘‘(i) designate information, other than 

5 information described in subsection (b)(3), 

6 for which the manufacturer, processor, or 

7 distributor requests confidential treatment 

8 under subsection (a) or (b); and 

9 ‘‘(ii) submit the designated data sepa10 rately from other data submitted under this 

11 Act. 

12 ‘‘(B) REQUIREMENTS.—A designation 

13 under this paragraph shall be made in writing 

14 and in such manner as the Administrator may 

15 prescribe, and shall include— 

16 ‘‘(i) documentation and justification 

17 for each request for confidentiality, except 

18 for requests relating to the information de19 scribed in subsection (b)(1); 

20 ‘‘(ii) the period of time for which 

21 maintenance of confidentiality of the infor22 mation is requested except with respect to 

23 requests subject to a rule issued pursuant to 

24 subsection (c)(1)(A)(iii); 


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1 ‘‘(iii) a certification that the informa2 tion is not otherwise publicly available; 

3 ‘‘(iv) separate copies of all submitted 

4 information, with 1 copy containing and 1 

5 copy excluding the information to which the 

6 request applies; and 

7 ‘‘(v) any additional information re8 quired by the Administrator. 

9 ‘‘(C) REQUEST FOR RENEWAL.—Prior to 

10 the expiration of the specified time period deter11 mined by the Administrator under paragraph 

12 (1)(B)(iv), a manufacturer, processor, or dis13 tributor may submit a request for renewal of 

14 protection for protected information. This request 

15 for renewal shall follow the same procedures and 

16 requirements as the initial submission under 

17 subparagraphs (A) and (B). 

18 ‘‘(d) CIVIL PENALTY FOR WRONGFUL DISCLOSURE OR

19 WRONGFUL REQUESTS FOR PROTECTION.— 

20 ‘‘(1) IN GENERAL.—Any officer or employee of 

21 the United States or former officer or employee of the 

22 United States, who, by virtue of employment or offi23 cial position has obtained possession of, or has access 

24 to, material the disclosure of which is prohibited by 

25 subsection (a), and who knowing that disclosure of the 


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1 material is prohibited by that subsection, willfully 

2 discloses the material in any manner to any person 

3 not entitled to receive the information, shall be subject 

4 to appropriate disciplinary action and subject to a 

5 civil money penalty of not more than $10,000 for 

6 each violation. 

7 ‘‘(2) APPLICABILITY OF OTHER LAWS.—Section 

8 1905 of title 18, United States Code, shall not apply 

9 with respect to the publishing, divulging, disclosure, 

10 making known, or making available of, information 

11 reported or otherwise obtained under this Act. 

12 ‘‘(3) CONTRACTORS.—For the purposes of para13 graph (1), any contractor with the United States who 

14 is furnished information as authorized by subsection 

15 (a)(2), including any employee of such a contractor, 

16 shall be considered to be an employee of the United 

17 States. 

18 ‘‘(4) FALSE REQUESTS.—Any officer or employee 

19 of a company that submits information under this 

20 Act who willfully designates information as eligible 

21 for confidential treatment, knowing that the informa22 tion is ineligible for such treatment, shall be subject 

23 to a civil money penalty of not more than $10,000 for 

24 each such violation. 


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1 ‘‘(e) ACCESS BY CONGRESS.—Notwithstanding this 

2 section or any other provision of law, all information re3 ported to or otherwise obtained by the Administrator (or 

4 any representative of the Administrator) under this Act 

5 shall be made available, on written request of any duly au6 thorized committee of Congress, to that committee. 

7 ‘‘(f) RISK INFORMATION FOR WORKERS.—The Admin8 istrator shall facilitate the sharing of information that per9 tains to chemical substances or mixtures or articles con10 taining chemical substances that workers may come into 

11 contact with or may otherwise be exposed to during the 

12 course of work with those workers and representatives of 

13 each certified or recognized bargaining agent representing 

14 those workers. Nothing in this subsection authorizes disclo15 sure of information other than those disclosures that may 

16 be made pursuant to subsections (a) through (e).’’. 

