In the Senate of the United States, 

December 17, 2015. 

Resolved, That the bill from the House of Representatives (H.R. 2576) entitled ‘‘An Act to modernize the Toxic 

Substances Control Act, and for other purposes.’’, do pass 

with the following 

AMENDMENT: 

Strike all after the enacting clause and insert the 

following: 

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’’; 
2 

† HR 2576 EAS 

1 (2) in paragraph (1) (as so redesignated), by in2 serting ‘‘, as provided under this Act’’ before the pe3 riod at the end; and 

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

5 ‘‘(2) REFORM.—This Act, including reforms in 

6 accordance with the amendments made by the Frank 

7 R. Lautenberg Chemical Safety for the 21st Century 

8 Act— 

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

10 that— 

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

12 pregnant women, the elderly, workers, con13 sumers, the general public, and the environ14 ment from the risks of harmful exposures to 

15 chemical substances and mixtures; and 

16 ‘‘(ii) ensures that appropriate informa17 tion on chemical substances and mixtures is 

18 available to public health officials and first 

19 responders in the event of an emergency; 

20 and 

21 ‘‘(B) shall not displace or supplant common 

22 law rights of action or remedies for civil relief.’’. 

23 SEC. 3. DEFINITIONS. 

24 Section 3 of the Toxic Substances Control Act (15 

25 U.S.C. 2602) is amended— 
3 

† HR 2576 EAS 

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

2 (7), (8), (9), (10), (11), (12), (13), and (14) as para3 graphs (5), (6), (7), (8), (9), (10), (12), (13), (17), 

4 (18), and (19), respectively; 

5 (2) by inserting after paragraph (3) the fol6 lowing: 

7 ‘‘(4) CONDITIONS OF USE.—The term ‘conditions 

8 of use’ means the intended, known, or reasonably fore9 seeable circumstances the Administrator determines a 

10 chemical substance is manufactured, processed, dis11 tributed in commerce, used, or disposed of.’’; 

12 (3) by inserting after paragraph (10) (as so re13 designated) the following: 

14 ‘‘(11) POTENTIALLY EXPOSED OR SUSCEPTIBLE

15 POPULATION.—The term ‘potentially exposed or sus16 ceptible population’ means 1 or more groups— 

17 ‘‘(A) of individuals within the general pop18 ulation who may be— 

19 ‘‘(i) differentially exposed to chemical 

20 substances under the conditions of use; or 

21 ‘‘(ii) susceptible to greater adverse 

22 health consequences from chemical exposures 

23 than the general population; and 

24 ‘‘(B) that when identified by the Adminis25 trator may include such groups as infants, chil-
4 

† HR 2576 EAS 

1 dren, pregnant women, workers, and the elder2 ly.’’; and 

3 (4) by inserting after paragraph (13) (as so re4 designated) the following: 

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

6 assessment’ means an assessment of the risk posed by 

7 a chemical substance under the conditions of use, in8 tegrating hazard, use, and exposure information re9 garding the chemical substance. 

10 ‘‘(15) SAFETY DETERMINATION.—The term ‘safe11 ty determination’ means a determination by the Ad12 ministrator as to whether a chemical substance meets 

13 the safety standard under the conditions of use. 

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

15 standard’ means a standard that ensures, without 

16 taking into consideration cost or other nonrisk fac17 tors, that no unreasonable risk of injury to health or 

18 the environment will result from exposure to a chem19 ical substance under the conditions of use, including 

20 no unreasonable risk of injury to— 

21 ‘‘(A) the general population; or 

22 ‘‘(B) any potentially exposed or susceptible 

23 population that the Administrator has identified 

24 as relevant to the safety assessment and safety 

25 determination for a chemical substance.’’. 
5 

† HR 2576 EAS 

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

2 The Toxic Substances Control Act is amended by in3 serting after section 3 (15 U.S.C. 2602) the following: 

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

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

6 term ‘guidance’ includes any significant written guidance 

7 of general applicability prepared by the Administrator. 

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

9 of enactment of the Frank R. Lautenberg Chemical Safety 

10 for the 21st Century Act, the Administrator shall develop, 

11 after providing public notice and an opportunity for com12 ment, any policies, procedures, and guidance the Adminis13 trator determines to be necessary to carry out sections 4, 

14 4A, 5, and 6, including the policies, procedures, and guid15 ance required by this section. 

16 ‘‘(c) USE OF SCIENCE.— 

17 ‘‘(1) IN GENERAL.—The Administrator shall es18 tablish policies, procedures, and guidance on the use 

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

20 5, and 6. 

21 ‘‘(2) GOAL.—A goal of the policies, procedures, 

22 and guidance described in paragraph (1) shall be to 

23 make the basis of decisions clear to the public. 

24 ‘‘(3) REQUIREMENTS.—The policies, procedures, 

25 and guidance issued under this section shall ensure 

26 that— 
6 

† HR 2576 EAS 

1 ‘‘(A) decisions made by the Adminis2 trator— 

3 ‘‘(i) are based on information, proce4 dures, measures, methods, and models em5 ployed in a manner consistent with the best 

6 available science; 

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

8 which— 

9 ‘‘(I) assumptions and methods are 

10 clearly and completely described and 

11 documented; 

12 ‘‘(II) variability and uncertainty 

13 are evaluated and characterized; and 

14 ‘‘(III) the information has been 

15 subject to independent verification and 

16 peer review; and 

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

18 scientific evidence, by which the Adminis19 trator considers all information in a sys20 tematic and integrative framework to con21 sider the relevance of different information; 

22 ‘‘(B) to the extent practicable and if appro23 priate, the use of peer review, standardized test 

24 design and methods, consistent data evaluation 
7 

† HR 2576 EAS 

1 procedures, and good laboratory practices will be 

2 encouraged; 

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

4 and entity that funded the generation or assess5 ment of information, and the degree of control 

6 those individuals and entities had over the gen7 eration, assessment, and dissemination of infor8 mation (including control over the design of the 

9 work and the publication of information) is 

10 made available; and 

11 ‘‘(D) if appropriate, the recommendations 

12 in reports of the National Academy of Sciences 

13 that provide advice regarding assessing the haz14 ards, exposures, and risks of chemical substances 

15 are considered. 

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

17 GUIDANCE.—The policies, procedures, and guidance de18 scribed in subsection (b) shall incorporate existing relevant 

19 policies, procedures, and guidance, as appropriate and con20 sistent with this Act. 

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

22 of enactment of the Frank R. Lautenberg Chemical Safety 

23 for the 21st Century Act, and not less frequently than once 

24 every 5 years thereafter, the Administrator shall— 
8 

† HR 2576 EAS 

1 ‘‘(1) review the adequacy of any policies, proce2 dures, and guidance developed under this section, in3 cluding animal, nonanimal, and epidemiological test 

4 methods and procedures for assessing and deter5 mining risk under this Act; and 

6 ‘‘(2) after providing public notice and an oppor7 tunity for comment, revise the policies, procedures, 

8 and guidance if necessary to reflect new scientific de9 velopments or understandings. 

10 ‘‘(f) SOURCES OF INFORMATION.—In carrying out sec11 tions 4, 4A, 5, and 6, the Administrator shall take into con12 sideration information relating to a chemical substance, in13 cluding hazard and exposure information, under the condi14 tions of use that is reasonably available to the Adminis15 trator, including information that is— 

16 ‘‘(1) submitted to the Administrator pursuant to 

17 any rule, consent agreement, order, or other require18 ment of this Act, or on a voluntary basis, including 

19 pursuant to any request made under this Act, by— 

20 ‘‘(A) manufacturers or processors of a sub21 stance; 

22 ‘‘(B) the public; 

23 ‘‘(C) other Federal departments or agencies; 

24 or 
9 

† HR 2576 EAS 

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

2 agency with responsibility for protecting health 

3 or the environment; 

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

5 jurisdiction pursuant to a governmental requirement 

6 relating to the protection of health or the environ7 ment; or 

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

9 Administrator of information sources that are pub10 licly available or otherwise accessible by the Adminis11 trator. 

12 ‘‘(g) TESTING OF CHEMICAL SUBSTANCES AND MIX13 TURES.— 

14 ‘‘(1) IN GENERAL.—The Administrator shall es15 tablish policies, procedures, and guidance for the test16 ing of chemical substances or mixtures under section 

17 4. 

18 ‘‘(2) GOAL.—A goal of the policies, procedures, 

19 and guidance established under paragraph (1) shall 

20 be to make the basis of decisions clear to the public. 

21 ‘‘(3) CONTENTS.—The policies, procedures, and 

22 guidance established under paragraph (1) shall— 

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

24 level or exposure potential of a chemical sub25 stance would factor into decisions to require new 
10 

† HR 2576 EAS 

1 testing, subject to the condition that the Admin2 istrator shall not interpret the lack of exposure 

3 information as a lack of exposure or exposure po4 tential; and 

5 ‘‘(B) describe the manner in which the Ad6 ministrator will determine that additional infor7 mation is necessary to carry out this Act, includ8 ing information relating to potentially exposed 

9 or susceptible populations. 

10 ‘‘(4) EPIDEMIOLOGICAL STUDIES.—Before pre11 scribing epidemiological studies of employees, the Ad12 ministrator shall consult with the Director of the Na13 tional Institute for Occupational Safety and Health. 

14 ‘‘(h) SAFETY ASSESSMENTS AND SAFETY DETERMINA15 TIONS.— 

16 ‘‘(1) SCHEDULE.— 

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

18 shall inform the public regarding the schedule 

19 and the resources necessary for the completion of 

20 each safety assessment and safety determination 

21 as soon as practicable after designation as a 

22 high-priority substance pursuant to section 4A. 

23 ‘‘(B) DIFFERING TIMES.—The Adminis24 trator may allot different times for different 

25 chemical substances in the schedules under this 
11 

† HR 2576 EAS 

1 paragraph, subject to the condition that all 

2 schedules shall comply with the deadlines estab3 lished under section 6. 

4 ‘‘(C) ANNUAL PLAN.— 

5 ‘‘(i) IN GENERAL.—At the beginning of 

6 each calendar year, the Administrator shall 

7 publish an annual plan. 

8 ‘‘(ii) INCLUSIONS.—The annual plan 

9 shall— 

10 ‘‘(I) identify the substances subject 

11 to safety assessments and safety deter12 minations to be completed that year; 

13 ‘‘(II) describe the status of each 

14 safety assessment and safety deter15 mination that has been initiated but 

16 not yet completed, including milestones 

17 achieved since the previous annual re18 port; and 

19 ‘‘(III) if the schedule for comple20 tion of a safety assessment and safety 

21 determination prepared pursuant to 

22 subparagraph (A) has changed, include 

23 an updated schedule for that safety as24 sessment and safety determination. 
12 

† HR 2576 EAS 

1 ‘‘(2) POLICIES AND PROCEDURES FOR SAFETY

2 ASSESSMENTS AND SAFETY DETERMINATIONS.— 

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

4 shall establish, by rule, policies and procedures 

5 regarding the manner in which the Adminis6 trator shall carry out section 6. 

7 ‘‘(B) GOAL.—A goal of the policies and pro8 cedures under this paragraph shall be to make 

9 the basis of decisions of the Administrator clear 

10 to the public. 

11 ‘‘(C) MINIMUM REQUIREMENTS.—The poli12 cies and procedures under this paragraph shall, 

13 at a minimum— 

14 ‘‘(i) describe— 

15 ‘‘(I) the manner in which the Ad16 ministrator will identify informational 

17 needs and seek that information from 

18 the public; 

19 ‘‘(II) the information (including 

20 draft safety assessments) that may be 

21 submitted by interested individuals or 

22 entities, including States; and 

23 ‘‘(III) the criteria by which infor24 mation submitted by interested indi25 viduals or entities will be evaluated; 
13 

† HR 2576 EAS 

1 ‘‘(ii) require that each draft and final 

2 safety assessment and safety determination 

3 of the Administrator include a description 

4 of— 

5 ‘‘(I)(aa) the scope of the safety as6 sessment and safety determination to 

7 be conducted under section 6, including 

8 the hazards, exposures, and conditions 

9 of use of the chemical substance, and 

10 potentially exposed and susceptible 

11 populations that the Administrator has 

12 identified as relevant; and 

13 ‘‘(bb) the basis for the scope of the 

14 safety assessment and safety deter15 mination; 

16 ‘‘(II) the manner in which aggre17 gate exposures, or significant subsets of 

18 exposures, to a chemical substance 

19 under the conditions of use were con20 sidered, and the basis for that consider21 ation; 

22 ‘‘(III) the weight of the scientific 

23 evidence of risk; and 

24 ‘‘(IV) the information regarding 

25 the impact on health and the environ-
14 

† HR 2576 EAS 

1 ment of the chemical substance that 

2 was used to make the assessment or de3 termination, including, as available, 

4 mechanistic, animal toxicity, and epi5 demiology studies; 

6 ‘‘(iii) establish a timely and trans7 parent process for evaluating whether new 

8 information submitted or obtained after the 

9 date of a final safety assessment or safety 

10 determination warrants reconsideration of 

11 the safety assessment or safety determina12 tion; and 

13 ‘‘(iv) when relevant information is pro14 vided or otherwise made available to the 

15 Administrator, require the Administrator to 

16 consider the extent of Federal regulation 

17 under other Federal laws. 

18 ‘‘(D) GUIDANCE.— 

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

20 year after the date of enactment of the 

21 Frank R. Lautenberg Chemical Safety for 

22 the 21st Century Act, the Administrator 

23 shall develop guidance to assist interested 

24 persons in developing their own draft safety 

25 assessments and other information for sub-
15 

† HR 2576 EAS 

1 mission to the Administrator, which may be 

2 considered by the Administrator. 

3 ‘‘(ii) REQUIREMENT.—The guidance 

4 shall, at a minimum, address the quality of 

5 the information submitted and the process 

6 to be followed in developing a draft safety 

7 assessment for consideration by the Admin8 istrator. 

9 ‘‘(i) PUBLICLY AVAILABLE INFORMATION.—Subject to 

10 section 14, the Administrator shall— 

11 ‘‘(1) make publicly available a nontechnical 

12 summary, and the final version, of each safety assess13 ment and safety determination; 

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

15 for comment on each proposed safety assessment and 

16 safety determination; and 

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

18 and safety determination— 

19 ‘‘(A) the list of studies considered by the Ad20 ministrator in carrying out the safety assessment 

21 or safety determination; and 

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

23 guidance that were followed in carrying out the 

24 safety assessment or safety determination. 
16 

† HR 2576 EAS 

1 ‘‘(j) CONSULTATION WITH SCIENCE ADVISORY COM2 MITTEE ON CHEMICALS.— 

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

4 after the date of enactment of this section, the Admin5 istrator shall establish an advisory committee, to be 

6 known as the ‘Science Advisory Committee on Chemi7 cals’ (referred to in this subsection as the ‘Com8 mittee’). 

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

10 shall be to provide independent advice and expert 

11 consultation, on the request of the Administrator, 

12 with respect to the scientific and technical aspects of 

13 issues relating to the implementation of this title. 

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

15 composed of representatives of such science, govern16 ment, labor, public health, public interest, animal 

17 protection, industry, and other groups as the Admin18 istrator determines to be advisable, including, at a 

19 minimum, representatives that have specific scientific 

20 expertise in the relationship of chemical exposures to 

21 women, children, and other potentially exposed or 

22 susceptible populations. 

23 ‘‘(4) SCHEDULE.—The Administrator shall con24 vene the Committee in accordance with such schedule 
17 

† HR 2576 EAS 

1 as the Administrator determines to be appropriate, 

2 but not less frequently than once every 2 years. 

3 ‘‘(5) RELATIONSHIP TO OTHER LAW.—All pro4 ceedings and meetings of the Committee shall be sub5 ject to the Federal Advisory Committee Act (5 U.S.C. 

6 App.).’’. 

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

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

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

10 (1) by striking subsections (a), (b), (c), (d), (e), 

11 and (g); 

12 (2) in subsection (f)— 

13 (A) in the first sentence— 

14 (i) by striking ‘‘from cancer, gene 

15 mutations, or birth defects’’; and 

16 (ii) by inserting ‘‘, without taking into 

17 account cost or other nonrisk factors’’ before 

18 the period at the end; and 

19 (B) by striking the last sentence; and 

20 (3) by inserting before subsection (f) the fol21 lowing: 

22 ‘‘(a) DEVELOPMENT OF NEW INFORMATION ON CHEM23 ICAL SUBSTANCES AND MIXTURES.— 

24 ‘‘(1) IN GENERAL.—The Administrator may re25 quire the development of new information relating to 
18 

† HR 2576 EAS 

1 a chemical substance or mixture in accordance with 

2 this section if the Administrator determines that the 

3 information is necessary— 

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

5 or to perform a safety assessment or safety deter6 mination under section 6; 

7 ‘‘(B) to implement a requirement imposed 

8 in a consent agreement or order issued under 

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

10 under section 6(d)(3); 

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

12 ‘‘(D) at the request of the implementing au13 thority under another Federal law, to meet the 

14 regulatory testing needs of that authority. 

15 ‘‘(2) LIMITED TESTING FOR PRIORITIZATION

16 PURPOSES.— 

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

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

20 purposes of section 4A. 

21 ‘‘(B) PROHIBITION.—Testing required 

22 under subparagraph (A) shall not be required for 

23 the purpose of establishing or implementing a 

24 minimum information requirement. 
19 

† HR 2576 EAS 

1 ‘‘(C) LIMITATION.—The Administrator may 

2 require the development of new information pur3 suant to subparagraph (A) only if the Adminis4 trator determines that additional information is 

5 necessary to establish the priority of a chemical 

6 substance. 

7 ‘‘(3) FORM.—The Administrator may require the 

8 development of information described in paragraph 

9 (1) or (2) by— 

10 ‘‘(A) promulgating a rule; 

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

13 ‘‘(C) issuing an order. 

14 ‘‘(4) CONTENTS.— 

15 ‘‘(A) IN GENERAL.—A rule, testing consent 

16 agreement, or order issued under this subsection 

17 shall include— 

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

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

23 ‘‘(iii) test protocols and methodologies 

24 for the development of information for the 

25 chemical substance or mixture, including 
20 

† HR 2576 EAS 

1 specific reference to any reliable nonanimal 

2 test procedures; and 

3 ‘‘(iv) specification of the period within 

4 which individuals and entities required to 

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

7 accordance with the procedures described in 

8 clause (iii). 

9 ‘‘(B) CONSIDERATIONS.—In determining 

10 the procedures and period to be required under 

11 subparagraph (A), the Administrator shall take 

12 into consideration— 

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

14 protocols and methodologies that may be re15 quired; 

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

18 to perform the testing; and 

19 ‘‘(iii) the deadlines applicable to the 

20 Administrator under section 6(a). 

21 ‘‘(5) CONSIDERATION OF FEDERAL AGENCY REC22 OMMENDATIONS.—The Administrator shall consider 

23 the recommendations of other Federal agencies regard24 ing the chemical substances and mixtures to which the 
21 

† HR 2576 EAS 

1 Administrator shall give priority consideration under 

2 this section. 

3 ‘‘(b) STATEMENT OF NEED.— 

4 ‘‘(1) IN GENERAL.—In promulgating a rule, en5 tering into a testing consent agreement, or issuing an 

6 order for the development of additional information 

7 (including information on exposure or exposure po8 tential) pursuant to this section, the Administrator 

9 shall— 

10 ‘‘(A) identify the need intended to be met by 

11 the rule, agreement, or order; 

12 ‘‘(B) explain why information reasonably 

13 available to the Administrator at that time is in14 adequate to meet that need, including a ref15 erence, as appropriate, to the information identi16 fied in paragraph (2)(B); and 

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

18 requires the use of vertebrate animals. 

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

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

21 issues an order under this section, the Adminis22 trator shall issue a statement providing a jus23 tification for why issuance of an order is war24 ranted instead of promulgating a rule or enter25 ing into a testing consent agreement. 
22 

† HR 2576 EAS 

1 ‘‘(B) CONTENTS.—A statement described in 

2 subparagraph (A) shall contain a description 

3 of— 

4 ‘‘(i) information that is readily acces5 sible to the Administrator, including infor6 mation submitted under any other provi7 sion of law; 

8 ‘‘(ii) the extent to which the Adminis9 trator has obtained or attempted to obtain 

10 the information through voluntary submis11 sions; and 

12 ‘‘(iii) any information relied on in 

13 safety assessments for other chemical sub14 stances relevant to the chemical substances 

15 that would be the subject of the order. 

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

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

18 minimize, to the extent practicable, the use of 

19 vertebrate animals in testing of chemical substances 

20 or mixtures, by— 

21 ‘‘(A) prior to making a request or adopting 

22 a requirement for testing using vertebrate ani23 mals, taking into consideration, as appropriate 

24 and to the extent practicable, reasonably avail25 able— 
23 

† HR 2576 EAS 

1 ‘‘(i) toxicity information; 

2 ‘‘(ii) computational toxicology and 

3 bioinformatics; 

4 ‘‘(iii) high-throughput screening meth5 ods and the prediction models of those meth6 ods; and 

7 ‘‘(iv) scientifically reliable and rel8 evant alternatives to tests on animals that 

9 would provide equivalent information; 

10 ‘‘(B) encouraging and facilitating— 

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

12 testing and assessment strategies; 

13 ‘‘(ii) the use of best available science in 

14 existence on the date on which the test is 

15 conducted; 

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

17 eliminate or reduce the use of animals while 

18 providing information of high scientific 

19 quality; 

20 ‘‘(iv) the grouping of 2 or more chem21 ical substances into scientifically appro22 priate categories in cases in which testing of 

23 a chemical substance would provide reliable 

24 and useful information on other chemical 

25 substances in the category; 
24 

† HR 2576 EAS 

1 ‘‘(v) the formation of industry con2 sortia to jointly conduct testing to avoid 

3 unnecessary duplication of tests; and 

4 ‘‘(vi) the submission of information 

5 from— 

6 ‘‘(I) animal-based studies; and 

7 ‘‘(II) emerging methods and mod8 els; and 

9 ‘‘(C) funding research and validation stud10 ies to reduce, refine, and replace the use of ani11 mal tests in accordance with this subsection. 

12 ‘‘(2) IMPLEMENTATION OF ALTERNATIVE TESTING

13 METHODS.—To promote the development and timely 

14 incorporation of new testing methods that are not 

15 based on vertebrate animals, the Administrator 

16 shall— 

17 ‘‘(A) not later than 2 years after the date 

18 of enactment of the Frank R. Lautenberg Chem19 ical Safety for the 21st Century Act, develop a 

20 strategic plan to promote the development and 

21 implementation of alternative test methods and 

22 testing strategies to generate information under 

23 this title that can reduce, refine, or replace the 

24 use of vertebrate animals, including toxicity 

25 pathway-based risk assessment, in vitro studies, 
25 

† HR 2576 EAS 

1 systems biology, computational toxicology, 

2 bioinformatics, and high-throughput screening; 

3 ‘‘(B) as practicable, ensure that the stra4 tegic plan developed under subparagraph (A) is 

5 reflected in the development of requirements for 

6 testing under this section; 

7 ‘‘(C) identify in the strategic plan developed 

8 under subparagraph (A) particular alternative 

9 test methods or testing strategies that do not re10 quire new vertebrate animal testing and are sci11 entifically reliable, relevant, and capable of pro12 viding information of equivalent scientific reli13 ability and quality to that which would be ob14 tained from vertebrate animal testing; 

15 ‘‘(D) provide an opportunity for public no16 tice and comment on the contents of the plan de17 veloped under subparagraph (A), including the 

18 criteria for considering scientific reliability, rel19 evance, and equivalent information and the test 

20 methods and strategies identified in subpara21 graph (C); 

22 ‘‘(E) beginning on the date that is 5 years 

23 after the date of enactment of the Frank R. Lau24 tenberg Chemical Safety for the 21st Century Act 

25 and every 5 years thereafter, submit to Congress 
26 

† HR 2576 EAS 

1 a report that describes the progress made in im2 plementing this subsection and goals for future 

3 alternative test methods implementation; 

4 ‘‘(F) fund and carry out research, develop5 ment, performance assessment, and translational 

6 studies to accelerate the development of test meth7 ods and testing strategies that reduce, refine, or 

8 replace the use of vertebrate animals in any test9 ing under this title; and 

10 ‘‘(G) identify synergies with the related in11 formation requirements of other jurisdictions to 

12 minimize the potential for additional or duplica13 tive testing. 

