II 

114TH CONGRESS 

1ST SESSION S. 697 

To amend the Toxic Substances Control Act to reauthorize and modernize 

that Act, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MARCH 10, 2015 

Mr. UDALL (for himself, Mr. VITTER, Mr. MANCHIN, Mr. INHOFE, Mr. CARPER, Mr. BLUNT, Mr. COONS, Mr. BOOZMAN, Mr. DONNELLY, Mrs. CAPITO, Mr. HEINRICH, Mr. CASSIDY, Ms. HEITKAMP, Mr. CRAPO, Ms. STABENOW, Mr. HOEVEN, and Mr. PORTMAN) introduced the following bill; 

which was read twice and referred to the Committee on Environment and 

Public Works 

A BILL 

To amend the Toxic Substances Control Act to reauthorize 

and modernize that Act, and for other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Frank R. Lautenberg 

5 Chemical Safety for the 21st Century Act’’. 

6 SEC. 2. FINDINGS, POLICY, AND INTENT. 

7 Section 2(c) of the Toxic Substances Control Act (15 

8 U.S.C. 2601(c)) is amended— 


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1 (1) by striking ‘‘It is the intent’’ and inserting 

2 the following: 

3 ‘‘(1) ADMINISTRATION.—It is the intent’’; 

4 (2) in paragraph (1) (as so redesignated), by 

5 inserting ‘‘, as provided under this Act’’ before the 

6 period at the end; and 

7 (3) by adding at the following: 

8 ‘‘(2) REFORM.—It is the intent of Congress 

9 that reform of this Act in accordance with the 

10 amendments made by the Frank R. Lautenberg 

11 Chemical Safety for the 21st Century Act— 

12 ‘‘(A) shall be administered in a manner 

13 that— 

14 ‘‘(i) protects the health of children, 

15 pregnant women, the elderly, workers, con16 sumers, the general public, and the envi17 ronment from the risks of harmful expo18 sures to chemical substances and mixtures; 

19 and 

20 ‘‘(ii) ensures that appropriate infor21 mation on chemical substances and mix22 tures is available to public health officials 

23 and first responders in the event of an 

24 emergency; and 


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1 ‘‘(B) shall not displace or supplant com2 mon law rights of action or remedies for civil 

3 relief.’’. 

4 SEC. 3. DEFINITIONS. 

5 Section 3 of the Toxic Substances Control Act (15 

6 U.S.C. 2602) is amended— 

7 (1) by redesignating paragraphs (4), (5), (6), 

8 (7), (8), (9), (10), (11), (12), (13), and (14) as 

9 paragraphs (5), (6), (7), (8), (9), (10), (12), (13), 

10 (17), (18), and (19), respectively; 

11 (2) by inserting after paragraph (3) the fol12 lowing: 

13 ‘‘(4) CONDITIONS OF USE.—The term ‘condi14 tions of use’ means the intended, known, or reason15 ably foreseeable circumstances the Administrator de16 termines a chemical substance is manufactured, 

17 processed, distributed in commerce, used, or dis18 posed of.’’; 

19 (3) by inserting after paragraph (10) (as so re20 designated) the following: 

21 ‘‘(11) POTENTIALLY EXPOSED OR SUSCEPTIBLE

22 POPULATION.—The term ‘potentially exposed or sus23 ceptible population’ means 1 or more groups— 

24 ‘‘(A) of individuals within the general pop25 ulation who may be— 


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1 ‘‘(i) differentially exposed to chemical 

2 substances under the conditions of use; or 

3 ‘‘(ii) susceptible to greater adverse 

4 health consequences from chemical expo5 sures than the general population; and 

6 ‘‘(B) that when identified by the Adminis7 trator may include such groups as infants, chil8 dren, pregnant women, workers, and the elder9 ly.’’; and 

10 (4) by inserting after paragraph (13) (as so re11 designated) the following: 

12 ‘‘(14) SAFETY ASSESSMENT.—The term ‘safety 

13 assessment’ means an assessment of the risk posed 

14 by a chemical substance under the conditions of use, 

15 integrating hazard, use, and exposure information 

16 regarding the chemical substance. 

17 ‘‘(15) SAFETY DETERMINATION.—The term 

18 ‘safety determination’ means a determination by the 

19 Administrator as to whether a chemical substance 

20 meets the safety standard under the conditions of 

21 use. 

22 ‘‘(16) SAFETY STANDARD.—The term ‘safety 

23 standard’ means a standard that ensures, without 

24 taking into consideration cost or other nonrisk fac25 tors, that no unreasonable risk of harm to health or 


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1 the environment will result from exposure to a chem2 ical substance under the conditions of use, including 

3 no unreasonable risk of harm to— 

4 ‘‘(A) the general population; or 

5 ‘‘(B) any potentially exposed or susceptible 

6 population that the Administrator has identified 

7 as relevant to the safety assessment and safety 

8 determination for a chemical substance.’’. 

9 SEC. 4. POLICIES, PROCEDURES, AND GUIDANCE. 

10 The Toxic Substances Control Act is amended by in11 serting after section 3 (15 U.S.C. 2602) the following: 

12 ‘‘SEC. 3A. POLICIES, PROCEDURES, AND GUIDANCE. 

13 ‘‘(a) DEFINITION OF GUIDANCE.—In this section, the 

14 term ‘guidance’ includes any significant written guidance 

15 of general applicability prepared by the Administrator. 

16 ‘‘(b) DEADLINE.—Not later than 2 years after the 

17 date of enactment of the Frank R. Lautenberg Chemical 

18 Safety for the 21st Century Act, the Administrator shall 

19 develop, after providing public notice and an opportunity 

20 for comment, any policies, procedures, and guidance the 

21 Administrator determines to be necessary to carry out sec22 tions 4, 4A, 5, and 6, including the policies, procedures, 

23 and guidance required by this section. 

24 ‘‘(c) USE OF SCIENCE.— 


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1 ‘‘(1) IN GENERAL.—The Administrator shall es2 tablish policies, procedures, and guidance on the use 

3 of science in making decisions under sections 4, 4A, 

4 5, and 6. 

5 ‘‘(2) GOAL.—A goal of the policies and proce6 dures described in paragraph (1) shall be to make 

7 the basis of decisions clear to the public. 

8 ‘‘(3) REQUIREMENTS.—The policies, proce9 dures, and guidance issued under this section shall 

10 describe the manner in which the Administrator 

11 shall ensure that— 

12 ‘‘(A) decisions made by the Adminis13 trator— 

14 ‘‘(i) are based on information, proce15 dures, measures, methods, and models em16 ployed in a manner consistent with the 

17 best available science; 

18 ‘‘(ii) take into account the extent to 

19 which— 

20 ‘‘(I) assumptions and methods 

21 are clearly and completely described 

22 and documented; 

23 ‘‘(II) variability and uncertainty 

24 are evaluated and characterized; and 


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1 ‘‘(III) the information has been 

2 subject to independent verification 

3 and peer review; and 

4 ‘‘(iii) are based on the weight of the 

5 scientific evidence, by which the Adminis6 trator considers all information in a sys7 tematic and integrative framework to con8 sider the relevance of different informa9 tion; 

10 ‘‘(B) to the extent practicable and if ap11 propriate, the use of peer review, standardized 

12 test design and methods, consistent data eval13 uation procedures, and good laboratory prac14 tices will be encouraged; 

15 ‘‘(C) a clear description of each individual 

16 and entity that funded the generation or assess17 ment of information, and the degree of control 

18 those individuals and entities had over the gen19 eration, assessment, and dissemination of infor20 mation (including control over the design of the 

21 work and the publication of information) is 

22 made available; and 

23 ‘‘(D) if appropriate, the recommendations 

24 in reports of the National Academy of Sciences 

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1 ards, exposures, and risks of chemical sub2 stances are considered. 

3 ‘‘(d) EXISTING EPA POLICIES, PROCEDURES, AND

4 GUIDANCE.—The policies, procedures, and guidance de5 scribed in subsection (b) shall incorporate, as appropriate, 

6 existing relevant hazard, exposure, and risk assessment 

7 guidelines and methodologies, data evaluation and quality 

8 criteria, testing methodologies, and other relevant guide9 lines and policies of the Environmental Protection Agency. 

10 ‘‘(e) REVIEW.—Not later than 5 years after the date 

11 of enactment of this section, and not less frequently than 

12 once every 5 years thereafter, the Administrator shall— 

13 ‘‘(1) review the adequacy of any policies, proce14 dures, and guidance developed under this section, in15 cluding animal, nonanimal, and epidemiological test 

16 methods and procedures for assessing and deter17 mining risk under this Act; and 

18 ‘‘(2) after providing public notice and an oppor19 tunity for comment, revise the policies, procedures, 

20 and guidance if necessary to reflect new scientific 

21 developments or understandings. 

22 ‘‘(f) SOURCES OF INFORMATION.—In making any de23 cision with respect to a chemical substance under section 

24 4, 4A, 5, or 6, the Administrator shall take into consider25 ation information relating to the hazards and exposures 


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1 of a chemical substance under the conditions of use that 

2 is reasonably available to the Administrator, including in3 formation that is— 

4 ‘‘(1) submitted to the Administrator pursuant 

5 to any rule, consent agreement, order, or other re6 quirement of this Act, or on a voluntary basis, in7 cluding pursuant to any request made under this 

8 Act, by— 

9 ‘‘(A) manufacturers or processors of a sub10 stance; 

11 ‘‘(B) the public; 

12 ‘‘(C) other Federal departments or agen13 cies; or 

14 ‘‘(D) the Governor of a State or a State 

15 agency with responsibility for protecting health 

16 or the environment; 

17 ‘‘(2) submitted to a governmental entity in any 

18 jurisdiction pursuant to a governmental requirement 

19 relating to the protection of health or the environ20 ment; or 

21 ‘‘(3) identified through an active search by the 

22 Administrator of information sources that are pub23 licly available or otherwise accessible by the Admin24 istrator. 


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1 ‘‘(g) TESTING OF CHEMICAL SUBSTANCES AND MIX2 TURES.— 

3 ‘‘(1) IN GENERAL.—The Administrator shall es4 tablish policies and procedures for the testing of 

5 chemical substances or mixtures under section 4. 

6 ‘‘(2) GOAL.—A goal of the policies and proce7 dures established under paragraph (1) shall be to 

8 make the basis of decisions clear to the public. 

9 ‘‘(3) CONTENTS.—The policies and procedures 

10 established under paragraph (1) shall— 

11 ‘‘(A) address how and when the exposure 

12 level or exposure potential of a chemical sub13 stance would factor into decisions to require 

14 new testing, subject to the condition that the 

15 Administrator shall not interpret the lack of ex16 posure information as a lack of exposure or ex17 posure potential; 

18 ‘‘(B) describe the manner in which the Ad19 ministrator will determine that additional infor20 mation is necessary to carry out this Act, in21 cluding information relating to potentially ex22 posed or susceptible populations; 

23 ‘‘(C) require the Administrator to consult 

24 with the Director of the National Institute for 


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1 Occupational Safety and Health prior to pre2 scribing epidemiologic studies of employees; and 

3 ‘‘(D) prior to adopting a requirement for 

4 testing using vertebrate animals, require the 

5 Administrator to take into consideration, as ap6 propriate and to the extent practicable, reason7 ably available— 

8 ‘‘(i) toxicity information; 

9 ‘‘(ii) computational toxicology and 

10 bioinformatics; 

11 ‘‘(iii) high-throughput screening meth12 ods and the prediction models of those 

13 methods; and 

14 ‘‘(iv) scientifically reliable and rel15 evant alternatives to tests on animals that 

16 would provide equivalent information. 

17 ‘‘(4) TIERED TESTING.— 

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

19 subparagraph (D), the Administrator shall em20 ploy a tiered screening and testing process, 

21 under which the results of screening-level tests 

22 or assessments of available information inform 

23 the decision as to whether 1 or more additional 

24 tests are necessary. 

25 ‘‘(B) SCREENING-LEVEL TESTS.— 


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1 ‘‘(i) IN GENERAL.—The screening2 level tests required for a chemical sub3 stance or mixture may include tests for 

4 hazard (which may include in silico, in 

5 vitro, and in vivo tests), environmental and 

6 biological fate and transport, and measure7 ments or modeling of exposure or exposure 

8 potential, as appropriate. 

9 ‘‘(ii) USE.—Screening-level tests shall 

10 be used— 

11 ‘‘(I) to screen chemical sub12 stances or mixtures for potential ad13 verse effects; and 

14 ‘‘(II) to inform a decision of the 

15 Administrator regarding whether 

16 more complex or targeted additional 

17 testing is necessary. 

18 ‘‘(C) ADDITIONAL TESTING.—If the Ad19 ministrator determines under subparagraph (B) 

20 that additional testing is necessary to provide 

21 more definitive information for safety assess22 ments or safety determinations, the Adminis23 trator may require more advanced tests for po24 tential health or environmental effects or expo25 sure potential. 


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1 ‘‘(D) ADVANCED TESTING WITHOUT

2 SCREENING.—The Administrator may require 

3 more advanced testing without conducting 

4 screening-level testing when other information 

5 available to the Administrator justifies the ad6 vanced testing, pursuant to guidance developed 

7 by the Administrator under this section. 

8 ‘‘(h) SAFETY ASSESSMENTS AND SAFETY DETER9 MINATIONS.— 

10 ‘‘(1) SCHEDULE.— 

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

12 shall inform the public regarding the schedule 

13 for the completion of each safety assessment 

14 and safety determination as soon as practicable 

15 after designation as a high-priority substance 

16 pursuant to section 4A. 

17 ‘‘(B) DIFFERING TIMES.—The Adminis18 trator may allot different times for different 

19 chemical substances in the schedules under this 

20 paragraph, subject to the condition that all 

21 schedules shall comply with the deadlines estab22 lished under section 6. 

23 ‘‘(C) ANNUAL PLAN.—At the beginning of 

24 each calendar year, the Administrator shall 

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1 ments and safety determinations to be com2 pleted that year. 

3 ‘‘(2) POLICIES AND PROCEDURES FOR SAFETY

4 ASSESSMENTS AND SAFETY DETERMINATIONS.— 

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

6 shall establish, by rule, policies and procedures 

7 regarding the manner in which the Adminis8 trator shall carry out section 6. 

9 ‘‘(B) GOAL.—A goal of the policies and 

10 procedures under this paragraph shall be to 

11 make the basis of decisions of the Adminis12 trator clear to the public. 

13 ‘‘(C) MINIMUM REQUIREMENTS.—At a 

14 minimum, the policies and procedures under 

15 this paragraph shall— 

16 ‘‘(i) describe— 

17 ‘‘(I) the manner in which the Ad18 ministrator will identify informational 

19 needs and seek that information from 

20 the public; 

21 ‘‘(II) the information (including 

22 draft safety assessments) that may be 

23 submitted by interested individuals or 

24 entities, including States; and 


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1 ‘‘(III) the criteria by which that 

2 information will be evaluated; 

3 ‘‘(ii) require the Administrator— 

4 ‘‘(I)(aa) to define the scope of 

5 the safety assessment and safety de6 termination to be conducted under 

7 section 6, including the hazards, expo8 sures, conditions of use, and poten9 tially exposed and susceptible popu10 lations that the Administrator expects 

11 to consider in a safety assessment; 

12 ‘‘(bb) to explain the basis for the 

13 scope of the safety assessment and 

14 safety determination; and 

15 ‘‘(cc) to accept comments regard16 ing the scope of the safety assessment 

17 and safety determination; and 

18 ‘‘(II)(aa) to identify the items de19 scribed in subclause (I) that the Ad20 ministrator has considered in the final 

21 safety assessment; and 

22 ‘‘(bb) to explain the basis for the 

23 consideration of those items; 

24 ‘‘(iii) describe the manner in which 

25 aggregate exposures, or significant subsets 


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1 of exposures, to a chemical substance 

2 under the conditions of use will be consid3 ered, and explain the basis for that consid4 eration in the final safety assessment; 

5 ‘‘(iv) require that each safety assess6 ment and safety determination shall in7 clude— 

8 ‘‘(I) a description of the weight 

9 of the scientific evidence of risk; and 

10 ‘‘(II) a summary of the informa11 tion regarding the impact on health 

12 and the environment of the chemical 

13 substance that was used to make the 

14 assessment or determination, includ15 ing, as available, mechanistic, animal 

16 toxicity, and epidemiology studies; 

17 ‘‘(v) establish a timely and trans18 parent process for evaluating whether new 

19 information submitted or obtained after 

20 the date of a final safety assessment or 

21 safety determination warrants reconsider22 ation of the safety assessment or safety de23 termination; and 

24 ‘‘(vi) when relevant information is 

25 provided or otherwise made available to the 


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1 Administrator, shall consider the extent of 

2 Federal regulation under other Federal 

3 laws. 

4 ‘‘(D) GUIDANCE.— 

5 ‘‘(i) IN GENERAL.—Not later than 1 

6 year after the date of enactment of the 

7 Frank R. Lautenberg Chemical Safety for 

8 the 21st Century Act, the Administrator 

9 shall develop guidance to assist interested 

10 persons in developing draft safety assess11 ments and other information for submis12 sion to the Administrator, which may be 

13 considered at the discretion of the Admin14 istrator. 

15 ‘‘(ii) REQUIREMENT.—The guidance 

16 shall, at a minimum, address the quality of 

17 the information submitted and the process 

18 to be followed in developing a draft assess19 ment for consideration by the Adminis20 trator. 

21 ‘‘(3) ARTICLES.—If the Administrator intends 

22 to prohibit or otherwise restrict an article on the 

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1 cant exposure to the chemical substance from such 

2 article. 

3 ‘‘(i) PUBLICLY AVAILABLE INFORMATION.—Subject 

4 to section 14, the Administrator shall— 

5 ‘‘(1) make publicly available a nontechnical 

6 summary, and the final version, of each safety as7 sessment and safety determination; 

8 ‘‘(2) provide public notice and an opportunity 

9 for comment on each proposed safety assessment 

10 and safety determination; and 

11 ‘‘(3) make public in a final safety assessment 

12 and safety determination— 

13 ‘‘(A) the list of studies considered by the 

14 Administrator in carrying out the safety assess15 ment or safety determination; and 

16 ‘‘(B) the list of policies, procedures, and 

17 guidance that were followed in carrying out the 

18 safety assessment or safety determination. 

19 ‘‘(j) CONSULTATION WITH SCIENCE ADVISORY COM20 MITTEE ON CHEMICALS.— 

21 ‘‘(1) ESTABLISHMENT.—Not later than 1 year 

22 after the date of enactment of this section, the Ad23 ministrator shall establish an advisory committee, to 

24 be known as the ‘Science Advisory Committee on 


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1 Chemicals’ (referred to in this subsection as the 

2 ‘Committee’). 

3 ‘‘(2) PURPOSE.—The purpose of the Committee 

4 shall be to provide independent advice and expert 

5 consultation, on the request of the Administrator, 

6 with respect to the scientific and technical aspects of 

7 issues relating to the implementation of this title. 

8 ‘‘(3) COMPOSITION.—The Committee shall be 

9 composed of representatives of such science, govern10 ment, labor, public health, public interest, animal 

11 protection, industry, and other groups as the Admin12 istrator determines to be advisable, including, at a 

13 minimum, representatives that have specific sci14 entific expertise in the relationship of chemical expo15 sures to women, children, and other potentially ex16 posed or susceptible populations. 

17 ‘‘(4) SCHEDULE.—The Administrator shall con18 vene the Committee in accordance with such sched19 ule as the Administrator determines to be appro20 priate, but not less frequently than once every 2 

21 years. 

22 ‘‘(5) RELATIONSHIP TO OTHER LAW.—All pro23 ceedings and meetings of the Committee shall be 

24 subject to the Federal Advisory Committee Act (5 

25 U.S.C. App.).’’. 


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1 SEC. 5. TESTING OF CHEMICAL SUBSTANCES OR MIXTURES. 

2 (a) IN GENERAL.—Section 4 of the Toxic Substances 

3 Control Act (15 U.S.C. 2603) is amended— 

4 (1) by striking subsections (a), (b), (c), (d), and 

5 (g); 

6 (2) by redesignating subsections (e) and (f) as 

7 subsections (f) and (g), respectively; 

8 (3) in subsection (f) (as so redesignated)— 

9 (A) by striking ‘‘rule’’ each place it ap10 pears and inserting ‘‘rule, testing consent 

11 agreement, or order’’; 

12 (B) by striking ‘‘under subsection (a)’’ 

13 each place it appears and inserting ‘‘under this 

14 subsection’’; and 

15 (C) in paragraph (1)(B), in the last sen16 tence, by striking ‘‘rulemaking’’; 

17 (4) in subsection (g) (as so redesignated)— 

18 (A) in the first sentence, by striking ‘‘from 

19 cancer, gene mutations, or birth defects’’; and 

20 (B) by striking the last sentence; and 

21 (5) by inserting before subsection (f) (as so re22 designated) the following: 

23 ‘‘(a) DEVELOPMENT OF NEW INFORMATION ON

24 CHEMICAL SUBSTANCES AND MIXTURES.— 

25 ‘‘(1) IN GENERAL.—The Administrator may re26 quire the development of new information relating to 


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1 a chemical substance or mixture in accordance with 

2 this section if the Administrator determines that the 

3 information is necessary— 

4 ‘‘(A) to review a notice under section 5(d) 

5 or to perform a safety assessment or safety de6 termination under section 6; 

7 ‘‘(B) to implement a requirement imposed 

8 in a consent agreement or order issued under 

9 section 5(d)(4) or under a rule promulgated 

10 under section 6(d)(3); 

11 ‘‘(C) pursuant to section 12(a)(4); or 

12 ‘‘(D) at the request of the implementing 

13 authority under another Federal law, to meet 

14 the regulatory testing needs of that authority. 

15 ‘‘(2) LIMITED TESTING FOR PRIORITIZATION

16 PURPOSES.— 

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

18 subparagraph (B), the Administrator may re19 quire the development of new information for 

20 the purposes of section 4A. 

21 ‘‘(B) PROHIBITION.—Testing required 

22 under subparagraph (A) shall not be required 

23 for the purpose of establishing or implementing 

24 a minimum information requirement. 


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1 ‘‘(C) LIMITATION.—The Administrator 

2 may require the development of new informa3 tion pursuant to subparagraph (A) only if the 

4 Administrator determines that additional infor5 mation is necessary to establish the priority of 

6 a chemical substance. 

7 ‘‘(3) FORM.—Subject to section 3A(h), the Ad8 ministrator may require the development of informa9 tion described in paragraph (1) or (2) by— 

10 ‘‘(A) promulgating a rule; 

11 ‘‘(B) entering into a testing consent agree12 ment; or 

13 ‘‘(C) issuing an order. 

