II 

114TH CONGRESS 

1ST SESSION S. 725 

To amend the Toxic Substances Control Act, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MARCH 12, 2015 

Mrs. BOXER (for herself, Mr. MARKEY, and Mr. SANDERS) introduced the following bill; which was read twice and referred to the Committee on Environment and Public Works 

A BILL 

To amend the Toxic Substances Control Act, and for other 

purposes. 

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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Alan Reinstein and Trevor Schaefer Toxic Chemical Pro6 tection Act’’. 

7 (b) TABLE OF CONTENTS.—The table of contents for 

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. References. 

TITLE I—AMENDMENTS TO THE TOXIC SUBSTANCES CONTROL 

ACT 


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Sec. 101. Findings, policy, and intent. 

Sec. 102. Definitions. 

Sec. 103. Policies, procedures and guidance. 

Sec. 104. Testing of chemical substances or mixtures. 

Sec. 105. Prioritization screening. 

Sec. 106. New chemicals and significant new uses. 

Sec. 107. Safety assessments and determinations. 

Sec. 108. Imminent hazards. 

Sec. 109. Information collection and reporting. 

Sec. 110. Relationship to other Federal laws. 

Sec. 111. Research, development, collection, dissemination, and utilization of 

data. 

Sec. 112. Exports. 

Sec. 113. Imports. 

Sec. 114. Confidential information. 

Sec. 115. Prohibited acts. 

Sec. 116. Penalties. 

Sec. 117. Preemption. 

Sec. 118. Judicial review. 

Sec. 119. Citizens’ petitions. 

Sec. 120. Studies. 

Sec. 121. Administration. 

Sec. 122. Development and evaluation of test methods. 

Sec. 123. State programs. 

Sec. 124. Authorization of appropriations. 

Sec. 125. Annual report. 

TITLE II—STRENGTHENING PROTECTIONS FOR CHILDREN AND 

COMMUNITIES FROM DISEASE CLUSTERS 

Sec. 201. Purposes. 

Sec. 202. Definitions. 

Sec. 203. Guidelines for environmental investigations of disease clusters. 

Sec. 204. Enhanced support for environmental investigations of disease clusters. 

Sec. 205. Federal reports to Congress. 

Sec. 206. Authorization of appropriations. 

Sec. 207. Effect on other law. 

TITLE III—COMMUNITY DISEASE CLUSTER TECHNICAL 

ASSISTANCE GRANTS 

Sec. 301. Community disease cluster technical assistance grants. 

Sec. 302. Authorization of appropriations. 

1 SEC. 2. REFERENCES. 

2 Except as otherwise expressly provided, wherever in 

3 this Act an amendment or repeal is expressed in terms 

4 of an amendment to, or repeal of, a section or other provi5 sion, the reference shall be considered to be made to a 


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1 section or other provision of the Toxic Substances Control 

2 Act (15 U.S.C. 2601 et seq.). 

3 TITLE I—AMENDMENTS TO THE 

4 TOXIC SUBSTANCES CON5 TROL ACT 

6 SEC. 101. FINDINGS, POLICY, AND INTENT. 

7 Section 2(a) (15 U.S.C. 2601(a)) is amended— 

8 (1) In paragraph (2)— 

9 (A) by striking ‘‘injury’’ and inserting 

10 ‘‘harm’’; and 

11 (B) by striking ‘‘and’’ at the end; 

12 (2) by redesignating paragraph (3) as para13 graph (6); and 

14 (3) by inserting after paragraph (2) the fol15 lowing: 

16 ‘‘(3) reform of this Act shall be administered to 

17 protect the health of children, pregnant women, the 

18 elderly, workers, consumers, the general public and 

19 the environment from the risks of harmful exposures 

20 to chemical substances and mixtures; 

21 ‘‘(4) reform of this Act shall not displace or 

22 supplant common law rights of action or remedies 

23 for civil relief; 

24 ‘‘(5) reform of this Act shall be administered to 

25 ensure that appropriate information on chemical 


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1 substances and mixtures should be available to pub2 lic health officials and first responders in the event 

3 of an emergency; and’’. 