14 ‘‘(3) CRITERIA FOR ADAPTING OR WAIVING ANI15 MAL TESTING REQUIREMENTS.—On request from a 

16 manufacturer or processor that is required to conduct 

17 testing of a chemical substance or mixture on 

18 vertebrate animals under this section, the Adminis19 trator may adapt or waive the requirement, if the Ad20 ministrator determines that— 

21 ‘‘(A) there is sufficient evidence from several 

22 independent sources of information to support a 

23 conclusion that a chemical substance or mixture 

24 has, or does not have, a particular property if 
27 

† HR 2576 EAS 

1 the information from each individual source 

2 alone is insufficient to support the conclusion; 

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

4 chemical properties of the chemical substance or 

5 mixture or other toxicokinetic considerations— 

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

7 or 

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

9 technically not practicable to conduct; or 

10 ‘‘(C) a chemical substance or mixture can11 not be tested in vertebrate animals at concentra12 tions that do not result in significant pain or 

13 distress, because of physical or chemical prop14 erties of the chemical substance or mixture, such 

15 as a potential to cause severe corrosion or severe 

16 irritation to the tissues of the animal. 

17 ‘‘(4) VOLUNTARY TESTING.— 

18 ‘‘(A) IN GENERAL.—Any person developing 

19 information for submission under this title on a 

20 voluntary basis and not pursuant to any request 

21 or requirement by the Administrator shall first 

22 attempt to develop the information by means of 

23 an alternative or nonanimal test method or test24 ing strategy that the Administrator has deter25 mined under paragraph (2)(C) to be scientif-
28 

† HR 2576 EAS 

1 ically reliable, relevant, and capable of providing 

2 equivalent information, before conducting new 

3 animal testing. 

4 ‘‘(B) EFFECT OF PARAGRAPH.—Nothing in 

5 this paragraph— 

6 ‘‘(i) requires the Administrator to re7 view the basis on which the person is con8 ducting testing described in subparagraph 

9 (A); 

10 ‘‘(ii) prohibits the use of other test 

11 methods or testing strategies by any person 

12 for purposes other than developing informa13 tion for submission under this title on a 

14 voluntary basis; or 

15 ‘‘(iii) prohibits the use of other test 

16 methods or testing strategies by any person, 

17 subsequent to the attempt to develop infor18 mation using the test methods and testing 

19 strategies identified by the Administrator 

20 under paragraph (2)(C). 

21 ‘‘(d) TESTING REQUIREMENTS.— 

22 ‘‘(1) IN GENERAL.—The Administrator may re23 quire the development of information by— 

24 ‘‘(A) manufacturers and processors of the 

25 chemical substance or mixture; and 
29 

† HR 2576 EAS 

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

2 process the chemical substance or mixture after 

3 the effective date of the rule, testing consent 

4 agreement, or order. 

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

6 permit 2 or more persons identified in subparagraph 

7 (A) or (B) of paragraph (1) to designate 1 of the per8 sons or a qualified third party— 

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

10 ‘‘(B) to submit the information on behalf of 

11 the persons making the designation. 

12 ‘‘(3) EXEMPTIONS.— 

13 ‘‘(A) IN GENERAL.—A person otherwise sub14 ject to a rule, testing consent agreement, or order 

15 under this section may submit to the Adminis16 trator an application for an exemption on the 

17 basis that submission of information by the ap18 plicant on the chemical substance or mixture 

19 would be duplicative of— 

20 ‘‘(i) information on the chemical sub21 stance or mixture that— 

22 ‘‘(I) has been submitted to the Ad23 ministrator pursuant to a rule, consent 

24 agreement, or order under this section; 

25 or 
30 

† HR 2576 EAS 

1 ‘‘(II) is being developed by a per2 son designated under paragraph (2); or 

3 ‘‘(ii) information on an equivalent 

4 chemical substance or mixture that— 

5 ‘‘(I) has been submitted to the Ad6 ministrator pursuant to a rule, consent 

7 agreement, or order under this section; 

8 or 

9 ‘‘(II) is being developed by a per10 son designated under paragraph (2). 

11 ‘‘(B) FAIR AND EQUITABLE REIMBURSE12 MENT TO DESIGNEE.— 

13 ‘‘(i) IN GENERAL.—If the Adminis14 trator accepts an application submitted 

15 under subparagraph (A), before the end of 

16 the reimbursement period described in 

17 clause (iii), the Administrator shall direct 

18 the applicant to provide to the person des19 ignated under paragraph (2) fair and equi20 table reimbursement, as agreed to between 

21 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 
31 

† HR 2576 EAS 

1 of fair and equitable reimbursement, the 

2 amount shall be determined by arbitration. 

3 ‘‘(iii) REIMBURSEMENT PERIOD.—For 

4 the purposes of this subparagraph, the reim5 bursement period for any information for a 

6 chemical substance or mixture is a period— 

7 ‘‘(I) beginning on the date the in8 formation is submitted in accordance 

9 with a rule, testing consent agreement, 

10 or order under this section; and 

11 ‘‘(II) ending on the later of— 

12 ‘‘(aa) 5 years after the date 

13 referred to in subclause (I); or 

14 ‘‘(bb) the last day of the pe15 riod that begins on the date re16 ferred to in subclause (I) and that 

17 is equal to the period that the Ad18 ministrator determines was nec19 essary to develop the information. 

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

21 exemption under this paragraph, the Adminis22 trator determines that no person designated 

23 under paragraph (2) has complied with the rule, 

24 testing consent agreement, or order, the Adminis25 trator shall— 
32 

† HR 2576 EAS 

1 ‘‘(i) by order, terminate the exemption; 

2 and 

3 ‘‘(ii) notify in writing each person that 

4 received an exemption of the requirements 

5 with respect to which the exemption was 

6 granted. 

7 ‘‘(4) TIERED TESTING.— 

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

9 subparagraph (D), the Administrator shall em10 ploy a tiered screening and testing process, 

11 under which the results of screening-level tests or 

12 assessments of available information inform the 

13 decision as to whether 1 or more additional tests 

14 are necessary. 

15 ‘‘(B) SCREENING-LEVEL TESTS.— 

16 ‘‘(i) IN GENERAL.—The screening-level 

17 tests required for a chemical substance or 

18 mixture may include tests for hazard 

19 (which may include in silico, in vitro, and 

20 in vivo tests), environmental and biological 

21 fate and transport, and measurements or 

22 modeling of exposure or exposure potential, 

23 as appropriate. 

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

25 be used— 
33 

† HR 2576 EAS 

1 ‘‘(I) to screen chemical substances 

2 or mixtures for potential adverse ef3 fects; and 

4 ‘‘(II) to inform a decision of the 

5 Administrator regarding whether more 

6 complex or targeted additional testing 

7 is necessary. 

8 ‘‘(C) ADDITIONAL TESTING.—If the Admin9 istrator determines under subparagraph (B) that 

10 additional testing is necessary to provide more 

11 definitive information for safety assessments or 

12 safety determinations, the Administrator may 

13 require more advanced tests for potential health 

14 or environmental effects or exposure potential. 

15 ‘‘(D) ADVANCED TESTING WITHOUT

16 SCREENING.—The Administrator may require 

17 more advanced testing without conducting 

18 screening-level testing when other information 

19 available to the Administrator justifies the ad20 vanced testing, pursuant to guidance developed 

21 by the Administrator under this section. 

22 ‘‘(e) TRANSPARENCY.—Subject to section 14, the Ad23 ministrator shall make available to the public all testing 

24 consent agreements and orders and all information sub25 mitted under this section.’’. 
34 

† HR 2576 EAS 

1 (b) CONFORMING AMENDMENT.—Section 104(i)(5)(A) 

2 of the Comprehensive Environmental Response, Compensa3 tion, and Liability Act of 1980 (42 U.S.C. 9604(i)(5)(A)) 

4 is amended in the third sentence by inserting ‘‘(as in effect 

5 on the day before the date of enactment of the Frank R. 

6 Lautenberg Chemical Safety for the 21st Century Act)’’ 

7 after ‘‘Toxic Substances Control Act’’. 

8 SEC. 6. PRIORITIZATION SCREENING. 

9 The Toxic Substances Control Act is amended by in10 serting after section 4 (15 U.S.C. 2603) the following: 

11 ‘‘SEC. 4A. PRIORITIZATION SCREENING. 

12 ‘‘(a) PRIORITIZATION SCREENING PROCESS AND LIST

13 OF SUBSTANCES.— 

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

15 the date of enactment of this section, the Adminis16 trator shall establish, by rule, a risk-based screening 

17 process and criteria for identifying existing chemical 

18 substances that are— 

19 ‘‘(A) a high priority for a safety assessment 

20 and safety determination under section 6 (re21 ferred to in this Act as ‘high-priority sub22 stances’); and 

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

24 and safety determination (referred to in this Act 

25 as ‘low-priority substances’). 
35 

† HR 2576 EAS 

1 ‘‘(2) INITIAL AND SUBSEQUENT LISTS OF HIGH2 AND LOW-PRIORITY SUBSTANCES.— 

3 ‘‘(A) IN GENERAL.—Before the date of pro4 mulgation of the rule under paragraph (1) and 

5 not later than 180 days after the date of enact6 ment of this section, the Administrator shall 

7 publish an initial list of high-priority substances 

8 and low-priority substances. 

9 ‘‘(B) REQUIREMENTS.— 

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

11 chemical substances shall contain at least 

12 10 high-priority substances, at least 5 of 

13 which are drawn from the list of chemical 

14 substances identified by the Administrator 

15 in the October 2014 TSCA Work Plan and 

16 subsequent updates, and at least 10 low-pri17 ority substances. 

18 ‘‘(ii) SUBSEQUENTLY IDENTIFIED SUB19 STANCES.—Insofar as possible, at least 50 

20 percent of all substances subsequently iden21 tified by the Administrator as high-priority 

22 substances shall be drawn from the list of 

23 chemical substances identified by the Ad24 ministrator in the October 2014 TSCA 

25 Work Plan and subsequent updates, until 
36 

† HR 2576 EAS 

1 all Work Plan chemicals have been des2 ignated under this subsection. 

3 ‘‘(iii) PREFERENCES.— 

4 ‘‘(I) IN GENERAL.—In developing 

5 the initial list and in identifying addi6 tional high-priority substances, the Ad7 ministrator shall give preference to— 

8 ‘‘(aa) chemical substances 

9 that, with respect to persistence 

10 and bioaccumulation, score high 

11 for 1 and either high or moderate 

12 for the other, pursuant to the 

13 TSCA Work Plan Chemicals 

14 Methods Document published by 

15 the Administrator in February 

16 2012; and 

17 ‘‘(bb) chemical substances 

18 listed in the October 2014 TSCA 

19 Work Plan and subsequent up20 dates that are known human car21 cinogens and have high acute and 

22 chronic toxicity. 

23 ‘‘(II) METALS AND METAL COM24 POUNDS.—In prioritizing and assess25 ing metals and metal compounds, the 
37 

† HR 2576 EAS 

1 Administrator shall use the Framework 

2 for Metals Risk Assessment of the Of3 fice of the Science Advisor, Risk Assess4 ment Forum, and dated March 2007 

5 (or a successor document), and may 

6 use other applicable information con7 sistent with the best available science. 

8 ‘‘(C) ADDITIONAL CHEMICAL REVIEWS.— 

9 The Administrator shall, as soon as practicable 

10 and not later than— 

11 ‘‘(i) 3 years after the date of enactment 

12 of the Frank R. Lautenberg Chemical Safe13 ty for the 21st Century Act, add additional 

14 high-priority substances sufficient to ensure 

15 that at least a total of 20 high-priority sub16 stances have undergone or are undergoing 

17 the process established in section 6(a), and 

18 additional low-priority substances sufficient 

19 to ensure that at least a total of 20 low-pri20 ority substances have been designated; and 

21 ‘‘(ii) 5 years after the date of enact22 ment of the Frank R. Lautenberg Chemical 

23 Safety for the 21st Century Act, add addi24 tional high-priority substances sufficient to 

25 ensure that at least a total of 25 high-pri-
38 

† HR 2576 EAS 

1 ority substances have undergone or are un2 dergoing the process established in section 

3 6(a), and additional low-priority substances 

4 sufficient to ensure that at least a total of 

5 25 low-priority substances have been des6 ignated. 

7 ‘‘(3) IMPLEMENTATION.— 

8 ‘‘(A) CONSIDERATION OF ACTIVE AND INAC9 TIVE SUBSTANCES.— 

10 ‘‘(i) ACTIVE SUBSTANCES.—In imple11 menting the prioritization screening process 

12 established under paragraph (1), the Ad13 ministrator shall take into consideration ac14 tive substances, as determined under section 

15 8, which may include chemical substances 

16 on the interim list of active substances es17 tablished under that section. 

18 ‘‘(ii) INACTIVE SUBSTANCES.—In im19 plementing the prioritization screening 

20 process established under paragraph (1), the 

21 Administrator may take into consideration 

22 inactive substances, as determined under 

23 section 8, that the Administrator deter24 mines— 
39 

† HR 2576 EAS 

1 ‘‘(I)(aa) have not 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) have the potential for high 

6 hazard and widespread exposure; or 

7 ‘‘(II)(aa) have been subject to a 

8 regulatory or other enforceable action 

9 by the Administrator to ban or phase 

10 out the substances; and 

11 ‘‘(bb) with respect to which there 

12 exists the potential for residual high 

13 hazards or widespread exposures not 

14 otherwise addressed by the regulatory 

15 or other action. 

16 ‘‘(iii) REPOPULATION.— 

17 ‘‘(I) IN GENERAL.—On the com18 pletion of a safety determination under 

19 section 6 for a chemical substance, the 

20 Administrator shall remove the chem21 ical substance from the list of high-pri22 ority substances established under this 

23 subsection. 

24 ‘‘(II) ADDITIONS.—The Adminis25 trator shall add at least 1 chemical 
40 

† HR 2576 EAS 

1 substance to the list of high-priority 

2 substances for each chemical substance 

3 removed from the list of high-priority 

4 substances established under this sub5 section, until a safety assessment and 

6 safety determination is completed for 

7 all chemical substances not designated 

8 as high-priority. 

9 ‘‘(B) TIMELY COMPLETION OF

10 PRIORITIZATION SCREENING PROCESS.— 

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

12 shall— 

13 ‘‘(I) except as provided under 

14 paragraph (2), not later than 180 days 

15 after the effective date of the final rule 

16 under paragraph (1), begin the 

17 prioritization screening process; and 

18 ‘‘(II) make every effort to complete 

19 the designation of all active substances 

20 as high-priority substances or low-pri21 ority substances in a timely manner. 

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

24 PURPOSES.—Not later than 90 days after 

25 the date of receipt of information regarding 
41 

† HR 2576 EAS 

1 a chemical substance complying with a rule, 

2 testing consent agreement, or order issued 

3 under section 4(a)(2), the Administrator 

4 shall designate the chemical substance as a 

5 high-priority substance or low-priority sub6 stance. 

7 ‘‘(iii) CONSIDERATION.— 

8 ‘‘(I) IN GENERAL.—The Adminis9 trator shall screen substances and des10 ignate high-priority substances con11 sistent with the ability of the Adminis12 trator to schedule and complete safety 

13 assessments and safety determinations 

14 under section 6 in accordance with the 

15 deadlines under subsection (a) of that 

16 section. 

17 ‘‘(II) ANNUAL GOAL.—The Ad18 ministrator shall publish an annual 

19 goal for the number of chemical sub20 stances to be subject to the 

21 prioritization screening process. 

22 ‘‘(C) SCREENING OF CATEGORIES OF SUB23 STANCES.—The Administrator may screen cat24 egories of chemical substances to ensure an effi25 cient prioritization screening process to allow for 
42 

† HR 2576 EAS 

1 timely and adequate designations of high-pri2 ority substances and low-priority substances and 

3 safety assessments and safety determinations for 

4 high-priority substances. 

5 ‘‘(D) PUBLICATION OF LIST OF CHEMICAL

6 SUBSTANCES.—The Administrator shall keep 

7 current and publish a list of chemical substances 

8 that includes and identifies substances— 

9 ‘‘(i) that are being considered in the 

10 prioritization screening process and the sta11 tus of the substances in the prioritization 

12 process; 

13 ‘‘(ii) for which prioritization decisions 

14 have been postponed pursuant to subsection 

15 (b)(5), including the basis for the postpone16 ment; and 

17 ‘‘(iii) that are designated as high-pri18 ority substances or low-priority substances, 

19 including the bases for such designations. 

20 ‘‘(4) CRITERIA.—The criteria described in para21 graph (1) shall account for— 

22 ‘‘(A) the recommendation of the Governor of 

23 a State or a State agency with responsibility for 

24 protecting health or the environment from chem-
43 

† HR 2576 EAS 

1 ical substances appropriate for prioritization 

2 screening; 

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

4 the chemical substance (or category of sub5 stances), including persistence, bioaccumulation, 

6 and specific scientific classifications and des7 ignations by authoritative governmental entities; 

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

9 changes in the conditions of use of the chemical 

10 substance; 

11 ‘‘(D) evidence and indicators of exposure 

12 potential to humans or the environment from the 

13 chemical substance, including potentially exposed 

14 or susceptible populations and storage near sig15 nificant sources of drinking water; 

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

17 manufactured or processed; 

18 ‘‘(F) whether the volume of a chemical sub19 stance as reported pursuant to a rule promul20 gated pursuant to section 8(a) has significantly 

21 increased or decreased; 

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

24 conducting a safety assessment or safety deter25 mination, with limited availability of relevant 
44 

† HR 2576 EAS 

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 the 

8 impact of State regulation of the chemical sub9 stance on the United States, with existing Fed10 eral or State regulation of any uses evaluated in 

11 the prioritization screening process as a factor in 

12 designating a chemical substance to be a high13 priority or a low-priority substance. 

14 ‘‘(b) PRIORITIZATION SCREENING PROCESS AND DECI15 SIONS.— 

16 ‘‘(1) IN GENERAL.—In implementing the 

17 prioritization screening process developed under sub18 section (a), the Administrator shall— 

19 ‘‘(A) identify the chemical substances being 

20 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 
45 

† HR 2576 EAS 

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

2 information available to the Administrator at 

3 the time of the decision, identify a chemical sub4 stance as a high-priority substance or a low-pri5 ority substance. 

6 ‘‘(2) REASONABLY AVAILABLE INFORMATION.— 

7 The prioritization screening decision regarding a 

8 chemical substance shall consider any hazard and ex9 posure information relating to the chemical substance 

10 that is reasonably 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 active chemical substances, the Adminis16 trator determines has the potential for signifi17 cant hazard and significant exposure; 

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

20 other active chemical substances, the Adminis21 trator determines has the potential for signifi22 cant hazard or significant 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), 
46 

† HR 2576 EAS 

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 low6 priority substance a chemical substance that the Ad7 ministrator concludes has information sufficient to es8 tablish that the chemical substance is likely to meet 

9 the safety standard. 

10 ‘‘(5) POSTPONING A DECISION.—If the Adminis11 trator determines that additional information is need12 ed to establish the priority of a chemical substance 

13 under this section, the Administrator may postpone a 

14 prioritization screening decision for a reasonable pe15 riod— 

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 informa21 tion pursuant to a rule, testing consent agree22 ment, or order issued under section 4(a)(2). 

23 ‘‘(6) DEADLINES FOR SUBMISSION OF INFORMA24 TION.—If the Administrator requests the development 

25 or submission of information under this section, the 
47 

† HR 2576 EAS 

1 Administrator shall establish a deadline for submis2 sion of the information. 

3 ‘‘(7) NOTICE AND COMMENT.—The Administrator 

4 shall— 

5 ‘‘(A) publish, including in the Federal Reg6 ister, the proposed decisions made under para7 graphs (3), (4), and (5) and the basis for the de8 cisions; 

9 ‘‘(B) identify the information and analysis 

10 on which the decisions are based; and 

11 ‘‘(C) provide 90 days for public comment. 

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

13 ‘‘(A) IN GENERAL.—At any time, the Ad14 ministrator may revise the designation of a 

15 chemical substance as a high-priority substance 

16 or a 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. 
48 

† HR 2576 EAS 

1 ‘‘(9) OTHER INFORMATION RELEVANT TO

2 PRIORITIZATION.— 

3 ‘‘(A) IN GENERAL.—If, after the date of en4 actment of the Frank R. Lautenberg Chemical 

5 Safety for the 21st Century Act, a State proposes 

6 an administrative action or enacts a statute or 

7 takes an administrative action to prohibit or 

8 otherwise restrict the manufacturing, processing, 

9 distribution in commerce, or use of a chemical 

10 substance that the Administrator has not des11 ignated as a high-priority substance, the Gov12 ernor or State agency with responsibility for im13 plementing the statute or administrative action 

14 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 chemical 

22 substance under the conditions of use which 

23 the statute or administrative action is in24 tended to address; 
49 

† HR 2576 EAS 

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 substances 

14 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 significant 

21 impact on interstate commerce; or 

22 ‘‘(III) have been subject to a pro23 hibition or other restriction under a 

24 statute or administrative action in 2 

25 or more States. 
50 

† HR 2576 EAS 

1 ‘‘(D) POST-PRIORITIZATION NOTICE.—If, 

2 after the date of enactment of the Frank R. Lau3 tenberg Chemical Safety for the 21st Century 

4 Act, a State proposes or takes an administrative 

5 action or enacts a statute to prohibit or other6 wise restrict the manufacturing, processing, dis7 tribution in commerce, or use of a high-priority 

8 substance, after the date on which the deadline 

9 established pursuant to subsection (a) of section 

10 6 for completion of the safety determination 

11 under that subsection expires but before the date 

12 on which the Administrator publishes the safety 

13 determination under that subsection, the Gov14 ernor or State agency with responsibility for im15 plementing the statute or administrative action 

16 shall— 

17 ‘‘(i) notify the Administrator; and 

18 ‘‘(ii) provide the scientific and legal 

19 basis for the action. 

20 ‘‘(E) AVAILABILITY TO PUBLIC.—Subject to 

21 section 14 and any applicable State law regard22 ing the protection of confidential information 

23 provided to the State or to the Administrator, 

24 the Administrator shall make information re-
51 

† HR 2576 EAS 

1 ceived from a Governor or State agency under 

2 subparagraph (A) publicly available. 

3 ‘‘(F) EFFECT OF PARAGRAPH.—Nothing in 

4 this paragraph shall preempt a State statute or 

5 administrative action, require approval of a 

6 State statute or administrative action, or apply 

7 section 15 to a State. 

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

9 every 5 years after the date on which the process 

10 under this subsection is established, the Administrator 

11 shall— 

12 ‘‘(A) review the process on the basis of expe13 rience and taking into consideration resources 

14 available to efficiently and effectively screen and 

15 prioritize chemical substances; and 

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

17 screening process. 

18 ‘‘(11) EFFECT.—Subject to section 18, a designa19 tion by the Administrator under this section with re20 spect to a chemical substance shall not affect— 

21 ‘‘(A) the manufacture, processing, distribu22 tion in commerce, use, or disposal of the chem23 ical substance; or 

24 ‘‘(B) the regulation of those activities. 
52 

† HR 2576 EAS 

1 ‘‘(c) ADDITIONAL PRIORITIES FOR SAFETY ASSESS2 MENTS AND DETERMINATIONS.— 

3 ‘‘(1) REQUIREMENTS.— 

4 ‘‘(A) IN GENERAL.—The rule promulgated 

5 under subsection (a) shall— 

6 ‘‘(i) include a process by which a man7 ufacturer or processor of an active chemical 

8 substance that has not been designated a 

9 high-priority substance or is not in the 

10 process of a prioritization screening by the 

11 Administrator, may request that the Ad12 ministrator designate the substance as an 

13 additional priority for a safety assessment 

14 and safety determination, subject to the 

15 payment of fees pursuant to section 

16 26(b)(3)(D); 

17 ‘‘(ii) specify the information to be pro18 vided in such requests; and 

19 ‘‘(iii) specify the criteria (which may 

20 include criteria identified in subsection 

21 (a)(4)) that the Administrator shall use to 

22 determine whether or not to grant such a 

23 request, which shall include whether the sub24 stance is subject to restrictions imposed by 

25 statutes enacted or administrative actions 
53 

† HR 2576 EAS 

1 taken by 1 or more States on the manufac2 ture, processing, distribution in commerce, 

3 or use of the substance. 

4 ‘‘(B) PREFERENCE.—Subject to paragraph 

5 (2), in deciding whether to grant requests under 

6 this subsection the Administrator shall give a 

7 preference to requests concerning substances for 

8 which the Administrator determines that restric9 tions imposed by 1 or more States have the po10 tential to have a significant impact on interstate 

11 commerce or health or the environment. 

12 ‘‘(C) EXCEPTIONS.—Chemical substances 

13 for which requests have been granted under this 

14 subsection shall not be subject to subsection 

15 (a)(3)(A)(iii) or section 18(b). 