14 ‘‘(4) CONTENTS.— 

15 ‘‘(A) IN GENERAL.—A rule, testing con16 sent agreement, or order issued under this sub17 section shall include— 

18 ‘‘(i) identification of the chemical sub19 stance or mixture for which testing is re20 quired; 

21 ‘‘(ii) identification of the persons re22 quired to conduct the testing; 

23 ‘‘(iii) test protocols and methodologies 

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1 ture, including specific reference to reliable 

2 nonanimal test procedures; and 

3 ‘‘(iv) specification of the period within 

4 which individuals and entities required to 

5 conduct the testing shall submit to the Ad6 ministrator the information developed in 

7 accordance with the procedures described 

8 in clause (iii). 

9 ‘‘(B) CONSIDERATIONS.—In determining 

10 the procedures and period to be required under 

11 subparagraph (A), the Administrator shall take 

12 into consideration— 

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

14 test protocols and methodologies that may 

15 be required; and 

16 ‘‘(ii) the reasonably foreseeable avail17 ability of facilities and personnel required 

18 to perform the testing. 

19 ‘‘(b) STATEMENT OF NEED.— 

20 ‘‘(1) IN GENERAL.—In promulgating a rule, en21 tering into a testing consent agreement, or issuing 

22 an order for the development of additional informa23 tion (including information on exposure or exposure 

24 potential) pursuant to this section, the Adminis25 trator shall— 


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1 ‘‘(A) identify the need intended to be met 

2 by the rule, agreement, or order; 

3 ‘‘(B) explain why information reasonably 

4 available to the Administrator at that time is 

5 inadequate to meet that need, including a ref6 erence, as appropriate, to the information iden7 tified in paragraph (2)(B); and 

8 ‘‘(C) explain the basis for any decision that 

9 requires the use of vertebrate animals. 

10 ‘‘(2) EXPLANATION IN CASE OF ORDER.— 

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

12 issues an order under this section, the Adminis13 trator shall issue a statement providing a jus14 tification for why issuance of an order is war15 ranted instead of promulgating a rule or enter16 ing into a testing consent agreement. 

17 ‘‘(B) CONTENTS.—A statement described 

18 in subparagraph (A) shall contain a description 

19 of— 

20 ‘‘(i) information that is readily acces21 sible to the Administrator, including infor22 mation submitted under any other provi23 sion of law; 

24 ‘‘(ii) the extent to which the Adminis25 trator has obtained or attempted to obtain 


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1 the information through voluntary submis2 sions; and 

3 ‘‘(iii) any information relied on in 

4 safety assessments for other chemical sub5 stances relevant to the chemical substances 

6 that would be the subject of the order. 

7 ‘‘(c) REDUCTION OF TESTING ON VERTEBRATES.— 

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

9 minimize, to the extent practicable, the use of 

10 vertebrate animals in testing of chemical substances 

11 or mixtures, by— 

12 ‘‘(A) encouraging and facilitating— 

13 ‘‘(i) the use of integrated and tiered 

14 testing and assessment strategies; 

15 ‘‘(ii) the use of best available science 

16 in existence on the date on which the test 

17 is conducted; 

18 ‘‘(iii) the use of test methods that 

19 eliminate or reduce the use of animals 

20 while providing information of high sci21 entific quality; 

22 ‘‘(iv) the grouping of 2 or more chem23 ical substances into scientifically appro24 priate categories in cases in which testing 

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1 able and useful information on other chem2 ical substances in the category; 

3 ‘‘(v) the formation of industry con4 sortia to jointly conduct testing to avoid 

5 unnecessary duplication of tests; and 

6 ‘‘(vi) the submission of information 

7 from— 

8 ‘‘(I) animal-based studies; and 

9 ‘‘(II) emerging methods and 

10 models; and 

11 ‘‘(B) funding research and validation stud12 ies to reduce, refine, and replace the use of ani13 mal tests in accordance with this subsection. 

14 ‘‘(2) IMPLEMENTATION OF ALTERNATIVE TEST15 ING METHODS.—To promote the development and 

16 timely incorporation of new testing methods that are 

17 not based on vertebrate animals, the Administrator 

18 shall— 

19 ‘‘(A) after providing an opportunity for 

20 public comment, develop a strategic plan to pro21 mote the development and implementation of al22 ternative test methods and testing strategies to 

23 generate information under this title that can 

24 reduce, refine, or replace the use of vertebrate 

25 animals, including toxicity pathway-based risk 


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1 assessment, in vitro studies, systems biology, 

2 computational toxicology, bioinformatics, and 

3 high-throughput screening; 

4 ‘‘(B) as practicable, ensure that the stra5 tegic plan developed under subparagraph (A) is 

6 reflected in the development of requirements for 

7 testing under this section; 

8 ‘‘(C) beginning on the date that is 5 years 

9 after the date of enactment of the Frank R. 

10 Lautenberg Chemical Safety for the 21st Cen11 tury Act and every 5 years thereafter, submit to 

12 Congress a report that describes the progress 

13 made in implementing this subsection and goals 

14 for future alternative test methods implementa15 tion; and 

16 ‘‘(D) fund and carry out research, develop17 ment, performance assessment, and 

18 translational studies to accelerate the develop19 ment of test methods and testing strategies that 

20 reduce, refine, or replace the use of vertebrate 

21 animals in any testing under this title. 

22 ‘‘(3) CRITERIA FOR ADAPTING OR WAIVING ANI23 MAL TESTING REQUIREMENTS.—On request from a 

24 manufacturer or processor that is required to con25 duct testing of a chemical substance or mixture on 


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1 vertebrate animals under this section, the Adminis2 trator may adapt or waive the requirement, if the 

3 Administrator determines that— 

4 ‘‘(A) there is sufficient evidence from sev5 eral independent sources of information to sup6 port a conclusion that a chemical substance or 

7 mixture has, or does not have, a particular 

8 property if the information from each individual 

9 source alone is insufficient to support the con10 clusion; 

11 ‘‘(B) as a result of 1 or more physical or 

12 chemical properties of the chemical substance 

13 or mixture or other toxicokinetic consider14 ations— 

15 ‘‘(i) the substance cannot be absorbed; 

16 or 

17 ‘‘(ii) testing for a specific endpoint is 

18 technically not practicable to conduct; or 

19 ‘‘(C) a chemical substance or mixture can20 not be tested in vertebrate animals at con21 centrations that do not result in significant 

22 pain or distress, because of physical or chemical 

23 properties of the chemical substance or mixture, 

24 such as a potential to cause severe corrosion or 

25 severe irritation to the tissues of the animal. 


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1 ‘‘(d) TESTING REQUIREMENTS.— 

2 ‘‘(1) IN GENERAL.—The Administrator may re3 quire the development of information by— 

4 ‘‘(A) manufacturers and processors of the 

5 chemical substance or mixture; and 

6 ‘‘(B) persons that begin to manufacture or 

7 process the chemical substance or mixture— 

8 ‘‘(i) after the effective date of the 

9 rule, testing consent agreement, or order; 

10 but 

11 ‘‘(ii) subject to paragraph (3), before 

12 the period ending on the date that is 180 

13 days after the end of the period described 

14 in this section. 

15 ‘‘(2) DESIGNATION.—The Administrator may 

16 permit 2 or more persons identified in subparagraph 

17 (A) or (B) of paragraph (1) to designate 1 of the 

18 persons or a qualified third party— 

19 ‘‘(A) to develop the information; and 

20 ‘‘(B) to submit the information on behalf 

21 of the persons making the designation. 

22 ‘‘(3) EXEMPTIONS.— 

23 ‘‘(A) IN GENERAL.—A person otherwise 

24 subject to a rule, testing consent agreement, or 

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1 ministrator an application for an exemption on 

2 the basis that the information is being devel3 oped by a person designated under paragraph 

4 (2). 

5 ‘‘(B) FAIR AND EQUITABLE REIMBURSE6 MENT TO DESIGNEE.— 

7 ‘‘(i) IN GENERAL.—If the Adminis8 trator accepts an application submitted 

9 under subparagraph (A), the Adminis10 trator shall direct the applicant to provide 

11 to the person designated under paragraph 

12 (2) fair and equitable reimbursement, as 

13 agreed to between the applicant and the 

14 designee. 

15 ‘‘(ii) ARBITRATION.—If the applicant 

16 and a person designated under paragraph 

17 (2) cannot reach agreement on the amount 

18 of fair and equitable reimbursement, the 

19 amount shall be determined by arbitration. 

20 ‘‘(C) TERMINATION.—If, after granting an 

21 exemption under this paragraph, the Adminis22 trator determines that a person covered by the 

23 exemption has failed to comply with the rule, 

24 testing consent agreement, or order, the Admin25 istrator shall— 


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1 ‘‘(i) by order, terminate the exemp2 tion; and 

3 ‘‘(ii) notify in writing each person 

4 that received an exemption of the require5 ments with respect to which the exemption 

6 was granted. 

7 ‘‘(e) TRANSPARENCY.—Subject to section 14, the Ad8 ministrator shall make available to the public all testing 

9 consent agreements and orders and all information sub10 mitted under this section.’’. 

11 (b) CONFORMING AMENDMENT.—Section 

12 104(i)(5)(A) of the Comprehensive Environmental Re13 sponse, Compensation, and Liability Act of 1980 (42 

14 U.S.C. 9604(i)(5)(A)) is amended in the third sentence 

15 by striking ‘‘section 4(e)’’ and inserting ‘‘section 4(f)’’. 

16 SEC. 6. PRIORITIZATION SCREENING. 

17 The Toxic Substances Control Act is amended by in18 serting after section 4 (15 U.S.C. 2603) the following: 

19 ‘‘SEC. 4A. PRIORITIZATION SCREENING. 

20 ‘‘(a) ESTABLISHMENT AND LIST OF SUBSTANCES.— 

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

22 the date of enactment of this section, the Adminis23 trator shall establish, by rule, a risk-based screening 

24 process and explicit criteria for identifying existing 

25 chemical substances that are— 


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1 ‘‘(A) a high priority for a safety assess2 ment and safety determination under section 6 

3 (referred to in this Act as ‘high-priority sub4 stances’); and 

5 ‘‘(B) a low priority for a safety assessment 

6 and safety determination (referred to in this 

7 Act as ‘low-priority substances’). 

8 ‘‘(2) INITIAL LIST OF HIGH- AND LOW-PRIORITY

9 SUBSTANCES.— 

10 ‘‘(A) IN GENERAL.—Before the date of 

11 promulgation of the rule under paragraph (1) 

12 and not later than 180 days after the date of 

13 enactment of this section, the Administrator— 

14 ‘‘(i) shall take into consideration and 

15 publish an initial list of high-priority sub16 stances and low-priority substances; and 

17 ‘‘(ii) pursuant to section 6(b), may 

18 initiate or continue safety assessments and 

19 safety determinations for those high-pri20 ority substances. 

21 ‘‘(B) REQUIREMENTS.— 

22 ‘‘(i) IN GENERAL.—The initial list of 

23 chemical substances shall contain at least 

24 10 high-priority substances, at least 5 of 

25 which are drawn from the list of chemical 


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1 substances identified by the Administrator 

2 in the October, 2014 TSCA Work Plan 

3 and subsequent updates, and at least 10 

4 low-priority substances. 

5 ‘‘(ii) SUBSEQUENTLY IDENTIFIED

6 SUBSTANCES.—Insofar as possible, at least 

7 50 percent of all substances subsequently 

8 identified by the Administrator as high-pri9 ority substances shall be drawn from the 

10 list of chemical substances identified by the 

11 Administrator in the October, 2014 TSCA 

12 Work Plan and subsequent updates, until 

13 all Work Plan chemicals have been des14 ignated under this subsection. 

15 ‘‘(C) ADDITIONAL CHEMICAL REVIEWS.— 

16 The Administrator shall— 

17 ‘‘(i) 3 years after the date of enact18 ment of the Frank R. Lautenberg Chem19 ical Safety for the 21st Century Act, add 

20 additional high-priority substances suffi21 cient to ensure that at least a total of 20 

22 high-priority substances have undergone or 

23 are undergoing the process established in 

24 section 6(a), and additional low-priority 

25 substances sufficient to ensure that at 


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1 least a total of 20 low-priority substances 

2 have been designated; and 

3 ‘‘(ii) as soon as practicable and not 

4 later than 5 years after the date of enact5 ment of the Frank R. Lautenberg Chem6 ical Safety for the 21st Century Act, add 

7 additional high-priority substances suffi8 cient to ensure that at least a total of 25 

9 high-priority substances have undergone or 

10 are undergoing the process established in 

11 section 6(a), and additional low-priority 

12 substances sufficient to ensure that at 

13 least a total of 25 low-priority substances 

14 have been designated. 

15 ‘‘(3) IMPLEMENTATION.— 

16 ‘‘(A) CONSIDERATION OF ACTIVE AND IN17 ACTIVE SUBSTANCES.— 

18 ‘‘(i) ACTIVE SUBSTANCES.—In car19 rying out paragraph (1), the Administrator 

20 shall take into consideration active sub21 stances, as determined under section 8, 

22 which may include chemical substances on 

23 the interim list of active substances estab24 lished under that section. 


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1 ‘‘(ii) INACTIVE SUBSTANCES.—In car2 rying out paragraph (1), the Administrator 

3 may take into consideration inactive sub4 stances, as determined under section 8, 

5 that the Administrator determines— 

6 ‘‘(I)(aa) have not been subject to 

7 a regulatory or other enforceable ac8 tion by the Administrator to ban or 

9 phase out the substances; and 

10 ‘‘(bb) have the potential for high 

11 hazard and widespread exposure; or 

12 ‘‘(II)(aa) have been subject to a 

13 regulatory or other enforceable action 

14 by the Administrator to ban or phase 

15 out the substances; and 

16 ‘‘(bb) with respect to which there 

17 exists the potential for residual high 

18 hazards or widespread exposures not 

19 otherwise addressed by the regulatory 

20 or other action. 

21 ‘‘(iii) REPOPULATION.— 

22 ‘‘(I) IN GENERAL.—On the com23 pletion of a safety determination 

24 under section 6 for a chemical sub25 stance, the Administrator shall reVerDate Sep 11 2014 05:33 Mar 17, 2015 Jkt 049200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6201 E:\BILLS\S697.IS S697

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1 move the chemical substance from the 

2 list of high-priority substances estab3 lished under this subsection. 

4 ‘‘(II) ADDITIONS.—The Adminis5 trator shall add at least 1 chemical 

6 substance to the list of high-priority 

7 substances for each chemical sub8 stance removed from the list of high9 priority substances established under 

10 this subsection, until a safety assess11 ment and safety determination is com12 pleted for all high-priority substances. 

13 ‘‘(III) LOW-PRIORITY SUB14 STANCES.—If a low-priority substance 

15 is subsequently designated as a high16 priority substance, the Administrator 

17 shall remove that substance from the 

18 list of low-priority substances. 

19 ‘‘(B) TIMELY COMPLETION OF

20 PRIORITIZATION SCREENING PROCESS.— 

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

22 shall— 

23 ‘‘(I) not later than 180 days 

24 after the effective date of the final 


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1 rule under paragraph (1), begin the 

2 prioritization screening process; and 

3 ‘‘(II) make every effort to com4 plete the designation of all active sub5 stances as high-priority substances or 

6 low-priority substances in a timely 

7 manner. 

8 ‘‘(ii) DECISIONS ON SUBSTANCES SUB9 JECT TO TESTING FOR PRIORITIZATION

10 PURPOSES.—Not later than 90 days after 

11 the date of receipt of information regard12 ing a chemical substance complying with a 

13 rule, testing consent agreement, or order 

14 issued under section 4(a)(2), the Adminis15 trator shall designate the chemical sub16 stance as a high-priority substance or low17 priority substance. 

18 ‘‘(iii) CONSIDERATION.— 

19 ‘‘(I) IN GENERAL.—The Admin20 istrator shall screen substances and 

21 designate high-priority substances 

22 taking into consideration the ability of 

23 the Administrator to schedule and 

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1 ty determinations under section 6 in a 

2 timely manner. 

3 ‘‘(II) ANNUAL GOAL.—The Ad4 ministrator shall publish an annual 

5 goal for the number of chemical sub6 stances to be subject to the 

7 prioritization screening process. 

8 ‘‘(C) SCREENING OF CATEGORIES OF SUB9 STANCES.—The Administrator may screen cat10 egories of chemical substances to ensure an effi11 cient prioritization screening process to allow 

12 for timely and adequate designations of high13 priority substances and low-priority substances 

14 and safety assessments and safety determina15 tions for high-priority substances. 

16 ‘‘(D) PUBLICATION OF LIST OF CHEMICAL

17 SUBSTANCES.—Not less frequently than once 

18 each year, the Administrator shall publish a list 

19 of chemical substances that— 

20 ‘‘(i) are being considered in the 

21 prioritization screening process and the 

22 status of the chemical substances in the 

23 prioritization process, including those 

24 chemical substances for which 


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1 prioritization decisions have been deferred; 

2 and 

3 ‘‘(ii) are designated as high-priority 

4 substances or low-priority substances, in5 cluding the bases for such designations. 

6 ‘‘(4) CRITERIA.—The criteria described in para7 graph (1) shall account for— 

8 ‘‘(A) the recommendation of the Governor 

9 of a State or a State agency with responsibility 

10 for protecting health or the environment from 

11 chemical substances appropriate for 

12 prioritization screening; 

13 ‘‘(B) the hazard and exposure potential of 

14 the chemical substance (or category of sub15 stances), including specific scientific classifica16 tions and designations by authoritative govern17 mental entities; 

18 ‘‘(C) the conditions of use or significant 

19 changes in the conditions of use of the chemical 

20 substance; 

21 ‘‘(D) evidence and indicators of exposure 

22 potential to humans or the environment from 

23 the chemical substance, including potentially ex24 posed or susceptible populations; 


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1 ‘‘(E) the volume of a chemical substance 

2 manufactured or processed; 

3 ‘‘(F) whether the volume of a chemical 

4 substance as reported under a rule promulgated 

5 pursuant to section 8(a) has significantly in6 creased or decreased during the period begin7 ning on the date of a previous report or the 

8 date on which a notice has been submitted 

9 under section 5(b) for that chemical substance; 

10 ‘‘(G) the availability of information regard11 ing potential hazards and exposures required 

12 for conducting a safety assessment or safety de13 termination, with limited availability of relevant 

14 information to be a sufficient basis for desig15 nating a chemical substance as a high-priority 

16 substance, subject to the condition that limited 

17 availability shall not require designation as a 

18 high-priority substance; and 

19 ‘‘(H) the extent of Federal or State regula20 tion of the chemical substance or the extent of 

21 the impact of State regulation of the chemical 

22 substance on the United States, with existing 

23 Federal or State regulation of any uses evalu24 ated in the prioritization screening process as a 


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1 factor in designating a chemical substance to be 

2 a low-priority substance. 

3 ‘‘(b) PRIORITIZATION SCREENING PROCESS AND DE4 CISIONS.— 

5 ‘‘(1) IN GENERAL.—The prioritization screening 

6 process developed under subsection (a) shall include 

7 a requirement that the Administrator shall— 

8 ‘‘(A) identify the chemical substances 

9 being considered for prioritization; 

10 ‘‘(B) request interested persons to supply 

11 information regarding the chemical substances 

12 being considered; 

13 ‘‘(C) apply the criteria identified in sub14 section (a)(4); and 

15 ‘‘(D) subject to paragraph (5) and using 

16 the information available to the Administrator 

17 at the time of the decision, identify a chemical 

18 substance as a high-priority substance or a low19 priority substance. 

20 ‘‘(2) INTEGRATION OF INFORMATION.—The 

21 prioritization screening decision regarding a chem22 ical substance shall integrate any hazard and expo23 sure information relating to the chemical substance 

24 that is available to the Administrator. 


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1 ‘‘(3) IDENTIFICATION OF HIGH-PRIORITY SUB2 STANCES.—The Administrator— 

3 ‘‘(A) shall identify as a high-priority sub4 stance a chemical substance that, relative to 

5 other chemical substances, the Administrator 

6 determines has the potential for high hazard 

7 and widespread exposure; 

8 ‘‘(B) may identify as a high-priority sub9 stance a chemical substance that, relative to 

10 other chemical substances, the Administrator 

11 determines has the potential for high hazard or 

12 widespread exposure; and 

13 ‘‘(C) may identify as a high-priority sub14 stance an inactive substance, as determined 

15 under subsection (a)(3)(A)(ii) and section 8(b), 

16 that the Administrator determines warrants a 

17 safety assessment and safety determination 

18 under section 6. 

19 ‘‘(4) IDENTIFICATION OF LOW-PRIORITY SUB20 STANCES.—The Administrator shall identify as a 

21 low-priority substance a chemical substance that the 

22 Administrator concludes has information sufficient 

23 to establish that the chemical substance is likely to 

24 meet the applicable safety standard. 


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1 ‘‘(5) DEFERRING A DECISION.—If the Adminis2 trator determines that additional information is re3 quired to establish the priority of a chemical sub4 stance under this section, the Administrator may 

5 defer the prioritization screening decision for a rea6 sonable period— 

7 ‘‘(A) to allow for the submission of addi8 tional information by an interested person and 

9 for the Administrator to evaluate the additional 

10 information; or 

11 ‘‘(B) to require the development of infor12 mation pursuant to a rule, testing consent 

13 agreement, or order issued under section 

14 4(a)(2). 

15 ‘‘(6) DEADLINES FOR SUBMISSION OF INFOR16 MATION.—If the Administrator requests the develop17 ment or submission of information under this sec18 tion, the Administrator shall establish a deadline for 

19 submission of the information. 

20 ‘‘(7) NOTICE AND COMMENT.—The Adminis21 trator shall— 

22 ‘‘(A) publish the proposed decisions made 

23 under paragraphs (3), (4), and (5) and the 

24 basis for the decisions; and 


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1 ‘‘(B) provide an opportunity for public 

2 comment. 

3 ‘‘(8) REVISIONS OF PRIOR DESIGNATIONS.— 

4 ‘‘(A) IN GENERAL.—At any time, and at 

5 the discretion of the Administrator, the Admin6 istrator may revise the designation of a chem7 ical substance as a high-priority substance or a 

8 low-priority substance based on information 

9 available to the Administrator after the date of 

10 the determination under paragraph (3) or (4). 

11 ‘‘(B) LIMITED AVAILABILITY.—If limited 

12 availability of relevant information was a basis 

13 in the designation of a chemical substance as a 

14 high-priority substance, the Administrator shall 

15 reevaluate the prioritization screening of the 

16 chemical substance on receiving the relevant in17 formation. 

18 ‘‘(9) OTHER INFORMATION RELEVANT TO

19 PRIORITIZATION.— 

20 ‘‘(A) IN GENERAL.—If, after the date of 

21 enactment of the Frank R. Lautenberg Chem22 ical Safety for the 21st Century Act, a State 

23 proposes an administrative action or enacts a 

24 statute or takes an administrative action to pro25 hibit or otherwise restrict the manufacturing, 


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1 processing, distribution in commerce, or use of 

2 a chemical substance that the Administrator 

3 has not as designated a high-priority substance, 

4 the Governor or State agency with responsi5 bility for implementing the statute or adminis6 trative action shall notify the Administrator. 