4 SEC. 102. DEFINITIONS. 

5 Section 3 (15 U.S.C. 2602) is amended— 

6 (1) by redesignating paragraphs (7), (8), (9), 

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

8 (10), (11), (13), (14), (19), (20), and (21), respec9 tively; 

10 (2) by inserting after paragraph (6) the fol11 lowing: 

12 ‘‘(7) INFORMATION.—Except in section 14, the 

13 term ‘information’ means any qualitative, quan14 titative or descriptive facts, data, analysis or assess15 ment related to chemical hazards, use, or exposure 

16 (including the nature and extent of exposure to a 

17 chemical substance), including from health and safe18 ty studies. 

19 ‘‘(8) INTENDED OR REASONABLY FORESEEABLE

20 CONDITIONS OF USE.—The term ‘intended or rea21 sonably foreseeable conditions of use’ means the cir22 cumstances under which a chemical substance is in23 tended, reasonably known, or reasonably anticipated 

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1 ronment, including reasonably foreseeable but unin2 tended exposure conditions from unplanned releases 

3 into the environment.’’; 

4 (3) by inserting after paragraph 11 (as so re5 designated) the following: 

6 ‘‘(12) POTENTIALLY EXPOSED OR SUSCEPTIBLE

7 POPULATION.—The term ‘potentially exposed or sus8 ceptible population’ means a group or groups of in9 dividuals within the general population who may 

10 be— 

11 ‘‘(A) differentially exposed to chemical sub12 stances under the intended or reasonably fore13 seeable conditions of use; or 

14 ‘‘(B) more susceptible to adverse health 

15 consequences from chemical exposures than the 

16 general population, which when identified by 

17 the Administrator may include such groups as 

18 infants, children, pregnant women, workers, 

19 and the elderly.’’; and 

20 (4) by inserting after paragraph (14) (as so re21 designated) the following: 

22 ‘‘(15) PUBLICLY AVAILABLE INFORMATION.— 

23 The term ‘publicly available information’ means in24 formation that is generally accessible and available 

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1 ing information that has been published in periodi2 cals, books, print, or electronic or other media avail3 able for general distribution to any member of the 

4 public. 

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

6 assessment’ means an assessment of the risk posed 

7 by a chemical substance under the intended or rea8 sonably foreseeable conditions of use, integrating 

9 hazard, use, and exposure information about the 

10 chemical substance. 

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

12 ‘safety determination’ means a determination by the 

13 Administrator as to whether a chemical substance 

14 meets the safety standard under the intended or rea15 sonably foreseeable conditions of use. 

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

17 standard’ means a standard that ensures with rea18 sonable certainty, without taking into consideration 

19 cost or other non-risk factors, that no harm to 

20 human health or the environment will result from 

21 exposure to a chemical substance under the intended 

22 or reasonably foreseeable conditions of use, including 

23 no harm to the general population or to any poten24 tially exposed or susceptible subpopulation that the 

25 Administrator has identified as relevant to the safety 


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1 assessment and determination for a chemical sub2 stance.’’. 

3 SEC. 103. POLICIES, PROCEDURES AND GUIDANCE. 

4 The Toxic Substances Control Act (15 U.S.C. 2601 

5 et seq.) is amended by adding after section 3 the following: 

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

7 ‘‘(a) DEADLINE.—Not later than 2 years after the 

8 date of enactment of the Alan Reinstein and Trevor 

9 Schaefer Toxic Chemical Protection Act, the Adminis10 trator shall, after providing an opportunity for public no11 tice and comment, develop the policies, procedures and 

12 guidance required by this section. As used in this section, 

13 the term ‘guidance’ includes any significant written guid14 ance of general applicability prepared by the Adminis15 trator. 

