II 

Calendar No. 121 

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, Mr. PORTMAN, Mr. WARNER, Mr. PETERS, Mr. 

ROUNDS, Mr. BROWN, Mr. THUNE, Mr. BARRASSO, Mr. BOOKER, Mr. 

CORNYN, Mr. COTTON, Mr. ISAKSON, Mr. KAINE, Mrs. MCCASKILL, Mr. 

MERKLEY, Ms. MURKOWSKI, Mr. MURPHY, Mr. RUBIO, Mr. SCOTT, Mrs. 

SHAHEEN, Mr. WHITEHOUSE, Mr. CASEY, Mr. PERDUE, Ms. KLOBUCHAR, Mr. COATS, and Mr. TOOMEY) introduced the following bill; 

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

Public Works 

JUNE 17, 2015 

Reported by Mr. INHOFE, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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, 


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1 SECTION 1. SHORT TITLE. 

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

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

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

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

6 U.S.C. 2601(c)) is amended— 

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

8 the following: 

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

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

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

12 period at the end; and 

13 (3) by adding at the following: 

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

15 that reform of this Act in accordance with the 

16 amendments made by the Frank R. Lautenberg 

17 Chemical Safety for the 21st Century Act— 

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

19 that— 

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

21 pregnant women, the elderly, workers, con22 sumers, the general public, and the envi23 ronment from the risks of harmful expo24 sures to chemical substances and mixtures; 

25 and 


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1 ‘‘(ii) ensures that appropriate infor2 mation on chemical substances and mix3 tures is available to public health officials 

4 and first responders in the event of an 

5 emergency; and 

6 ‘‘(B) shall not displace or supplant com7 mon law rights of action or remedies for civil 

8 relief.’’. 

9 SEC. 3. DEFINITIONS. 

10 Section 3 of the Toxic Substances Control Act (15 

11 U.S.C. 2602) is amended— 

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

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

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

15 (17), (18), and (19), respectively; 

16 (2) by inserting after paragraph (3) the fol17 lowing: 

18 ‘‘(4) CONDITIONS OF USE.—The term ‘condi19 tions of use’ means the intended, known, or reason20 ably foreseeable circumstances the Administrator de21 termines a chemical substance is manufactured, 

22 processed, distributed in commerce, used, or dis23 posed of.’’; 

24 (3) by inserting after paragraph (10) (as so re25 designated) the following: 


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1 ‘‘(11) POTENTIALLY EXPOSED OR SUSCEPTIBLE

2 POPULATION.—The term ‘potentially exposed or sus3 ceptible population’ means 1 or more groups— 

4 ‘‘(A) of individuals within the general pop5 ulation who may be— 

6 ‘‘(i) differentially exposed to chemical 

7 substances under the conditions of use; or 

8 ‘‘(ii) susceptible to greater adverse 

9 health consequences from chemical expo10 sures than the general population; and 

11 ‘‘(B) that when identified by the Adminis12 trator may include such groups as infants, chil13 dren, pregnant women, workers, and the elder14 ly.’’; and 

15 (4) by inserting after paragraph (13) (as so re16 designated) the following: 

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

18 assessment’ means an assessment of the risk posed 

19 by a chemical substance under the conditions of use, 

20 integrating hazard, use, and exposure information 

21 regarding the chemical substance. 

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

23 ‘safety determination’ means a determination by the 

24 Administrator as to whether a chemical substance 


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1 meets the safety standard under the conditions of 

2 use. 

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

4 standard’ means a standard that ensures, without 

5 taking into consideration cost or other nonrisk fac6 tors, that no unreasonable risk of harm to health or 

7 the environment will result from exposure to a chem8 ical substance under the conditions of use, including 

9 no unreasonable risk of harm to— 

10 ‘‘(A) the general population; or 

11 ‘‘(B) any potentially exposed or susceptible 

12 population that the Administrator has identified 

13 as relevant to the safety assessment and safety 

14 determination for a chemical substance.’’. 

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

16 The Toxic Substances Control Act is amended by in17 serting after section 3 (15 U.S.C. 2602) the following: 

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

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

20 term ‘guidance’ includes any significant written guidance 

21 of general applicability prepared by the Administrator. 

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

23 date of enactment of the Frank R. Lautenberg Chemical 

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

25 develop, after providing public notice and an opportunity 


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

2 Administrator determines to be necessary to carry out sec3 tions 4, 4A, 5, and 6, including the policies, procedures, 

4 and guidance required by this section. 

5 ‘‘(c) USE OF SCIENCE.— 

6 ‘‘(1) IN GENERAL.—The Administrator shall es7 tablish policies, procedures, and guidance on the use 

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

9 5, and 6. 

10 ‘‘(2) GOAL.—A goal of the policies and proce11 dures described in paragraph (1) shall be to make 

12 the basis of decisions clear to the public. 

13 ‘‘(3) REQUIREMENTS.—The policies, proce14 dures, and guidance issued under this section shall 

15 describe the manner in which the Administrator 

16 shall ensure that— 

17 ‘‘(A) decisions made by the Adminis18 trator— 

19 ‘‘(i) are based on information, proce20 dures, measures, methods, and models em21 ployed in a manner consistent with the 

22 best available science; 

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

24 which— 


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1 ‘‘(I) assumptions and methods 

2 are clearly and completely described 

3 and documented; 

4 ‘‘(II) variability and uncertainty 

5 are evaluated and characterized; and 

6 ‘‘(III) the information has been 

7 subject to independent verification 

8 and peer review; and 

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

10 scientific evidence, by which the Adminis11 trator considers all information in a sys12 tematic and integrative framework to con13 sider the relevance of different informa14 tion; 

15 ‘‘(B) to the extent practicable and if ap16 propriate, the use of peer review, standardized 

17 test design and methods, consistent data eval18 uation procedures, and good laboratory prac19 tices will be encouraged; 

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

21 and entity that funded the generation or assess22 ment of information, and the degree of control 

23 those individuals and entities had over the gen24 eration, assessment, and dissemination of infor25 mation (including control over the design of the 


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1 work and the publication of information) is 

2 made available; and 

3 ‘‘(D) if appropriate, the recommendations 

4 in reports of the National Academy of Sciences 

5 that provide advice regarding assessing the haz6 ards, exposures, and risks of chemical sub7 stances are considered. 

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

9 GUIDANCE.—The policies, procedures, and guidance de10 scribed in subsection (b) shall incorporate, as appropriate, 

11 existing relevant hazard, exposure, and risk assessment 

12 guidelines and methodologies, data evaluation and quality 

13 criteria, testing methodologies, and other relevant guide14 lines and policies of the Environmental Protection Agency. 

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

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

17 once every 5 years thereafter, the Administrator shall— 

18 ‘‘(1) review the adequacy of any policies, proce19 dures, and guidance developed under this section, in20 cluding animal, nonanimal, and epidemiological test 

21 methods and procedures for assessing and deter22 mining risk under this Act; and 

23 ‘‘(2) after providing public notice and an oppor24 tunity for comment, revise the policies, procedures, 


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1 and guidance if necessary to reflect new scientific 

2 developments or understandings. 

3 ‘‘(f) SOURCES OF INFORMATION.—In making any de4 cision with respect to a chemical substance under section 

5 4, 4A, 5, or 6, the Administrator shall take into consider6 ation information relating to the hazards and exposures 

7 of a chemical substance under the conditions of use that 

8 is reasonably available to the Administrator, including in9 formation that is— 

10 ‘‘(1) submitted to the Administrator pursuant 

11 to any rule, consent agreement, order, or other re12 quirement of this Act, or on a voluntary basis, in13 cluding pursuant to any request made under this 

14 Act, by— 

15 ‘‘(A) manufacturers or processors of a sub16 stance; 

17 ‘‘(B) the public; 

18 ‘‘(C) other Federal departments or agen19 cies; or 

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

21 agency with responsibility for protecting health 

22 or the environment; 

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

24 jurisdiction pursuant to a governmental requirement 


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1 relating to the protection of health or the environ2 ment; or 

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

4 Administrator of information sources that are pub5 licly available or otherwise accessible by the Admin6 istrator. 

7 ‘‘(g) TESTING OF CHEMICAL SUBSTANCES AND MIX8 TURES.— 

9 ‘‘(1) IN GENERAL.—The Administrator shall es10 tablish policies and procedures for the testing of 

11 chemical substances or mixtures under section 4. 

12 ‘‘(2) GOAL.—A goal of the policies and proce13 dures established under paragraph (1) shall be to 

14 make the basis of decisions clear to the public. 

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

16 established under paragraph (1) shall— 

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

18 level or exposure potential of a chemical sub19 stance would factor into decisions to require 

20 new testing, subject to the condition that the 

21 Administrator shall not interpret the lack of ex22 posure information as a lack of exposure or ex23 posure potential; 

24 ‘‘(B) describe the manner in which the Ad25 ministrator will determine that additional inforVerDate Sep 11 2014 21:05 Jun 17, 2015 Jkt 049200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6401 E:\BILLS\S697.RS S697

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1 mation is necessary to carry out this Act, in2 cluding information relating to potentially ex3 posed or susceptible populations; 

4 ‘‘(C) require the Administrator to consult 

5 with the Director of the National Institute for 

6 Occupational Safety and Health prior to pre7 scribing epidemiologic studies of employees; and 

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

9 testing using vertebrate animals, require the 

10 Administrator to take into consideration, as ap11 propriate and to the extent practicable, reason12 ably available— 

13 ‘‘(i) toxicity information; 

14 ‘‘(ii) computational toxicology and 

15 bioinformatics; 

16 ‘‘(iii) high-throughput screening meth17 ods and the prediction models of those 

18 methods; and 

19 ‘‘(iv) scientifically reliable and rel20 evant alternatives to tests on animals that 

21 would provide equivalent information. 

22 ‘‘(4) TIERED TESTING.— 

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

24 subparagraph (D), the Administrator shall em25 ploy a tiered screening and testing process, 


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1 under which the results of screening-level tests 

2 or assessments of available information inform 

3 the decision as to whether 1 or more additional 

4 tests are necessary. 

5 ‘‘(B) SCREENING-LEVEL TESTS.— 

6 ‘‘(i) IN GENERAL.—The screening7 level tests required for a chemical sub8 stance or mixture may include tests for 

9 hazard (which may include in silico, in 

10 vitro, and in vivo tests), environmental and 

11 biological fate and transport, and measure12 ments or modeling of exposure or exposure 

13 potential, as appropriate. 

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

15 be used— 

16 ‘‘(I) to screen chemical sub17 stances or mixtures for potential ad18 verse effects; and 

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

20 Administrator regarding whether 

21 more complex or targeted additional 

22 testing is necessary. 

23 ‘‘(C) ADDITIONAL TESTING.—If the Ad24 ministrator determines under subparagraph (B) 

25 that additional testing is necessary to provide 


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1 more definitive information for safety assess2 ments or safety determinations, the Adminis3 trator may require more advanced tests for po4 tential health or environmental effects or expo5 sure potential. 

6 ‘‘(D) ADVANCED TESTING WITHOUT

7 SCREENING.—The Administrator may require 

8 more advanced testing without conducting 

9 screening-level testing when other information 

10 available to the Administrator justifies the ad11 vanced testing, pursuant to guidance developed 

12 by the Administrator under this section. 

13 ‘‘(h) SAFETY ASSESSMENTS AND SAFETY DETER14 MINATIONS.— 

15 ‘‘(1) SCHEDULE.— 

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

17 shall inform the public regarding the schedule 

18 for the completion of each safety assessment 

19 and safety determination as soon as practicable 

20 after designation as a high-priority substance 

21 pursuant to section 4A. 

22 ‘‘(B) DIFFERING TIMES.—The Adminis23 trator may allot different times for different 

24 chemical substances in the schedules under this 

25 paragraph, subject to the condition that all 


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1 schedules shall comply with the deadlines estab2 lished under section 6. 

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

4 each calendar year, the Administrator shall 

5 identify the substances subject to safety assess6 ments and safety determinations to be com7 pleted that year. 

8 ‘‘(2) POLICIES AND PROCEDURES FOR SAFETY

9 ASSESSMENTS AND SAFETY DETERMINATIONS.— 

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

11 shall establish, by rule, policies and procedures 

12 regarding the manner in which the Adminis13 trator shall carry out section 6. 

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

15 procedures under this paragraph shall be to 

16 make the basis of decisions of the Adminis17 trator clear to the public. 

18 ‘‘(C) MINIMUM REQUIREMENTS.—At a 

19 minimum, the policies and procedures under 

20 this paragraph shall— 

21 ‘‘(i) describe— 

22 ‘‘(I) the manner in which the Ad23 ministrator will identify informational 

24 needs and seek that information from 

25 the public; 


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1 ‘‘(II) the information (including 

2 draft safety assessments) that may be 

3 submitted by interested individuals or 

4 entities, including States; and 

5 ‘‘(III) the criteria by which that 

6 information will be evaluated; 

7 ‘‘(ii) require the Administrator— 

8 ‘‘(I)(aa) to define the scope of 

9 the safety assessment and safety de10 termination to be conducted under 

11 section 6, including the hazards, expo12 sures, conditions of use, and poten13 tially exposed and susceptible popu14 lations that the Administrator expects 

15 to consider in a safety assessment; 

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

17 scope of the safety assessment and 

18 safety determination; and 

19 ‘‘(cc) to accept comments regard20 ing the scope of the safety assessment 

21 and safety determination; and 

22 ‘‘(II)(aa) to identify the items de23 scribed in subclause (I) that the Ad24 ministrator has considered in the final 

25 safety assessment; and 


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

2 consideration of those items; 

3 ‘‘(iii) describe the manner in which 

4 aggregate exposures, or significant subsets 

5 of exposures, to a chemical substance 

6 under the conditions of use will be consid7 ered, and explain the basis for that consid8 eration in the final safety assessment; 

9 ‘‘(iv) require that each safety assess10 ment and safety determination shall in11 clude— 

12 ‘‘(I) a description of the weight 

13 of the scientific evidence of risk; and 

14 ‘‘(II) a summary of the informa15 tion regarding the impact on health 

16 and the environment of the chemical 

17 substance that was used to make the 

18 assessment or determination, includ19 ing, as available, mechanistic, animal 

20 toxicity, and epidemiology studies; 

21 ‘‘(v) establish a timely and trans22 parent process for evaluating whether new 

23 information submitted or obtained after 

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1 ation of the safety assessment or safety de2 termination; and 

3 ‘‘(vi) when relevant information is 

4 provided or otherwise made available to the 

5 Administrator, shall consider the extent of 

6 Federal regulation under other Federal 

7 laws. 

8 ‘‘(D) GUIDANCE.— 

9 ‘‘(i) IN GENERAL.—Not later than 1 

10 year after the date of enactment of the 

11 Frank R. Lautenberg Chemical Safety for 

12 the 21st Century Act, the Administrator 

13 shall develop guidance to assist interested 

14 persons in developing draft safety assess15 ments and other information for submis16 sion to the Administrator, which may be 

17 considered at the discretion of the Admin18 istrator. 

19 ‘‘(ii) REQUIREMENT.—The guidance 

20 shall, at a minimum, address the quality of 

21 the information submitted and the process 

22 to be followed in developing a draft assess23 ment for consideration by the Adminis24 trator. 


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

2 to prohibit or otherwise restrict an article on the 

3 basis of a chemical substance contained in that arti4 cle, the Administrator shall have evidence of signifi5 cant exposure to the chemical substance from such 

6 article. 

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

8 to section 14, the Administrator shall— 

9 ‘‘(1) make publicly available a nontechnical 

10 summary, and the final version, of each safety as11 sessment and safety determination; 

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

13 for comment on each proposed safety assessment 

14 and safety determination; and 

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

16 and safety determination— 

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

18 Administrator in carrying out the safety assess19 ment or safety determination; and 

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

21 guidance that were followed in carrying out the 

22 safety assessment or safety determination. 

23 ‘‘(j) CONSULTATION WITH SCIENCE ADVISORY COM24 MITTEE ON CHEMICALS.— 


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

2 after the date of enactment of this section, the Ad3 ministrator shall establish an advisory committee, to 

4 be known as the ‘Science Advisory Committee on 

5 Chemicals’ (referred to in this subsection as the 

6 ‘Committee’). 

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

8 shall be to provide independent advice and expert 

9 consultation, on the request of the Administrator, 

10 with respect to the scientific and technical aspects of 

11 issues relating to the implementation of this title. 

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

13 composed of representatives of such science, govern14 ment, labor, public health, public interest, animal 

15 protection, industry, and other groups as the Admin16 istrator determines to be advisable, including, at a 

17 minimum, representatives that have specific sci18 entific expertise in the relationship of chemical expo19 sures to women, children, and other potentially ex20 posed or susceptible populations. 

21 ‘‘(4) SCHEDULE.—The Administrator shall con22 vene the Committee in accordance with such sched23 ule as the Administrator determines to be appro24 priate, but not less frequently than once every 2 

25 years. 


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1 ‘‘(5) RELATIONSHIP TO OTHER LAW.—All pro2 ceedings and meetings of the Committee shall be 

3 subject to the Federal Advisory Committee Act (5 

4 U.S.C. App.).’’. 

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

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

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

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

9 (g); 

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

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

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

13 (A) by striking ‘‘rule’’ each place it ap14 pears and inserting ‘‘rule, testing consent 

15 agreement, or order’’; 

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

17 each place it appears and inserting ‘‘under this 

18 subsection’’; and 

19 (C) in paragraph (1)(B), in the last sen20 tence, by striking ‘‘rulemaking’’; 

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

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

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

24 (B) by striking the last sentence; and 


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1 (5) by inserting before subsection (f) (as so re2 designated) the following: 

3 ‘‘(a) DEVELOPMENT OF NEW INFORMATION ON

4 CHEMICAL SUBSTANCES AND MIXTURES.— 

5 ‘‘(1) IN GENERAL.—The Administrator may re6 quire the development of new information relating to 

7 a chemical substance or mixture in accordance with 

8 this section if the Administrator determines that the 

9 information is necessary— 

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

11 or to perform a safety assessment or safety de12 termination under section 6; 

13 ‘‘(B) to implement a requirement imposed 

14 in a consent agreement or order issued under 

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

16 under section 6(d)(3); 

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

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

19 authority under another Federal law, to meet 

20 the regulatory testing needs of that authority. 

21 ‘‘(2) LIMITED TESTING FOR PRIORITIZATION

22 PURPOSES.— 

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

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1 quire the development of new information for 

2 the purposes of section 4A. 

3 ‘‘(B) PROHIBITION.—Testing required 

4 under subparagraph (A) shall not be required 

5 for the purpose of establishing or implementing 

6 a minimum information requirement. 

7 ‘‘(C) LIMITATION.—The Administrator 

8 may require the development of new informa9 tion pursuant to subparagraph (A) only if the 

10 Administrator determines that additional infor11 mation is necessary to establish the priority of 

12 a chemical substance. 

13 ‘‘(3) FORM.—Subject to section 3A(h), the Ad14 ministrator may require the development of informa15 tion described in paragraph (1) or (2) by— 

16 ‘‘(A) promulgating a rule; 

17 ‘‘(B) entering into a testing consent agree18 ment; or 

19 ‘‘(C) issuing an order. 

20 ‘‘(4) CONTENTS.— 

21 ‘‘(A) IN GENERAL.—A rule, testing con22 sent agreement, or order issued under this sub23 section shall include— 


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1 ‘‘(i) identification of the chemical sub2 stance or mixture for which testing is re3 quired; 

4 ‘‘(ii) identification of the persons re5 quired to conduct the testing; 

6 ‘‘(iii) test protocols and methodologies 

7 for the development of test data and infor8 mation for the chemical substance or mix9 ture, including specific reference to reliable 

10 nonanimal test procedures; and 

11 ‘‘(iv) specification of the period within 

12 which individuals and entities required to 

13 conduct the testing shall submit to the Ad14 ministrator the information developed in 

15 accordance with the procedures described 

16 in clause (iii). 

17 ‘‘(B) CONSIDERATIONS.—In determining 

18 the procedures and period to be required under 

19 subparagraph (A), the Administrator shall take 

20 into consideration— 

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

22 test protocols and methodologies that may 

23 be required; and 


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1 ‘‘(ii) the reasonably foreseeable avail2 ability of facilities and personnel required 

3 to perform the testing. 

4 ‘‘(b) STATEMENT OF NEED.— 

5 ‘‘(1) IN GENERAL.—In promulgating a rule, en6 tering into a testing consent agreement, or issuing 

7 an order for the development of additional informa8 tion (including information on exposure or exposure 

9 potential) pursuant to this section, the Adminis10 trator shall— 

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

12 by the rule, agreement, or order; 

13 ‘‘(B) explain why information reasonably 

14 available to the Administrator at that time is 

15 inadequate to meet that need, including a ref16 erence, as appropriate, to the information iden17 tified in paragraph (2)(B); and 

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

19 requires the use of vertebrate animals. 

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

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

22 issues an order under this section, the Adminis23 trator shall issue a statement providing a jus24 tification for why issuance of an order is warVerDate Sep 11 2014 21:05 Jun 17, 2015 Jkt 049200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6401 E:\BILLS\S697.RS S697

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1 ranted instead of promulgating a rule or enter2 ing into a testing consent agreement. 

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

4 in subparagraph (A) shall contain a description 

5 of— 

6 ‘‘(i) information that is readily acces7 sible to the Administrator, including infor8 mation submitted under any other provi9 sion of law; 

10 ‘‘(ii) the extent to which the Adminis11 trator has obtained or attempted to obtain 

12 the information through voluntary submis13 sions; and 

14 ‘‘(iii) any information relied on in 

15 safety assessments for other chemical sub16 stances relevant to the chemical substances 

17 that would be the subject of the order. 

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

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

20 minimize, to the extent practicable, the use of 

21 vertebrate animals in testing of chemical substances 

22 or mixtures, by— 

23 ‘‘(A) encouraging and facilitating— 

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

25 testing and assessment strategies; 


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

2 in existence on the date on which the test 

3 is conducted; 

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

5 eliminate or reduce the use of animals 

6 while providing information of high sci7 entific quality; 

8 ‘‘(iv) the grouping of 2 or more chem9 ical substances into scientifically appro10 priate categories in cases in which testing 

11 of a chemical substance would provide reli12 able and useful information on other chem13 ical substances in the category; 

14 ‘‘(v) the formation of industry con15 sortia to jointly conduct testing to avoid 

16 unnecessary duplication of tests; and 

17 ‘‘(vi) the submission of information 

18 from— 

19 ‘‘(I) animal-based studies; and 

20 ‘‘(II) emerging methods and 

21 models; and 

22 ‘‘(B) funding research and validation stud23 ies to reduce, refine, and replace the use of ani24 mal tests in accordance with this subsection. 


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1 ‘‘(2) IMPLEMENTATION OF ALTERNATIVE TEST2 ING METHODS.—To promote the development and 

3 timely incorporation of new testing methods that are 

4 not based on vertebrate animals, the Administrator 

5 shall— 

6 ‘‘(A) after providing an opportunity for 

7 public comment, develop a strategic plan to pro8 mote the development and implementation of al9 ternative test methods and testing strategies to 

10 generate information under this title that can 

11 reduce, refine, or replace the use of vertebrate 

12 animals, including toxicity pathway-based risk 

13 assessment, in vitro studies, systems biology, 

14 computational toxicology, bioinformatics, and 

15 high-throughput screening; 

16 ‘‘(B) as practicable, ensure that the stra17 tegic plan developed under subparagraph (A) is 

18 reflected in the development of requirements for 

19 testing under this section; 

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

21 after the date of enactment of the Frank R. 

22 Lautenberg Chemical Safety for the 21st Cen23 tury Act and every 5 years thereafter, submit to 

24 Congress a report that describes the progress 

25 made in implementing this subsection and goals 


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1 for future alternative test methods implementa2 tion; and 

3 ‘‘(D) fund and carry out research, develop4 ment, performance assessment, and 

5 translational studies to accelerate the develop6 ment of test methods and testing strategies that 

7 reduce, refine, or replace the use of vertebrate 

8 animals in any testing under this title. 

9 ‘‘(3) CRITERIA FOR ADAPTING OR WAIVING ANI10 MAL TESTING REQUIREMENTS.—On request from a 

11 manufacturer or processor that is required to con12 duct testing of a chemical substance or mixture on 

13 vertebrate animals under this section, the Adminis14 trator may adapt or waive the requirement, if the 

15 Administrator determines that— 

16 ‘‘(A) there is sufficient evidence from sev17 eral independent sources of information to sup18 port a conclusion that a chemical substance or 

19 mixture has, or does not have, a particular 

20 property if the information from each individual 

21 source alone is insufficient to support the con22 clusion; 

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

24 chemical properties of the chemical substance 


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1 or mixture or other toxicokinetic consider2 ations— 

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

4 or 

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

6 technically not practicable to conduct; or 

7 ‘‘(C) a chemical substance or mixture can8 not be tested in vertebrate animals at con9 centrations that do not result in significant 

10 pain or distress, because of physical or chemical 

11 properties of the chemical substance or mixture, 

12 such as a potential to cause severe corrosion or 

13 severe irritation to the tissues of the animal. 

14 ‘‘(d) TESTING REQUIREMENTS.— 

15 ‘‘(1) IN GENERAL.—The Administrator may re16 quire the development of information by— 

17 ‘‘(A) manufacturers and processors of the 

18 chemical substance or mixture; and 

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

20 process the chemical substance or mixture— 

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

22 rule, testing consent agreement, or order; 

23 but 

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

25 the period ending on the date that is 180 


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1 days after the end of the period described 

2 in this section. 

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

4 permit 2 or more persons identified in subparagraph 

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

6 persons or a qualified third party— 

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

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

9 of the persons making the designation. 

10 ‘‘(3) EXEMPTIONS.— 

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

12 subject to a rule, testing consent agreement, or 

13 order under this section may submit to the Ad14 ministrator an application for an exemption on 

15 the basis that the information is being devel16 oped by a person designated under paragraph 

17 (2). 

18 ‘‘(B) FAIR AND EQUITABLE REIMBURSE19 MENT TO DESIGNEE.— 

20 ‘‘(i) IN GENERAL.—If the Adminis21 trator accepts an application submitted 

22 under subparagraph (A), the Adminis23 trator shall direct the applicant to provide 

24 to the person designated under paragraph 

25 (2) fair and equitable reimbursement, as 


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1 agreed to between the applicant and the 

2 designee. 

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

4 and a person designated under paragraph 

5 (2) cannot reach agreement on the amount 

6 of fair and equitable reimbursement, the 

7 amount shall be determined by arbitration. 

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

9 exemption under this paragraph, the Adminis10 trator determines that a person covered by the 

11 exemption has failed to comply with the rule, 

12 testing consent agreement, or order, the Admin13 istrator shall— 

14 ‘‘(i) by order, terminate the exemp15 tion; and 

16 ‘‘(ii) notify in writing each person 

17 that received an exemption of the require18 ments with respect to which the exemption 

19 was granted. 

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

22 consent agreements and orders and all information sub23 mitted under this section.’’. 

24 (b) CONFORMING AMENDMENT.—Section 

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1 sponse, Compensation, and Liability Act of 1980 (42 

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

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

4 SEC. 6. PRIORITIZATION SCREENING. 

5 The Toxic Substances Control Act is amended by in6 serting after section 4 (15 U.S.C. 2603) the following: 

7 ‘‘SEC. 4A. PRIORITIZATION SCREENING. 

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

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

10 the date of enactment of this section, the Adminis11 trator shall establish, by rule, a risk-based screening 

12 process and explicit criteria for identifying existing 

13 chemical substances that are— 

14 ‘‘(A) a high priority for a safety assess15 ment and safety determination under section 6 

16 (referred to in this Act as ‘high-priority sub17 stances’); and 

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

19 and safety determination (referred to in this 

20 Act as ‘low-priority substances’). 

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

22 SUBSTANCES.— 

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

24 promulgation of the rule under paragraph (1) 


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1 and not later than 180 days after the date of 

2 enactment of this section, the Administrator— 

3 ‘‘(i) shall take into consideration and 

4 publish an initial list of high-priority sub5 stances and low-priority substances; and 

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

7 initiate or continue safety assessments and 

8 safety determinations for those high-pri9 ority substances. 

10 ‘‘(B) REQUIREMENTS.— 

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

12 chemical substances shall contain at least 

13 10 high-priority substances, at least 5 of 

14 which are drawn from the list of chemical 

15 substances identified by the Administrator 

16 in the October, 2014 TSCA Work Plan 

17 and subsequent updates, and at least 10 

18 low-priority substances. 

19 ‘‘(ii) SUBSEQUENTLY IDENTIFIED

20 SUBSTANCES.—Insofar as possible, at least 

21 50 percent of all substances subsequently 

22 identified by the Administrator as high-pri23 ority substances shall be drawn from the 

24 list of chemical substances identified by the 

25 Administrator in the October, 2014 TSCA 


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1 Work Plan and subsequent updates, until 

2 all Work Plan chemicals have been des3 ignated under this subsection. 

4 ‘‘(C) ADDITIONAL CHEMICAL REVIEWS.— 

5 The Administrator shall— 

6 ‘‘(i) 3 years after the date of enact7 ment of the Frank R. Lautenberg Chem8 ical Safety for the 21st Century Act, add 

9 additional high-priority substances suffi10 cient to ensure that at least a total of 20 

11 high-priority substances have undergone or 

12 are undergoing the process established in 

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

14 substances sufficient to ensure that at 

15 least a total of 20 low-priority substances 

16 have been designated; and 

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

18 later than 5 years after the date of enact19 ment of the Frank R. Lautenberg Chem20 ical Safety for the 21st Century Act, add 

21 additional high-priority substances suffi22 cient to ensure that at least a total of 25 

23 high-priority substances have undergone or 

24 are undergoing the process established in 

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


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1 substances sufficient to ensure that at 

2 least a total of 25 low-priority substances 

3 have been designated. 

4 ‘‘(3) IMPLEMENTATION.— 

5 ‘‘(A) CONSIDERATION OF ACTIVE AND IN6 ACTIVE SUBSTANCES.— 

7 ‘‘(i) ACTIVE SUBSTANCES.—In car8 rying out paragraph (1), the Administrator 

9 shall take into consideration active sub10 stances, as determined under section 8, 

11 which may include chemical substances on 

12 the interim list of active substances estab13 lished under that section. 

14 ‘‘(ii) INACTIVE SUBSTANCES.—In car15 rying out paragraph (1), the Administrator 

16 may take into consideration inactive sub17 stances, as determined under section 8, 

18 that the Administrator determines— 

19 ‘‘(I)(aa) have not been subject to 

20 a regulatory or other enforceable ac21 tion by the Administrator to ban or 

22 phase out the substances; and 

23 ‘‘(bb) have the potential for high 

24 hazard and widespread exposure; or 


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1 ‘‘(II)(aa) have been subject to a 

2 regulatory or other enforceable action 

3 by the Administrator to ban or phase 

4 out the substances; and 

5 ‘‘(bb) with respect to which there 

6 exists the potential for residual high 

7 hazards or widespread exposures not 

8 otherwise addressed by the regulatory 

9 or other action. 

10 ‘‘(iii) REPOPULATION.— 

11 ‘‘(I) IN GENERAL.—On the com12 pletion of a safety determination 

13 under section 6 for a chemical sub14 stance, the Administrator shall re15 move the chemical substance from the 

16 list of high-priority substances estab17 lished under this subsection. 

18 ‘‘(II) ADDITIONS.—The Adminis19 trator shall add at least 1 chemical 

20 substance to the list of high-priority 

21 substances for each chemical sub22 stance removed from the list of high23 priority substances established under 

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1 ment and safety determination is com2 pleted for all high-priority substances. 

3 ‘‘(III) LOW-PRIORITY SUB4 STANCES.—If a low-priority substance 

5 is subsequently designated as a high6 priority substance, the Administrator 

7 shall remove that substance from the 

8 list of low-priority substances. 

9 ‘‘(B) TIMELY COMPLETION OF

10 PRIORITIZATION SCREENING PROCESS.— 

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

12 shall— 

13 ‘‘(I) not later than 180 days 

14 after the effective date of the final 

15 rule under paragraph (1), begin the 

16 prioritization screening process; and 

17 ‘‘(II) make every effort to com18 plete the designation of all active sub19 stances as high-priority substances or 

20 low-priority substances in a timely 

21 manner. 

22 ‘‘(ii) DECISIONS ON SUBSTANCES SUB23 JECT TO TESTING FOR PRIORITIZATION

24 PURPOSES.—Not later than 90 days after 

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1 ing a chemical substance complying with a 

2 rule, testing consent agreement, or order 

3 issued under section 4(a)(2), the Adminis4 trator shall designate the chemical sub5 stance as a high-priority substance or low6 priority substance. 

7 ‘‘(iii) CONSIDERATION.— 

8 ‘‘(I) IN GENERAL.—The Admin9 istrator shall screen substances and 

10 designate high-priority substances 

11 taking into consideration the ability of 

12 the Administrator to schedule and 

13 complete safety assessments and safe14 ty determinations under section 6 in a 

15 timely manner. 

16 ‘‘(II) ANNUAL GOAL.—The Ad17 ministrator shall publish an annual 

18 goal for the number of chemical sub19 stances to be subject to the 

20 prioritization screening process. 

21 ‘‘(C) SCREENING OF CATEGORIES OF SUB22 STANCES.—The Administrator may screen cat23 egories of chemical substances to ensure an effi24 cient prioritization screening process to allow 

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1 priority substances and low-priority substances 

2 and safety assessments and safety determina3 tions for high-priority substances. 

4 ‘‘(D) PUBLICATION OF LIST OF CHEMICAL

5 SUBSTANCES.—Not less frequently than once 

6 each year, the Administrator shall publish a list 

7 of chemical substances that— 

8 ‘‘(i) are being considered in the 

9 prioritization screening process and the 

10 status of the chemical substances in the 

11 prioritization process, including those 

12 chemical substances for which 

13 prioritization decisions have been deferred; 

14 and 

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

16 substances or low-priority substances, in17 cluding the bases for such designations. 