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

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

18 Administrator shall ensure that— 

19 ‘‘(A) the number of substances designated to 

20 undergo safety assessments and safety determina21 tions under the process and criteria pursuant to 

22 paragraph (1) is not less than 25 percent, or 

23 more than 30 percent, of the cumulative number 

24 of substances designated to undergo safety assess25 ments and safety determinations under sub-
54 

† HR 2576 EAS 

1 sections (a)(2) and (b)(3) (except that if less 

2 than 25 percent are received by the Adminis3 trator, the Administrator shall grant each re4 quest that meets the requirements of paragraph 

5 (1)); 

6 ‘‘(B) the resources allocated to conducting 

7 safety assessments and safety determinations for 

8 additional priorities designated under this sub9 section are proportionate to the number of such 

10 substances relative to the total number of sub11 stances currently designated to undergo safety 

12 assessments and safety determinations under this 

13 section; and 

14 ‘‘(C) the number of additional priority re15 quests stipulated under subparagraph (A) is in 

16 addition to the total number of high-priority 

17 substances identified under subsections (a)(2) 

18 and (b)(3). 

19 ‘‘(3) ADDITIONAL REVIEW OF WORK PLAN CHEMI20 CALS FOR SAFETY ASSESSMENT AND SAFETY DETER21 MINATION.—In the case of a request under paragraph 

22 (1) with respect to a chemical substance identified by 

23 the Administrator in the October 2014 TSCA Work 

24 Plan— 
55 

† HR 2576 EAS 

1 ‘‘(A) the 30-percent cap specified in para2 graph (2)(A) shall not apply and the addition of 

3 Work Plan chemicals shall be at the discretion of 

4 the Administrator; and 

5 ‘‘(B) notwithstanding paragraph (1)(C), re6 quests for additional Work Plan chemicals under 

7 this subsection shall be considered high-priority 

8 chemicals subject to section 18(b) but not sub9 section (a)(3)(A)(iii). 

10 ‘‘(4) REQUIREMENTS.— 

11 ‘‘(A) IN GENERAL.—The public shall be pro12 vided notice and an opportunity to comment on 

13 requests submitted under this subsection. 

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

15 later than 180 days after the date on which the 

16 Administrator receives a request under this sub17 section, the Administrator shall decide whether 

18 or not to grant the request. 

19 ‘‘(C) ASSESSMENT AND DETERMINATION.— 

20 If the Administrator grants a request under this 

21 subsection, the safety assessment and safety de22 termination— 

23 ‘‘(i) shall be conducted in accordance 

24 with the deadlines and other requirements 

25 of sections 3A(i) and 6; and 
56 

† HR 2576 EAS 

1 ‘‘(ii) shall not be expedited or otherwise 

2 subject to special treatment relative to high3 priority substances designated pursuant to 

4 subsection (b)(3) that are undergoing safety 

5 assessments and safety determinations.’’. 

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

7 Section 5 of the Toxic Substances Control Act (15 

8 U.S.C. 2604) is amended— 

9 (1) by striking the section designation and head10 ing and inserting the following: 

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

12 (2) by striking subsection (b); 

13 (3) by redesignating subsection (a) as subsection 

14 (b); 

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

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

17 beginning of the section; 

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

19 (A) in the subsection heading, by striking 

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

21 (B) in paragraph (1)— 

22 (i) in the matter preceding subpara23 graph (A), by striking ‘‘subsection (h)’’ and 

24 inserting ‘‘paragraph (3) and subsection 

25 (h)’’; and 
57 

† HR 2576 EAS 

1 (ii) in the matter following subpara2 graph (B)— 

3 (I) by striking ‘‘subsection (d)’’ 

4 and inserting ‘‘subsection (c)’’; and 

5 (II) by striking ‘‘and such person 

6 complies with any applicable require7 ment of subsection (b)’’; and 

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

9 ‘‘(3) ARTICLE CONSIDERATION.—The Adminis10 trator may require notification under this section for 

11 the import or processing of a chemical substance as 

12 part of an article or category of articles under para13 graph (1)(B) if the Administrator makes an affirma14 tive finding in a rule under paragraph (2) that the 

15 reasonable potential for exposure to the chemical sub16 stance through the article or category of articles sub17 ject to the rule warrants notification.’’; 

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

19 subsections (d) and (c), respectively, and moving sub20 section (c) (as so redesigned) so as appear after sub21 section (b) (as redesignated by paragraph (3)); 

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

23 (A) by striking paragraph (1) and inserting 

24 the following: 
58 

† HR 2576 EAS 

1 ‘‘(1) IN GENERAL.—The notice required by sub2 section (b) shall include, with respect to a chemical 

3 substance— 

4 ‘‘(A) the information required by sections 

5 720.45 and 720.50 of title 40, Code of Federal 

6 Regulations (or successor regulations); and 

7 ‘‘(B) all known or reasonably ascertainable 

8 information regarding conditions of use and rea9 sonably anticipated exposures.’’; 

10 (B) in paragraph (2)— 

11 (i) in the matter preceding subpara12 graph (A)— 

13 (I) by striking ‘‘subsection (a)’’ 

14 and inserting ‘‘subsection (b)’’; and 

15 (II) by striking ‘‘or of data under 

16 subsection (b)’’; 

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

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

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

20 ‘‘; and’’ and inserting a period; and 

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

22 (C) in paragraph (3), by striking ‘‘sub23 section (a) and for which the notification period 

24 prescribed by subsection (a), (b), or (c)’’ and in25 serting ‘‘subsection (b) and for which the notifi-
59 

† HR 2576 EAS 

1 cation period prescribed by subsection (b) or 

2 (d)’’; 

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

4 paragraph (6)) and inserting the following: 

5 ‘‘(d) REVIEW OF NOTICE.— 

6 ‘‘(1) INITIAL REVIEW.— 

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

9 of receipt of a notice submitted under subsection 

10 (b), the Administrator shall— 

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

12 notice; 

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

14 relevant chemical substance and the poten15 tial for exposure to humans and the envi16 ronment; and 

17 ‘‘(iii) make a determination under 

18 paragraph (3). 

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

20 paragraph (5), the Administrator may extend 

21 the period described in subparagraph (A) for 

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

23 which shall be not more than 90 days. 
60 

† HR 2576 EAS 

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

2 notice under paragraph (1), the Administrator shall 

3 take into consideration— 

4 ‘‘(A) any relevant information identified in 

5 subsection (c)(1); and 

6 ‘‘(B) any other relevant additional informa7 tion available to the Administrator. 

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

9 applicable period for review under paragraph (1), 

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

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

12 determine that— 

13 ‘‘(A) the relevant chemical substance or sig14 nificant new use is not likely to meet the safety 

15 standard, in which case the Administrator shall 

16 take appropriate action under paragraph (4); 

17 ‘‘(B) the relevant chemical substance or sig18 nificant new use is likely to meet the safety 

19 standard, in which case the Administrator shall 

20 allow the review period to expire without addi21 tional restrictions; or 

22 ‘‘(C) additional information is necessary in 

23 order to make a determination under subpara24 graph (A) or (B), in which case the Adminis-
61 

† HR 2576 EAS 

1 trator shall take appropriate action under para2 graphs (4) and (5). 

3 ‘‘(4) RESTRICTIONS.— 

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

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

9 respect to a notice submitted under sub10 section (b)— 

11 ‘‘(I) the Administrator, before the 

12 end of the applicable period for review 

13 under paragraph (1) and by consent 

14 agreement or order, as appropriate, 

15 shall prohibit or otherwise restrict the 

16 manufacture, processing, use, distribu17 tion in commerce, or disposal (as ap18 plicable) of the chemical substance, or 

19 of the chemical substance for a signifi20 cant new use, without compliance with 

21 the restrictions specified in the consent 

22 agreement or order that the Adminis23 trator determines are sufficient to en24 sure that the chemical substance or sig-
62 

† HR 2576 EAS 

1 nificant new use is likely to meet the 

2 safety standard; and 

3 ‘‘(II) no person may commence 

4 manufacture of the chemical substance, 

5 or manufacture or processing of the 

6 chemical substance for a significant 

7 new use, except in compliance with the 

8 restrictions specified in the consent 

9 agreement or order. 

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

11 the Administrator makes a determination 

12 under subparagraph (B) of paragraph (3) 

13 with respect to a chemical substance or sig14 nificant new use for which a notice was 

15 submitted under subsection (b), then not16 withstanding any remaining portion of the 

17 applicable period for review under para18 graph (1), the submitter of the notice may 

19 commence manufacture for commercial pur20 poses of the chemical substance or manufac21 ture or processing of the chemical substance 

22 for a significant new use. 

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

24 days after issuing a consent agreement or order 
63 

† HR 2576 EAS 

1 under subparagraph (A), the Administrator 

2 shall— 

3 ‘‘(i) consider whether to promulgate a 

4 rule pursuant to subsection (b)(2) that iden5 tifies as a significant new use any manu6 facturing, processing, use, distribution in 

7 commerce, or disposal of the chemical sub8 stance that does not conform to the restric9 tions imposed by the consent agreement or 

10 order; and 

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

12 in clause (i); or 

13 ‘‘(II) publish a statement describing 

14 the reasons of the Administrator for not ini15 tiating a rulemaking. 

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

17 restriction under subparagraph (A) may include, 

18 as appropriate— 

19 ‘‘(i) subject to section 18(g), a require20 ment that a chemical substance shall be 

21 marked with, or accompanied by, clear and 

22 adequate minimum warnings and instruc23 tions with respect to use, distribution in 

24 commerce, or disposal, or any combination 

25 of those activities, with the form and con-
64 

† HR 2576 EAS 

1 tent of the minimum warnings and instruc2 tions to be prescribed by the Administrator 

3 ‘‘(ii) a requirement that manufacturers 

4 or processors of the chemical substance 

5 shall— 

6 ‘‘(I) make and retain records of 

7 the processes used to manufacture or 

8 process, as applicable, the chemical 

9 substance; or 

10 ‘‘(II) monitor or conduct such ad11 ditional tests as are reasonably nec12 essary to address potential risks from 

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

15 applicable, of the chemical substance, 

16 subject to section 4; 

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

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

21 ‘‘(I) in general; or 

22 ‘‘(II) for a particular use; 

23 ‘‘(iv) a prohibition or other restriction 

24 of— 
65 

† HR 2576 EAS 

1 ‘‘(I) the manufacture, processing, 

2 or distribution in commerce of the 

3 chemical substance for a significant 

4 new use; 

5 ‘‘(II) any method of commercial 

6 use of the chemical substance; or 

7 ‘‘(III) any method of disposal of 

8 the chemical substance; or 

9 ‘‘(v) a prohibition or other restriction 

10 on the manufacture, processing, or distribu11 tion in commerce of the chemical sub12 stance— 

13 ‘‘(I) in general; or 

14 ‘‘(II) for a particular use. 

15 ‘‘(D) PERSISTENT AND BIOACCUMULATIVE

16 SUBSTANCES.—For a chemical substance the Ad17 ministrator determines, with respect to persist18 ence and bioaccumulation, scores high for 1 and 

19 either high or moderate for the other, pursuant 

20 to the TSCA Work Plan Chemicals Methods Doc21 ument published by the Administrator in Feb22 ruary 2012, the Administrator shall, in selecting 

23 among prohibitions and other restrictions that 

24 the Administrator determines are sufficient to 

25 ensure that the chemical substance is likely to 
66 

† HR 2576 EAS 

1 meet the safety standard, reduce potential expo2 sure to the substance to the maximum extent 

3 practicable. 

4 ‘‘(E) WORKPLACE EXPOSURES.—To the ex5 tent practicable, the Administrator shall consult 

6 with the Assistant Secretary of Labor for Occu7 pational Safety and Health prior to adopting 

8 any prohibition or other restriction under this 

9 subsection to address workplace exposures. 

10 ‘‘(F) DEFINITION OF REQUIREMENT.—For 

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

12 used in this section does not displace common 

13 law. 

14 ‘‘(5) ADDITIONAL INFORMATION.—If the Admin15 istrator determines under paragraph (3)(C) that ad16 ditional information is necessary to conduct a review 

17 under this subsection, the Administrator— 

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

19 submitter of the notice to submit the additional 

20 information; 

21 ‘‘(B) may, by agreement with the submitter, 

22 extend the review period for a reasonable time to 

23 allow the development and submission of the ad24 ditional information; 
67 

† HR 2576 EAS 

1 ‘‘(C) 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; and 

5 ‘‘(D) on receipt of information the Adminis6 trator finds supports the determination under 

7 paragraph (3), shall promptly make the deter8 mination.’’; 

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

10 inserting the following: 

11 ‘‘(e) NOTICE OF COMMENCEMENT.— 

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

13 the date on which a manufacturer that has submitted 

14 a notice under subsection (b) commences nonexempt 

15 commercial manufacture of a chemical substance, the 

16 manufacturer shall submit to the Administrator a no17 tice of commencement that identifies— 

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

19 ‘‘(B) the initial date of nonexempt commer20 cial manufacture. 

21 ‘‘(2) WITHDRAWAL.—A manufacturer or proc22 essor that has submitted a notice under subsection (b), 

23 but that has not commenced nonexempt commercial 

24 manufacture or processing of the chemical substance, 

25 may withdraw the notice. 
68 

† HR 2576 EAS 

1 ‘‘(f) FURTHER EVALUATION.—The Administrator may 

2 review a chemical substance under section 4A at any time 

3 after the Administrator receives— 

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

5 substance under subsection (e); or 

6 ‘‘(2) new information regarding the chemical 

7 substance. 

8 ‘‘(g) TRANSPARENCY.—Subject to section 14, the Ad9 ministrator shall make available to the public— 

10 ‘‘(1) all notices, determinations, consent agree11 ments, rules, and orders submitted under this section 

12 or made by the Administrator under this section; and 

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

14 this section.’’; and 

15 (10) in subsection (h)— 

16 (A) in paragraph (1)— 

17 (i) in the matter preceding subpara18 graph (A), by striking ‘‘(a) or’’; and 

19 (ii) in subparagraph (A), by inserting 

20 ‘‘, without taking into account cost or other 

21 nonrisk factors’’ after ‘‘the environment’’; 

22 (B) by striking paragraph (2); 

23 (C) by redesignating paragraphs (3) 

24 through (6) as paragraphs (2) through (5), re25 spectively; 
69 

† HR 2576 EAS 

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

2 in the matter preceding subparagraph (A), by 

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

4 ‘‘subsection (b)’’; 

5 (E) in paragraph (3) (as so redesignated)— 

6 (i) in the first sentence, by striking 

7 ‘‘will not present an unreasonable risk of 

8 injury to health or the environment’’ and 

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

10 and 

11 (ii) by striking the second sentence; 

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

13 by striking ‘‘subsections (a) and (b)’’ and insert14 ing ‘‘subsection (b)’’; and 

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

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

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

18 SEC. 8. SAFETY ASSESSMENTS AND SAFETY DETERMINA19 TIONS. 

20 Section 6 of the Toxic Substances Control Act (15 

21 U.S.C. 2605) is amended— 

22 (1) by striking the section designation and head23 ing and inserting the following: 
70 

† HR 2576 EAS 

1 ‘‘SEC. 6. SAFETY ASSESSMENTS AND SAFETY DETERMINA2 TIONS.’’; 

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

4 subsections (h) and (i), respectively; 

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

6 inserting the following: 

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

8 ‘‘(1) shall conduct a safety assessment and make 

9 a safety determination of each high-priority substance 

10 in accordance with subsections (b) and (c); 

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

12 than 6 months after the date on which a chemical 

13 substance is designated as a high-priority substance, 

14 define and publish the scope of the safety assessment 

15 and safety determination to be conducted pursuant to 

16 this section, including the hazards, exposures, condi17 tions of use, and potentially exposed or susceptible 

18 populations that the Administrator expects to con19 sider; 

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

21 safety determination, shall establish restrictions pur22 suant to subsection (d); 

23 ‘‘(4) shall complete and publish a safety assess24 ment and safety determination not later than 3 years 

25 after the date on which a chemical substance is des26 ignated as a high-priority substance; 
71 

† HR 2576 EAS 

1 ‘‘(5) shall promulgate any necessary final rule 

2 pursuant to subsection (d) by not later than 2 years 

3 after the date on which the safety determination is 

4 completed; 

5 ‘‘(6) may extend any deadline under paragraph 

6 (4) for not more than 1 year, if information relating 

7 to the high-priority substance, required to be devel8 oped in a rule, order, or consent agreement under sec9 tion 4— 

10 ‘‘(A) has not yet been submitted to the Ad11 ministrator; or 

12 ‘‘(B) was submitted to the Administrator— 

13 ‘‘(i) within the time specified in the 

14 rule, order, or consent agreement pursuant 

15 to section 4(a)(4)(A)(iv); and 

16 ‘‘(ii) on or after the date that is 120 

17 days before the expiration of the deadline 

18 described in paragraph (4); and 

19 ‘‘(7) may extend the deadline under paragraph 

20 (5) for not more than 2 years, subject to the condition 

21 that the aggregate length of all extensions of deadlines 

22 under this subsection does not exceed 2 years. 

23 ‘‘(b) PRIOR ACTIONS AND NOTICE OF EXISTING INFOR24 MATION.— 

25 ‘‘(1) PRIOR-INITIATED ASSESSMENTS.— 
72 

† HR 2576 EAS 

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, prior to the effective date of the 

7 policies, procedures, and guidance required to be 

8 established by the Administrator under section 

9 3A or 4A. 

10 ‘‘(B) INTEGRATION OF PRIOR POLICIES AND

11 PROCEDURES.—As policies and procedures under 

12 section 3A and 4A are established, to the max13 imum extent practicable, the Administrator shall 

14 integrate the policies and procedures into ongo15 ing safety assessments and safety determinations. 

16 ‘‘(2) ACTIONS COMPLETED PRIOR TO COMPLE17 TION OF POLICIES AND PROCEDURES.—Nothing in 

18 this Act requires the Administrator to revise or with19 draw a completed safety assessment, safety determina20 tion, or rule solely because the action was completed 

21 prior to the completion of a policy or procedure estab22 lished under section 3A or 4A, and the validity of a 

23 completed assessment, determination, or rule shall not 

24 be determined based on the content of such a policy 

25 or procedure. 
73 

† HR 2576 EAS 

1 ‘‘(3) NOTICE OF EXISTING INFORMATION.— 

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

3 shall, where such information is available, take 

4 notice of existing information regarding hazard 

5 and exposure published by other Federal agencies 

6 and the National Academies and incorporate the 

7 information in safety assessments and safety de8 terminations with the objective of increasing the 

9 efficiency of the safety assessments and safety de10 terminations. 

11 ‘‘(B) INCLUSION OF INFORMATION.—Exist12 ing information described in subparagraph (A) 

13 should be included to the extent practicable and 

14 where the Administrator determines the informa15 tion is relevant and scientifically reliable. 

16 ‘‘(c) SAFETY DETERMINATIONS.— 

17 ‘‘(1) IN GENERAL.—Based on a review of the in18 formation available to the Administrator, including 

19 draft safety assessments submitted by interested per20 sons pursuant to section 3A(h)(2)(D), and subject to 

21 section 18(g), the Administrator shall determine— 

22 ‘‘(A) by order, that the relevant chemical 

23 substance meets the safety standard; 

24 ‘‘(B) that the relevant chemical substance 

25 does not meet the safety standard, in which case 
74 

† HR 2576 EAS 

1 the Administrator shall, by rule under subsection 

2 (d)— 

3 ‘‘(i) impose restrictions necessary to 

4 ensure that the chemical substance meets the 

5 safety standard under the conditions of use; 

6 or 

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

8 met with the application of other restric9 tions under subsection (d)(3), ban or phase 

10 out the chemical substance, as appropriate; 

11 or 

12 ‘‘(C) that additional information is nec13 essary in order to make a determination under 

14 subparagraph (A) or (B), in which case the Ad15 ministrator shall take appropriate action under 

16 paragraph (2). 

17 ‘‘(2) ADDITIONAL INFORMATION.—If the Admin18 istrator determines that additional information is 

19 necessary to make a safety assessment or safety deter20 mination for a high-priority substance, the Adminis21 trator— 

22 ‘‘(A) shall provide an opportunity for inter23 ested persons to submit the additional informa24 tion; 
75 

† HR 2576 EAS 

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.— 
76 

† HR 2576 EAS 

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, but not later than 4 years after 

9 the date of promulgation of the rule, 

10 except in the case of a use exempted 

11 under paragraph (5); 

12 ‘‘(II) in the case of a ban or 

13 phase-out of the chemical substance, 

14 shall implement the ban or phase-out 

15 in as short a period as practicable; 

16 ‘‘(III) as determined by the Ad17 ministrator, may vary for different af18 fected persons; and 

19 ‘‘(IV) following a determination 

20 by the Administrator that compliance 

21 is technologically or economically in22 feasible within the timeframe specified 

23 in subclause (I), shall provide up to an 

24 additional 18 months for compliance to 

25 be mandatory; 
77 

† HR 2576 EAS 

1 ‘‘(iii) shall exempt replacement parts 

2 that are manufactured prior to the effective 

3 date of the rule for articles that are first 

4 manufactured prior to the effective date of 

5 the rule unless the Administrator finds the 

6 replacement parts contribute significantly 

7 to the identified risk; 

8 ‘‘(iv) shall, in selecting among prohibi9 tions and other restrictions, apply such pro10 hibitions or other restrictions to an article 

11 or category of articles containing the chem12 ical substance only to the extent necessary 

13 to address the identified risks from exposure 

14 to the chemical substance from the article or 

15 category of articles, in order to determine 

16 that the chemical substance meets the safety 

17 standard; and 

18 ‘‘(v) shall, when the Administrator de19 termines that the chemical substance does 

20 not meet the safety standard for a poten21 tially exposed or susceptible population, 

22 apply prohibitions or other restrictions nec23 essary to ensure that the substance meets the 

24 safety standard for that population. 
78 

† HR 2576 EAS 

1 ‘‘(B) PERSISTENT AND BIOACCUMULATIVE

2 SUBSTANCES.—For a chemical substance the Ad3 ministrator determines, with respect to persist4 ence and bioaccumulation, scores high for 1 and 

5 either high or moderate for the other, pursuant 

6 to the TSCA Work Plan Chemicals Methods Doc7 ument published by the Administrator in Feb8 ruary 2012, the Administrator shall, in selecting 

9 among prohibitions and other restrictions that 

10 the Administrator determines are sufficient to 

11 ensure that the chemical substance meets the 

12 safety standard, reduce exposure to the substance 

13 to the maximum extent practicable. 

14 ‘‘(C) WORKPLACE EXPOSURES.—The Ad15 ministrator shall consult with the Assistant Sec16 retary of Labor for Occupational Safety and 

17 Health before adopting any prohibition or other 

18 restriction under this subsection to address work19 place exposures. 

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

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

22 as used in this section does not displace common 

23 law. 
79 

† HR 2576 EAS 

1 ‘‘(3) RESTRICTIONS.—Subject to section 18, a re2 striction under paragraph (1) may include, as appro3 priate— 

4 ‘‘(A) a requirement that a chemical sub5 stance shall be marked with, or accompanied by, 

6 clear and adequate minimum warnings and in7 structions with respect to use, distribution in 

8 commerce, or disposal, or any combination of 

9 those activities, with the form and content of the 

10 minimum warnings and instructions to be pre11 scribed by the Administrator; 

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; 
80 

† HR 2576 EAS 

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 otherwise restrict the manufacture, processing, or 

6 distribution in commerce of the chemical sub7 stance 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 
81 

† HR 2576 EAS 

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 

24 more technically and economically feasible alter25 natives to the chemical substance that the Ad-
82 

† HR 2576 EAS 

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, as part of a rule promulgated under para15 graph (1) or in a separate rule, exempt 1 or 

16 more uses of a chemical substance from any re17 striction in a rule promulgated under paragraph 

18 (1) if the Administrator determines that— 

19 ‘‘(i) the restriction cannot be complied 

20 with, without— 

21 ‘‘(I) harming national security; 

22 ‘‘(II) causing significant disrup23 tion in the national economy due to 

24 the lack of availability of a chemical 

25 substance; or 
83 

† HR 2576 EAS 

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 this paragraph, the Administrator 

12 shall make publicly available any analysis con13 ducted under this paragraph to assess the need 

14 for the exemption. 

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

16 final a rule under this paragraph, the Adminis17 trator shall include a statement describing how 

18 the analysis considered under subparagraph (B) 

19 was taken into account. 

20 ‘‘(D) ANALYSIS IN CASE OF BAN OR PHASE21 OUT.—In determining whether an exemption 

22 should be granted under this paragraph for a 

23 chemical substance for which a ban or phase-out 

24 is included in a proposed or final rule under 

25 paragraph (1), the Administrator shall take into 
84 

† HR 2576 EAS 

1 consideration, to the extent practicable based on 

2 reasonably available information, the quantifi3 able and nonquantifiable costs and benefits of the 

4 1 or more alternatives to the chemical substance 

5 the Administrator determines to be technically 

6 and economically feasible and most likely to be 

7 used in place of the chemical substance under the 

8 conditions of use. 