7 ‘‘(B) REQUESTS FOR INFORMATION.—Fol8 lowing receipt of a notification provided under 

9 subparagraph (A), the Administrator may re10 quest any available information from the Gov11 ernor or the State agency with respect to— 

12 ‘‘(i) scientific evidence related to the 

13 hazards, exposures and risks of the chem14 ical substance under the conditions of use 

15 which the statute or administrative action 

16 is intended to address; 

17 ‘‘(ii) any State or local conditions 

18 which warranted the statute or administra19 tive action; 

20 ‘‘(iii) the statutory or administrative 

21 authority on which the action is based; and 

22 ‘‘(iv) any other available information 

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1 natives considered and their hazards, expo2 sures, and risks. 

3 ‘‘(C) PRIORITIZATION SCREENING.—The 

4 Administrator shall conduct a prioritization 

5 screening under this subsection for all sub6 stances that— 

7 ‘‘(i) are the subject of notifications re8 ceived under subparagraph (A); and 

9 ‘‘(ii) the Administrator determines— 

10 ‘‘(I) are likely to have significant 

11 health or environmental impacts; 

12 ‘‘(II) are likely to have signifi13 cant impact on interstate commerce; 

14 or 

15 ‘‘(III) have been subject to a pro16 hibition or other restriction under a 

17 statute or administrative action in 2 

18 or more States. 

19 ‘‘(D) AVAILABILITY TO PUBLIC.—Subject 

20 to section 14 and any applicable State law re21 garding the protection of confidential informa22 tion provided to the State or to the Adminis23 trator, the Administrator shall make informa24 tion received from a Governor or State agency 

25 under subparagraph (A) publicly available. 


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1 ‘‘(E) EFFECT OF PARAGRAPH.—Nothing 

2 in this paragraph shall preempt a State statute 

3 or administrative action, require approval of a 

4 State statute or administrative action, or apply 

5 section 15 to a State. 

6 ‘‘(10) REVIEW.—Not less frequently than once 

7 every 5 years after the date on which the process 

8 under this subsection is established, the Adminis9 trator shall— 

10 ‘‘(A) review the process on the basis of ex11 perience and taking into consideration resources 

12 available to efficiently and effectively screen and 

13 prioritize chemical substances; and 

14 ‘‘(B) if necessary, modify the prioritization 

15 screening process. 

16 ‘‘(11) EFFECT.—Subject to section 18, a des17 ignation by the Administrator under this section 

18 with respect to a chemical substance shall not af19 fect— 

20 ‘‘(A) the manufacture, processing, distribu21 tion in commerce, use, or disposal of the chem22 ical substance; or 

23 ‘‘(B) the regulation of those activities. 

24 ‘‘(c) ADDITIONAL PRIORITIES FOR SAFETY ASSESS25 MENTS AND DETERMINATIONS.— 


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1 ‘‘(1) IN GENERAL.—The prioritization screening 

2 process developed under subsection (a) shall— 

3 ‘‘(A) include a process by which a manu4 facturer or processor of an active chemical sub5 stance that has not been designated a high-pri6 ority substance, or that has not been subject to 

7 or is not in the process of a prioritization 

8 screening by the Administrator, may request 

9 that the Administrator designate the substance 

10 for a safety assessment and safety determina11 tion, subject to the payment of fees pursuant to 

12 section 26(b)(3)(E); and 

13 ‘‘(B) provide guidance to submitters on the 

14 information to be provided in such requests, 

15 and specify the criteria the Administrator shall 

16 use to determine whether or not to grant such 

17 a request, which shall include whether the sub18 stance is subject to restrictions imposed by stat19 utes enacted or administrative actions taken by 

20 1 or more States on the manufacture, proc21 essing, distribution in commerce, or use of the 

22 substance. 

23 ‘‘(2) PREFERENCE.—Subject to paragraph (3), 

24 in deciding whether to grant requests under this 

25 subsection the Administrator shall give a preference 


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1 to requests concerning substances for which the Ad2 ministrator determines that restrictions imposed by 

3 1 or more States have the potential to have a signifi4 cant impact on interstate commerce or health or the 

5 environment. 

6 ‘‘(3) LIMITATIONS.—In considering whether to 

7 grant a request submitted under paragraph (1), the 

8 Administrator shall ensure that— 

9 ‘‘(A) not more than 15 percent of the total 

10 number of substances designated to undergo 

11 safety assessments and safety determinations 

12 under this section are substances designated 

13 under the process and criteria pursuant to 

14 paragraph (1); and 

15 ‘‘(B) the resources allocated to conducting 

16 safety assessments and safety determinations 

17 for additional priorities designated under this 

18 subsection are proportionate to the number of 

19 such substances relative to the total number of 

20 substances designated to undergo safety assess21 ments and safety determinations under this sec22 tion. 

23 ‘‘(4) REQUIREMENTS.— 


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1 ‘‘(A) IN GENERAL.—The public shall be 

2 provided notice and an opportunity to comment 

3 on requests submitted under this subsection. 

4 ‘‘(B) DECISION BY ADMINISTRATOR.—Not 

5 later than 180 days after the date on which the 

6 Administrator receives a request under this 

7 subsection, the Administrator shall decide 

8 whether or not to grant the request. 

9 ‘‘(C) ASSESSMENT AND DETERMINA10 TION.—If the Administrator grants a request 

11 under this subsection, the safety assessment 

12 and safety determination— 

13 ‘‘(i) shall be conducted in accordance 

14 with the deadlines and other requirements 

15 of sections 3A(i) and 6; and 

16 ‘‘(ii) shall not be expedited or other17 wise subject to special treatment relative to 

18 high-priority substances designated pursu19 ant to subsection (b)(3) that are under20 going safety assessments and safety deter21 minations. 

22 ‘‘(5) EXCEPTIONS.—Requests granted under 

23 this subsection shall not be subject to subsection 

24 (a)(3)(A)(iii) or section 18(b).’’. 


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1 SEC. 7. NEW CHEMICALS AND SIGNIFICANT NEW USES. 

2 Section 5 of the Toxic Substances Control Act (15 

3 U.S.C. 2604) is amended— 

4 (1) by striking the section designation and 

5 heading and inserting the following: 

6 ‘‘SEC. 5. NEW CHEMICALS AND SIGNIFICANT NEW USES.’’; 

7 (2) by striking subsection (b); 

8 (3) by redesignating subsection (a) as sub9 section (b); 

10 (4) by redesignating subsection (i) as subsection 

11 (a) and moving the subsection so as to appear at the 

12 beginning of the section; 

13 (5) in subsection (b) (as so redesignated)— 

14 (A) in the subsection heading, by striking 

15 ‘‘IN GENERAL’’ and inserting ‘‘NOTICES’’; and 

16 (B) in paragraph (1), in the matter fol17 lowing subparagraph (B)— 

18 (i) by striking ‘‘subsection (d)’’ and 

19 inserting ‘‘subsection (b)’’; and 

20 (ii) by striking ‘‘and such person com21 plies with any applicable requirement of 

22 subsection (b)’’; 

23 (6) by redesignating subsections (c) and (d) as 

24 subsection (d) and (c), respectively, and moving sub25 section (c) (as so redesigned) so as appear after sub26 section (b) (as redesignated by paragraph (3)); 


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1 (7) in subsection (c) (as so redesignated)— 

2 (A) by striking paragraph (1) and insert3 ing the following: 

4 ‘‘(1) IN GENERAL.—The notice required by sub5 section (a) shall include, with respect to a chemical 

6 substance— 

7 ‘‘(A) the information required by sections 

8 720.45 and 720.50 of title 40, Code of Federal 

9 Regulations (or successor regulations); and 

10 ‘‘(B) information regarding conditions of 

11 use and reasonably anticipated exposures.’’; 

12 (B) in paragraph (2)— 

13 (i) in the matter preceding subpara14 graph (A), by striking ‘‘or of data under 

15 subsection (b)’’; 

16 (ii) in subparagraph (A), by adding 

17 ‘‘and’’ after the semicolon at the end; 

18 (iii) in subparagraph (B), by striking 

19 ‘‘; and’’ and inserting a period; and 

20 (iv) by striking subparagraph (C); and 

21 (C) in paragraph (3), by striking ‘‘sub22 section (a) and for which the notification period 

23 prescribed by subsection (a), (b), or (c)’’ and 

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1 tification period prescribed by subsection (b) or 

2 (d)’’; 

3 (8) by striking subsection (d) (as redesignated 

4 by paragraph (6)) and inserting the following: 

5 ‘‘(d) REVIEW OF NOTICE.— 

6 ‘‘(1) INITIAL REVIEW.— 

7 ‘‘(A) IN GENERAL.—Subject to subpara8 graph (B), not later than 90 days after the date 

9 of receipt of a notice submitted under sub10 section (b), the Administrator shall— 

11 ‘‘(i) conduct an initial review of the 

12 notice; 

13 ‘‘(ii) as needed, develop a profile of 

14 the relevant chemical substance and the 

15 potential for exposure to humans and the 

16 environment; and 

17 ‘‘(iii) make any necessary determina18 tion under paragraph (3). 

19 ‘‘(B) EXTENSION.—Except as provided in 

20 paragraph (5), the Administrator may extend 

21 the period described in subparagraph (A) for 

22 good cause for 1 or more periods, the total of 

23 which shall be not more than 90 days. 


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1 ‘‘(2) INFORMATION SOURCES.—In evaluating a 

2 notice under paragraph (1), the Administrator shall 

3 take into consideration— 

4 ‘‘(A) any relevant information identified in 

5 subsection (c)(1); and 

6 ‘‘(B) any other relevant additional infor7 mation available to the Administrator. 

8 ‘‘(3) DETERMINATIONS.—Before the end of the 

9 applicable period for review under paragraph (1), 

10 based on the information described in paragraph (2), 

11 and subject to section 18(g), the Administrator shall 

12 determine that— 

13 ‘‘(A) the relevant chemical substance or 

14 significant new use is not likely to meet the 

15 safety standard, in which case the Adminis16 trator shall take appropriate action under para17 graph (4); 

18 ‘‘(B) the relevant chemical substance or 

19 significant new use is likely to meet the safety 

20 standard, in which case the Administrator shall 

21 allow the review period to expire without addi22 tional restrictions; or 

23 ‘‘(C) additional information is necessary in 

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1 trator shall take appropriate action under para2 graph (5). 

3 ‘‘(4) RESTRICTIONS.— 

4 ‘‘(A) DETERMINATION BY ADMINIS5 TRATOR.— 

6 ‘‘(i) IN GENERAL.—If the Adminis7 trator makes a determination under sub8 paragraph (A) or (C) of paragraph (3) 

9 with respect to a notice submitted under 

10 subsection (b)— 

11 ‘‘(I) the Administrator, before 

12 the end of the applicable period for re13 view under paragraph (1) and by con14 sent agreement or order, as appro15 priate, shall prohibit or otherwise re16 strict the manufacture, processing, 

17 use, distribution in commerce, or dis18 posal (as applicable) of the chemical 

19 substance, or of the chemical sub20 stance for a significant new use, with21 out compliance with the restrictions 

22 specified in the consent agreement or 

23 order that the Administrator deter24 mines are sufficient to ensure that the 

25 chemical substance or significant new 


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1 use is likely to meet the safety stand2 ard; and 

3 ‘‘(II) no person may commence 

4 manufacture of the chemical sub5 stance, or manufacture or processing 

6 of the chemical substance for a sig7 nificant new use, except in compliance 

8 with the restrictions specified in the 

9 consent agreement or order. 

10 ‘‘(ii) LIKELY TO MEET STANDARD.—If 

11 the Administrator makes a determination 

12 under subparagraph (B) of paragraph (3) 

13 with respect to a chemical substance or 

14 significant new use for which a notice was 

15 submitted under subsection (b), at the end 

16 of the applicable period for review under 

17 paragraph (1), the submitter of the notice 

18 may commence manufacture for commer19 cial purposes of the chemical substance or 

20 manufacture or processing of the chemical 

21 substance for a significant new use. 

22 ‘‘(B) REQUIREMENTS.—Not later than 90 

23 days after issuing a consent agreement or order 

24 under subparagraph (A), the Administrator 

25 shall— 


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1 ‘‘(i) take into consideration whether to 

2 promulgate a rule pursuant to subsection 

3 (b)(2) that identifies as a significant new 

4 use any manufacturing, processing, use, 

5 distribution in commerce, or disposal of 

6 the chemical substance, or of the chemical 

7 substance for a new use, that is not in 

8 compliance with the restrictions imposed 

9 by the consent agreement or order; and 

10 ‘‘(ii)(I) initiate a rulemaking described 

11 in clause (i); or 

12 ‘‘(II) publish a statement describing 

13 the reasons of the Administrator for not 

14 initiating a rulemaking. 

15 ‘‘(C) INCLUSIONS.—A prohibition or other 

16 restriction under subparagraph (A) may in17 clude, as appropriate— 

18 ‘‘(i) subject to section 18(g), a re19 quirement that a chemical substance shall 

20 be marked with, or accompanied by, clear 

21 and adequate minimum warnings and in22 structions with respect to use, distribution 

23 in commerce, or disposal, or any combina24 tion of those activities, with the form and 

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1 structions to be prescribed by the Adminis2 trator; 

3 ‘‘(ii) a requirement that manufactur4 ers or processors of the chemical substance 

5 shall— 

6 ‘‘(I) make and retain records of 

7 the processes used to manufacture or 

8 process, as applicable, the chemical 

9 substance; or 

10 ‘‘(II) monitor or conduct such 

11 additional tests as are reasonably nec12 essary to address potential risks from 

13 the manufacture, processing, distribu14 tion in commerce, use, or disposal, as 

15 applicable, of the chemical substance, 

16 subject to section 4; 

17 ‘‘(iii) a restriction on the quantity of 

18 the chemical substance that may be manu19 factured, processed, or distributed in com20 merce— 

21 ‘‘(I) in general; or 

22 ‘‘(II) for a particular use; 

23 ‘‘(iv) a prohibition or other restriction 

24 of— 


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1 ‘‘(I) the manufacture, processing, 

2 or distribution in commerce of the 

3 chemical substance for a significant 

4 new use; 

5 ‘‘(II) any method of commercial 

6 use of the chemical substance; or 

7 ‘‘(III) any method of disposal of 

8 the chemical substance; or 

9 ‘‘(v) a prohibition or other restriction 

10 on the manufacture, processing, or dis11 tribution in commerce of the chemical sub12 stance— 

13 ‘‘(I) in general; or 

14 ‘‘(II) for a particular use. 

15 ‘‘(D) WORKPLACE EXPOSURES.—The Ad16 ministrator shall consult with the Assistant Sec17 retary of Labor for Occupational Safety and 

18 Health prior to adopting any prohibition or 

19 other restriction under this subsection to ad20 dress workplace exposures. 

21 ‘‘(E) DEFINITION OF REQUIREMENT.—For 

22 purposes of this Act, the term ‘requirement’ as 

23 used in this section does not displace common 

24 law. 


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1 ‘‘(5) ADDITIONAL INFORMATION.—If the Ad2 ministrator determines under paragraph (3)(C) that 

3 additional information is necessary to conduct a re4 view under this subsection, the Administrator— 

5 ‘‘(A) shall provide an opportunity for the 

6 submitter of the notice to submit the additional 

7 information; 

8 ‘‘(B) may, by agreement with the sub9 mitter, extend the review period for a reason10 able time to allow the development and submis11 sion of the additional information; 

12 ‘‘(C) may promulgate a rule, enter into a 

13 testing consent agreement, or issue an order 

14 under section 4 to require the development of 

15 the information; and 

16 ‘‘(D) on receipt of information the Admin17 istrator finds supports the determination under 

18 paragraph (3), shall promptly make the deter19 mination.’’; 

20 (9) by striking subsections (e) through (g) and 

21 inserting the following: 

22 ‘‘(e) NOTICE OF COMMENCEMENT.— 

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

24 after the date on which a manufacturer that has 

25 submitted a notice under subsection (b) commences 


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1 nonexempt commercial manufacture of a chemical 

2 substance, the manufacturer shall submit to the Ad3 ministrator a notice of commencement that identi4 fies— 

5 ‘‘(A) the name of the manufacturer; and 

6 ‘‘(B) the initial date of nonexempt com7 mercial manufacture. 

8 ‘‘(2) WITHDRAWAL.—A manufacturer or proc9 essor that has submitted a notice under subsection 

10 (b), but that has not commenced nonexempt com11 mercial manufacture or processing of the chemical 

12 substance, may withdraw the notice. 

13 ‘‘(f) FURTHER EVALUATION.—The Administrator 

14 may review a chemical substance under section 4A at any 

15 time after the Administrator receives— 

16 ‘‘(1) a notice of commencement for a chemical 

17 substance under subsection (c); or 

18 ‘‘(2) new information regarding the chemical 

19 substance. 

20 ‘‘(g) TRANSPARENCY.—Subject to section 14, the Ad21 ministrator shall make available to the public— 

22 ‘‘(1) all notices, determinations, consent agree23 ments, rules, and orders of the Administrator; and 

24 ‘‘(2) all information submitted or issued under 

25 this section.’’; and 


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1 (10) in subsection (h)— 

2 (A) in paragraph (1), in the matter pre3 ceding subparagraph (A), by striking ‘‘(a) or’’; 

4 (B) by striking paragraph (2); 

5 (C) by redesignating paragraphs (3) 

6 through (6) as paragraphs (2) through (5), re7 spectively; 

8 (D) in paragraph (2) (as so redesignated), 

9 in the matter preceding subparagraph (A), by 

10 striking ‘‘subsections (a) and (b)’’ and inserting 

11 ‘‘subsection (b)’’; 

12 (E) in paragraph (3) (as so redesig13 nated)— 

14 (i) in the first sentence, by striking 

15 ‘‘will not present an unreasonable risk of 

16 injury to health or the environment’’ and 

17 inserting ‘‘will meet the safety standard’’; 

18 and 

19 (ii) by striking the second sentence; 

20 (F) in paragraph (4) (as so redesignated), 

21 by striking ‘‘subsections (a) and (b)’’ and in22 serting ‘‘subsection (b)’’; and 

23 (G) in paragraph (5) (as so redesignated), 

24 in the first sentence, by striking ‘‘paragraph (1) 

25 or (5)’’ and inserting ‘‘paragraph (1) or (4)’’. 


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1 SEC. 8. SAFETY ASSESSMENTS AND SAFETY DETERMINA2 TIONS. 

3 Section 6 of the Toxic Substances Control Act (15 

4 U.S.C. 2605) is amended— 

5 (1) by striking the section designation and 

6 heading and inserting the following: 

7 ‘‘SEC. 6. SAFETY ASSESSMENTS AND SAFETY DETERMINA8 TIONS.’’; 

9 (2) by redesignating subsections (e) and (f) as 

10 subsections (g) and (h), respectively; 

11 (3) by striking subsections (a) through (d) and 

12 inserting the following: 

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

14 ‘‘(1) shall conduct a safety assessment and 

15 make a safety determination of each high-priority 

16 substance in accordance with subsections (b) and 

17 (c); 

18 ‘‘(2) shall, as soon as practicable and not later 

19 than 6 months after the date on which a chemical 

20 substance is designated as a high-priority substance, 

21 define the scope of the safety assessment and safety 

22 determination to be conducted pursuant to this sec23 tion, including the hazards, exposures, conditions of 

24 use, and potentially exposed or susceptible popu25 lations that the Administrator expects to consider; 


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1 ‘‘(3) as appropriate based on the results of a 

2 safety determination, shall establish restrictions pur3 suant to subsection (d); 

4 ‘‘(4) shall complete a safety assessment and 

5 safety determination not later than 3 years after the 

6 date on which a chemical substance is designated as 

7 a high-priority substance; 

8 ‘‘(5) shall promulgate a final rule pursuant to 

9 subsection (d) by not later than 2 years after the 

10 date on which the safety determination is completed; 

11 and 

12 ‘‘(6) may extend any deadline under this sub13 section for a reasonable period of time after an ade14 quate public justification, subject to the condition 

15 that the aggregate length of all extensions of dead16 lines under paragraphs (4) and (5) and any deferral 

17 under subsection (c)(2) does not exceed 2 years. 

18 ‘‘(b) PRIOR ACTIONS.— 

19 ‘‘(1) PRIOR-INITIATED ASSESSMENTS.— 

20 ‘‘(A) IN GENERAL.—Nothing in this Act 

21 prevents the Administrator from initiating a 

22 safety assessment or safety determination re23 garding a chemical substance, or from con24 tinuing or completing such a safety assessment 

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1 fore the date of enactment of the Frank R. 

2 Lautenberg Chemical Safety for the 21st Cen3 tury Act, prior to the effective date of the poli4 cies and procedures required to be established 

5 by the Administrator under section 3A or 4A. 

6 ‘‘(B) INTEGRATION OF PRIOR POLICIES

7 AND PROCEDURES.—As policies and procedures 

8 under section 3A and 4A are established, to the 

9 maximum extent practicable, the Administrator 

10 shall integrate the policies and procedures into 

11 ongoing safety assessments and safety deter12 minations. 

13 ‘‘(2) ACTIONS COMPLETED PRIOR TO COMPLE14 TION OF POLICIES AND PROCEDURES.—Nothing in 

15 this Act requires the Administrator to revise or with16 draw a completed safety assessment, safety deter17 mination, or rule solely because the action was com18 pleted prior to the completion of a policy or proce19 dure established under section 3A or 4A, and the va20 lidity of a completed assessment, determination, or 

21 rule shall not be determined based on the content of 

22 such a policy or procedure. 

23 ‘‘(c) SAFETY DETERMINATIONS.— 

24 ‘‘(1) IN GENERAL.—Based on a review of the 

25 information available to the Administrator, including 


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1 draft safety assessments submitted by interested 

2 persons, and subject to section 18, the Adminis3 trator shall determine that— 

4 ‘‘(A) the relevant chemical substance meets 

5 the safety standard; 

6 ‘‘(B) the relevant chemical substance does 

7 not meet the safety standard, in which case the 

8 Administrator shall, by rule under subsection 

9 (d)— 

10 ‘‘(i) impose restrictions necessary to 

11 ensure that the chemical substance meets 

12 the safety standard under the conditions of 

13 use; or 

14 ‘‘(ii) if the safety standard cannot be 

15 met with the application of restrictions, 

16 ban or phase out the chemical substance, 

17 as appropriate; or 

18 ‘‘(C) additional information is necessary in 

19 order to make a determination under subpara20 graph (A) or (B), in which case the Adminis21 trator shall take appropriate action under para22 graph (2). 