16 ‘‘(b) USE OF SCIENCE.—In establishing any policies, 

17 procedures, and guidance, on the use of science in making 

18 decisions under this section and sections 4, 4A, 5, and 

19 6, the Administrator shall have the goal of making the 

20 basis of decisions clear to the public. The policies, proce21 dures and any guidance issued under this subsection shall 

22 describe how the Administrator will ensure that— 

23 ‘‘(1) decisions by the Administrator— 

24 ‘‘(A) are based on the best available 

25 science; and 


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1 ‘‘(B) take into account the extent to 

2 which— 

3 ‘‘(i) assumptions and methods used to 

4 develop information considered by the Ad5 ministrator are clearly and completely de6 scribed and documented; 

7 ‘‘(ii) variability and uncertainty in 

8 such information are evaluated and charac9 terized; and 

10 ‘‘(iii) the information has been subject 

11 to independent peer review; 

12 ‘‘(2) to the extent practicable and where appro13 priate, the use of peer review, standardized test de14 sign and methods, consistent data evaluation proce15 dures, and appropriate laboratory practices will be 

16 encouraged; 

17 ‘‘(3) the names of the organizations or individ18 uals funding the generation and assessment of infor19 mation and the degree of control they had over the 

20 generation, assessment, and dissemination of infor21 mation (including control over the design of the 

22 work and the publication of information) will be 

23 made clear; and 

24 ‘‘(4) decisions by the Administrator follow the 

25 applicable recommendations in relevant National 


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1 Academy of Sciences reports, including the reports 

2 titled: Science and Decisions: Advancing Risk As3 sessment, Phthalates and Cumulative Risk Assess4 ment: The Task Ahead, Review of EPA’s Integrated 

5 Risk Information System (IRIS) Process, Review of 

6 the Formaldehyde Assessment in the National Toxi7 cology Program 12th Report on Carcinogens, and 

8 Review of the Styrene Assessment in the National 

9 Toxicology Program 12th Report on Carcinogens. 

10 ‘‘(c) EXISTING EPA POLICIES, PROCEDURES AND

11 GUIDANCE.—The policies, procedures, and guidance de12 scribed in subsections (a) and (b) shall incorporate, as ap13 propriate, existing relevant hazard, exposure, and risk as14 sessment guidelines and methodologies, data evaluation 

15 and quality criteria, testing methodologies and other rel16 evant guidelines and policies previously issued by the Ad17 ministrator. 

18 ‘‘(d) REVIEW.—Not less than 5 years after the date 

19 of enactment of this Act, and not less frequently than 

20 every 5 years thereafter, the Administrator shall— 

21 ‘‘(1) review the adequacy of any policies, proce22 dures, and guidance developed under this section, in23 cluding procedures for assessing and determining 

24 risk under this Act; and 


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1 ‘‘(2) after providing an opportunity for public 

2 notice and comment, revise the policies, procedures, 

3 and guidance if necessary to reflect new scientific 

4 developments or understandings. 

5 ‘‘(e) SOURCES OF INFORMATION.—In making any de6 cision with respect to a chemical substance under sections 

7 4, 4A, 5, and 6, the Administrator shall consider informa8 tion on the hazards and exposures of a chemical substance 

9 under the intended or reasonably foreseeable conditions of 

10 use that is reasonably available to the Administrator, in11 cluding information that is— 

12 ‘‘(1) submitted to the Administrator pursuant 

13 to any rule, consent agreement, order, or other re14 quirement of this Act, or on a voluntary basis (in15 cluding pursuant to any request made under this 

16 Act) by— 

17 ‘‘(A) manufacturers and processors of a 

18 substance; 

19 ‘‘(B) the public; 

20 ‘‘(C) other Federal agencies and depart21 ments; or 

22 ‘‘(D) a Governor of a State or a State 

23 agency with responsibility for protecting health 

24 or the environment; 


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1 ‘‘(2) submitted to a governmental body in any 

2 jurisdiction under a governmental requirement relat3 ing to the protection of human health and the envi4 ronment; or 

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

6 Administrator of information sources that are pub7 licly available or otherwise accessible by the Admin8 istrator. 

9 ‘‘(f) TESTING OF CHEMICAL SUBSTANCES AND MIX10 TURES.— 

11 ‘‘(1) IN GENERAL.—The Administrator shall es12 tablish policies and procedures for the testing of 

13 chemical substances or mixtures under section 4. A 

14 goal of the policies and procedures shall be to make 

15 the basis of decisions clear to the public. 