9 ‘‘(E) CONDITIONS.—As part of a rule pro10 mulgated under this paragraph, the Adminis11 trator shall include conditions, including reason12 able recordkeeping, monitoring, and reporting 

13 requirements, to the extent that the Adminis14 trator determines the conditions are necessary to 

15 protect health and the environment while achiev16 ing the purposes of the exemption. 

17 ‘‘(F) DURATION.— 

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

19 shall establish, as part of a rule under this 

20 paragraph, a time limit on any exemption 

21 for a time to be determined by the Adminis22 trator as reasonable on a case-by-case basis. 

23 ‘‘(ii) AUTHORITY OF ADMINIS24 TRATOR.—The Administrator, by rule, may 

25 extend, modify, or eliminate an exemption 
85 

† HR 2576 EAS 

1 if the Administrator determines, on the 

2 basis of reasonably available information 

3 and after adequate public justification, the 

4 exemption warrants extension or is no 

5 longer necessary. 

6 ‘‘(iii) CONSIDERATIONS.— 

7 ‘‘(I) IN GENERAL.—Subject to 

8 subclause (II), the Administrator shall 

9 issue exemptions and establish time pe10 riods by considering factors determined 

11 by the Administrator to be relevant to 

12 the goals of fostering innovation and 

13 the development of alternatives that 

14 meet the safety standard. 

15 ‘‘(II) LIMITATION.—Any renewal 

16 of an exemption in the case of a rule 

17 under paragraph (1) requiring the ban 

18 or phase-out of a chemical substance 

19 shall not exceed 5 years. 

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

21 declare a proposed rule under subsection (d)(1) to be effec22 tive on publication of the rule in the Federal Register and 

23 until the effective date of final action taken respecting the 

24 rule, if— 

25 ‘‘(1) the Administrator determines that— 
86 

† HR 2576 EAS 

1 ‘‘(A) the manufacture, processing, distribu2 tion in commerce, use, or disposal of the chem3 ical substance or mixture subject to the proposed 

4 rule or any combination of those activities is 

5 likely to result in a risk of serious or widespread 

6 injury to health or the environment before the ef7 fective date; and 

8 ‘‘(B) making the proposed rule so effective is 

9 necessary to protect the public interest; and 

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

11 manufacture, processing, or distribution in commerce 

12 of a chemical substance or mixture because of the risk 

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

14 granted relief in an action under section 7 with re15 spect to that risk associated with the chemical sub16 stance or mixture. 

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

18 subject to section 18— 

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

20 safety assessment, for a chemical substance that the 

21 Administrator determines under subsection (c) meets 

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

23 agency action, effective beginning on the date of 

24 issuance of the final safety determination; and 
87 

† HR 2576 EAS 

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

2 (d)(1), and the associated safety assessment and safe3 ty determination that a chemical substance does not 

4 meet the safety standard, shall be considered to be a 

5 final agency action, effective beginning on the date of 

6 promulgation of the final rule. 

7 ‘‘(g) EXTENSION OF DEADLINES FOR CERTAIN CHEM8 ICAL SUBSTANCES.—The Administrator may not extend 

9 any deadline under subsection (a) for a chemical substance 

10 designated as a high priority that is listed in the 2014 up11 date of the TSCA Work Plan without adequate public jus12 tification that demonstrates, following a review of the infor13 mation reasonably available to the Administrator, that the 

14 Administrator cannot adequately complete a safety assess15 ment and safety determination, or a final rule pursuant 

16 to subsection (d), without additional information regarding 

17 the chemical substance.’’; and 

18 (4) in subsection (h) (as redesignated by para19 graph (2))— 

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

21 (B) by redesignating paragraph (5) as 

22 paragraph (4). 

23 SEC. 9. IMMINENT HAZARDS. 

24 Section 7 of the Toxic Substances Control Act (15 

25 U.S.C. 2606) is amended— 
88 

† HR 2576 EAS 

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

2 following: 

3 ‘‘(a) CIVIL ACTIONS.— 

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

5 commence a civil action in an appropriate United 

6 States district court for— 

7 ‘‘(A) seizure of an imminently hazardous 

8 chemical substance or mixture or any article 

9 containing the chemical substance or mixture; 

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

11 against any person that manufactures, processes, 

12 distributes in commerce, uses, or disposes of, an 

13 imminently hazardous chemical substance or 

14 mixture or any article containing the chemical 

15 substance or mixture; or 

16 ‘‘(C) both seizure described in subparagraph 

17 (A) and relief described in subparagraph (B). 

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

19 civil action may be commenced under this paragraph, 

20 notwithstanding— 

21 ‘‘(A) the existence of a decision, rule, con22 sent agreement, or order by the Administrator 

23 under section 4, 4A, 5, or 6 or title IV or VI; or 
89 

† HR 2576 EAS 

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

2 judicial proceeding under any provision of this 

3 Act.’’; 

4 (2) in subsection (b)(1), by striking ‘‘unreason5 able’’; 

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

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

8 (4) in subsection (f), in the first sentence, by 

9 striking ‘‘and unreasonable’’. 

10 SEC. 10. INFORMATION COLLECTION AND REPORTING. 

11 Section 8 of the Toxic Substances Control Act (15 

12 U.S.C. 2607) is amended— 

13 (1) in subsection (a)— 

14 (A) in paragraph (3)— 

15 (i) in subparagraph (A)(ii)(I)— 

16 (I) by striking ‘‘5(b)(4)’’ and in17 serting ‘‘5’’; 

18 (II) by inserting ‘‘section 4 or’’ 

19 after ‘‘in effect under’’; and 

20 (III) by striking ‘‘5(e),’’ and in21 serting ‘‘5(d)(4);’’; and 

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

23 ‘‘(C) Not later than 180 days after the date of 

24 enactment of the Frank R. Lautenberg Chemical Safe25 ty for the 21st Century Act, and not less frequently 
90 

† HR 2576 EAS 

1 than once every 10 years thereafter, the Adminis2 trator, after consultation with the Administrator of 

3 the Small Business Administration, shall— 

4 ‘‘(i) review the adequacy of the standards 

5 prescribed according to subparagraph (B); 

6 ‘‘(ii) after providing public notice and an 

7 opportunity for comment, make a determination 

8 as to whether revision of the standards is war9 ranted; and 

10 ‘‘(iii) revise the standards if the Adminis11 trator so determines.’’; and 

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

13 ‘‘(4) RULES.— 

14 ‘‘(A) DEADLINE.— 

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

16 years after the date of enactment of the 

17 Frank R. Lautenberg Chemical Safety for 

18 the 21st Century Act, the Administrator 

19 shall promulgate rules requiring the main20 tenance of records and the reporting of ad21 ditional information known or reasonably 

22 ascertainable by the person making the re23 port, including rules applicable to proc24 essors so that the Administrator has the in25 formation necessary to carry out this title. 
91 

† HR 2576 EAS 

1 ‘‘(ii) MODIFICATION OF PRIOR

2 RULES.—In carrying out this subpara3 graph, the Administrator may modify, as 

4 appropriate, rules promulgated before the 

5 date of enactment of the Frank R. Lauten6 berg Chemical Safety for the 21st Century 

7 Act. 

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

9 pursuant to subparagraph (A)— 

10 ‘‘(i) may impose different reporting 

11 and recordkeeping requirements on manu12 facturers and processors; and 

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

14 necessary to be reported, including the man15 ner by which use and exposure information 

16 may be reported. 

17 ‘‘(C) ADMINISTRATION.—In implementing 

18 the reporting and recordkeeping requirements 

19 under this paragraph, the Administrator shall 

20 take measures— 

21 ‘‘(i) to limit the potential for duplica22 tion in reporting requirements; 

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

24 rules on small manufacturers and proc25 essors; and 
92 

† HR 2576 EAS 

1 ‘‘(iii) to apply any reporting obliga2 tions to those persons likely to have infor3 mation relevant to the effective implementa4 tion of this title.’’; 

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 enactment 

12 of the Frank R. Lautenberg Chemical Safe13 ty 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 of 

18 the document entitled ‘Candidate List of 

19 Chemical Substances’, and further described 

20 in the appendix A of volume I of the 1985 

21 edition of the Toxic Substances Control Act 

22 Substances Inventory (EPA Document No. 

23 EPA–560/7–85–002a); and 

24 ‘‘(iii) treat all components of categories 

25 that are considered to be statutory mixtures 
93 

† HR 2576 EAS 

1 under this Act as being included on the list 

2 published under paragraph (1) under the 

3 Chemical Abstracts Service numbers for the 

4 respective categories, including, without 

5 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, chemicals, 

15 CAS No. 65997–19–5; and 

16 ‘‘(VI) ceramic materials and 

17 wares, chemicals, CAS No. 66402–68– 

18 4. 

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

21 ‘‘(i) IN GENERAL.—If an existing guid22 ance allows for multiple nomenclature con23 ventions, the Administrator shall— 

24 ‘‘(I) maintain the nomenclature 

25 conventions for substances; and 
94 

† HR 2576 EAS 

1 ‘‘(II) develop new guidance that— 

2 ‘‘(aa) establishes equivalency 

3 between the nomenclature conven4 tions for chemical substances on 

5 the list published under para6 graph (1); and 

7 ‘‘(bb) permits persons to rely 

8 on the new guidance for purposes 

9 of determining whether a chemical 

10 substance is on the list published 

11 under paragraph (1). 

12 ‘‘(ii) MULTIPLE CAS NUMBERS.—For 

13 any chemical substance appearing multiple 

14 times on the list under different Chemical 

15 Abstracts Service numbers, the Adminis16 trator shall develop guidance recognizing 

17 the multiple listings as a single chemical 

18 substance. 

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

20 ‘‘(A) RULES.— 

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

22 year after the date of enactment of the 

23 Frank R. Lautenberg Chemical Safety for 

24 the 21st Century Act, the Administrator, by 

25 rule, shall require manufacturers and proc-
95 

† HR 2576 EAS 

1 essors to notify the Administrator, by not 

2 later than 180 days after the date of pro3 mulgation of the rule, of each chemical sub4 stance on the list published under para5 graph (1) that the manufacturer or proc6 essor, as applicable, has manufactured or 

7 processed for a nonexempt commercial pur8 pose during the 10-year period ending on 

9 the day before the date of enactment of the 

10 Frank R. Lautenberg Chemical Safety for 

11 the 21st Century Act. 

12 ‘‘(ii) ACTIVE SUBSTANCES.—The Ad13 ministrator shall designate chemical sub14 stances for which notices are received under 

15 clause (i) to be active substances on the list 

16 published under paragraph (1). 

17 ‘‘(iii) INACTIVE SUBSTANCES.—The 

18 Administrator shall designate chemical sub19 stances for which no notices are received 

20 under clause (i) to be inactive substances on 

21 the list published under paragraph (1). 

22 ‘‘(B) CONFIDENTIAL CHEMICAL SUB23 STANCES.—In promulgating the rule established 

24 pursuant to subparagraph (A), the Adminis25 trator shall— 
96 

† HR 2576 EAS 

1 ‘‘(i) maintain the list under paragraph 

2 (1), which shall include a confidential por3 tion and a nonconfidential portion con4 sistent with this section and section 14; 

5 ‘‘(ii) require a manufacturer or proc6 essor that is submitting a notice pursuant 

7 to subparagraph (A) for a chemical sub8 stance on the confidential portion of the list 

9 published under paragraph (1) to indicate 

10 in the notice whether the manufacturer or 

11 processor seeks to maintain any existing 

12 claim for protection against disclosure of 

13 the specific identity of the substance as con14 fidential pursuant to section 14; and 

15 ‘‘(iii) require the substantiation of 

16 those claims pursuant to section 14 and in 

17 accordance with the review plan described 

18 in subparagraph (C). 

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

20 after the date on which the Administrator com21 piles the initial list of active substances pursuant 

22 to subparagraph (A), the Administrator shall 

23 promulgate a rule that establishes a plan to re24 view all claims to protect the specific identities 

25 of chemical substances on the confidential por-
97 

† HR 2576 EAS 

1 tion of the list published under paragraph (1) 

2 that are asserted pursuant to subparagraph (B). 

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

4 Under the review plan under subparagraph (C), 

5 the Administrator 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 substan11 tiated the claim in a submission made to 

12 the Administrator during the 5-year period 

13 ending on the date of the request by the Ad14 ministrator; 

15 ‘‘(ii) in accordance with section 14— 

16 ‘‘(I) review each substantiation— 

17 ‘‘(aa) submitted pursuant to 

18 clause (i) to determine if the 

19 claim warrants protection from 

20 disclosure; and 

21 ‘‘(bb) submitted previously 

22 by a manufacturer or processor 

23 and relied on in lieu of the sub24 stantiation required pursuant to 

25 clause (i), if the substantiation 
98 

† HR 2576 EAS 

1 has not been previously reviewed 

2 by the Administrator, to deter3 mine if the claim warrants pro4 tection from disclosure; 

5 ‘‘(II) approve, modify, or deny 

6 each claim; and 

7 ‘‘(III) except as provided in this 

8 section and section 14, protect from 

9 disclosure information for which the 

10 Administrator approves such a claim 

11 for a period of 10 years, unless, prior 

12 to the expiration of the period— 

13 ‘‘(aa) the person notifies the 

14 Administrator that the person is 

15 withdrawing the claim, in which 

16 case the Administrator shall 

17 promptly make the information 

18 available to the public; or 

19 ‘‘(bb) the Administrator oth20 erwise becomes aware that the 

21 need for protection from disclosure 

22 can no longer be substantiated, in 

23 which case the Administrator 

24 shall take the actions described in 

25 section 14(g)(2); and 
99 

† HR 2576 EAS 

1 ‘‘(iii) encourage manufacturers or 

2 processors that have previously made claims 

3 to protect the specific identities of chemical 

4 substances identified as inactive pursuant 

5 to subsection (f)(2) to review and either 

6 withdraw or substantiate the claims. 

7 ‘‘(E) TIMELINE FOR COMPLETION OF RE8 VIEWS.— 

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

10 shall implement the review plan so as to 

11 complete reviews of all claims specified in 

12 subparagraph (C) not later than 5 years 

13 after the date on which the Administrator 

14 compiles the initial list of active substances 

15 pursuant to subparagraph (A). 

16 ‘‘(ii) CONSIDERATIONS.— 

17 ‘‘(I) IN GENERAL.—The Adminis18 trator may extend the deadline for 

19 completion of the reviews for not more 

20 than 2 additional years, after an ade21 quate public justification, if the Ad22 ministrator determines that the exten23 sion is necessary based on the number 

24 of claims needing review and the avail25 able resources. 
100 

† HR 2576 EAS 

1 ‘‘(II) ANNUAL REVIEW GOAL AND

2 RESULTS.—At the beginning of each 

3 year, the Administrator shall publish 

4 an annual goal for reviews and the 

5 number of reviews completed in the 

6 prior year. 

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

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

9 shall maintain and keep current designations of 

10 active substances and inactive substances on the 

11 list published under paragraph (1). 

12 ‘‘(B) CHANGE TO ACTIVE STATUS.— 

13 ‘‘(i) IN GENERAL.—Any person that 

14 intends to manufacture or process for a 

15 nonexempt commercial purpose a chemical 

16 substance that is designated as an inactive 

17 substance shall notify the Administrator be18 fore the date on which the inactive sub19 stance is manufactured or processed. 

20 ‘‘(ii) CONFIDENTIAL CHEMICAL IDEN21 TITY CLAIMS.—If a person submitting a no22 tice under clause (i) for an inactive sub23 stance on the confidential portion of the list 

24 published under paragraph (1) seeks to 

25 maintain an existing claim for protection 
101 

† HR 2576 EAS 

1 against disclosure of the specific identity of 

2 the inactive substance as confidential, the 

3 person shall— 

4 ‘‘(I) in the notice submitted under 

5 clause (i), assert the claim; and 

6 ‘‘(II) by not later than 30 days 

7 after providing the notice under clause 

8 (i), substantiate the claim. 

9 ‘‘(iii) ACTIVE STATUS.—On receiving a 

10 notification under clause (i), the Adminis11 trator shall— 

12 ‘‘(I) designate the applicable 

13 chemical substance as an active sub14 stance; 

15 ‘‘(II) pursuant to section 14, 

16 promptly review any claim and associ17 ated substantiation submitted pursu18 ant to clause (ii) for protection against 

19 disclosure of the specific identity of the 

20 chemical substance and approve, mod21 ify, or deny the claim; 

22 ‘‘(III) except as provided in this 

23 section and section 14, protect from 

24 disclosure the specific identity of the 

25 chemical substance for which the Ad-
102 

† HR 2576 EAS 

1 ministrator approves a claim under 

2 subclause (II) for a period of 10 years, 

3 unless, prior to the expiration of the 

4 period— 

5 ‘‘(aa) the person notifies the 

6 Administrator that the person is 

7 withdrawing the claim, in which 

8 case the Administrator shall 

9 promptly make the information 

10 available to the public; or 

11 ‘‘(bb) the Administrator oth12 erwise becomes aware that the 

13 need for protection from disclosure 

14 can no longer be substantiated, in 

15 which case the Administrator 

16 shall take the actions described in 

17 section 14(g)(2); and 

18 ‘‘(IV) pursuant to section 4A, re19 view the priority of the chemical sub20 stance as the Administrator determines 

21 to be necessary. 

22 ‘‘(C) CATEGORY STATUS.—The list of inac23 tive substances shall not be considered to be a 

24 category for purposes of section 26(c). 
103 

† HR 2576 EAS 

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

2 Prior to the promulgation of the rule required under 

3 paragraph (4)(A), the Administrator shall designate 

4 the chemical substances reported under part 711 of 

5 title 40, Code of Federal Regulations (as in effect on 

6 the date of enactment of the Frank R. Lautenberg 

7 Chemical Safety for the 21st Century Act), during the 

8 reporting period that most closely preceded the date 

9 of enactment of the Frank R. Lautenberg Chemical 

10 Safety for the 21st Century Act, as the interim list 

11 of active substances for the purposes of section 4A. 

12 ‘‘(7) PUBLIC INFORMATION.—Subject to this sub13 section, the Administrator shall make available to the 

14 public— 

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

16 substance on the nonconfidential portion of the 

17 list published under paragraph (1) that the Ad18 ministrator has designated as— 

19 ‘‘(i) an active substance; or 

20 ‘‘(ii) an inactive substance; 

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

22 and, if applicable, premanufacture notice case 

23 number for each chemical substance on the con24 fidential portion of the list published under 
104 

† HR 2576 EAS 

1 paragraph (1) for which a claim of confiden2 tiality was received; and 

3 ‘‘(C) subject to subsections (f) and (g) of sec4 tion 14, the specific identity of any active sub5 stance for which— 

6 ‘‘(i) a claim for protection against dis7 closure of the specific identity of the active 

8 chemical substance was not asserted, as re9 quired under this subsection or subsection 

10 (d) or (f) of section 14; 

11 ‘‘(ii) a claim for protection against 

12 disclosure of the specific identity of the ac13 tive substance has been denied by the Ad14 ministrator; or 

15 ‘‘(iii) the time period for protection 

16 against disclosure of the specific identity of 

17 the active substance has expired. 

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

19 claim under this subsection for protection from disclo20 sure of a specific identity of any active or inactive 

21 chemical substance for which a notice is received 

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

23 the confidential portion of the list published under 

24 paragraph (1). 
105 

† HR 2576 EAS 

1 ‘‘(9) CERTIFICATION.—Under the rules promul2 gated under this subsection, manufacturers and proc3 essors shall be required— 

4 ‘‘(A) to certify that each notice or substan5 tiation the manufacturer or processor submits 

6 complies with the requirements of the rule, and 

7 that any confidentiality claims are true and cor8 rect; and 

9 ‘‘(B) to retain a record supporting the cer10 tification for a period of 5 years beginning on 

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

12 (3) in subsection (e)— 

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

14 the following: 

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

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

17 ‘‘(2) ADDITIONAL INFORMATION.—Any person 

18 may submit to the Administrator information reason19 ably supporting the conclusion that a chemical sub20 stance or mixture presents, will present, or does not 

21 present a substantial risk of injury to health and the 

22 environment.’’; and 

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

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

25 this section: 
106 

† HR 2576 EAS 

1 ‘‘(1) ACTIVE SUBSTANCE.—The term ‘active sub2 stance’ means a chemical substance— 

3 ‘‘(A) that has been manufactured or proc4 essed for a nonexempt commercial purpose at 

5 any point during the 10-year period ending on 

6 the date of enactment of the Frank R. Lauten7 berg Chemical Safety for the 21st Century Act; 

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

9 under subsection (b)(1) after that date of enact10 ment; or 

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

12 subsection (b)(5)(C). 

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

14 substance’ means a chemical substance on the list 

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

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

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

18 SEC. 11. RELATIONSHIP TO OTHER FEDERAL LAWS. 

19 Section 9 of the Toxic Substances Control Act (15 

20 U.S.C. 2608) is amended— 

21 (1) in subsection (a)— 

22 (A) in paragraph (1), in the first sen23 tence— 

24 (i) by striking ‘‘presents or will present 

25 an unreasonable risk to health or the envi-
107 

† HR 2576 EAS 

1 ronment’’ and inserting ‘‘does not or will 

2 not meet the safety standard’’; and 

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

4 place it appears and inserting ‘‘the risk 

5 posed by the substance or mixture’’; 

6 (B) in paragraph (2)— 

7 (i) in subparagraph (A), by inserting 

8 ‘‘within the time period specified by the Ad9 ministrator in the report’’ after ‘‘issues an 

10 order’’; 

11 (ii) in subparagraph (B), by inserting 

12 ‘‘responds within the time period specified 

13 by the Administrator in the report and’’ be14 fore ‘‘initiates, within 90 days’’; and 

15 (iii) in the matter following subpara16 graph (B), by striking ‘‘section 6 or 7’’ and 

17 inserting ‘‘section 6(d) or section 7’’; 

18 (C) by redesignating paragraph (3) as 

19 paragraph (6); 

20 (D) in paragraph (6) (as so redesignated), 

21 by striking ‘‘section 6 or 7’’ and inserting ‘‘sec22 tion 6(d) or 7’’; and 

23 (E) by inserting after paragraph (2) the fol24 lowing: 
108 

† HR 2576 EAS 

1 ‘‘(3) The Administrator shall take the actions de2 scribed in paragraph (4) if the Administrator makes 

3 a report under paragraph (1) with respect to a chem4 ical substance or mixture and the agency to which the 

5 report was made does not— 

6 ‘‘(A) issue the order described in paragraph 

7 (2)(A) within the time period specified by the 

8 Administrator in the report; or 

9 ‘‘(B)(i) respond under paragraph (1) with10 in the time frame specified by the Administrator 

11 in the report; and 

12 ‘‘(ii) initiate action within 90 days of pub13 lication in the Federal Register of the response 

14 described in clause (i). 

15 ‘‘(4) If an agency to which a report under para16 graph (1) does not take the actions described in sub17 paragraphs (A) or (B) of paragraph (3), the Admin18 istrator shall— 

19 ‘‘(A) if a safety assessment and safety deter20 mination for the substance under section 6 has 

21 not been completed, complete the safety assess22 ment and safety determination; 

23 ‘‘(B) if the Administrator has determined or 

24 determines that the chemical substance does not 
109 

† HR 2576 EAS 

1 meet the safety standard, initiate action under 

2 section 6(d) with respect to the risk; or 

3 ‘‘(C) take any action authorized or required 

4 under section 7, as appropriate. 

5 ‘‘(5) This subsection shall not relieve the Admin6 istrator of any obligation to complete a safety assess7 ment and safety determination or take any required 

8 action under section 6(d) or 7 to address risks from 

9 the manufacture, processing, distribution in com10 merce, use, or disposal of a chemical substance or 

11 mixture, or any combination of those activities, that 

12 are not identified in a report issued by the Adminis13 trator under paragraph (1).’’; 

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

15 striking ‘‘Health, Education, and Welfare’’ and in16 serting ‘‘Health and Human Services’’; and 

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

18 ‘‘(e) EXPOSURE INFORMATION.—If the Administrator 

19 obtains information related to exposures or releases of a 

20 chemical substance that may be prevented or reduced under 

21 another Federal law, including laws not administered by 

22 the Administrator, the Administrator shall make such in23 formation available to the relevant Federal agency or office 

24 of the Environmental Protection Agency.’’. 
110 

† HR 2576 EAS 

1 SEC. 12. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMI2 NATION, AND UTILIZATION OF DATA. 

3 Section 10 of the Toxic Substances Control Act (15 

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

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

6 and Human Services’’. 