17 SEC. 15. PROHIBITED ACTS. 

18 Section 15 of the Toxic Substances Control Act (15 

19 U.S.C. 2614) is amended— 

20 (1) by striking paragraph (1) and inserting the 

21 following: 

22 ‘‘(1) fail or refuse to comply with any rule, 

23 order, prohibition, restriction, or other requirement 

24 imposed by this Act or by the Administrator under 

25 this Act;’’; 


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1 (2) in paragraph (2)— 

2 (A) by striking ‘‘use’’ and inserting ‘‘man3 ufacture, process, distribute in commerce, use, 

4 or dispose of’’; 

5 (B) by striking ‘‘or mixture’’ and inserting 

6 ‘‘, mixture, or article’’; and 

7 (C) by striking ‘‘section 5 or 6, a rule or 

8 order under section 5 or 6, or an order issued 

9 in action brought under section 5 or 7’’ and in10 serting ‘‘any rule, order, prohibition, restriction, 

11 or other requirement imposed by this Act or by 

12 the Administrator under this Act’’; 

13 (3) in paragraph (3)— 

14 (A) in subparagraph (A), by inserting ‘‘ac15 curate and complete’’ after ‘‘maintain’’; 

16 (B) in subparagraph (B)— 

17 (i) by inserting ‘‘or make accurate 

18 and complete’’ after ‘‘submit’’; and 

19 (ii) by inserting ‘‘information submis20 sions, disclosures, declarations, certifi21 cations,’’ after ‘‘notices,’’; and 

22 (C) in subparagraph (C), by striking ‘‘or’’ 

23 after the semicolon; 

24 (4) in paragraph (4), by striking the period at 

25 the end and inserting a semicolon; and 


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1 (5) by adding at the end the following: 

2 ‘‘(5) make or submit a statement, declaration, 

3 disclosure, certification, writing, data set, or rep4 resentation that is materially false, in whole or in 

5 part, or to falsify or conceal any material fact, in 

6 taking any action or making any communication 

7 pursuant to this Act or pursuant to any rule or 

8 order promulgated or issued under this Act; or 

9 ‘‘(6) take any action prohibited by this Act.’’. 

10 SEC. 16. PENALTIES. 

11 Section 16 of the Toxic Substances Control Act (15 

12 U.S.C. 2615) is amended— 

13 (1) in subsection (a)— 

14 (A) in paragraph (1)— 

15 (i) in the first sentence— 

16 (I) by inserting ‘‘this Act or a 

17 rule or order promulgated or issued 

18 pursuant to this Act, as described in’’ 

19 after ‘‘a provision of’’; and 

20 (II) by striking ‘‘$25,000’’ and 

21 inserting ‘‘$37,500’’; and 

22 (ii) in the second sentence, by striking 

23 ‘‘violation of section 15 or 409’’ and in24 serting ‘‘violation of this Act’’; 


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1 (B) by redesignating paragraphs (2), (3), 

2 and (4) as paragraphs (3), (4), and (5), respec3 tively; 

4 (C) by inserting after paragraph (1) the 

5 following: 

6 ‘‘(2) In the case of any violation described in 

7 paragraph (1), the Administrator may commence a 

8 civil action in the appropriate United States district 

9 court to assess penalties pursuant to that para10 graph.’’; 

11 (D) in subparagraph (A) of paragraph (3) 

12 (as redesignated by subparagraph (B))— 

13 (i) in the first sentence, by inserting 

14 ‘‘this Act, as described in’’ before ‘‘section 

15 15 or 409’’; and 

16 (ii) in the last sentence, by striking 

17 ‘‘within 15 days of’’ and inserting ‘‘not 

18 later than 15 days after’’; 

19 (E) in the first sentence of paragraph (4) 

20 (as redesignated by subparagraph (B))— 

21 (i) by striking ‘‘paragraph (2)(A)’’ 

22 and inserting ‘‘paragraph (3)(A)’’; and 

23 (ii) by striking ‘‘the United States 

24 Court of Appeals for the District of Co25 lumbia Circuit or for any other circuit’’ 


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1 and inserting ‘‘the appropriate district 

2 court of the United States for the dis3 trict’’; and 

4 (F) in paragraph (5) (as redesignated by 

5 subparagraph (B)), by striking ‘‘paragraph (3)’’ 

6 each place it appears and inserting ‘‘paragraph 

7 (4)’’; and 

8 (2) in subsection (b)— 

9 (A) by striking ‘‘Any person’’ and inserting 

10 the following: 

11 ‘‘(1) IN GENERAL.—Any person’’; 

12 (B) by striking ‘‘or willfully’’; 

13 (C) by inserting ‘‘this Act, as described in’’ 

14 after ‘‘any provision of’’; 