16 ‘‘(2) CONTENTS.—The policies and procedures 

17 established under paragraph (1) shall— 

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

19 level or exposure potential of a chemical sub20 stance would factor into decisions to require 

21 new testing, provided that the Administrator 

22 shall not interpret the lack of exposure informa23 tion as a lack of exposure or exposure potential 

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1 posure potential shall not, by itself, be a reason 

2 not to require testing; 

3 ‘‘(B) describe how the Administrator will 

4 determine that additional testing is needed to 

5 carry out this Act, including testing related to 

6 potentially exposed or susceptible populations 

7 and testing related to the accumulation of 

8 chemical substances in the human body; 

9 ‘‘(C) require the Administrator to consult 

10 with the Director of the National Institute for 

11 Occupational Safety and Health prior to pre12 scribing epidemiologic studies of employees; and 

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

14 testing using mammals, require the Adminis15 trator to consider, as appropriate and to the ex16 tent practicable, reasonably available— 

17 ‘‘(i) toxicity information; 

18 ‘‘(ii) computational toxicology and 

19 bioinformatics; 

20 ‘‘(iii) high-throughput screening meth21 ods and their prediction models; and 

22 ‘‘(iv) scientifically reliable and rel23 evant alternatives to tests on mammals 

24 that would provide equivalent information. 


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1 ‘‘(3) TIERED TESTING.—Except as provided in 

2 subparagraph (C), the Administrator shall employ a 

3 tiered screening and testing process, in which the re4 sults of screening level tests or assessments of avail5 able information inform the decision as to whether 

6 1 or more additional tests are necessary. 

7 ‘‘(A) SCREENING LEVEL.—The screening 

8 level tests required for a chemical substance or 

9 mixture may include tests for hazard (which 

10 may include in silico, in vitro, and in vivo tests), 

11 environmental and biological fate and transport, 

12 and measurements or modeling of exposure, as 

13 appropriate. Screening level tests shall be 

14 used— 

15 ‘‘(i) to screen chemical substances or 

16 mixtures for potential adverse effects; and 

17 ‘‘(ii) to inform the decision of the Ad18 ministrator whether additional testing is 

19 necessary. 

20 ‘‘(B) ADDITIONAL TESTING.—If the Ad21 ministrator determines under subparagraph (A) 

22 that additional testing is necessary to provide 

23 more definitive information for prioritization or 

24 safety assessments and safety determinations, 

25 the Administrator may require more advanced 


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1 tests for potential human health or environ2 mental effects or exposure. 

3 ‘‘(C) ADVANCED TESTING WITHOUT

4 SCREENING.—The Administrator may require 

5 more advanced testing without conducting 

6 screening-level testing when other information 

7 available to the Administrator justifies the ad8 vanced test, pursuant to policies or procedures 

9 developed by the Administrator under this sub10 section. 

11 ‘‘(g) SAFETY ASSESSMENTS AND SAFETY DETER12 MINATIONS.— 

13 ‘‘(1) SCHEDULE.—The Administrator shall in14 form the public regarding the schedule for the com15 pletion of each safety assessment and safety deter16 mination as soon as possible after designation as a 

17 high priority substance pursuant to section 4A. The 

18 time allotted may be different for different chemi19 cals, provided that all schedules shall comply with 

20 the deadlines established under section 6. 

21 ‘‘(2) POLICIES AND PROCEDURES FOR SAFETY

22 ASSESSMENTS AND SAFETY DETERMINATIONS.—The 

23 Administrator shall establish policies and procedures 

24 on how the Administrator shall carry out section 6. 

25 A goal of the policies and procedures shall be to 


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1 make the basis of decisions clear to the public. At 

2 a minimum, the policies and procedures shall— 

3 ‘‘(A) describe— 

4 ‘‘(i) how the Administrator will iden5 tify informational needs and seek such in6 formation from the public; 

7 ‘‘(ii) what information (including 

8 draft safety assessments) may be sub9 mitted by interested persons, including 

10 States; and 

11 ‘‘(iii) the criteria by which that infor12 mation will be evaluated; 

13 ‘‘(B) require the Administrator, in each 

14 safety assessment and safety determination, 

15 to— 

16 ‘‘(i) identify the substance’s intended 

17 or reasonably foreseeable conditions of use 

18 based on information provided by its man19 ufacturers and processors or otherwise 

20 available to the Administrator; 