23 ‘‘(2) ADDITIONAL INFORMATION.—If the Ad24 ministrator determines that additional information is 

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1 termination for a high-priority substance, the Ad2 ministrator— 

3 ‘‘(A) shall provide an opportunity for inter4 ested persons to submit the additional informa5 tion; 

6 ‘‘(B) may promulgate a rule, enter into a 

7 testing consent agreement, or issue an order 

8 under section 4 to require the development of 

9 the information; 

10 ‘‘(C) may defer, for a reasonable period 

11 consistent with the deadlines described in sub12 section (a), a safety assessment and safety de13 termination until after receipt of the informa14 tion; and 

15 ‘‘(D) consistent with the deadlines de16 scribed in subsection (a), on receipt of informa17 tion the Administrator finds supports the safety 

18 assessment and safety determination, shall 

19 make a determination under paragraph (1). 

20 ‘‘(3) ESTABLISHMENT OF DEADLINE.—In re21 questing the development or submission of informa22 tion under this section, the Administrator shall es23 tablish a deadline for the submission of the informa24 tion. 

25 ‘‘(d) RULE.— 


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1 ‘‘(1) IMPLEMENTATION.—If the Administrator 

2 makes a determination under subsection (c)(1)(B) 

3 with respect to a chemical substance, the Adminis4 trator shall promulgate a rule establishing restric5 tions necessary to ensure that the chemical sub6 stance meets the safety standard. 

7 ‘‘(2) SCOPE.—The rule promulgated pursuant 

8 to this subsection— 

9 ‘‘(A) may— 

10 ‘‘(i) apply to mixtures containing the 

11 chemical substance, as appropriate; and 

12 ‘‘(ii) exempt replacement parts for ar13 ticles manufactured prior to the applicable 

14 compliance deadline; and 

15 ‘‘(B) shall include dates by which compli16 ance is mandatory, which— 

17 ‘‘(i) shall be as soon as practicable; 

18 and 

19 ‘‘(ii) as determined by the Adminis20 trator, may vary for different affected per21 sons. 

22 ‘‘(C) WORKPLACE EXPOSURES.—The Ad23 ministrator shall consult with the Assistant Sec24 retary of Labor for Occupational Safety and 

25 Health before adopting any prohibition or other 


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1 restriction under this subsection to address 

2 workplace exposures. 

3 ‘‘(D) DEFINITION OF REQUIREMENT.—For 

4 the purposes of this Act, the term ‘requirement’ 

5 as used in this section does not displace com6 mon law. 

7 ‘‘(3) RESTRICTIONS.—A restriction under para8 graph (1) may include, as appropriate— 

9 ‘‘(A) subject to section 18, a requirement 

10 that a chemical substance shall be marked with, 

11 or accompanied by, clear and adequate min12 imum warnings and instructions with respect to 

13 use, distribution in commerce, or disposal, or 

14 any combination of those activities, with the 

15 form and content of the minimum warnings and 

16 instructions to be prescribed by the Adminis17 trator; 

18 ‘‘(B) a requirement that manufacturers or 

19 processors of the chemical substance shall— 

20 ‘‘(i) make and retain records of the 

21 processes used to manufacture or process 

22 the chemical substance; 

23 ‘‘(ii) describe and apply the relevant 

24 quality control procedures followed in the 


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1 manufacturing or processing of the sub2 stance; or 

3 ‘‘(iii) monitor or conduct tests that 

4 are reasonably necessary to ensure compli5 ance with the requirements of any rule 

6 under this subsection; 

7 ‘‘(C) a restriction on the quantity of the 

8 chemical substance that may be manufactured, 

9 processed, or distributed in commerce; 

10 ‘‘(D) a requirement to ban or phase out, or 

11 any other rule regarding, the manufacture, 

12 processing, or distribution in commerce of the 

13 chemical substance for— 

14 ‘‘(i) a particular use; 

15 ‘‘(ii) a particular use at a concentra16 tion in excess of a level specified by the 

17 Administrator; or 

18 ‘‘(iii) all uses; 

19 ‘‘(E) a restriction on the quantity of the 

20 chemical substance that may be manufactured, 

21 processed, or distributed in commerce for— 

22 ‘‘(i) a particular use; or 

23 ‘‘(ii) a particular use at a concentra24 tion in excess of a level specified by the 

25 Administrator; 


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1 ‘‘(F) a requirement to ban, phase out, or 

2 otherwise restrict any method of commercial 

3 use of the chemical substance; 

4 ‘‘(G) a requirement to ban, phase out, or 

5 otherwise restrict any method of disposal of the 

6 chemical substance or any article containing the 

7 chemical substance; and 

8 ‘‘(H) a requirement directing manufactur9 ers or processors of the chemical substance to 

10 give notice of the Administrator’s determination 

11 under subsection (c)(1)(B) to distributors in 

12 commerce of the chemical substance and, to the 

13 extent reasonably ascertainable, to other per14 sons in the chain of commerce in possession of 

15 the chemical substance. 

16 ‘‘(4) ANALYSIS FOR RULEMAKING.— 

17 ‘‘(A) CONSIDERATIONS.—In deciding 

18 which restrictions to impose under paragraph 

19 (3) as part of developing a rule under para20 graph (1), the Administrator shall take into 

21 consideration, to the extent practicable based on 

22 reasonably available information, the quantifi23 able and nonquantifiable costs and benefits of 

24 the proposed regulatory action and of the 1 or 


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1 more primary alternative regulatory actions 

2 considered by the Administrator. 

3 ‘‘(B) ALTERNATIVES.—As part of the 

4 analysis, the Administrator shall review any 1 

5 or more technically and economically feasible al6 ternatives to the chemical substance that the 

7 Administrator determines are relevant to the 

8 rulemaking. 

9 ‘‘(C) PUBLIC AVAILABILITY.—In proposing 

10 a rule under paragraph (1), the Administrator 

11 shall make publicly available any analysis con12 ducted under this paragraph. 

13 ‘‘(D) STATEMENT REQUIRED.—In making 

14 final a rule under paragraph (1), the Adminis15 trator shall include a statement describing how 

16 the analysis considered under subparagraph (A) 

17 was taken into account. 

18 ‘‘(5) EXEMPTIONS.— 

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

20 may exempt 1 or more uses of a chemical sub21 stance from any restriction in a rule promul22 gated under paragraph (1) if the Administrator 

23 determines that— 

24 ‘‘(i) the rule cannot be complied with, 

25 without— 


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1 ‘‘(I) harming national security; 

2 ‘‘(II) causing significant disrup3 tion in the national economy due to 

4 the lack of availability of a chemical 

5 substance; or 

6 ‘‘(III) interfering with a critical 

7 or essential use for which no tech8 nically and economically feasible safer 

9 alternative is available, taking into 

10 consideration hazard and exposure; or 

11 ‘‘(ii) the use of the chemical sub12 stance, as compared to reasonably available 

13 alternatives, provides a substantial benefit 

14 to health, the environment, or public safe15 ty. 

16 ‘‘(B) EXEMPTION ANALYSIS.—In pro17 posing a rule under paragraph (1) that includes 

18 an exemption under this paragraph, the Admin19 istrator shall make publicly available any anal20 ysis conducted under this paragraph to assess 

21 the need for the exemption. 

22 ‘‘(C) STATEMENT REQUIRED.—In making 

23 final a rule under paragraph (1) that includes 

24 an exemption under this paragraph, the Admin25 istrator shall include a statement describing 


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1 how the analysis considered under subpara2 graph (B) was taken into account. 

3 ‘‘(D) ANALYSIS IN CASE OF BAN OR

4 PHASE-OUT.—In determining whether an ex5 emption should be granted under this para6 graph for a chemical substance for which a ban 

7 or phase-out is proposed, the Administrator 

8 shall take into consideration, to the extent prac9 ticable based on reasonably available informa10 tion, the quantifiable and nonquantifiable costs 

11 and benefits of the 1 or more technically and 

12 economically feasible alternatives to the chem13 ical substance most likely to be used in place of 

14 the chemical substance under the conditions of 

15 use if the rule is promulgated. 

16 ‘‘(E) CONDITIONS.—As part of a rule pro17 mulgated under paragraph (1), the Adminis18 trator shall include conditions in any exemption 

19 established under this paragraph, including rea20 sonable recordkeeping, monitoring, and report21 ing requirements, to the extent that the Admin22 istrator determines the conditions are necessary 

23 to protect health and the environment while 

24 achieving the purposes of the exemption. 

25 ‘‘(F) DURATION.— 


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

2 shall establish, as part of a rule under 

3 paragraph (1) that contains an exemption 

4 under this paragraph, a time limit on any 

5 exemption for a time to be determined by 

6 the Administrator as reasonable on a case7 by-case basis. 

8 ‘‘(ii) AUTHORITY OF ADMINIS9 TRATOR.—The Administrator, by rule, may 

10 extend, modify, or eliminate the exemption 

11 if the Administrator determines, on the 

12 basis of reasonably available information 

13 and after adequate public justification, the 

14 exemption warrants extension or is no 

15 longer necessary. 

16 ‘‘(iii) CONSIDERATIONS.— 

17 ‘‘(I) IN GENERAL.—Subject to 

18 subclause (II), the Administrator shall 

19 issue exemptions and establish time 

20 periods by considering factors deter21 mined by the Administrator to be rel22 evant to the goals of fostering innova23 tion and the development of alter24 natives that meet the safety standard. 


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1 ‘‘(II) LIMITATION.—Any renewal 

2 of an exemption in the case of a rule 

3 requiring the ban or phase-out of a 

4 chemical substance shall not exceed 5 

5 years. 

6 ‘‘(e) IMMEDIATE EFFECT.—The Administrator may 

7 declare a proposed rule under subsection (d) to be effective 

8 on publication of the rule in the Federal Register and until 

9 the effective date of final action taken respecting the rule, 

10 if— 

11 ‘‘(1) the Administrator determines that— 

12 ‘‘(A) the manufacture, processing, distribu13 tion in commerce, use, or disposal of the chem14 ical substance or mixture subject to the pro15 posed rule or any combination of those activi16 ties is likely to result in an unreasonable risk 

17 of serious or widespread harm to health or the 

18 environment before the effective date; and 

19 ‘‘(B) making the proposed rule so effective 

20 is necessary to protect the public interest; and 

21 ‘‘(2) in the case of a proposed rule to prohibit 

22 the manufacture, processing, or distribution of a 

23 chemical substance or mixture because of the risk 

24 determined under paragraph (1)(A), a court has 

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1 spect to that risk associated with the chemical sub2 stance or mixture. 

3 ‘‘(f) FINAL AGENCY ACTION.—Under this section 

4 and subject to section 18— 

5 ‘‘(1) a safety determination, and the associated 

6 safety assessment, for a chemical substance that the 

7 Administrator determines under subsection (c) meets 

8 the safety standard, shall be considered to be a final 

9 agency action, effective beginning on the date of 

10 issuance of the final safety determination; and 

11 ‘‘(2) a final rule promulgated under subsection 

12 (d), and the associated safety assessment and safety 

13 determination that a chemical substance does not 

14 meet the safety standard, shall be considered to be 

15 a final agency action, effective beginning on the date 

16 of promulgation of the final rule.’’; and 

17 (4) in subsection (g) (as redesignated by para18 graph (2))— 

19 (A) by striking paragraph (4); and 

20 (B) by redesignating paragraph (5) as 

21 paragraph (4). 

22 SEC. 9. IMMINENT HAZARDS. 

23 Section 7 of the Toxic Substances Control Act (15 

24 U.S.C. 2606) is amended— 


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1 (1) by striking subsection (a) and inserting the 

2 following: 

3 ‘‘(a) CIVIL ACTIONS.— 

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

5 commence a civil action in an appropriate United 

6 States district court for— 

7 ‘‘(A) seizure of an imminently hazardous 

8 chemical substance or mixture or any article 

9 containing the chemical substance or mixture; 

10 ‘‘(B) relief (as authorized by subsection 

11 (b)) against any person that manufactures, 

12 processes, distributes in commerce, uses, or dis13 poses of, an imminently hazardous chemical 

14 substance or mixture or any article containing 

15 the chemical substance or mixture; or 

16 ‘‘(C) both seizure described in subpara17 graph (A) and relief described in subparagraph 

18 (B). 

19 ‘‘(2) RULE, ORDER, OR OTHER PROCEEDING.— 

20 A civil action may be commenced under this para21 graph, notwithstanding— 

22 ‘‘(A) the existence of— 

23 ‘‘(i) a decision by the Administrator 

24 under section 4A, 5(d)(3), or 6(c)(1); or 


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1 ‘‘(ii) a rule, testing consent agree2 ment, or order under section 4, 5(d)(4), 

3 6(d), or 6(h); or 

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

5 judicial proceeding under any provision of this 

6 Act.’’; 

7 (2) in subsection (d), by striking ‘‘section 6(a)’’ 

8 and inserting ‘‘section 6(c)’’; and 

9 (3) in subsection (f), in the first sentence, by 

10 striking ‘‘and unreasonable’’. 

11 SEC. 10. INFORMATION COLLECTION AND REPORTING. 

12 Section 8 of the Toxic Substances Control Act (15 

13 U.S.C. 2607) is amended— 

14 (1) in subsection (a)— 

15 (A) in paragraph (3)(A)(ii)(I)— 

16 (i) by striking ‘‘5(b)(4)’’ and inserting 

17 ‘‘5’’; 

18 (ii) by inserting ‘‘section 4 or’’ after 

19 ‘‘in effect under’’; and 

20 (iii) by striking ‘‘5(e),’’ and inserting 

21 ‘‘5(d)(4);’’; and 

22 (B) by adding at the end the following: 

23 ‘‘(4) RULES.— 

24 ‘‘(A) DEADLINE.— 


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1 ‘‘(i) IN GENERAL.—Not later than 2 

2 years after the date of enactment of the 

3 Frank R. Lautenberg Chemical Safety for 

4 the 21st Century Act, the Administrator 

5 shall promulgate rules requiring the main6 tenance of records and the reporting of in7 formation known or reasonably ascertain8 able by the person making the report, in9 cluding rules requiring processors to report 

10 information, so that the Administrator has 

11 the information necessary to carry out sec12 tions 4 and 6. 

13 ‘‘(ii) MODIFICATION OF PRIOR

14 RULES.—In carrying out this subpara15 graph, the Administrator may modify, as 

16 appropriate, rules promulgated before the 

17 date of enactment of the Frank R. Lauten18 berg Chemical Safety for the 21st Century 

19 Act. 

20 ‘‘(B) CONTENTS.—The rules promulgated 

21 pursuant to subparagraph (A)— 

22 ‘‘(i) may impose different reporting 

23 and recordkeeping requirements on manu24 facturers and processors; and 


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1 ‘‘(ii) shall include the level of detail 

2 necessary to be reported, including the 

3 manner by which use and exposure infor4 mation may be reported. 

5 ‘‘(C) ADMINISTRATION.—In implementing 

6 the reporting and recordkeeping requirements 

7 under this paragraph, the Administrator shall 

8 take measures— 

9 ‘‘(i) to limit the potential for duplica10 tion in reporting requirements; 

11 ‘‘(ii) to minimize the impact of the 

12 rules on small manufacturers and proc13 essors; and 

14 ‘‘(iii) to apply any reporting obliga15 tions to those persons likely to have infor16 mation relevant to the effective implemen17 tation of this title. 

18 ‘‘(5) GUIDANCE.—The Administrator shall de19 velop guidance relating to the information required 

20 to be reported under the rules promulgated under 

21 this subsection.’’; 

22 (2) in subsection (b), by adding at the end the 

23 following: 

24 ‘‘(3) NOMENCLATURE.— 


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1 ‘‘(A) IN GENERAL.—In carrying out para2 graph (1), the Administrator shall— 

3 ‘‘(i) maintain the use of Class 2 no4 menclature in use on the date of enact5 ment of the Frank R. Lautenberg Chem6 ical Safety for the 21st Century Act; 

7 ‘‘(ii) maintain the use of the Soap and 

8 Detergent Association Nomenclature Sys9 tem, published in March 1978 by the Ad10 ministrator in section 1 of addendum III 

11 of the document entitled ‘Candidate List of 

12 Chemical Substances’, and further de13 scribed in the appendix A of volume I of 

14 the 1985 edition of the Toxic Substances 

15 Control Act Substances Inventory (EPA 

16 Document No. EPA–560/7–85–002a); and 

17 ‘‘(iii) treat all components of cat18 egories that are considered to be statutory 

19 mixtures under this Act as being included 

20 on the list published under paragraph (1) 

21 under the Chemical Abstracts Service 

22 numbers for the respective categories, in23 cluding, without limitation— 

24 ‘‘(I) cement, Portland, chemicals, 

25 CAS No. 65997–15–1; 


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1 ‘‘(II) cement, alumina, chemicals, 

2 CAS No. 65997–16–2; 

3 ‘‘(III) glass, oxide, chemicals, 

4 CAS No. 65997–17–3; 

5 ‘‘(IV) frits, chemicals, CAS No. 

6 65997–18–4; 

7 ‘‘(V) steel manufacture, chemi8 cals, CAS No. 65997–19–5; and 

9 ‘‘(VI) ceramic materials and 

10 wares, chemicals, CAS No. 66402– 

11 68–4. 

12 ‘‘(B) MULTIPLE NOMENCLATURE CONVEN13 TIONS.— 

14 ‘‘(i) IN GENERAL.—If an existing 

15 guidance allows for multiple nomenclature 

16 conventions, the Administrator shall— 

17 ‘‘(I) maintain the nomenclature 

18 conventions for substances; and 

19 ‘‘(II) develop new guidance 

20 that— 

21 ‘‘(aa) establishes equivalency 

22 between the nomenclature con23 ventions for chemical substances 

24 on the list published under para25 graph (1); and 


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1 ‘‘(bb) permits persons to 

2 rely on the new guidance for pur3 poses of determining whether a 

4 chemical substance is on the list 

5 published under paragraph (1). 

6 ‘‘(ii) MULTIPLE CAS NUMBERS.—For 

7 any chemical substance appearing multiple 

8 times on the list under different Chemical 

9 Abstracts Service numbers, the Adminis10 trator shall develop guidance recognizing 

11 the multiple listings as a single chemical 

12 substance. 

13 ‘‘(4) CHEMICAL SUBSTANCES IN COMMERCE.— 

14 ‘‘(A) RULES.— 

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

16 year after the date of enactment of the 

17 Frank R. Lautenberg Chemical Safety for 

18 the 21st Century Act, the Administrator, 

19 by rule, shall require manufacturers and 

20 processors to notify the Administrator, by 

21 not later than 180 days after the date of 

22 promulgation of the rule, of each chemical 

23 substance on the list published under para24 graph (1) that the manufacturer or proc25 essor, as applicable, has manufactured or 


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1 processed for a nonexempt commercial pur2 pose during the 10-year period ending on 

3 the day before the date of enactment of the 

4 Frank R. Lautenberg Chemical Safety for 

5 the 21st Century Act. 

6 ‘‘(ii) ACTIVE SUBSTANCES.—The Ad7 ministrator shall, pursuant to paragraph 

8 (5)(A), designate chemical substances for 

9 which notices are received under clause (i) 

10 to be active substances on the list pub11 lished under paragraph (1). 

12 ‘‘(B) CONFIDENTIAL CHEMICAL SUB13 STANCES.—The rule promulgated by the Ad14 ministrator pursuant to subparagraph (A) shall 

15 require— 

16 ‘‘(i) the Administrator to maintain the 

17 list under paragraph (1), which shall in18 clude a confidential portion and a noncon19 fidential portion consistent with this sec20 tion and section 14; 

21 ‘‘(ii) a manufacturer or processor that 

22 is submitting a notice pursuant to sub23 paragraph (A) for a chemical substance on 

24 the confidential portion of the list pub25 lished under paragraph (1) to indicate in 


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1 the notice whether the manufacturer or 

2 processor seeks to maintain any existing 

3 claim for protection against disclosure of 

4 the specific identity of the substance as 

5 confidential pursuant to section 14; and 

6 ‘‘(iii) the substantiation of those 

7 claims pursuant to section 14 and in ac8 cordance with the review plan described in 

9 subparagraph (C). 

10 ‘‘(C) REVIEW PLAN.—Not later than 1 

11 year after the date on which the Administrator 

12 compiles the initial list of active substances pur13 suant to subparagraph (A), the Administrator 

14 shall promulgate a rule that establishes a plan 

15 to review all claims to protect the specific iden16 tities of chemical substances on the confidential 

17 portion of the list published under paragraph 

18 (1) that are notified pursuant to subparagraph 

19 (A) or identified as active substances under 

20 subsection (f)(1). 

21 ‘‘(D) REQUIREMENTS OF REVIEW PLAN.— 

22 The review plan under subparagraph (C) 

23 shall— 

24 ‘‘(i) require, at the time requested by 

25 the Administrator, all manufacturers or 


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1 processors asserting claims under subpara2 graph (B) to substantiate the claim unless 

3 the manufacturer or processor has sub4 stantiated the claim in a submission made 

5 to the Administrator during the 5-year pe6 riod ending on the date of the request by 

7 the Administrator; 

8 ‘‘(ii) require the Administrator, in ac9 cordance with section 14— 

10 ‘‘(I) to review each substan11 tiation— 

12 ‘‘(aa) submitted pursuant to 

13 clause (i) to determine if the 

14 claim warrants protection from 

15 disclosure; and 

16 ‘‘(bb) submitted previously 

17 by a manufacturer or processor 

18 and relied on in lieu of the sub19 stantiation required pursuant to 

20 clause (i), if the substantiation 

21 has not been previously reviewed 

22 by the Administrator, to deter23 mine if the claim warrants pro24 tection from disclosure; 


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1 ‘‘(II) approve, modify, or deny 

2 each claim; and 

3 ‘‘(III) except as provided in this 

4 section and section 14, protect from 

5 disclosure information for which the 

6 Administrator approves such a claim 

7 for a period of 10 years, unless, prior 

8 to the expiration of the period— 

9 ‘‘(aa) the person notifies the 

10 Administrator that the person is 

11 withdrawing the confidentiality 

12 claim, in which case the Adminis13 trator shall promptly make the 

14 information available to the pub15 lic; or 

16 ‘‘(bb) the Administrator oth17 erwise becomes aware that the 

18 need for protection from disclo19 sure can no longer be substan20 tiated, in which case the Admin21 istrator shall take the actions de22 scribed in section 14(g)(2); and 

23 ‘‘(iii) encourage manufacturers or 

24 processors that have previously made 

25 claims to protect the specific identities of 


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1 chemical substances identified as inactive 

2 pursuant to subsection (f)(2) to review and 

3 either withdraw or substantiate the claims. 

4 ‘‘(E) TIMELINE FOR COMPLETION OF RE5 VIEWS.— 

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

7 shall implement the review plan so as to 

8 complete reviews of all claims specified in 

9 subparagraph (C) not later than 5 years 

10 after the date on which the Administrator 

11 compiles the initial list of active substances 

12 pursuant to subparagraph (A). 

13 ‘‘(ii) CONSIDERATIONS.— 

14 ‘‘(I) IN GENERAL.—The Admin15 istrator may extend the deadline for 

16 completion of the reviews for not more 

17 than 2 additional years, after an ade18 quate public justification, if the Ad19 ministrator determines that the exten20 sion is necessary based on the number 

21 of applicable claims needing review 

22 and the available resources. 