18 ‘‘(4) CRITERIA.—The criteria described in para19 graph (1) shall account for— 

20 ‘‘(A) the recommendation of the Governor 

21 of a State or a State agency with responsibility 

22 for protecting health or the environment from 

23 chemical substances appropriate for 

24 prioritization screening; 


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

2 the chemical substance (or category of sub3 stances), including specific scientific classifica4 tions and designations by authoritative govern5 mental entities; 

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

7 changes in the conditions of use of the chemical 

8 substance; 

9 ‘‘(D) evidence and indicators of exposure 

10 potential to humans or the environment from 

11 the chemical substance, including potentially ex12 posed or susceptible populations; 

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

14 manufactured or processed; 

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

16 substance as reported under a rule promulgated 

17 pursuant to section 8(a) has significantly in18 creased or decreased during the period begin19 ning on the date of a previous report or the 

20 date on which a notice has been submitted 

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

22 ‘‘(G) the availability of information regard23 ing potential hazards and exposures required 

24 for conducting a safety assessment or safety de25 termination, with limited availability of relevant 


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1 information to be a sufficient basis for desig2 nating a chemical substance as a high-priority 

3 substance, subject to the condition that limited 

4 availability shall not require designation as a 

5 high-priority substance; and 

6 ‘‘(H) the extent of Federal or State regula7 tion of the chemical substance or the extent of 

8 the impact of State regulation of the chemical 

9 substance on the United States, with existing 

10 Federal or State regulation of any uses evalu11 ated in the prioritization screening process as a 

12 factor in designating a chemical substance to be 

13 a low-priority substance. 

14 ‘‘(b) PRIORITIZATION SCREENING PROCESS AND DE15 CISIONS.— 

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

17 process developed under subsection (a) shall include 

18 a requirement that the Administrator shall— 

19 ‘‘(A) identify the chemical substances 

20 being considered for prioritization; 

21 ‘‘(B) request interested persons to supply 

22 information regarding the chemical substances 

23 being considered; 

24 ‘‘(C) apply the criteria identified in sub25 section (a)(4); and 


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

2 the information available to the Administrator 

3 at the time of the decision, identify a chemical 

4 substance as a high-priority substance or a low5 priority substance. 

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

7 prioritization screening decision regarding a chem8 ical substance shall integrate any hazard and expo9 sure information relating to the chemical substance 

10 that is available to the Administrator. 

11 ‘‘(3) IDENTIFICATION OF HIGH-PRIORITY SUB12 STANCES.—The Administrator— 

13 ‘‘(A) shall identify as a high-priority sub14 stance a chemical substance that, relative to 

15 other chemical substances, the Administrator 

16 determines has the potential for high hazard 

17 and widespread exposure; 

18 ‘‘(B) may identify as a high-priority sub19 stance a chemical substance that, relative to 

20 other chemical substances, the Administrator 

21 determines has the potential for high hazard or 

22 widespread exposure; and 

23 ‘‘(C) may identify as a high-priority sub24 stance an inactive substance, as determined 

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


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1 that the Administrator determines warrants a 

2 safety assessment and safety determination 

3 under section 6. 

4 ‘‘(4) IDENTIFICATION OF LOW-PRIORITY SUB5 STANCES.—The Administrator shall identify as a 

6 low-priority substance a chemical substance that the 

7 Administrator concludes has information sufficient 

8 to establish that the chemical substance is likely to 

9 meet the applicable safety standard. 

10 ‘‘(5) DEFERRING A DECISION.—If the Adminis11 trator determines that additional information is re12 quired to establish the priority of a chemical sub13 stance under this section, the Administrator may 

14 defer the prioritization screening decision for a rea15 sonable period— 

16 ‘‘(A) to allow for the submission of addi17 tional information by an interested person and 

18 for the Administrator to evaluate the additional 

19 information; or 

20 ‘‘(B) to require the development of infor21 mation pursuant to a rule, testing consent 

22 agreement, or order issued under section 

23 4(a)(2). 

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1 ment or submission of information under this sec2 tion, the Administrator shall establish a deadline for 

3 submission of the information. 

4 ‘‘(7) NOTICE AND COMMENT.—The Adminis5 trator shall— 

6 ‘‘(A) publish the proposed decisions made 

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

8 basis for the decisions; and 

9 ‘‘(B) provide an opportunity for public 

10 comment. 

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

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

13 the discretion of the Administrator, the Admin14 istrator may revise the designation of a chem15 ical substance as a high-priority substance or a 

16 low-priority substance based on information 

17 available to the Administrator after the date of 

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

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

20 availability of relevant information was a basis 

21 in the designation of a chemical substance as a 

22 high-priority substance, the Administrator shall 

23 reevaluate the prioritization screening of the 

24 chemical substance on receiving the relevant in25 formation. 


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1 ‘‘(9) OTHER INFORMATION RELEVANT TO

2 PRIORITIZATION.— 

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

4 enactment of the Frank R. Lautenberg Chem5 ical Safety for the 21st Century Act, a State 

6 proposes an administrative action or enacts a 

7 statute or takes an administrative action to pro8 hibit or otherwise restrict the manufacturing, 

9 processing, distribution in commerce, or use of 

10 a chemical substance that the Administrator 

11 has not as designated a high-priority substance, 

12 the Governor or State agency with responsi13 bility for implementing the statute or adminis14 trative action shall notify the Administrator. 

15 ‘‘(B) REQUESTS FOR INFORMATION.—Fol16 lowing receipt of a notification provided under 

17 subparagraph (A), the Administrator may re18 quest any available information from the Gov19 ernor or the State agency with respect to— 

20 ‘‘(i) scientific evidence related to the 

21 hazards, exposures and risks of the chem22 ical substance under the conditions of use 

23 which the statute or administrative action 

24 is intended to address; 


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1 ‘‘(ii) any State or local conditions 

2 which warranted the statute or administra3 tive action; 

4 ‘‘(iii) the statutory or administrative 

5 authority on which the action is based; and 

6 ‘‘(iv) any other available information 

7 relevant to the prohibition or other restric8 tion, including information on any alter9 natives considered and their hazards, expo10 sures, and risks. 

11 ‘‘(C) PRIORITIZATION SCREENING.—The 

12 Administrator shall conduct a prioritization 

13 screening under this subsection for all sub14 stances that— 

15 ‘‘(i) are the subject of notifications re16 ceived under subparagraph (A); and 

17 ‘‘(ii) the Administrator determines— 

18 ‘‘(I) are likely to have significant 

19 health or environmental impacts; 

20 ‘‘(II) are likely to have signifi21 cant impact on interstate commerce; 

22 or 

23 ‘‘(III) have been subject to a pro24 hibition or other restriction under a 


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1 statute or administrative action in 2 

2 or more States. 

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

4 to section 14 and any applicable State law re5 garding the protection of confidential informa6 tion provided to the State or to the Adminis7 trator, the Administrator shall make informa8 tion received from a Governor or State agency 

9 under subparagraph (A) publicly available. 

10 ‘‘(E) EFFECT OF PARAGRAPH.—Nothing 

11 in this paragraph shall preempt a State statute 

12 or administrative action, require approval of a 

13 State statute or administrative action, or apply 

14 section 15 to a State. 

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

16 every 5 years after the date on which the process 

17 under this subsection is established, the Adminis18 trator shall— 

19 ‘‘(A) review the process on the basis of ex20 perience and taking into consideration resources 

21 available to efficiently and effectively screen and 

22 prioritize chemical substances; and 

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

24 screening process. 


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1 ‘‘(11) EFFECT.—Subject to section 18, a des2 ignation by the Administrator under this section 

3 with respect to a chemical substance shall not af4 fect— 

5 ‘‘(A) the manufacture, processing, distribu6 tion in commerce, use, or disposal of the chem7 ical substance; or 

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

9 ‘‘(c) ADDITIONAL PRIORITIES FOR SAFETY ASSESS10 MENTS AND DETERMINATIONS.— 

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

12 process developed under subsection (a) shall— 

13 ‘‘(A) include a process by which a manu14 facturer or processor of an active chemical sub15 stance that has not been designated a high-pri16 ority substance, or that has not been subject to 

17 or is not in the process of a prioritization 

18 screening by the Administrator, may request 

19 that the Administrator designate the substance 

20 for a safety assessment and safety determina21 tion, subject to the payment of fees pursuant to 

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

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

24 information to be provided in such requests, 

25 and specify the criteria the Administrator shall 


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1 use to determine whether or not to grant such 

2 a request, which shall include whether the sub3 stance is subject to restrictions imposed by stat4 utes enacted or administrative actions taken by 

5 1 or more States on the manufacture, proc6 essing, distribution in commerce, or use of the 

7 substance. 

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

9 in deciding whether to grant requests under this 

10 subsection the Administrator shall give a preference 

11 to requests concerning substances for which the Ad12 ministrator determines that restrictions imposed by 

13 1 or more States have the potential to have a signifi14 cant impact on interstate commerce or health or the 

15 environment. 

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

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

18 Administrator shall ensure that— 

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

20 number of substances designated to undergo 

21 safety assessments and safety determinations 

22 under this section are substances designated 

23 under the process and criteria pursuant to 

24 paragraph (1); and 


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1 ‘‘(B) the resources allocated to conducting 

2 safety assessments and safety determinations 

3 for additional priorities designated under this 

4 subsection are proportionate to the number of 

5 such substances relative to the total number of 

6 substances designated to undergo safety assess7 ments and safety determinations under this sec8 tion. 

9 ‘‘(4) REQUIREMENTS.— 

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

11 provided notice and an opportunity to comment 

12 on requests submitted under this subsection. 

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

14 later than 180 days after the date on which the 

15 Administrator receives a request under this 

16 subsection, the Administrator shall decide 

17 whether or not to grant the request. 

18 ‘‘(C) ASSESSMENT AND DETERMINA19 TION.—If the Administrator grants a request 

20 under this subsection, the safety assessment 

21 and safety determination— 

22 ‘‘(i) shall be conducted in accordance 

23 with the deadlines and other requirements 

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


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1 ‘‘(ii) shall not be expedited or other2 wise subject to special treatment relative to 

3 high-priority substances designated pursu4 ant to subsection (b)(3) that are under5 going safety assessments and safety deter6 minations. 

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

8 this subsection shall not be subject to subsection 

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

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

11 Section 5 of the Toxic Substances Control Act (15 

12 U.S.C. 2604) is amended— 

13 (1) by striking the section designation and 

14 heading and inserting the following: 

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

16 (2) by striking subsection (b); 

17 (3) by redesignating subsection (a) as sub18 section (b); 

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

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

21 beginning of the section; 

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

23 (A) in the subsection heading, by striking 

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


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1 (B) in paragraph (1), in the matter fol2 lowing subparagraph (B)— 

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

4 inserting ‘‘subsection (b)’’; and 

5 (ii) by striking ‘‘and such person com6 plies with any applicable requirement of 

7 subsection (b)’’; 

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

9 subsection (d) and (c), respectively, and moving sub10 section (c) (as so redesigned) so as appear after sub11 section (b) (as redesignated by paragraph (3)); 

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

13 (A) by striking paragraph (1) and insert14 ing the following: 

15 ‘‘(1) IN GENERAL.—The notice required by sub16 section (a) shall include, with respect to a chemical 

17 substance— 

18 ‘‘(A) the information required by sections 

19 720.45 and 720.50 of title 40, Code of Federal 

20 Regulations (or successor regulations); and 

21 ‘‘(B) information regarding conditions of 

22 use and reasonably anticipated exposures.’’; 

23 (B) in paragraph (2)— 


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1 (i) in the matter preceding subpara2 graph (A), by striking ‘‘or of data under 

3 subsection (b)’’; 

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

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

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

7 ‘‘; and’’ and inserting a period; and 

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

9 (C) in paragraph (3), by striking ‘‘sub10 section (a) and for which the notification period 

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

12 inserting ‘‘subsection (b) and for which the no13 tification period prescribed by subsection (b) or 

14 (d)’’; 

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

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

17 ‘‘(d) REVIEW OF NOTICE.— 

18 ‘‘(1) INITIAL REVIEW.— 

19 ‘‘(A) IN GENERAL.—Subject to subpara20 graph (B), not later than 90 days after the date 

21 of receipt of a notice submitted under sub22 section (b), the Administrator shall— 

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

24 notice; 


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

2 the relevant chemical substance and the 

3 potential for exposure to humans and the 

4 environment; and 

5 ‘‘(iii) make any necessary determina6 tion under paragraph (3). 

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

8 paragraph (5), the Administrator may extend 

9 the period described in subparagraph (A) for 

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

11 which shall be not more than 90 days. 

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

13 notice under paragraph (1), the Administrator shall 

14 take into consideration— 

15 ‘‘(A) any relevant information identified in 

16 subsection (c)(1); and 

17 ‘‘(B) any other relevant additional infor18 mation available to the Administrator. 

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

20 applicable period for review under paragraph (1), 

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

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

23 determine that— 

24 ‘‘(A) the relevant chemical substance or 

25 significant new use is not likely to meet the 


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1 safety standard, in which case the Adminis2 trator shall take appropriate action under para3 graph (4); 

4 ‘‘(B) the relevant chemical substance or 

5 significant new use is likely to meet the safety 

6 standard, in which case the Administrator shall 

7 allow the review period to expire without addi8 tional restrictions; or 

9 ‘‘(C) additional information is necessary in 

10 order to make a determination under subpara11 graph (A) or (B), in which case the Adminis12 trator shall take appropriate action under para13 graph (5). 

14 ‘‘(4) RESTRICTIONS.— 

15 ‘‘(A) DETERMINATION BY ADMINIS16 TRATOR.— 

17 ‘‘(i) IN GENERAL.—If the Adminis18 trator makes a determination under sub19 paragraph (A) or (C) of paragraph (3) 

20 with respect to a notice submitted under 

21 subsection (b)— 

22 ‘‘(I) the Administrator, before 

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1 priate, shall prohibit or otherwise re2 strict the manufacture, processing, 

3 use, distribution in commerce, or dis4 posal (as applicable) of the chemical 

5 substance, or of the chemical sub6 stance for a significant new use, with7 out compliance with the restrictions 

8 specified in the consent agreement or 

9 order that the Administrator deter10 mines are sufficient to ensure that the 

11 chemical substance or significant new 

12 use is likely to meet the safety stand13 ard; and 

14 ‘‘(II) no person may commence 

15 manufacture of the chemical sub16 stance, or manufacture or processing 

17 of the chemical substance for a sig18 nificant new use, except in compliance 

19 with the restrictions specified in the 

20 consent agreement or order. 

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

22 the Administrator makes a determination 

23 under subparagraph (B) of paragraph (3) 

24 with respect to a chemical substance or 

25 significant new use for which a notice was 


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1 submitted under subsection (b), at the end 

2 of the applicable period for review under 

3 paragraph (1), the submitter of the notice 

4 may commence manufacture for commer5 cial purposes of the chemical substance or 

6 manufacture or processing of the chemical 

7 substance for a significant new use. 

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

9 days after issuing a consent agreement or order 

10 under subparagraph (A), the Administrator 

11 shall— 

12 ‘‘(i) take into consideration whether to 

13 promulgate a rule pursuant to subsection 

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

15 use any manufacturing, processing, use, 

16 distribution in commerce, or disposal of 

17 the chemical substance, or of the chemical 

18 substance for a new use, that is not in 

19 compliance with the restrictions imposed 

20 by the consent agreement or order; and 

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

22 in clause (i); or 

23 ‘‘(II) publish a statement describing 

24 the reasons of the Administrator for not 

25 initiating a rulemaking. 


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

2 restriction under subparagraph (A) may in3 clude, as appropriate— 

4 ‘‘(i) subject to section 18(g), a re5 quirement that a chemical substance shall 

6 be marked with, or accompanied by, clear 

7 and adequate minimum warnings and in8 structions with respect to use, distribution 

9 in commerce, or disposal, or any combina10 tion of those activities, with the form and 

11 content of the minimum warnings and in12 structions to be prescribed by the Adminis13 trator; 

14 ‘‘(ii) a requirement that manufactur15 ers or processors of the chemical substance 

16 shall— 

17 ‘‘(I) make and retain records of 

18 the processes used to manufacture or 

19 process, as applicable, the chemical 

20 substance; or 

21 ‘‘(II) monitor or conduct such 

22 additional tests as are reasonably nec23 essary to address potential risks from 

24 the manufacture, processing, distribu25 tion in commerce, use, or disposal, as 


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1 applicable, of the chemical substance, 

2 subject to section 4; 

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

4 the chemical substance that may be manu5 factured, processed, or distributed in com6 merce— 

7 ‘‘(I) in general; or 

8 ‘‘(II) for a particular use; 

9 ‘‘(iv) a prohibition or other restriction 

10 of— 

11 ‘‘(I) the manufacture, processing, 

12 or distribution in commerce of the 

13 chemical substance for a significant 

14 new use; 

15 ‘‘(II) any method of commercial 

16 use of the chemical substance; or 

17 ‘‘(III) any method of disposal of 

18 the chemical substance; or 

19 ‘‘(v) a prohibition or other restriction 

20 on the manufacture, processing, or dis21 tribution in commerce of the chemical sub22 stance— 

23 ‘‘(I) in general; or 

24 ‘‘(II) for a particular use. 


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1 ‘‘(D) WORKPLACE EXPOSURES.—The Ad2 ministrator shall consult with the Assistant Sec3 retary of Labor for Occupational Safety and 

4 Health prior to adopting any prohibition or 

5 other restriction under this subsection to ad6 dress workplace exposures. 

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

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

9 used in this section does not displace common 

10 law. 

11 ‘‘(5) ADDITIONAL INFORMATION.—If the Ad12 ministrator determines under paragraph (3)(C) that 

13 additional information is necessary to conduct a re14 view under this subsection, the Administrator— 

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

16 submitter of the notice to submit the additional 

17 information; 

18 ‘‘(B) may, by agreement with the sub19 mitter, extend the review period for a reason20 able time to allow the development and submis21 sion of the additional information; 

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

23 testing consent agreement, or issue an order 

24 under section 4 to require the development of 

25 the information; and 


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1 ‘‘(D) on receipt of information the Admin2 istrator finds supports the determination under 

3 paragraph (3), shall promptly make the deter4 mination.’’; 

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

6 inserting the following: 

7 ‘‘(e) NOTICE OF COMMENCEMENT.— 

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

9 after the date on which a manufacturer that has 

10 submitted a notice under subsection (b) commences 

11 nonexempt commercial manufacture of a chemical 

12 substance, the manufacturer shall submit to the Ad13 ministrator a notice of commencement that identi14 fies— 

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

16 ‘‘(B) the initial date of nonexempt com17 mercial manufacture. 

18 ‘‘(2) WITHDRAWAL.—A manufacturer or proc19 essor that has submitted a notice under subsection 

20 (b), but that has not commenced nonexempt com21 mercial manufacture or processing of the chemical 

22 substance, may withdraw the notice. 

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

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

25 time after the Administrator receives— 


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

2 substance under subsection (c); or 

3 ‘‘(2) new information regarding the chemical 

4 substance. 

5 ‘‘(g) TRANSPARENCY.—Subject to section 14, the Ad6 ministrator shall make available to the public— 

7 ‘‘(1) all notices, determinations, consent agree8 ments, rules, and orders of the Administrator; and 

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

10 this section.’’; and 

11 (10) in subsection (h)— 

12 (A) in paragraph (1), in the matter pre13 ceding subparagraph (A), by striking ‘‘(a) or’’; 

14 (B) by striking paragraph (2); 

15 (C) by redesignating paragraphs (3) 

16 through (6) as paragraphs (2) through (5), re17 spectively; 

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

19 in the matter preceding subparagraph (A), by 

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

21 ‘‘subsection (b)’’; 

22 (E) in paragraph (3) (as so redesig23 nated)— 

24 (i) in the first sentence, by striking 

25 ‘‘will not present an unreasonable risk of 


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1 injury to health or the environment’’ and 

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

3 and 

4 (ii) by striking the second sentence; 

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

6 by striking ‘‘subsections (a) and (b)’’ and in7 serting ‘‘subsection (b)’’; and 

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

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

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

11 SEC. 8. SAFETY ASSESSMENTS AND SAFETY DETERMINA12 TIONS. 

13 Section 6 of the Toxic Substances Control Act (15 

14 U.S.C. 2605) is amended— 

15 (1) by striking the section designation and 

16 heading and inserting the following: 

17 ‘‘SEC. 6. SAFETY ASSESSMENTS AND SAFETY DETERMINA18 TIONS.’’; 

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

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

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

22 inserting the following: 

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

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

25 make a safety determination of each high-priority 


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1 substance in accordance with subsections (b) and 

2 (c); 

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

4 than 6 months after the date on which a chemical 

5 substance is designated as a high-priority substance, 

6 define the scope of the safety assessment and safety 

7 determination to be conducted pursuant to this sec8 tion, including the hazards, exposures, conditions of 

9 use, and potentially exposed or susceptible popu10 lations that the Administrator expects to consider; 

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

12 safety determination, shall establish restrictions pur13 suant to subsection (d); 

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

15 safety determination not later than 3 years after the 

16 date on which a chemical substance is designated as 

17 a high-priority substance; 

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

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

20 date on which the safety determination is completed; 

21 and 

22 ‘‘(6) may extend any deadline under this sub23 section for a reasonable period of time after an ade24 quate public justification, subject to the condition 

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1 lines under paragraphs (4) and (5) and any deferral 

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

3 ‘‘(b) PRIOR ACTIONS.— 

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

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

6 prevents the Administrator from initiating a 

7 safety assessment or safety determination re8 garding a chemical substance, or from con9 tinuing or completing such a safety assessment 

10 or safety determination that was initiated be11 fore the date of enactment of the Frank R. 

12 Lautenberg Chemical Safety for the 21st Cen13 tury Act, prior to the effective date of the poli14 cies and procedures required to be established 

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

16 ‘‘(B) INTEGRATION OF PRIOR POLICIES

17 AND PROCEDURES.—As policies and procedures 

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

19 maximum extent practicable, the Administrator 

20 shall integrate the policies and procedures into 

21 ongoing safety assessments and safety deter22 minations. 

23 ‘‘(2) ACTIONS COMPLETED PRIOR TO COMPLE24 TION OF POLICIES AND PROCEDURES.—Nothing in 

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1 draw a completed safety assessment, safety deter2 mination, or rule solely because the action was com3 pleted prior to the completion of a policy or proce4 dure established under section 3A or 4A, and the va5 lidity of a completed assessment, determination, or 

6 rule shall not be determined based on the content of 

7 such a policy or procedure. 

8 ‘‘(c) SAFETY DETERMINATIONS.— 

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

10 information available to the Administrator, including 

11 draft safety assessments submitted by interested 

12 persons, and subject to section 18, the Adminis13 trator shall determine that— 

14 ‘‘(A) the relevant chemical substance meets 

15 the safety standard; 

16 ‘‘(B) the relevant chemical substance does 

17 not meet the safety standard, in which case the 

18 Administrator shall, by rule under subsection 

19 (d)— 

20 ‘‘(i) impose restrictions necessary to 

21 ensure that the chemical substance meets 

22 the safety standard under the conditions of 

23 use; or 

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

25 met with the application of restrictions, 


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1 ban or phase out the chemical substance, 

2 as appropriate; or 

3 ‘‘(C) additional information is necessary in 

4 order to make a determination under subpara5 graph (A) or (B), in which case the Adminis6 trator shall take appropriate action under para7 graph (2). 

8 ‘‘(2) ADDITIONAL INFORMATION.—If the Ad9 ministrator determines that additional information is 

10 necessary to make a safety assessment or safety de11 termination for a high-priority substance, the Ad12 ministrator— 

13 ‘‘(A) shall provide an opportunity for inter14 ested persons to submit the additional informa15 tion; 

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

17 testing consent agreement, or issue an order 

18 under section 4 to require the development of 

19 the information; 

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

21 consistent with the deadlines described in sub22 section (a), a safety assessment and safety de23 termination until after receipt of the informa24 tion; and 


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1 ‘‘(D) consistent with the deadlines de2 scribed in subsection (a), on receipt of informa3 tion the Administrator finds supports the safety 

4 assessment and safety determination, shall 

5 make a determination under paragraph (1). 

6 ‘‘(3) ESTABLISHMENT OF DEADLINE.—In re7 questing the development or submission of informa8 tion under this section, the Administrator shall es9 tablish a deadline for the submission of the informa10 tion. 

11 ‘‘(d) RULE.— 

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

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

14 with respect to a chemical substance, the Adminis15 trator shall promulgate a rule establishing restric16 tions necessary to ensure that the chemical sub17 stance meets the safety standard. 

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

19 to this subsection— 

20 ‘‘(A) may— 

21 ‘‘(i) apply to mixtures containing the 

22 chemical substance, as appropriate; and 

23 ‘‘(ii) exempt replacement parts for ar24 ticles manufactured prior to the applicable 

25 compliance deadline; and 


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1 ‘‘(B) shall include dates by which compli2 ance is mandatory, which— 

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

4 and 

5 ‘‘(ii) as determined by the Adminis6 trator, may vary for different affected per7 sons. 

8 ‘‘(C) WORKPLACE EXPOSURES.—The Ad9 ministrator shall consult with the Assistant Sec10 retary of Labor for Occupational Safety and 

11 Health before adopting any prohibition or other 

12 restriction under this subsection to address 

13 workplace exposures. 

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

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

16 as used in this section does not displace com17 mon law. 

18 ‘‘(3) RESTRICTIONS.—A restriction under para19 graph (1) may include, as appropriate— 

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

21 that a chemical substance shall be marked with, 

22 or accompanied by, clear and adequate min23 imum warnings and instructions with respect to 

24 use, distribution in commerce, or disposal, or 

25 any combination of those activities, with the 


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1 form and content of the minimum warnings and 

2 instructions to be prescribed by the Adminis3 trator; 

4 ‘‘(B) a requirement that manufacturers or 

5 processors of the chemical substance shall— 

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

7 processes used to manufacture or process 

8 the chemical substance; 

9 ‘‘(ii) describe and apply the relevant 

10 quality control procedures followed in the 

11 manufacturing or processing of the sub12 stance; or 

13 ‘‘(iii) monitor or conduct tests that 

14 are reasonably necessary to ensure compli15 ance with the requirements of any rule 

16 under this subsection; 

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

18 chemical substance that may be manufactured, 

19 processed, or distributed in commerce; 

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

21 any other rule regarding, the manufacture, 

22 processing, or distribution in commerce of the 

23 chemical substance for— 

24 ‘‘(i) a particular use; 


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1 ‘‘(ii) a particular use at a concentra2 tion in excess of a level specified by the 

3 Administrator; or 

4 ‘‘(iii) all uses; 

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

6 chemical substance that may be manufactured, 

7 processed, or distributed in commerce for— 

8 ‘‘(i) a particular use; or 

9 ‘‘(ii) a particular use at a concentra10 tion in excess of a level specified by the 

11 Administrator; 

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

13 otherwise restrict any method of commercial 

14 use of the chemical substance; 

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

16 otherwise restrict any method of disposal of the 

17 chemical substance or any article containing the 

18 chemical substance; and 

19 ‘‘(H) a requirement directing manufactur20 ers or processors of the chemical substance to 

21 give notice of the Administrator’s determination 

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

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1 sons in the chain of commerce in possession of 

2 the chemical substance. 

3 ‘‘(4) ANALYSIS FOR RULEMAKING.— 

4 ‘‘(A) CONSIDERATIONS.—In deciding 

5 which restrictions to impose under paragraph 

6 (3) as part of developing a rule under para7 graph (1), the Administrator shall take into 

8 consideration, to the extent practicable based on 

9 reasonably available information, the quantifi10 able and nonquantifiable costs and benefits of 

11 the proposed regulatory action and of the 1 or 

12 more primary alternative regulatory actions 

13 considered by the Administrator. 

14 ‘‘(B) ALTERNATIVES.—As part of the 

15 analysis, the Administrator shall review any 1 

16 or more technically and economically feasible al17 ternatives to the chemical substance that the 

18 Administrator determines are relevant to the 

19 rulemaking. 

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

21 a rule under paragraph (1), the Administrator 

22 shall make publicly available any analysis con23 ducted under this paragraph. 

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

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1 trator shall include a statement describing how 

2 the analysis considered under subparagraph (A) 

3 was taken into account. 

4 ‘‘(5) EXEMPTIONS.— 

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

6 may exempt 1 or more uses of a chemical sub7 stance from any restriction in a rule promul8 gated under paragraph (1) if the Administrator 

9 determines that— 

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

11 without— 

12 ‘‘(I) harming national security; 

13 ‘‘(II) causing significant disrup14 tion in the national economy due to 

15 the lack of availability of a chemical 

16 substance; or 

17 ‘‘(III) interfering with a critical 

18 or essential use for which no tech19 nically and economically feasible safer 

20 alternative is available, taking into 

21 consideration hazard and exposure; or 

22 ‘‘(ii) the use of the chemical sub23 stance, as compared to reasonably available 

24 alternatives, provides a substantial benefit 


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1 to health, the environment, or public safe2 ty. 

3 ‘‘(B) EXEMPTION ANALYSIS.—In pro4 posing a rule under paragraph (1) that includes 

5 an exemption under this paragraph, the Admin6 istrator shall make publicly available any anal7 ysis conducted under this paragraph to assess 

8 the need for the exemption. 

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

10 final a rule under paragraph (1) that includes 

11 an exemption under this paragraph, the Admin12 istrator shall include a statement describing 

13 how the analysis considered under subpara14 graph (B) was taken into account. 

15 ‘‘(D) ANALYSIS IN CASE OF BAN OR

16 PHASE-OUT.—In determining whether an ex17 emption should be granted under this para18 graph for a chemical substance for which a ban 

19 or phase-out is proposed, the Administrator 

20 shall take into consideration, to the extent prac21 ticable based on reasonably available informa22 tion, the quantifiable and nonquantifiable costs 

23 and benefits of the 1 or more technically and 

24 economically feasible alternatives to the chem25 ical substance most likely to be used in place of 


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1 the chemical substance under the conditions of 

2 use if the rule is promulgated. 

3 ‘‘(E) CONDITIONS.—As part of a rule pro4 mulgated under paragraph (1), the Adminis5 trator shall include conditions in any exemption 

6 established under this paragraph, including rea7 sonable recordkeeping, monitoring, and report8 ing requirements, to the extent that the Admin9 istrator determines the conditions are necessary 

10 to protect health and the environment while 

11 achieving the purposes of the exemption. 

12 ‘‘(F) DURATION.— 

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

14 shall establish, as part of a rule under 

15 paragraph (1) that contains an exemption 

16 under this paragraph, a time limit on any 

17 exemption for a time to be determined by 

18 the Administrator as reasonable on a case19 by-case basis. 

20 ‘‘(ii) AUTHORITY OF ADMINIS21 TRATOR.—The Administrator, by rule, may 

22 extend, modify, or eliminate the exemption 

23 if the Administrator determines, on the 

24 basis of reasonably available information 

25 and after adequate public justification, the 


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1 exemption warrants extension or is no 

2 longer necessary. 

3 ‘‘(iii) CONSIDERATIONS.— 

4 ‘‘(I) IN GENERAL.—Subject to 

5 subclause (II), the Administrator shall 

6 issue exemptions and establish time 

7 periods by considering factors deter8 mined by the Administrator to be rel9 evant to the goals of fostering innova10 tion and the development of alter11 natives that meet the safety standard. 

12 ‘‘(II) LIMITATION.—Any renewal 

13 of an exemption in the case of a rule 

14 requiring the ban or phase-out of a 

15 chemical substance shall not exceed 5 

16 years. 

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

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

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

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

21 if— 

22 ‘‘(1) the Administrator determines that— 

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1 posed rule or any combination of those activi2 ties is likely to result in an unreasonable risk 

3 of serious or widespread harm to health or the 

4 environment before the effective date; and 

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

6 is necessary to protect the public interest; and 

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

8 the manufacture, processing, or distribution of a 

9 chemical substance or mixture because of the risk 

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

11 granted relief in an action under section 7 with re12 spect to that risk associated with the chemical sub13 stance or mixture. 

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

15 and subject to section 18— 

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

17 safety assessment, for a chemical substance that the 

18 Administrator determines under subsection (c) meets 

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

20 agency action, effective beginning on the date of 

21 issuance of the final safety determination; and 

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

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

24 determination that a chemical substance does not 

25 meet the safety standard, shall be considered to be 


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1 a final agency action, effective beginning on the date 

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

3 (4) in subsection (g) (as redesignated by para4 graph (2))— 

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

6 (B) by redesignating paragraph (5) as 

7 paragraph (4). 

8 SEC. 9. IMMINENT HAZARDS. 

9 Section 7 of the Toxic Substances Control Act (15 

10 U.S.C. 2606) is amended— 

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

12 following: 

13 ‘‘(a) CIVIL ACTIONS.— 

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

15 commence a civil action in an appropriate United 

16 States district court for— 

17 ‘‘(A) seizure of an imminently hazardous 

18 chemical substance or mixture or any article 

19 containing the chemical substance or mixture; 

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

21 (b)) against any person that manufactures, 

22 processes, distributes in commerce, uses, or dis23 poses of, an imminently hazardous chemical 

24 substance or mixture or any article containing 

25 the chemical substance or mixture; or 


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1 ‘‘(C) both seizure described in subpara2 graph (A) and relief described in subparagraph 

3 (B). 

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

5 A civil action may be commenced under this para6 graph, notwithstanding— 

7 ‘‘(A) the existence of— 

8 ‘‘(i) a decision by the Administrator 

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

10 ‘‘(ii) a rule, testing consent agree11 ment, or order under section 4, 5(d)(4), 

12 6(d), or 6(h); or 

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

14 judicial proceeding under any provision of this 

15 Act.’’; 

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

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

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

19 striking ‘‘and unreasonable’’. 