15 (D) by striking ‘‘$25,000’’ and inserting 

16 ‘‘$50,000’’; 

17 (E) by striking ‘‘one year’’ and inserting 

18 ‘‘5 years’’; and 

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

20 ‘‘(2) IMMINENT DANGER OF DEATH OR SERIOUS

21 BODILY INJURY.— 

22 ‘‘(A) IN GENERAL.—Any individual who 

23 knowingly violates any provision of this Act and 

24 who knows at the time that the violation places 

25 another person in imminent danger of death or 


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1 serious bodily injury shall upon conviction be 

2 subject to a fine of not more than $250,000, or 

3 imprisonment of not more than 15 years, or 

4 both. 

5 ‘‘(B) OTHER PERSONS.—A person that is 

6 not an individual shall, upon conviction of vio7 lating this paragraph, be subject to a fine of 

8 not more than $1,000,000.’’. 

9 SEC. 17. SPECIFIC ENFORCEMENT AND SEIZURE. 

10 Section 17 of the Toxic Substances Control Act (15 

11 U.S.C. 2616) is amended— 

12 (1) in subsection (a)— 

13 (A) in paragraph (1)— 

14 (i) by striking ‘‘(1) The district 

15 courts’’ and all that follows through the 

16 end of subparagraph (C) and inserting the 

17 following: 

18 ‘‘(1) AUTHORITY OF THE ADMINISTRATOR.— 

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

20 may commence a civil action in the appropriate 

21 United States district court to compel compli22 ance of any person with any provision of this 

23 Act or any rule or order promulgated pursuant 

24 to this Act. 


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1 ‘‘(B) ENFORCEMENT.—The authority of 

2 the Administrator to enforce this Act includes 

3 the authority— 

4 ‘‘(i) to seek civil or criminal penalties 

5 under section 16 for any violation of this 

6 Act, as described in sections 15 and 409; 

7 ‘‘(ii) to enjoin any violation of this 

8 Act, or of a rule or order promulgated or 

9 issued under this Act, as described in sec10 tions 15 and 409; 

11 ‘‘(iii) to order the compliance of any 

12 person with any provision of this Act, or 

13 with any rule or order promulgated or 

14 issued under this Act, through an adminis15 trative proceeding (which may proceed con16 currently with action under this section), 

17 in which the Administrator may levy pen18 alties under section 16; and’’; and 

19 (ii) in subparagraph (D)— 

20 (I) by redesignating clause (i) 

21 through (iii) as subclauses (I) through 

22 (III), respectively, and indenting ap23 propriately; 


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1 (II) by striking ‘‘(D) direct any 

2 manufacturer’’ and inserting the fol3 lowing: 

4 ‘‘(iv) to order any manufacturer’’; 

5 (III) by striking ‘‘product subject 

6 to title IV’’ and inserting ‘‘article sub7 ject to this Act’’; 

8 (IV) by striking ‘‘product’’ each 

9 place it appears and inserting ‘‘arti10 cle’’; 

11 (V) by striking ‘‘of section 5, 6, 

12 or title IV’’ and inserting ‘‘this Act’’; 

13 and 

14 (VI) by striking ‘‘under section 

15 5, 6, or title IV’’ and inserting ‘‘pro16 mulgated and issued under this Act, 

17 as described in section 15 or 409,’’; 

18 (B) in paragraph (2)— 

19 (i) by striking ‘‘(2) A civil action’’ and 

20 all that follows through ‘‘described in sub21 paragraph (A) of such paragraph’’ in sub22 paragraph (A) and inserting the following: 

23 ‘‘(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 38; 

21 (2) by redesignating section 30 (15 U.S.C. 

22 2629) as section 37; 

23 (3) by striking section 31 (Public Law 94–469; 

24 100 Stat. 2989); and 


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1 (4) by amending section 38 (as redesignated by 

2 paragraph (1)) to read as follows: 

3 ‘‘SEC. 38. 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 23:53 Dec 27, 2012 Jkt 029200 PO 00000 Frm 00340 Fmt 6652 Sfmt 6201 E:\BILLS\S847.RS 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.’’. 


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Calendar No. 578 

112TH CONGRESS 

2D SESSION S. 847 

[Report No. 112–264] 

A BILL 

To amend the Toxic Substances Control Act to enderstood and managed, and for other purposes. sure that risks from chemicals are adequately unDECEMBER 27, 2012 

Reported with amendments 


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