21 ‘‘(ii) identify all potentially exposed or 

22 susceptible populations that the Adminis23 trator determines are pertinent to the sub24 stance; 


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1 ‘‘(iii) identify the hazards of the sub2 stance and its metabolites and breakdown 

3 products and any differences in the mag4 nitude or nature of these hazards for po5 tentially exposed or susceptible popu6 lations, including the potential for chemical 

7 substances to accumulate in the human 

8 body; 

9 ‘‘(iv) determine the nature and extent 

10 of exposures to the chemical substance by 

11 the general population and each potentially 

12 exposed or susceptible population, includ13 ing aggregate exposures resulting from 

14 multiple pathways or routes of exposure; 

15 ‘‘(v) to the extent practicable, review 

16 and incorporate any available scientific in17 formation on the cumulative effects of ex18 posure to the chemical substance and other 

19 chemical substances posing similar hazards 

20 to human health and the environment; and 

21 ‘‘(vi) characterize the nature and ex22 tent of the risk presented by the chemical 

23 substance, taking into account aggregate 

24 exposures resulting from multiple pathways 

25 or routes of exposure and the cumulative 


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1 effects of exposure to the chemical sub2 stance and other chemicals posing similar 

3 hazards; and 

4 ‘‘(C) establish a timely and transparent 

5 process for evaluating whether new information 

6 submitted or obtained after the date of a final 

7 safety assessment or safety determination war8 rants reconsideration of the assessment or de9 termination. 

10 ‘‘(h) RELEASE OF SAFETY ASSESSMENTS.—Subject 

11 to section 14, the Administrator shall— 

12 ‘‘(1) make available to the public a nontechnical 

13 summary and the final version of each safety assess14 ment and safety determination; 

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

16 for comment on each proposed safety assessment 

17 and safety determination; and 

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

19 and safety determination the list of studies consid20 ered by the Administrator in carrying out the safety 

21 assessment and safety determination, as well as the 

22 list of policies and procedures that were followed in 

23 carrying out the safety assessment and safety deter24 mination. 


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

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

4 the date of enactment of the Alan Reinstein and 

5 Trevor Schaefer Toxic Chemical Protection Act, the 

6 Administrator shall establish a Science Advisory 

7 Committee on Chemicals (referred to in this sub8 section as the ‘Committee’) to provide independent 

9 advice and expert consultation, upon the request of 

10 the Administrator, with respect to the scientific and 

11 technical aspects of issues relating to the implemen12 tation of this title. 

13 ‘‘(2) COMPOSITION OF COMMITTEE.—The Com14 mittee shall be composed of representatives of such 

15 science, government, labor, public health, public in16 terest, industry, and other groups as the Adminis17 trator deems advisable, including, at a minimum, 

18 representatives that have specific scientific expertise 

19 in the relationship of chemical exposures to women, 

20 children, and other potentially exposed or susceptible 

21 populations. 

22 ‘‘(3) MEETINGS.—The Administrator shall con23 vene the Committee on a schedule the Administrator 

24 determines appropriate, but not less frequently than 

25 once every 2 years. 


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1 ‘‘(4) FEDERAL ADVISORY COMMITTEE ACT.—All 

2 proceedings and meetings of the Committee shall be 

3 subject to the Federal Advisory Committee Act (5 

4 U.S.C. App.). 

5 ‘‘(5) CONFLICT OF INTEREST POLICIES.—The 

6 Administrator shall establish and make public con7 flict of interest policies that shall apply to the Com8 mittee members, who shall be appointed as Special 

9 Government Employees. 

10 ‘‘(j) NATIONAL ACADEMY OF SCIENCES REPORTS.— 

11 Not later than 120 days after the issuance of any report 

12 by the National Academy of Sciences concerning hazards, 

13 exposures, or risks of chemical substances, the Adminis14 trator shall issue a public response to the principal rec15 ommendations of the report.’’. 