20 SEC. 10. INFORMATION COLLECTION AND REPORTING. 

21 Section 8 of the Toxic Substances Control Act (15 

22 U.S.C. 2607) is amended— 

23 (1) in subsection (a)— 

24 (A) in paragraph (3)(A)(ii)(I)— 


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

2 ‘‘5’’; 

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

4 ‘‘in effect under’’; and 

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

6 ‘‘5(d)(4);’’; and 

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

8 ‘‘(4) RULES.— 

9 ‘‘(A) DEADLINE.— 

10 ‘‘(i) IN GENERAL.—Not later than 2 

11 years after the date of enactment of the 

12 Frank R. Lautenberg Chemical Safety for 

13 the 21st Century Act, the Administrator 

14 shall promulgate rules requiring the main15 tenance of records and the reporting of in16 formation known or reasonably ascertain17 able by the person making the report, in18 cluding rules requiring processors to report 

19 information, so that the Administrator has 

20 the information necessary to carry out sec21 tions 4 and 6. 

22 ‘‘(ii) MODIFICATION OF PRIOR

23 RULES.—In carrying out this subpara24 graph, the Administrator may modify, as 

25 appropriate, rules promulgated before the 


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1 date of enactment of the Frank R. Lauten2 berg Chemical Safety for the 21st Century 

3 Act. 

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

5 pursuant to subparagraph (A)— 

6 ‘‘(i) may impose different reporting 

7 and recordkeeping requirements on manu8 facturers and processors; and 

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

10 necessary to be reported, including the 

11 manner by which use and exposure infor12 mation may be reported. 

13 ‘‘(C) ADMINISTRATION.—In implementing 

14 the reporting and recordkeeping requirements 

15 under this paragraph, the Administrator shall 

16 take measures— 

17 ‘‘(i) to limit the potential for duplica18 tion in reporting requirements; 

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

20 rules on small manufacturers and proc21 essors; and 

22 ‘‘(iii) to apply any reporting obliga23 tions to those persons likely to have infor24 mation relevant to the effective implemen25 tation of this title. 


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1 ‘‘(5) GUIDANCE.—The Administrator shall de2 velop guidance relating to the information required 

3 to be reported under the rules promulgated under 

4 this subsection.’’; 

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

6 following: 

7 ‘‘(3) NOMENCLATURE.— 

8 ‘‘(A) IN GENERAL.—In carrying out para9 graph (1), the Administrator shall— 

10 ‘‘(i) maintain the use of Class 2 no11 menclature in use on the date of enact12 ment of the Frank R. Lautenberg Chem13 ical Safety for the 21st Century Act; 

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

15 Detergent Association Nomenclature Sys16 tem, published in March 1978 by the Ad17 ministrator in section 1 of addendum III 

18 of the document entitled ‘Candidate List of 

19 Chemical Substances’, and further de20 scribed in the appendix A of volume I of 

21 the 1985 edition of the Toxic Substances 

22 Control Act Substances Inventory (EPA 

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

24 ‘‘(iii) treat all components of cat25 egories that are considered to be statutory 


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1 mixtures under this Act as being included 

2 on the list published under paragraph (1) 

3 under the Chemical Abstracts Service 

4 numbers for the respective categories, in5 cluding, without limitation— 

6 ‘‘(I) cement, Portland, chemicals, 

7 CAS No. 65997–15–1; 

8 ‘‘(II) cement, alumina, chemicals, 

9 CAS No. 65997–16–2; 

10 ‘‘(III) glass, oxide, chemicals, 

11 CAS No. 65997–17–3; 

12 ‘‘(IV) frits, chemicals, CAS No. 

13 65997–18–4; 

14 ‘‘(V) steel manufacture, chemi15 cals, CAS No. 65997–19–5; and 

16 ‘‘(VI) ceramic materials and 

17 wares, chemicals, CAS No. 66402– 

18 68–4. 

19 ‘‘(B) MULTIPLE NOMENCLATURE CONVEN20 TIONS.— 

21 ‘‘(i) IN GENERAL.—If an existing 

22 guidance allows for multiple nomenclature 

23 conventions, the Administrator shall— 

24 ‘‘(I) maintain the nomenclature 

25 conventions for substances; and 


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1 ‘‘(II) develop new guidance 

2 that— 

3 ‘‘(aa) establishes equivalency 

4 between the nomenclature con5 ventions for chemical substances 

6 on the list published under para7 graph (1); and 

8 ‘‘(bb) permits persons to 

9 rely on the new guidance for pur10 poses of determining whether a 

11 chemical substance is on the list 

12 published under paragraph (1). 

13 ‘‘(ii) MULTIPLE CAS NUMBERS.—For 

14 any chemical substance appearing multiple 

15 times on the list under different Chemical 

16 Abstracts Service numbers, the Adminis17 trator shall develop guidance recognizing 

18 the multiple listings as a single chemical 

19 substance. 

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

21 ‘‘(A) RULES.— 

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

23 year after the date of enactment of the 

24 Frank R. Lautenberg Chemical Safety for 

25 the 21st Century Act, the Administrator, 


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1 by rule, shall require manufacturers and 

2 processors to notify the Administrator, by 

3 not later than 180 days after the date of 

4 promulgation of the rule, of each chemical 

5 substance on the list published under para6 graph (1) that the manufacturer or proc7 essor, as applicable, has manufactured or 

8 processed for a nonexempt commercial pur9 pose during the 10-year period ending on 

10 the day before the date of enactment of the 

11 Frank R. Lautenberg Chemical Safety for 

12 the 21st Century Act. 

13 ‘‘(ii) ACTIVE SUBSTANCES.—The Ad14 ministrator shall, pursuant to paragraph 

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

16 which notices are received under clause (i) 

17 to be active substances on the list pub18 lished under paragraph (1). 

19 ‘‘(B) CONFIDENTIAL CHEMICAL SUB20 STANCES.—The rule promulgated by the Ad21 ministrator pursuant to subparagraph (A) shall 

22 require— 

23 ‘‘(i) the Administrator to maintain the 

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1 fidential portion consistent with this sec2 tion and section 14; 

3 ‘‘(ii) a manufacturer or processor that 

4 is submitting a notice pursuant to sub5 paragraph (A) for a chemical substance on 

6 the confidential portion of the list pub7 lished under paragraph (1) to indicate in 

8 the notice whether the manufacturer or 

9 processor seeks to maintain any existing 

10 claim for protection against disclosure of 

11 the specific identity of the substance as 

12 confidential pursuant to section 14; and 

13 ‘‘(iii) the substantiation of those 

14 claims pursuant to section 14 and in ac15 cordance with the review plan described in 

16 subparagraph (C). 

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

18 year after the date on which the Administrator 

19 compiles the initial list of active substances pur20 suant to subparagraph (A), the Administrator 

21 shall promulgate a rule that establishes a plan 

22 to review all claims to protect the specific iden23 tities of chemical substances on the confidential 

24 portion of the list published under paragraph 

25 (1) that are notified pursuant to subparagraph 


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1 (A) or identified as active substances under 

2 subsection (f)(1). 

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

4 The review plan under subparagraph (C) 

5 shall— 

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

7 the Administrator, all manufacturers or 

8 processors asserting claims under subpara9 graph (B) to substantiate the claim unless 

10 the manufacturer or processor has sub11 stantiated the claim in a submission made 

12 to the Administrator during the 5-year pe13 riod ending on the date of the request by 

14 the Administrator; 

15 ‘‘(ii) require the Administrator, in ac16 cordance with section 14— 

17 ‘‘(I) to review each substan18 tiation— 

19 ‘‘(aa) submitted pursuant to 

20 clause (i) to determine if the 

21 claim warrants protection from 

22 disclosure; and 

23 ‘‘(bb) submitted previously 

24 by a manufacturer or processor 

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1 stantiation required pursuant to 

2 clause (i), if the substantiation 

3 has not been previously reviewed 

4 by the Administrator, to deter5 mine if the claim warrants pro6 tection from disclosure; 

7 ‘‘(II) approve, modify, or deny 

8 each claim; and 

9 ‘‘(III) except as provided in this 

10 section and section 14, protect from 

11 disclosure information for which the 

12 Administrator approves such a claim 

13 for a period of 10 years, unless, prior 

14 to the expiration of the period— 

15 ‘‘(aa) the person notifies the 

16 Administrator that the person is 

17 withdrawing the confidentiality 

18 claim, in which case the Adminis19 trator shall promptly make the 

20 information available to the pub21 lic; or 

22 ‘‘(bb) the Administrator oth23 erwise becomes aware that the 

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1 tiated, in which case the Admin2 istrator shall take the actions de3 scribed in section 14(g)(2); and 

4 ‘‘(iii) encourage manufacturers or 

5 processors that have previously made 

6 claims to protect the specific identities of 

7 chemical substances identified as inactive 

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

9 either withdraw or substantiate the claims. 

10 ‘‘(E) TIMELINE FOR COMPLETION OF RE11 VIEWS.— 

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

13 shall implement the review plan so as to 

14 complete reviews of all claims specified in 

15 subparagraph (C) not later than 5 years 

16 after the date on which the Administrator 

17 compiles the initial list of active substances 

18 pursuant to subparagraph (A). 

19 ‘‘(ii) CONSIDERATIONS.— 

20 ‘‘(I) IN GENERAL.—The Admin21 istrator may extend the deadline for 

22 completion of the reviews for not more 

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1 sion is necessary based on the number 

2 of applicable claims needing review 

3 and the available resources. 

4 ‘‘(II) ANNUAL GOAL.—The Ad5 ministrator shall publish an annual 

6 goal for the number of reviews to be 

7 completed over the course of imple8 mentation of the plan. 

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

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

11 shall maintain and keep current designations of 

12 active substances and inactive substances on 

13 the list published under paragraph (1). 

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

15 update the list of chemical substances des16 ignated as active substances as soon as prac17 ticable after the date of publication of the most 

18 recent data reported under— 

19 ‘‘(i) part 711 of title 40, Code of Fed20 eral Regulations (or successor regulations); 

21 and 

22 ‘‘(ii) the rules promulgated pursuant 

23 to subsection (a)(4). 

24 ‘‘(C) CHANGE TO ACTIVE STATUS.— 


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1 ‘‘(i) IN GENERAL.—Any person that 

2 intends to manufacture or process for a 

3 nonexempt commercial purpose a chemical 

4 substance that is designated as an inactive 

5 substance shall notify the Administrator 

6 before the date on which the inactive sub7 stance is manufactured or processed. 

8 ‘‘(ii) CONFIDENTIAL CHEMICAL IDEN9 TITY CLAIMS.—If a person submitting a 

10 notice under clause (i) for an inactive sub11 stance on the confidential portion of the 

12 list published under paragraph (1) seeks to 

13 maintain an existing claim for protection 

14 against disclosure of the specific identity of 

15 the inactive substance as confidential, the 

16 person shall— 

17 ‘‘(I) in the notice submitted 

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

19 ‘‘(II) by not later than 30 days 

20 after providing the notice under clause 

21 (i), substantiate the claim. 

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

23 a notification under clause (i), the Admin24 istrator shall— 


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1 ‘‘(I) designate the applicable 

2 chemical substance as an active sub3 stance; 

4 ‘‘(II) pursuant to section 14, 

5 promptly review any claim and associ6 ated substantiation submitted pursu7 ant to clause (ii) for protection 

8 against disclosure of the specific iden9 tity of the chemical substance and ap10 prove, modify, or deny the claim; 

11 ‘‘(III) except as provided in this 

12 section and section 14, protect from 

13 disclosure the specific identity of the 

14 chemical substance for which the Ad15 ministrator approves a claim under 

16 subclause (II) for a period of not less 

17 than 10 years, unless, prior to the ex18 piration of the period— 

19 ‘‘(aa) the person notifies the 

20 Administrator that the person is 

21 withdrawing the confidentiality 

22 claim, in which case the Adminis23 trator shall promptly make the 

24 information available to the pub25 lic; or 


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1 ‘‘(bb) the Administrator oth2 erwise becomes aware that the 

3 need for protection from disclo4 sure can no longer be substan5 tiated, in which case the Admin6 istrator shall take the actions de7 scribed in section 14(g)(2); and 

8 ‘‘(IV) pursuant to section 4A, re9 view the priority of the chemical sub10 stance as the Administrator deter11 mines to be necessary. 

12 ‘‘(D) CATEGORY STATUS.—The list of in13 active substances shall not be considered to be 

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

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

16 Prior to the promulgation of the rule required under 

17 this subsection, the Administrator shall designate 

18 the chemical substances reported under part 711 of 

19 title 40, Code of Federal Regulations (or successor 

20 regulations), during the reporting period that most 

21 closely preceded the date of enactment of the Frank 

22 R. Lautenberg Chemical Safety for the 21st Century 

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

24 purposes of section 4A. 


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

2 subsection, the Administrator shall make available to 

3 the public— 

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

5 substance on the nonconfidential portion of the 

6 list published under paragraph (1) that the Ad7 ministrator has designated as— 

8 ‘‘(i) an active substance; or 

9 ‘‘(ii) an inactive substance; 

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

11 and, if applicable, premanufacture notice case 

12 number for each chemical substance on the con13 fidential portion of the list published under 

14 paragraph (1) for which a claim of confiden15 tiality was received and approved by the Admin16 istrator pursuant to section 14; and 

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

18 identity of any active substance for which— 

19 ‘‘(i) no claim of protection against dis20 closure of the specific identity of the active 

21 substance pursuant to this subsection was 

22 received; 

23 ‘‘(ii) a claim for protection against 

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1 tive substance has been denied by the Ad2 ministrator; or 

3 ‘‘(iii) the time period for protection 

4 against disclosure of the specific identity of 

5 the active substance has expired. 

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

7 new claim under this subsection for protection from 

8 disclosure of a specific identity of any active or inac9 tive chemical substance for which a notice is received 

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

11 the confidential portion of the list published under 

12 paragraph (1). 

13 ‘‘(9) CERTIFICATION.—Under the rule promul14 gated under this subsection, manufacturers and 

15 processors shall be required— 

16 ‘‘(A) to certify that each report the manu17 facturer or processor submits complies with the 

18 requirements of the rule, and that any confiden19 tiality claims are true and correct; and 

20 ‘‘(B) to retain a record supporting the cer21 tification for a period of 5 years beginning on 

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

23 (3) in subsection (e)— 

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

25 the following: 


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

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

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

4 to the Administrator information reasonably sup5 porting the conclusion that a chemical substance or 

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

7 substantial risk of harm to health and the environ8 ment.’’; and 

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

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

11 this section: 

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

13 substance’ means a chemical substance— 

14 ‘‘(A) that has been manufactured or proc15 essed for a nonexempt commercial purpose at 

16 any point during the 10-year period ending on 

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

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

20 under subsection (b)(1) after that date of en21 actment; or 

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

23 subsection (b)(5)(C). 

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

25 substance’ means a chemical substance on the list 


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

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

3 ‘‘(3) MANUFACTURE; PROCESS.—The’’. 

4 SEC. 11. RELATIONSHIP TO OTHER FEDERAL LAWS. 

5 Section 9 of the Toxic Substances Control Act (15 

6 U.S.C. 2608) is amended— 

7 (1) in subsection (a)— 

8 (A) in paragraph (1), in the first sen9 tence— 

10 (i) by striking ‘‘presents or will 

11 present an unreasonable risk to health or 

12 the environment’’ and inserting ‘‘does not 

13 meet the safety standard’’; and 

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

15 place it appears and inserting ‘‘the risk 

16 posed by the substance or mixture’’; 

17 (B) in paragraph (2), in the matter fol18 lowing subparagraph (B), by striking ‘‘section 6 

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

20 and 

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

22 6 or 7’’ and inserting ‘‘section 6(d) or 7’’; 

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

24 striking ‘‘Health, Education, and Welfare’’ and in25 serting ‘‘Health and Human Services’’; and 


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

2 ‘‘(e) EXPOSURE INFORMATION.—If the Adminis3 trator obtains information related to exposures or releases 

4 of a chemical substance that may be prevented or reduced 

5 under another Federal law, including laws not adminis6 tered by the Administrator, the Administrator shall make 

7 such information available to the relevant Federal agency 

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

9 SEC. 12. RESEARCH, DEVELOPMENT, COLLECTION, DIS10 SEMINATION, AND UTILIZATION OF DATA. 

11 Section 10 of the Toxic Substances Control Act (15 

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

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

14 and Human Services’’. 

15 SEC. 13. EXPORTS. 

16 Section 12 of the Toxic Substances Control Act (15 

17 U.S.C. 2611) is amended— 

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

19 and inserting the following: 

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

21 apply to any chemical substance that the Adminis22 trator determines— 

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

24 the safety standard; or 


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

2 safety standard. 

3 ‘‘(3) WAIVERS.—For a mixture or article con4 taining a chemical substance described in paragraph 

5 (2), the Administrator may— 

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

7 not apply to the mixture or article; or 

8 ‘‘(B) establish a threshold concentration in 

9 a mixture or article at which paragraph (1) 

10 shall not apply. 

11 ‘‘(4) TESTING.—The Administrator may re12 quire testing under section 4 of any chemical sub13 stance or mixture exempted from this Act under 

14 paragraph (1) for the purpose of determining wheth15 er the chemical substance or mixture meets the safe16 ty standard within the United States.’’; 

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

18 following: 

19 ‘‘(b) NOTICE.— 

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

21 Administrator that the person is exporting or in22 tends to export to a foreign country— 

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

24 containing a chemical substance that the Ad25 ministrator has determined under section 5 is 


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1 not likely to meet the safety standard and for 

2 which a prohibition or other restriction has 

3 been proposed or established under that section; 

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

5 containing a chemical substance that the Ad6 ministrator has determined under section 6 

7 does not meet the safety standard and for 

8 which a prohibition or other restriction has 

9 been proposed or established under that section; 

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

11 United States is obligated by treaty to provide 

12 export notification; 

13 ‘‘(D) a chemical substance or mixture sub14 ject to a prohibition or other restriction pursu15 ant to a rule, order, or consent agreement in ef16 fect under this Act; or 

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

18 which the submission of information is required 

19 under section 4. 

20 ‘‘(2) RULES.— 

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

22 shall promulgate rules to carry out paragraph 

23 (1). 

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

25 pursuant to subparagraph (A) shall— 


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1 ‘‘(i) include such exemptions as the 

2 Administrator determines to be appro3 priate, which may include exemptions iden4 tified under section 5(h); and 

5 ‘‘(ii) indicate whether, or to what ex6 tent, the rules apply to articles containing 

7 a chemical substance or mixture described 

8 in paragraph (1). 

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

10 submit to the government of each country to which 

11 a chemical substance or mixture is exported— 

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

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

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

15 rule, order, consent agreement, requirement, or 

16 designation; 

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

18 paragraph (1)(C), a notice that satisfies the ob19 ligation of the United States under the applica20 ble treaty; and 

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

22 described in paragraph (1)(E), a notice of avail23 ability of the information on the chemical sub24 stance or mixture submitted to the Adminis25 trator.’’; and 


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1 (3) in subsection (c)— 

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

3 (B) by redesignating paragraphs (4) 

4 through (6) as paragraphs (3) through (5), re5 spectively. 

6 SEC. 14. IMPORTS. 

7 Section 13 of the Toxic Substances Control Act (15 

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

9 ‘‘SEC. 13. IMPORTS. 

10 ‘‘(a) REFUSAL OF ENTRY.— 

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

12 Security shall refuse entry into the customs territory 

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

14 to the Harmonized Tariff Schedule of the United 

15 States) any chemical substance, mixture, or article 

16 containing a chemical substance or mixture offered 

17 for such entry, if— 

18 ‘‘(A) the Administrator— 

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

20 that the chemical substance or mixture 

21 does not meet the safety standard; and 

22 ‘‘(ii) has promulgated a rule pursuant 

23 to section 6(d) banning the chemical sub24 stance or mixture, as of the effective date 

25 of the rule; 


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1 ‘‘(B) the chemical substance— 

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

3 section 8(b)(1); and 

4 ‘‘(ii) is not exempt from any require5 ment to be included on that list by this 

6 title or a rule promulgated by the Adminis7 trator pursuant to this title; or 

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

9 any article containing the chemical substance or 

10 mixture is offered for entry in violation of— 

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

12 order in effect under this Act; or 

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

14 brought under section 7 or title IV. 

15 ‘‘(2) PROCEDURE.— 

16 ‘‘(A) IN GENERAL.—Subject to subpara17 graph (B), if a chemical substance, mixture, or 

18 article containing a chemical substance or mix19 ture is refused entry under paragraph (1), the 

20 Secretary of Homeland Security— 

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

22 entry of the refusal; 

23 ‘‘(ii) shall not release the chemical 

24 substance or mixture to the consignee; and 


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1 ‘‘(iii) shall cause the disposal or stor2 age of the chemical substance or mixture 

3 under such rules as the Secretary may pre4 scribe, if the chemical substance or mix5 ture has not been exported by the con6 signee during the 90-day period beginning 

7 on the date of receipt of the notice of the 

8 refused entry. 

9 ‘‘(B) EXCEPTION.— 

10 ‘‘(i) IN GENERAL.—The Secretary of 

11 Homeland Security, pending a review by 

12 the Administrator, may release to the con13 signee the chemical substance or mixture if 

14 the consignee— 

15 ‘‘(I) executes a bond for the 

16 amount of the full invoice of the 

17 chemical substance or mixture (as set 

18 forth in the customs entry); and 

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

20 substance or mixture. 

21 ‘‘(ii) ADMINISTRATION.—If a con22 signee fails to return a chemical substance 

23 or mixture released to that consignee 

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1 rity on demand, the consignee shall be lia2 ble to the United States for liquidated 

3 damages equal to the full amount of the 

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

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

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

7 chemical substance or mixture that is refused 

8 entry or released under this subsection shall be 

9 paid by the owner or consignee, and a default 

10 on that payment shall constitute a lien against 

11 any future entry made by the owner or con12 signee. 

13 ‘‘(b) CERTIFICATION.— 

14 ‘‘(1) IN GENERAL.—A person offering a chem15 ical substance or mixture subject to this Act for 

16 entry into the customs territory of the United States 

17 shall certify to the Secretary of Homeland Security 

18 that— 

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

20 best knowledge and belief of the person, the 

21 chemical substance or mixture is in compliance 

22 with any applicable rule, consent agreement, or 

23 order under section 5 or 6; and 

24 ‘‘(B) the chemical substance— 


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1 ‘‘(i) is included on the list under sec2 tion 8(b)(1); or 

3 ‘‘(ii) is exempt from any requirement 

4 to be included on that list by this title or 

5 a rule promulgated by the Administrator 

6 pursuant to this title. 

7 ‘‘(2) ARTICLES.— 

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

9 rule, may require certification under paragraph 

10 (1) for an article containing a chemical sub11 stance or mixture that is subject to rule under 

12 section 5 or 6. 

13 ‘‘(B) REQUIREMENT.—The rule under sub14 paragraph (A) shall identify, with reasonable 

15 specificity, the types of articles, including parts 

16 or components of articles, that will be subject to 

17 the certification requirement. 

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

19 determining the need for and content of a cer20 tification rule under this paragraph, the Admin21 istrator shall take into consideration— 

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

23 enforcement of the applicable rule, consent 

24 agreement, or order under section 5 or 6; 


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1 ‘‘(ii) the contribution of imported arti2 cles to the potential risk presented by ex3 posure to the chemical substance or mix4 ture subject to rule under section 5 or 6; 

5 ‘‘(iii) the impact on commerce and po6 tential for the certification to impede or 

7 disrupt import of articles; 

8 ‘‘(iv) the frequency or duration of the 

9 certification requirement; and 

10 ‘‘(v) specification of the concentration 

11 of a chemical substance in an article that 

12 would subject the article to the certifi13 cation requirement. 

14 ‘‘(3) REASONABLE INQUIRY.— 

15 ‘‘(A) IN GENERAL.—For purposes of a cer16 tification under paragraph (1), reasonable in17 quiry shall include good faith reliance by an im18 porter on— 

19 ‘‘(i) a safety data sheet or similar dec20 laration provided by a supplier that docu21 ments the specific identity of the chemical 

22 substance or the specific identities of all 

23 chemical substances in a mixture; or 

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1 tial, or not otherwise disclosed by the sup2 plier, a certification by the supplier that 

3 the imported chemical substance or mix4 ture satisfies the applicable certification re5 quirements under paragraph (1). 

6 ‘‘(B) ARTICLES.—For purposes of a cer7 tification under paragraph (2), reasonable in8 quiry shall include good faith reliance by an im9 porter on a certification by the supplier that the 

10 imported article satisfies the applicable certifi11 cation requirements in a rule promulgated pur12 suant to paragraph (2). 

13 ‘‘(4) INFORMATION REGARDING IDENTITY.— 

14 For purposes of this subsection, the Administrator 

15 shall provide publicly accessible information regard16 ing the identity of a chemical substance or mixture 

17 subject to rule under this Act that would be readily 

18 understood in import transactions. 

19 ‘‘(c) NOTICE.—A person offering a chemical sub20 stance for entry into the customs territory of the United 

21 States shall notify the Secretary of Homeland Security 

22 if— 

23 ‘‘(1) the chemical substance or chemical sub24 stance in a mixture is a high-priority substance; 


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1 ‘‘(2) the chemical substance or chemical sub2 stance in a mixture is 1 for which the United States 

3 is obligated to provide export notification by treaty; 

4 or 

5 ‘‘(3) the chemical substance or chemical sub6 stance in a mixture— 

7 ‘‘(A) is the subject of a safety assessment 

8 and safety determination conducted pursuant to 

9 section 6; and 

10 ‘‘(B) has been found not to meet the safety 

11 standard. 

12 ‘‘(d) RULES.— 

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

14 Security, after consultation with the Administrator, 

15 shall promulgate rules to carry out this section. 

16 ‘‘(2) APPLICATION.—The rules under para17 graph (1) may modify the application of any require18 ment of this section, as appropriate for the efficient 

19 and effective implementation of this Act.’’. 

20 SEC. 15. CONFIDENTIAL INFORMATION. 

21 Section 14 of the Toxic Substances Control Act (15 

22 U.S.C. 2613) is amended to read as follows: 

23 ‘‘SEC. 14. CONFIDENTIAL INFORMATION. 

24 ‘‘(a) IN GENERAL.—Except as otherwise provided in 

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1 tion that is exempt from disclosure pursuant to subsection 

2 (a) of section 552 of title 5, United States Code, under 

3 subsection (b)(4) of that section— 

4 ‘‘(1) that is reported to, or otherwise obtained 

5 by, the Administrator under this Act; and 

6 ‘‘(2) for which the requirements of subsection 

7 (d) are met. 

8 ‘‘(b) INFORMATION GENERALLY PROTECTED FROM

9 DISCLOSURE.—The following information specific to, and 

10 submitted by, a manufacturer, processor, or distributor 

11 that meets the requirements of subsections (a) and (d) 

12 shall be presumed to be protected from disclosure, subject 

13 to the condition that nothing in this Act prohibits the dis14 closure of any such information through discovery, sub15 poena, other court order, or any other judicial process oth16 erwise allowed under applicable Federal or State law: 

17 ‘‘(1) Specific information describing the proc18 esses used in manufacture or processing of a chem19 ical substance, mixture, or article. 

20 ‘‘(2) Marketing and sales information. 

21 ‘‘(3) Information identifying a supplier or cus22 tomer. 

23 ‘‘(4) Details of the full composition of a mixture 

24 and the respective percentages of constituents. 


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1 ‘‘(5) Specific information regarding the use, 

2 function, or application of a chemical substance or 

3 mixture in a process, mixture, or product. 

4 ‘‘(6) Specific production or import volumes of 

5 the manufacturer and specific aggregated volumes 

6 across manufacturers, if the Administrator deter7 mines that disclosure of the specific aggregated vol8 umes would reveal confidential information. 

9 ‘‘(7) Except as otherwise provided in this sec10 tion, the specific identity of a chemical substance 

11 prior to the date on which the chemical substance is 

12 first offered for commercial distribution, including 

13 the chemical name, molecular formula, Chemical Ab14 stracts Service number, and other information that 

15 would identify a specific chemical substance, if— 

16 ‘‘(A) the specific identity was claimed as 

17 confidential information at the time it was sub18 mitted in a notice under section 5; and 

19 ‘‘(B) the claim— 

20 ‘‘(i) is not subject to an exception 

21 under subsection (e); or 

22 ‘‘(ii) has not subsequently been with23 drawn or found by the Administrator not 

24 to warrant protection as confidential infor25 mation under subsection (f)(2) or (g). 


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1 ‘‘(c) INFORMATION NOT PROTECTED FROM DISCLO2 SURE.—Notwithstanding subsections (a) and (b), the fol3 lowing information shall not be protected from disclosure: 

4 ‘‘(1) INFORMATION FROM HEALTH AND SAFETY

5 STUDIES.— 

6 ‘‘(A) IN GENERAL.—Subject to subpara7 graph (B), subsection (a) does not prohibit the 

8 disclosure of— 

9 ‘‘(i) any health and safety study that 

10 is submitted under this Act with respect 

11 to— 

12 ‘‘(I) any chemical substance or 

13 mixture that, on the date on which 

14 the study is to be disclosed, has been 

15 offered for commercial distribution; or 

16 ‘‘(II) any chemical substance or 

17 mixture for which— 

18 ‘‘(aa) testing is required 

19 under section 4; or 

20 ‘‘(bb) a notification is re21 quired under section 5; or 

22 ‘‘(ii) any information reported to, or 

23 otherwise obtained by, the Administrator 

24 from a health and safety study relating to 


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1 a chemical substance or mixture described 

2 in subclause (I) or (II) of clause (i). 

3 ‘‘(B) EFFECT OF PARAGRAPH.—Nothing 

4 in this paragraph authorizes the release of any 

5 information that discloses— 

6 ‘‘(i) a process used in the manufac7 turing or processing of a chemical sub8 stance or mixture; or 

9 ‘‘(ii) in the case of a mixture, the por10 tion of the mixture comprised by any 

11 chemical substance in the mixture. 

12 ‘‘(2) CERTAIN REQUESTS.—If a request is made 

13 to the Administrator under section 552(a) of title 5, 

14 United States Code, for information that is de15 scribed in paragraph (1) that is not described in 

16 paragraph (1)(B), the Administrator may not deny 

17 the request on the basis of section 552(b)(4) of title 

18 5, United States Code. 

19 ‘‘(3) OTHER INFORMATION NOT PROTECTED

20 FROM DISCLOSURE.—The following information is 

21 not protected from disclosure under this section: 

22 ‘‘(A) For information submitted after the 

23 date of enactment of the Frank R. Lautenberg 

24 Chemical Safety for the 21st Century Act, the 

25 specific identity of a chemical substance as of 


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1 the date on which the chemical substance is 

2 first offered for commercial distribution, if the 

3 person submitting the information does not 

4 meet the requirements of subsection (d). 

5 ‘‘(B) A safety assessment developed, or a 

6 safety determination made, under section 6. 

7 ‘‘(C) Any general information describing 

8 the manufacturing volumes, expressed as spe9 cific aggregated volumes or, if the Adminis10 trator determines that disclosure of specific ag11 gregated volumes would reveal confidential in12 formation, expressed in ranges. 

13 ‘‘(D) A general description of a process 

14 used in the manufacture or processing and in15 dustrial, commercial, or consumer functions and 

16 uses of a chemical substance, mixture, or article 

17 containing a chemical substance or mixture, in18 cluding information specific to an industry or 

19 industry sector that customarily would be 

20 shared with the general public or within an in21 dustry or industry sector. 

22 ‘‘(4) MIXED CONFIDENTIAL AND NONCON23 FIDENTIAL INFORMATION.—Any information that is 

24 otherwise eligible for protection under this section 

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1 scribed in this subsection shall be protected from 

2 disclosure, if the submitter complies with subsection 

3 (d), subject to the condition that information in the 

4 submission that is not eligible for protection against 

5 disclosure shall be disclosed. 

6 ‘‘(5) BAN OR PHASE-OUT.—If the Adminis7 trator promulgates a rule pursuant to section 6(d) 

8 that establishes a ban or phase-out of the manufac9 ture, processing, or distribution in commerce of a 

10 chemical substance— 

11 ‘‘(A) any protection from disclosure pro12 vided under this section with respect to infor13 mation relating to the chemical substance shall 

14 no longer apply; and 

15 ‘‘(B) the Administrator promptly shall 

16 make the information public. 

17 ‘‘(d) REQUIREMENTS FOR CONFIDENTIALITY

18 CLAIMS.— 

19 ‘‘(1) ASSERTION OF CLAIMS.— 

20 ‘‘(A) IN GENERAL.—A person seeking to 

21 protect any information submitted under this 

22 Act from disclosure (including information de23 scribed in subsection (b)) shall assert to the Ad24 ministrator a claim for protection concurrent 

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1 ance with such rules regarding a claim for pro2 tection from disclosure as the Administrator 

3 has promulgated or may promulgate pursuant 

4 to this title. 

5 ‘‘(B) INCLUSION.—An assertion of a claim 

6 under subparagraph (A) shall include a state7 ment that the person has— 

8 ‘‘(i) taken reasonable measures to pro9 tect the confidentiality of the information; 

10 ‘‘(ii) determined that the information 

11 is not required to be disclosed or otherwise 

12 made available to the public under any 

13 other Federal law; 

14 ‘‘(iii) a reasonable basis to conclude 

15 that disclosure of the information is likely 

16 to cause substantial harm to the competi17 tive position of the person; and 

18 ‘‘(iv) a reasonable basis to believe that 

19 the information is not readily discoverable 

20 through reverse engineering. 

21 ‘‘(C) SPECIFIC CHEMICAL IDENTITY.—In 

22 the case of a claim under subparagraph (A) for 

23 protection against disclosure of a specific chem24 ical identity, the claim shall include a struc25 turally descriptive generic name for the chemVerDate Sep 11 2014 21:05 Jun 17, 2015 Jkt 049200 PO 00000 Frm 00116 Fmt 6652 Sfmt 6401 E:\BILLS\S697.RS S697

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1 ical substance that the Administrator may dis2 close to the public, subject to the condition that 

3 the generic name shall— 

4 ‘‘(i) conform with guidance prescribed 

5 by the Administrator under paragraph 

6 (3)(A); and 

7 ‘‘(ii) describe the chemical structure 

8 of the substance as specifically as prac9 ticable while protecting those features of 

10 the chemical structure— 

11 ‘‘(I) that are considered to be 

12 confidential; and 

13 ‘‘(II) the disclosure of which 

14 would be likely to harm the competi15 tive position of the person. 