7 SEC. 13. EXPORTS. 

8 Section 12 of the Toxic Substances Control Act (15 

9 U.S.C. 2611) is amended— 

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

11 and inserting the following: 

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

13 apply to— 

14 ‘‘(A) any new chemical substance that the 

15 Administrator determines is likely to present an 

16 unreasonable risk of injury to health within the 

17 United States or to the environment of the 

18 United States, without taking into account cost 

19 or other non-risk factors; 

20 ‘‘(B) any chemical substance that the Ad21 ministrator determines presents or will present 

22 an unreasonable risk of injury to health within 

23 the United States or to the environment of the 

24 United States, without taking into account cost 

25 or other non-risk factors; or 

26 ‘‘(C) any chemical substance that— 
111 

† HR 2576 EAS 

1 ‘‘(i) the Administrator determines is 

2 likely to present an unreasonable risk of in3 jury to health within the United States or 

4 to the environment of the United States, 

5 without taking into account cost or other 

6 non-risk factors; and 

7 ‘‘(ii) is subject to restriction under sec8 tion 5(d)(4). 

9 ‘‘(3) WAIVERS FOR CERTAIN MIXTURES AND AR10 TICLES.—For a mixture or article containing a chem11 ical substance described in paragraph (2), the Admin12 istrator may— 

13 ‘‘(A) determine that paragraph (1) shall not 

14 apply to the mixture or article; or 

15 ‘‘(B) establish a threshold concentration in 

16 a mixture or article at which paragraph (1) 

17 shall not apply. 

18 ‘‘(4) TESTING.—The Administrator may require 

19 testing under section 4 of any chemical substance or 

20 mixture exempted from this Act under paragraph (1) 

21 for the purpose of determining whether the chemical 

22 substance meets the safety standard within the United 

23 States.’’; 

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

25 following: 
112 

† HR 2576 EAS 

1 ‘‘(b) NOTICE.— 

2 ‘‘(1) IN GENERAL.—A person shall notify the Ad3 ministrator that the person is exporting or intends to 

4 export to a foreign country— 

5 ‘‘(A) a chemical substance or a mixture con6 taining a chemical substance that the Adminis7 trator has determined under section 5 is not like8 ly to meet the safety standard and for which a 

9 prohibition or other restriction has been proposed 

10 or established under that section; 

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

12 containing a chemical substance that the Admin13 istrator has determined under section 6 does not 

14 meet the safety standard and for which a prohi15 bition or other restriction has been proposed or 

16 established under that section; 

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

18 United States is obligated by treaty to provide 

19 export notification; 

20 ‘‘(D) a chemical substance or mixture con21 taining a chemical substance subject to a pro22 posed or promulgated significant new use rule, 

23 or a prohibition or other restriction pursuant to 

24 a rule, order, or consent agreement in effect 

25 under this Act; 
113 

† HR 2576 EAS 

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

2 which the submission of information is required 

3 under section 4; or 

4 ‘‘(F) a chemical substance or mixture for 

5 which an action is pending or for which relief 

6 has been granted under section 7. 

7 ‘‘(2) RULES.— 

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

9 shall promulgate rules to carry out paragraph 

10 (1). 

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

12 pursuant to subparagraph (A) shall— 

13 ‘‘(i) include such exemptions as the 

14 Administrator determines to be appropriate, 

15 which may include exemptions identified 

16 under section 5(h); and 

17 ‘‘(ii) indicate whether, or to what ex18 tent, the rules apply to articles containing 

19 a chemical substance or mixture described 

20 in paragraph (1). 

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

22 submit to the government of each country to which a 

23 chemical substance or mixture is exported— 

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

25 described in subparagraph (A), (B), (D), or (F) 
114 

† HR 2576 EAS 

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

2 rule, order, consent agreement, action, relief, or 

3 requirement; 

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

5 paragraph (1)(C), a notice that satisfies the obli6 gation of the United States under the applicable 

7 treaty; and 

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

9 described in paragraph (1)(E), a notice of avail10 ability of the information on the chemical sub11 stance or mixture submitted to the Adminis12 trator.’’; and 

13 (3) in subsection (c), by striking paragraph (3). 

14 SEC. 14. CONFIDENTIAL INFORMATION. 

15 Section 14 of the Toxic Substances Control Act (15 

16 U.S.C. 2613) is amended to read as follows: 

17 ‘‘SEC. 14. CONFIDENTIAL INFORMATION. 

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

19 this section, the Administrator shall not disclose informa20 tion that is exempt from disclosure pursuant to subsection 

21 (a) of section 552 of title 5, United States Code, under sub22 section (b)(4) of that section— 

23 ‘‘(1) that is reported to, or otherwise obtained by, 

24 the Administrator under this Act; and 
115 

† HR 2576 EAS 

1 ‘‘(2) for which the requirements of subsection (d) 

2 are met. 

3 ‘‘(b) INFORMATION GENERALLY PROTECTED FROM

4 DISCLOSURE.—The following information specific to, and 

5 submitted by, a manufacturer, processor, or distributor that 

6 meets the requirements of subsections (a) and (d) shall be 

7 presumed to be protected from disclosure, subject to the con8 dition that nothing in this Act prohibits the disclosure of 

9 any such information, or information that is the subject 

10 of subsection (g)(3), through discovery, subpoena, other 

11 court order, or any other judicial process otherwise allowed 

12 under applicable Federal or State law: 

13 ‘‘(1) Specific information describing the proc14 esses used in manufacture or processing of a chemical 

15 substance, mixture, or article. 

16 ‘‘(2) Marketing and sales information. 

17 ‘‘(3) Information identifying a supplier or cus18 tomer. 

19 ‘‘(4) Details of the full composition of a mixture 

20 and the respective percentages of constituents. 

21 ‘‘(5) Specific information regarding the use, 

22 function, or application of a chemical substance or 

23 mixture in a process, mixture, or product. 

24 ‘‘(6) Specific production or import volumes of 

25 the manufacturer. 
116 

† HR 2576 EAS 

1 ‘‘(7) Specific aggregated volumes across manu2 facturers, if the Administrator determines that disclo3 sure of the specific aggregated volumes would reveal 

4 confidential information. 

5 ‘‘(8) Except as otherwise provided in this section, 

6 the specific identity of a chemical substance prior to 

7 the date on which the chemical substance is first of8 fered for commercial distribution, including the chem9 ical name, molecular formula, Chemical Abstracts 

10 Service number, and other information that would 

11 identify a specific chemical substance, if the specific 

12 identity was claimed as confidential information at 

13 the time it was submitted in a notice under section 

14 5. 

15 ‘‘(c) INFORMATION NOT PROTECTED FROM DISCLO16 SURE.— 

17 ‘‘(1) IN GENERAL.—Notwithstanding subsections 

18 (a) and (b), the following information shall not be 

19 protected from disclosure: 

20 ‘‘(A) INFORMATION FROM HEALTH AND

21 SAFETY STUDIES.— 

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

23 (ii)— 
117 

† HR 2576 EAS 

1 ‘‘(I) any health and safety study 

2 that is submitted under this Act with 

3 respect to— 

4 ‘‘(aa) any chemical substance 

5 or mixture that, on the date on 

6 which the study is to be disclosed, 

7 has been offered for commercial 

8 distribution; or 

9 ‘‘(bb) any chemical substance 

10 or mixture for which— 

11 ‘‘(AA) testing is re12 quired under section 4; or 

13 ‘‘(BB) a notification is 

14 required under section 5; or 

15 ‘‘(II) any information reported to, 

16 or otherwise obtained by, the Adminis17 trator from a health and safety study 

18 relating to a chemical substance or 

19 mixture described in item (aa) or (bb) 

20 of subclause (I). 

21 ‘‘(ii) EFFECT OF SUBPARAGRAPH.— 

22 Nothing in this subparagraph authorizes the 

23 release of any information that discloses— 
118 

† HR 2576 EAS 

1 ‘‘(I) a process used in the manu2 facturing or processing of a chemical 

3 substance or mixture; or 

4 ‘‘(II) in the case of a mixture, the 

5 portion of the mixture comprised by 

6 any chemical substance in the mixture. 

7 ‘‘(B) OTHER INFORMATION NOT PROTECTED

8 FROM DISCLOSURE.— 

9 ‘‘(i) For information submitted after 

10 the date of enactment of the Frank R. Lau11 tenberg Chemical Safety for the 21st Cen12 tury Act, the specific identity of a chemical 

13 substance as of the date on which the chem14 ical substance is first offered for commercial 

15 distribution, if the person submitting the 

16 information does not meet the requirements 

17 of subsection (d). 

18 ‘‘(ii) A safety assessment developed, or 

19 a safety determination made, under section 

20 6. 

21 ‘‘(iii) Any general information describ22 ing the manufacturing volumes, expressed 

23 as specific aggregated volumes or, if the Ad24 ministrator determines that disclosure of 

25 specific aggregated volumes would reveal 
119 

† HR 2576 EAS 

1 confidential information, expressed in 

2 ranges. 

3 ‘‘(iv) A general description of a process 

4 used in the manufacture or processing and 

5 industrial, commercial, or consumer func6 tions and uses of a chemical substance, mix7 ture, or article containing a chemical sub8 stance or mixture, including information 

9 specific to an industry or industry sector 

10 that customarily would be shared with the 

11 general public or within an industry or in12 dustry sector. 

13 ‘‘(2) MIXED CONFIDENTIAL AND NONCONFIDEN14 TIAL INFORMATION.—Any information that is eligible 

15 for protection under this section and is submitted 

16 with information described in this subsection shall be 

17 protected from disclosure, if the submitter complies 

18 with subsection (d), subject to the condition that in19 formation in the submission that is not eligible for 

20 protection against disclosure shall be disclosed. 

21 ‘‘(3) BAN OR PHASE-OUT.—If the Administrator 

22 promulgates a rule pursuant to section 6(d) that es23 tablishes a ban or phase-out of the manufacture, proc24 essing, or distribution in commerce of a chemical sub25 stance, subject to paragraphs (2), (3), and (4) of sub-
120 

† HR 2576 EAS 

1 section (g), any protection from disclosure provided 

2 under this section with respect to the specific identity 

3 of the chemical substance and other information relat4 ing to the chemical substance shall no longer apply. 

5 ‘‘(4) CERTAIN REQUESTS.—If a request is made 

6 to the Administrator under section 552(a) of title 5, 

7 United States Code, for information that is subject to 

8 disclosure under this subsection, the Administrator 

9 may not deny the request on the basis of section 

10 552(b)(4) of title 5, United States Code. 

11 ‘‘(d) REQUIREMENTS FOR CONFIDENTIALITY

12 CLAIMS.— 

13 ‘‘(1) ASSERTION OF CLAIMS.— 

14 ‘‘(A) IN GENERAL.—A person seeking to 

15 protect any information submitted under this 

16 Act from disclosure (including information de17 scribed in subsection (b)) shall assert to the Ad18 ministrator a claim for protection concurrent 

19 with submission of the information, in accord20 ance with such rules regarding a claim for pro21 tection from disclosure as the Administrator has 

22 promulgated or may promulgate pursuant to 

23 this title. 
121 

† HR 2576 EAS 

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— 
122 

† HR 2576 EAS 

1 ‘‘(i) be consistent with guidance issued 

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 cause substantial 

12 harm to the competitive position of the 

13 person. 

14 ‘‘(D) PUBLIC INFORMATION.—No person 

15 may assert a claim under this section for protec16 tion from disclosure of information that is al17 ready publicly available. 

18 ‘‘(2) ADDITIONAL REQUIREMENTS FOR CON19 FIDENTIALITY CLAIMS.—Except for information de20 scribed in subsection (b), a person asserting a claim 

21 to protect information from disclosure under this Act 

22 shall substantiate the claim, in accordance with the 

23 rules promulgated and consistent with the guidance 

24 issued by the Administrator. 
123 

† HR 2576 EAS 

1 ‘‘(3) GUIDANCE.—The Administrator shall de2 velop guidance regarding— 

3 ‘‘(A) the determination of structurally de4 scriptive generic names, in the case of claims for 

5 the protection against disclosure of specific chem6 ical identity; and 

7 ‘‘(B) the content and form of the statements 

8 of need and agreements required under para9 graphs (4), (5), and (6) of subsection (e). 

10 ‘‘(4) CERTIFICATION.—An authorized official of 

11 a person described in paragraph (1)(A) shall certify 

12 that the statement required to assert a claim sub13 mitted pursuant to paragraph (1)(B) and any infor14 mation required to substantiate a claim submitted 

15 pursuant to paragraph (2) are true and correct. 

16 ‘‘(e) EXCEPTIONS TO PROTECTION FROM DISCLO17 SURE.—Information described in subsection (a)— 

18 ‘‘(1) shall be disclosed if the information is to be 

19 disclosed to an officer or employee of the United 

20 States in connection with the official duties of the of21 ficer or employee— 

22 ‘‘(A) under any law for the protection of 

23 health or the environment; or 

24 ‘‘(B) for a specific law enforcement purpose; 
124 

† HR 2576 EAS 

1 ‘‘(2) shall be disclosed if the information is to be 

2 disclosed to a contractor of the United States and em3 ployees of that contractor— 

4 ‘‘(A) if, in the opinion of the Administrator, 

5 the disclosure is necessary for the satisfactory 

6 performance by the contractor of a contract with 

7 the United States for the performance of work in 

8 connection with this Act; and 

9 ‘‘(B) subject to such conditions as the Ad10 ministrator may specify; 

11 ‘‘(3) shall be disclosed if the Administrator deter12 mines that disclosure is necessary to protect health or 

13 the environment; 

14 ‘‘(4) shall be disclosed if the information is to be 

15 disclosed to a State or political subdivision of a State, 

16 on written request, for the purpose of development, 

17 administration, or enforcement of a law, if 1 or more 

18 applicable agreements with the Administrator that 

19 are consistent with the guidance issued under sub20 section (d)(3)(B) ensure that the recipient will take 

21 appropriate measures, and has adequate authority, to 

22 maintain the confidentiality of the information in ac23 cordance with procedures comparable to the proce24 dures used by the Administrator to safeguard the in25 formation; 
125 

† HR 2576 EAS 

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 are consistent 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 
126 

† HR 2576 EAS 

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, 

24 public health or environmental official of a State 

25 or a political subdivision of a State, or first re-
127 

† HR 2576 EAS 

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 
128 

† HR 2576 EAS 

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 NOT SUBJECT TO TIME

18 LIMIT FOR PROTECTION FROM DISCLOSURE.— 

19 Subject to paragraph (2), the Administrator 

20 shall protect from disclosure information de21 scribed in subsection (b) that meets the require22 ments of subsections (a) and (d), unless— 

23 ‘‘(i) the person that asserted the claim 

24 notifies the Administrator that the person is 

25 withdrawing the claim, in which case the 
129 

† HR 2576 EAS 

1 Administrator shall promptly make the in2 formation available to the public; or 

3 ‘‘(ii) the Administrator otherwise be4 comes aware that the information does not 

5 qualify or no longer qualifies for protection 

6 against disclosure under subsection (a), in 

7 which case the Administrator shall take any 

8 actions required under subsection (g)(2). 

9 ‘‘(B) INFORMATION SUBJECT TO TIME LIMIT

10 FOR PROTECTION FROM DISCLOSURE.—Subject to 

11 paragraph (2), the Administrator shall protect 

12 from disclosure information, other than informa13 tion described in subsection (b), that meets the 

14 requirements of subsections (a) and (d) for a pe15 riod of 10 years, unless, prior to the expiration 

16 of the period— 

17 ‘‘(i) the person that asserted the claim 

18 notifies the Administrator that the person is 

19 withdrawing the claim, in which case the 

20 Administrator shall promptly make the in21 formation available to the public; or 

22 ‘‘(ii) the Administrator otherwise be23 comes aware that the information does not 

24 qualify or no longer qualifies for protection 

25 against disclosure under subsection (a), in 
130 

† HR 2576 EAS 

1 which case the Administrator shall take any 

2 actions required under subsection (g)(2). 

3 ‘‘(C) EXTENSIONS.— 

4 ‘‘(i) IN GENERAL.—Not later than the 

5 date that is 60 days before the expiration of 

6 the period described in subparagraph (B), 

7 the Administrator shall provide to the per8 son that asserted the claim a notice of the 

9 impending expiration of the period. 

10 ‘‘(ii) STATEMENT.— 

11 ‘‘(I) IN GENERAL.—Not later than 

12 the date that is 30 days before the expi13 ration of the period described in sub14 paragraph (B), a person reasserting 

15 the relevant claim shall submit to the 

16 Administrator a request for extension 

17 substantiating, in accordance with sub18 section (d)(2), the need to extend the 

19 period. 

20 ‘‘(II) ACTION BY ADMINIS21 TRATOR.—Not later than the date of 

22 expiration of the period described in 

23 subparagraph (B), the Administrator 

24 shall, in accordance with subsection 

25 (g)(1)(C)— 
131 

† HR 2576 EAS 

1 ‘‘(aa) review the request sub2 mitted under subclause (I); 

3 ‘‘(bb) make a determination 

4 regarding whether the claim for 

5 which the request was submitted 

6 continues to meet the relevant cri7 teria established under this sec8 tion; and 

9 ‘‘(cc)(AA) grant an extension 

10 of 10 years; or 

11 ‘‘(BB) deny the request. 

12 ‘‘(D) NO LIMIT ON NUMBER OF EXTEN13 SIONS.—There shall be no limit on the number 

14 of extensions granted under subparagraph (C), if 

15 the Administrator determines that the relevant 

16 request under subparagraph (C)(ii)(I)— 

17 ‘‘(i) establishes the need to extend the 

18 period; and 

19 ‘‘(ii) meets the requirements established 

20 by the Administrator. 

21 ‘‘(2) REVIEW AND RESUBSTANTIATION.— 

22 ‘‘(A) DISCRETION OF ADMINISTRATOR.—The 

23 Administrator may review, at any time, a claim 

24 for protection of information against disclosure 

25 under subsection (a) and require any person that 
132 

† HR 2576 EAS 

1 has claimed protection for that information, 

2 whether before, on, or after the date of enactment 

3 of the Frank R. Lautenberg Chemical Safety for 

4 the 21st Century Act, to withdraw or reassert 

5 and substantiate or resubstantiate the claim in 

6 accordance with this section— 

7 ‘‘(i) after the chemical substance is 

8 identified as a high-priority substance 

9 under section 4A; 

10 ‘‘(ii) for any chemical substance for 

11 which the Administrator has made a deter12 mination under section 6(c)(1)(C); 

13 ‘‘(iii) for any inactive chemical sub14 stance identified under section 8(b)(5); or 

15 ‘‘(iv) in limited circumstances, if the 

16 Administrator determines that disclosure of 

17 certain information currently protected 

18 from disclosure would assist the Adminis19 trator in conducting safety assessments and 

20 safety determinations under subsections (b) 

21 and (c) of section 6 or promulgating rules 

22 pursuant to section 6(d). 

23 ‘‘(B) REVIEW REQUIRED.—The Adminis24 trator shall review a claim for protection of in25 formation against disclosure under subsection (a) 
133 

† HR 2576 EAS 

1 and require any person that has claimed protec2 tion for that information, whether before, on, or 

3 after the date of enactment of the Frank R. Lau4 tenberg Chemical Safety for the 21st Century 

5 Act, to withdraw or reassert and substantiate or 

6 resubstantiate the claim in accordance with this 

7 section— 

8 ‘‘(i) as necessary to determine whether 

9 the information qualifies for an exemption 

10 from disclosure in connection with a request 

11 for information received by the Adminis12 trator under section 552 of title 5, United 

13 States Code; 

14 ‘‘(ii) if the Administrator has a rea15 sonable basis to believe that the information 

16 does not qualify for protection against dis17 closure under subsection (a); or 

18 ‘‘(iii) for any substance for which the 

19 Administrator has made a determination 

20 under section 6(c)(1)(B). 

21 ‘‘(C) ACTION BY RECIPIENT.—If the Admin22 istrator makes a request under subparagraph (A) 

23 or (B), the recipient of the request shall— 

24 ‘‘(i) reassert and substantiate or re25 substantiate the claim; or 
134 

† HR 2576 EAS 

1 ‘‘(ii) withdraw the claim. 

2 ‘‘(D) PERIOD OF PROTECTION.—Protection 

3 from disclosure of information subject to a claim 

4 that is reviewed and approved by the Adminis5 trator under this paragraph shall be extended for 

6 a period of 10 years from the date of approval, 

7 subject to any subsequent request by the Admin8 istrator under this paragraph. 

9 ‘‘(3) UNIQUE IDENTIFIER.—The Administrator 

10 shall— 

11 ‘‘(A)(i) develop a system to assign a unique 

12 identifier to each specific chemical identity for 

13 which the Administrator approves a request for 

14 protection from disclosure, other than a specific 

15 chemical identity or structurally descriptive ge16 neric term; and 

17 ‘‘(ii) apply that identifier consistently to all 

18 information relevant to the applicable chemical 

19 substance; 

20 ‘‘(B) annually publish and update a list of 

21 chemical substances, referred to by unique identi22 fier, for which claims to protect the specific 

23 chemical identity from disclosure have been ap24 proved, including the expiration date for each 

25 such claim; 
135 

† HR 2576 EAS 

1 ‘‘(C) ensure that any nonconfidential infor2 mation received by the Administrator with re3 spect to such a chemical substance during the pe4 riod 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 specific 

9 chemical identity that has been denied by the 

10 Administrator or expired, or that has been with11 drawn by the submitter, provide public access to 

12 the specific chemical identity clearly linked to all 

13 nonconfidential information received by the Ad14 ministrator with respect to the chemical sub15 stance. 

16 ‘‘(g) DUTIES OF ADMINISTRATOR.— 

17 ‘‘(1) DETERMINATION.— 

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

19 subsection (b), the Administrator shall, subject to 

20 subparagraph (C), not later than 90 days after 

21 the receipt of a claim under subsection (d), and 

22 not later than 30 days after the receipt of a re23 quest for extension of a claim under subsection 

24 (f), review and approve, modify, or deny the 

25 claim or request. 
136 

† HR 2576 EAS 

1 ‘‘(B) REASONS FOR DENIAL OR MODIFICA2 TION.—If the Administrator denies or modifies a 

3 claim or request under subparagraph (A), the 

4 Administrator shall provide to the person that 

5 submitted the claim or request a written state6 ment of the reasons for the denial or modifica7 tion of the claim or request. 

8 ‘‘(C) SUBSETS.—The Administrator shall— 

9 ‘‘(i) except for claims described in sub10 section (b)(8), review all claims or requests 

11 under this section for the protection against 

12 disclosure of the specific identity of a chem13 ical substance; and 

14 ‘‘(ii) review a representative subset, 

15 comprising at least 25 percent, of all other 

16 claims or requests for protection against 

17 disclosure. 

18 ‘‘(D) EFFECT OF FAILURE TO ACT.—The 

19 failure of the Administrator to make a decision 

20 regarding a claim or request for protection 

21 against disclosure or extension under this section 

22 shall not be the basis for denial or elimination 

23 of a claim or request for protection against dis24 closure. 

25 ‘‘(2) NOTIFICATION.— 
137 

† HR 2576 EAS 

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

2 subparagraph (B) and subsections (c), (e), and 

3 (f), if the Administrator denies or modifies a 

4 claim or request under paragraph (1), intends to 

5 release information pursuant to subsection (e), or 

6 promulgates a rule under section 6(d) estab7 lishing a ban or phase-out of a chemical sub8 stance, the Administrator shall notify, in writing 

9 and by certified mail, the person that submitted 

10 the claim of the intent of the Administrator to 

11 release the information. 

12 ‘‘(B) RELEASE OF INFORMATION.—Except 

13 as provided in subparagraph (C), the Adminis14 trator shall not release information under this 

15 subsection until the date that is 30 days after the 

16 date on which the person that submitted the re17 quest receives notification under subparagraph 

18 (A). 

19 ‘‘(C) EXCEPTIONS.— 

20 ‘‘(i) IN GENERAL.—For information 

21 under paragraph (3) or (8) of subsection 

22 (e), the Administrator shall not release that 

23 information until the date that is 15 days 

24 after the date on which the person that sub25 mitted the claim or request receives a notifi-
138 

† HR 2576 EAS 

1 cation, unless the Administrator determines 

2 that release of the information is necessary 

3 to protect against an imminent and sub4 stantial harm to health or the environment, 

5 in which case no prior notification shall be 

6 necessary. 

7 ‘‘(ii) NOTIFICATION AS SOON AS PRAC8 TICABLE.—For information under para9 graphs (4) and (6) of subsection (e), the Ad10 ministrator shall notify the person that sub11 mitted the information that the information 

12 has been disclosed as soon as practicable 

13 after disclosure of the information. 