23 ‘‘(II) ANNUAL GOAL.—The Ad24 ministrator shall publish an annual 

25 goal for the number of reviews to be 


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1 completed over the course of imple2 mentation of the plan. 

3 ‘‘(5) ACTIVE AND INACTIVE SUBSTANCES.— 

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

5 shall maintain and keep current designations of 

6 active substances and inactive substances on 

7 the list published under paragraph (1). 

8 ‘‘(B) UPDATE.—The Administrator shall 

9 update the list of chemical substances des10 ignated as active substances as soon as prac11 ticable after the date of publication of the most 

12 recent data reported under— 

13 ‘‘(i) part 711 of title 40, Code of Fed14 eral Regulations (or successor regulations); 

15 and 

16 ‘‘(ii) the rules promulgated pursuant 

17 to subsection (a)(4). 

18 ‘‘(C) CHANGE TO ACTIVE STATUS.— 

19 ‘‘(i) IN GENERAL.—Any person that 

20 intends to manufacture or process for a 

21 nonexempt commercial purpose a chemical 

22 substance that is designated as an inactive 

23 substance shall notify the Administrator 

24 before the date on which the inactive sub25 stance is manufactured or processed. 


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1 ‘‘(ii) CONFIDENTIAL CHEMICAL IDEN2 TITY CLAIMS.—If a person submitting a 

3 notice under clause (i) for an inactive sub4 stance on the confidential portion of the 

5 list published under paragraph (1) seeks to 

6 maintain an existing claim for protection 

7 against disclosure of the specific identity of 

8 the inactive substance as confidential, the 

9 person shall— 

10 ‘‘(I) in the notice submitted 

11 under clause (i), assert the claim; and 

12 ‘‘(II) by not later than 30 days 

13 after providing the notice under clause 

14 (i), substantiate the claim. 

15 ‘‘(iii) ACTIVE STATUS.—On receiving 

16 a notification under clause (i), the Admin17 istrator shall— 

18 ‘‘(I) designate the applicable 

19 chemical substance as an active sub20 stance; 

21 ‘‘(II) pursuant to section 14, 

22 promptly review any claim and associ23 ated substantiation submitted pursu24 ant to clause (ii) for protection 

25 against disclosure of the specific idenVerDate Sep 11 2014 05:33 Mar 17, 2015 Jkt 049200 PO 00000 Frm 00091 Fmt 6652 Sfmt 6201 E:\BILLS\S697.IS S697

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1 tity of the chemical substance and ap2 prove, modify, or deny the claim; 

3 ‘‘(III) except as provided in this 

4 section and section 14, protect from 

5 disclosure the specific identity of the 

6 chemical substance for which the Ad7 ministrator approves a claim under 

8 subclause (II) for a period of not less 

9 than 10 years, unless, prior to the ex10 piration of the period— 

11 ‘‘(aa) the person notifies the 

12 Administrator that the person is 

13 withdrawing the confidentiality 

14 claim, in which case the Adminis15 trator shall promptly make the 

16 information available to the pub17 lic; or 

18 ‘‘(bb) the Administrator oth19 erwise becomes aware that the 

20 need for protection from disclo21 sure can no longer be substan22 tiated, in which case the Admin23 istrator shall take the actions de24 scribed in section 14(g)(2); and 


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1 ‘‘(IV) pursuant to section 4A, re2 view the priority of the chemical sub3 stance as the Administrator deter4 mines to be necessary. 

5 ‘‘(D) CATEGORY STATUS.—The list of in6 active substances shall not be considered to be 

7 a category for purposes of section 26(c). 

8 ‘‘(6) INTERIM LIST OF ACTIVE SUBSTANCES.— 

9 Prior to the promulgation of the rule required under 

10 this subsection, the Administrator shall designate 

11 the chemical substances reported under part 711 of 

12 title 40, Code of Federal Regulations (or successor 

13 regulations), during the reporting period that most 

14 closely preceded the date of enactment of the Frank 

15 R. Lautenberg Chemical Safety for the 21st Century 

16 Act, as the interim list of active substances for the 

17 purposes of section 4A. 

18 ‘‘(7) PUBLIC PARTICIPATION.—Subject to this 

19 subsection, the Administrator shall make available to 

20 the public— 

21 ‘‘(A) the specific identity of each chemical 

22 substance on the nonconfidential portion of the 

23 list published under paragraph (1) that the Ad24 ministrator has designated as— 

25 ‘‘(i) an active substance; or 


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1 ‘‘(ii) an inactive substance; 

2 ‘‘(B) the accession number, generic name, 

3 and, if applicable, premanufacture notice case 

4 number for each chemical substance on the con5 fidential portion of the list published under 

6 paragraph (1) for which a claim of confiden7 tiality was received and approved by the Admin8 istrator pursuant to section 14; and 

9 ‘‘(C) subject to section 14(g), the specific 

10 identity of any active substance for which— 

11 ‘‘(i) no claim of protection against dis12 closure of the specific identity of the active 

13 substance pursuant to this subsection was 

14 received; 

15 ‘‘(ii) a claim for protection against 

16 disclosure of the specific identity of the ac17 tive substance has been denied by the Ad18 ministrator; or 

19 ‘‘(iii) the time period for protection 

20 against disclosure of the specific identity of 

21 the active substance has expired. 

22 ‘‘(8) LIMITATION.—No person may assert a 

23 new claim under this subsection for protection from 

24 disclosure of a specific identity of any active or inac25 tive chemical substance for which a notice is received 


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1 under paragraph (4)(A)(i) or (5)(C)(i) that is not on 

2 the confidential portion of the list published under 

3 paragraph (1). 

4 ‘‘(9) CERTIFICATION.—Under the rule promul5 gated under this subsection, manufacturers and 

6 processors shall be required— 

7 ‘‘(A) to certify that each report the manu8 facturer or processor submits complies with the 

9 requirements of the rule, and that any confiden10 tiality claims are true and correct; and 

11 ‘‘(B) to retain a record supporting the cer12 tification for a period of 5 years beginning on 

13 the last day of the submission period.’’; 

14 (3) in subsection (e)— 

15 (A) by striking ‘‘Any person’’ and inserting 

16 the following: 

17 ‘‘(1) IN GENERAL.—Any person’’; and 

18 (B) by adding at the end the following: 

19 ‘‘(2) APPLICABILITY.—Any person may submit 

20 to the Administrator information reasonably sup21 porting the conclusion that a chemical substance or 

22 mixture presents, will present, or does not present a 

23 substantial risk of harm to health and the environ24 ment.’’; and 


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1 (4) in subsection (f), by striking ‘‘For purposes 

2 of this section, the’’ and inserting the following: ‘‘In 

3 this section: 

4 ‘‘(1) ACTIVE SUBSTANCE.—The term ‘active 

5 substance’ means a chemical substance— 

6 ‘‘(A) that has been manufactured or proc7 essed for a nonexempt commercial purpose at 

8 any point during the 10-year period ending on 

9 the date of enactment of the Frank R. Lauten10 berg Chemical Safety for the 21st Century Act; 

11 ‘‘(B) that is added to the list published 

12 under subsection (b)(1) after that date of en13 actment; or 

14 ‘‘(C) for which a notice is received under 

15 subsection (b)(5)(C). 

16 ‘‘(2) INACTIVE SUBSTANCE.—The term ‘inactive 

17 substance’ means a chemical substance on the list 

18 published under subsection (b)(1) that does not meet 

19 any of the criteria described in paragraph (1). 

20 ‘‘(3) MANUFACTURE; PROCESS.—The’’. 

21 SEC. 11. RELATIONSHIP TO OTHER FEDERAL LAWS. 

22 Section 9 of the Toxic Substances Control Act (15 

23 U.S.C. 2608) is amended— 

24 (1) in subsection (a)— 


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1 (A) in paragraph (1), in the first sen2 tence— 

3 (i) by striking ‘‘presents or will 

4 present an unreasonable risk to health or 

5 the environment’’ and inserting ‘‘does not 

6 meet the safety standard’’; and 

7 (ii) by striking ‘‘such risk’’ the first 

8 place it appears and inserting ‘‘the risk 

9 posed by the substance or mixture’’; 

10 (B) in paragraph (2), in the matter fol11 lowing subparagraph (B), by striking ‘‘section 6 

12 or 7’’ and inserting ‘‘section 6(d) or section 7’’; 

13 and 

14 (C) in paragraph (3), by striking ‘‘section 

15 6 or 7’’ and inserting ‘‘section 6(d) or 7’’; 

16 (2) in subsection (d), in the first sentence, by 

17 striking ‘‘Health, Education, and Welfare’’ and in18 serting ‘‘Health and Human Services’’; and 

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

20 ‘‘(e) EXPOSURE INFORMATION.—If the Adminis21 trator obtains information related to exposures or releases 

22 of a chemical substance that may be prevented or reduced 

23 under another Federal law, including laws not adminis24 tered by the Administrator, the Administrator shall make 


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1 such information available to the relevant Federal agency 

2 or office of the Environmental Protection Agency.’’. 

3 SEC. 12. RESEARCH, DEVELOPMENT, COLLECTION, DIS4 SEMINATION, AND UTILIZATION OF DATA. 

5 Section 10 of the Toxic Substances Control Act (15 

6 U.S.C. 2609) is amended by striking ‘‘Health, Education, 

7 and Welfare’’ each place it appears and inserting ‘‘Health 

8 and Human Services’’. 

9 SEC. 13. EXPORTS. 

10 Section 12 of the Toxic Substances Control Act (15 

11 U.S.C. 2611) is amended— 

12 (1) in subsection (a), by striking paragraph (2) 

13 and inserting the following: 

14 ‘‘(2) EXCEPTION.—Paragraph (1) shall not 

15 apply to any chemical substance that the Adminis16 trator determines— 

17 ‘‘(A) under section 5 is not likely to meet 

18 the safety standard; or 

19 ‘‘(B) under section 6 does not meet the 

20 safety standard. 

21 ‘‘(3) WAIVERS.—For a mixture or article con22 taining a chemical substance described in paragraph 

23 (2), the Administrator may— 

24 ‘‘(A) determine that paragraph (1) shall 

25 not apply to the mixture or article; or 


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1 ‘‘(B) establish a threshold concentration in 

2 a mixture or article at which paragraph (1) 

3 shall not apply. 

4 ‘‘(4) TESTING.—The Administrator may re5 quire testing under section 4 of any chemical sub6 stance or mixture exempted from this Act under 

7 paragraph (1) for the purpose of determining wheth8 er the chemical substance or mixture meets the safe9 ty standard within the United States.’’; 

10 (2) by striking subsection (b) and inserting the 

11 following: 

12 ‘‘(b) NOTICE.— 

13 ‘‘(1) IN GENERAL.—A person shall notify the 

14 Administrator that the person is exporting or in15 tends to export to a foreign country— 

16 ‘‘(A) a chemical substance or a mixture 

17 containing a chemical substance that the Ad18 ministrator has determined under section 5 is 

19 not likely to meet the safety standard and for 

20 which a prohibition or other restriction has 

21 been proposed or established under that section; 

22 ‘‘(B) a chemical substance or a mixture 

23 containing a chemical substance that the Ad24 ministrator has determined under section 6 

25 does not meet the safety standard and for 


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1 which a prohibition or other restriction has 

2 been proposed or established under that section; 

3 ‘‘(C) a chemical substance for which the 

4 United States is obligated by treaty to provide 

5 export notification; 

6 ‘‘(D) a chemical substance or mixture sub7 ject to a prohibition or other restriction pursu8 ant to a rule, order, or consent agreement in ef9 fect under this Act; or 

10 ‘‘(E) a chemical substance or mixture for 

11 which the submission of information is required 

12 under section 4. 

13 ‘‘(2) RULES.— 

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

15 shall promulgate rules to carry out paragraph 

16 (1). 

17 ‘‘(B) CONTENTS.—The rules promulgated 

18 pursuant to subparagraph (A) shall— 

19 ‘‘(i) include such exemptions as the 

20 Administrator determines to be appro21 priate, which may include exemptions iden22 tified under section 5(h); and 

23 ‘‘(ii) indicate whether, or to what ex24 tent, the rules apply to articles containing 


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1 a chemical substance or mixture described 

2 in paragraph (1). 

3 ‘‘(3) NOTIFICATION.—The Administrator shall 

4 submit to the government of each country to which 

5 a chemical substance or mixture is exported— 

6 ‘‘(A) for a chemical substance or mixture 

7 described in subparagraph (A), (B), or (D) of 

8 paragraph (1), a notice of the determination, 

9 rule, order, consent agreement, requirement, or 

10 designation; 

11 ‘‘(B) for a chemical substance described in 

12 paragraph (1)(C), a notice that satisfies the ob13 ligation of the United States under the applica14 ble treaty; and 

15 ‘‘(C) for a chemical substance or mixture 

16 described in paragraph (1)(E), a notice of avail17 ability of the information on the chemical sub18 stance or mixture submitted to the Adminis19 trator.’’; and 

20 (3) in subsection (c)— 

21 (A) by striking paragraph (3); and 

22 (B) by redesignating paragraphs (4) 

23 through (6) as paragraphs (3) through (5), re24 spectively. 


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1 SEC. 14. IMPORTS. 

2 Section 13 of the Toxic Substances Control Act (15 

3 U.S.C. 2612) is amended to read as follows: 

4 ‘‘SEC. 13. IMPORTS. 

5 ‘‘(a) REFUSAL OF ENTRY.— 

6 ‘‘(1) IN GENERAL.—The Secretary of Homeland 

7 Security shall refuse entry into the customs territory 

8 of the United States (as defined in general note 2 

9 to the Harmonized Tariff Schedule of the United 

10 States) any chemical substance, mixture, or article 

11 containing a chemical substance or mixture offered 

12 for such entry, if— 

13 ‘‘(A) the Administrator— 

14 ‘‘(i) has determined under section 6(c) 

15 that the chemical substance or mixture 

16 does not meet the safety standard; and 

17 ‘‘(ii) has promulgated a rule pursuant 

18 to section 6(d) banning the chemical sub19 stance or mixture, as of the effective date 

20 of the rule; 

21 ‘‘(B) the chemical substance— 

22 ‘‘(i) is not included on the list under 

23 section 8(b)(1); and 

24 ‘‘(ii) is not exempt from any require25 ment to be included on that list by this 


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1 title or a rule promulgated by the Adminis2 trator pursuant to this title; or 

3 ‘‘(C) the chemical substance, mixture, or 

4 any article containing the chemical substance or 

5 mixture is offered for entry in violation of— 

6 ‘‘(i) a rule, consent agreement, or 

7 order in effect under this Act; or 

8 ‘‘(ii) an order issued in a civil action 

9 brought under section 7 or title IV. 

10 ‘‘(2) PROCEDURE.— 

11 ‘‘(A) IN GENERAL.—Subject to subpara12 graph (B), if a chemical substance, mixture, or 

13 article containing a chemical substance or mix14 ture is refused entry under paragraph (1), the 

15 Secretary of Homeland Security— 

16 ‘‘(i) shall notify the consignee of the 

17 entry of the refusal; 

18 ‘‘(ii) shall not release the chemical 

19 substance or mixture to the consignee; and 

20 ‘‘(iii) shall cause the disposal or stor21 age of the chemical substance or mixture 

22 under such rules as the Secretary may pre23 scribe, if the chemical substance or mix24 ture has not been exported by the con25 signee during the 90-day period beginning 


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1 on the date of receipt of the notice of the 

2 refused entry. 

3 ‘‘(B) EXCEPTION.— 

4 ‘‘(i) IN GENERAL.—The Secretary of 

5 Homeland Security, pending a review by 

6 the Administrator, may release to the con7 signee the chemical substance or mixture if 

8 the consignee— 

9 ‘‘(I) executes a bond for the 

10 amount of the full invoice of the 

11 chemical substance or mixture (as set 

12 forth in the customs entry); and 

13 ‘‘(II) pays a duty on the chemical 

14 substance or mixture. 

15 ‘‘(ii) ADMINISTRATION.—If a con16 signee fails to return a chemical substance 

17 or mixture released to that consignee 

18 under clause (i) for any cause to the cus19 tody of the Secretary of Homeland Secu20 rity on demand, the consignee shall be lia21 ble to the United States for liquidated 

22 damages equal to the full amount of the 

23 bond executed under clause (i)(I). 

24 ‘‘(C) STORAGE.—All charges for storage, 

25 cartage, and labor on or for the disposal of a 


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1 chemical substance or mixture that is refused 

2 entry or released under this subsection shall be 

3 paid by the owner or consignee, and a default 

4 on that payment shall constitute a lien against 

5 any future entry made by the owner or con6 signee. 

7 ‘‘(b) CERTIFICATION.— 

8 ‘‘(1) IN GENERAL.—A person offering a chem9 ical substance or mixture subject to this Act for 

10 entry into the customs territory of the United States 

11 shall certify to the Secretary of Homeland Security 

12 that— 

13 ‘‘(A) after reasonable inquiry and to the 

14 best knowledge and belief of the person, the 

15 chemical substance or mixture is in compliance 

16 with any applicable rule, consent agreement, or 

17 order under section 5 or 6; and 

18 ‘‘(B) the chemical substance— 

19 ‘‘(i) is included on the list under sec20 tion 8(b)(1); or 

21 ‘‘(ii) is exempt from any requirement 

22 to be included on that list by this title or 

23 a rule promulgated by the Administrator 

24 pursuant to this title. 

25 ‘‘(2) ARTICLES.— 


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

2 rule, may require certification under paragraph 

3 (1) for an article containing a chemical sub4 stance or mixture that is subject to rule under 

5 section 5 or 6. 

6 ‘‘(B) REQUIREMENT.—The rule under sub7 paragraph (A) shall identify, with reasonable 

8 specificity, the types of articles, including parts 

9 or components of articles, that will be subject to 

10 the certification requirement. 

11 ‘‘(C) FACTORS FOR CONSIDERATION.—In 

12 determining the need for and content of a cer13 tification rule under this paragraph, the Admin14 istrator shall take into consideration— 

15 ‘‘(i) the utility of the certification to 

16 enforcement of the applicable rule, consent 

17 agreement, or order under section 5 or 6; 

18 ‘‘(ii) the contribution of imported arti19 cles to the potential risk presented by ex20 posure to the chemical substance or mix21 ture subject to rule under section 5 or 6; 

22 ‘‘(iii) the impact on commerce and po23 tential for the certification to impede or 

24 disrupt import of articles; 


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1 ‘‘(iv) the frequency or duration of the 

2 certification requirement; and 

3 ‘‘(v) specification of the concentration 

4 of a chemical substance in an article that 

5 would subject the article to the certifi6 cation requirement. 

7 ‘‘(3) REASONABLE INQUIRY.— 

8 ‘‘(A) IN GENERAL.—For purposes of a cer9 tification under paragraph (1), reasonable in10 quiry shall include good faith reliance by an im11 porter on— 

12 ‘‘(i) a safety data sheet or similar dec13 laration provided by a supplier that docu14 ments the specific identity of the chemical 

15 substance or the specific identities of all 

16 chemical substances in a mixture; or 

17 ‘‘(ii) for chemical substances or mix18 tures claimed by the supplier as confiden19 tial, or not otherwise disclosed by the sup20 plier, a certification by the supplier that 

21 the imported chemical substance or mix22 ture satisfies the applicable certification re23 quirements under paragraph (1). 

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1 quiry shall include good faith reliance by an im2 porter on a certification by the supplier that the 

3 imported article satisfies the applicable certifi4 cation requirements in a rule promulgated pur5 suant to paragraph (2). 

6 ‘‘(4) INFORMATION REGARDING IDENTITY.— 

7 For purposes of this subsection, the Administrator 

8 shall provide publicly accessible information regard9 ing the identity of a chemical substance or mixture 

10 subject to rule under this Act that would be readily 

11 understood in import transactions. 

12 ‘‘(c) NOTICE.—A person offering a chemical sub13 stance for entry into the customs territory of the United 

14 States shall notify the Secretary of Homeland Security 

15 if— 

16 ‘‘(1) the chemical substance or chemical sub17 stance in a mixture is a high-priority substance; 

18 ‘‘(2) the chemical substance or chemical sub19 stance in a mixture is 1 for which the United States 

20 is obligated to provide export notification by treaty; 

21 or 

22 ‘‘(3) the chemical substance or chemical sub23 stance in a mixture— 


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1 ‘‘(A) is the subject of a safety assessment 

2 and safety determination conducted pursuant to 

3 section 6; and 

4 ‘‘(B) has been found not to meet the safety 

5 standard. 

6 ‘‘(d) RULES.— 

7 ‘‘(1) IN GENERAL.—The Secretary of Homeland 

8 Security, after consultation with the Administrator, 

9 shall promulgate rules to carry out this section. 

10 ‘‘(2) APPLICATION.—The rules under para11 graph (1) may modify the application of any require12 ment of this section, as appropriate for the efficient 

13 and effective implementation of this Act.’’. 

14 SEC. 15. CONFIDENTIAL INFORMATION. 

15 Section 14 of the Toxic Substances Control Act (15 

16 U.S.C. 2613) is amended to read as follows: 

17 ‘‘SEC. 14. CONFIDENTIAL INFORMATION. 

18 ‘‘(a) IN GENERAL.—Except as otherwise provided in 

19 this section, the Administrator shall not disclose informa20 tion that is exempt from disclosure pursuant to subsection 

21 (a) of section 552 of title 5, United States Code, under 

22 subsection (b)(4) of that section— 

23 ‘‘(1) that is reported to, or otherwise obtained 

24 by, the Administrator under this Act; and 


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1 ‘‘(2) for which the requirements of subsection 

2 (d) are met. 

3 ‘‘(b) INFORMATION GENERALLY PROTECTED FROM

4 DISCLOSURE.—The following information specific to, and 

5 submitted by, a manufacturer, processor, or distributor 

6 that meets the requirements of subsections (a) and (d) 

7 shall be presumed to be protected from disclosure, subject 

8 to the condition that nothing in this Act prohibits the dis9 closure of any such information through discovery, sub10 poena, other court order, or any other judicial process oth11 erwise allowed under applicable Federal or State law: 

12 ‘‘(1) Specific information describing the proc13 esses used in manufacture or processing of a chem14 ical substance, mixture, or article. 

15 ‘‘(2) Marketing and sales information. 

16 ‘‘(3) Information identifying a supplier or cus17 tomer. 

18 ‘‘(4) Details of the full composition of a mixture 

19 and the respective percentages of constituents. 

20 ‘‘(5) Specific information regarding the use, 

21 function, or application of a chemical substance or 

22 mixture in a process, mixture, or product. 

23 ‘‘(6) Specific production or import volumes of 

24 the manufacturer and specific aggregated volumes 

25 across manufacturers, if the Administrator deterVerDate Sep 11 2014 05:33 Mar 17, 2015 Jkt 049200 PO 00000 Frm 00110 Fmt 6652 Sfmt 6201 E:\BILLS\S697.IS S697

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1 mines that disclosure of the specific aggregated vol2 umes would reveal confidential information. 