16 ‘‘(D) PUBLIC INFORMATION.—No person 

17 may assert a claim under this section for pro18 tection from disclosure of information that is al19 ready publicly available. 

20 ‘‘(2) ADDITIONAL REQUIREMENTS FOR CON21 FIDENTIALITY CLAIMS.—Except for information de22 scribed in paragraphs (1) through (7) of subsection 

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1 tiate the claim, in accordance with the rules promul2 gated and guidance issued by the Administrator. 

3 ‘‘(3) GUIDANCE.—The Administrator shall de4 velop guidance regarding— 

5 ‘‘(A) the determination of structurally de6 scriptive generic names, in the case of claims 

7 for the protection against disclosure of specific 

8 chemical identity; and 

9 ‘‘(B) the content and form of the state10 ments of need and agreements required under 

11 paragraphs (4), (5), and (6) of subsection (e). 

12 ‘‘(4) CERTIFICATION.—An authorized official of 

13 a person described in paragraph (1)(A) shall certify 

14 that the information that has been submitted is true 

15 and correct. 

16 ‘‘(e) EXCEPTIONS TO PROTECTION FROM DISCLO17 SURE.—Information described in subsection (a) shall be 

18 disclosed if— 

19 ‘‘(1) the information is to be disclosed to an of20 ficer or employee of the United States in connection 

21 with the official duties of the officer or employee— 

22 ‘‘(A) under any law for the protection of 

23 health or the environment; or 

24 ‘‘(B) for a specific law enforcement pur25 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.— 

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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 21:05 Jun 17, 2015 Jkt 049200 PO 00000 Frm 00141 Fmt 6652 Sfmt 6401 E:\BILLS\S697.RS 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.’’. 

19 SECTION 1. SHORT TITLE. 

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

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

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

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

24 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 in5 serting ‘‘, as provided under this Act’’ before the pe6 riod at the end; and 

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

8 ‘‘(2) REFORM.—This Act, including reforms in 

9 accordance with the amendments made by the Frank 

10 R. Lautenberg Chemical Safety for the 21st Century 

11 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 environ17 ment from the risks of harmful exposures to 

18 chemical substances and mixtures; and 

19 ‘‘(ii) ensures that appropriate informa20 tion on chemical substances and mixtures is 

21 available to public health officials and first 

22 responders in the event of an emergency; 

23 and 

24 ‘‘(B) shall not displace or supplant common 

25 law rights of action or remedies for civil relief.’’. 


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1 SEC. 3. DEFINITIONS. 

2 Section 3 of the Toxic Substances Control Act (15 

3 U.S.C. 2602) is amended— 

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

5 (7), (8), (9), (10), (11), (12), (13), and (14) as para6 graphs (5), (6), (7), (8), (9), (10), (12), (13), (17), 

7 (18), and (19), respectively; 

8 (2) by inserting after paragraph (3) the fol9 lowing: 

10 ‘‘(4) CONDITIONS OF USE.—The term ‘conditions 

11 of use’ means the intended, known, or reasonably fore12 seeable circumstances the Administrator determines a 

13 chemical substance is manufactured, processed, dis14 tributed in commerce, used, or disposed of.’’; 

15 (3) by inserting after paragraph (10) (as so re16 designated) the following: 

17 ‘‘(11) POTENTIALLY EXPOSED OR SUSCEPTIBLE

18 POPULATION.—The term ‘potentially exposed or sus19 ceptible population’ means 1 or more groups— 

20 ‘‘(A) of individuals within the general pop21 ulation who may be— 

22 ‘‘(i) differentially exposed to chemical 

23 substances under the conditions of use; or 

24 ‘‘(ii) susceptible to greater adverse 

25 health consequences from chemical exposures 

26 than the general population; and 


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1 ‘‘(B) that when identified by the Adminis2 trator may include such groups as infants, chil3 dren, pregnant women, workers, and the elder4 ly.’’; and 

5 (4) by inserting after paragraph (13) (as so re6 designated) the following: 

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

8 assessment’ means an assessment of the risk posed by 

9 a chemical substance under the conditions of use, in10 tegrating hazard, use, and exposure information re11 garding the chemical substance. 

12 ‘‘(15) SAFETY DETERMINATION.—The term ‘safe13 ty determination’ means a determination by the Ad14 ministrator as to whether a chemical substance meets 

15 the safety standard under the conditions of use. 

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

17 standard’ means a standard that ensures, without 

18 taking into consideration cost or other nonrisk fac19 tors, that no unreasonable risk of injury to health or 

20 the environment will result from exposure to a chem21 ical substance under the conditions of use, including 

22 no unreasonable risk of injury to— 

23 ‘‘(A) the general population; or 

24 ‘‘(B) any potentially exposed or susceptible 

25 population that the Administrator has identified 


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1 as relevant to the safety assessment and safety 

2 determination for a chemical substance.’’. 

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

4 The Toxic Substances Control Act is amended by in5 serting after section 3 (15 U.S.C. 2602) the following: 

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

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

8 term ‘guidance’ includes any significant written guidance 

9 of general applicability prepared by the Administrator. 

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

11 of enactment of the Frank R. Lautenberg Chemical Safety 

12 for the 21st Century Act, the Administrator shall develop, 

13 after providing public notice and an opportunity for com14 ment, any policies, procedures, and guidance the Adminis15 trator determines to be necessary to carry out sections 4, 

16 4A, 5, and 6, including the policies, procedures, and guid17 ance required by this section. 

18 ‘‘(c) USE OF SCIENCE.— 

19 ‘‘(1) IN GENERAL.—The Administrator shall es20 tablish policies, procedures, and guidance on the use 

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

22 5, and 6. 

23 ‘‘(2) GOAL.—A goal of the policies, procedures, 

24 and guidance described in paragraph (1) shall be to 

25 make the basis of decisions clear to the public. 


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1 ‘‘(3) REQUIREMENTS.—The policies, procedures, 

2 and guidance issued under this section shall describe 

3 the manner in which the Administrator shall ensure 

4 that — 

5 ‘‘(A) decisions made by the Adminis6 trator— 

7 ‘‘(i) are based on information, proce8 dures, measures, methods, and models em9 ployed in a manner consistent with the best 

10 available science; 

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

12 which— 

13 ‘‘(I) assumptions and methods are 

14 clearly and completely described and 

15 documented; 

16 ‘‘(II) variability and uncertainty 

17 are evaluated and characterized; and 

18 ‘‘(III) the information has been 

19 subject to independent verification and 

20 peer review; and 

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

22 scientific evidence, by which the Adminis23 trator considers all information in a sys24 tematic and integrative framework to con25 sider the relevance of different information; 


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1 ‘‘(B) to the extent practicable and if appro2 priate, the use of peer review, standardized test 

3 design and methods, consistent data evaluation 

4 procedures, and good laboratory practices will be 

5 encouraged; 

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

7 and entity that funded the generation or assess8 ment of information, and the degree of control 

9 those individuals and entities had over the gen10 eration, assessment, and dissemination of infor11 mation (including control over the design of the 

12 work and the publication of information) is 

13 made available; and 

14 ‘‘(D) if appropriate, the recommendations 

15 in reports of the National Academy of Sciences 

16 that provide advice regarding assessing the haz17 ards, exposures, and risks of chemical substances 

18 are considered. 

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

20 GUIDANCE.—The policies, procedures, and guidance de21 scribed in subsection (b) shall incorporate, as appropriate, 

22 existing relevant hazard, exposure, and risk assessment 

23 guidelines and methodologies, data evaluation and quality 

24 criteria, testing methodologies, and other relevant guidelines 

25 and policies of the Environmental Protection Agency. 


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

2 of enactment of the Frank R. Lautenberg Chemical Safety 

3 for the 21st Century Act, and not less frequently than once 

4 every 5 years thereafter, the Administrator shall— 

5 ‘‘(1) review the adequacy of any policies, proce6 dures, and guidance developed under this section, in7 cluding animal, nonanimal, and epidemiological test 

8 methods and procedures for assessing and deter9 mining risk under this Act; and 

10 ‘‘(2) after providing public notice and an oppor11 tunity for comment, revise the policies, procedures, 

12 and guidance if necessary to reflect new scientific de13 velopments or understandings. 

14 ‘‘(f) SOURCES OF INFORMATION.—In carrying out sec15 tions 4, 4A, 5, and 6, the Administrator shall take into con16 sideration information relating to a chemical substance, in17 cluding hazard and exposure information, under the condi18 tions of use that is reasonably available to the Adminis19 trator, including information that is— 

20 ‘‘(1) submitted to the Administrator pursuant to 

21 any rule, consent agreement, order, or other require22 ment of this Act, or on a voluntary basis, including 

23 pursuant to any request made under this Act, by— 

24 ‘‘(A) manufacturers or processors of a sub25 stance; 


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1 ‘‘(B) the public; 

2 ‘‘(C) other Federal departments or agencies; 

3 or 

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

5 agency with responsibility for protecting health 

6 or the environment; 

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

8 jurisdiction pursuant to a governmental requirement 

9 relating to the protection of health or the environ10 ment; or 

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

12 Administrator of information sources that are pub13 licly available or otherwise accessible by the Adminis14 trator. 

15 ‘‘(g) TESTING OF CHEMICAL SUBSTANCES AND MIX16 TURES.— 

17 ‘‘(1) IN GENERAL.—The Administrator shall es18 tablish policies and procedures for the testing of chem19 ical substances or mixtures under section 4. 

20 ‘‘(2) GOAL.—A goal of the policies and proce21 dures established under paragraph (1) shall be to 

22 make the basis of decisions clear to the public. 

23 ‘‘(3) CONTENTS.—The policies and procedures es24 tablished under paragraph (1) shall— 


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

2 level or exposure potential of a chemical sub3 stance would factor into decisions to require new 

4 testing, subject to the condition that the Admin5 istrator shall not interpret the lack of exposure 

6 information as a lack of exposure or exposure po7 tential; 

8 ‘‘(B) describe the manner in which the Ad9 ministrator will determine that additional infor10 mation is necessary to carry out this Act, includ11 ing information relating to potentially exposed 

12 or susceptible populations; 

13 ‘‘(C) require the Administrator to consult 

14 with the Director of the National Institute for 

15 Occupational Safety and Health prior to pre16 scribing epidemiologic studies of employees; and 

17 ‘‘(D) require that prior to making a request 

18 or adopting a requirement for testing using 

19 vertebrate animals, the Administrator shall take 

20 into consideration, as appropriate and to the ex21 tent practicable, reasonably available— 

22 ‘‘(i) toxicity information; 

23 ‘‘(ii) computational toxicology and 

24 bioinformatics; 


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1 ‘‘(iii) high-throughput screening meth2 ods and the prediction models of those meth3 ods; and 

4 ‘‘(iv) scientifically reliable and rel5 evant alternatives to tests on animals that 

6 would provide equivalent information. 

7 ‘‘(h) SAFETY ASSESSMENTS AND SAFETY DETERMINA8 TIONS.— 

9 ‘‘(1) SCHEDULE.— 

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

11 shall inform the public regarding the schedule for 

12 the completion of each safety assessment and 

13 safety determination as soon as practicable after 

14 designation as a high-priority substance pursu15 ant to section 4A. 

16 ‘‘(B) DIFFERING TIMES.—The Adminis17 trator may allot different times for different 

18 chemical substances in the schedules under this 

19 paragraph, subject to the condition that all 

20 schedules shall comply with the deadlines estab21 lished under section 6. 

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

23 each calendar year, the Administrator shall iden24 tify the substances subject to safety assessments 


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1 and safety determinations to be completed that 

2 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 pro10 cedures under this paragraph shall be to make 

11 the basis of decisions of the Administrator clear 

12 to the public. 

13 ‘‘(C) MINIMUM REQUIREMENTS.—At a min14 imum, the policies and procedures under this 

15 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 the 

5 safety assessment and safety deter6 mination to be conducted under section 

7 6, including the hazards, exposures, 

8 conditions of use, and potentially ex9 posed and susceptible populations that 

10 the Administrator expects to consider 

11 in a safety assessment; 

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

13 scope of the safety assessment and safe14 ty 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 ag25 gregate exposures, or significant subsets of 


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1 exposures, to a chemical substance under the 

2 conditions of use will be considered, and ex3 plain the basis for that consideration in the 

4 final safety assessment; 

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

8 ‘‘(I) a description of the weight of 

9 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 transparent 

18 process for evaluating whether new informa19 tion submitted or obtained after the date of 

20 a final safety assessment or safety deter21 mination warrants reconsideration of the 

22 safety assessment or safety determination; 

23 and 

24 ‘‘(vi) when relevant information is pro25 vided 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 their own draft safety 

11 assessments and other information for sub12 mission to the Administrator, which may be 

13 considered at the discretion of the Adminis14 trator. 

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 safety 

19 assessment for consideration by the Admin20 istrator. 

21 ‘‘(i) PUBLICLY AVAILABLE INFORMATION.—Subject to 

22 section 14, the Administrator shall— 

23 ‘‘(1) make publicly available a nontechnical 

24 summary, and the final version, of each safety assess25 ment and safety determination; 


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

2 for comment on each proposed safety assessment and 

3 safety determination; and 

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

5 and safety determination— 

6 ‘‘(A) the list of studies considered by the Ad7 ministrator in carrying out the safety assessment 

8 or safety determination; and 

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

10 guidance that were followed in carrying out the 

11 safety assessment or safety determination. 

12 ‘‘(j) CONSULTATION WITH SCIENCE ADVISORY COM13 MITTEE ON CHEMICALS.— 

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

15 after the date of enactment of this section, the Admin16 istrator shall establish an advisory committee, to be 

17 known as the ‘Science Advisory Committee on Chemi18 cals’ (referred to in this subsection as the ‘Com19 mittee’). 

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

21 shall be to provide independent advice and expert 

22 consultation, on the request of the Administrator, 

23 with respect to the scientific and technical aspects of 

24 issues relating to the implementation of this title. 


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

2 composed of representatives of such science, govern3 ment, labor, public health, public interest, animal 

4 protection, industry, and other groups as the Admin5 istrator determines to be advisable, including, at a 

6 minimum, representatives that have specific scientific 

7 expertise in the relationship of chemical exposures to 

8 women, children, and other potentially exposed or 

9 susceptible populations. 

10 ‘‘(4) SCHEDULE.—The Administrator shall con11 vene the Committee in accordance with such schedule 

12 as the Administrator determines to be appropriate, 

13 but not less frequently than once every 2 years. 

14 ‘‘(5) RELATIONSHIP TO OTHER LAW.—All pro15 ceedings and meetings of the Committee shall be sub16 ject to the Federal Advisory Committee Act (5 U.S.C. 

17 App.).’’. 

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

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

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

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

22 (g); 

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

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

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


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1 (A) by striking ‘‘rule’’ each place it appears 

2 and inserting ‘‘rule, testing consent agreement, 

3 or order’’; 

4 (B) by striking ‘‘under subsection (a)’’ each 

5 place it appears and inserting ‘‘under this sub6 section’’; and 

7 (C) in paragraph (1)— 

8 (i) in subparagraph (A)(v), by insert9 ing ‘‘, without taking into account cost or 

10 other nonrisk factors’’ after ‘‘the environ11 ment’’; and 

12 (ii) in subparagraph (B), in the last 

13 sentence, by striking ‘‘rulemaking’’; 

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

15 (A) in the first sentence— 

16 (i) by striking ‘‘from cancer, gene 

17 mutations, or birth defects’’; and 

18 (ii) by inserting ‘‘, without taking into 

19 account cost or other nonrisk factors’’ before 

20 the period at the end; and 

21 (B) by striking the last sentence; and 

22 (5) by inserting before subsection (f) (as so redes23 ignated) the following: 

24 ‘‘(a) DEVELOPMENT OF NEW INFORMATION ON CHEM25 ICAL SUBSTANCES AND MIXTURES.— 


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1 ‘‘(1) IN GENERAL.—The Administrator may re2 quire the development of new information relating to 

3 a chemical substance or mixture in accordance with 

4 this section if the Administrator determines that the 

5 information is necessary— 

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

7 or to perform a safety assessment or safety deter8 mination under section 6; 

9 ‘‘(B) to implement a requirement imposed 

10 in a consent agreement or order issued under 

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

12 under section 6(d)(3); 

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

14 ‘‘(D) at the request of the implementing au15 thority under another Federal law, to meet the 

16 regulatory testing needs of that authority. 

17 ‘‘(2) LIMITED TESTING FOR PRIORITIZATION

18 PURPOSES.— 

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

20 subparagraph (B), the Administrator may re21 quire the development of new information for the 

22 purposes of section 4A. 

23 ‘‘(B) PROHIBITION.—Testing required 

24 under subparagraph (A) shall not be required for 


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1 the purpose of establishing or implementing a 

2 minimum information requirement. 

3 ‘‘(C) LIMITATION.—The Administrator may 

4 require the development of new information pur5 suant to subparagraph (A) only if the Adminis6 trator determines that additional information is 

7 necessary to establish the priority of a chemical 

8 substance. 

9 ‘‘(3) FORM.—The Administrator may require the 

10 development of information described in paragraph 

11 (1) or (2) by— 

12 ‘‘(A) promulgating a rule; 

13 ‘‘(B) entering into a testing consent agree14 ment; or 

15 ‘‘(C) issuing an order. 

16 ‘‘(4) CONTENTS.— 

17 ‘‘(A) IN GENERAL.—A rule, testing consent 

18 agreement, or order issued under this subsection 

19 shall include— 

20 ‘‘(i) identification of the chemical sub21 stance or mixture for which testing is re22 quired; 

23 ‘‘(ii) identification of the persons re24 quired to conduct the testing; 


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1 ‘‘(iii) test protocols and methodologies 

2 for the development of information for the 

3 chemical substance or mixture, including 

4 specific reference to any reliable nonanimal 

5 test procedures; and 

6 ‘‘(iv) specification of the period within 

7 which individuals and entities required to 

8 conduct the testing shall submit to the Ad9 ministrator the information developed in 

10 accordance with the procedures described in 

11 clause (iii). 

12 ‘‘(B) CONSIDERATIONS.—In determining 

13 the procedures and period to be required under 

14 subparagraph (A), the Administrator shall take 

15 into consideration— 

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

17 protocols and methodologies that may be re18 quired; and 

19 ‘‘(ii) the reasonably foreseeable avail20 ability of facilities and personnel required 

21 to perform the testing. 

22 ‘‘(b) STATEMENT OF NEED.— 

23 ‘‘(1) IN GENERAL.—In promulgating a rule, en24 tering into a testing consent agreement, or issuing an 

25 order for the development of additional information 


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1 (including information on exposure or exposure po2 tential) pursuant to this section, the Administrator 

3 shall— 

4 ‘‘(A) identify the need intended to be met by 

5 the rule, agreement, or order; 

6 ‘‘(B) explain why information reasonably 

7 available to the Administrator at that time is in8 adequate to meet that need, including a ref9 erence, as appropriate, to the information identi10 fied in paragraph (2)(B); and 

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

12 requires the use of vertebrate animals. 

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

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

15 issues an order under this section, the Adminis16 trator shall issue a statement providing a jus17 tification for why issuance of an order is war18 ranted instead of promulgating a rule or enter19 ing into a testing consent agreement. 

20 ‘‘(B) CONTENTS.—A statement described in 

21 subparagraph (A) shall contain a description 

22 of— 

23 ‘‘(i) information that is readily acces24 sible to the Administrator, including inforVerDate Sep 11 2014 21:05 Jun 17, 2015 Jkt 049200 PO 00000 Frm 00196 Fmt 6652 Sfmt 6203 E:\BILLS\S697.RS S697

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1 mation submitted under any other provi2 sion of law; 

3 ‘‘(ii) the extent to which the Adminis4 trator has obtained or attempted to obtain 

5 the information through voluntary submis6 sions; and 

7 ‘‘(iii) any information relied on in 

8 safety assessments for other chemical sub9 stances relevant to the chemical substances 

10 that would be the subject of the order. 

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

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

13 minimize, to the extent practicable, the use of 

14 vertebrate animals in testing of chemical substances 

15 or mixtures, by— 

16 ‘‘(A) encouraging and facilitating— 

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

18 testing and assessment strategies; 

19 ‘‘(ii) the use of best available science in 

20 existence on the date on which the test is 

21 conducted; 

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

23 eliminate or reduce the use of animals while 

24 providing information of high scientific 

25 quality; 


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1 ‘‘(iv) the grouping of 2 or more chem2 ical substances into scientifically appro3 priate categories in cases in which testing of 

4 a chemical substance would provide reliable 

5 and useful information on other chemical 

6 substances in the category; 

7 ‘‘(v) the formation of industry con8 sortia to jointly conduct testing to avoid 

9 unnecessary duplication of tests; and 

10 ‘‘(vi) the submission of information 

11 from— 

12 ‘‘(I) animal-based studies; and 

13 ‘‘(II) emerging methods and mod14 els; and 

15 ‘‘(B) funding research and validation stud16 ies to reduce, refine, and replace the use of ani17 mal tests in accordance with this subsection. 

18 ‘‘(2) IMPLEMENTATION OF ALTERNATIVE TESTING

19 METHODS.—To promote the development and timely 

20 incorporation of new testing methods that are not 

21 based on vertebrate animals, the Administrator 

22 shall— 

23 ‘‘(A) not later than 2 years after the date 

24 of enactment of the Frank R. Lautenberg Chem25 ical Safety for the 21st Century Act, develop a 


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1 strategic plan to promote the development and 

2 implementation of alternative test methods and 

3 testing strategies to generate information under 

4 this title that can reduce, refine, or replace the 

5 use of vertebrate animals, including toxicity 

6 pathway-based risk assessment, in vitro studies, 

7 systems biology, computational toxicology, 

8 bioinformatics, and high-throughput screening; 

9 ‘‘(B) as practicable, ensure that the stra10 tegic plan developed under subparagraph (A) is 

11 reflected in the development of requirements for 

12 testing under this section; 

13 ‘‘(C) identify in the strategic plan developed 

14 under subparagraph (A) particular alternative 

15 test methods or testing strategies that do not re16 quire new vertebrate animal testing and are sci17 entifically reliable, relevant, and capable of pro18 viding information of equivalent scientific reli19 ability and quality to that which would be ob20 tained from vertebrate animal testing; 

21 ‘‘(D) provide an opportunity for public no22 tice and comment on the contents of the plan de23 veloped under subparagraph (A), including the 

24 criteria for considering scientific reliability, rel25 evance, and equivalent information and the test 


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1 methods and strategies identified in subpara2 graph (C); 

3 ‘‘(E) beginning on the date that is 5 years 

4 after the date of enactment of the Frank R. Lau5 tenberg Chemical Safety for the 21st Century Act 

6 and every 5 years thereafter, submit to Congress 

7 a report that describes the progress made in im8 plementing this subsection and goals for future 

9 alternative test methods implementation; 

10 ‘‘(F) fund and carry out research, develop11 ment, performance assessment, and translational 

12 studies to accelerate the development of test meth13 ods and testing strategies that reduce, refine, or 

14 replace the use of vertebrate animals in any test15 ing under this title; and 

16 ‘‘(G) identify synergies with the related in17 formation requirements of other jurisdictions to 

18 minimize the potential for additional or duplica19 tive testing. 

20 ‘‘(3) CRITERIA FOR ADAPTING OR WAIVING ANI21 MAL TESTING REQUIREMENTS.—On request from a 

22 manufacturer or processor that is required to conduct 

23 testing of a chemical substance or mixture on 

24 vertebrate animals under this section, the AdminisVerDate Sep 11 2014 21:05 Jun 17, 2015 Jkt 049200 PO 00000 Frm 00200 Fmt 6652 Sfmt 6203 E:\BILLS\S697.RS S697

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1 trator may adapt or waive the requirement, if the Ad2 ministrator determines that— 

3 ‘‘(A) there is sufficient evidence from several 

4 independent sources of information to support a 

5 conclusion that a chemical substance or mixture 

6 has, or does not have, a particular property if 

7 the information from each individual source 

8 alone is insufficient to support the conclusion; 

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

10 chemical properties of the chemical substance or 

11 mixture or other toxicokinetic considerations— 

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

13 or 

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

15 technically not practicable to conduct; or 

16 ‘‘(C) a chemical substance or mixture can17 not be tested in vertebrate animals at concentra18 tions that do not result in significant pain or 

19 distress, because of physical or chemical prop20 erties of the chemical substance or mixture, such 

21 as a potential to cause severe corrosion or severe 

22 irritation to the tissues of the animal. 

23 ‘‘(4) VOLUNTARY TESTING.— 

24 ‘‘(A) IN GENERAL.—Any person developing 

25 information for submission under this title on a 


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1 voluntary basis and not pursuant to any request 

2 or requirement by the Administrator shall first 

3 attempt to develop the information by means of 

4 an alternative or nonanimal test method or test5 ing strategy that the Administrator has deter6 mined under paragraph (2)(C) to be scientif7 ically reliable, relevant, and capable of providing 

8 equivalent information, before conducting new 

9 animal testing. 

10 ‘‘(B) EFFECT OF PARAGRAPH.—Nothing in 

11 this paragraph— 

12 ‘‘(i) requires the Administrator to re13 view the basis on which the person is con14 ducting testing described in subparagraph 

15 (A); 

16 ‘‘(ii) prohibits the use of other test 

17 methods or testing strategies by any person 

18 for purposes other than developing informa19 tion for submission under this title on a 

20 voluntary basis; or 

21 ‘‘(iii) prohibits the use of other test 

22 methods or testing strategies by any person, 

23 subsequent to the attempt to develop infor24 mation using the test methods and testing 


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1 strategies identified by the Administrator 

2 under paragraph (2)(C). 

3 ‘‘(d) TESTING REQUIREMENTS.— 

4 ‘‘(1) IN GENERAL.—The Administrator may re5 quire the development of information by— 

6 ‘‘(A) manufacturers and processors of the 

7 chemical substance or mixture; and 

8 ‘‘(B) subject to paragraph (3), persons that 

9 begin to manufacture or process the chemical 

10 substance or mixture— 

11 ‘‘(i) after the effective date of the rule, 

12 testing consent agreement, or order; but 

13 ‘‘(ii) before the period ending on the 

14 later of— 

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

16 to in clause (i); or 

17 ‘‘(II) the last day of the period 

18 that begins on the date referred to in 

19 clause (i) and that is equal to the pe20 riod that the Administrator determines 

21 was necessary to develop the informa22 tion. 

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

24 permit 2 or more persons identified in subparagraph 


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1 (A) or (B) of paragraph (1) to designate 1 of the per2 sons or a qualified third party— 

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

4 ‘‘(B) to submit the information on behalf of 

5 the persons making the designation. 

6 ‘‘(3) EXEMPTIONS.— 

7 ‘‘(A) IN GENERAL.—A person otherwise sub8 ject to a rule, testing consent agreement, or order 

9 under this section may submit to the Adminis10 trator an application for an exemption on the 

11 basis that the information is being developed by 

12 a person designated under paragraph (2). 

13 ‘‘(B) FAIR AND EQUITABLE REIMBURSE14 MENT TO DESIGNEE.— 

15 ‘‘(i) IN GENERAL.—If the Adminis16 trator accepts an application submitted 

17 under subparagraph (A), the Administrator 

18 shall direct the applicant to provide to the 

19 person designated under paragraph (2) fair 

20 and equitable reimbursement, as agreed to 

21 between the applicant and the designee. 

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

23 and a person designated under paragraph 

24 (2) cannot reach agreement on the amount 


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1 of fair and equitable reimbursement, the 

2 amount shall be determined by arbitration. 

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

4 exemption under this paragraph, the Adminis5 trator determines that no person designated 

6 under paragraph (2) has complied with the rule, 

7 testing consent agreement, or order, the Adminis8 trator shall— 

9 ‘‘(i) by order, terminate the exemption; 

10 and 

11 ‘‘(ii) notify in writing each person that 

12 received an exemption of the requirements 

13 with respect to which the exemption was 

14 granted. 

15 ‘‘(4) TIERED TESTING.— 

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

17 subparagraph (D), the Administrator shall em18 ploy a tiered screening and testing process, 

19 under which the results of screening-level tests or 

20 assessments of available information inform the 

21 decision as to whether 1 or more additional tests 

22 are necessary. 

23 ‘‘(B) SCREENING-LEVEL TESTS.— 

24 ‘‘(i) IN GENERAL.—The screening-level 

25 tests required for a chemical substance or 


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1 mixture may include tests for hazard 

2 (which may include in silico, in vitro, and 

3 in vivo tests), environmental and biological 

4 fate and transport, and measurements or 

5 modeling of exposure or exposure potential, 

6 as appropriate. 

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

8 be used— 

9 ‘‘(I) to screen chemical substances 

10 or mixtures for potential adverse ef11 fects; and 

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

13 Administrator regarding whether more 

14 complex or targeted additional testing 

15 is necessary. 

16 ‘‘(C) ADDITIONAL TESTING.—If the Admin17 istrator determines under subparagraph (B) that 

18 additional testing is necessary to provide more 

19 definitive information for safety assessments or 

20 safety determinations, the Administrator may 

21 require more advanced tests for potential health 

22 or environmental effects or exposure potential. 

23 ‘‘(D) ADVANCED TESTING WITHOUT

24 SCREENING.—The Administrator may require 

25 more advanced testing without conducting 


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1 screening-level testing when other information 

2 available to the Administrator justifies the ad3 vanced testing, pursuant to guidance developed 

4 by the Administrator under this section. 

5 ‘‘(e) TRANSPARENCY.—Subject to section 14, the Ad6 ministrator shall make available to the public all testing 

7 consent agreements and orders and all information sub8 mitted under this section.’’. 

9 (b) CONFORMING AMENDMENT.—Section 104(i)(5)(A) 

10 of the Comprehensive Environmental Response, Compensa11 tion, and Liability Act of 1980 (42 U.S.C. 9604(i)(5)(A)) 

12 is amended in the third sentence by striking ‘‘section 4(e)’’ 

13 and inserting ‘‘section 4(f)’’. 

14 SEC. 6. PRIORITIZATION SCREENING. 

15 The Toxic Substances Control Act is amended by in16 serting after section 4 (15 U.S.C. 2603) the following: 

17 ‘‘SEC. 4A. PRIORITIZATION SCREENING. 

18 ‘‘(a) PRIORITIZATION SCREENING PROCESS AND LIST

19 OF SUBSTANCES.— 

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

21 the date of enactment of this section, the Adminis22 trator shall establish, by rule, a risk-based screening 

23 process and explicit criteria for identifying existing 

24 chemical substances that are— 


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1 ‘‘(A) a high priority for a safety assessment 

2 and safety determination under section 6 (re3 ferred 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 Act 

7 as ‘low-priority substances’). 

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

9 SUBSTANCES.— 

10 ‘‘(A) IN GENERAL.—Before the date of pro11 mulgation of the rule under paragraph (1) and 

12 not later than 180 days after the date of enact13 ment 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-priority 

20 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 and 

3 subsequent updates, and at least 10 low-pri4 ority substances. 

5 ‘‘(ii) SUBSEQUENTLY IDENTIFIED SUB6 STANCES.—Insofar as possible, at least 50 

7 percent of all substances subsequently iden8 tified by the Administrator as high-priority 

9 substances shall be drawn from the list of 

10 chemical substances identified by the Ad11 ministrator 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 ‘‘(iii) PERSISTENCE AND BIOACCUMU16 LATION.—In developing the initial list and 

17 in identifying additional high-priority sub18 stances, the Administrator shall give pref19 erence to chemical substances scored as high 

20 for persistence and bioaccumulation in the 

21 October 2014 TSCA Work Plan and subse22 quent updates. 

23 ‘‘(C) ADDITIONAL CHEMICAL REVIEWS.— 

24 The Administrator shall, as soon as practicable 

25 and not later than— 


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1 ‘‘(i) 3 years after the date of enactment 

2 of the Frank R. Lautenberg Chemical Safe3 ty for the 21st Century Act, add additional 

4 high-priority substances sufficient to ensure 

5 that at least a total of 20 high-priority sub6 stances have undergone or are undergoing 

7 the process established in section 6(a), and 

8 additional low-priority substances sufficient 

9 to ensure that at least a total of 20 low-pri10 ority substances have been designated; and 

11 ‘‘(ii) 5 years after the date of enact12 ment of the Frank R. Lautenberg Chemical 

13 Safety for the 21st Century Act, add addi14 tional high-priority substances sufficient to 

15 ensure that at least a total of 25 high-pri16 ority substances have undergone or are un17 dergoing the process established in section 

18 6(a), and additional low-priority substances 

19 sufficient to ensure that at least a total of 

20 25 low-priority substances have been des21 ignated. 

22 ‘‘(3) IMPLEMENTATION.— 

23 ‘‘(A) CONSIDERATION OF ACTIVE AND INAC24 TIVE SUBSTANCES.— 


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1 ‘‘(i) ACTIVE SUBSTANCES.—In car2 rying out paragraph (1), the Administrator 

3 shall take into consideration active sub4 stances, as determined under section 8, 

5 which may include chemical substances on 

6 the interim list of active substances estab7 lished under that section. 

8 ‘‘(ii) INACTIVE SUBSTANCES.—In car9 rying out paragraph (1), the Administrator 

10 may take into consideration inactive sub11 stances, as determined under section 8, that 

12 the Administrator determines— 

13 ‘‘(I)(aa) have not been subject to a 

14 regulatory or other enforceable action 

15 by the Administrator to ban or phase 

16 out the substances; and 

17 ‘‘(bb) have the potential for high 

18 hazard and widespread exposure; or 

19 ‘‘(II)(aa) have been subject to a 

20 regulatory or other enforceable action 

21 by the Administrator to ban or phase 

22 out the substances; and 

23 ‘‘(bb) with respect to which there 

24 exists the potential for residual high 

25 hazards or widespread exposures not 


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1 otherwise addressed by the regulatory 

2 or other action. 