14 ‘‘(iii) NO NOTIFICATION REQUIRED.— 

15 Notification shall not be required— 

16 ‘‘(I) for the disclosure of informa17 tion under paragraph (1), (2), (7), or 

18 (9) of subsection (e); or 

19 ‘‘(II) for the disclosure of informa20 tion for which— 

21 ‘‘(aa) a notice under sub22 section (f)(1)(C)(i) was received; 

23 and 

24 ‘‘(bb) no request was received 

25 by the Administrator on or before 
139 

† HR 2576 EAS 

1 the date of expiration of the pe2 riod for which protection from 

3 disclosure applies. 

4 ‘‘(3) REBUTTABLE PRESUMPTION.— 

5 ‘‘(A) IN GENERAL.—With respect to notifi6 cations provided by the Administrator under 

7 paragraph (2) with respect to information per8 taining to a chemical substance subject to a rule 

9 as described in subsection (c)(3), there shall be a 

10 rebuttable presumption that the public interest 

11 in disclosing confidential information related to 

12 a chemical substance subject to a rule promul13 gated under section 6(d) that establishes a ban or 

14 phase-out of the manufacture, processing, or dis15 tribution in commerce of the substance outweighs 

16 the proprietary interest in maintaining the pro17 tection from disclosure of that information. 

18 ‘‘(B) REQUEST FOR NONDISCLOSURE.—A 

19 person that receives a notification under para20 graph (2) with respect to the information de21 scribed in subparagraph (A) may submit to the 

22 Administrator, before the date on which the in23 formation is to be released pursuant to para24 graph (2)(B), a request with supporting docu25 mentation describing why the person believes 
140 

† HR 2576 EAS 

1 some or all of that information should not be dis2 closed. 

3 ‘‘(C) DETERMINATION BY ADMINIS4 TRATOR.— 

5 ‘‘(i) IN GENERAL.—Not later than 30 

6 days after the Administrator receives a re7 quest under subparagraph (B), the Admin8 istrator shall determine whether the docu9 mentation provided by the person making 

10 the request rebuts or does not rebut the pre11 sumption described in subparagraph (A), 

12 for all or a portion of the information that 

13 the person has requested not be disclosed. 

14 ‘‘(ii) OBJECTIVE.—The Administrator 

15 shall make the determination with the objec16 tive of ensuring that information relevant to 

17 protection of health and the environment is 

18 disclosed to the maximum extent prac19 ticable. 

20 ‘‘(D) TIMING.—Not later than 30 days after 

21 making the determination described in subpara22 graph (C), the Administrator shall make public 

23 the information the Administrator has deter24 mined is not to be protected from disclosure. 
141 

† HR 2576 EAS 

1 ‘‘(E) NO TIMELY REQUEST RECEIVED.—If 

2 the Administrator does not receive, before the 

3 date on which the information described in sub4 paragraph (A) is to be released pursuant to 

5 paragraph (2)(B), a request pursuant to sub6 paragraph (B), the Administrator shall prompt7 ly make public all of the information. 

8 ‘‘(4) APPEALS.— 

9 ‘‘(A) IN GENERAL.—If a person receives a 

10 notification under paragraph (2) and believes 

11 disclosure of the information is prohibited under 

12 subsection (a), before the date on which the infor13 mation is to be released pursuant to paragraph 

14 (2)(B), the person may bring an action to re15 strain disclosure of the information in— 

16 ‘‘(i) the United States district court of 

17 the district in which the complainant re18 sides or has the principal place of business; 

19 or 

20 ‘‘(ii) the United States District Court 

21 for the District of Columbia. 

22 ‘‘(B) NO DISCLOSURE.—The Administrator 

23 shall not disclose any information that is the 

24 subject of an appeal under this section before the 
142 

† HR 2576 EAS 

1 date on which the applicable court rules on an 

2 action under subparagraph (A). 

3 ‘‘(5) REQUEST AND NOTIFICATION SYSTEM.—The 

4 Administrator, in consultation with the Director of 

5 the Centers for Disease Control and Prevention, shall 

6 develop a request and notification system that allows 

7 for expedient and swift access to information disclosed 

8 pursuant to paragraphs (5) and (6) of subsection (e) 

9 in a format and language that is readily accessible 

10 and understandable. 

11 ‘‘(h) CRIMINAL PENALTY FOR WRONGFUL DISCLO12 SURE.— 

13 ‘‘(1) OFFICERS AND EMPLOYEES OF UNITED

14 STATES.— 

15 ‘‘(A) IN GENERAL.—Subject to paragraph 

16 (2), a current or former officer or employee of the 

17 United States described in subparagraph (B) 

18 shall be guilty of a misdemeanor and fined 

19 under title 18, United States Code, or impris20 oned for not more than 1 year, or both. 

21 ‘‘(B) DESCRIPTION.—A current or former 

22 officer or employee of the United States referred 

23 to in subparagraph (A) is a current or former 

24 officer or employee of the United States who— 
143 

† HR 2576 EAS 

1 ‘‘(i) by virtue of that employment or 

2 official position has obtained possession of, 

3 or has access to, material the disclosure of 

4 which is prohibited by subsection (a); and 

5 ‘‘(ii) knowing that disclosure of that 

6 material is prohibited by subsection (a), 

7 willfully discloses the material in any man8 ner to any person not entitled to receive 

9 that material. 

10 ‘‘(2) OTHER LAWS.—Section 1905 of title 18, 

11 United States Code, shall not apply with respect to 

12 the publishing, divulging, disclosure, making known 

13 of, or making available, information reported or oth14 erwise obtained under this Act. 

15 ‘‘(3) CONTRACTORS.—For purposes of this sub16 section, any contractor of the United States that is 

17 provided information in accordance with subsection 

18 (e)(2), including any employee of that contractor, 

19 shall be considered to be an employee of the United 

20 States. 

21 ‘‘(i) APPLICABILITY.— 

22 ‘‘(1) IN GENERAL.—Except as otherwise provided 

23 in this section, section 8, or any other applicable Fed24 eral law, the Administrator shall have no authority— 
144 

† HR 2576 EAS 

1 ‘‘(A) to require the substantiation or re2 substantiation of a claim for the protection from 

3 disclosure of information reported to or otherwise 

4 obtained by the Administrator under this Act be5 fore the date of enactment of the Frank R. Lau6 tenberg Chemical Safety for the 21st Century 

7 Act; or 

8 ‘‘(B) to impose substantiation or resubstan9 tiation requirements under this Act that are 

10 more extensive than those required under this 

11 section. 

12 ‘‘(2) ACTIONS PRIOR TO PROMULGATION OF

13 RULES.—Nothing in this Act prevents the Adminis14 trator from reviewing, requiring substantiation or re15 substantiation for, or approving, modifying or deny16 ing any claim for the protection from disclosure of in17 formation before the effective date of such rules appli18 cable to those claims as the Administrator may pro19 mulgate after the date of enactment of the Frank R. 

20 Lautenberg Chemical Safety for the 21st Century 

21 Act.’’. 

22 SEC. 15. PROHIBITED ACTS. 

23 Section 15 of the Toxic Substances Control Act (15 

24 U.S.C. 2614) is amended by striking paragraph (1) and 

25 inserting the following: 
145 

† HR 2576 EAS 

1 ‘‘(1) fail or refuse to comply with— 

2 ‘‘(A) any rule promulgated, consent agree3 ment entered into, or order issued under section 

4 4; 

5 ‘‘(B) any requirement under section 5 or 6; 

6 ‘‘(C) any rule promulgated, consent agree7 ment entered into, or order issued under section 

8 5 or 6; or 

9 ‘‘(D) any requirement of, or any rule pro10 mulgated or order issued pursuant to title II;’’. 

11 SEC. 16. PENALTIES. 

12 Section 16 of the Toxic Substances Control Act (15 

13 U.S.C. 2615) is amended— 

14 (1) in subsection (a)(1)— 

15 (A) in the first sentence, by striking 

16 ‘‘$25,000’’ and inserting ‘‘$37,500’’; and 

17 (B) in the second sentence, by striking‘‘ vio18 lation of section 15 or 409’’ and inserting ‘‘viola19 tion of this Act’’; and 

20 (2) in subsection (b)— 

21 (A) by striking ‘‘Any person who’’ and in22 serting the following: 

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

24 (B) by striking ‘‘$25,000’’ and inserting 

25 ‘‘$50,000’’; and 
146 

† HR 2576 EAS 

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

2 ‘‘(2) IMMINENT DANGER OF DEATH OR SERIOUS

3 BODILY INJURY.— 

4 ‘‘(A) IN GENERAL.—Any person that know5 ingly or willfully violates any provision of sec6 tion 15 or 409, and that knows at the time of 

7 the violation that the violation places an indi8 vidual in imminent danger of death or serious 

9 bodily injury, shall be subject on conviction to a 

10 fine of not more than $250,000, or imprisonment 

11 for not more than 15 years, or both. 

12 ‘‘(B) ORGANIZATIONS.—An organization 

13 that commits a violation described in subpara14 graph (A) shall be subject on conviction to a fine 

15 of not more than $1,000,000 for each violation. 

16 ‘‘(C) INCORPORATION OF CORRESPONDING

17 PROVISIONS.—Subparagraphs (B) through (F) of 

18 section 113(c)(5) of the Clean Air Act (42 U.S.C. 

19 7413(c)(5)) shall apply to the prosecution of a 

20 violation under this paragraph.’’. 

21 SEC. 17. STATE-FEDERAL RELATIONSHIP. 

22 Section 18 of the Toxic Substances Control Act (15 

23 U.S.C. 2617) is amended by striking subsections (a) and 

24 (b) and inserting the following: 

25 ‘‘(a) IN GENERAL.— 
147 

† HR 2576 EAS 

1 ‘‘(1) ESTABLISHMENT OR ENFORCEMENT.—Ex2 cept as provided in subsections (c), (d), (e), (f), and 

3 (g), and subject to paragraph (2), no State or polit4 ical subdivision of a State may establish or continue 

5 to enforce any of the following: 

6 ‘‘(A) TESTING.—A statute or administrative 

7 action to require the development of information 

8 on a chemical substance or category of substances 

9 that is reasonably likely to produce the same in10 formation required under section 4, 5, or 6 in— 

11 ‘‘(i) a rule promulgated by the Admin12 istrator; 

13 ‘‘(ii) a testing consent agreement en14 tered into by the Administrator; or 

15 ‘‘(iii) an order issued by the Adminis16 trator. 

17 ‘‘(B) CHEMICAL SUBSTANCES FOUND TO

18 MEET THE SAFETY STANDARD OR RE19 STRICTED.—A statute or administrative action 

20 to prohibit or otherwise restrict the manufacture, 

21 processing, or distribution in commerce or use of 

22 a chemical substance— 

23 ‘‘(i) found to meet the safety standard 

24 and consistent with the scope of the deter25 mination made under section 6; or 
148 

† HR 2576 EAS 

1 ‘‘(ii) found not to meet the safety 

2 standard, after the effective date of the rule 

3 issued under section 6(d) for the substance, 

4 consistent with the scope of the determina5 tion made by the Administrator. 

6 ‘‘(C) SIGNIFICANT NEW USE.—A statute or 

7 administrative action requiring the notification 

8 of a use of a chemical substance that the Admin9 istrator has specified as a significant new use 

10 and for which the Administrator has required 

11 notification pursuant to a rule promulgated 

12 under section 5. 

13 ‘‘(2) EFFECTIVE DATE OF PREEMPTION.—Under 

14 this subsection, Federal preemption of statutes and 

15 administrative actions applicable to specific sub16 stances shall not occur until the effective date of the 

17 applicable action described in paragraph (1) taken by 

18 the Administrator. 

19 ‘‘(b) NEW STATUTES OR ADMINISTRATIVE ACTIONS

20 CREATING PROHIBITIONS OR OTHER RESTRICTIONS.— 

21 ‘‘(1) IN GENERAL.—Except as provided in sub22 sections (c), (d), (e), (f), and (g), beginning on the 

23 date on which the Administrator defines and pub24 lishes the scope of a safety assessment and safety de25 termination under section 6(a)(2) and ending on the 
149 

† HR 2576 EAS 

1 date on which the deadline established pursuant to 

2 section 6(a) for completion of the safety determination 

3 expires, or on the date on which the Administrator 

4 publishes the safety determination under section 6(a), 

5 whichever is earlier, no State or political subdivision 

6 of a State may establish a statute or administrative 

7 action prohibiting or restricting the manufacture, 

8 processing, distribution in commerce or use of a 

9 chemical substance that is a high-priority substance 

10 designated under section 4A. 

11 ‘‘(2) EFFECT OF SUBSECTION.— 

12 ‘‘(A) IN GENERAL.—This subsection does 

13 not restrict the authority of a State or political 

14 subdivision of a State to continue to enforce any 

15 statute enacted, or administrative action taken, 

16 prior to the date on which the Administrator de17 fines and publishes the scope of a safety assess18 ment and safety determination under section 

19 6(a)(2). 

20 ‘‘(B) LIMITATION.—Subparagraph (A) does 

21 not allow a State or political subdivision of a 

22 State to enforce any new prohibition or restric23 tion under a statute or administrative action de24 scribed in that subparagraph, if the prohibition 
150 

† HR 2576 EAS 

1 or restriction is established after the date de2 scribed in that subparagraph. 

3 ‘‘(c) SCOPE OF PREEMPTION.—Federal preemption 

4 under subsections (a) and (b) of statutes and administrative 

5 actions applicable to specific substances shall apply only 

6 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 hazards, exposures, risks, and uses or 

11 conditions of use of such substances that are identified 

12 by the Administrator as subject to review in a safety 

13 assessment and included in the scope of the safety de14 termination made by the Administrator for the sub15 stance, or of any rule the Administrator promulgates 

16 pursuant to section 6(d); 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 STATUTES AND ADMIN23 ISTRATIVE ACTIONS.— 

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

25 nor any amendment made by this Act, nor any 
151 

† HR 2576 EAS 

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 
152 

† HR 2576 EAS 

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 a law of a 

19 State or political subdivision of a State in 

20 the event of noncompliance with the iden21 tical requirement shall be no more stringent 

22 than the penalties and other sanctions 

23 available to the Administrator under section 

24 16 of this Act. 
153 

† HR 2576 EAS 

1 ‘‘(ii) PENALTIES.—In the case of an 

2 identical requirement— 

3 ‘‘(I) a State or political subdivi4 sion of a State may not assess a pen5 alty for a specific violation for which 

6 the Administrator has assessed an ade7 quate penalty under section 16; and 

8 ‘‘(II) if a State or political sub9 division of a State has assessed a pen10 alty for a specific violation, the Ad11 ministrator may not assess a penalty 

12 for that violation in an amount that 

13 would cause the total of the penalties 

14 assessed for the violation by the State 

15 or political subdivision of a State and 

16 the Administrator combined to exceed 

17 the maximum amount that may be as18 sessed for that violation by the Admin19 istrator under section 16. 

20 ‘‘(2) APPLICABILITY TO CERTAIN RULES OR OR21 DERS.—Notwithstanding subsection (e)— 

22 ‘‘(A) nothing in this section shall be con23 strued as modifying the effect under this section, 

24 as in effect on the day before the effective date of 

25 the Frank R. Lautenberg Chemical Safety for the 
154 

† HR 2576 EAS 

1 21st Century Act, of any rule or order promul2 gated or issued under this Act prior to that effec3 tive date; and 

4 ‘‘(B) with respect to a chemical substance or 

5 mixture for which any rule or order was promul6 gated or issued under section 6 prior to the effec7 tive date of the Frank R. Lautenberg Chemical 

8 Safety for the 21st Century Act with regards to 

9 manufacturing, processing, distribution in com10 merce, use, or disposal of a chemical substance, 

11 this section (as in effect on the day before the ef12 fective date of the Frank R. Lautenberg Chemical 

13 Safety for the 21st Century Act) shall govern the 

14 preemptive effect of any rule or order that is pro15 mulgated or issued respecting such chemical sub16 stance or mixture under section 6 of this Act 

17 after that effective date, unless the latter rule or 

18 order is with respect to a chemical substance or 

19 mixture containing a chemical substance and fol20 lows a designation of that chemical substance as 

21 a high-priority substance under subsection (b) or 

22 (c) of section 4A or as an additional priority for 

23 safety assessment and safety determination 

24 under section 4A(c). 

25 ‘‘(e) PRESERVATION OF CERTAIN LAWS.— 
155 

† HR 2576 EAS 

1 ‘‘(1) IN GENERAL.—Nothing in this Act, subject 

2 to subsection (g) of this section, shall— 

3 ‘‘(A) be construed to preempt or otherwise 

4 affect the authority of a State or political sub5 division of a State to continue to enforce any ac6 tion taken before August 1, 2015, under the au7 thority of a law of the State or political subdivi8 sion of the State that prohibits or otherwise re9 stricts manufacturing, processing, distribution in 

10 commerce, use, or disposal of a chemical sub11 stance; or 

12 ‘‘(B) be construed to preempt or otherwise 

13 affect any action taken pursuant to a State law 

14 that was in effect on August 31, 2003. 

15 ‘‘(2) EFFECT OF SUBSECTION.—This subsection 

16 does not affect, modify, or alter the relationship be17 tween Federal law and laws of a State or political 

18 subdivision of a State pursuant to any other Federal 

19 law. 

20 ‘‘(f) WAIVERS.— 

21 ‘‘(1) DISCRETIONARY EXEMPTIONS.—Upon ap22 plication of a State or political subdivision of a 

23 State, the Administrator may by rule, exempt from 

24 subsection (a), under such conditions as may be pre25 scribed in the rule, a statute or administrative action 
156 

† HR 2576 EAS 

1 of that State or political subdivision of the State that 

2 relates to the effects of, or exposure to, a chemical sub3 stance under the conditions of use if the Adminis4 trator determines that— 

5 ‘‘(A) compelling conditions warrant grant6 ing the waiver to protect health or the environ7 ment; 

8 ‘‘(B) compliance with the proposed require9 ment of the State or political subdivision of the 

10 State would not unduly burden interstate com11 merce in the manufacture, processing, distribu12 tion in commerce, or use of a chemical substance; 

13 ‘‘(C) compliance with the proposed require14 ment of the State or political subdivision of the 

15 State would not cause a violation of any appli16 cable Federal law, rule, or order; and 

17 ‘‘(D) in the judgment of the Administrator, 

18 the proposed requirement of the State or political 

19 subdivision of the State is designed to address a 

20 risk of a chemical substance, under the condi21 tions of use, that was identified— 

22 ‘‘(i) consistent with the best available 

23 science; 
157 

† HR 2576 EAS 

1 ‘‘(ii) using supporting studies con2 ducted in accordance with sound and objec3 tive scientific practices; and 

4 ‘‘(iii) based on the weight of the sci5 entific evidence. 

6 ‘‘(2) REQUIRED EXEMPTIONS.—Upon applica7 tion of a State or political subdivision of a State, the 

8 Administrator shall exempt from subsection (b) a 

9 statute or administrative action of a State or polit10 ical subdivision of a State that relates to the effects 

11 of exposure to a chemical substance under the condi12 tions of use if the Administrator determines that— 

13 ‘‘(A) compliance with the proposed require14 ment of the State or political subdivision of the 

15 State would not unduly burden interstate com16 merce in the manufacture, processing, distribu17 tion in commerce, or use of a chemical substance; 

18 ‘‘(B) compliance with the proposed require19 ment of the State or political subdivision of the 

20 State would not cause a violation of any appli21 cable Federal law, rule, or order; and 

22 ‘‘(C) the State or political subdivision of the 

23 State has a concern about the chemical substance 

24 or use of the chemical substance based in peer25 reviewed science. 
158 

† HR 2576 EAS 

1 ‘‘(3) DETERMINATION OF A WAIVER REQUEST.— 

2 The duty of the Administrator to grant or deny a 

3 waiver application shall be nondelegable and shall be 

4 exercised— 

5 ‘‘(A) not later than 180 days after the date 

6 on which an application under paragraph (1) is 

7 submitted; and 

8 ‘‘(B) not later than 110 days after the date 

9 on which an application under paragraph (2) is 

10 submitted. 

11 ‘‘(4) FAILURE TO MAKE DETERMINATION.—If the 

12 Administrator fails to make a determination under 

13 paragraph (3)(B) during the 110-day period begin14 ning on the date on which an application under 

15 paragraph (2) is submitted, the statute or adminis16 trative action of the State or political subdivision of 

17 the State that was the subject of the application shall 

18 not be considered to be an existing statute or admin19 istrative action for purposes of subsection (b) by rea20 son of the failure of the Administrator to make a de21 termination. 

22 ‘‘(5) NOTICE AND COMMENT.—Except in the case 

23 of an application approved under paragraph (9), the 

24 application of a State or political subdivision of a 

25 State shall be subject to public notice and comment. 
159 

† HR 2576 EAS 

1 ‘‘(6) FINAL AGENCY ACTION.—The decision of the 

2 Administrator on the application of a State or polit3 ical subdivision of a State shall be— 

4 ‘‘(A) considered to be a final agency action; 

5 and 

6 ‘‘(B) subject to judicial review. 

7 ‘‘(7) DURATION OF WAIVERS.—A waiver granted 

8 under paragraph (2) or approved under paragraph 

9 (9) shall remain in effect until such time as the Ad10 ministrator publishes the safety determination under 

11 section 6(a)(4). 

12 ‘‘(8) JUDICIAL REVIEW OF WAIVERS.—Not later 

13 than 60 days after the date on which the Adminis14 trator makes a determination on an application of a 

15 State or political subdivision of a State under para16 graph (1) or (2), any person may file a petition for 

17 judicial review in the United States Court of Appeals 

18 for the District of Columbia Circuit, which shall have 

19 exclusive jurisdiction over the determination. 

20 ‘‘(9) APPROVAL.— 

21 ‘‘(A) AUTOMATIC APPROVAL.—If the Admin22 istrator fails to meet the deadline established 

23 under paragraph (3)(B), the application of a 

24 State or political subdivision of a State under 

25 paragraph (2) shall be automatically approved, 
160 

† HR 2576 EAS 

1 effective on the date that is 10 days after the 

2 deadline. 

3 ‘‘(B) REQUIREMENTS.—Notwithstanding 

4 paragraph (6), approval of a waiver application 

5 under subparagraph (A) for failure to meet the 

6 deadline under paragraph (3)(B) shall not be 

7 considered final agency action or be subject to ju8 dicial review or public notice and comment. 

9 ‘‘(g) SAVINGS.— 

10 ‘‘(1) NO PREEMPTION OF COMMON LAW OR STAT11 UTORY CAUSES OF ACTION FOR CIVIL RELIEF OR

12 CRIMINAL CONDUCT.— 

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

14 nor any amendment made by this Act, nor any 

15 safety standard, rule, requirement, standard of 

16 performance, safety determination, or scientific 

17 assessment implemented pursuant to this Act, 

18 shall be construed to preempt, displace, or sup19 plant any state or Federal common law rights or 

20 any state or Federal statute creating a remedy 

21 for civil relief, including those for civil damage, 

22 or a penalty for a criminal conduct. 

23 ‘‘(B) CLARIFICATION OF NO PREEMPTION.— 

24 Notwithstanding any other provision of this Act, 

25 nothing in this Act, nor any amendments made 
161 

† HR 2576 EAS 

1 by this Act, shall preempt or preclude any cause 

2 of action for personal injury, wrongful death, 

3 property damage, or other injury based on neg4 ligence, strict liability, products liability, failure 

5 to warn, or any other legal theory of liability 

6 under any State law, maritime law, or Federal 

7 common law or statutory theory. 

8 ‘‘(2) NO EFFECT ON PRIVATE REMEDIES.— 

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

10 nor any amendments made by this Act, nor any 

11 rules, regulations, requirements, safety assess12 ments, safety determinations, scientific assess13 ments, or orders issued pursuant to this Act shall 

14 be interpreted as, in either the plaintiff’s or de15 fendant’s favor, dispositive in any civil action. 