3 ‘‘(7) Except as otherwise provided in this sec4 tion, the specific identity of a chemical substance 

5 prior to the date on which the chemical substance is 

6 first offered for commercial distribution, including 

7 the chemical name, molecular formula, Chemical Ab8 stracts Service number, and other information that 

9 would identify a specific chemical substance, if— 

10 ‘‘(A) the specific identity was claimed as 

11 confidential information at the time it was sub12 mitted in a notice under section 5; and 

13 ‘‘(B) the claim— 

14 ‘‘(i) is not subject to an exception 

15 under subsection (e); or 

16 ‘‘(ii) has not subsequently been with17 drawn or found by the Administrator not 

18 to warrant protection as confidential infor19 mation under subsection (f)(2) or (g). 

20 ‘‘(c) INFORMATION NOT PROTECTED FROM DISCLO21 SURE.—Notwithstanding subsections (a) and (b), the fol22 lowing information shall not be protected from disclosure: 

23 ‘‘(1) INFORMATION FROM HEALTH AND SAFETY

24 STUDIES.— 


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1 ‘‘(A) IN GENERAL.—Subject to subpara2 graph (B), subsection (a) does not prohibit the 

3 disclosure of— 

4 ‘‘(i) any health and safety study that 

5 is submitted under this Act with respect 

6 to— 

7 ‘‘(I) any chemical substance or 

8 mixture that, on the date on which 

9 the study is to be disclosed, has been 

10 offered for commercial distribution; or 

11 ‘‘(II) any chemical substance or 

12 mixture for which— 

13 ‘‘(aa) testing is required 

14 under section 4; or 

15 ‘‘(bb) a notification is re16 quired under section 5; or 

17 ‘‘(ii) any information reported to, or 

18 otherwise obtained by, the Administrator 

19 from a health and safety study relating to 

20 a chemical substance or mixture described 

21 in subclause (I) or (II) of clause (i). 

22 ‘‘(B) EFFECT OF PARAGRAPH.—Nothing 

23 in this paragraph authorizes the release of any 

24 information that discloses— 


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1 ‘‘(i) a process used in the manufac2 turing or processing of a chemical sub3 stance or mixture; or 

4 ‘‘(ii) in the case of a mixture, the por5 tion of the mixture comprised by any 

6 chemical substance in the mixture. 

7 ‘‘(2) CERTAIN REQUESTS.—If a request is made 

8 to the Administrator under section 552(a) of title 5, 

9 United States Code, for information that is de10 scribed in paragraph (1) that is not described in 

11 paragraph (1)(B), the Administrator may not deny 

12 the request on the basis of section 552(b)(4) of title 

13 5, United States Code. 

14 ‘‘(3) OTHER INFORMATION NOT PROTECTED

15 FROM DISCLOSURE.—The following information is 

16 not protected from disclosure under this section: 

17 ‘‘(A) For information submitted after the 

18 date of enactment of the Frank R. Lautenberg 

19 Chemical Safety for the 21st Century Act, the 

20 specific identity of a chemical substance as of 

21 the date on which the chemical substance is 

22 first offered for commercial distribution, if the 

23 person submitting the information does not 

24 meet the requirements of subsection (d). 


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1 ‘‘(B) A safety assessment developed, or a 

2 safety determination made, under section 6. 

3 ‘‘(C) Any general information describing 

4 the manufacturing volumes, expressed as spe5 cific aggregated volumes or, if the Adminis6 trator determines that disclosure of specific ag7 gregated volumes would reveal confidential in8 formation, expressed in ranges. 

9 ‘‘(D) A general description of a process 

10 used in the manufacture or processing and in11 dustrial, commercial, or consumer functions and 

12 uses of a chemical substance, mixture, or article 

13 containing a chemical substance or mixture, in14 cluding information specific to an industry or 

15 industry sector that customarily would be 

16 shared with the general public or within an in17 dustry or industry sector. 

18 ‘‘(4) MIXED CONFIDENTIAL AND NONCON19 FIDENTIAL INFORMATION.—Any information that is 

20 otherwise eligible for protection under this section 

21 and contained in a submission of information de22 scribed in this subsection shall be protected from 

23 disclosure, if the submitter complies with subsection 

24 (d), subject to the condition that information in the 


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1 submission that is not eligible for protection against 

2 disclosure shall be disclosed. 

3 ‘‘(5) BAN OR PHASE-OUT.—If the Adminis4 trator promulgates a rule pursuant to section 6(d) 

5 that establishes a ban or phase-out of the manufac6 ture, processing, or distribution in commerce of a 

7 chemical substance— 

8 ‘‘(A) any protection from disclosure pro9 vided under this section with respect to infor10 mation relating to the chemical substance shall 

11 no longer apply; and 

12 ‘‘(B) the Administrator promptly shall 

13 make the information public. 

14 ‘‘(d) REQUIREMENTS FOR CONFIDENTIALITY

15 CLAIMS.— 

16 ‘‘(1) ASSERTION OF CLAIMS.— 

17 ‘‘(A) IN GENERAL.—A person seeking to 

18 protect any information submitted under this 

19 Act from disclosure (including information de20 scribed in subsection (b)) shall assert to the Ad21 ministrator a claim for protection concurrent 

22 with submission of the information, in accord23 ance with such rules regarding a claim for pro24 tection from disclosure as the Administrator 


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1 has promulgated or may promulgate pursuant 

2 to this title. 

3 ‘‘(B) INCLUSION.—An assertion of a claim 

4 under subparagraph (A) shall include a state5 ment that the person has— 

6 ‘‘(i) taken reasonable measures to pro7 tect the confidentiality of the information; 

8 ‘‘(ii) determined that the information 

9 is not required to be disclosed or otherwise 

10 made available to the public under any 

11 other Federal law; 

12 ‘‘(iii) a reasonable basis to conclude 

13 that disclosure of the information is likely 

14 to cause substantial harm to the competi15 tive position of the person; and 

16 ‘‘(iv) a reasonable basis to believe that 

17 the information is not readily discoverable 

18 through reverse engineering. 

19 ‘‘(C) SPECIFIC CHEMICAL IDENTITY.—In 

20 the case of a claim under subparagraph (A) for 

21 protection against disclosure of a specific chem22 ical identity, the claim shall include a struc23 turally descriptive generic name for the chem24 ical substance that the Administrator may disVerDate Sep 11 2014 05:33 Mar 17, 2015 Jkt 049200 PO 00000 Frm 00116 Fmt 6652 Sfmt 6201 E:\BILLS\S697.IS S697

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1 close to the public, subject to the condition that 

2 the generic name shall— 

3 ‘‘(i) conform with guidance prescribed 

4 by the Administrator under paragraph 

5 (3)(A); and 

6 ‘‘(ii) describe the chemical structure 

7 of the substance as specifically as prac8 ticable while protecting those features of 

9 the chemical structure— 

10 ‘‘(I) that are considered to be 

11 confidential; and 

12 ‘‘(II) the disclosure of which 

13 would be likely to harm the competi14 tive position of the person. 

15 ‘‘(D) PUBLIC INFORMATION.—No person 

16 may assert a claim under this section for pro17 tection from disclosure of information that is al18 ready publicly available. 

19 ‘‘(2) ADDITIONAL REQUIREMENTS FOR CON20 FIDENTIALITY CLAIMS.—Except for information de21 scribed in paragraphs (1) through (7) of subsection 

22 (b), a person asserting a claim to protect informa23 tion from disclosure under this Act shall substan24 tiate the claim, in accordance with the rules promul25 gated and guidance issued by the Administrator. 


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1 ‘‘(3) GUIDANCE.—The Administrator shall de2 velop guidance regarding— 

3 ‘‘(A) the determination of structurally de4 scriptive generic names, in the case of claims 

5 for the protection against disclosure of specific 

6 chemical identity; and 

7 ‘‘(B) the content and form of the state8 ments of need and agreements required under 

9 paragraphs (4), (5), and (6) of subsection (e). 

10 ‘‘(4) CERTIFICATION.—An authorized official of 

11 a person described in paragraph (1)(A) shall certify 

12 that the information that has been submitted is true 

13 and correct. 

14 ‘‘(e) EXCEPTIONS TO PROTECTION FROM DISCLO15 SURE.—Information described in subsection (a) shall be 

16 disclosed if— 

17 ‘‘(1) the information is to be disclosed to an of18 ficer or employee of the United States in connection 

19 with the official duties of the officer or employee— 

20 ‘‘(A) under any law for the protection of 

21 health or the environment; or 

22 ‘‘(B) for a specific law enforcement pur23 pose; 


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1 ‘‘(2) the information is to be disclosed to a con2 tractor of the United States and employees of that 

3 contractor— 

4 ‘‘(A) if, in the opinion of the Adminis5 trator, the disclosure is necessary for the satis6 factory performance by the contractor of a con7 tract with the United States for the perform8 ance of work in connection with this Act; and 

9 ‘‘(B) subject to such conditions as the Ad10 ministrator may specify; 

11 ‘‘(3) the Administrator determines that disclo12 sure is necessary to protect health or the environ13 ment; 

14 ‘‘(4) the information is to be disclosed to a 

15 State or political subdivision of a State, on written 

16 request, for the purpose of development, administra17 tion, or enforcement of a law, if— 

18 ‘‘(A) 1 or more applicable agreements with 

19 the Administrator that conform with the guid20 ance issued under subsection (d)(3)(B) ensure 

21 that the recipient will take appropriate meas22 ures, and has adequate authority, to maintain 

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1 dures used by the Administrator to safeguard 

2 the information; and 

3 ‘‘(B) the Administrator notifies the person 

4 that submitted the information that the infor5 mation has been disclosed to the State or polit6 ical subdivision of a State; 

7 ‘‘(5) a health or environmental professional em8 ployed by a Federal or State agency or a treating 

9 physician or nurse in a nonemergency situation pro10 vides a written statement of need and agrees to sign 

11 a written confidentiality agreement with the Admin12 istrator, subject to the conditions that— 

13 ‘‘(A) the statement of need and confiden14 tiality agreement shall conform with the guid15 ance issued under subsection (d)(3)(B); 

16 ‘‘(B) the written statement of need shall be 

17 a statement that the person has a reasonable 

18 basis to suspect that— 

19 ‘‘(i) the information is necessary for, 

20 or will assist in— 

21 ‘‘(I) the diagnosis or treatment of 

22 1 or more individuals; or 

23 ‘‘(II) responding to an environ24 mental release or exposure; and 


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1 ‘‘(ii) 1 or more individuals being diag2 nosed or treated have been exposed to the 

3 chemical substance concerned, or an envi4 ronmental release or exposure has oc5 curred; and 

6 ‘‘(C) the confidentiality agreement shall 

7 provide that the person will not use the infor8 mation for any purpose other than the health or 

9 environmental needs asserted in the statement 

10 of need, except as otherwise may be authorized 

11 by the terms of the agreement or by the person 

12 submitting the information to the Adminis13 trator, except that nothing in this Act prohibits 

14 the disclosure of any such information through 

15 discovery, subpoena, other court order, or any 

16 other judicial process otherwise allowed under 

17 applicable Federal or State law; 

18 ‘‘(6) in the event of an emergency, a treating 

19 physician, nurse, agent of a poison control center, 

20 public health or environmental official of a State or 

21 political subdivision of a State, or first responder 

22 (including any individual duly authorized by a Fed23 eral agency, State, or political subdivision of a State 

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1 fighter, or emergency medical technician) requests 

2 the information, subject to the conditions that— 

3 ‘‘(A) the treating physician, nurse, agent, 

4 public health or environmental official of a 

5 State or a political subdivision of a State, or 

6 first responder shall have a reasonable basis to 

7 suspect that— 

8 ‘‘(i) a medical or public health or en9 vironmental emergency exists; 

10 ‘‘(ii) the information is necessary for, 

11 or will assist in, emergency or first-aid di12 agnosis or treatment; or 

13 ‘‘(iii) 1 or more individuals being di14 agnosed or treated have likely been ex15 posed to the chemical substance concerned, 

16 or a serious environmental release of or ex17 posure to the chemical substance con18 cerned has occurred; 

19 ‘‘(B) if requested by the person submitting 

20 the information to the Administrator, the treat21 ing physician, nurse, agent, public health or en22 vironmental official of a State or a political sub23 division of a State, or first responder shall, as 

24 described in paragraph (5)— 


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1 ‘‘(i) provide a written statement of 

2 need; and 

3 ‘‘(ii) agree to sign a confidentiality 

4 agreement; and 

5 ‘‘(C) the written confidentiality agreement 

6 or statement of need shall be submitted as soon 

7 as practicable, but not necessarily before the in8 formation is disclosed; 

9 ‘‘(7) the Administrator determines that disclo10 sure is relevant in a proceeding under this Act, sub11 ject to the condition that the disclosure shall be 

12 made in such a manner as to preserve confidentiality 

13 to the maximum extent practicable without impair14 ing the proceeding; 

15 ‘‘(8) the information is to be disclosed, on writ16 ten request of any duly authorized congressional 

17 committee, to that committee; or 

18 ‘‘(9) the information is required to be disclosed 

19 or otherwise made public under any other provision 

20 of Federal law. 

21 ‘‘(f) DURATION OF PROTECTION FROM DISCLO22 SURE.— 

23 ‘‘(1) IN GENERAL.— 

24 ‘‘(A) INFORMATION PROTECTED FROM DIS25 CLOSURE.—Subject to paragraph (2), the AdVerDate Sep 11 2014 05:33 Mar 17, 2015 Jkt 049200 PO 00000 Frm 00123 Fmt 6652 Sfmt 6201 E:\BILLS\S697.IS S697

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1 ministrator shall protect from disclosure infor2 mation that meets the requirements of sub3 section (d) for a period of 10 years, unless, 

4 prior to the expiration of the period— 

5 ‘‘(i) an affected person notifies the 

6 Administrator that the person is with7 drawing the confidentiality claim, in which 

8 case the Administrator shall promptly 

9 make the information available to the pub10 lic; or 

11 ‘‘(ii) the Administrator otherwise be12 comes aware that the need for protection 

13 from disclosure can no longer be substan14 tiated, in which case the Administrator 

15 shall take the actions described in sub16 section (g)(2). 

17 ‘‘(B) EXTENSIONS.— 

18 ‘‘(i) IN GENERAL.—Not later than the 

19 date that is 60 days before the expiration 

20 of the period described in subparagraph 

21 (A), the Administrator shall provide to the 

22 person that asserted the claim a notice of 

23 the impending expiration of the period. 

24 ‘‘(ii) STATEMENT.— 


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1 ‘‘(I) IN GENERAL.—Not later 

2 than the date that is 30 days before 

3 the expiration of the period described 

4 in subparagraph (A), a person re5 asserting the relevant claim shall sub6 mit to the Administrator a statement 

7 substantiating, in accordance with 

8 subsection (d)(2), the need to extend 

9 the period. 

10 ‘‘(II) ACTION BY ADMINIS11 TRATOR.—Not later than the date 

12 that is 30 days after the date of re13 ceipt of a statement under subclause 

14 (I), the Administrator shall— 

15 ‘‘(aa) review the request; 

16 ‘‘(bb) make a determination 

17 regarding whether the informa18 tion for which the request is 

19 made continues to meet the rel20 evant criteria established under 

21 this section; and 

22 ‘‘(cc)(AA) grant an exten23 sion of not more than 10 years; 

24 or 

25 ‘‘(BB) deny the claim. 


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1 ‘‘(C) NO LIMIT ON NUMBER OF EXTEN2 SIONS.—There shall be no limit on the number 

3 of extensions granted under subparagraph (B), 

4 if the Administrator determines that the rel5 evant statement under subparagraph 

6 (B)(ii)(I)— 

7 ‘‘(i) establishes the need to extend the 

8 period; and 

9 ‘‘(ii) meets the requirements estab10 lished by the Administrator. 

11 ‘‘(2) REVIEW AND RESUBSTANTIATION.— 

12 ‘‘(A) DISCRETION OF ADMINISTRATOR.— 

13 The Administrator may review, at any time, a 

14 claim for protection against disclosure under 

15 subsection (a) for information submitted to the 

16 Administrator regarding a chemical substance 

17 and require any person that has claimed protec18 tion for that information, whether before, on, or 

19 after the date of enactment of the Frank R. 

20 Lautenberg Chemical Safety for the 21st Cen21 tury Act, to withdraw or reassert and substan22 tiate or resubstantiate the claim in accordance 

23 with this section— 


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1 ‘‘(i) after the chemical substance is 

2 identified as a high-priority substance 

3 under section 4A; 

4 ‘‘(ii) for any chemical substance for 

5 which the Administrator has made a deter6 mination under section 6(c)(1)(C); 

7 ‘‘(iii) for any inactive chemical sub8 stance identified under section 8(b)(5); or 

9 ‘‘(iv) in limited circumstances, if the 

10 Administrator determines that disclosure 

11 of certain information currently protected 

12 from disclosure would assist the Adminis13 trator in conducting safety assessments 

14 and safety determinations under sub15 sections (b) and (c) of section 6 or promul16 gating rules pursuant to section 6(d), sub17 ject to the condition that the information 

18 shall not be disclosed unless the claimant 

19 withdraws the claim or the Administrator 

20 determines that the information does not 

21 meet the requirements of subsection (d). 

22 ‘‘(B) REVIEW REQUIRED.—The Adminis23 trator shall review a claim for protection from 

24 disclosure under subsection (a) for information 

25 submitted to the Administrator regarding a 


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1 chemical substance and require any person that 

2 has claimed protection for that information, 

3 whether before, on, or after the date of enact4 ment of the Frank R. Lautenberg Chemical 

5 Safety for the 21st Century Act, to withdraw or 

6 reassert and substantiate or resubstantiate the 

7 claim in accordance with this section— 

8 ‘‘(i) as necessary to comply with a re9 quest for information received by the Ad10 ministrator under section 552 of title 5, 

11 United States Code; 

12 ‘‘(ii) if information available to the 

13 Administrator provides a basis that the re14 quirements of section 552(b)(4) of title 5, 

15 United States Code, are no longer met; or 

16 ‘‘(iii) for any substance for which the 

17 Administrator has made a determination 

18 under section 6(c)(1)(B). 

19 ‘‘(C) ACTION BY RECIPIENT.—If the Ad20 ministrator makes a request under subpara21 graph (A) or (B), the recipient of the request 

22 shall— 

23 ‘‘(i) reassert and substantiate or re24 substantiate the claim; or 

25 ‘‘(ii) withdraw the claim. 


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1 ‘‘(D) PERIOD OF PROTECTION.—Protec2 tion from disclosure of information subject to a 

3 claim that is reviewed and approved by the Ad4 ministrator under this paragraph shall be ex5 tended for a period of 10 years from the date 

6 of approval, subject to any subsequent request 

7 by the Administrator under this paragraph. 

8 ‘‘(3) UNIQUE IDENTIFIER.—The Administrator 

9 shall— 

10 ‘‘(A)(i) develop a system to assign a 

11 unique identifier to each specific chemical iden12 tity for which the Administrator approves a re13 quest for protection from disclosure, other than 

14 a specific chemical identity or structurally de15 scriptive generic term; and 

16 ‘‘(ii) apply that identifier consistently to all 

17 information relevant to the applicable chemical 

18 substance; 

19 ‘‘(B) annually publish and update a list of 

20 chemical substances, referred to by unique iden21 tifier, for which claims to protect the specific 

22 chemical identity from disclosure have been ap23 proved, including the expiration date for each 

24 such claim; 


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1 ‘‘(C) ensure that any nonconfidential infor2 mation received by the Administrator with re3 spect to such a chemical substance during the 

4 period of protection from disclosure— 

5 ‘‘(i) is made public; and 

6 ‘‘(ii) identifies the chemical substance 

7 using the unique identifier; and 

8 ‘‘(D) for each claim for protection of spe9 cific chemical identity that has been denied by 

10 the Administrator on expiration of the period 

11 for appeal under subsection (g)(3), that has ex12 pired, or that has been withdrawn by the sub13 mitter, provide public access to the specific 

14 chemical identity clearly linked to all noncon15 fidential information received by the Adminis16 trator with respect to the chemical substance. 

17 ‘‘(g) DUTIES OF ADMINISTRATOR.— 

18 ‘‘(1) DETERMINATION.— 

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

20 subsection (b), the Administrator shall, subject 

21 to subparagraph (C), not later than 90 days 

22 after the receipt of a claim under subsection 

23 (d), and not later than 30 days after the receipt 

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1 section (f), review and approve, modify, or deny 

2 the claim or request. 

3 ‘‘(B) DENIAL OR MODIFICATION.— 

4 ‘‘(i) IN GENERAL.—Except as pro5 vided in subsections (c) and (f), the Ad6 ministrator shall deny a claim to protect a 

7 chemical identity from disclosure only if 

8 the person that has submitted the claim 

9 fails to meet the requirements of sub10 sections (a) and (d). 

11 ‘‘(ii) REASONS FOR DENIAL OR MODI12 FICATION.—The Administrator shall pro13 vide to a person that has submitted a 

14 claim described in clause (i) a written 

15 statement of the reasons for the denial or 

16 modification of the claim. 

17 ‘‘(C) SUBSETS.—The Administrator 

18 shall— 

19 ‘‘(i) except for claims described in 

20 subsection (b)(7), review all claims under 

21 this section for the protection against dis22 closure of the specific identity of a chem23 ical substance; and 


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1 ‘‘(ii) review a representative subset, 

2 comprising at least 25 percent, of all other 

3 claims for protection against disclosure. 

4 ‘‘(D) EFFECT OF FAILURE TO ACT.—The 

5 failure of the Administrator to make a decision 

6 regarding a claim for protection against disclo7 sure or extension under this section shall not be 

8 the basis for denial or elimination of a claim for 

9 protection against disclosure. 

10 ‘‘(2) NOTIFICATION.— 

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

12 subparagraph (B) and subsections (c), (e), and 

13 (f), if the Administrator denies or modifies a 

14 claim under paragraph (1), the Administrator 

15 shall notify, in writing and by certified mail, the 

16 person that submitted the claim of the intent of 

17 the Administrator to release the information. 

18 ‘‘(B) RELEASE OF INFORMATION.— 

19 ‘‘(i) IN GENERAL.—Except as pro20 vided in clause (ii), the Administrator shall 

21 not release information under this sub22 section until the date that is 30 days after 

23 the date on which the person that sub24 mitted the request receives notification 

25 under subparagraph (A). 


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1 ‘‘(ii) EXCEPTIONS.— 

2 ‘‘(I) IN GENERAL.—For informa3 tion under paragraph (3) or (8) of 

4 subsection (e), the Administrator shall 

5 not release that information until the 

6 date that is 15 days after the date on 

7 which the person that submitted the 

8 claim receives a notification, unless 

9 the Administrator determines that re10 lease of the information is necessary 

11 to protect against an imminent and 

12 substantial harm to health or the en13 vironment, in which case no prior no14 tification shall be necessary. 