3 ‘‘(iii) REPOPULATION.— 

4 ‘‘(I) IN GENERAL.—On the com5 pletion of a safety determination under 

6 section 6 for a chemical substance, the 

7 Administrator shall remove the chem8 ical substance from the list of high-pri9 ority substances established under this 

10 subsection. 

11 ‘‘(II) ADDITIONS.—The Adminis12 trator shall add at least 1 chemical 

13 substance to the list of high-priority 

14 substances for each chemical substance 

15 removed from the list of high-priority 

16 substances established under this sub17 section, until a safety assessment and 

18 safety determination is completed for 

19 all high-priority substances. 

20 ‘‘(III) LOW-PRIORITY SUB21 STANCES.—If a low-priority substance 

22 is subsequently designated as a high23 priority substance, the Administrator 

24 shall remove that substance from the 

25 list of low-priority substances. 


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1 ‘‘(B) TIMELY COMPLETION OF

2 PRIORITIZATION SCREENING PROCESS.— 

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

4 shall— 

5 ‘‘(I) except as provided under 

6 paragraph (2), not later than 180 days 

7 after the effective date of the final rule 

8 under paragraph (1), begin the 

9 prioritization screening process; and 

10 ‘‘(II) make every effort to complete 

11 the designation of all active substances 

12 as high-priority substances or low-pri13 ority substances in a timely manner. 

14 ‘‘(ii) DECISIONS ON SUBSTANCES SUB15 JECT TO TESTING FOR PRIORITIZATION

16 PURPOSES.—Not later than 90 days after 

17 the date of receipt of information regarding 

18 a chemical substance complying with a rule, 

19 testing consent agreement, or order issued 

20 under section 4(a)(2), the Administrator 

21 shall designate the chemical substance as a 

22 high-priority substance or low-priority sub23 stance. 

24 ‘‘(iii) CONSIDERATION.— 


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1 ‘‘(I) IN GENERAL.—The Adminis2 trator shall screen substances and des3 ignate high-priority substances taking 

4 into consideration the ability of the 

5 Administrator to schedule and com6 plete safety assessments and safety de7 terminations under section 6 in a 

8 timely manner. 

9 ‘‘(II) ANNUAL GOAL.—The Ad10 ministrator shall publish an annual 

11 goal for the number of chemical sub12 stances to be subject to the 

13 prioritization screening process. 

14 ‘‘(C) SCREENING OF CATEGORIES OF SUB15 STANCES.—The Administrator may screen cat16 egories of chemical substances to ensure an effi17 cient prioritization screening process to allow for 

18 timely and adequate designations of high-pri19 ority substances and low-priority substances and 

20 safety assessments and safety determinations for 

21 high-priority substances. 

22 ‘‘(D) PUBLICATION OF LIST OF CHEMICAL

23 SUBSTANCES.—The Administrator shall keep 

24 current and publish a list of chemical substances 

25 that— 


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1 ‘‘(i) are being considered in the 

2 prioritization screening process and the sta3 tus of the chemical substances in the 

4 prioritization process, including those chem5 ical substances for which prioritization de6 cisions have been deferred; and 

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

8 substances or low-priority substances, in9 cluding the bases for such designations. 

10 ‘‘(4) CRITERIA.—The criteria described in para11 graph (1) shall account for— 

12 ‘‘(A) the recommendation of the Governor of 

13 a State or a State agency with responsibility for 

14 protecting health or the environment from chem15 ical substances appropriate for prioritization 

16 screening; 

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

18 the chemical substance (or category of sub19 stances), including persistence, bioaccumulation, 

20 and specific scientific classifications and des21 ignations by authoritative governmental entities; 

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

23 changes in the conditions of use of the chemical 

24 substance; 


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1 ‘‘(D) evidence and indicators of exposure 

2 potential to humans or the environment from the 

3 chemical substance, including potentially exposed 

4 or susceptible populations; 

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

6 manufactured or processed; 

7 ‘‘(F) whether the volume of a chemical sub8 stance as reported under a rule promulgated 

9 pursuant to section 8(a) has significantly in10 creased or decreased during the period beginning 

11 on the date of a previous report or the date on 

12 which a notice has been submitted under section 

13 5(b) for that chemical substance; 

14 ‘‘(G) the availability of information regard15 ing potential hazards and exposures required for 

16 conducting a safety assessment or safety deter17 mination, with limited availability of relevant 

18 information to be a sufficient basis for desig19 nating a chemical substance as a high-priority 

20 substance, subject to the condition that limited 

21 availability shall not require designation as a 

22 high-priority substance; and 

23 ‘‘(H) the extent of Federal or State regula24 tion of the chemical substance or the extent of the 

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1 stance on the United States, with existing Fed2 eral or State regulation of any uses evaluated in 

3 the prioritization screening process as a factor in 

4 designating a chemical substance to be a high5 priority or a low-priority substance. 

6 ‘‘(b) PRIORITIZATION SCREENING PROCESS AND DECI7 SIONS.— 

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

9 process developed under subsection (a) shall include a 

10 requirement that the Administrator shall— 

11 ‘‘(A) identify the chemical substances being 

12 considered for prioritization; 

13 ‘‘(B) request interested persons to supply 

14 information regarding the chemical substances 

15 being considered; 

16 ‘‘(C) apply the criteria identified in sub17 section (a)(4); and 

18 ‘‘(D) subject to paragraph (5) and using the 

19 information available to the Administrator at 

20 the time of the decision, identify a chemical sub21 stance as a high-priority substance or a low-pri22 ority substance. 

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

24 prioritization screening decision regarding a chemical 

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1 formation relating to the chemical substance that is 

2 available to the Administrator. 

3 ‘‘(3) IDENTIFICATION OF HIGH-PRIORITY SUB4 STANCES.—The Administrator— 

5 ‘‘(A) shall identify as a high-priority sub6 stance a chemical substance that, relative to 

7 other active chemical substances, the Adminis8 trator determines has the potential for signifi9 cant hazard and significant exposure; 

10 ‘‘(B) may identify as a high-priority sub11 stance a chemical substance that, relative to 

12 other active chemical substances, the Adminis13 trator determines has the potential for signifi14 cant hazard or significant exposure; and 

15 ‘‘(C) may identify as a high-priority sub16 stance an inactive substance, as determined 

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

18 that the Administrator determines warrants a 

19 safety assessment and safety determination 

20 under section 6. 

21 ‘‘(4) IDENTIFICATION OF LOW-PRIORITY SUB22 STANCES.—The Administrator shall identify as a low23 priority substance a chemical substance that the Ad24 ministrator concludes has information sufficient to esVerDate Sep 11 2014 21:05 Jun 17, 2015 Jkt 049200 PO 00000 Frm 00218 Fmt 6652 Sfmt 6203 E:\BILLS\S697.RS S697

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1 tablish that the chemical substance is likely to meet 

2 the safety standard. 

3 ‘‘(5) DEFERRING A DECISION.—If the Adminis4 trator determines that additional information is re5 quired to establish the priority of a chemical sub6 stance under this section, the Administrator may 

7 defer the prioritization screening decision for a rea8 sonable period— 

9 ‘‘(A) to allow for the submission of addi10 tional information by an interested person and 

11 for the Administrator to evaluate the additional 

12 information; or 

13 ‘‘(B) to require the development of informa14 tion pursuant to a rule, testing consent agree15 ment, or order issued under section 4(a)(2). 

16 ‘‘(6) DEADLINES FOR SUBMISSION OF INFORMA17 TION.—If the Administrator requests the development 

18 or submission of information under this section, the 

19 Administrator shall establish a deadline for submis20 sion of the information. 

21 ‘‘(7) NOTICE AND COMMENT.—The Administrator 

22 shall— 

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1 graphs (3), (4), and (5) and the basis for the de2 cisions; and 

3 ‘‘(B) provide 90 days for public comment. 

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

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

6 discretion of the Administrator, the Adminis7 trator may revise the designation of a chemical 

8 substance as a high-priority substance or a low9 priority substance based on information avail10 able to the Administrator after the date of the de11 termination under paragraph (3) or (4). 

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

13 availability of relevant information was a basis 

14 in the designation of a chemical substance as a 

15 high-priority substance, the Administrator shall 

16 reevaluate the prioritization screening of the 

17 chemical substance on receiving the relevant in18 formation. 

19 ‘‘(9) OTHER INFORMATION RELEVANT TO

20 PRIORITIZATION.— 

21 ‘‘(A) IN GENERAL.—If, after the date of en22 actment of the Frank R. Lautenberg Chemical 

23 Safety for the 21st Century Act, a State proposes 

24 an administrative action or enacts a statute or 

25 takes an administrative action to prohibit or 


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1 otherwise restrict the manufacturing, processing, 

2 distribution in commerce, or use of a chemical 

3 substance that the Administrator has not des4 ignated as a high-priority substance, the Gov5 ernor or State agency with responsibility for im6 plementing the statute or administrative action 

7 shall notify the Administrator. 

8 ‘‘(B) REQUESTS FOR INFORMATION.—Fol9 lowing receipt of a notification provided under 

10 subparagraph (A), the Administrator may re11 quest any available information from the Gov12 ernor or the State agency with respect to— 

13 ‘‘(i) scientific evidence related to the 

14 hazards, exposures and risks of the chemical 

15 substance under the conditions of use which 

16 the statute or administrative action is in17 tended to address; 

18 ‘‘(ii) any State or local conditions 

19 which warranted the statute or administra20 tive action; 

21 ‘‘(iii) the statutory or administrative 

22 authority on which the action is based; and 

23 ‘‘(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 substances 

6 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 significant 

13 impact on interstate commerce; or 

14 ‘‘(III) have been subject to a pro15 hibition or other restriction under a 

16 statute or administrative action in 2 

17 or more States. 

18 ‘‘(D) AVAILABILITY TO PUBLIC.—Subject to 

19 section 14 and any applicable State law regard20 ing the protection of confidential information 

21 provided to the State or to the Administrator, 

22 the Administrator shall make information re23 ceived from a Governor or State agency under 

24 subparagraph (A) publicly available. 


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1 ‘‘(E) EFFECT OF PARAGRAPH.—Nothing in 

2 this paragraph shall preempt a State statute or 

3 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 Administrator 

9 shall— 

10 ‘‘(A) review the process on the basis of expe11 rience 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 designa17 tion by the Administrator under this section with re18 spect to a chemical substance shall not affect— 

19 ‘‘(A) the manufacture, processing, distribu20 tion in commerce, use, or disposal of the chem21 ical substance; or 

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

23 ‘‘(c) ADDITIONAL PRIORITIES FOR SAFETY ASSESS24 MENTS AND DETERMINATIONS.— 

25 ‘‘(1) REQUIREMENTS.— 


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

2 screening process developed under subsection (a) 

3 shall— 

4 ‘‘(i) include a process by which a man5 ufacturer or processor of an active chemical 

6 substance that has not been designated a 

7 high-priority substance or is not in the 

8 process of a prioritization screening by the 

9 Administrator, may request that the Ad10 ministrator designate the substance as an 

11 additional priority for a safety assessment 

12 and safety determination, subject to the 

13 payment of fees pursuant to section 

14 26(b)(3)(E); 

15 ‘‘(ii) specify the information to be pro16 vided in such requests; and 

17 ‘‘(iii) specify the criteria the Adminis18 trator shall use to determine whether or not 

19 to grant such a request, which shall include 

20 whether the substance is subject to restric21 tions imposed by statutes enacted or admin22 istrative actions taken by 1 or more States 

23 on the manufacture, processing, distribution 

24 in commerce, or use of the substance. 


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1 ‘‘(B) PREFERENCE.—Subject to paragraph 

2 (2), in deciding whether to grant requests under 

3 this subsection the Administrator shall give a 

4 preference to requests concerning substances for 

5 which the Administrator determines that restric6 tions imposed by 1 or more States have the po7 tential to have a significant impact on interstate 

8 commerce or health or the environment. 

9 ‘‘(C) EXCEPTIONS.—Chemical substances 

10 for which requests have been granted under this 

11 subsection shall not be subject to subsection 

12 (a)(3)(A)(iii) or section 18(b). 

13 ‘‘(2) LIMITATIONS.—In considering whether to 

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

15 Administrator shall ensure that— 

16 ‘‘(A) if a sufficient number of additional 

17 priority requests meet the requirements of para18 graph (1), not less than 25 percent, or more than 

19 30 percent, of the cumulative number of sub20 stances designated to undergo safety assessments 

21 and safety determinations under subsections 

22 (a)(2) and (b)(3) are substances designated 

23 under the process and criteria pursuant to para24 graph (1); 


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1 ‘‘(B) the resources allocated to conducting 

2 safety assessments and safety determinations for 

3 additional priorities designated under this sub4 section are proportionate to the number of such 

5 substances relative to the total number of sub6 stances designated to undergo safety assessments 

7 and safety determinations under this section; 

8 and 

9 ‘‘(C) the number of additional priority re10 quests stipulated under subparagraph (A) is in 

11 addition to the total number of high-priority 

12 substances identified under subsections (a)(2) 

13 and (b)(3). 

14 ‘‘(3) ADDITIONAL REVIEW OF WORK PLAN CHEMI15 CALS FOR SAFETY ASSESSMENT AND SAFETY DETER16 MINATION.—In the case of a request under paragraph 

17 (1) with respect to a chemical substance identified by 

18 the Administrator in the October 2014 Work Plan— 

19 ‘‘(A) the 30-percent cap specified in para20 graph (2)(A) shall not apply and the addition of 

21 Work Plan chemicals shall be at the discretion of 

22 the Administrator; and 

23 ‘‘(B) notwithstanding paragraph (1)(C), re24 quests for additional Work Plan chemicals under 

25 this subsection shall be considered high-priority 


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1 chemicals subject to section 18(b) but not sub2 section (a)(3)(A)(iii). 

3 ‘‘(4) REQUIREMENTS.— 

4 ‘‘(A) IN GENERAL.—The public shall be pro5 vided notice and an opportunity to comment on 

6 requests submitted under this subsection. 

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

8 later than 180 days after the date on which the 

9 Administrator receives a request under this sub10 section, the Administrator shall decide whether 

11 or not to grant the request. 

12 ‘‘(C) ASSESSMENT AND DETERMINATION.— 

13 If the Administrator grants a request under this 

14 subsection, the safety assessment and safety de15 termination— 

16 ‘‘(i) shall be conducted in accordance 

17 with the deadlines and other requirements 

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

19 ‘‘(ii) shall not be expedited or otherwise 

20 subject to special treatment relative to high21 priority substances designated pursuant to 

22 subsection (b)(3) that are undergoing safety 

23 assessments and safety determinations.’’. 


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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 head5 ing 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 subsection 

9 (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’’; 

16 (B) in paragraph (1)— 

17 (i) in the matter preceding subpara18 graph (A), by striking ‘‘subsection (h)’’ and 

19 inserting ‘‘paragraph (3) and subsection 

20 (h)’’; and 

21 (ii) in the matter following subpara22 graph (B)— 

23 (I) by striking ‘‘subsection (d)’’ 

24 and inserting ‘‘subsection (c)’’; and 


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1 (II) by striking ‘‘and such person 

2 complies with any applicable require3 ment of subsection (b)’’; and 

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

5 ‘‘(3) ARTICLE CONSIDERATION.—The Adminis6 trator may require the notification for the import or 

7 processing of a chemical substance as part of an arti8 cle or category of articles under paragraph (1)(B) if 

9 the Administrator makes an affirmative finding in a 

10 rule under paragraph (2) that the reasonable poten11 tial for exposure to the chemical substance through the 

12 article or category of articles subject to the rule war13 rants notification.’’; 

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

15 subsections (d) and (c), respectively, and moving sub16 section (c) (as so redesigned) so as appear after sub17 section (b) (as redesignated by paragraph (3)); 

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

19 (A) by striking paragraph (1) and inserting 

20 the following: 

21 ‘‘(1) IN GENERAL.—The notice required by sub22 section (b) shall include, with respect to a chemical 

23 substance— 


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1 ‘‘(A) the information required by sections 

2 720.45 and 720.50 of title 40, Code of Federal 

3 Regulations (or successor regulations); and 

4 ‘‘(B) information regarding conditions of 

5 use and reasonably anticipated exposures.’’; 

6 (B) in paragraph (2)— 

7 (i) in the matter preceding subpara8 graph (A)— 

9 (I) by striking ‘‘subsection (a)’’ 

10 and inserting ‘‘subsection (b)’’; and 

11 (II) by striking ‘‘or of data under 

12 subsection (b)’’; 

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

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

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

16 ‘‘; and’’ and inserting a period; and 

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

18 (C) in paragraph (3), by striking ‘‘sub19 section (a) and for which the notification period 

20 prescribed by subsection (a), (b), or (c)’’ and in21 serting ‘‘subsection (b) and for which the notifi22 cation period prescribed by subsection (b) or 

23 (d)’’; 

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

25 paragraph (6)) and inserting the following: 


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1 ‘‘(d) REVIEW OF NOTICE.— 

2 ‘‘(1) INITIAL REVIEW.— 

3 ‘‘(A) IN GENERAL.—Subject to subpara4 graph (B), not later than 90 days after the date 

5 of receipt of a notice submitted under subsection 

6 (b), the Administrator shall— 

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

8 notice; 

9 ‘‘(ii) as needed, develop a profile of the 

10 relevant chemical substance and the poten11 tial for exposure to humans and the envi12 ronment; and 

13 ‘‘(iii) make any necessary determina14 tion under paragraph (3). 

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

16 paragraph (5), the Administrator may extend 

17 the period described in subparagraph (A) for 

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

19 which shall be not more than 90 days. 

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

21 notice under paragraph (1), the Administrator shall 

22 take into consideration— 

23 ‘‘(A) any relevant information identified in 

24 subsection (c)(1); and 


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1 ‘‘(B) any other relevant additional informa2 tion available to the Administrator. 

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

4 applicable period for review under paragraph (1), 

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

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

7 determine that— 

8 ‘‘(A) the relevant chemical substance or sig9 nificant new use is not likely to meet the safety 

10 standard, in which case the Administrator shall 

11 take appropriate action under paragraph (4); 

12 ‘‘(B) the relevant chemical substance or sig13 nificant new use is likely to meet the safety 

14 standard, in which case the Administrator shall 

15 allow the review period to expire without addi16 tional restrictions; or 

17 ‘‘(C) additional information is necessary in 

18 order to make a determination under subpara19 graph (A) or (B), in which case the Adminis20 trator shall take appropriate action under para21 graphs (4) and (5). 

22 ‘‘(4) RESTRICTIONS.— 

23 ‘‘(A) DETERMINATION BY ADMINIS24 TRATOR.— 


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1 ‘‘(i) IN GENERAL.—If the Adminis2 trator makes a determination under sub3 paragraph (A) or (C) of paragraph (3) with 

4 respect to a notice submitted under sub5 section (b)— 

6 ‘‘(I) the Administrator, before the 

7 end of the applicable period for review 

8 under paragraph (1) and by consent 

9 agreement or order, as appropriate, 

10 shall prohibit or otherwise restrict the 

11 manufacture, processing, use, distribu12 tion in commerce, or disposal (as ap13 plicable) of the chemical substance, or 

14 of the chemical substance for a signifi15 cant new use, without compliance with 

16 the restrictions specified in the consent 

17 agreement or order that the Adminis18 trator determines are sufficient to en19 sure that the chemical substance or sig20 nificant new use is likely to meet the 

21 safety standard; and 

22 ‘‘(II) no person may commence 

23 manufacture of the chemical substance, 

24 or manufacture or processing of the 

25 chemical substance for a significant 


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1 new use, except in compliance with the 

2 restrictions specified in the consent 

3 agreement or order. 

4 ‘‘(ii) LIKELY TO MEET STANDARD.—If 

5 the Administrator makes a determination 

6 under subparagraph (B) of paragraph (3) 

7 with respect to a chemical substance or sig8 nificant new use for which a notice was 

9 submitted under subsection (b), at the end 

10 of the applicable period for review under 

11 paragraph (1), the submitter of the notice 

12 may commence manufacture for commercial 

13 purposes of the chemical substance or man14 ufacture or processing of the chemical sub15 stance for a significant new use. 

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

17 days after issuing a consent agreement or order 

18 under subparagraph (A), the Administrator 

19 shall— 

20 ‘‘(i) take into consideration whether to 

21 promulgate a rule pursuant to subsection 

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

23 use any manufacturing, processing, use, dis24 tribution in commerce, or disposal of the 

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1 stance for a new use, that is not in compli2 ance with the restrictions imposed by the 

3 consent agreement or order; and 

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

5 in clause (i); or 

6 ‘‘(II) publish a statement describing 

7 the reasons of the Administrator for not ini8 tiating a rulemaking. 

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

10 restriction under subparagraph (A) may include, 

11 as appropriate— 

12 ‘‘(i) subject to section 18(g), a require13 ment that a chemical substance shall be 

14 marked with, or accompanied by, clear and 

15 adequate minimum warnings and instruc16 tions with respect to use, distribution in 

17 commerce, or disposal, or any combination 

18 of those activities, with the form and con19 tent of the minimum warnings and instruc20 tions to be prescribed by the Administrator 

21 ‘‘(ii) a requirement that manufacturers 

22 or processors of the chemical substance 

23 shall— 

24 ‘‘(I) make and retain records of 

25 the processes used to manufacture or 


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1 process, as applicable, the chemical 

2 substance; or 

3 ‘‘(II) monitor or conduct such ad4 ditional tests as are reasonably nec5 essary to address potential risks from 

6 the manufacture, processing, distribu7 tion in commerce, use, or disposal, as 

8 applicable, of the chemical substance, 

9 subject to section 4; 

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

11 the chemical substance that may be manu12 factured, processed, or distributed in com13 merce— 

14 ‘‘(I) in general; or 

15 ‘‘(II) for a particular use; 

16 ‘‘(iv) a prohibition or other restriction 

17 of— 

18 ‘‘(I) the manufacture, processing, 

19 or distribution in commerce of the 

20 chemical substance for a significant 

21 new use; 

22 ‘‘(II) any method of commercial 

23 use of the chemical substance; or 

24 ‘‘(III) any method of disposal of 

25 the chemical substance; or 


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1 ‘‘(v) a prohibition or other restriction 

2 on the manufacture, processing, or distribu3 tion in commerce of the chemical sub4 stance— 

5 ‘‘(I) in general; or 

6 ‘‘(II) for a particular use. 

7 ‘‘(D) PERSISTENT AND BIOACCUMULATIVE

8 SUBSTANCES.—For a chemical substance the Ad9 ministrator determines ranks high for persistence 

10 and bioaccumulation, the Administrator shall, in 

11 selecting among prohibitions and other restric12 tions that the Administrator determines are suf13 ficient to ensure that the chemical substance is 

14 likely to meet the safety standard, reduce poten15 tial exposure to the substance to the maximum 

16 extent practicable. 

17 ‘‘(E) WORKPLACE EXPOSURES.—The Ad18 ministrator shall consult with the Assistant Sec19 retary of Labor for Occupational Safety and 

20 Health prior to adopting any prohibition or 

21 other restriction under this subsection to address 

22 workplace exposures. 

23 ‘‘(F) DEFINITION OF REQUIREMENT.—For 

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


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1 used in this section does not displace common 

2 law. 

3 ‘‘(5) ADDITIONAL INFORMATION.—If the Admin4 istrator determines under paragraph (3)(C) that ad5 ditional information is necessary to conduct a review 

6 under this subsection, the Administrator— 

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

8 submitter of the notice to submit the additional 

9 information; 

10 ‘‘(B) may, by agreement with the submitter, 

11 extend the review period for a reasonable time to 

12 allow the development and submission of the ad13 ditional information; 

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

15 testing consent agreement, or issue an order 

16 under section 4 to require the development of the 

17 information; and 

18 ‘‘(D) on receipt of information the Adminis19 trator finds supports the determination under 

20 paragraph (3), shall promptly make the deter21 mination.’’; 

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

23 inserting the following: 

24 ‘‘(e) NOTICE OF COMMENCEMENT.— 


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

2 the date on which a manufacturer that has submitted 

3 a notice under subsection (b) commences nonexempt 

4 commercial manufacture of a chemical substance, the 

5 manufacturer shall submit to the Administrator a no6 tice of commencement that identifies— 

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

8 ‘‘(B) the initial date of nonexempt commer9 cial manufacture. 

10 ‘‘(2) WITHDRAWAL.—A manufacturer or proc11 essor that has submitted a notice under subsection (b), 

12 but that has not commenced nonexempt commercial 

13 manufacture or processing of the chemical substance, 

14 may withdraw the notice. 

15 ‘‘(f) FURTHER EVALUATION.—The Administrator may 

16 review a chemical substance under section 4A at any time 

17 after the Administrator receives— 

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

19 substance under subsection (e); or 

20 ‘‘(2) new information regarding the chemical 

21 substance. 

22 ‘‘(g) TRANSPARENCY.—Subject to section 14, the Ad23 ministrator shall make available to the public— 

24 ‘‘(1) all notices, determinations, consent agree25 ments, rules, and orders of the Administrator; and 


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

2 this section.’’; and 

3 (10) in subsection (h)— 

4 (A) in paragraph (1)— 

5 (i) in the matter preceding subpara6 graph (A), by striking ‘‘(a) or’’; and 

7 (ii) in subparagraph (A), by inserting 

8 ‘‘, without taking into account cost or other 

9 nonrisk factors’’ after ‘‘the environment’’; 

10 (B) by striking paragraph (2); 

11 (C) by redesignating paragraphs (3) 

12 through (6) as paragraphs (2) through (5), re13 spectively; 

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

15 in the matter preceding subparagraph (A), by 

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

17 ‘‘subsection (b)’’; 

18 (E) in paragraph (3) (as so redesignated)— 

19 (i) in the first sentence, by striking 

20 ‘‘will not present an unreasonable risk of 

21 injury to health or the environment’’ and 

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

23 and 

24 (ii) by striking the second sentence; 


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

2 by striking ‘‘subsections (a) and (b)’’ and insert3 ing ‘‘subsection (b)’’; and 

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

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

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

7 SEC. 8. SAFETY ASSESSMENTS AND SAFETY DETERMINA8 TIONS. 

9 Section 6 of the Toxic Substances Control Act (15 

10 U.S.C. 2605) is amended— 

11 (1) by striking the section designation and head12 ing and inserting the following: 

13 ‘‘SEC. 6. SAFETY ASSESSMENTS AND SAFETY DETERMINA14 TIONS.’’; 

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

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

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

18 inserting the following: 

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

20 ‘‘(1) shall conduct a safety assessment and make 

21 a safety determination of each high-priority substance 

22 in accordance with subsections (b) and (c); 

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

24 than 6 months after the date on which a chemical 

25 substance is designated as a high-priority substance, 


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1 define and publish the scope of the safety assessment 

2 and safety determination to be conducted pursuant to 

3 this section, including the hazards, exposures, condi4 tions of use, and potentially exposed or susceptible 

5 populations that the Administrator expects to con6 sider; 

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

8 safety determination, shall establish restrictions pur9 suant to subsection (d); 

10 ‘‘(4) shall complete a safety assessment and safe11 ty determination not later than 3 years after the date 

12 on which a chemical substance is designated as a 

13 high-priority substance; 

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

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

16 on which the safety determination is completed; and 

17 ‘‘(6) may extend any deadline under paragraph 

18 (4) or (5) for a reasonable period of time after an 

19 adequate public justification, subject to the condition 

20 that the aggregate length of all extensions of deadlines 

21 under this subsection, plus any deferral under sub22 section (c)(2), does not exceed 2 years. 

23 ‘‘(b) PRIOR ACTIONS AND NOTICE OF EXISTING INFOR24 MATION.— 

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


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

2 prevents the Administrator from initiating a 

3 safety assessment or safety determination regard4 ing a chemical substance, or from continuing or 

5 completing such a safety assessment or safety de6 termination that was initiated before the date of 

7 enactment of the Frank R. Lautenberg Chemical 

8 Safety for the 21st Century Act, prior to the ef9 fective date of the policies and procedures re10 quired to be established by the Administrator 

11 under section 3A or 4A. 

12 ‘‘(B) INTEGRATION OF PRIOR POLICIES AND

13 PROCEDURES.—As policies and procedures under 

14 section 3A and 4A are established, to the max15 imum extent practicable, the Administrator shall 

16 integrate the policies and procedures into ongo17 ing safety assessments and safety determinations. 

18 ‘‘(2) ACTIONS COMPLETED PRIOR TO COMPLE19 TION OF POLICIES AND PROCEDURES.—Nothing in 

20 this Act requires the Administrator to revise or with21 draw a completed safety assessment, safety determina22 tion, or rule solely because the action was completed 

23 prior to the completion of a policy or procedure estab24 lished under section 3A or 4A, and the validity of a 

25 completed assessment, determination, or rule shall not 


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1 be determined based on the content of such a policy 

2 or procedure. 

3 ‘‘(3) NOTICE OF EXISTING INFORMATION.— 

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

5 shall, where such information is available, take 

6 notice of existing information regarding hazard 

7 and exposure published by other Federal agencies 

8 and the National Academies and incorporate the 

9 information in safety assessments and safety de10 terminations with the objective of increasing the 

11 efficiency of the safety assessments and safety de12 terminations. 

13 ‘‘(B) INCLUSION OF INFORMATION.—Exist14 ing information described in subparagraph (A) 

15 should be included to the extent practicable and 

16 where the Administrator determines the informa17 tion is relevant and scientifically reliable. 

18 ‘‘(c) SAFETY DETERMINATIONS.— 

19 ‘‘(1) IN GENERAL.—Based on a review of the in20 formation available to the Administrator, including 

21 draft safety assessments submitted by interested per22 sons, and subject to section 18, the Administrator 

23 shall determine that— 

24 ‘‘(A) the relevant chemical substance meets 

25 the safety standard; 


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1 ‘‘(B) the relevant chemical substance does 

2 not meet the safety standard, in which case the 

3 Administrator shall, by rule under subsection 

4 (d)— 

5 ‘‘(i) impose restrictions necessary to 

6 ensure that the chemical substance meets the 

7 safety standard under the conditions of use; 

8 or 

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

10 met with the application of restrictions, ban 

11 or phase out the chemical substance, as ap12 propriate; or 

13 ‘‘(C) additional information is necessary in 

14 order to make a determination under subpara15 graph (A) or (B), in which case the Adminis16 trator shall take appropriate action under para17 graph (2). 

18 ‘‘(2) ADDITIONAL INFORMATION.—If the Admin19 istrator determines that additional information is 

20 necessary to make a safety assessment or safety deter21 mination for a high-priority substance, the Adminis22 trator— 

23 ‘‘(A) shall provide an opportunity for inter24 ested persons to submit the additional informa25 tion; 


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

2 testing consent agreement, or issue an order 

3 under section 4 to require the development of the 

4 information; 

5 ‘‘(C) may defer, for a reasonable period con6 sistent with the deadlines described in subsection 

7 (a), a safety assessment and safety determination 

8 until after receipt of the information; and 

9 ‘‘(D) consistent with the deadlines described 

10 in subsection (a), on receipt of information the 

11 Administrator finds supports the safety assess12 ment and safety determination, shall make a de13 termination under paragraph (1). 

14 ‘‘(3) ESTABLISHMENT OF DEADLINE.—In re15 questing the development or submission of informa16 tion under this section, the Administrator shall estab17 lish a deadline for the submission of the information. 

18 ‘‘(d) RULE.— 

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

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

21 with respect to a chemical substance, the Adminis22 trator shall promulgate a rule establishing restrictions 

23 necessary to ensure that the chemical substance meets 

24 the safety standard. 

25 ‘‘(2) SCOPE.— 


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1 ‘‘(A) IN GENERAL.—The rule promulgated 

2 pursuant to this subsection— 

3 ‘‘(i) may apply to mixtures containing 

4 the chemical substance, as appropriate; 

5 ‘‘(ii) shall include dates by which com6 pliance is mandatory, which— 

7 ‘‘(I) shall be as soon as prac8 ticable; 

9 ‘‘(II) in the case of a ban or 

10 phase-out of the chemical substance, 

11 shall implement the ban or phase-out 

12 in as short a period as practicable; 

13 and 

14 ‘‘(III) as determined by the Ad15 ministrator, may vary for different af16 fected persons; and 

17 ‘‘(iii) shall exempt replacement parts 

18 that are manufactured prior to the effective 

19 date of the rule for articles that are first 

20 manufactured prior to the effective date of 

21 the rule unless the Administrator finds the 

22 replacement parts contribute significantly 

23 to the identified risk; and 

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1 hibitions or other restrictions to articles 

2 containing the chemical substance only to 

3 the extent necessary to address the identified 

4 risks in order to determine that the chem5 ical substance meets the safety standard. 

6 ‘‘(B) PERSISTENT AND BIOACCUMULATIVE

7 SUBSTANCES.—For a chemical substance the Ad8 ministrator determines ranks high for persistence 

9 and bioaccumulation, the Administrator shall, in 

10 selecting among prohibitions and other restric11 tions that the Administrator determines are suf12 ficient to ensure that the chemical substance 

13 meets the safety standard, reduce exposure to the 

14 substance to the maximum extent practicable. 

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

18 Health before adopting any prohibition or other 

19 restriction under this subsection to address work20 place exposures. 

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

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

23 as used in this section does not displace common 

24 law. 