16 ‘‘(B) AUTHORITY OF COURTS.—This Act 

17 does not affect the authority of any court to 

18 make a determination in an adjudicatory pro19 ceeding under applicable State or Federal law 

20 with respect to the admission into evidence or 

21 any other use of this Act or rules, regulations, re22 quirements, standards of performance, safety as23 sessments, scientific assessments, or orders issued 

24 pursuant to this Act.’’. 
162 

† HR 2576 EAS 

1 SEC. 18. JUDICIAL REVIEW. 

2 Section 19 of the Toxic Substances Control Act (15 

3 U.S.C. 2618) is amended— 

4 (1) in subsection (a)— 

5 (A) in paragraph (1)— 

6 (i) in subparagraph (A)— 

7 (I) in the first sentence— 

8 (aa) by striking ‘‘Not’’ and 

9 inserting ‘‘Except as otherwise 

10 provided in this title, not’’; 

11 (bb) by striking ‘‘section 

12 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), 

13 or 8, or under title II or IV’’ and 

14 inserting ‘‘this title or title II or 

15 IV, or an order under section 

16 6(c)(1)(A)’’; and 

17 (cc) by striking ‘‘judicial re18 view of such rule’’ and inserting 

19 ‘‘judicial review of such rule or 

20 order’’; and 

21 (II) in the second sentence, by 

22 striking ‘‘such a rule’’ and inserting 

23 ‘‘such a rule or order’’; and 

24 (ii) in subparagraph (B)— 
163 

† HR 2576 EAS 

1 (I) by striking ‘‘Courts’’ and in2 serting ‘‘Except as otherwise provided 

3 in this title, courts’’; and 

4 (II) by striking ‘‘an order issued 

5 under subparagraph (A) or (B) of sec6 tion 6(b)(1)’’ and inserting ‘‘an order 

7 issued under this title’’; 

8 (B) in paragraph (2), in the second sen9 tence, by striking ‘‘the filing of the rulemaking 

10 record of proceedings on which the Administrator 

11 based the rule being reviewed’’ and inserting ‘‘the 

12 filing of the record of proceedings on which the 

13 Administrator based the rule or order being re14 viewed’’; and 

15 (C) by striking paragraph (3) and inserting 

16 the following: 

17 ‘‘(3) JUDICIAL REVIEW OF LOW-PRIORITY DECI18 SIONS.— 

19 ‘‘(A) IN GENERAL.—Not later than 60 days 

20 after the publication of a designation under sec21 tion 4A(b)(4), or a designation under section 

22 4A(b)(8) of a chemical substance as a low-pri23 ority substance, any person may commence a 

24 civil action to challenge the designation. 
164 

† HR 2576 EAS 

1 ‘‘(B) JURISDICTION.—The United States 

2 Court of Appeals for the District of Columbia 

3 Circuit shall have exclusive jurisdiction over a 

4 civil action filed under this paragraph.’’; 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 6(d), or 6(g), or an order under section 

10 6(c)(1)(A)’’; and 

11 (ii) by striking ‘‘evidence in the rule12 making record (as defined in subsection 

13 (a)(3)) taken as a whole;’’ and inserting 

14 ‘‘evidence (including any matter) in the 

15 rulemaking record, taken as a whole; and’’; 

16 and 

17 (B) by striking clauses (ii) and (iii) and 

18 the matter following clause (iii) and inserting 

19 the following: 

20 ‘‘(ii) the court may not review the con21 tents and adequacy of any statement of 

22 basis and purpose required by section 

23 553(c) of title 5, United States Code, to be 

24 incorporated in the rule, except as part of 

25 the rulemaking record, taken as a whole.’’. 
165 

† HR 2576 EAS 

1 SEC. 19. CITIZENS’ CIVIL ACTIONS. 

2 Section 20 of the Toxic Substances Control Act (15 

3 U.S.C. 2619) is amended— 

4 (1) in subsection (a)(1), by striking ‘‘or order 

5 issued under section 5’’ and inserting ‘‘or order issued 

6 under section 4 or 5’’; and 

7 (2) in subsection (b)— 

8 (A) in paragraph (1)(B), by striking ‘‘or’’ 

9 at the end; 

10 (B) in paragraph (2), by striking the period 

11 at the end and inserting ‘‘, except that no prior 

12 notification shall be required in the case of a 

13 civil action brought to compel a decision by the 

14 Administrator pursuant to section 18(f)(3)(B); 

15 or’’; and 

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

17 ‘‘(3) in the case of a civil action brought to com18 pel a decision by the Administrator pursuant to sec19 tion 18(f)(3)(B), after the date that is 60 days after 

20 the deadline specified in section 18(f)(3)(B).’’. 

21 SEC. 20. CITIZENS’ PETITIONS. 

22 Section 21 of the Toxic Substances Control Act (15 

23 U.S.C. 2620) is amended— 

24 (1) in subsection (a), by striking ‘‘an order 

25 under section 5(e) or 6(b)(2)’’ and inserting ‘‘an 

26 order under section 4 or 5(d)’’; and 
166 

† HR 2576 EAS 

1 (2) in subsection (b)— 

2 (A) in paragraph (1), by striking ‘‘an order 

3 under section 5(e), 6(b)(1)(A), or 6(b)(1)(B)’’ 

4 and inserting ‘‘an order under section 4 or 

5 5(d)’’; and 

6 (B) in paragraph (4), by striking subpara7 graph (B) and inserting the following: 

8 ‘‘(B) DE NOVO PROCEEDING.— 

9 ‘‘(i) IN GENERAL.—In an action under 

10 subparagraph (A) to initiate a proceeding 

11 to issue a rule pursuant to section 4, 5, 6, 

12 or 8 or issue an order under section 4 or 

13 5(d), the petitioner shall be provided an op14 portunity to have the petition considered by 

15 the court in a de novo proceeding. 

16 ‘‘(ii) DEMONSTRATION.— 

17 ‘‘(I) IN GENERAL.—The court in a 

18 de novo proceeding under this subpara19 graph shall order the Administrator to 

20 initiate the action requested by the pe21 titioner if the petitioner demonstrates 

22 to the satisfaction of the court by a 

23 preponderance of the evidence that— 

24 ‘‘(aa) in the case of a peti25 tion to initiate a proceeding for 
167 

† HR 2576 EAS 

1 the issuance of a rule or order 

2 under section 4, the information 

3 is needed for a purpose identified 

4 in section 4(a); 

5 ‘‘(bb) in the case of a petition 

6 to issue an order under section 

7 5(d), the chemical substance is not 

8 likely to meet the safety standard; 

9 ‘‘(cc) in the case of a petition 

10 to initiate a proceeding for the 

11 issuance of a rule under section 

12 6(d), the chemical substance does 

13 not meet the safety standard; or 

14 ‘‘(dd) in the case of a peti15 tion to initiate a proceeding for 

16 the issuance of a rule under sec17 tion 8, there is a reasonable basis 

18 to conclude that the rule is nec19 essary to protect health or the en20 vironment or ensure that the 

21 chemical substance meets the safe22 ty standard. 

23 ‘‘(II) DEFERMENT.—The court in 

24 a de novo proceeding under this sub25 paragraph may permit the Adminis-
168 

† HR 2576 EAS 

1 trator to defer initiating the action re2 quested by the petitioner until such 

3 time as the court prescribes, if the 

4 court finds that— 

5 ‘‘(aa) the extent of the risk to 

6 health or the environment alleged 

7 by the petitioner is less than the 

8 extent of risks to health or the en9 vironment with respect to which 

10 the Administrator is taking action 

11 under this Act; and 

12 ‘‘(bb) there are insufficient 

13 resources available to the Admin14 istrator to take the action re15 quested by the petitioner.’’. 

16 SEC. 21. EMPLOYMENT EFFECTS. 

17 Section 24(b)(2)(B)(ii) of the Toxic Substances Control 

18 Act (15 U.S.C. 2623(b)(2)(B)(ii)) is amended by striking 

19 ‘‘section 6(c)(3),’’ and inserting ‘‘the applicable require20 ments of this Act;’’. 

21 SEC. 22. STUDIES. 

22 Section 25 of the Toxic Substances Control Act (15 

23 U.S.C. 2624) is repealed. 
169 

† HR 2576 EAS 

1 SEC. 23. ADMINISTRATION. 

2 Section 26 of the Toxic Substances Control Act (15 

3 U.S.C. 2625) is amended— 

4 (1) by striking subsection (b) and inserting the 

5 following: 

6 ‘‘(b) FEES.— 

7 ‘‘(1) IN GENERAL.—The Administrator shall es8 tablish, not later than 1 year after the date of enact9 ment of the Frank R. Lautenberg Chemical Safety for 

10 the 21st Century Act, by rule— 

11 ‘‘(A) the payment of 1 or more reasonable 

12 fees as a condition of submitting a notice or re13 questing an exemption under section 5; and 

14 ‘‘(B) the payment of 1 or more reasonable 

15 fees by a manufacturer or processor that— 

16 ‘‘(i) is required to submit a notice pur17 suant to the rule promulgated under section 

18 8(b)(4)(A)(i) identifying a chemical sub19 stance as active; 

20 ‘‘(ii) is required to submit a notice 

21 pursuant to section 8(b)(5)(B)(i) changing 

22 the status of a chemical substance from in23 active to active; 

24 ‘‘(iii) is required to report information 

25 pursuant to the rules promulgated under 

26 paragraph (1) or (4) of section 8(a); or 
170 

† HR 2576 EAS 

1 ‘‘(iv) manufactures or processes a 

2 chemical substance subject to a safety assess3 ment and safety determination pursuant to 

4 section 6. 

5 ‘‘(2) UTILIZATION AND COLLECTION OF FEES.— 

6 The Administrator shall— 

7 ‘‘(A) utilize the fees collected under para8 graph (1) only to defray costs associated with the 

9 actions of the Administrator— 

10 ‘‘(i) to collect, process, review, provide 

11 access to, and protect from disclosure (where 

12 appropriate) information on chemical sub13 stances under this Act; 

14 ‘‘(ii) to review notices and make deter15 minations for chemical substances under 

16 paragraphs (1) and (3) of section 5(d) and 

17 impose any necessary restrictions under sec18 tion 5(d)(4); 

19 ‘‘(iii) to make prioritization decisions 

20 under section 4A; 

21 ‘‘(iv) to conduct and complete safety 

22 assessments and determinations under sec23 tion 6; and 

24 ‘‘(v) to conduct any necessary rule25 making pursuant to section 6(d); 
171 

† HR 2576 EAS 

1 ‘‘(B) insofar as possible, collect the fees de2 scribed in paragraph (1) in advance of con3 ducting any fee-supported activity; 

4 ‘‘(C) deposit the fees in the Fund established 

5 by paragraph (4)(A); and 

6 ‘‘(D) insofar as possible, not collect excess 

7 fees or retain a significant amount of unused 

8 fees. 

9 ‘‘(3) AMOUNT AND ADJUSTMENT OF FEES; RE10 FUNDS.—In setting fees under this section, the Ad11 ministrator shall— 

12 ‘‘(A) prescribe lower fees for small business 

13 concerns, after consultation with the Adminis14 trator of the Small Business Administration; 

15 ‘‘(B) set the fees established under para16 graph (1) at levels such that the fees will, in ag17 gregate, provide a sustainable source of funds to 

18 annually defray— 

19 ‘‘(i) the lower of— 

20 ‘‘(I) 25 percent of the costs of con21 ducting the activities identified in 

22 paragraph (2)(A), other than the costs 

23 to conduct and complete safety assess24 ments and determinations under sec-
172 

† HR 2576 EAS 

1 tion 6 for chemical substances identi2 fied pursuant to section 4A(c); or 

3 ‘‘(II) $25,000,000 (subject to ad4 justment pursuant to subparagraph 

5 (F)); and 

6 ‘‘(ii) the full costs and the 50-percent 

7 portion of the costs of safety assessments 

8 and safety determinations specified in sub9 paragraph (D); 

10 ‘‘(C) reflect an appropriate balance in the 

11 assessment of fees between manufacturers and 

12 processors, and allow the payment of fees by con13 sortia of manufacturers or processors; 

14 ‘‘(D) notwithstanding subparagraph (B) 

15 and paragraph (4)(D)— 

16 ‘‘(i) for substances designated pursuant 

17 to section 4A(c)(1), establish the fee at a 

18 level sufficient to defray the full annual 

19 costs to the Administrator of conducting the 

20 safety assessment and safety determination 

21 under section 6; and 

22 ‘‘(ii) for substances designated pursu23 ant to section 4A(c)(3), establish the fee at 

24 a level sufficient to defray 50 percent of the 

25 annual costs to the Administrator of con-
173 

† HR 2576 EAS 

1 ducting the safety assessment and safety de2 termination under section 6; 

3 ‘‘(E) prior to the establishment or amend4 ment of any fees under paragraph (1), consult 

5 and meet with parties potentially subject to the 

6 fees or their representatives, subject to the condi7 tion that no obligation under the Federal Advi8 sory Committee Act (5 U.S.C. App.) or sub9 chapter III of chapter 5 of title 5, United States 

10 Code, is applicable with respect to such meetings; 

11 ‘‘(F) beginning with the fiscal year that is 

12 3 years after the date of enactment of the Frank 

13 R. Lautenberg Chemical Safety for the 21st Cen14 tury Act, and every 3 years thereafter, after con15 sultation with parties potentially subject to the 

16 fees and their representatives pursuant to sub17 paragraph (E), increase or decrease the fees es18 tablished under paragraph (1) as necessary to 

19 adjust for inflation and to ensure, based on the 

20 audit analysis required under paragraph (5)(B), 

21 that funds deposited in the Fund are sufficient 

22 to defray— 

23 ‘‘(i) approximately but not more than 

24 25 percent of the annual costs to conduct 

25 the activities identified in paragraph 
174 

† HR 2576 EAS 

1 (2)(A), other than the costs to conduct and 

2 complete safety assessments and determina3 tions under section 6 for chemical sub4 stances identified pursuant to section 4A(c); 

5 and 

6 ‘‘(ii) the full annual costs and the 50- 

7 percent portion of the annual costs of safety 

8 assessments and safety determinations spec9 ified in subparagraph (D); 

10 ‘‘(G) adjust fees established under para11 graph (1) as necessary to vary on account of dif12 fering circumstances, including reduced fees or 

13 waivers in appropriate circumstances, to reduce 

14 the burden on manufacturing or processing, re15 move barriers to innovation, or where the costs 

16 to the Administrator of collecting the fees exceed 

17 the fee revenue anticipated to be collected; and 

18 ‘‘(H) if a notice submitted under section 5 

19 is refused or subsequently withdrawn, refund the 

20 fee or a portion of the fee if no substantial work 

21 was performed on the notice. 

22 ‘‘(4) TSCA IMPLEMENTATION FUND.— 

23 ‘‘(A) ESTABLISHMENT.—There is estab24 lished in the Treasury of the United States a 

25 fund, to be known as the ‘TSCA Implementation 
175 

† HR 2576 EAS 

1 Fund’ (referred to in this subsection as the 

2 ‘Fund’), consisting of— 

3 ‘‘(i) such amounts as are deposited in 

4 the Fund under paragraph (2)(C); and 

5 ‘‘(ii) any interest earned on the invest6 ment of amounts in the Fund; and 

7 ‘‘(iii) any proceeds from the sale or re8 demption of investments held in the Fund. 

9 ‘‘(B) CREDITING AND AVAILABILITY OF

10 FEES.— 

11 ‘‘(i) IN GENERAL.—Fees authorized 

12 under this section shall be collected and 

13 available for obligation only to the extent 

14 and in the amount provided in advance in 

15 appropriations Acts, and shall be available 

16 without fiscal year limitation. 

17 ‘‘(ii) REQUIREMENTS.—Fees collected 

18 under this section shall not— 

19 ‘‘(I) be made available or obli20 gated for any purpose other than to de21 fray the costs of conducting the activi22 ties identified in paragraph (2)(A); 

23 ‘‘(II) otherwise be available for 

24 any purpose other than implementa25 tion of this Act; and 
176 

† HR 2576 EAS 

1 ‘‘(III) so long as amounts in the 

2 Fund remain available, be subject to 

3 restrictions on expenditures applicable 

4 to the Federal government as a whole. 

5 ‘‘(C) UNUSED FUNDS.—Amounts in the 

6 Fund not currently needed to carry out this sub7 section shall be— 

8 ‘‘(i) maintained readily available or 

9 on deposit; 

10 ‘‘(ii) invested in obligations of the 

11 United States or guaranteed by the United 

12 States; or 

13 ‘‘(iii) invested in obligations, partici14 pations, or other instruments that are law15 ful investments for fiduciary, trust, or pub16 lic funds. 

17 ‘‘(D) MINIMUM AMOUNT OF APPROPRIA18 TIONS.—Fees may not be assessed for a fiscal 

19 year under this section unless the amount of ap20 propriations for the Chemical Risk Review and 

21 Reduction program project of the Environmental 

22 Protection Agency for the fiscal year (excluding 

23 the amount of any fees appropriated for the fis24 cal year) are equal to or greater than the 
177 

† HR 2576 EAS 

1 amount of appropriations for that program 

2 project for fiscal year 2014. 

3 ‘‘(5) AUDITING.— 

4 ‘‘(A) FINANCIAL STATEMENTS OF AGEN5 CIES.—For the purpose of section 3515(c) of title 

6 31, United States Code, the Fund shall be con7 sidered 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 paragraph 

14 (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 to 

19 meet the requirements of sections 4, 4A, 5, 

20 6, 8, and 14, including the allocation of full 

21 time equivalent employees to each such sec22 tion or activity; and 

23 ‘‘(iv) the reasonableness of the alloca24 tion of the overhead associated with the con-
178 

† HR 2576 EAS 

1 duct of the activities described in paragraph 

2 (2)(A). 

3 ‘‘(C) INSPECTOR GENERAL.—The Inspector 

4 General of the Environmental Protection Agency 

5 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 of 

11 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 enactment 

15 of the Frank R. Lautenberg Chemical Safety for the 

16 21st Century Act, unless otherwise reauthorized or 

17 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 eliminates, 

23 modifies, or withdraws any rule promulgated, order issued, 

24 or exemption established pursuant to this Act before the date 
179 

† HR 2576 EAS 

1 of enactment of the Frank R. Lautenberg Chemical Safety 

2 for the 21st Century Act.’’. 

3 SEC. 24. DEVELOPMENT AND EVALUATION OF TEST METH4 ODS AND SUSTAINABLE CHEMISTRY. 

5 (a) IN GENERAL.—Section 27 of the Toxic Substances 

6 Control Act (15 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) NATIONAL COORDINATING ENTITY FOR SUSTAIN12 ABLE CHEMISTRY.— 

13 ‘‘(1) ESTABLISHMENT.—Not later than 180 days 

14 after the date of enactment of the Frank R. Lauten15 berg Chemical Safety for the 21st Century Act, the 

16 Director of the Office of Science and Technology Pol17 icy shall convene an entity under the National 

18 Science and Technology Council with the responsi19 bility to coordinate Federal programs and activities 

20 in support of sustainable chemistry, including, as ap21 propriate, at the National Science Foundation, the 

22 Department of Energy, the Department of Agri23 culture, the Environmental Protection Agency, the 

24 National Institute of Standards and Technology, the 
180 

† HR 2576 EAS 

1 Department of Defense, the National Institutes of 

2 Health, and other related Federal agencies. 

3 ‘‘(2) CHAIRMAN.—The entity described in para4 graph (1) shall be chaired by the Director of the Na5 tional Science Foundation and the Assistant Admin6 istrator for the Office of Research and Development of 

7 the Environmental Protection Agency, or their des8 ignees. 

9 ‘‘(3) DUTIES.— 

10 ‘‘(A) IN GENERAL.—The entity described in 

11 paragraph (1) shall— 

12 ‘‘(i) develop a working definition of 

13 sustainable chemistry, after seeking advice 

14 and input from stakeholders as described in 

15 clause (v); 

16 ‘‘(ii) oversee the planning, manage17 ment, and coordination of the Sustainable 

18 Chemistry Initiative described in subsection 

19 (d); 

20 ‘‘(iii) develop a national strategy for 

21 sustainable chemistry as described in sub22 section (f); 

23 ‘‘(iv) develop an implementation plan 

24 for sustainable chemistry as described in 

25 subsection (g); and 
181 

† HR 2576 EAS 

1 ‘‘(v) consult and coordinate with stake2 holders qualified to provide advice and in3 formation on the development of the initia4 tive, national strategy, and implementation 

5 plan for sustainable chemistry, at least once 

6 per year, to carry out activities that may 

7 include workshops, requests for information, 

8 and other efforts as necessary. 

9 ‘‘(B) STAKEHOLDERS.—The stakeholders de10 scribed in subparagraph (A)(v) shall include rep11 resentatives from— 

12 ‘‘(i) industry (including small- and 

13 medium-sized enterprises from across the 

14 value chain); 

15 ‘‘(ii) the scientific community (includ16 ing the National Academy of Sciences, sci17 entific professional societies, and academia); 

18 ‘‘(iii) the defense community; 

19 ‘‘(iv) State, tribal, and local govern20 ments; 

21 ‘‘(v) State or regional sustainable 

22 chemistry programs; 

23 ‘‘(vi) nongovernmental organizations; 

24 and 

25 ‘‘(vii) other appropriate organizations. 
182 

† HR 2576 EAS 

1 ‘‘(4) SUNSET.— 

2 ‘‘(A) IN GENERAL.—On completion of the 

3 national strategy and accompanying implemen4 tation plan for sustainable chemistry as de5 scribed in paragraph (3), the Director of the Of6 fice of Science and Technology Policy— 

7 ‘‘(i) shall review the need for further 

8 work; and 

9 ‘‘(ii) may disband the entity described 

10 in paragraph (1) if no further efforts are 

11 determined to be necessary. 

12 ‘‘(B) NOTICE AND JUSTIFICATION.—The Di13 rector of the Office of Science and Technology 

14 Policy shall provide notice and justification, in15 cluding an analysis of options to establish the 

16 Sustainable Chemistry Initiative described in 

17 subsection (d) and the partnerships described in 

18 subsection (e) within 1 or more appropriate Fed19 eral agencies, regarding a decision to disband the 

20 entity not less than 90 days prior to the termi21 nation date to the Committee on Science, Space, 

22 and Technology and the Committee on Energy 

23 and Commerce of the House of Representatives 

24 and the Committee on Environment and Public 
183 

† HR 2576 EAS 

1 Works and the Committee on Commerce, Science, 

2 and Transportation of the Senate. 

3 ‘‘(d) SUSTAINABLE CHEMISTRY INITIATIVE.—The enti4 ty described in subsection (c)(1) shall oversee the establish5 ment of an interagency Sustainable Chemistry Initiative 

6 to promote and coordinate activities designed— 

7 ‘‘(1) to provide sustained support for sustainable 

8 chemistry research, development, demonstration, tech9 nology transfer, commercialization, education, and 

10 training through— 

11 ‘‘(A) coordination and promotion of sus12 tainable chemistry research, development, dem13 onstration, and technology transfer conducted at 

14 Federal and national laboratories and Federal 

15 agencies and at public and private institutions 

16 of higher education; and 

17 ‘‘(B) to the extent practicable, encourage18 ment of consideration of sustainable chemistry 

19 in, as appropriate— 

20 ‘‘(i) the conduct of Federal, State, and 

21 private science and engineering research 

22 and development; and 

23 ‘‘(ii) the solicitation and evaluation of 

24 applicable proposals for science and engi25 neering research and development; 
184 

† HR 2576 EAS 

1 ‘‘(2) to examine methods by which the Federal 

2 Government can offer incentives for consideration and 

3 use of sustainable chemistry processes and products 

4 that encourage competition and overcoming market 

5 barriers, including grants, loans, loan guarantees, 

6 and innovative financing mechanisms; 

7 ‘‘(3) to expand the education and training of un8 dergraduate and graduate students and professional 

9 scientists and engineers, including through partner10 ships with industry as described in subsection (e), in 

11 sustainable chemistry science and engineering; 

12 ‘‘(4) to collect and disseminate information on 

13 sustainable chemistry research, development, and 

14 technology transfer, including information on— 

15 ‘‘(A) incentives and impediments to devel16 opment, manufacturing, and commercialization; 

17 ‘‘(B) accomplishments; 

18 ‘‘(C) best practices; and 

19 ‘‘(D) costs and benefits; and 

20 ‘‘(5) to support (including through technical as21 sistance, participation, financial support, or other 

22 forms of support) economic, legal, and other appro23 priate social science research to identify barriers to 

24 commercialization and methods to advance commer25 cialization of sustainable chemistry. 
185 

† HR 2576 EAS 

1 ‘‘(e) PARTNERSHIPS IN SUSTAINABLE CHEMISTRY.— 

2 ‘‘(1) IN GENERAL.—The entity described in sub3 section (c)(1), itself or through an appropriate sub4 group designated or established by the entity, shall 

5 work through the agencies described in subsection 

6 (c)(1) to support, through financial, technical, or 

7 other assistance, the establishment of partnerships be8 tween institutions of higher education, nongovern9 mental organizations, consortia, and companies 

10 across the value chain in the chemical industry, in11 cluding small- and medium-sized enterprises— 

12 ‘‘(A) to establish collaborative research, de13 velopment, demonstration, technology transfer, 

14 and commercialization programs; and 

15 ‘‘(B) to train students and retrain profes16 sional scientists and engineers in the use of sus17 tainable chemistry concepts and strategies by 

18 methods including— 

19 ‘‘(i) developing curricular materials 

20 and courses for undergraduate and graduate 

21 levels and for the professional development 

22 of scientists and engineers; and 

23 ‘‘(ii) publicizing the availability of 

24 professional development courses in sustain-
186 

† HR 2576 EAS 

1 able chemistry and recruiting scientists and 

2 engineers to pursue those courses. 