15 ‘‘(II) NO NOTIFICATION.—For 

16 information under paragraph (1), (2), 

17 (6), (7), or (9) of subsection (e), no 

18 prior notification shall be necessary. 

19 ‘‘(3) APPEALS.— 

20 ‘‘(A) IN GENERAL.—If a person receives a 

21 notification under paragraph (2) and believes 

22 disclosure of the information is prohibited 

23 under subsection (a), before the date on which 

24 the information is to be released, the person 


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1 may bring an action to restrain disclosure of 

2 the information in— 

3 ‘‘(i) the United States district court of 

4 the district in which the complainant re5 sides or has the principal place of business; 

6 or 

7 ‘‘(ii) the United States District Court 

8 for the District of Columbia. 

9 ‘‘(B) NO DISCLOSURE.—The Adminis10 trator shall not disclose any information that is 

11 the subject of an appeal under this section be12 fore the date on which the applicable court 

13 rules on an action under subparagraph (A). 

14 ‘‘(4) ADMINISTRATION.—In carrying out this 

15 subsection, the Administrator shall use the proce16 dures described in part 2 of title 40, Code of Fed17 eral Regulations (or successor regulations). 

18 ‘‘(h) CRIMINAL PENALTY FOR WRONGFUL DISCLO19 SURE.— 

20 ‘‘(1) OFFICERS AND EMPLOYEES OF UNITED

21 STATES.— 

22 ‘‘(A) IN GENERAL.—Subject to paragraph 

23 (2), a current or former officer or employee of 

24 the United States described in subparagraph 

25 (B) shall be guilty of a misdemeanor and fined 


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1 under title 18, United States Code, or impris2 oned for not more than 1 year, or both. 

3 ‘‘(B) DESCRIPTION.—A current or former 

4 officer or employee of the United States re5 ferred to in subparagraph (A) is a current or 

6 former officer or employee of the United States 

7 who— 

8 ‘‘(i) by virtue of that employment or 

9 official position has obtained possession of, 

10 or has access to, material the disclosure of 

11 which is prohibited by subsection (a); and 

12 ‘‘(ii) knowing that disclosure of that 

13 material is prohibited by subsection (a), 

14 willfully discloses the material in any man15 ner to any person not entitled to receive 

16 that material. 

17 ‘‘(2) OTHER LAWS.—Section 1905 of title 18, 

18 United States Code, shall not apply with respect to 

19 the publishing, divulging, disclosure, making known 

20 of, or making available, information reported or oth21 erwise obtained under this Act. 

22 ‘‘(3) CONTRACTORS.—For purposes of this sub23 section, any contractor of the United States that is 

24 provided information in accordance with subsection 

25 (e)(2), including any employee of that contractor, 


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1 shall be considered to be an employee of the United 

2 States. 

3 ‘‘(i) APPLICABILITY.— 

4 ‘‘(1) IN GENERAL.—Except as otherwise pro5 vided in this section, section 8, or any other applica6 ble Federal law, the Administrator shall have no au7 thority— 

8 ‘‘(A) to require the substantiation or re9 substantiation of a claim for the protection 

10 from disclosure of information submitted to the 

11 Administrator under this Act before the date of 

12 enactment of the Frank R. Lautenberg Chem13 ical Safety for the 21st Century Act; or 

14 ‘‘(B) to impose substantiation or re15 substantiation requirements under this Act that 

16 are more extensive than those required under 

17 this section. 

18 ‘‘(2) PRIOR ACTIONS.—Nothing in this Act pre19 vents the Administrator from reviewing, requiring 

20 substantiation or resubstantiation for, or approving, 

21 modifying or denying any claim for the protection 

22 from disclosure of information before the effective 

23 date of such rules applicable to those claims as the 

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1 actment of the Frank R. Lautenberg Chemical Safe2 ty for the 21st Century Act.’’. 

3 SEC. 16. PROHIBITED ACTS. 

4 Section 15 of the Toxic Substances Control Act (15 

5 U.S.C. 2614) is amended by striking paragraph (1) and 

6 inserting the following: 

7 ‘‘(1) fail or refuse to comply with— 

8 ‘‘(A) any rule promulgated, consent agree9 ment entered into, or order issued under section 

10 4; 

11 ‘‘(B) any requirement under section 5 or 6; 

12 ‘‘(C) any rule promulgated, consent agree13 ment entered into, or order issued under section 

14 5 or 6; or 

15 ‘‘(D) any requirement of, or any rule pro16 mulgated or order issued pursuant to title II;’’. 

17 SEC. 17. PENALTIES. 

18 Section 16 of the Toxic Substances Control Act (15 

19 U.S.C. 2615) is amended— 

20 (1) in subsection (a)(1)— 

21 (A) in the first sentence— 

22 (i) by inserting ‘‘this Act or a rule or 

23 order promulgated or issued pursuant to 

24 this Act, including’’ after ‘‘a provision of’’; 

25 and 


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1 (ii) by striking ‘‘$25,000’’ and insert2 ing ‘‘$37,500’’; and 

3 (B) in the second sentence, by striking‘‘ 

4 violation of section 15 or 409’’ and inserting 

5 ‘‘violation of this Act’’; and 

6 (2) in subsection (b)— 

7 (A) by striking ‘‘Any person who’’ and in8 serting the following: 

9 ‘‘(1) IN GENERAL.—Any person that’’; 

10 (B) by striking ‘‘section 15 or 409’’ and 

11 inserting ‘‘this Act’’; 

12 (C) by striking ‘‘$25,000’’ and inserting 

13 ‘‘$50,000’’; and 

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

15 ‘‘(2) IMMINENT DANGER OF DEATH OR SERIOUS

16 BODILY INJURY.— 

17 ‘‘(A) IN GENERAL.—Any person that 

18 knowingly or willfully violates any provision of 

19 this Act, and that knows at the time of the vio20 lation that the violation places an individual in 

21 imminent danger of death or serious bodily in22 jury, shall be subject on conviction to a fine of 

23 not more than $250,000, or imprisonment for 

24 not more than 15 years, or both. 


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1 ‘‘(B) ORGANIZATIONS.—An organization 

2 that commits a violation described in subpara3 graph (A) shall be subject on conviction to a 

4 fine of not more than $1,000,000 for each vio5 lation. 

6 ‘‘(3) KNOWLEDGE OF IMMINENT DANGER OR

7 INJURY.—For purposes of determining whether a 

8 defendant knew that the violation placed another in9 dividual in imminent danger of death or serious bod10 ily injury— 

11 ‘‘(A) the defendant shall be responsible 

12 only for actual awareness or actual belief pos13 sessed; and 

14 ‘‘(B) knowledge possessed by an individual 

15 may not be attributed to the defendant.’’. 

16 SEC. 18. STATE-FEDERAL RELATIONSHIP. 

17 Section 18 of the Toxic Substances Control Act (15 

18 U.S.C. 2617) is amended by striking subsections (a) and 

19 (b) and inserting the following: 

20 ‘‘(a) IN GENERAL.— 

21 ‘‘(1) ESTABLISHMENT OR ENFORCEMENT.—Ex22 cept as provided in subsections (c), (d), (e), (f), and 

23 (g), and subject to paragraph (2), no State or polit24 ical subdivision of a State may establish or continue 

25 to enforce any of the following: 


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1 ‘‘(A) TESTING AND INFORMATION COLLEC2 TION.—A statute or administrative action to re3 quire the development of information on a 

4 chemical substance or category of substances 

5 that is reasonably likely to produce the same in6 formation required under section 4, 5, or 6 in— 

7 ‘‘(i) a rule promulgated by the Admin8 istrator; 

9 ‘‘(ii) a testing consent agreement en10 tered into by the Administrator; or 

11 ‘‘(iii) an order issued by the Adminis12 trator. 

13 ‘‘(B) CHEMICAL SUBSTANCES FOUND TO

14 MEET THE SAFETY STANDARD OR RE15 STRICTED.—A statute or administrative action 

16 to prohibit or otherwise restrict the manufac17 ture, processing, or distribution in commerce or 

18 use of a chemical substance— 

19 ‘‘(i) found to meet the safety standard 

20 and consistent with the scope of the deter21 mination made under section 6; or 

22 ‘‘(ii) found not to meet the safety 

23 standard, after the effective date of the 

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1 stance, consistent with the scope of the de2 termination made by the Administrator. 

3 ‘‘(C) SIGNIFICANT NEW USE.—A statute or 

4 administrative action requiring the notification 

5 of a use of a chemical substance that the Ad6 ministrator has specified as a significant new 

7 use and for which the Administrator has re8 quired notification pursuant to a rule promul9 gated under section 5. 

10 ‘‘(2) EFFECTIVE DATE OF PREEMPTION.— 

11 Under this subsection, Federal preemption of State 

12 statutes and administrative actions applicable to spe13 cific substances shall not occur until the effective 

14 date of the applicable action described in paragraph 

15 (1) taken by the Administrator. 

16 ‘‘(b) NEW STATUTES OR ADMINISTRATIVE ACTIONS

17 CREATING PROHIBITIONS OR OTHER RESTRICTIONS.— 

18 Except as provided in subsections (c), (d), and (e), no 

19 State or political subdivision of a State may establish 

20 (after the date of enactment of the Frank R. Lautenberg 

21 Chemical Safety for the 21st Century Act) a statute or 

22 administrative action prohibiting or restricting the manu23 facture, processing, distribution in commerce or use of a 

24 chemical substance that is a high-priority substance des25 ignated under section 4A, as of the date on which the AdVerDate Sep 11 2014 05:33 Mar 17, 2015 Jkt 049200 PO 00000 Frm 00141 Fmt 6652 Sfmt 6201 E:\BILLS\S697.IS S697

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1 ministrator commences a safety assessment under section 

2 6. 

3 ‘‘(c) SCOPE OF PREEMPTION.—Federal preemption 

4 under subsections (a) and (b) of State statutes and admin5 istrative actions applicable to specific substances shall 

6 apply only to— 

7 ‘‘(1) the chemical substances or category of 

8 substances subject to a rule, order, or consent agree9 ment under section 4; 

10 ‘‘(2) the uses or conditions of use of such sub11 stances that are identified by the Administrator as 

12 subject to review in a safety assessment and in13 cluded in the scope of the safety determination made 

14 by the Administrator for the substance, or of any 

15 rule the Administrator promulgates pursuant to sec16 tion 6(d); or 

17 ‘‘(3) the uses of such substances that the Ad18 ministrator has specified as significant new uses and 

19 for which the Administrator has required notifica20 tion pursuant to a rule promulgated under section 5. 

21 ‘‘(d) EXCEPTIONS.— 

22 ‘‘(1) IN GENERAL.—Subsections (a) and (b) 

23 shall not apply to a statute or administrative action 

24 of a State or a political subdivision of a State appli25 cable to a specific chemical substance that— 


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1 ‘‘(A) is adopted under the authority of, or 

2 authorized to comply with, any other Federal 

3 law; 

4 ‘‘(B) implements a reporting, monitoring, 

5 or other information collection obligation for 

6 the chemical substance not otherwise required 

7 by the Administrator under this Act or required 

8 under any other Federal law; or 

9 ‘‘(C) is adopted pursuant to authority 

10 under a law of the State or political subdivision 

11 of the State related to water quality, air qual12 ity, or waste treatment or disposal, unless the 

13 action taken by the State or political subdivi14 sion of a State— 

15 ‘‘(i) imposes a restriction on the man16 ufacture, processing, distribution in com17 merce, or use of a chemical substance; and 

18 ‘‘(ii)(I) is already required by a deci19 sion by the Administrator under section 5 

20 or 6; 

21 ‘‘(II) is taken to address a health or 

22 environmental concern that applies to the 

23 uses or conditions of use that are included 

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1 cant new use rule promulgated pursuant to 

2 section 5, but is inconsistent with the ac3 tion of the Administrator; or 

4 ‘‘(III) would cause a violation of the 

5 applicable action by the Administrator 

6 under section 5 or 6. 

7 ‘‘(2) NO PREEMPTION OF STATE STATUTES

8 AND ADMINISTRATIVE ACTIONS.—Nothing in this 

9 Act, nor any amendment made by this Act, nor any 

10 rule, standard of performance, safety determination, 

11 or scientific assessment implemented pursuant to 

12 this Act, shall affect the right of a State or a polit13 ical subdivision of a State to adopt or enforce any 

14 rule, standard of performance, safety determination, 

15 scientific assessment, or any protection for public 

16 health or the environment that— 

17 ‘‘(A) is adopted under the authority of, or 

18 authorized to comply with, any other Federal 

19 law; 

20 ‘‘(B) implements a reporting, monitoring, 

21 or other information collection obligation for 

22 the chemical substance not otherwise required 

23 by the Administrator under this Act or required 

24 under any other Federal law; or 


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1 ‘‘(C) is adopted pursuant to authority 

2 under a law of the State or political subdivision 

3 of the State related to water quality, air qual4 ity, or waste treatment or disposal, unless the 

5 action taken by the State or political subdivi6 sion of a State— 

7 ‘‘(i) imposes a restriction on the man8 ufacture, processing, distribution in com9 merce, or use of a chemical substance; and 

10 ‘‘(ii)(I) is already required by a deci11 sion by the Administrator under section 5 

12 or 6; 

13 ‘‘(II) is taken to address a health or 

14 environmental concern that applies to the 

15 uses or conditions of use that are included 

16 in the scope of a safety determination pur17 suant to section 6 or the scope of a signifi18 cant new use rule promulgated pursuant to 

19 section 5, but is inconsistent with the ac20 tion of the Administrator; or 

21 ‘‘(III) would cause a violation of the 

22 applicable action by the Administrator 

23 under section 5 or 6. 

24 ‘‘(3) APPLICABILITY TO CERTAIN RULES OR OR25 DERS.—Notwithstanding subsection (e)— 


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1 ‘‘(A) nothing in this section shall be con2 strued as modifying the effect under this sec3 tion, as in effect on the day before the effective 

4 date of the Frank R. Lautenberg Chemical 

5 Safety for the 21st Century Act, of any rule or 

6 order promulgated or issued under this Act 

7 prior to that effective date; and 

8 ‘‘(B) with respect to a chemical substance 

9 or mixture for which any rule or order was pro10 mulgated or issued under section 6 prior to the 

11 effective date of the Frank R. Lautenberg 

12 Chemical Safety for the 21st Century Act with 

13 regards to manufacturing, processing, distribu14 tion in commerce, use, or disposal of a chemical 

15 substance, this section (as in effect on the day 

16 before the effective date of the Frank R. Lau17 tenberg Chemical Safety for the 21st Century 

18 Act) shall govern the preemptive effect of any 

19 rule or order that is promulgated or issued re20 specting such chemical substance or mixture 

21 under section 6 of this Act after that effective 

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1 priority substance under subsection (b) or (c) of 

2 section 4A or as an additional priority for safe3 ty assessment and safety determination under 

4 section 4A(d). 

5 ‘‘(e) PRESERVATION OF CERTAIN STATE LAW.— 

6 ‘‘(1) IN GENERAL.—Nothing in this Act, sub7 ject to subsection (g) of this section, shall— 

8 ‘‘(A) be construed to preempt or otherwise 

9 affect any action taken before January 1, 2015, 

10 under the authority of a State law that pro11 hibits or otherwise restricts manufacturing, 

12 processing, distribution in commerce, use, or 

13 disposal of a chemical substance; or 

14 ‘‘(B) be construed to preempt or otherwise 

15 affect any action taken pursuant to a State law 

16 that was in effect on August 31, 2003. 

17 ‘‘(2) EFFECT OF SUBSECTION.—This sub18 section does not affect, modify, or alter the relation19 ship between State and Federal law pursuant to any 

20 other Federal law. 

21 ‘‘(f) STATE WAIVERS.— 

22 ‘‘(1) IN GENERAL.—Upon application of a State 

23 or political subdivision of a State, the Administrator 

24 may— 


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1 ‘‘(A) by rule, exempt from subsection (a), 

2 under such conditions as may be prescribed in 

3 the rule, a statute or administrative action of 

4 that State or political subdivision of the State 

5 that relates to the effects of, or exposure to, a 

6 chemical substance under the conditions of use 

7 if the Administrator determines that— 

8 ‘‘(i) compelling State or local condi9 tions warrant granting the waiver to pro10 tect health or the environment; 

11 ‘‘(ii) compliance with the proposed re12 quirement of the State or political subdivi13 sion of the State would not unduly burden 

14 interstate commerce in the manufacture, 

15 processing, distribution in commerce, or 

16 use of a chemical substance; 

17 ‘‘(iii) compliance with the proposed re18 quirement of the State or political subdivi19 sion of the State would not cause a viola20 tion of any applicable Federal law, rule, or 

21 order; and 

22 ‘‘(iv) based on the judgment of the 

23 Administrator, the proposed requirement 

24 of the State or political subdivision of the 

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1 entific practices, the weight of the evi2 dence, and the best available science; or 

3 ‘‘(B) exempt from subsection (b) a statute 

4 or administrative action of a State or political 

5 subdivision of a State that relates to the effects 

6 of exposure to a chemical substance under the 

7 conditions of use if the Administrator deter8 mines that— 

9 ‘‘(i) the State has a compelling local 

10 interest that warrants granting the waiver 

11 to protect health or the environment; 

12 ‘‘(ii) compliance with the proposed re13 quirement of the State will not unduly bur14 den interstate commerce in the manufac15 ture, processing, distribution in commerce, 

16 or use of a chemical substance; 

17 ‘‘(iii) compliance with the proposed re18 quirement would not cause a violation of 

19 any applicable Federal law, rule, or order; 

20 and 

21 ‘‘(iv) the proposed requirement is 

22 grounded in reasonable scientific concern. 

23 ‘‘(2) APPROVAL OF A STATE WAIVER RE24 QUEST.—The Administrator shall grant or deny a 

25 waiver application— 


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1 ‘‘(A) not later than 180 days after the date 

2 on which an application under paragraph (1)(A) 

3 is submitted; and 

4 ‘‘(B) not later than 90 days after the date 

5 on which an application under paragraph 

6 (1)(B) is submitted. 

7 ‘‘(3) NOTICE AND COMMENT.—The application 

8 of a State or political subdivision of the State shall 

9 be subject to public notice and comment. 

10 ‘‘(4) FINAL AGENCY ACTION.—The decision of 

11 the Administrator on the application of a State or 

12 political subdivision of the State shall be— 

13 ‘‘(A) considered to be a final agency ac14 tion; and 

15 ‘‘(B) subject to judicial review. 

16 ‘‘(5) DURATION OF WAIVERS.—A waiver grant17 ed under paragraph (1)(B) shall remain in effect 

18 until the later of— 

19 ‘‘(A) such time as the safety assessment 

20 and safety determination is completed; and 

21 ‘‘(B) the date on which compliance with an 

22 applicable rule issued under section 6(d) is re23 quired. 

24 ‘‘(6) JUDICIAL REVIEW OF WAIVERS.—Not later 

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1 trator makes a determination on an application of a 

2 State or political subdivision of the State under sub3 paragraph (A) or (B) of paragraph (1), any person 

4 may file a petition for judicial review in the United 

5 States Court of Appeals for the District of Columbia 

6 Circuit, which shall have exclusive jurisdiction over 

7 the determination. 

8 ‘‘(7) JUDICIAL REVIEW OF PRIORITIZATION

9 SCREENING DECISION.—Not later than 60 days after 

10 the date on which the Administrator makes a deci11 sion on a recommendation made under section 

12 4A(b)(4) to designate a chemical substance as a low 

13 priority, the Governor of a State or a State agency 

14 with responsibility for protecting health and the en15 vironment that submitted the recommendation under 

16 section 4A(a)(4)(A), as applicable, may file a peti17 tion for judicial review in the United States Court 

18 of Appeals for the District of Columbia Circuit, 

19 which shall have exclusive jurisdiction over the deter20 mination. 

21 ‘‘(g) SAVINGS.— 

22 ‘‘(1) NO PREEMPTION OF COMMON LAW OR

23 STATUTORY CAUSES OF ACTION FOR CIVIL RELIEF

24 OR CRIMINAL CONDUCT.— 


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1 ‘‘(A) IN GENERAL.—Nothing in this Act, 

2 nor any amendment made by this Act, nor any 

3 safety standard, rule, requirement, standard of 

4 performance, safety determination, or scientific 

5 assessment implemented pursuant to this Act, 

6 shall be construed to preempt, displace, or sup7 plant any state or Federal common law rights 

8 or any state or Federal statute creating a rem9 edy for civil relief, including those for civil dam10 age, or a penalty for a criminal conduct. 

11 ‘‘(B) CLARIFICATION OF NO PREEMP12 TION.—Notwithstanding any other provision of 

13 this Act, nothing in this Act, nor any amend14 ments made by this Act, shall preempt or pre15 clude any cause of action for personal injury, 

16 wrongful death, property damage, or other in17 jury based on negligence, strict liability, prod18 ucts liability, failure to warn, or any other legal 

19 theory of liability under any State law, mari20 time law, or Federal common law or statutory 

21 theory. 

22 ‘‘(2) NO EFFECT ON PRIVATE REMEDIES.— 

23 ‘‘(A) Nothing in this Act, nor any amend24 ments made by this Act, nor any rules, regula25 tions, requirements, safety assessments, safety 


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1 determinations, scientific assessments, or orders 

2 issued pursuant to this Act shall be interpreted 

3 as, in either the plaintiff’s or defendant’s favor, 

4 dispositive in any civil action. 

5 ‘‘(B) This Act does not affect the authority 

6 of any court to make a determination in an ad7 judicatory proceeding under applicable State or 

8 Federal law with respect to the admission into 

9 evidence or any other use of this Act or rules, 

10 regulations, requirements, standards of per11 formance, safety assessments, scientific assess12 ments, or orders issued pursuant to this Act.’’. 

13 SEC. 19. JUDICIAL REVIEW. 

14 Section 19 of the Toxic Substances Control Act (15 

15 U.S.C. 2618) is amended— 

16 (1) in subsection (a)— 

17 (A) in paragraph (1)— 

18 (i) in subparagraph (A), by striking 

19 ‘‘section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), 

20 or 8, or under title II or IV’’ and inserting 

21 ‘‘section 4(a), 5(d), 6(c), 6(d), 6(g), or 8, 

22 or title II or IV’’; and 

23 (ii) in subparagraph (B), by striking 

24 ‘‘an order issued under subparagraph (A) 


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1 or (B) of section 6(b)(1)’’ and inserting 

2 ‘‘an order issued under this title’’; and 

3 (B) in paragraph (2), in the first sentence, 

4 by striking ‘‘paragraph (1)(A)’’ and inserting 

5 ‘‘paragraph (1)’’; and 

6 (C) by striking paragraph (3); and 

7 (2) in subsection (c)(1)(B)— 

8 (A) in clause (i)— 

9 (i) by striking ‘‘section 4(a), 5(b)(4), 

10 6(a), or 6(e)’’ and inserting ‘‘section 4(a), 

11 5(d), 6(d), or 6(g)’’; and 

12 (ii) by striking ‘‘evidence in the rule13 making record (as defined in subsection 

14 (a)(3)) taken as a whole;’’ and inserting 

15 ‘‘evidence (including any matter) in the 

16 rulemaking record, taken as a whole; and’’; 

17 and 

18 (B) by striking clauses (ii) and (iii) and 

19 the matter following clause (iii) and inserting 

20 the following: 

21 ‘‘(ii) the court may not review the 

22 contents and adequacy of any statement of 

23 basis and purpose required by section 

24 553(c) of title 5, United States Code, to be 


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1 incorporated in the rule, except as part of 

2 the rulemaking record, taken as a whole.’’. 