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1 ‘‘(3) RESTRICTIONS.—A restriction under para2 graph (1) may include, as appropriate— 

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

4 that a chemical substance shall be marked with, 

5 or accompanied by, clear and adequate min6 imum warnings and instructions with respect to 

7 use, distribution in commerce, or disposal, or 

8 any combination of those activities, with the 

9 form and content of the minimum warnings and 

10 instructions to be prescribed by the Adminis11 trator; 

12 ‘‘(B) a requirement that manufacturers or 

13 processors of the chemical substance shall— 

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

15 processes used to manufacture or process the 

16 chemical substance; 

17 ‘‘(ii) describe and apply the relevant 

18 quality control procedures followed in the 

19 manufacturing or processing of the sub20 stance; or 

21 ‘‘(iii) monitor or conduct tests that are 

22 reasonably necessary to ensure compliance 

23 with the requirements of any rule under 

24 this subsection; 


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

2 chemical substance that may be manufactured, 

3 processed, or distributed in commerce; 

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

5 any other rule regarding, the manufacture, proc6 essing, or distribution in commerce of the chem7 ical substance for— 

8 ‘‘(i) a particular use; 

9 ‘‘(ii) a particular use at a concentra10 tion in excess of a level specified by the Ad11 ministrator; or 

12 ‘‘(iii) all uses; 

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

14 chemical substance that may be manufactured, 

15 processed, or distributed in commerce for— 

16 ‘‘(i) a particular use; or 

17 ‘‘(ii) a particular use at a concentra18 tion in excess of a level specified by the Ad19 ministrator; 

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

21 otherwise restrict any method of commercial use 

22 of the chemical substance; 

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

24 otherwise restrict any method of disposal of the 


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1 chemical substance or any article containing the 

2 chemical substance; and 

3 ‘‘(H) a requirement directing manufactur4 ers or processors of the chemical substance to give 

5 notice of the Administrator’s determination 

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

7 commerce of the chemical substance and, to the 

8 extent reasonably ascertainable, to other persons 

9 in the chain of commerce in possession of the 

10 chemical substance. 

11 ‘‘(4) ANALYSIS FOR RULEMAKING.— 

12 ‘‘(A) CONSIDERATIONS.—In deciding which 

13 restrictions to impose under paragraph (3) as 

14 part of developing a rule under paragraph (1), 

15 the Administrator shall take into consideration, 

16 to the extent practicable based on reasonably 

17 available information, the quantifiable and non18 quantifiable costs and benefits of the proposed 

19 regulatory action and of the 1 or more primary 

20 alternative regulatory actions considered by the 

21 Administrator. 

22 ‘‘(B) ALTERNATIVES.—As part of the anal23 ysis, the Administrator shall review any 1 or 

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1 ministrator determines are relevant to the rule2 making. 

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

4 a rule under paragraph (1), the Administrator 

5 shall make publicly available any analysis con6 ducted under this paragraph. 

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

8 final a rule under paragraph (1), the Adminis9 trator shall include a statement describing how 

10 the analysis considered under subparagraph (A) 

11 was taken into account. 

12 ‘‘(5) EXEMPTIONS.— 

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

14 may exempt 1 or more uses of a chemical sub15 stance from any restriction in a rule promul16 gated under paragraph (1) if the Administrator 

17 determines that— 

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

19 without— 

20 ‘‘(I) harming national security; 

21 ‘‘(II) causing significant disrup22 tion in the national economy due to 

23 the lack of availability of a chemical 

24 substance; or 


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1 ‘‘(III) interfering with a critical 

2 or essential use for which no tech3 nically and economically feasible safer 

4 alternative is available, taking into 

5 consideration hazard and exposure; or 

6 ‘‘(ii) the use of the chemical substance, 

7 as compared to reasonably available alter8 natives, provides a substantial benefit to 

9 health, the environment, or public safety. 

10 ‘‘(B) EXEMPTION ANALYSIS.—In proposing 

11 a rule under paragraph (1) that includes an ex12 emption under this paragraph, the Adminis13 trator shall make publicly available any analysis 

14 conducted under this paragraph to assess the 

15 need for the exemption. 

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

17 final a rule under paragraph (1) that includes 

18 an exemption under this paragraph, the Admin19 istrator shall include a statement describing how 

20 the analysis considered under subparagraph (B) 

21 was taken into account. 

22 ‘‘(D) ANALYSIS IN CASE OF BAN OR PHASE23 OUT.—In determining whether an exemption 

24 should be granted under this paragraph for a 

25 chemical substance for which a ban or phase-out 


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1 is proposed, the Administrator shall take into 

2 consideration, to the extent practicable based on 

3 reasonably available information, the quantifi4 able and nonquantifiable costs and benefits of the 

5 1 or more technically and economically feasible 

6 alternatives to the chemical substance most likely 

7 to be used in place of the chemical substance 

8 under the conditions of use if the rule is promul9 gated. 

10 ‘‘(E) CONDITIONS.—As part of a rule pro11 mulgated under paragraph (1), the Adminis12 trator shall include conditions in any exemption 

13 established under this paragraph, including rea14 sonable recordkeeping, monitoring, and reporting 

15 requirements, to the extent that the Adminis16 trator determines the conditions are necessary to 

17 protect health and the environment while achiev18 ing the purposes of the exemption. 

19 ‘‘(F) DURATION.— 

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

21 shall establish, as part of a rule under 

22 paragraph (1) that contains an exemption 

23 under this paragraph, a time limit on any 

24 exemption for a time to be determined by 


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1 the Administrator as reasonable on a case2 by-case basis. 

3 ‘‘(ii) AUTHORITY OF ADMINIS4 TRATOR.—The Administrator, by rule, may 

5 extend, modify, or eliminate the exemption 

6 if the Administrator determines, on the 

7 basis of reasonably available information 

8 and after adequate public justification, the 

9 exemption warrants extension or is no 

10 longer necessary. 

11 ‘‘(iii) CONSIDERATIONS.— 

12 ‘‘(I) IN GENERAL.—Subject to 

13 subclause (II), the Administrator shall 

14 issue exemptions and establish time pe15 riods by considering factors determined 

16 by the Administrator to be relevant to 

17 the goals of fostering innovation and 

18 the development of alternatives that 

19 meet the safety standard. 

20 ‘‘(II) LIMITATION.—Any renewal 

21 of an exemption in the case of a rule 

22 requiring the ban or phase-out of a 

23 chemical substance shall not exceed 5 

24 years. 


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

2 declare a proposed rule under subsection (d)(1) to be effec3 tive on publication of the rule in the Federal Register and 

4 until the effective date of final action taken respecting the 

5 rule, if— 

6 ‘‘(1) the Administrator determines that— 

7 ‘‘(A) the manufacture, processing, distribu8 tion in commerce, use, or disposal of the chem9 ical substance or mixture subject to the proposed 

10 rule or any combination of those activities is 

11 likely to result in a risk of serious or widespread 

12 injury to health or the environment before the ef13 fective date; and 

14 ‘‘(B) making the proposed rule so effective is 

15 necessary to protect the public interest; and 

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

17 manufacture, processing, or distribution in commerce 

18 of a chemical substance or mixture because of the risk 

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

20 granted relief in an action under section 7 with re21 spect to that risk associated with the chemical sub22 stance or mixture. 

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

24 subject to section 18— 


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

2 safety assessment, for a chemical substance that the 

3 Administrator determines under subsection (c) meets 

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

5 agency action, effective beginning on the date of 

6 issuance of the final safety determination; and 

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

8 (d)(1), and the associated safety assessment and safe9 ty determination that a chemical substance does not 

10 meet the safety standard, shall be considered to be a 

11 final agency action, effective beginning on the date of 

12 promulgation of the final rule.’’; and 

13 (4) in subsection (g) (as redesignated by para14 graph (2))— 

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

16 (B) by redesignating paragraph (5) as 

17 paragraph (4). 

18 SEC. 9. IMMINENT HAZARDS. 

19 Section 7 of the Toxic Substances Control Act (15 

20 U.S.C. 2606) is amended— 

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

22 following: 

23 ‘‘(a) CIVIL ACTIONS.— 


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

2 commence a civil action in an appropriate United 

3 States district court for— 

4 ‘‘(A) seizure of an imminently hazardous 

5 chemical substance or mixture or any article 

6 containing the chemical substance or mixture; 

7 ‘‘(B) relief (as authorized by subsection (b)) 

8 against any person that manufactures, processes, 

9 distributes in commerce, uses, or disposes of, an 

10 imminently hazardous chemical substance or 

11 mixture or any article containing the chemical 

12 substance or mixture; or 

13 ‘‘(C) both seizure described in subparagraph 

14 (A) and relief described in subparagraph (B). 

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

16 civil action may be commenced under this paragraph, 

17 notwithstanding— 

18 ‘‘(A) the existence of a decision, rule, con19 sent agreement, or order by the Administrator 

20 under section 4, 4A, 5, or 6 or title IV or VI; or 

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

22 judicial proceeding under any provision of this 

23 Act.’’; 

24 (2) in subsection (b)(1), by striking ‘‘unreason25 able’’; 


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1 (3) in subsection (d), by striking ‘‘section 6(a)’’ 

2 and inserting ‘‘section 6(d)’’; and 

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

4 striking ‘‘and unreasonable’’. 

5 SEC. 10. INFORMATION COLLECTION AND REPORTING. 

6 Section 8 of the Toxic Substances Control Act (15 

7 U.S.C. 2607) is amended— 

8 (1) in subsection (a)— 

9 (A) in paragraph (3)(A)(ii)(I)— 

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

11 ‘‘5’’; 

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

13 ‘‘in effect under’’; and 

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

15 ‘‘5(d)(4);’’; and 

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

17 ‘‘(4) RULES.— 

18 ‘‘(A) DEADLINE.— 

19 ‘‘(i) IN GENERAL.—Not later than 2 

20 years after the date of enactment of the 

21 Frank R. Lautenberg Chemical Safety for 

22 the 21st Century Act, the Administrator 

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1 able by the person making the report, in2 cluding rules requiring processors to report 

3 information, so that the Administrator has 

4 the information necessary to carry out sec5 tions 4 and 6. 

6 ‘‘(ii) MODIFICATION OF PRIOR

7 RULES.—In carrying out this subpara8 graph, the Administrator may modify, as 

9 appropriate, rules promulgated before the 

10 date of enactment of the Frank R. Lauten11 berg Chemical Safety for the 21st Century 

12 Act. 

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

14 pursuant to subparagraph (A)— 

15 ‘‘(i) may impose different reporting 

16 and recordkeeping requirements on manu17 facturers and processors; and 

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

19 necessary to be reported, including the man20 ner by which use and exposure information 

21 may be reported. 

22 ‘‘(C) ADMINISTRATION.—In implementing 

23 the reporting and recordkeeping requirements 

24 under this paragraph, the Administrator shall 

25 take measures— 


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1 ‘‘(i) to limit the potential for duplica2 tion in reporting requirements; 

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

4 rules on small manufacturers and proc5 essors; and 

6 ‘‘(iii) to apply any reporting obliga7 tions to those persons likely to have infor8 mation relevant to the effective implementa9 tion of this title. 

10 ‘‘(5) GUIDANCE.—The Administrator shall de11 velop guidance relating to the information required to 

12 be reported under the rules promulgated under this 

13 subsection.’’; 

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

15 following: 

16 ‘‘(3) NOMENCLATURE.— 

17 ‘‘(A) IN GENERAL.—In carrying out para18 graph (1), the Administrator shall— 

19 ‘‘(i) maintain the use of Class 2 no20 menclature in use on the date of enactment 

21 of the Frank R. Lautenberg Chemical Safe22 ty for the 21st Century Act; 

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

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1 ministrator in section 1 of addendum III of 

2 the document entitled ‘Candidate List of 

3 Chemical Substances’, and further described 

4 in the appendix A of volume I of the 1985 

5 edition of the Toxic Substances Control Act 

6 Substances Inventory (EPA Document No. 

7 EPA–560/7–85–002a); and 

8 ‘‘(iii) treat all components of categories 

9 that are considered to be statutory mixtures 

10 under this Act as being included on the list 

11 published under paragraph (1) under the 

12 Chemical Abstracts Service numbers for the 

13 respective categories, including, without 

14 limitation— 

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

16 CAS No. 65997–15–1; 

17 ‘‘(II) cement, alumina, chemicals, 

18 CAS No. 65997–16–2; 

19 ‘‘(III) glass, oxide, chemicals, 

20 CAS No. 65997–17–3; 

21 ‘‘(IV) frits, chemicals, CAS No. 

22 65997–18–4; 

23 ‘‘(V) steel manufacture, chemicals, 

24 CAS No. 65997–19–5; and 


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1 ‘‘(VI) ceramic materials and 

2 wares, chemicals, CAS No. 66402–68– 

3 4. 

4 ‘‘(B) MULTIPLE NOMENCLATURE CONVEN5 TIONS.— 

6 ‘‘(i) IN GENERAL.—If an existing guid7 ance allows for multiple nomenclature con8 ventions, the Administrator shall— 

9 ‘‘(I) maintain the nomenclature 

10 conventions for substances; and 

11 ‘‘(II) develop new guidance that— 

12 ‘‘(aa) establishes equivalency 

13 between the nomenclature conven14 tions for chemical substances on 

15 the list published under para16 graph (1); and 

17 ‘‘(bb) permits persons to rely 

18 on the new guidance for purposes 

19 of determining whether a chemical 

20 substance is on the list published 

21 under paragraph (1). 

22 ‘‘(ii) MULTIPLE CAS NUMBERS.—For 

23 any chemical substance appearing multiple 

24 times on the list under different Chemical 

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1 trator shall develop guidance recognizing 

2 the multiple listings as a single chemical 

3 substance. 

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

5 ‘‘(A) RULES.— 

6 ‘‘(i) IN GENERAL.—Not later than 1 

7 year after the date of enactment of the 

8 Frank R. Lautenberg Chemical Safety for 

9 the 21st Century Act, the Administrator, by 

10 rule, shall require manufacturers and proc11 essors to notify the Administrator, by not 

12 later than 180 days after the date of pro13 mulgation of the rule, of each chemical sub14 stance on the list published under para15 graph (1) that the manufacturer or proc16 essor, as applicable, has manufactured or 

17 processed for a nonexempt commercial pur18 pose during the 10-year period ending on 

19 the day before the date of enactment of the 

20 Frank R. Lautenberg Chemical Safety for 

21 the 21st Century Act. 

22 ‘‘(ii) ACTIVE SUBSTANCES.—The Ad23 ministrator shall, pursuant to paragraph 

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

25 which notices are received under clause (i) 


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1 to be active substances on the list published 

2 under paragraph (1). 

3 ‘‘(B) CONFIDENTIAL CHEMICAL SUB4 STANCES.—The rule promulgated by the Admin5 istrator pursuant to subparagraph (A) shall re6 quire— 

7 ‘‘(i) the Administrator to maintain the 

8 list under paragraph (1), which shall in9 clude a confidential portion and a noncon10 fidential portion consistent with this section 

11 and section 14; 

12 ‘‘(ii) a manufacturer or processor that 

13 is submitting a notice pursuant to subpara14 graph (A) for a chemical substance on the 

15 confidential portion of the list published 

16 under paragraph (1) to indicate in the no17 tice whether the manufacturer or processor 

18 seeks to maintain any existing claim for 

19 protection against disclosure of the specific 

20 identity of the substance as confidential 

21 pursuant to section 14; and 

22 ‘‘(iii) the substantiation of those claims 

23 pursuant to section 14 and in accordance 

24 with the review plan described in subpara25 graph (C). 


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

2 after the date on which the Administrator com3 piles the initial list of active substances pursuant 

4 to subparagraph (A), the Administrator shall 

5 promulgate a rule that establishes a plan to re6 view all claims to protect the specific identities 

7 of chemical substances on the confidential por8 tion of the list published under paragraph (1) 

9 that are notified pursuant to subparagraph (A) 

10 or identified as active substances under sub11 section (f)(1). 

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

13 The review plan under subparagraph (C) shall— 

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

15 the Administrator, all manufacturers or 

16 processors asserting claims under subpara17 graph (B) to substantiate the claim unless 

18 the manufacturer or processor has substan19 tiated the claim in a submission made to 

20 the Administrator during the 5-year period 

21 ending on the date of the request by the Ad22 ministrator; 

23 ‘‘(ii) require the Administrator, in ac24 cordance with section 14— 


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1 ‘‘(I) to review each substan2 tiation— 

3 ‘‘(aa) submitted pursuant to 

4 clause (i) to determine if the 

5 claim warrants protection from 

6 disclosure; and 

7 ‘‘(bb) submitted previously 

8 by a manufacturer or processor 

9 and relied on in lieu of the sub10 stantiation required pursuant to 

11 clause (i), if the substantiation 

12 has not been previously reviewed 

13 by the Administrator, to deter14 mine if the claim warrants pro15 tection from disclosure; 

16 ‘‘(II) approve, modify, or deny 

17 each claim; and 

18 ‘‘(III) except as provided in this 

19 section and section 14, protect from 

20 disclosure information for which the 

21 Administrator approves such a claim 

22 for a period of 10 years, unless, prior 

23 to the expiration of the period— 

24 ‘‘(aa) the person notifies the 

25 Administrator that the person is 


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1 withdrawing the confidentiality 

2 claim, in which case the Adminis3 trator shall promptly make the 

4 information available to the pub5 lic; or 

6 ‘‘(bb) the Administrator oth7 erwise becomes aware that the 

8 need for protection from disclosure 

9 can no longer be substantiated, in 

10 which case the Administrator 

11 shall take the actions described in 

12 section 14(g)(2); and 

13 ‘‘(iii) encourage manufacturers or 

14 processors that have previously made claims 

15 to protect the specific identities of chemical 

16 substances identified as inactive pursuant 

17 to subsection (f)(2) to review and either 

18 withdraw or substantiate the claims. 

19 ‘‘(E) TIMELINE FOR COMPLETION OF RE20 VIEWS.— 

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

22 shall implement the review plan so as to 

23 complete reviews of all claims specified in 

24 subparagraph (C) not later than 5 years 

25 after the date on which the Administrator 


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1 compiles the initial list of active substances 

2 pursuant to subparagraph (A). 

3 ‘‘(ii) CONSIDERATIONS.— 

4 ‘‘(I) IN GENERAL.—The Adminis5 trator may extend the deadline for 

6 completion of the reviews for not more 

7 than 2 additional years, after an ade8 quate public justification, if the Ad9 ministrator determines that the exten10 sion is necessary based on the number 

11 of applicable claims needing review 

12 and the available resources. 

13 ‘‘(II) ANNUAL GOAL.—The Ad14 ministrator shall publish an annual 

15 goal for the number of reviews to be 

16 completed over the course of implemen17 tation of the plan. 

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

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

20 shall maintain and keep current designations of 

21 active substances and inactive substances on the 

22 list published under paragraph (1). 

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

24 update the list of chemical substances designated 

25 as active substances as soon as practicable after 


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1 the date of publication of the most recent data 

2 reported under— 

3 ‘‘(i) part 711 of title 40, Code of Fed4 eral Regulations (or successor regulations); 

5 and 

6 ‘‘(ii) the rules promulgated pursuant to 

7 subsection (a)(4). 

8 ‘‘(C) CHANGE TO ACTIVE STATUS.— 

9 ‘‘(i) IN GENERAL.—Any person that 

10 intends to manufacture or process for a 

11 nonexempt commercial purpose a chemical 

12 substance that is designated as an inactive 

13 substance shall notify the Administrator be14 fore the date on which the inactive sub15 stance is manufactured or processed. 

16 ‘‘(ii) CONFIDENTIAL CHEMICAL IDEN17 TITY CLAIMS.—If a person submitting a no18 tice under clause (i) for an inactive sub19 stance on the confidential portion of the list 

20 published under paragraph (1) seeks to 

21 maintain an existing claim for protection 

22 against disclosure of the specific identity of 

23 the inactive substance as confidential, the 

24 person shall— 


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1 ‘‘(I) in the notice submitted under 

2 clause (i), assert the claim; and 

3 ‘‘(II) by not later than 30 days 

4 after providing the notice under clause 

5 (i), substantiate the claim. 

6 ‘‘(iii) ACTIVE STATUS.—On receiving a 

7 notification under clause (i), the Adminis8 trator shall— 

9 ‘‘(I) designate the applicable 

10 chemical substance as an active sub11 stance; 

12 ‘‘(II) pursuant to section 14, 

13 promptly review any claim and associ14 ated substantiation submitted pursu15 ant to clause (ii) for protection against 

16 disclosure of the specific identity of the 

17 chemical substance and approve, mod18 ify, or deny the claim; 

19 ‘‘(III) except as provided in this 

20 section and section 14, protect from 

21 disclosure the specific identity of the 

22 chemical substance for which the Ad23 ministrator approves a claim under 

24 subclause (II) for a period of not less 


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1 than 10 years, unless, prior to the ex2 piration of the period— 

3 ‘‘(aa) the person notifies the 

4 Administrator that the person is 

5 withdrawing the confidentiality 

6 claim, in which case the Adminis7 trator shall promptly make the 

8 information available to the pub9 lic; or 

10 ‘‘(bb) the Administrator oth11 erwise becomes aware that the 

12 need for protection from disclosure 

13 can no longer be substantiated, in 

14 which case the Administrator 

15 shall take the actions described in 

16 section 14(g)(2); and 

17 ‘‘(IV) pursuant to section 4A, re18 view the priority of the chemical sub19 stance as the Administrator determines 

20 to be necessary. 

21 ‘‘(D) CATEGORY STATUS.—The list of inac22 tive substances shall not be considered to be a 

23 category for purposes of section 26(c). 

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

25 Prior to the promulgation of the rule required under 


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1 paragraph (4)(A), the Administrator shall designate 

2 the chemical substances reported under part 711 of 

3 title 40, Code of Federal Regulations (or successor reg4 ulations), during the reporting period that most close5 ly preceded the date of enactment of the Frank R. 

6 Lautenberg Chemical Safety for the 21st Century Act, 

7 as the interim list of active substances for the pur8 poses of section 4A. 

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

10 subsection, the Administrator shall make available to 

11 the public— 

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

13 substance on the nonconfidential portion of the 

14 list published under paragraph (1) that the Ad15 ministrator has designated as— 

16 ‘‘(i) an active substance; or 

17 ‘‘(ii) an inactive substance; 

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

19 and, if applicable, premanufacture notice case 

20 number for each chemical substance on the con21 fidential portion of the list published under 

22 paragraph (1) for which a claim of confiden23 tiality was received and approved by the Admin24 istrator pursuant to section 14; and 


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

2 identity of any active substance for which— 

3 ‘‘(i) no claim of protection against dis4 closure of the specific identity of the active 

5 substance pursuant to this subsection was 

6 received; 

7 ‘‘(ii) a claim for protection against 

8 disclosure of the specific identity of the ac9 tive substance has been denied by the Ad10 ministrator; or 

11 ‘‘(iii) the time period for protection 

12 against disclosure of the specific identity of 

13 the active substance has expired. 

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

15 claim under this subsection for protection from disclo16 sure of a specific identity of any active or inactive 

17 chemical substance for which a notice is received 

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

19 the confidential portion of the list published under 

20 paragraph (1). 

21 ‘‘(9) CERTIFICATION.—Under the rules promul22 gated under this subsection, manufacturers and proc23 essors shall be required— 

24 ‘‘(A) to certify that each report the manu25 facturer or processor submits complies with the 


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1 requirements of the rule, and that any confiden2 tiality claims are true and correct; and 

3 ‘‘(B) to retain a record supporting the cer4 tification for a period of 5 years beginning on 

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

6 (3) in subsection (e)— 

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

8 the following: 

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

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

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

12 to the Administrator information reasonably sup13 porting the conclusion that a chemical substance or 

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

15 substantial risk of injury to health and the environ16 ment.’’; and 

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

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

19 this section: 

20 ‘‘(1) ACTIVE SUBSTANCE.—The term ‘active sub21 stance’ means a chemical substance— 

22 ‘‘(A) that has been manufactured or proc23 essed for a nonexempt commercial purpose at 

24 any point during the 10-year period ending on 


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1 the date of enactment of the Frank R. Lauten2 berg Chemical Safety for the 21st Century Act; 

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

4 under subsection (b)(1) after that date of enact5 ment; or 

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

7 subsection (b)(5)(C). 

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

9 substance’ means a chemical substance on the list 

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

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

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

13 SEC. 11. RELATIONSHIP TO OTHER FEDERAL LAWS. 

14 Section 9 of the Toxic Substances Control Act (15 

15 U.S.C. 2608) is amended— 

16 (1) in subsection (a)— 

17 (A) in paragraph (1), in the first sen18 tence— 

19 (i) by striking ‘‘presents or will present 

20 an unreasonable risk to health or the envi21 ronment’’ and inserting ‘‘does not meet the 

22 safety standard’’; and 

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

24 place it appears and inserting ‘‘the risk 

25 posed by the substance or mixture’’; 


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1 (B) in paragraph (2), in the matter fol2 lowing subparagraph (B), by striking ‘‘section 6 

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

4 and 

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

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

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

8 striking ‘‘Health, Education, and Welfare’’ and in9 serting ‘‘Health and Human Services’’; and 

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

11 ‘‘(e) EXPOSURE INFORMATION.—If the Administrator 

12 obtains information related to exposures or releases of a 

13 chemical substance that may be prevented or reduced under 

14 another Federal law, including laws not administered by 

15 the Administrator, the Administrator shall make such in16 formation available to the relevant Federal agency or office 

17 of the Environmental Protection Agency.’’. 

18 SEC. 12. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMI19 NATION, AND UTILIZATION OF DATA. 

20 Section 10 of the Toxic Substances Control Act (15 

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

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

23 and Human Services’’. 


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1 SEC. 13. EXPORTS. 

2 Section 12 of the Toxic Substances Control Act (15 

3 U.S.C. 2611) is amended— 

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

5 and inserting the following: 

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

7 apply to any chemical substance that the Adminis8 trator determines— 

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

10 the safety standard; or 

11 ‘‘(B) under section 6 does not meet the safe12 ty standard. 

13 ‘‘(3) WAIVERS.—For a mixture or article con14 taining a chemical substance described in paragraph 

15 (2), the Administrator may— 

16 ‘‘(A) determine that paragraph (1) shall not 

17 apply to the mixture or article; or 

18 ‘‘(B) establish a threshold concentration in 

19 a mixture or article at which paragraph (1) 

20 shall not apply. 

21 ‘‘(4) TESTING.—The Administrator may require 

22 testing under section 4 of any chemical substance or 

23 mixture exempted from this Act under paragraph (1) 

24 for the purpose of determining whether the chemical 

25 substance or mixture meets the safety standard within 

26 the United States.’’; 


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

2 following: 

3 ‘‘(b) NOTICE.— 

4 ‘‘(1) IN GENERAL.—A person shall notify the Ad5 ministrator that the person is exporting or intends to 

6 export to a foreign country— 

7 ‘‘(A) a chemical substance or a mixture con8 taining a chemical substance that the Adminis9 trator has determined under section 5 is not like10 ly to meet the safety standard and for which a 

11 prohibition or other restriction has been proposed 

12 or established under that section; 

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

14 containing a chemical substance that the Admin15 istrator has determined under section 6 does not 

16 meet the safety standard and for which a prohi17 bition or other restriction has been proposed or 

18 established under that section; 

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

20 United States is obligated by treaty to provide 

21 export notification; 

22 ‘‘(D) a chemical substance or mixture sub23 ject to a significant new use rule, or a prohibi24 tion or other restriction pursuant to a rule, 


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1 order, or consent agreement in effect under this 

2 Act; or 

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

4 which the submission of information is required 

5 under section 4. 

6 ‘‘(2) RULES.— 

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

8 shall promulgate rules to carry out paragraph 

9 (1). 

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

11 pursuant to subparagraph (A) shall— 

12 ‘‘(i) include such exemptions as the 

13 Administrator determines to be appropriate, 

14 which may include exemptions identified 

15 under section 5(h); and 

16 ‘‘(ii) indicate whether, or to what ex17 tent, the rules apply to articles containing 

18 a chemical substance or mixture described 

19 in paragraph (1). 

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

21 submit to the government of each country to which a 

22 chemical substance or mixture is exported— 

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

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

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


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1 rule, order, consent agreement, requirement, or 

2 designation; 

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

4 paragraph (1)(C), a notice that satisfies the obli5 gation of the United States under the applicable 

6 treaty; and 

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

8 described in paragraph (1)(E), a notice of avail9 ability of the information on the chemical sub10 stance or mixture submitted to the Adminis11 trator.’’; and 

12 (3) in subsection (c)— 

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

14 (B) by redesignating paragraphs (4) 

15 through (6) as paragraphs (3) through (5), re16 spectively. 

17 SEC. 14. CONFIDENTIAL INFORMATION. 

18 Section 14 of the Toxic Substances Control Act (15 

19 U.S.C. 2613) is amended to read as follows: 

20 ‘‘SEC. 14. CONFIDENTIAL INFORMATION. 

21 ‘‘(a) IN GENERAL.—Except as otherwise provided in 

22 this section, the Administrator shall not disclose informa23 tion that is exempt from disclosure pursuant to subsection 

24 (a) of section 552 of title 5, United States Code, under sub25 section (b)(4) of that section— 


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1 ‘‘(1) that is reported to, or otherwise obtained by, 

2 the Administrator under this Act; and 

3 ‘‘(2) for which the requirements of subsection (d) 

4 are met. 

5 ‘‘(b) INFORMATION GENERALLY PROTECTED FROM

6 DISCLOSURE.—The following information specific to, and 

7 submitted by, a manufacturer, processor, or distributor that 

8 meets the requirements of subsections (a) and (d) shall be 

9 presumed to be protected from disclosure, subject to the con10 dition that nothing in this Act prohibits the disclosure of 

11 any such information, or information that is the subject 

12 of subsection (g)(3), through discovery, subpoena, other 

13 court order, or any other judicial process otherwise allowed 

14 under applicable Federal or State law: 

15 ‘‘(1) Specific information describing the proc16 esses used in manufacture or processing of a chemical 

17 substance, mixture, or article. 

18 ‘‘(2) Marketing and sales information. 

19 ‘‘(3) Information identifying a supplier or cus20 tomer. 

21 ‘‘(4) Details of the full composition of a mixture 

22 and the respective percentages of constituents. 

23 ‘‘(5) Specific information regarding the use, 

24 function, or application of a chemical substance or 

25 mixture in a process, mixture, or product. 


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1 ‘‘(6) Specific production or import volumes of 

2 the manufacturer and specific aggregated volumes 

3 across manufacturers, if the Administrator determines 

4 that disclosure of the specific aggregated volumes 

5 would reveal confidential information. 

6 ‘‘(7) Except as otherwise provided in this section, 

7 the specific identity of a chemical substance prior to 

8 the date on which the chemical substance is first of9 fered for commercial distribution, including the chem10 ical name, molecular formula, Chemical Abstracts 

11 Service number, and other information that would 

12 identify a specific chemical substance, if— 

13 ‘‘(A) the specific identity was claimed as 

14 confidential information at the time it was sub15 mitted in a notice under section 5; and 

16 ‘‘(B) the claim— 

17 ‘‘(i) is not subject to an exception 

18 under subsection (e); or 

19 ‘‘(ii) has not subsequently been with20 drawn or found by the Administrator not to 

21 warrant protection as confidential informa22 tion under subsection (f)(2) or (g). 

23 ‘‘(c) INFORMATION NOT PROTECTED FROM DISCLO24 SURE.—Notwithstanding subsections (a) and (b), the fol25 lowing information shall not be protected from disclosure: 


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1 ‘‘(1) INFORMATION FROM HEALTH AND SAFETY

2 STUDIES.— 

3 ‘‘(A) IN GENERAL.—Subject to subpara4 graph (B), subsection (a) does not prohibit the 

5 disclosure of— 

6 ‘‘(i) any health and safety study that 

7 is submitted under this Act with respect 

8 to— 

9 ‘‘(I) any chemical substance or 

10 mixture that, on the date on which the 

11 study is to be disclosed, has been of12 fered for commercial distribution; or 

13 ‘‘(II) any chemical substance or 

14 mixture for which— 

15 ‘‘(aa) testing is required 

16 under section 4; or 

17 ‘‘(bb) a notification is re18 quired under section 5; or 

19 ‘‘(ii) any information reported to, or 

20 otherwise obtained by, the Administrator 

21 from a health and safety study relating to 

22 a chemical substance or mixture described 

23 in subclause (I) or (II) of clause (i). 


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1 ‘‘(B) EFFECT OF PARAGRAPH.—Nothing in 

2 this paragraph authorizes the release of any in3 formation that discloses— 

4 ‘‘(i) a process used in the manufac5 turing or processing of a chemical substance 

6 or mixture; or 

7 ‘‘(ii) in the case of a mixture, the por8 tion of the mixture comprised by any chem9 ical substance in the mixture. 

10 ‘‘(2) CERTAIN REQUESTS.—If a request is made 

11 to the Administrator under section 552(a) of title 5, 

12 United States Code, for information that is described 

13 in paragraph (1) that is not described in paragraph 

14 (1)(B), the Administrator may not deny the request 

15 on the basis of section 552(b)(4) of title 5, United 

16 States Code. 

17 ‘‘(3) OTHER INFORMATION NOT PROTECTED

18 FROM DISCLOSURE.—The following information is not 

19 protected from disclosure under this section: 

20 ‘‘(A) For information submitted after the 

21 date of enactment of the Frank R. Lautenberg 

22 Chemical Safety for the 21st Century Act, the 

23 specific identity of a chemical substance as of the 

24 date on which the chemical substance is first of25 fered for commercial distribution, if the person 


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1 submitting the information does not meet the re2 quirements of subsection (d). 

3 ‘‘(B) A safety assessment developed, or a 

4 safety determination made, under section 6. 

5 ‘‘(C) Any general information describing 

6 the manufacturing volumes, expressed as specific 

7 aggregated volumes or, if the Administrator de8 termines that disclosure of specific aggregated 

9 volumes would reveal confidential information, 

10 expressed in ranges. 

11 ‘‘(D) A general description of a process used 

12 in the manufacture or processing and industrial, 

13 commercial, or consumer functions and uses of a 

14 chemical substance, mixture, or article con15 taining a chemical substance or mixture, includ16 ing information specific to an industry or indus17 try sector that customarily would be shared with 

18 the general public or within an industry or in19 dustry sector. 

20 ‘‘(4) MIXED CONFIDENTIAL AND NONCONFIDEN21 TIAL INFORMATION .—Any information that is other22 wise eligible for protection under this section and con23 tained in a submission of information described in 

24 this subsection shall be protected from disclosure, if 

25 the submitter complies with subsection (d), subject to 


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1 the condition that information in the submission that 

2 is not eligible for protection against disclosure shall 

3 be disclosed. 