3 ‘‘(2) PRIVATE SECTOR ENTITIES.—To be eligible 

4 for support under this section, a partnership in sus5 tainable chemistry shall include at least 1 private sec6 tor entity. 

7 ‘‘(3) SELECTION OF PARTNERSHIPS.—In select8 ing partnerships for support under this section, the 

9 entity and the agencies described in subsection (c)(1) 

10 shall also consider the extent to which the applicants 

11 are willing and able to demonstrate evidence of sup12 port for, and commitment— 

13 ‘‘(A) to achieving the goals of the Sustain14 able Chemistry Initiative described in subsection 

15 (d); and 

16 ‘‘(B) to sustaining any new innovations, 

17 tools, and resources generated from funding 

18 under the program. 

19 ‘‘(4) PROHIBITED USE OF FUNDS.—Financial 

20 support provided under this section may not be 

21 used— 

22 ‘‘(A) to support or expand a regulatory 

23 chemical management program at an imple24 menting agency under a State law; or 
187 

† HR 2576 EAS 

1 ‘‘(B) to construct or renovate a building or 

2 structure. 

3 ‘‘(f) NATIONAL STRATEGY TO CONGRESS.— 

4 ‘‘(1) IN GENERAL.—Not later than 2 years after 

5 the date of enactment of the Frank R. Lautenberg 

6 Chemical Safety for the 21st Century Act, the entity 

7 described in subsection (c)(1) shall submit to the 

8 Committee on Science, Space, and Technology and the 

9 Committee on Energy and Commerce of the House of 

10 Representatives and the Committee on Environment 

11 and Public Works and the Committee on Commerce, 

12 Science, and Transportation of the Senate, a national 

13 strategy that shall include— 

14 ‘‘(A) a summary of federally funded sus15 tainable chemistry research, development, dem16 onstration, technology transfer, commercializa17 tion, education, and training activities; 

18 ‘‘(B) a summary of the financial resources 

19 allocated to sustainable chemistry initiatives; 

20 ‘‘(C) an analysis of the progress made to21 ward achieving the goals and priorities of the 

22 Sustainable Chemistry Initiative described in 

23 subsection (d), and recommendations for future 

24 initiative activities, including consideration of 

25 options to establish the Sustainable Chemistry 
188 

† HR 2576 EAS 

1 Initiative and the partnerships described in sub2 section (e) within 1 or more appropriate Federal 

3 agencies; 

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 establishment of 1 or more dedicated sustain9 able chemistry centers of excellence or hubs; 

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 Sustain15 able Chemistry Initiative; and 

16 ‘‘(F) a framework for advancing sustainable 

17 chemistry research, development, technology 

18 transfer, commercialization, and education and 

19 training. 

20 ‘‘(2) SUBMISSION TO GAO.—The entity described 

21 in subsection (c)(1) shall submit the national strategy 

22 described in paragraph (1) to the Government Ac23 countability Office for consideration in future Con24 gressional inquiries. 
189 

† HR 2576 EAS 

1 ‘‘(g) IMPLEMENTATION PLAN.—Not later than 3 years 

2 after the date of enactment of the Frank R. Lautenberg 

3 Chemical Safety for the 21st Century Act, the entity de4 scribed in subsection (c)(1) shall submit to the Committee 

5 on Science, Space, and Technology and the Committee on 

6 Energy and Commerce of the House of Representatives and 

7 the Committee on Environment and Public Works and the 

8 Committee on Commerce, Science, and Transportation of 

9 the Senate, an implementation plan, based on the findings 

10 of the national strategy and other assessments, as appro11 priate, for sustainable chemistry.’’. 

12 (b) SUSTAINABLE CHEMISTRY BASIC RESEARCH.— 

13 Subject to the availability of appropriated funds, the Direc14 tor of the National Science Foundation shall continue to 

15 carry out the Green Chemistry Basic Research program au16 thorized under section 509 of the National Science Founda17 tion Authorization Act of 2010 (42 U.S.C. 1862p–3). 

18 SEC. 25. STATE PROGRAMS. 

19 Section 28 of the Toxic Substances Control Act (15 

20 U.S.C. 2627) is amended— 

21 (1) in subsection (b)(1)— 

22 (A) in subparagraphs (A) through (D), by 

23 striking the comma at the end of each subpara24 graph and inserting a semicolon; and 
190 

† HR 2576 EAS 

1 (B) in subparagraph (E), by striking ‘‘, 

2 and’’ and inserting ‘‘; and’’; and 

3 (2) by striking subsections (c) and (d). 

4 SEC. 26. AUTHORIZATION OF APPROPRIATIONS. 

5 Section 29 of the Toxic Substances Control Act (15 

6 U.S.C. 2628) is repealed. 

7 SEC. 27. ANNUAL REPORT. 

8 Section 30 of the Toxic Substances Control Act (15 

9 U.S.C. 2629) is amended by striking paragraph (2) and 

10 inserting the following: 

11 ‘‘(2)(A) the number of notices received during 

12 each year under section 5; and 

13 ‘‘(B) the number of the notices described in sub14 paragraph (A) for chemical substances subject to a 

15 rule, testing consent agreement, or order under section 

16 4;’’. 

17 SEC. 28. EFFECTIVE DATE. 

18 Section 31 of the Toxic Substances Control Act (15 

19 U.S.C. 2601 note; Public Law 94–469) is amended— 

20 (1) by striking ‘‘Except as provided in section 

21 4(f), this’’ and inserting the following: 

22 ‘‘(a) IN GENERAL.—This’’; and 

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

24 ‘‘(b) RETROACTIVE APPLICABILITY.—Nothing in this 

25 Act shall be interpreted to apply retroactively to any State, 
191 

† HR 2576 EAS 

1 Federal, or maritime legal action commenced prior to the 

2 effective date of the Frank R. Lautenberg Chemical Safety 

3 for the 21st Century Act.’’. 

4 SEC. 29. ELEMENTAL MERCURY. 

5 (a) TEMPORARY GENERATOR ACCUMULATION.—Sec6 tion 5 of the Mercury Export Ban Act of 2008 (42 U.S.C. 

7 6939f) is amended— 

8 (1) in subsection (a)(2), by striking ‘‘2013’’ and 

9 inserting ‘‘2019’’; 

10 (2) in subsection (b)— 

11 (A) in paragraph (1)— 

12 (i) by redesignating subparagraphs 

13 (A), (B), and (C), as clauses (i), (ii), and 

14 (iii), respectively and indenting appro15 priately; 

16 (ii) in the first sentence, by striking 

17 ‘‘After consultation’’ and inserting the fol18 lowing: 

19 ‘‘(A) ASSESSMENT AND COLLECTION.—After 

20 consultation’’; 

21 (iii) in the second sentence, by striking 

22 ‘‘The amount of such fees’’ and inserting the 

23 following: 

24 ‘‘(B) AMOUNT.—The amount of the fees de25 scribed in subparagraph (A)’’; 
192 

† HR 2576 EAS 

1 (iv) in subparagraph (B) (as so des2 ignated)— 

3 (I) in clause (i) (as so redesig4 nated), by striking ‘‘publically avail5 able not later than October 1, 2012’’ 

6 and inserting ‘‘publicly available not 

7 later than October 1, 2018’’; 

8 (II) in clause (ii) (as so redesig9 nated), by striking ‘‘and’’; 

10 (III) in clause (iii) (as so redesig11 nated), by striking the period at the 

12 end and inserting ‘‘, subject to clause 

13 (iv); and’’; and 

14 (IV) by adding at the end the fol15 lowing: 

16 ‘‘(iv) for generators temporarily accu17 mulating elemental mercury in a facility 

18 subject to subparagraphs (B) and (D)(iv) of 

19 subsection (g)(2) if the facility designated 

20 in subsection (a) is not operational by Jan21 uary 1, 2019, shall be adjusted to subtract 

22 the cost of the temporary accumulation dur23 ing the period in which the facility des24 ignated under subsection (a) is not oper25 ational.’’; and 
193 

† HR 2576 EAS 

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

2 ‘‘(C) CONVEYANCE OF TITLE AND PERMIT3 TING.—If the facility designated in subsection 

4 (a) is not operational by January 1, 2020, the 

5 Secretary— 

6 ‘‘(i) shall immediately accept the con7 veyance of title to all elemental mercury 

8 that has accumulated in facilities in accord9 ance with subsection (g)(2)(D), before Janu10 ary 1, 2020, and deliver the accumulated 

11 mercury to the facility designated under 

12 subsection (a) on the date on which the fa13 cility becomes operational; 

14 ‘‘(ii) shall pay any applicable Federal 

15 permitting costs, including the costs for per16 mits issued under section 3005(c) of the 

17 Solid Waste Disposal Act (42 U.S.C. 

18 6925(c)); and 

19 ‘‘(iii) shall store, or pay the cost of 

20 storage of, until the time at which a facility 

21 designated in subsection (a) is operational, 

22 accumulated mercury to which the Sec23 retary has title under this subparagraph in 

24 a facility that has been issued a permit 
194 

† HR 2576 EAS 

1 under section 3005(c) of the Solid Waste 

2 Disposal Act (42 U.S.C. 6925(c)).’’; and 

3 (B) in paragraph (2), in the first sentence, 

4 by striking ‘‘paragraph (1)(C)’’ and inserting 

5 ‘‘paragraph (1)(B)(iii)’’; and 

6 (3) in subsection (g)(2)— 

7 (A) in the undesignated material at the end, 

8 by striking ‘‘This subparagraph’’ and inserting 

9 the following: 

10 ‘‘(C) Subparagraph (B)’’; 

11 (B) in subparagraph (C) (as added by 

12 paragraph (1)), by inserting ‘‘of that subpara13 graph’’ before the period at the end; and 

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

15 ‘‘(D) A generator producing elemental mer16 cury incidentally from the beneficiation or proc17 essing of ore or related pollution control activi18 ties, may accumulate the mercury produced on19 site that is destined for a facility designated by 

20 the Secretary under subsection (a), for more than 

21 90 days without a permit issued under section 

22 3005(c) of the Solid Waste Disposal Act (42 

23 U.S.C. 6925(c)), and shall not be subject to the 

24 storage prohibition of section 3004(j) of that Act 

25 (42 U.S.C. 6924(j)), if— 
195 

† HR 2576 EAS 

1 ‘‘(i) the Secretary is unable to accept 

2 the mercury at a facility designated by the 

3 Secretary under subsection (a) for reasons 

4 beyond the control of the generator; 

5 ‘‘(ii) the generator certifies in writing 

6 to the Secretary that the generator will ship 

7 the mercury to a designated facility when 

8 the Secretary is able to accept the mercury; 

9 ‘‘(iii) the generator certifies in writing 

10 to the Secretary that the generator is stor11 ing only mercury the generator has pro12 duced or recovered onsite and will not sell, 

13 or otherwise place into commerce, the mer14 cury; and 

15 ‘‘(iv) the generator has obtained an 

16 identification number under section 262.12 

17 of title 40, Code of Federal Regulations, and 

18 complies with the requirements described in 

19 paragraphs (1) through (4) of section 

20 262.34(a) of title 40, Code of Federal Regu21 lations (as in effect on the date of enactment 

22 of this subparagraph). 

23 ‘‘(E) MANAGEMENT STANDARDS FOR TEM24 PORARY STORAGE.—Not later than January 1, 

25 2017, the Secretary, after consultation with the 
196 

† HR 2576 EAS 

1 Administrator of the Environmental Protection 

2 Agency and State agencies in affected States, 

3 shall develop and make available guidance that 

4 establishes procedures and standards for the 

5 management and short-term storage of elemental 

6 mercury at a generator covered under subpara7 graph (D), including requirements to ensure ap8 propriate use of flasks or other suitable con9 tainers. Such procedures and standards shall be 

10 protective of human health and the environment 

11 and shall ensure that the elemental mercury is 

12 stored in a safe, secure, and effective manner. A 

13 generator may accumulate mercury in accord14 ance with subparagraph (D) immediately upon 

15 enactment of this Act, and notwithstanding that 

16 guidance called for by this paragraph (E) has 

17 not been developed or made available.’’. 

18 (b) INTERIM STATUS.—Section 5(d)(1) of the Mercury 

19 Export Ban Act of 2008 (42 U.S.C. 6939f(d)(1)) is amend20 ed— 

21 (1) in the fourth sentence, by striking ‘‘in exist22 ence on or before January 1, 2013,’’; and 

23 (2) in the last sentence, by striking ‘‘January 1, 

24 2015’’ and inserting ‘‘January 1, 2020’’. 
197 

† HR 2576 EAS 

1 (c) MERCURY INVENTORY.—Section 8(b) of the Toxic 

2 Substances Control Act (15 U.S.C. 2607(b)) (as amended 

3 by section 10(2)) is amended by adding at the end the fol4 lowing: 

5 ‘‘(10) MERCURY.— 

6 ‘‘(A) DEFINITION OF MERCURY.—In this 

7 paragraph, notwithstanding section 3(2)(B), the 

8 term ‘mercury’ means— 

9 ‘‘(i) elemental mercury; and 

10 ‘‘(ii) a mercury compound. 

11 ‘‘(B) PUBLICATION.—Not later than April 

12 1, 2017, and every 3 years thereafter, the Admin13 istrator shall publish in the Federal Register an 

14 inventory of mercury supply, use, and trade in 

15 the United States. 

16 ‘‘(C) PROCESS.—In carrying out the inven17 tory under subparagraph (B), the Administrator 

18 shall— 

19 ‘‘(i) identify any remaining manufac20 turing processes or products that inten21 tionally add mercury; and 

22 ‘‘(ii) recommend actions, including 

23 proposed revisions of Federal law (including 

24 regulations), to achieve further reductions 

25 in mercury use. 
198 

† HR 2576 EAS 

1 ‘‘(D) REPORTING.— 

2 ‘‘(i) IN GENERAL.—To assist in the 

3 preparation of the inventory under sub4 paragraph (B), any person who manufac5 tures mercury or mercury-added products or 

6 otherwise intentionally uses mercury in a 

7 manufacturing process shall make periodic 

8 reports to the Administrator, at such time 

9 and including such information as the Ad10 ministrator shall determine by rule promul11 gated not later than 2 years after the date 

12 of enactment of this paragraph. 

13 ‘‘(ii) COORDINATION.—To avoid dupli14 cation, the Administrator shall coordinate 

15 the reporting under this subparagraph with 

16 the Interstate Mercury Education and Re17 duction Clearinghouse. 

18 ‘‘(iii) EXEMPTION.—This subpara19 graph shall not apply to a person engaged 

20 in the generation, handling, or management 

21 of mercury-containing waste, unless that 

22 person manufactures or recovers mercury in 

23 the management of that waste.’’. 

24 (d) PROHIBITION ON EXPORT OF CERTAIN MERCURY

25 COMPOUNDS.—Section 12(c) of the Toxic Substances Con-
199 

† HR 2576 EAS 

1 trol Act (15 U.S.C. 2611(c)) (as amended by section 13(3)) 

2 is amended— 

3 (1) in the subsection heading, by inserting ‘‘AND

4 MERCURY COMPOUNDS’’ after ‘‘MERCURY’’; and 

5 (2) by inserting after paragraph (2) the fol6 lowing: 

7 ‘‘(3) PROHIBITION ON EXPORT OF CERTAIN MER8 CURY COMPOUNDS.— 

9 ‘‘(A) IN GENERAL.—Effective January 1, 

10 2020, the export of the following mercury com11 pounds is prohibited: 

12 ‘‘(i) Mercury (I) chloride or calomel. 

13 ‘‘(ii) Mercury (II) oxide. 

14 ‘‘(iii) Mercury (II) sulfate. 

15 ‘‘(iv) Mercury (II) nitrate. 

16 ‘‘(v) Cinnabar or mercury sulphide. 

17 ‘‘(vi) Any mercury compound that the 

18 Administrator, at the discretion of the Ad19 ministrator, adds to the list by rule, on de20 termining that exporting that mercury com21 pound for the purpose of regenerating ele22 mental mercury is technically feasible. 

23 ‘‘(B) PUBLICATION.—Not later than 90 

24 days after the date of enactment of the Frank R. 

25 Lautenberg Chemical Safety for the 21st Century 
200 

† HR 2576 EAS 

1 Act, and as appropriate thereafter, the Adminis2 trator shall publish in the Federal Register a list 

3 of the mercury compounds that are prohibited 

4 from export under this paragraph. 

5 ‘‘(C) PETITION.—Any person may petition 

6 the Administrator to add to the list of mercury 

7 compounds prohibited from export. 

8 ‘‘(D) ENVIRONMENTALLY SOUND DIS9 POSAL.—This paragraph does not prohibit the 

10 export of mercury (I) chloride or calomel for en11 vironmentally sound disposal to member coun12 tries of the Organization for Economic Coopera13 tion and Development, on the condition that no 

14 mercury or mercury compounds are to be recov15 ered, recycled, or reclaimed for use, or directly 

16 reused. 

17 ‘‘(E) REPORT.—Not later than 5 years after 

18 the date of enactment of the Frank R. Lauten19 berg Chemical Safety for the 21st Century Act, 

20 the Administrator shall evaluate any exports of 

21 calomel for disposal that occurred since that date 

22 of enactment and shall submit to Congress a re23 port that contains the following: 

24 ‘‘(i) volumes and sources of calomel ex25 ported for disposal; 
201 

† HR 2576 EAS 

1 ‘‘(ii) receiving countries of such ex2 ports; 

3 ‘‘(iii) methods of disposal used; 

4 ‘‘(iv) issues, if any, presented by the 

5 export of calomel; 

6 ‘‘(v) evaluation of calomel management 

7 options in the United States, if any, that 

8 are commercially available and comparable 

9 in cost and efficacy to methods being uti10 lized in the receiving countries; and 

11 ‘‘(vi) a recommendation regarding 

12 whether Congress should further limit or 

13 prohibit the export of calomel for disposal. 

14 ‘‘(F) EFFECT ON OTHER LAW.—Nothing in 

15 this paragraph shall be construed to affect the 

16 authority of the Administrator under Solid 

17 Waste Disposal Act (42 U.S.C. 6901 et seq.).’’. 

18 SEC. 30. TREVOR’S LAW. 

19 (a) PURPOSES.—The purposes of this section are— 

20 (1) to provide the appropriate Federal agencies 

21 with the authority to help conduct investigations into 

22 potential cancer clusters; 

23 (2) to ensure that Federal agencies have the au24 thority to undertake actions to help address cancer 
202 

† HR 2576 EAS 

1 clusters and factors that may contribute to the cre2 ation of potential cancer clusters; and 

3 (3) to enable Federal agencies to coordinate with 

4 other Federal, State, and local agencies, institutes of 

5 higher education, and the public in investigating and 

6 addressing cancer clusters. 

7 (b) DESIGNATION AND INVESTIGATION OF POTENTIAL

8 CANCER CLUSTERS.—Part P of title III of the Public 

9 Health Service Act (42 U.S.C. 280g et seq.) is amended by 

10 adding at the end the following: 

11 ‘‘SEC. 399V–6. DESIGNATION AND INVESTIGATION OF PO12 TENTIAL CANCER CLUSTERS. 

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

14 ‘‘(1) CANCER CLUSTER.—The term ‘cancer clus15 ter’ means the incidence of a particular cancer within 

16 a population group, a geographical area, or a period 

17 of time that is greater than expected for such group, 

18 area, or period. 

19 ‘‘(2) PARTICULAR CANCER.—The term ‘par20 ticular cancer’ means one specific type of cancer or 

21 a type of cancers scientifically proven to have the 

22 same cause. 

23 ‘‘(3) POPULATION GROUP.—The term ‘population 

24 group’ means a group, for purposes of calculating 
203 

† HR 2576 EAS 

1 cancer rates, defined by factors such as race, eth2 nicity, age, or gender. 

3 ‘‘(b) CRITERIA FOR DESIGNATION OF POTENTIAL CAN4 CER CLUSTERS.— 

5 ‘‘(1) DEVELOPMENT OF CRITERIA.—The Sec6 retary shall develop criteria for the designation of po7 tential cancer clusters. 

8 ‘‘(2) REQUIREMENTS.—The criteria developed 

9 under paragraph (1) shall consider, as appropriate— 

10 ‘‘(A) a standard for cancer cluster identi11 fication and reporting protocols used to deter12 mine when cancer incidence is greater than 

13 would be typically observed; 

14 ‘‘(B) scientific screening standards that en15 sure that a cluster of a particular cancer in16 volves the same type of cancer, or types of can17 cers; 

18 ‘‘(C) the population in which the cluster of 

19 a particular cancer occurs by factors such as 

20 race, ethnicity, age, and gender, for purposes of 

21 calculating cancer rates; 

22 ‘‘(D) the boundaries of a geographic area in 

23 which a cluster of a particular cancer occurs so 

24 as not to create or obscure a potential cluster by 

25 selection of a specific area; and 
204 

† HR 2576 EAS 

1 ‘‘(E) the time period over which the number 

2 of cases of a particular cancer, or the calculation 

3 of an expected number of cases, occurs. 

4 ‘‘(c) GUIDELINES FOR INVESTIGATION OF POTENTIAL

5 CANCER CLUSTERS.—The Secretary, in consultation with 

6 the Council of State and Territorial Epidemiologists and 

7 representatives of State and local health departments, shall 

8 develop, publish, and periodically update guidelines for in9 vestigating potential cancer clusters. The guidelines shall— 

10 ‘‘(1) require that investigations of cancer clus11 ters— 

12 ‘‘(A) use the criteria developed under sub13 section (b); 

14 ‘‘(B) use the best available science; and 

15 ‘‘(C) rely on a weight of the scientific evi16 dence; 

17 ‘‘(2) provide standardized methods of reviewing 

18 and categorizing data, including from health surveil19 lance systems and reports of potential cancer clusters; 

20 and 

21 ‘‘(3) provide guidance for using appropriate epi22 demiological and other approaches for investigations. 

23 ‘‘(d) INVESTIGATION OF CANCER CLUSTERS.— 

24 ‘‘(1) SECRETARY DISCRETION.—The Secretary— 
205 

† HR 2576 EAS 

1 ‘‘(A) in consultation with representatives of 

2 the relevant State and local health departments, 

3 shall consider whether it is appropriate to con4 duct an investigation of a potential cancer clus5 ter; and 

6 ‘‘(B) in conducting investigations shall have 

7 the discretion to prioritize certain potential can8 cer clusters, based on the availability of re9 sources. 

10 ‘‘(2) COORDINATION.—In investigating potential 

11 cancer clusters, the Secretary shall coordinate with 

12 agencies within the Department of Health and 

13 Human Services and other Federal agencies, such as 

14 the Environmental Protection Agency. 

15 ‘‘(3) BIOMONITORING.—In investigating poten16 tial cancer clusters, the Secretary shall rely on all ap17 propriate biomonitoring information collected under 

18 other Federal programs, such as the National Health 

19 and Nutrition Examination Survey. The Secretary 

20 may provide technical assistance for relevant biomon21 itoring studies of other Federal agencies. 

22 ‘‘(e) DUTIES.—The Secretary shall— 

23 ‘‘(1) ensure that appropriate staff of agencies 

24 within the Department of Health and Human Serv25 ices are prepared to provide timely assistance, to the 
206 

† HR 2576 EAS 

1 extent practicable, upon receiving a request to inves2 tigate a potential cancer cluster from a State or local 

3 health authority; 

4 ‘‘(2) maintain staff expertise in epidemiology, 

5 toxicology, data analysis, environmental health and 

6 cancer surveillance, exposure assessment, pediatric 

7 health, pollution control, community outreach, health 

8 education, laboratory sampling and analysis, spatial 

9 mapping, and informatics; 

10 ‘‘(3) consult with community members as inves11 tigations into potential cancer clusters are conducted, 

12 as the Secretary determines appropriate; 

13 ‘‘(4) collect, store, and disseminate reports on in14 vestigations of potential cancer clusters, the possible 

15 causes of such clusters, and the actions taken to ad16 dress such clusters; and 

17 ‘‘(5) provide technical assistance for inves18 tigating cancer clusters to State and local health de19 partments through existing programs, such as the 

20 Epi-Aids program of the Centers for Disease Control 

21 and Prevention and the Assessments of Chemical Ex-
207 

† HR 2576 EAS 

1 posures program of the Agency for Toxic Substances 

2 and Disease Registry.’’. 

Attest: 

Secretary. 
114TH CONGRESS 

1ST SESSION H.R. 2576 

AMENDMENT