3 SEC. 20. 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 ‘‘an order 

7 under section 5(e) or 6(b)(2)’’ and inserting ‘‘an 

8 order under section 4 or 5(d)’’; and 

9 (2) in subsection (b)— 

10 (A) in paragraph (1), by striking ‘‘an 

11 order under section 5(e), 6(b)(1)(A), or 

12 6(b)(1)(B)’’ and inserting ‘‘an order under sec13 tion 4 or 5(d)’’; and 

14 (B) in paragraph (4), by striking subpara15 graph (B) and inserting the following: 

16 ‘‘(B) DE NOVO PROCEEDING.— 

17 ‘‘(i) IN GENERAL.—In an action 

18 under subparagraph (A) to initiate a pro19 ceeding to promulgate a rule pursuant to 

20 section 4, 5, 6, or 8 or an order issued 

21 under section 4 or 5, the petitioner shall be 

22 provided an opportunity to have the peti23 tion considered by the court in a de novo 

24 proceeding. 

25 ‘‘(ii) DEMONSTRATION.— 


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1 ‘‘(I) IN GENERAL.—The court in 

2 a de novo proceeding under this sub3 paragraph shall order the Adminis4 trator to initiate the action requested 

5 by the petitioner if the petitioner dem6 onstrates to the satisfaction of the 

7 court by a preponderance of the evi8 dence that— 

9 ‘‘(aa) in the case of a peti10 tion to initiate a proceeding for 

11 the issuance of a rule or order 

12 under section 4, the information 

13 available to the Administrator is 

14 insufficient for the Administrator 

15 to perform an action described in 

16 section 4, 4A, 5, or 6(d); 

17 ‘‘(bb) in the case of a peti18 tion to issue an order under sec19 tion 5(d), there is a reasonable 

20 basis to conclude that the chem21 ical substance is not likely to 

22 meet the safety standard; 

23 ‘‘(cc) in the case of a peti24 tion to initiate a proceeding for 

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1 tion 6(d), there is a reasonable 

2 basis to conclude that the chem3 ical substance will not meet the 

4 safety standard; or 

5 ‘‘(dd) in the case of a peti6 tion to initiate a proceeding for 

7 the issuance of a rule under sec8 tion 8, there is a reasonable basis 

9 to conclude that the rule is nec10 essary to protect health or the 

11 environment or ensure that the 

12 chemical substance meets the 

13 safety standard. 

14 ‘‘(II) DEFERMENT.—The court 

15 in a de novo proceeding under this 

16 subparagraph may permit the Admin17 istrator to defer initiating the action 

18 requested by the petitioner until such 

19 time as the court prescribes, if the 

20 court finds that— 

21 ‘‘(aa) the extent of the risk 

22 to health or the environment al23 leged by the petitioner is less 

24 than the extent of risks to health 

25 or the environment with respect 


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1 to which the Administrator is 

2 taking action under this Act; and 

3 ‘‘(bb) there are insufficient 

4 resources available to the Admin5 istrator to take the action re6 quested by the petitioner.’’. 

7 SEC. 21. EMPLOYMENT EFFECTS. 

8 Section 24(b)(2)(B)(ii) of the Toxic Substances Con9 trol Act (15 U.S.C. 2623(b)(2)(B)(ii)) is amended by 

10 striking ‘‘section 6(c)(3),’’ and inserting ‘‘the applicable 

11 requirements of this Act;’’. 

12 SEC. 22. STUDIES. 

13 Section 25 of the Toxic Substances Control Act (15 

14 U.S.C. 2624) is repealed. 

15 SEC. 23. ADMINISTRATION. 

16 Section 26 of the Toxic Substances Control Act (15 

17 U.S.C. 2625) is amended— 

18 (1) by striking subsection (b) and inserting the 

19 following: 

20 ‘‘(b) FEES.— 

21 ‘‘(1) IN GENERAL.—The Administrator shall es22 tablish, not later than 1 year after the date of enact23 ment of the Frank R. Lautenberg Chemical Safety 

24 for the 21st Century Act, by rule— 


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1 ‘‘(A) the payment of 1 or more reasonable 

2 fees as a condition of submitting a notice or re3 questing an exemption under section 5; and 

4 ‘‘(B) the payment of 1 or more reasonable 

5 fees by a manufacturer or processor that— 

6 ‘‘(i) is required to submit a notice 

7 pursuant to the rule promulgated under 

8 section 8(b)(4)(A)(i) identifying a chemical 

9 substance as active; 

10 ‘‘(ii) is required to submit a notice 

11 pursuant to section 8(b)(5)(B)(i) changing 

12 the status of a chemical substance from in13 active to active; 

14 ‘‘(iii) is required to report information 

15 pursuant to the rules promulgated under 

16 section 8(a)(4); and 

17 ‘‘(iv) manufactures or processes a 

18 chemical substance subject to a safety as19 sessment and safety determination pursu20 ant to section 6. 

21 ‘‘(2) UTILIZATION AND COLLECTION OF

22 FEES.—The Administrator shall— 

23 ‘‘(A) utilize the fees collected under para24 graph (1) only to defray costs associated with 

25 the actions of the Administrator— 


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1 ‘‘(i) to collect, process, review, provide 

2 access to, and protect from disclosure 

3 (where appropriate) information on chem4 ical substances under this Act; 

5 ‘‘(ii) to review notices and make de6 terminations for chemical substances under 

7 paragraphs (1) and (3) of section 5(d) and 

8 impose any necessary restrictions under 

9 section 5(d)(4); 

10 ‘‘(iii) to make prioritization decisions 

11 under section 4A; 

12 ‘‘(iv) to conduct and complete safety 

13 assessments and determinations under sec14 tion 6; and 

15 ‘‘(v) to conduct any necessary rule16 making pursuant to section 6(d); 

17 ‘‘(B) insofar as possible, collect the fees 

18 described in paragraph (1) in advance of con19 ducting any fee-supported activity; 

20 ‘‘(C) deposit the fees in the Fund estab21 lished by paragraph (4)(A); and 

22 ‘‘(D) not collect excess fees or retain a sig23 nificant amount of unused fees. 


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1 ‘‘(3) AMOUNT AND ADJUSTMENT OF FEES; RE2 FUNDS.—In setting fees under this section, the Ad3 ministrator shall— 

4 ‘‘(A) take into account the cost to the Ad5 ministrator of conducting the activities de6 scribed in paragraph (2); 

7 ‘‘(B) prescribe lower fees for small busi8 ness concerns, after consultation with the Ad9 ministrator of the Small Business Administra10 tion; 

11 ‘‘(C) set the fees established under para12 graph (1) at levels such that the fees will, in 

13 aggregate, provide a sustainable source of funds 

14 to defray approximately 25 percent of the costs 

15 of conducting the activities identified in para16 graph (2)(A), not to exceed $18,000,000, not 

17 including fees under subparagraph (E) of this 

18 paragraph; 

19 ‘‘(D) reflect an appropriate balance in the 

20 assessment of fees between manufacturers and 

21 processors, and allow the payment of fees by 

22 consortia of manufacturers or processors; 

23 ‘‘(E) for substances designated as addi24 tional priorities pursuant to section 4A(c), es25 tablish the fee at a level sufficient to defray the 


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1 full costs to the Administrator of conducting 

2 the safety assessment and safety determination 

3 under section 6; 

4 ‘‘(F) prior to the establishment or amend5 ment of any fees under paragraph (1), consult 

6 and meet with parties potentially subject to the 

7 fees or their representatives, subject to the con8 dition that no obligation under the Federal Ad9 visory Committee Act (5 U.S.C. App.) or sub10 chapter III of chapter 5 of title 5, United 

11 States Code, is applicable with respect to such 

12 meetings; 

13 ‘‘(G) beginning with the fiscal year that is 

14 3 years after the date of enactment of the 

15 Frank R. Lautenberg Chemical Safety for the 

16 21st Century Act, and every 3 years thereafter, 

17 after consultation with parties potentially sub18 ject to the fees and their representatives, in19 crease or decrease the fees established under 

20 paragraph (1) as necessary— 

21 ‘‘(i) to ensure that funds deposited in 

22 the Fund are sufficient to conduct the ac23 tivities identified in paragraph (2)(A) and 

24 the full costs of safety assessments and 


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1 safety determinations pursuant to subpara2 graph (E); and 

3 ‘‘(ii) to account for inflation; 

4 ‘‘(H) adjust fees established under para5 graph (1) as necessary to vary on account of 

6 differing circumstances, including reduced fees 

7 or waivers in appropriate circumstances, to re8 duce the burden on manufacturing or proc9 essing, remove barriers to innovation, or where 

10 the costs to the Administrator of collecting the 

11 fees exceed the fee revenue anticipated to be 

12 collected; and 

13 ‘‘(I) if a notice submitted under section 5 

14 is refused or subsequently withdrawn, refund 

15 the fee or a portion of the fee if no substantial 

16 work was performed on the notice. 

17 ‘‘(4) TSCA IMPLEMENTATION FUND.— 

18 ‘‘(A) ESTABLISHMENT.—There is estab19 lished in the Treasury of the United States a 

20 fund, to be known as the ‘TSCA Implementa21 tion Fund’ (referred to in this subsection as the 

22 ‘Fund’), consisting of— 

23 ‘‘(i) such amounts as are deposited in 

24 the Fund under paragraph (2)(C); and 


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1 ‘‘(ii) any interest earned on the in2 vestment of amounts in the Fund; and 

3 ‘‘(iii) any proceeds from the sale or 

4 redemption of investments held in the 

5 Fund. 

6 ‘‘(B) CREDITING AND AVAILABILITY OF

7 FEES.— 

8 ‘‘(i) IN GENERAL.—Fees authorized 

9 under this section shall be collected and 

10 available for obligation only to the extent 

11 and in the amount provided in advance in 

12 appropriations Acts, and shall be available 

13 without fiscal year limitation. 

14 ‘‘(ii) REQUIREMENTS.—Fees collected 

15 under this section shall not— 

16 ‘‘(I) be made available or obli17 gated for any purpose other than to 

18 defray the costs of conducting the ac19 tivities identified in paragraph (2)(A); 

20 ‘‘(II) otherwise be available for 

21 any purpose other than implementa22 tion of this Act; and 

23 ‘‘(III) so long as amounts in the 

24 Fund remain available, be subject to 


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1 restrictions on expenditures applicable 

2 to the Federal government as a whole. 

3 ‘‘(C) UNUSED FUNDS.—Amounts in the 

4 Fund not currently needed to carry out this 

5 subsection shall be— 

6 ‘‘(i) maintained readily available or on 

7 deposit; 

8 ‘‘(ii) invested in obligations of the 

9 United States or guaranteed by the United 

10 States; or 

11 ‘‘(iii) invested in obligations, partici12 pations, or other instruments that are law13 ful investments for fiduciary, trust, or pub14 lic funds. 

15 ‘‘(D) MINIMUM AMOUNT OF APPROPRIA16 TIONS.—Fees may not be assessed for a fiscal 

17 year under this section unless the amount of 

18 appropriations for salaries, contracts, and ex19 penses for the functions (as in existence in fis20 cal year 2015) of the Office of Pollution Pre21 vention and Toxics of the Environmental Pro22 tection Agency for the fiscal year (excluding the 

23 amount of any fees appropriated for the fiscal 

24 year) are equal to or greater than the amount 

25 of appropriations for covered functions for fiscal 


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1 year 2015 (excluding the amount of any fees 

2 appropriated for the fiscal year). 

3 ‘‘(5) AUDITING.— 

4 ‘‘(A) FINANCIAL STATEMENTS OF AGEN5 CIES.—For the purpose of section 3515(c) of 

6 title 31, United States Code, the Fund shall be 

7 considered a component of an executive agency. 

8 ‘‘(B) COMPONENTS.—The annual audit re9 quired under sections 3515(b) and 3521 of that 

10 title of the financial statements of activities 

11 under this subsection shall include an analysis 

12 of— 

13 ‘‘(i) the fees collected under para14 graph (1) and disbursed; 

15 ‘‘(ii) compliance with the deadlines es16 tablished in section 6 of this Act; 

17 ‘‘(iii) the amounts budgeted, appro18 priated, collected from fees, and disbursed 

19 to meet the requirements of sections 4, 4A, 

20 5, 6, 8, and 14, including the allocation of 

21 full time equivalent employees to each such 

22 section or activity; and 

23 ‘‘(iv) the reasonableness of the alloca24 tion of the overhead associated with the 


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1 conduct of the activities described in para2 graph (2)(A). 

3 ‘‘(C) INSPECTOR GENERAL.—The Inspec4 tor General of the Environmental Protection 

5 Agency shall— 

6 ‘‘(i) conduct the annual audit required 

7 under this subsection; and 

8 ‘‘(ii) report the findings and rec9 ommendations of the audit to the Adminis10 trator and to the appropriate committees 

11 of Congress. 

12 ‘‘(6) TERMINATION.—The authority provided by 

13 this section shall terminate at the conclusion of the 

14 fiscal year that is 10 years after the date of enact15 ment of the Frank R. Lautenberg Chemical Safety 

16 for the 21st Century Act, unless otherwise reauthor17 ized or modified by Congress.’’; 

18 (2) in subsection (e), by striking ‘‘Health, Edu19 cation, and Welfare’’ each place it appears and in20 serting ‘‘Health and Human Services’’; and 

21 (3) adding at the end the following: 

22 ‘‘(h) PRIOR ACTIONS.—Nothing in this Act elimi23 nates, modifies, or withdraws any rule promulgated, order 

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1 fore the date of enactment of the Frank R. Lautenberg 

2 Chemical Safety for the 21st Century Act.’’. 

3 SEC. 24. DEVELOPMENT AND EVALUATION OF TEST METH4 ODS AND SUSTAINABLE CHEMISTRY. 

5 Section 27 of the Toxic Substances Control Act (15 

6 U.S.C. 2626) is amended— 

7 (1) in subsection (a), in the first sentence by 

8 striking ‘‘Health, Education, and Welfare’’ and in9 serting ‘‘Health and Human Services’’; and 

10 (2) by adding at the end the following: 

11 ‘‘(c) SUSTAINABLE CHEMISTRY PROGRAM.—The 

12 President shall establish an interagency Sustainable 

13 Chemistry Program to promote and coordinate Federal 

14 sustainable chemistry research, development, demonstra15 tion, technology transfer, commercialization, education, 

16 and training activities. 

17 ‘‘(d) PROGRAM ACTIVITIES.—The activities of the 

18 Program shall be designed to— 

19 ‘‘(1) provide sustained support for sustainable 

20 chemistry research, development, demonstration, 

21 technology transfer, commercialization, education, 

22 and training through— 

23 ‘‘(A) coordination of sustainable chemistry 

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1 nology transfer conducted at Federal labora2 tories and agencies; and 

3 ‘‘(B) to the extent practicable, encourage4 ment of consideration of sustainable chemistry 

5 in, as appropriate— 

6 ‘‘(i) the conduct of Federal and State 

7 science and engineering research and de8 velopment; and 

9 ‘‘(ii) the solicitation and evaluation of 

10 applicable proposals for science and engi11 neering research and development; 

12 ‘‘(2) examine methods by which the Federal 

13 Government can create incentives for consideration 

14 and use of sustainable chemistry processes and prod15 ucts, including innovative financing mechanisms; 

16 ‘‘(3) expand the education and training of un17 dergraduate and graduate students and professional 

18 scientists and engineers, including through partner19 ships with industry, in sustainable chemistry science 

20 and engineering; 

21 ‘‘(4) collect and disseminate information on sus22 tainable chemistry research, development, and tech23 nology transfer including information on— 

24 ‘‘(A) incentives and impediments to devel25 opment, manufacturing, and commercialization; 


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1 ‘‘(B) accomplishments; 

2 ‘‘(C) best practices; and 

3 ‘‘(D) costs and benefits; and 

4 ‘‘(5) support (including through technical as5 sistance, participation, financial support, or other 

6 forms of support) economic, legal, and other appro7 priate social science research to identify barriers to 

8 commercialization and methods to advance commer9 cialization of sustainable chemistry. 

10 ‘‘(e) INTERAGENCY WORKING GROUP.— 

11 ‘‘(1) ESTABLISHMENT.—Not later than 180 

12 days after the date of enactment of the Frank R. 

13 Lautenberg Chemical Safety for the 21st Century 

14 Act, the President, in consultation with the Office of 

15 Science and Technology Policy, shall establish an 

16 Interagency Working Group that shall include rep17 resentatives from the National Science Foundation, 

18 the National Institute of Standards and Technology, 

19 the Department of Energy, the Environmental Pro20 tection Agency, the Department of Agriculture, the 

21 Department of Defense, the National Institutes of 

22 Health, and any other agency that the President 

23 may designate to oversee the planning, management, 

24 and coordination of the Program. 


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1 ‘‘(2) GOVERNANCE.—The Director of the Na2 tional Science Foundation and the Assistant Admin3 istrator for Research and Development of the Envi4 ronmental Protection Agency, or their designees, 

5 shall serve as co-chairs of the Interagency Working 

6 Group. 

7 ‘‘(3) RESPONSIBILITIES.—In overseeing the 

8 planning, management, and coordination of the Pro9 gram, the Interagency Working Group shall— 

10 ‘‘(A) establish goals and priorities for the 

11 Program, in consultation with the Advisory 

12 Council; 

13 ‘‘(B) provide for interagency coordination, 

14 including budget coordination, of activities 

15 under the Program; 

16 ‘‘(C) meet not later than 90 days from its 

17 establishment and periodically thereafter; and 

18 ‘‘(D) establish and consult with an Advi19 sory Council on a regular basis. 

20 ‘‘(4) MEMBERSHIP.—The Advisory Council 

21 members shall not be employees of the Federal Gov22 ernment and shall include a diverse representation of 

23 knowledgeable individuals from the private sector 

24 (including small- and medium-sized enterprises from 

25 across the value chain), academia, State and tribal 


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1 governments, and nongovernmental organizations 

2 and others who are in a position to provide exper3 tise. 

4 ‘‘(f) AGENCY BUDGET REQUESTS.— 

5 ‘‘(1) IN GENERAL.—Each Federal agency and 

6 department participating in the Program shall, as 

7 part of its annual request for appropriations to the 

8 Office of Management and Budget, submit a report 

9 to the Office of Management and Budget that— 

10 ‘‘(A) identifies the activities of the agency 

11 or department that contribute directly to the 

12 Program; and 

13 ‘‘(B) states the portion of the agency or 

14 department’s request for appropriations that is 

15 allocated to those activities. 

16 ‘‘(2) ANNUAL BUDGET REQUEST TO CON17 GRESS.—The President shall include in the annual 

18 budget request to Congress a statement of the por19 tion of the annual budget request for each agency or 

20 department that will be allocated to activities under21 taken pursuant to the Program. 

22 ‘‘(g) REPORT TO CONGRESS.— 

23 ‘‘(1) IN GENERAL.—Not later than 2 years 

24 after the date of enactment of the Frank R. Lauten25 berg Chemical Safety for the 21st Century Act, the 


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1 Interagency Working Group shall submit a report to 

2 the Committee on Science, Space, and Technology 

3 and Committee on Energy and Commerce of the 

4 House of Representatives and the Committee on En5 vironment and Public Works and the Committee on 

6 Commerce, Science, and Transportation of the Sen7 ate that shall include— 

8 ‘‘(A) a summary of federally funded sus9 tainable chemistry research, development, dem10 onstration, technology transfer, commercializa11 tion, education, and training activities; 

12 ‘‘(B) a summary of the financial resources 

13 allocated to sustainable chemistry initiatives; 

14 ‘‘(C) an analysis of the progress made to15 ward achieving the goals and priorities of this 

16 Act, and recommendations for future program 

17 activities; 

18 ‘‘(D) an assessment of the benefits of ex19 panding existing, federally supported regional 

20 innovation and manufacturing hubs to include 

21 sustainable chemistry and the value of directing 

22 the creation of 1 or more dedicated sustainable 

23 chemistry centers of excellence or hubs; and 

24 ‘‘(E) an evaluation of steps taken and fu25 ture strategies to avoid duplication of efforts, 


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1 streamline interagency coordination, facilitate 

2 information sharing, and spread best practices 

3 between participating agencies in the Program. 

4 ‘‘(2) SUBMISSION TO GAO.—The Interagency 

5 Working Group shall also submit the report de6 scribed in paragraph (1) to the Government Ac7 countability Office for consideration in future Con8 gressional inquiries.’’. 

9 SEC. 25. STATE PROGRAMS. 

10 Section 28 of the Toxic Substances Control Act (15 

11 U.S.C. 2627) is amended— 

12 (1) in subsection (b)(1)— 

13 (A) in subparagraphs (A) through (D), by 

14 striking the comma at the end of each subpara15 graph and inserting a semicolon; and 

16 (B) in subparagraph (E), by striking ‘‘, 

17 and’’ and inserting ‘‘; and’’; and 

18 (2) by striking subsections (c) and (d). 

19 SEC. 26. AUTHORIZATION OF APPROPRIATIONS. 

20 Section 29 of the Toxic Substances Control Act (15 

21 U.S.C. 2628) is repealed. 

22 SEC. 27. ANNUAL REPORT. 

23 Section 30 of the Toxic Substances Control Act (15 

24 U.S.C. 2629) is amended by striking paragraph (2) and 

25 inserting the following: 


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1 ‘‘(2)(A) the number of notices received during 

2 each year under section 5; and 

3 ‘‘(B) the number of the notices described in 

4 subparagraph (A) for chemical substances subject to 

5 a rule, testing consent agreement, or order under 

6 section 4;’’. 

7 SEC. 28. EFFECTIVE DATE. 

8 Section 31 of the Toxic Substances Control Act (15 

9 U.S.C. 2601 note; Public Law 94–469) is amended— 

10 (1) by striking ‘‘Except as provided in section 

11 4(f), this’’ and inserting the following: 

12 ‘‘(a) IN GENERAL.—This’’; and 

13 (2) by adding at the end the following: 

14 ‘‘(b) RETROACTIVE APPLICABILITY.—Nothing in this 

15 Act shall be interpreted to apply retroactively to any State, 

16 Federal, or maritime legal action commenced prior to the 

17 effective date of the Frank R. Lautenberg Chemical Safety 

18 for the 21st Century Act.’’. 

Æ 


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