4 ‘‘(5) BAN OR PHASE-OUT.—If the Administrator 

5 promulgates a rule pursuant to section 6(d) that es6 tablishes a ban or phase-out of the manufacture, proc7 essing, or distribution in commerce of a chemical sub8 stance, subject to paragraphs (2), (3), and (4) of sub9 section (g), any protection from disclosure provided 

10 under this section with respect to the specific identity 

11 of the chemical substance and other information relat12 ing to the chemical substance shall no longer apply. 

13 ‘‘(d) REQUIREMENTS FOR CONFIDENTIALITY

14 CLAIMS.— 

15 ‘‘(1) ASSERTION OF CLAIMS.— 

16 ‘‘(A) IN GENERAL.—A person seeking to 

17 protect any information submitted under this 

18 Act from disclosure (including information de19 scribed in subsection (b)) shall assert to the Ad20 ministrator a claim for protection concurrent 

21 with submission of the information, in accord22 ance with such rules regarding a claim for pro23 tection from disclosure as the Administrator has 

24 promulgated or may promulgate pursuant to 

25 this title. 


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1 ‘‘(B) INCLUSION.—An assertion of a claim 

2 under subparagraph (A) shall include a state3 ment that the person has— 

4 ‘‘(i) taken reasonable measures to pro5 tect the confidentiality of the information; 

6 ‘‘(ii) determined that the information 

7 is not required to be disclosed or otherwise 

8 made available to the public under any 

9 other Federal law; 

10 ‘‘(iii) a reasonable basis to conclude 

11 that disclosure of the information is likely 

12 to cause substantial harm to the competitive 

13 position of the person; and 

14 ‘‘(iv) a reasonable basis to believe that 

15 the information is not readily discoverable 

16 through reverse engineering. 

17 ‘‘(C) SPECIFIC CHEMICAL IDENTITY.—In 

18 the case of a claim under subparagraph (A) for 

19 protection against disclosure of a specific chem20 ical identity, the claim shall include a struc21 turally descriptive generic name for the chemical 

22 substance that the Administrator may disclose to 

23 the public, subject to the condition that the ge24 neric name shall— 


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1 ‘‘(i) conform with guidance prescribed 

2 by the Administrator under paragraph 

3 (3)(A); and 

4 ‘‘(ii) describe the chemical structure of 

5 the substance as specifically as practicable 

6 while protecting those features of the chem7 ical structure— 

8 ‘‘(I) that are considered to be con9 fidential; and 

10 ‘‘(II) the disclosure of which 

11 would be likely to harm the competitive 

12 position of the person. 

13 ‘‘(D) PUBLIC INFORMATION.—No person 

14 may assert a claim under this section for protec15 tion from disclosure of information that is al16 ready publicly available. 

17 ‘‘(2) ADDITIONAL REQUIREMENTS FOR CON18 FIDENTIALITY CLAIMS.—Except for information de19 scribed in paragraphs (1) through (7) of subsection 

20 (b), a person asserting a claim to protect information 

21 from disclosure under this Act shall substantiate the 

22 claim, in accordance with the rules promulgated and 

23 guidance issued by the Administrator. 

24 ‘‘(3) GUIDANCE.—The Administrator shall de25 velop guidance regarding— 


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1 ‘‘(A) the determination of structurally de2 scriptive generic names, in the case of claims for 

3 the protection against disclosure of specific chem4 ical identity; and 

5 ‘‘(B) the content and form of the statements 

6 of need and agreements required under para7 graphs (4), (5), and (6) of subsection (e). 

8 ‘‘(4) CERTIFICATION.—An authorized official of 

9 a person described in paragraph (1)(A) shall certify 

10 that the information that has been submitted is true 

11 and correct. 

12 ‘‘(e) EXCEPTIONS TO PROTECTION FROM DISCLO13 SURE.—Information described in subsection (a)— 

14 ‘‘(1) shall be disclosed if the information is to be 

15 disclosed to an officer or employee of the United 

16 States in connection with the official duties of the of17 ficer or employee— 

18 ‘‘(A) under any law for the protection of 

19 health or the environment; or 

20 ‘‘(B) for a specific law enforcement purpose; 

21 ‘‘(2) shall be disclosed if the information is to be 

22 disclosed to a contractor of the United States and em23 ployees of that contractor— 

24 ‘‘(A) if, in the opinion of the Administrator, 

25 the disclosure is necessary for the satisfactory 


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1 performance by the contractor of a contract with 

2 the United States for the performance of work in 

3 connection with this Act; and 

4 ‘‘(B) subject to such conditions as the Ad5 ministrator may specify; 

6 ‘‘(3) shall be disclosed if the Administrator deter7 mines that disclosure is necessary to protect health or 

8 the environment; 

9 ‘‘(4) shall be disclosed if the information is to be 

10 disclosed to a State or political subdivision of a State, 

11 on written request, for the purpose of development, 

12 administration, or enforcement of a law, if— 

13 ‘‘(A) 1 or more applicable agreements with 

14 the Administrator that conform with the guid15 ance issued under subsection (d)(3)(B) ensure 

16 that the recipient will take appropriate meas17 ures, and has adequate authority, to maintain 

18 the confidentiality of the information in accord19 ance with procedures comparable to the proce20 dures used by the Administrator to safeguard the 

21 information; and 

22 ‘‘(B) the Administrator notifies the person 

23 that submitted the information that the informa24 tion has been disclosed to the State or political 

25 subdivision of a State; 


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1 ‘‘(5) shall be disclosed if a health or environ2 mental professional employed by a Federal or State 

3 agency or a treating physician or nurse in a non4 emergency situation provides a written statement of 

5 need and agrees to sign a written confidentiality 

6 agreement with the Administrator, subject to the con7 ditions that— 

8 ‘‘(A) the statement of need and confiden9 tiality agreement shall conform with the guid10 ance issued under subsection (d)(3)(B); 

11 ‘‘(B) the written statement of need shall be 

12 a statement that the person has a reasonable 

13 basis to suspect that— 

14 ‘‘(i) the information is necessary for, 

15 or will assist in— 

16 ‘‘(I) the diagnosis or treatment of 

17 1 or more individuals; or 

18 ‘‘(II) responding to an environ19 mental release or exposure; and 

20 ‘‘(ii) 1 or more individuals being diag21 nosed or treated have been exposed to the 

22 chemical substance concerned, or an envi23 ronmental release or exposure has occurred; 

24 and 


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1 ‘‘(C) the confidentiality agreement shall 

2 provide that the person will not use the informa3 tion for any purpose other than the health or en4 vironmental needs asserted in the statement of 

5 need, except as otherwise may be authorized by 

6 the terms of the agreement or by the person sub7 mitting the information to the Administrator, 

8 except that nothing in this Act prohibits the dis9 closure of any such information through dis10 covery, subpoena, other court order, or any other 

11 judicial process otherwise allowed under applica12 ble Federal or State law; 

13 ‘‘(6) shall be disclosed if in the event of an emer14 gency, a treating physician, nurse, agent of a poison 

15 control center, public health or environmental official 

16 of a State or political subdivision of a State, or first 

17 responder (including any individual duly authorized 

18 by a Federal agency, State, or political subdivision of 

19 a State who is trained in urgent medical care or 

20 other emergency procedures, including a police officer, 

21 firefighter, or emergency medical technician) requests 

22 the information, subject to the conditions that— 

23 ‘‘(A) the treating physician, nurse, agent, 

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1 sponder shall have a reasonable basis to suspect 

2 that— 

3 ‘‘(i) a medical or public health or envi4 ronmental emergency exists; 

5 ‘‘(ii) the information is necessary for, 

6 or will assist in, emergency or first-aid di7 agnosis or treatment; or 

8 ‘‘(iii) 1 or more individuals being di9 agnosed or treated have likely been exposed 

10 to the chemical substance concerned, or a se11 rious environmental release of or exposure 

12 to the chemical substance concerned has oc13 curred; 

14 ‘‘(B) if requested by the person submitting 

15 the information to the Administrator, the treat16 ing physician, nurse, agent, public health or en17 vironmental official of a State or a political sub18 division of a State, or first responder shall, as 

19 described in paragraph (5)— 

20 ‘‘(i) provide a written statement of 

21 need; and 

22 ‘‘(ii) agree to sign a confidentiality 

23 agreement; and 

24 ‘‘(C) the written confidentiality agreement 

25 or statement of need shall be submitted as soon 


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1 as practicable, but not necessarily before the in2 formation is disclosed; 

3 ‘‘(7) may be disclosed if the Administrator deter4 mines that disclosure is relevant in a proceeding 

5 under this Act, subject to the condition that the disclo6 sure shall be made in such a manner as to preserve 

7 confidentiality to the maximum extent practicable 

8 without impairing the proceeding; 

9 ‘‘(8) shall be disclosed if the information is to be 

10 disclosed, on written request of any duly authorized 

11 congressional committee, to that committee; or 

12 ‘‘(9) shall be disclosed if the information is re13 quired to be disclosed or otherwise made public under 

14 any other provision of Federal law. 

15 ‘‘(f) DURATION OF PROTECTION FROM DISCLOSURE.— 

16 ‘‘(1) IN GENERAL.— 

17 ‘‘(A) INFORMATION PROTECTED FROM DIS18 CLOSURE.—Subject to paragraph (2), the Ad19 ministrator shall protect from disclosure infor20 mation that meets the requirements of subsection 

21 (d) for a period of 10 years, unless, prior to the 

22 expiration of the period— 

23 ‘‘(i) an affected person notifies the Ad24 ministrator that the person is withdrawing 

25 the confidentiality claim, in which case the 


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1 Administrator shall promptly make the in2 formation available to the public; or 

3 ‘‘(ii) the Administrator otherwise be4 comes aware that the need for protection 

5 from disclosure can no longer be substan6 tiated, in which case the Administrator 

7 shall take the actions described in subsection 

8 (g)(2). 

9 ‘‘(B) EXTENSIONS.— 

10 ‘‘(i) IN GENERAL.—Not later than the 

11 date that is 60 days before the expiration of 

12 the period described in subparagraph (A), 

13 the Administrator shall provide to the per14 son that asserted the claim a notice of the 

15 impending expiration of the period. 

16 ‘‘(ii) STATEMENT.— 

17 ‘‘(I) IN GENERAL.—Not later than 

18 the date that is 30 days before the expi19 ration of the period described in sub20 paragraph (A), a person reasserting 

21 the relevant claim shall submit to the 

22 Administrator a statement substan23 tiating, in accordance with subsection 

24 (d)(2), the need to extend the period. 


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1 ‘‘(II) ACTION BY ADMINIS2 TRATOR.—Not later than the date that 

3 is 30 days after the date of receipt of 

4 a statement under subclause (I), the 

5 Administrator shall— 

6 ‘‘(aa) review the request; 

7 ‘‘(bb) make a determination 

8 regarding whether the information 

9 for which the request is made con10 tinues to meet the relevant cri11 teria established under this sec12 tion; and 

13 ‘‘(cc)(AA) grant an extension 

14 of not more than 10 years; or 

15 ‘‘(BB) deny the claim. 

16 ‘‘(C) NO LIMIT ON NUMBER OF EXTEN17 SIONS.—There shall be no limit on the number 

18 of extensions granted under subparagraph (B), if 

19 the Administrator determines that the relevant 

20 statement under subparagraph (B)(ii)(I)— 

21 ‘‘(i) establishes the need to extend the 

22 period; and 

23 ‘‘(ii) meets the requirements established 

24 by the Administrator. 

25 ‘‘(2) REVIEW AND RESUBSTANTIATION.— 


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1 ‘‘(A) DISCRETION OF ADMINISTRATOR.—The 

2 Administrator may review, at any time, a claim 

3 for protection against disclosure under subsection 

4 (a) for information submitted to the Adminis5 trator regarding a chemical substance and re6 quire any person that has claimed protection for 

7 that information, whether before, on, or after the 

8 date of enactment of the Frank R. Lautenberg 

9 Chemical Safety for the 21st Century Act, to 

10 withdraw or reassert and substantiate or re11 substantiate the claim in accordance with this 

12 section— 

13 ‘‘(i) after the chemical substance is 

14 identified as a high-priority substance 

15 under section 4A; 

16 ‘‘(ii) for any chemical substance for 

17 which the Administrator has made a deter18 mination under section 6(c)(1)(C); 

19 ‘‘(iii) for any inactive chemical sub20 stance identified under section 8(b)(5); or 

21 ‘‘(iv) in limited circumstances, if the 

22 Administrator determines that disclosure of 

23 certain information currently protected 

24 from disclosure would assist the Adminis25 trator in conducting safety assessments and 


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1 safety determinations under subsections (b) 

2 and (c) of section 6 or promulgating rules 

3 pursuant to section 6(d), subject to the con4 dition that the information shall not be dis5 closed unless the claimant withdraws the 

6 claim or the Administrator determines that 

7 the information does not meet the require8 ments of subsection (d). 

9 ‘‘(B) REVIEW REQUIRED.—The Adminis10 trator shall review a claim for protection from 

11 disclosure under subsection (a) for information 

12 submitted to the Administrator regarding a 

13 chemical substance and require any person that 

14 has claimed protection for that information, 

15 whether before, on, or after the date of enactment 

16 of the Frank R. Lautenberg Chemical Safety for 

17 the 21st Century Act, to withdraw or reassert 

18 and substantiate or resubstantiate the claim in 

19 accordance with this section— 

20 ‘‘(i) as necessary to comply with a re21 quest for information received by the Ad22 ministrator under section 552 of title 5, 

23 United States Code; 

24 ‘‘(ii) if information available to the 

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1 quirements of section 552(b)(4) of title 5, 

2 United States Code, are no longer met; or 

3 ‘‘(iii) for any substance for which the 

4 Administrator has made a determination 

5 under section 6(c)(1)(B). 

6 ‘‘(C) ACTION BY RECIPIENT.—If the Admin7 istrator makes a request under subparagraph (A) 

8 or (B), the recipient of the request shall— 

9 ‘‘(i) reassert and substantiate or re10 substantiate the claim; or 

11 ‘‘(ii) withdraw the claim. 

12 ‘‘(D) PERIOD OF PROTECTION.—Protection 

13 from disclosure of information subject to a claim 

14 that is reviewed and approved by the Adminis15 trator under this paragraph shall be extended for 

16 a period of 10 years from the date of approval, 

17 subject to any subsequent request by the Admin18 istrator under this paragraph. 

19 ‘‘(3) UNIQUE IDENTIFIER.—The Administrator 

20 shall— 

21 ‘‘(A)(i) develop a system to assign a unique 

22 identifier to each specific chemical identity for 

23 which the Administrator approves a request for 

24 protection from disclosure, other than a specific 


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1 chemical identity or structurally descriptive ge2 neric term; and 

3 ‘‘(ii) apply that identifier consistently to all 

4 information relevant to the applicable chemical 

5 substance; 

6 ‘‘(B) annually publish and update a list of 

7 chemical substances, referred to by unique identi8 fier, for which claims to protect the specific 

9 chemical identity from disclosure have been ap10 proved, including the expiration date for each 

11 such claim; 

12 ‘‘(C) ensure that any nonconfidential infor13 mation received by the Administrator with re14 spect to such a chemical substance during the pe15 riod of protection from disclosure— 

16 ‘‘(i) is made public; and 

17 ‘‘(ii) identifies the chemical substance 

18 using the unique identifier; and 

19 ‘‘(D) for each claim for protection of specific 

20 chemical identity that has been denied by the 

21 Administrator on expiration of the period for 

22 appeal under subsection (g)(4), that has expired, 

23 or that has been withdrawn by the submitter, 

24 provide public access to the specific chemical 

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1 formation received by the Administrator with re2 spect to the chemical substance. 

3 ‘‘(g) DUTIES OF ADMINISTRATOR.— 

4 ‘‘(1) DETERMINATION.— 

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

6 subsection (b), the Administrator shall, subject to 

7 subparagraph (C), not later than 90 days after 

8 the receipt of a claim under subsection (d), and 

9 not later than 30 days after the receipt of a re10 quest for extension of a claim under subsection 

11 (f), review and approve, modify, or deny the 

12 claim or request. 

13 ‘‘(B) DENIAL OR MODIFICATION.— 

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

15 in subsections (c) and (f), the Administrator 

16 shall deny a claim to protect a chemical 

17 identity from disclosure only if the person 

18 that has submitted the claim fails to meet 

19 the requirements of subsections (a) and (d). 

20 ‘‘(ii) REASONS FOR DENIAL OR MODI21 FICATION.—The Administrator shall pro22 vide to a person that has submitted a claim 

23 described in clause (i) a written statement 

24 of the reasons for the denial or modification 

25 of the claim. 


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1 ‘‘(C) SUBSETS.—The Administrator shall— 

2 ‘‘(i) except for claims described in sub3 section (b)(7), review all claims under this 

4 section for the protection against disclosure 

5 of the specific identity of a chemical sub6 stance; and 

7 ‘‘(ii) review a representative subset, 

8 comprising at least 25 percent, of all other 

9 claims for protection against disclosure. 

10 ‘‘(D) EFFECT OF FAILURE TO ACT.—The 

11 failure of the Administrator to make a decision 

12 regarding a claim for protection against disclo13 sure or extension under this section shall not be 

14 the basis for denial or elimination of a claim for 

15 protection against disclosure. 

16 ‘‘(2) NOTIFICATION.— 

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

18 subparagraph (B) and subsections (c), (e), and 

19 (f), if the Administrator denies or modifies a 

20 claim under paragraph (1), or promulgates a 

21 rule under section 6(d) establishing a ban or 

22 phase-out of a chemical substance, the Adminis23 trator shall notify, in writing and by certified 

24 mail, the person that submitted the claim of the 


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1 intent of the Administrator to release the infor2 mation. 

3 ‘‘(B) RELEASE OF INFORMATION.— 

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

5 in clause (ii), the Administrator shall not 

6 release information under this subsection 

7 until the date that is 30 days after the date 

8 on which the person that submitted the re9 quest receives notification under subpara10 graph (A). 

11 ‘‘(ii) EXCEPTIONS.— 

12 ‘‘(I) IN GENERAL.—For informa13 tion under paragraph (3) or (8) of sub14 section (e), the Administrator shall not 

15 release that information until the date 

16 that is 15 days after the date on which 

17 the person that submitted the claim re18 ceives a notification, unless the Admin19 istrator determines that release of the 

20 information is necessary to protect 

21 against an imminent and substantial 

22 harm to health or the environment, in 

23 which case no prior notification shall 

24 be necessary. 


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1 ‘‘(II) NO NOTIFICATION.—For in2 formation under paragraph (1), (2), 

3 (6), (7), or (9) of subsection (e), no 

4 prior notification shall be necessary. 

5 ‘‘(3) REBUTTABLE PRESUMPTION.— 

6 ‘‘(A) IN GENERAL.—With respect to notifi7 cations provided by the Administrator pursuant 

8 to subsection (c)(5), there shall be a rebuttable 

9 presumption that the public interest in dis10 closing confidential information related to a 

11 chemical substance subject to a rule promulgated 

12 under section 6(d) that establishes a ban or 

13 phase-out of the manufacture, processing, or dis14 tribution in commerce of the substance outweighs 

15 the proprietary interest in maintaining the pro16 tection from disclosure of that information. 

17 ‘‘(B) REQUEST FOR NONDISCLOSURE.—A 

18 person that receives a notification under para19 graph (2) with respect to the information de20 scribed in subparagraph (A) may submit to the 

21 Administrator, before the date on which the in22 formation is to be released, a request with sup23 porting documentation describing why the per24 son believes some or all of that information 

25 should not be disclosed. 


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1 ‘‘(C) DETERMINATION BY ADMINIS2 TRATOR.— 

3 ‘‘(i) IN GENERAL.—Not later than 30 

4 days after the Administrator receives a re5 quest under subparagraph (B), the Admin6 istrator shall determine, at the discretion of 

7 the Administrator, whether the documenta8 tion provided by the person making the re9 quest rebuts or does not rebut the presump10 tion described in subparagraph (A), for all 

11 or a portion of the information that the per12 son has requested not be disclosed. 

13 ‘‘(ii) OBJECTIVE.—The Administrator 

14 shall make the determination with the objec15 tive of ensuring that information relevant to 

16 protection of health and the environment is 

17 disclosed to the maximum extent prac18 ticable. 

19 ‘‘(D) TIMING.—Not later than 30 days after 

20 making the determination described in subpara21 graph (C), the Administrator shall make public 

22 the information the Administrator has deter23 mined is not to be protected from disclosure. 

24 ‘‘(E) NO TIMELY REQUEST RECEIVED.—If 

25 the Administrator does not receive, before the 


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1 date on which the information described in sub2 paragraph (A) is to be released, a request pursu3 ant to subparagraph (B), the Administrator 

4 shall promptly make public all of the informa5 tion. 

6 ‘‘(4) APPEALS.— 

7 ‘‘(A) IN GENERAL.—If a person receives a 

8 notification under paragraph (2) and believes 

9 disclosure of the information is prohibited under 

10 subsection (a), before the date on which the infor11 mation is to be released, the person may bring 

12 an action to restrain disclosure of the informa13 tion in— 

14 ‘‘(i) the United States district court of 

15 the district in which the complainant re16 sides or has the principal place of business; 

17 or 

18 ‘‘(ii) the United States District Court 

19 for the District of Columbia. 

20 ‘‘(B) NO DISCLOSURE.—The Administrator 

21 shall not disclose any information that is the 

22 subject of an appeal under this section before the 

23 date on which the applicable court rules on an 

24 action under subparagraph (A). 


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1 ‘‘(5) ADMINISTRATION.—In carrying out this 

2 subsection, the Administrator shall use the procedures 

3 described in part 2 of title 40, Code of Federal Regu4 lations (or successor regulations). 

5 ‘‘(h) CRIMINAL PENALTY FOR WRONGFUL DISCLO6 SURE.— 

7 ‘‘(1) OFFICERS AND EMPLOYEES OF UNITED

8 STATES.— 

9 ‘‘(A) IN GENERAL.—Subject to paragraph 

10 (2), a current or former officer or employee of the 

11 United States described in subparagraph (B) 

12 shall be guilty of a misdemeanor and fined 

13 under title 18, United States Code, or impris14 oned for not more than 1 year, or both. 

15 ‘‘(B) DESCRIPTION.—A current or former 

16 officer or employee of the United States referred 

17 to in subparagraph (A) is a current or former 

18 officer or employee of the United States who— 

19 ‘‘(i) by virtue of that employment or 

20 official position has obtained possession of, 

21 or has access to, material the disclosure of 

22 which is prohibited by subsection (a); and 

23 ‘‘(ii) knowing that disclosure of that 

24 material is prohibited by subsection (a), 

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1 ner to any person not entitled to receive 

2 that material. 

3 ‘‘(2) OTHER LAWS.—Section 1905 of title 18, 

4 United States Code, shall not apply with respect to 

5 the publishing, divulging, disclosure, making known 

6 of, or making available, information reported or oth7 erwise obtained under this Act. 

8 ‘‘(3) CONTRACTORS.—For purposes of this sub9 section, any contractor of the United States that is 

10 provided information in accordance with subsection 

11 (e)(2), including any employee of that contractor, 

12 shall be considered to be an employee of the United 

13 States. 

14 ‘‘(i) APPLICABILITY.— 

15 ‘‘(1) IN GENERAL.—Except as otherwise provided 

16 in this section, section 8, or any other applicable Fed17 eral law, the Administrator shall have no authority— 

18 ‘‘(A) to require the substantiation or re19 substantiation of a claim for the protection from 

20 disclosure of information submitted to the Ad21 ministrator under this Act before the date of en22 actment of the Frank R. Lautenberg Chemical 

23 Safety for the 21st Century Act; or 

24 ‘‘(B) to impose substantiation or resubstan25 tiation requirements under this Act that are 


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1 more extensive than those required under this 

2 section. 

3 ‘‘(2) PRIOR ACTIONS.—Nothing in this Act pre4 vents the Administrator from reviewing, requiring 

5 substantiation or resubstantiation for, or approving, 

6 modifying or denying any claim for the protection 

7 from disclosure of information before the effective date 

8 of such rules applicable to those claims as the Admin9 istrator may promulgate after the date of enactment 

10 of the Frank R. Lautenberg Chemical Safety for the 

11 21st Century Act.’’. 

12 SEC. 15. PROHIBITED ACTS. 

13 Section 15 of the Toxic Substances Control Act (15 

14 U.S.C. 2614) is amended by striking paragraph (1) and 

15 inserting the following: 

16 ‘‘(1) fail or refuse to comply with— 

17 ‘‘(A) any rule promulgated, consent agree18 ment entered into, or order issued under section 

19 4; 

20 ‘‘(B) any requirement under section 5 or 6; 

21 ‘‘(C) any rule promulgated, consent agree22 ment entered into, or order issued under section 

23 5 or 6; or 

24 ‘‘(D) any requirement of, or any rule pro25 mulgated or order issued pursuant to title II;’’. 


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1 SEC. 16. PENALTIES. 

2 Section 16 of the Toxic Substances Control Act (15 

3 U.S.C. 2615) is amended— 

4 (1) in subsection (a)(1)— 

5 (A) in the first sentence— 

6 (i) by inserting ‘‘this Act or a rule or 

7 order promulgated or issued pursuant to 

8 this Act, including’’ after ‘‘a provision of’’; 

9 and 

10 (ii) by striking ‘‘$25,000’’ and insert11 ing ‘‘$37,500’’; and 

12 (B) in the second sentence, by striking‘‘ vio13 lation of section 15 or 409’’ and inserting ‘‘viola14 tion of this Act’’; and 

15 (2) in subsection (b)— 

16 (A) by striking ‘‘Any person who’’ and in17 serting the following: 

18 ‘‘(1) IN GENERAL.—Any person that’’; 

19 (B) by striking ‘‘section 15 or 409’’ and in20 serting ‘‘this Act’’; 

21 (C) by striking ‘‘$25,000’’ and inserting 

22 ‘‘$50,000’’; and 

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

24 ‘‘(2) IMMINENT DANGER OF DEATH OR SERIOUS

25 BODILY INJURY.— 


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1 ‘‘(A) IN GENERAL.—Any person that know2 ingly or willfully violates any provision of this 

3 Act, and that knows at the time of the violation 

4 that the violation places an individual in immi5 nent danger of death or serious bodily injury, 

6 shall be subject on conviction to a fine of not 

7 more than $250,000, or imprisonment for not 

8 more than 15 years, or both. 

9 ‘‘(B) ORGANIZATIONS.—An organization 

10 that commits a violation described in subpara11 graph (A) shall be subject on conviction to a fine 

12 of not more than $1,000,000 for each violation. 

13 ‘‘(3) KNOWLEDGE OF IMMINENT DANGER OR IN14 JURY.—For purposes of determining whether a de15 fendant knew that the violation placed another indi16 vidual in imminent danger of death or serious bodily 

17 injury— 

18 ‘‘(A) the defendant shall be responsible only 

19 for actual awareness or actual belief possessed; 

20 and 

21 ‘‘(B) knowledge possessed by an individual 

22 may not be attributed to the defendant.’’. 


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1 SEC. 17. STATE-FEDERAL RELATIONSHIP. 

2 Section 18 of the Toxic Substances Control Act (15 

3 U.S.C. 2617) is amended by striking subsections (a) and 

4 (b) and inserting the following: 

5 ‘‘(a) IN GENERAL.— 

6 ‘‘(1) ESTABLISHMENT OR ENFORCEMENT.—Ex7 cept as provided in subsections (c), (d), (e), (f), and 

8 (g), and subject to paragraph (2), no State or polit9 ical subdivision of a State may establish or continue 

10 to enforce any of the following: 

11 ‘‘(A) TESTING AND INFORMATION COLLEC12 TION.—A statute or administrative action to re13 quire the development of information on a chem14 ical substance or category of substances that is 

15 reasonably likely to produce the same informa16 tion required under section 4, 5, or 6 in— 

17 ‘‘(i) a rule promulgated by the Admin18 istrator; 

19 ‘‘(ii) a testing consent agreement en20 tered into by the Administrator; or 

21 ‘‘(iii) an order issued by the Adminis22 trator. 

23 ‘‘(B) CHEMICAL SUBSTANCES FOUND TO

24 MEET THE SAFETY STANDARD OR RE25 STRICTED.—A statute or administrative action 

26 to prohibit or otherwise restrict the manufacture, 


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1 processing, or distribution in commerce or use of 

2 a chemical substance— 

3 ‘‘(i) found to meet the safety standard 

4 and consistent with the scope of the deter5 mination made under section 6; or 

6 ‘‘(ii) found not to meet the safety 

7 standard, after the effective date of the rule 

8 issued under section 6(d) for the substance, 

9 consistent with the scope of the determina10 tion made by the Administrator. 

11 ‘‘(C) SIGNIFICANT NEW USE.—A statute or 

12 administrative action requiring the notification 

13 of a use of a chemical substance that the Admin14 istrator has specified as a significant new use 

15 and for which the Administrator has required 

16 notification pursuant to a rule promulgated 

17 under section 5. 

18 ‘‘(2) EFFECTIVE DATE OF PREEMPTION.—Under 

19 this subsection, Federal preemption of State statutes 

20 and administrative actions applicable to specific sub21 stances shall not occur until the effective date of the 

22 applicable action described in paragraph (1) taken by 

23 the Administrator. 

24 ‘‘(b) NEW STATUTES OR ADMINISTRATIVE ACTIONS

25 CREATING PROHIBITIONS OR OTHER RESTRICTIONS.— 


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1 ‘‘(1) IN GENERAL.—Except as provided in sub2 sections (c), (d), and (e), beginning on the date on 

3 which the Administrator defines the scope of a safety 

4 assessment and safety determination under section 

5 6(a)(2) and ending on the date on which the Admin6 istrator publishes the safety determination, no State 

7 or political subdivision of a State may establish a 

8 statute or administrative action prohibiting or re9 stricting the manufacture, processing, distribution in 

10 commerce or use of a chemical substance that is a 

11 high-priority substance designated under section 4A. 

12 ‘‘(2) EFFECT OF SUBSECTION.— 

13 ‘‘(A) IN GENERAL.—This subsection does 

14 not restrict the authority of a State or political 

15 subdivision of a State to continue to enforce any 

16 State statute enacted, or administrative action 

17 taken, prior to the date on which the Adminis18 trator defines the scope of a safety assessment 

19 and safety determination under section 6(a)(2). 

20 ‘‘(B) LIMITATION.—Subparagraph (A) does 

21 not allow a State or political subdivision of a 

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1 hibition or restriction is established after the 

2 date described in that subparagraph. 

3 ‘‘(c) SCOPE OF PREEMPTION.—Federal preemption 

4 under subsections (a) and (b) of State statutes and adminis5 trative actions applicable to specific substances shall apply 

6 only to— 

7 ‘‘(1) the chemical substances or category of sub8 stances subject to a rule, order, or consent agreement 

9 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 included 

13 in the scope of the safety determination made by the 

14 Administrator for the substance, or of any rule the 

15 Administrator promulgates pursuant to section 6(d); 

16 or 

17 ‘‘(3) the uses of such substances that the Admin18 istrator has specified as significant new uses and for 

19 which the Administrator has required notification 

20 pursuant to a rule promulgated under section 5. 

21 ‘‘(d) EXCEPTIONS.— 

22 ‘‘(1) NO PREEMPTION OF STATE STATUTES AND

23 ADMINISTRATIVE ACTIONS.— 

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

25 nor any amendment made by this Act, nor any 


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1 rule, standard of performance, safety determina2 tion, or scientific assessment implemented pursu3 ant to this Act, shall affect the right of a State 

4 or a political subdivision of a State to adopt or 

5 enforce any rule, standard of performance, safety 

6 determination, scientific assessment, or any pro7 tection for public health or the environment 

8 that— 

9 ‘‘(i) is adopted or authorized under the 

10 authority of any other Federal law or 

11 adopted to satisfy or obtain authorization 

12 or approval under any other Federal law; 

13 ‘‘(ii) implements a reporting, moni14 toring, disclosure, or other information obli15 gation for the chemical substance not other16 wise required by the Administrator under 

17 this Act or required under any other Fed18 eral law; 

19 ‘‘(iii) is adopted pursuant to authority 

20 under a law of the State or political sub21 division of the State related to water qual22 ity, air quality, or waste treatment or dis23 posal, except to the extent that the action— 

24 ‘‘(I) imposes a restriction on the 

25 manufacture, processing, distribution 


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1 in commerce, or use of a chemical sub2 stance; and 

3 ‘‘(II)(aa) addresses the same haz4 ards and exposures, with respect to the 

5 same conditions of use as are included 

6 in the scope of the safety determination 

7 pursuant to section 6, but is incon8 sistent with the action of the Adminis9 trator; or 

10 ‘‘(bb) would cause a violation of 

11 the applicable action by the Adminis12 trator under section 5 or 6; or 

13 ‘‘(iv) subject to subparagraph (B), is 

14 identical to a requirement prescribed by the 

15 Administrator. 

16 ‘‘(B) IDENTICAL REQUIREMENTS.— 

17 ‘‘(i) IN GENERAL.—The penalties and 

18 other sanctions applicable under State law 

19 in the event of noncompliance with the 

20 identical requirement shall be no more 

21 stringent than the penalties and other sanc22 tions available to the Administrator under 

23 section 16 of this Act. 

24 ‘‘(ii) PENALTIES.—In the case of an 

25 identical requirement, no State may assess 


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1 a penalty for a specific violation for which 

2 the Administrator has already assessed a 

3 penalty under section 16, and the Adminis4 trator may not assess a penalty under sec5 tion 16 for a specific violation for which a 

6 State has already assessed a penalty. 

7 ‘‘(2) APPLICABILITY TO CERTAIN RULES OR OR8 DERS.—Notwithstanding subsection (e)— 

9 ‘‘(A) nothing in this section shall be con10 strued as modifying the effect under this section, 

11 as in effect on the day before the effective date of 

12 the Frank R. Lautenberg Chemical Safety for the 

13 21st Century Act, of any rule or order promul14 gated or issued under this Act prior to that effec15 tive date; and 

16 ‘‘(B) with respect to a chemical substance or 

17 mixture for which any rule or order was promul18 gated or issued under section 6 prior to the effec19 tive date of the Frank R. Lautenberg Chemical 

20 Safety for the 21st Century Act with regards to 

21 manufacturing, processing, distribution in com22 merce, use, or disposal of a chemical substance, 

23 this section (as in effect on the day before the ef24 fective date of the Frank R. Lautenberg Chemical 

25 Safety for the 21st Century Act) shall govern the 


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1 preemptive effect of any rule or order that is pro2 mulgated or issued respecting such chemical sub3 stance or mixture under section 6 of this Act 

4 after that effective date, unless the latter rule or 

5 order is with respect to a chemical substance or 

6 mixture containing a chemical substance and fol7 lows a designation of that chemical substance as 

8 a high-priority substance under section 4A(b) or 

9 as an additional priority for safety assessment 

10 and safety determination under section 4A(c). 

11 ‘‘(e) PRESERVATION OF CERTAIN STATE LAW.— 

12 ‘‘(1) IN GENERAL.—Nothing in this Act, subject 

13 to subsection (g) of this section, shall— 

14 ‘‘(A) be construed to preempt or otherwise 

15 affect the authority of a State or political sub16 division of a State to continue to enforce any ac17 tion taken before August 1, 2015, under the au18 thority of a State law that prohibits or otherwise 

19 restricts manufacturing, processing, distribution 

20 in commerce, use, or disposal of a chemical sub21 stance; or 

22 ‘‘(B) be construed to preempt or otherwise 

23 affect any action taken pursuant to a State law 

24 that was in effect on August 31, 2003. 


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1 ‘‘(2) EFFECT OF SUBSECTION.—This subsection 

2 does not affect, modify, or alter the relationship be3 tween State and Federal law pursuant to any other 

4 Federal law. 

5 ‘‘(f) STATE WAIVERS.— 

6 ‘‘(1) DISCRETIONARY EXEMPTIONS.—Upon ap7 plication of a State or political subdivision of a 

8 State, the Administrator may by rule, exempt from 

9 subsection (a), under such conditions as may be pre10 scribed in the rule, a statute or administrative action 

11 of that State or political subdivision of the State that 

12 relates to the effects of, or exposure to, a chemical sub13 stance under the conditions of use if the Adminis14 trator determines that— 

15 ‘‘(A) compelling State or local conditions 

16 warrant granting the waiver to protect health or 

17 the environment; 

18 ‘‘(B) compliance with the proposed require19 ment of the State or political subdivision of the 

20 State would not unduly burden interstate com21 merce in the manufacture, processing, distribu22 tion in commerce, or use of a chemical substance; 

23 ‘‘(C) compliance with the proposed require24 ment of the State or political subdivision of the 


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1 State would not cause a violation of any appli2 cable Federal law, rule, or order; and 

3 ‘‘(D) based on the judgment of the Adminis4 trator, the proposed requirement of the State or 

5 political subdivision of the State is consistent 

6 with sound objective scientific practices, the 

7 weight of the evidence, and the best available 

8 science. 

9 ‘‘(2) REQUIRED EXEMPTIONS.—Upon applica10 tion of a State or political subdivision of a State, the 

11 Administrator shall exempt from subsection (b) a 

12 statute or administrative action of a State or polit13 ical subdivision of a State that relates to the effects 

14 of exposure to a chemical substance under the condi15 tions of use if the Administrator determines that— 

16 ‘‘(A) compliance with the proposed require17 ment of the State will not unduly burden inter18 state commerce in the manufacture, processing, 

19 distribution in commerce, or use of a chemical 

20 substance; 

21 ‘‘(B) compliance with the proposed require22 ment would not cause a violation of any appli23 cable Federal law, rule, or order; and 

24 ‘‘(C) the State or political subdivision of a 

25 State has a concern about the chemical substance 


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1 or use of the chemical substance based in peer2 reviewed science. 

3 ‘‘(3) DETERMINATION OF A STATE WAIVER RE4 QUEST.—The duty of the Administrator to grant or 

5 deny a waiver application shall be nondelegable and 

6 shall be exercised— 

7 ‘‘(A) not later than 180 days after the date 

8 on which an application under paragraph (1) is 

9 submitted; and 

10 ‘‘(B) not later than 90 days after the date 

11 on which an application under paragraph (2) is 

12 submitted. 

13 ‘‘(4) FAILURE TO MAKE DETERMINATION.—If the 

14 Administrator fails to make a determination under 

15 paragraph (3)(B) during the 90-day period beginning 

16 on the date on which an application under paragraph 

17 (2) is submitted, the State statute or administrative 

18 action that was the subject of the application shall 

19 not be considered to be an existing statute or admin20 istrative action for purposes of subsection (b) by rea21 son of the failure of the Administrator to make a de22 termination. 

23 ‘‘(5) NOTICE AND COMMENT.—Except in the case 

24 of an application approved under paragraph (9), the 


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1 application of a State or political subdivision of the 

2 State shall be subject to public notice and comment. 

3 ‘‘(6) FINAL AGENCY ACTION.—The decision of the 

4 Administrator on the application of a State or polit5 ical subdivision of the State shall be— 

6 ‘‘(A) considered to be a final agency action; 

7 and 

8 ‘‘(B) subject to judicial review. 

9 ‘‘(7) DURATION OF WAIVERS.— 

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

11 subparagraph (B), a waiver granted under para12 graph (2) or approved under paragraph (9) shall 

13 remain in effect— 

14 ‘‘(i) until such time as the safety as15 sessment and safety determination is com16 pleted; or 

17 ‘‘(ii) subject to subparagraph (B), 

18 until judicial review of the failure of the 

19 Administrator to make a determination 

20 under paragraph (3) is sought under para21 graph (8). 

22 ‘‘(B) REINSTATEMENT OF WAIVER.—A 

23 waiver described in subparagraph (A)(ii) shall 

24 again take effect upon the earlier of— 


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1 ‘‘(i) the date of approval by the Ad2 ministrator of the waiver application; 

3 ‘‘(ii) the effective date of a court order 

4 directing the Administrator to approve the 

5 waiver application; or 

6 ‘‘(iii) 90 days after the date on which 

7 judicial review under paragraph (8) is 

8 sought. 

9 ‘‘(8) JUDICIAL REVIEW OF WAIVERS.—Not later 

10 than 60 days after the date on which the Adminis11 trator makes a determination on an application of a 

12 State or political subdivision of the State under para13 graph (1) or (2), or not later than 60 days after the 

14 date on which the Administrator fails to make a de15 termination under paragraph (3), any person may 

16 file a petition for judicial review in the United States 

17 Court of Appeals for the District of Columbia Circuit, 

18 which shall have exclusive jurisdiction over the deter19 mination. 

20 ‘‘(9) APPROVAL.— 

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

22 fails to meet the deadline under section 6(a)(4) 

23 (including an extension granted under section 

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1 ical subdivision of a State under paragraph (2) 

2 shall be automatically approved. 

3 ‘‘(B) REQUIREMENTS.—Notwithstanding 

4 paragraph (6), approval of a waiver application 

5 under subparagraph (A) for failure to meet the 

6 deadlines under section 6(a)(4) (including an ex7 tension granted under section 6(a)(6)) shall not 

8 be considered final agency action or be subject to 

9 judicial review or public notice and comment. 

10 ‘‘(10) JUDICIAL REVIEW OF LOW-PRIORITY DECI11 SIONS.— 

12 ‘‘(A) IN GENERAL.—Not later than 60 days 

13 after the publication of a designation under sec14 tion 4A(b)(4), any person may commence a civil 

15 action to challenge the designation. 

16 ‘‘(B) JURISDICTION.—The United States 

17 Court of Appeals for the District of Columbia 

18 Circuit shall have exclusive jurisdiction over a 

19 civil action filed under this paragraph. 

20 ‘‘(g) SAVINGS.— 

21 ‘‘(1) NO PREEMPTION OF COMMON LAW OR STAT22 UTORY CAUSES OF ACTION FOR CIVIL RELIEF OR

23 CRIMINAL CONDUCT.— 

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

25 nor any amendment made by this Act, nor any 


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1 safety standard, rule, requirement, standard of 

2 performance, safety determination, or scientific 

3 assessment implemented pursuant to this Act, 

4 shall be construed to preempt, displace, or sup5 plant any state or Federal common law rights or 

6 any state or Federal statute creating a remedy 

7 for civil relief, including those for civil damage, 

8 or a penalty for a criminal conduct. 

9 ‘‘(B) CLARIFICATION OF NO PREEMPTION.— 

10 Notwithstanding any other provision of this Act, 

11 nothing in this Act, nor any amendments made 

12 by this Act, shall preempt or preclude any cause 

13 of action for personal injury, wrongful death, 

14 property damage, or other injury based on neg15 ligence, strict liability, products liability, failure 

16 to warn, or any other legal theory of liability 

17 under any State law, maritime law, or Federal 

18 common law or statutory theory. 

19 ‘‘(2) NO EFFECT ON PRIVATE REMEDIES.— 

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

21 nor any amendments made by this Act, nor any 

22 rules, regulations, requirements, safety assess23 ments, safety determinations, scientific assess24 ments, or orders issued pursuant to this Act shall 


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1 be interpreted as, in either the plaintiff’s or de2 fendant’s favor, dispositive in any civil action. 

3 ‘‘(B) AUTHORITY OF COURTS.—This Act 

4 does not affect the authority of any court to 

5 make a determination in an adjudicatory pro6 ceeding under applicable State or Federal law 

7 with respect to the admission into evidence or 

8 any other use of this Act or rules, regulations, re9 quirements, standards of performance, safety as10 sessments, scientific assessments, or orders issued 

11 pursuant to this Act.’’. 

12 SEC. 18. JUDICIAL REVIEW. 

13 Section 19 of the Toxic Substances Control Act (15 

14 U.S.C. 2618) is amended— 

15 (1) in subsection (a)— 

16 (A) in paragraph (1)— 

17 (i) in subparagraph (A), by striking 

18 ‘‘section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 

19 8, or under title II or IV’’ and inserting 

20 ‘‘section 4(a), 5(d), 6(c), 6(d), 6(g), or 8, or 

21 title II or IV’’; and 

22 (ii) in subparagraph (B), by striking 

23 ‘‘an order issued under subparagraph (A) 

24 or (B) of section 6(b)(1)’’ and inserting ‘‘an 

25 order issued under this title’’; and 


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1 (B) in paragraph (2), in the first sentence, 

2 by striking ‘‘paragraph (1)(A)’’ and inserting 

3 ‘‘paragraph (1)’’; and 

4 (C) by striking paragraph (3); and 

5 (2) in subsection (c)(1)(B)— 

6 (A) in clause (i)— 

7 (i) by striking ‘‘section 4(a), 5(b)(4), 

8 6(a), or 6(e)’’ and inserting ‘‘section 4(a), 

9 5(d), 6(d), or 6(g)’’; and 

10 (ii) by striking ‘‘evidence in the rule11 making record (as defined in subsection 

12 (a)(3)) taken as a whole;’’ and inserting 

13 ‘‘evidence (including any matter) in the 

14 rulemaking record, taken as a whole; and’’; 

15 and 

16 (B) by striking clauses (ii) and (iii) and 

17 the matter following clause (iii) and inserting 

18 the following: 

19 ‘‘(ii) the court may not review the con20 tents and adequacy of any statement of 

21 basis and purpose required by section 

22 553(c) of title 5, United States Code, to be 

23 incorporated in the rule, except as part of 

24 the rulemaking record, taken as a whole.’’. 


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1 SEC. 19. CITIZENS’ PETITIONS. 

2 Section 21 of the Toxic Substances Control Act (15 

3 U.S.C. 2620) is amended— 

4 (1) in subsection (a), by striking ‘‘an order 

5 under section 5(e) or 6(b)(2)’’ and inserting ‘‘an 

6 order under section 4 or 5(d)’’; and 

7 (2) in subsection (b)— 

8 (A) in paragraph (1), by striking ‘‘an order 

9 under section 5(e), 6(b)(1)(A), or 6(b)(1)(B)’’ 

10 and inserting ‘‘an order under section 4 or 

11 5(d)’’; and 

12 (B) in paragraph (4), by striking subpara13 graph (B) and inserting the following: 

14 ‘‘(B) DE NOVO PROCEEDING.— 

15 ‘‘(i) IN GENERAL.—In an action under 

16 subparagraph (A) to initiate a proceeding 

17 to promulgate a rule pursuant to section 4, 

18 5, 6, or 8 or issue an order under section 

19 4 or 5(d), the petitioner shall be provided 

20 an opportunity to have the petition consid21 ered by the court in a de novo proceeding. 

22 ‘‘(ii) DEMONSTRATION.— 

23 ‘‘(I) IN GENERAL.—The court in a 

24 de novo proceeding under this subpara25 graph shall order the Administrator to 

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1 titioner if the petitioner demonstrates 

2 to the satisfaction of the court by a 

3 preponderance of the evidence that— 

4 ‘‘(aa) in the case of a peti5 tion to initiate a proceeding for 

6 the issuance of a rule or order 

7 under section 4, the information 

8 available to the Administrator is 

9 insufficient for the Administrator 

10 to perform an action described in 

11 section 4, 4A, 5, or 6(d); 

12 ‘‘(bb) in the case of a petition 

13 to issue an order under section 

14 5(d), there is a reasonable basis to 

15 conclude that the chemical sub16 stance is not likely to meet the 

17 safety standard; 

18 ‘‘(cc) in the case of a petition 

19 to initiate a proceeding for the 

20 issuance of a rule under section 

21 6(d), there is a reasonable basis to 

22 conclude that the chemical sub23 stance will not meet the safety 

24 standard; or 


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1 ‘‘(dd) in the case of a peti2 tion to initiate a proceeding for 

3 the issuance of a rule under sec4 tion 8, there is a reasonable basis 

5 to conclude that the rule is nec6 essary to protect health or the en7 vironment or ensure that the 

8 chemical substance meets the safe9 ty standard. 

10 ‘‘(II) DEFERMENT.—The court in 

11 a de novo proceeding under this sub12 paragraph may permit the Adminis13 trator to defer initiating the action re14 quested by the petitioner until such 

15 time as the court prescribes, if the 

16 court finds that— 

17 ‘‘(aa) the extent of the risk to 

18 health or the environment alleged 

19 by the petitioner is less than the 

20 extent of risks to health or the en21 vironment with respect to which 

22 the Administrator is taking action 

23 under this Act; and 

24 ‘‘(bb) there are insufficient 

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1 istrator to take the action re2 quested by the petitioner.’’. 

3 SEC. 20. EMPLOYMENT EFFECTS. 

4 Section 24(b)(2)(B)(ii) of the Toxic Substances Control 

5 Act (15 U.S.C. 2623(b)(2)(B)(ii)) is amended by striking 

6 ‘‘section 6(c)(3),’’ and inserting ‘‘the applicable require7 ments of this Act;’’. 

8 SEC. 21. STUDIES. 

9 Section 25 of the Toxic Substances Control Act (15 

10 U.S.C. 2624) is repealed. 

11 SEC. 22. ADMINISTRATION. 

12 Section 26 of the Toxic Substances Control Act (15 

13 U.S.C. 2625) is amended— 

14 (1) by striking subsection (b) and inserting the 

15 following: 

16 ‘‘(b) FEES.— 

17 ‘‘(1) IN GENERAL.—The Administrator shall es18 tablish, not later than 1 year after the date of enact19 ment of the Frank R. Lautenberg Chemical Safety for 

20 the 21st Century Act, by rule— 

21 ‘‘(A) the payment of 1 or more reasonable 

22 fees as a condition of submitting a notice or re23 questing an exemption under section 5; 

24 ‘‘(B) the payment of 1 or more reasonable 

25 fees by a manufacturer or processor that— 


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1 ‘‘(i) is required to submit a notice pur2 suant to the rule promulgated under section 

3 8(b)(4)(A)(i) identifying a chemical sub4 stance as active; 

5 ‘‘(ii) is required to submit a notice 

6 pursuant to section 8(b)(5)(B)(i) changing 

7 the status of a chemical substance from in8 active to active; 

9 ‘‘(iii) is required to report information 

10 pursuant to the rules promulgated under 

11 section 8(a)(4); and 

12 ‘‘(iv) manufactures or processes a 

13 chemical substance subject to a safety assess14 ment and safety determination pursuant to 

15 section 6. 

16 ‘‘(2) UTILIZATION AND COLLECTION OF FEES.— 

17 The Administrator shall— 

18 ‘‘(A) utilize the fees collected under para19 graph (1) only to defray costs associated with the 

20 actions of the Administrator— 

21 ‘‘(i) to collect, process, review, provide 

22 access to, and protect from disclosure (where 

23 appropriate) information on chemical sub24 stances under this Act; 


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1 ‘‘(ii) to review notices and make deter2 minations for chemical substances under 

3 paragraphs (1) and (3) of section 5(d) and 

4 impose any necessary restrictions under sec5 tion 5(d)(4); 

6 ‘‘(iii) to make prioritization decisions 

7 under section 4A; 

8 ‘‘(iv) to conduct and complete safety 

9 assessments and determinations under sec10 tion 6; and 

11 ‘‘(v) to conduct any necessary rule12 making pursuant to section 6(d); 

13 ‘‘(B) insofar as possible, collect the fees de14 scribed in paragraph (1) in advance of con15 ducting any fee-supported activity; 

16 ‘‘(C) deposit the fees in the Fund established 

17 by paragraph (4)(A); and 

18 ‘‘(D) not collect excess fees or retain a sig19 nificant amount of unused fees. 

20 ‘‘(3) AMOUNT AND ADJUSTMENT OF FEES; RE21 FUNDS.—In setting fees under this section, the Ad22 ministrator shall— 

23 ‘‘(A) take into account the cost to the Ad24 ministrator of conducting the activities described 

25 in paragraph (2); 


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1 ‘‘(B) prescribe lower fees for small business 

2 concerns, after consultation with the Adminis3 trator of the Small Business Administration; 

4 ‘‘(C) set the fees established under para5 graph (1) at levels such that the fees will, in ag6 gregate, provide a sustainable source of funds to 

7 defray approximately 25 percent of the costs of 

8 conducting the activities identified in paragraph 

9 (2)(A), not to exceed $18,000,000, not including 

10 fees under subparagraph (E) of this paragraph; 

11 ‘‘(D) reflect an appropriate balance in the 

12 assessment of fees between manufacturers and 

13 processors, and allow the payment of fees by con14 sortia of manufacturers or processors; 

15 ‘‘(E) for substances designated as additional 

16 priorities pursuant to section 4A(c), establish the 

17 fee at a level sufficient to defray the full costs to 

18 the Administrator of conducting the safety as19 sessment and safety determination under section 

20 6, except that for substances subject to section 

21 4A(c)(3), the Administrator shall establish the fee 

22 at a level sufficient to defray 50 percent of those 

23 costs; 

24 ‘‘(F) prior to the establishment or amend25 ment of any fees under paragraph (1), consult 


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1 and meet with parties potentially subject to the 

2 fees or their representatives, subject to the condi3 tion that no obligation under the Federal Advi4 sory Committee Act (5 U.S.C. App.) or sub5 chapter III of chapter 5 of title 5, United States 

6 Code, is applicable with respect to such meetings; 

7 ‘‘(G) beginning with the fiscal year that is 

8 3 years after the date of enactment of the Frank 

9 R. Lautenberg Chemical Safety for the 21st Cen10 tury Act, and every 3 years thereafter, after con11 sultation with parties potentially subject to the 

12 fees and their representatives, increase or de13 crease the fees established under paragraph (1) 

14 as necessary— 

15 ‘‘(i) to ensure that funds deposited in 

16 the Fund are sufficient to conduct the ac17 tivities identified in paragraph (2)(A) and 

18 the full cost or 50-percent portion of the 

19 costs of safety assessments and safety deter20 minations pursuant to subparagraph (E); 

21 and 

22 ‘‘(ii) to account for inflation; 

23 ‘‘(H) adjust fees established under para24 graph (1) as necessary to vary on account of dif25 fering circumstances, including reduced fees or 


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1 waivers in appropriate circumstances, to reduce 

2 the burden on manufacturing or processing, re3 move barriers to innovation, or where the costs 

4 to the Administrator of collecting the fees exceed 

5 the fee revenue anticipated to be collected; and 

6 ‘‘(I) if a notice submitted under section 5 is 

7 refused or subsequently withdrawn, refund the fee 

8 or a portion of the fee if no substantial work was 

9 performed on the notice. 

10 ‘‘(4) TSCA IMPLEMENTATION FUND.— 

11 ‘‘(A) ESTABLISHMENT.—There is estab12 lished in the Treasury of the United States a 

13 fund, to be known as the ‘TSCA Implementation 

14 Fund’ (referred to in this subsection as the 

15 ‘Fund’), consisting of— 

16 ‘‘(i) such amounts as are deposited in 

17 the Fund under paragraph (2)(C); and 

18 ‘‘(ii) any interest earned on the invest19 ment of amounts in the Fund; and 

20 ‘‘(iii) any proceeds from the sale or re21 demption of investments held in the Fund. 

22 ‘‘(B) CREDITING AND AVAILABILITY OF

23 FEES.— 

24 ‘‘(i) IN GENERAL.—Fees authorized 

25 under this section shall be collected and 


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1 available for obligation only to the extent 

2 and in the amount provided in advance in 

3 appropriations Acts, and shall be available 

4 without fiscal year limitation. 

5 ‘‘(ii) REQUIREMENTS.—Fees collected 

6 under this section shall not— 

7 ‘‘(I) be made available or obli8 gated for any purpose other than to de9 fray the costs of conducting the activi10 ties identified in paragraph (2)(A); 

11 ‘‘(II) otherwise be available for 

12 any purpose other than implementa13 tion of this Act; and 

14 ‘‘(III) so long as amounts in the 

15 Fund remain available, be subject to 

16 restrictions on expenditures applicable 

17 to the Federal government as a whole. 

18 ‘‘(C) UNUSED FUNDS.—Amounts in the 

19 Fund not currently needed to carry out this sub20 section shall be— 

21 ‘‘(i) maintained readily available or 

22 on deposit; 

23 ‘‘(ii) invested in obligations of the 

24 United States or guaranteed by the United 

25 States; or 


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1 ‘‘(iii) invested in obligations, partici2 pations, or other instruments that are law3 ful investments for fiduciary, trust, or pub4 lic funds. 

5 ‘‘(D) MINIMUM AMOUNT OF APPROPRIA6 TIONS.—Fees may not be assessed for a fiscal 

7 year under this section unless the amount of ap8 propriations for salaries, contracts, and expenses 

9 for the functions (as in existence in fiscal year 

10 2015) of the Office of Pollution Prevention and 

11 Toxics of the Environmental Protection Agency 

12 for the fiscal year (excluding the amount of any 

13 fees appropriated for the fiscal year) are equal to 

14 or greater than the amount of appropriations for 

15 covered functions for fiscal year 2015 (excluding 

16 the amount of any fees appropriated for the fis17 cal year). 

18 ‘‘(5) AUDITING.— 

19 ‘‘(A) FINANCIAL STATEMENTS OF AGEN20 CIES.—For the purpose of section 3515(c) of title 

21 31, United States Code, the Fund shall be con22 sidered a component of an executive agency. 

23 ‘‘(B) COMPONENTS.—The annual audit re24 quired under sections 3515(b) and 3521 of that 

25 title of the financial statements of activities 


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1 under this subsection shall include an analysis 

2 of— 

3 ‘‘(i) the fees collected under paragraph 

4 (1) and disbursed; 

5 ‘‘(ii) compliance with the deadlines es6 tablished in section 6 of this Act; 

7 ‘‘(iii) the amounts budgeted, appro8 priated, collected from fees, and disbursed to 

9 meet the requirements of sections 4, 4A, 5, 

10 6, 8, and 14, including the allocation of full 

11 time equivalent employees to each such sec12 tion or activity; and 

13 ‘‘(iv) the reasonableness of the alloca14 tion of the overhead associated with the con15 duct of the activities described in paragraph 

16 (2)(A). 

17 ‘‘(C) INSPECTOR GENERAL.—The Inspector 

18 General of the Environmental Protection Agency 

19 shall— 

20 ‘‘(i) conduct the annual audit required 

21 under this subsection; and 

22 ‘‘(ii) report the findings and rec23 ommendations of the audit to the Adminis24 trator and to the appropriate committees of 

25 Congress. 


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1 ‘‘(6) TERMINATION.—The authority provided by 

2 this section shall terminate at the conclusion of the 

3 fiscal year that is 10 years after the date of enactment 

4 of the Frank R. Lautenberg Chemical Safety for the 

5 21st Century Act, unless otherwise reauthorized or 

6 modified by Congress.’’; 

7 (2) in subsection (e), by striking ‘‘Health, Edu8 cation, and Welfare’’ each place it appears and in9 serting ‘‘Health and Human Services’’; and 

10 (3) adding at the end the following: 

11 ‘‘(h) PRIOR ACTIONS.—Nothing in this Act eliminates, 

12 modifies, or withdraws any rule promulgated, order issued, 

13 or exemption established pursuant to this Act before the date 

14 of enactment of the Frank R. Lautenberg Chemical Safety 

15 for the 21st Century Act.’’. 

16 SEC. 23. DEVELOPMENT AND EVALUATION OF TEST METH17 ODS AND SUSTAINABLE CHEMISTRY. 

18 Section 27 of the Toxic Substances Control Act (15 

19 U.S.C. 2626) is amended— 

20 (1) in subsection (a), in the first sentence by 

21 striking ‘‘Health, Education, and Welfare’’ and in22 serting ‘‘Health and Human Services’’; and 

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

24 ‘‘(c) SUSTAINABLE CHEMISTRY PROGRAM.—The Presi25 dent shall establish an interagency Sustainable Chemistry 


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1 Program to promote and coordinate Federal sustainable 

2 chemistry research, development, demonstration, technology 

3 transfer, commercialization, education, and training activi4 ties. 

5 ‘‘(d) PROGRAM ACTIVITIES.—The activities of the Pro6 gram shall be designed to— 

7 ‘‘(1) provide sustained support for sustainable 

8 chemistry research, development, demonstration, tech9 nology transfer, commercialization, education, and 

10 training through— 

11 ‘‘(A) coordination of sustainable chemistry 

12 research, development, demonstration, and tech13 nology transfer conducted at Federal laboratories 

14 and agencies; and 

15 ‘‘(B) to the extent practicable, encourage16 ment of consideration of sustainable chemistry 

17 in, as appropriate— 

18 ‘‘(i) the conduct of Federal and State 

19 science and engineering research and devel20 opment; and 

21 ‘‘(ii) the solicitation and evaluation of 

22 applicable proposals for science and engi23 neering research and development; 

24 ‘‘(2) examine methods by which the Federal Gov25 ernment can create incentives for consideration and 


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1 use of sustainable chemistry processes and products, 

2 including innovative financing mechanisms; 

3 ‘‘(3) expand the education and training of un4 dergraduate and graduate students and professional 

5 scientists and engineers, including through partner6 ships with industry, in sustainable chemistry science 

7 and engineering; 

8 ‘‘(4) collect and disseminate information on sus9 tainable chemistry research, development, and tech10 nology transfer including information on— 

11 ‘‘(A) incentives and impediments to devel12 opment, manufacturing, and commercialization; 

13 ‘‘(B) accomplishments; 

14 ‘‘(C) best practices; and 

15 ‘‘(D) costs and benefits; 

16 ‘‘(5) support (including through technical assist17 ance, participation, financial support, or other forms 

18 of support) economic, legal, and other appropriate so19 cial science research to identify barriers to commer20 cialization and methods to advance commercialization 

21 of sustainable chemistry. 

22 ‘‘(e) INTERAGENCY WORKING GROUP.— 

23 ‘‘(1) ESTABLISHMENT.—Not later than 180 days 

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 President, in consultation with the Office of Science 

2 and Technology Policy, shall establish an Interagency 

3 Working Group that shall include representatives 

4 from the National Science Foundation, the National 

5 Institute of Standards and Technology, the Depart6 ment of Energy, the Environmental Protection Agen7 cy, the Department of Agriculture, the Department of 

8 Defense, the National Institutes of Health, and any 

9 other agency that the President may designate to 

10 oversee the planning, management, and coordination 

11 of the Program. 

12 ‘‘(2) GOVERNANCE.—The Director of the Na13 tional Science Foundation and the Assistant Admin14 istrator for Research and Development of the Envi15 ronmental Protection Agency, or their designees, shall 

16 serve as co-chairs of the Interagency Working Group. 

17 ‘‘(3) RESPONSIBILITIES.—In overseeing the 

18 planning, management, and coordination of the Pro19 gram, the Interagency Working Group shall— 

20 ‘‘(A) establish goals and priorities for the 

21 Program, in consultation with the Advisory 

22 Council; 

23 ‘‘(B) provide for interagency coordination, 

24 including budget coordination, of activities 

25 under the Program; 


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1 ‘‘(C) meet not later than 90 days from its 

2 establishment and periodically thereafter; and 

3 ‘‘(D) establish and consult with an Advisory 

4 Council on a regular basis. 

5 ‘‘(4) MEMBERSHIP.—The Advisory Council 

6 members shall not be employees of the Federal Gov7 ernment and shall include a diverse representation of 

8 knowledgeable individuals from the private sector (in9 cluding small- and medium-sized enterprises from 

10 across the value chain), academia, State and tribal 

11 governments, and nongovernmental organizations and 

12 others who are in a position to provide expertise. 

13 ‘‘(f) AGENCY BUDGET REQUESTS.— 

14 ‘‘(1) IN GENERAL.—Each Federal agency and de15 partment participating in the Program shall, as part 

16 of its annual request for appropriations to the Office 

17 of Management and Budget, submit a report to the 

18 Office of Management and Budget that— 

19 ‘‘(A) identifies the activities of the agency 

20 or department that contribute directly to the 

21 Program; and 

22 ‘‘(B) states the portion of the agency or de23 partment’s request for appropriations that is al24 located to those activities. 


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1 ‘‘(2) ANNUAL BUDGET REQUEST TO CONGRESS.— 

2 The President shall include in the annual budget re3 quest to Congress a statement of the portion of the an4 nual budget request for each agency or department 

5 that will be allocated to activities undertaken pursu6 ant to the Program. 

7 ‘‘(g) REPORT TO CONGRESS.— 

8 ‘‘(1) IN GENERAL.—Not later than 2 years after 

9 the date of enactment of the Frank R. Lautenberg 

10 Chemical Safety for the 21st Century Act, the Inter11 agency Working Group shall submit a report to the 

12 Committee on Science, Space, and Technology and 

13 Committee on Energy and Commerce of the House of 

14 Representatives and the Committee on Environment 

15 and Public Works and the Committee on Commerce, 

16 Science, and Transportation of the Senate that shall 

17 include— 

18 ‘‘(A) a summary of federally funded sus19 tainable chemistry research, development, dem20 onstration, technology transfer, commercializa21 tion, education, and training activities; 

22 ‘‘(B) a summary of the financial resources 

23 allocated to sustainable chemistry initiatives; 

24 ‘‘(C) an analysis of the progress made to25 ward achieving the goals and priorities of the 


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1 program established pursuant to subsection (c), 

2 and recommendations for future program activi3 ties; 

4 ‘‘(D) an assessment of the benefits of ex5 panding existing, federally-supported regional 

6 innovation and manufacturing hubs to include 

7 sustainable chemistry and the value of directing 

8 the creation of 1 or more dedicated sustainable 

9 chemistry centers of excellence or hubs; and 

10 ‘‘(E) an evaluation of steps taken and fu11 ture strategies to avoid duplication of efforts, 

12 streamline interagency coordination, facilitate 

13 information sharing, and spread best practices 

14 between participating agencies in the Program. 

15 ‘‘(2) SUBMISSION TO GAO.—The Interagency 

16 Working Group shall also submit the report described 

17 in paragraph (1) to the Government Accountability 

18 Office for consideration in future Congressional in19 quiries.’’. 

20 SEC. 24. STATE PROGRAMS. 

21 Section 28 of the Toxic Substances Control Act (15 

22 U.S.C. 2627) is amended— 

23 (1) in subsection (b)(1)— 


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1 (A) in subparagraphs (A) through (D), by 

2 striking the comma at the end of each subpara3 graph and inserting a semicolon; and 

4 (B) in subparagraph (E), by striking ‘‘, 

5 and’’ and inserting ‘‘; and’’; and 

6 (2) by striking subsections (c) and (d). 

7 SEC. 25. AUTHORIZATION OF APPROPRIATIONS. 

8 Section 29 of the Toxic Substances Control Act (15 

9 U.S.C. 2628) is repealed. 

10 SEC. 26. ANNUAL REPORT. 

11 Section 30 of the Toxic Substances Control Act (15 

12 U.S.C. 2629) is amended by striking paragraph (2) and 

13 inserting the following: 

14 ‘‘(2)(A) the number of notices received during 

15 each year under section 5; and 

16 ‘‘(B) the number of the notices described in sub17 paragraph (A) for chemical substances subject to a 

18 rule, testing consent agreement, or order under section 

19 4;’’. 

20 SEC. 27. EFFECTIVE DATE. 

21 Section 31 of the Toxic Substances Control Act (15 

22 U.S.C. 2601 note; Public Law 94–469) is amended— 

23 (1) by striking ‘‘Except as provided in section 

24 4(f), this’’ and inserting the following: 

25 ‘‘(a) IN GENERAL.—This’’; and 


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1 (2) by adding at the end the following: 

2 ‘‘(b) RETROACTIVE APPLICABILITY.—Nothing in this 

3 Act shall be interpreted to apply retroactively to any State, 

4 Federal, or maritime legal action commenced prior to the 

5 effective date of the Frank R. Lautenberg Chemical Safety 

6 for the 21st Century Act.’’. 


asabaliauskas on DSK5VPTVN1PROD with BILLS

asabaliauskas on DSK5VPTVN1PROD with BILLS
Calendar No. 121 

114TH CONGRESS 

1ST SESSION S. 697 

A BILL 

To amend the Toxic Substances Control Act to repurposes. authorize and modernize that Act, and for other 

JUNE 17, 2015 

Reported with an amendment 


asabaliauskas on DSK5VPTVN1PROD with BILLS