16 SEC. 104. TESTING OF CHEMICAL SUBSTANCES OR MIX17 TURES. 

18 (a) IN GENERAL.—Section 4 (15 U.S.C. 2603) is 

19 amended— 

20 (1) by striking subsection (g) and redesignating 

21 subsections (e) and subsection (f) as subsections (f) 

22 and (g), respectively; 

23 (2) in subsection (f) (as so redesignated)— 


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1 (A) by striking ‘‘rule’’ each place it ap2 pears and inserting ‘‘rule, testing consent 

3 agreement, or order’’; 

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

5 each place it appears and inserting ‘‘under this 

6 subsection’’; and 

7 (C) in paragraph (1)(B), by striking ‘‘rule8 making’’; 

9 (3) in subsection (g) (as so redesignated)— 

10 (A) by striking ‘‘from cancer, gene 

11 mutations, or birth defects’’; 

12 (B) by striking ‘‘unreasonable’’ each place 

13 it appears and inserting ‘‘significant’’; and 

14 (C) by striking the last sentence; and 

15 (4) by striking subsections (a) through (d) and 

16 inserting the following: 

17 ‘‘(a) DEVELOPMENT OF NEW INFORMATION ON

18 CHEMICAL SUBSTANCES AND MIXTURES.— 

19 ‘‘(1) IN GENERAL.—The Administrator may re20 quire the development of new information related to 

21 a chemical substance or mixture in accordance with 

22 this section if the Administration determines that 

23 the information is needed— 

24 ‘‘(A) to perform a safety assessment or 

25 make a safety determination under section 6; 


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1 ‘‘(B) to implement a requirement imposed 

2 in a consent agreement or order issued under 

3 section 5(c)(4); 

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

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

6 authority under any other Federal law. 

7 ‘‘(2) TESTING FOR PRIORITIZATION PUR8 POSES.—The Administrator may require the devel9 opment of new information for the purposes of sec10 tion 4A, provided that any such testing shall not be 

11 based on a set of uniform minimum information re12 quirements for all or large groups of chemical sub13 stances. Use of this authority shall be limited to 

14 cases where the Administrator determines additional 

15 information is needed to establish the priority of a 

16 chemical substance. 

17 ‘‘(3) FORM.—Subject to section 3A(f), the Ad18 ministrator may require the development of test data 

19 and information described in paragraph (1) or (2) 

20 by— 

21 ‘‘(A) promulgating a rule; 

22 ‘‘(B) entering into a testing consent agree23 ment; or 

24 ‘‘(C) issuing an order. 

25 ‘‘(4) CONTENTS.— 


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1 ‘‘(A) IN GENERAL.—A rule, testing con2 sent agreement, or order issued under this sub3 section shall include— 

4 ‘‘(i) identification of the chemical sub5 stance or mixture for which testing is re6 quired; 

7 ‘‘(ii) identification of the persons re8 quired to conduct the testing; 

9 ‘‘(iii) to the extent practicable, test 

10 protocols and methodologies for the devel11 opment of information for the chemical 

12 substance or mixture, including specific 

13 reference to reliable nonmammal test pro14 cedures; and 

15 ‘‘(iv) specification of the period within 

16 which persons required to conduct the test17 ing shall submit to the Administrator the 

18 information developed in accordance with 

19 the procedures described in clause (iii). 

20 ‘‘(B) DURATION.—The period described in 

21 subparagraph (A)(iv) shall not be of an unrea22 sonable duration. 

23 ‘‘(C) CONSIDERATIONS.—In determining 

24 the procedures and period to be required under 


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1 subparagraph (A), the Administrator shall con2 sider— 

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

4 test protocols and methodologies that may 

5 be required; and 

6 ‘‘(ii) the reasonably foreseeable avail7 ability of facilities and personnel needed to 

8 perform the testing. 

9 ‘‘(b) STATEMENT OF NEED.— 

10 ‘‘(1) IN GENERAL.—In promulgating a rule, en11 tering into a testing consent agreement, or issuing 

12 an order for development of additional information 

13 (including information on exposure or exposure po14 tential) under this section, the Administrator shall— 

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

16 by the rule, agreement, or order; 

17 ‘‘(B) explain why information reasonably 

18 available to the Administrator at that time is 

19 inadequate to meet that need, including a ref20 erence, as appropriate, to the information iden21 tified in paragraph (2)(B); and 

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

23 requires the use of mammals. 

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


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

2 issues an order under this section, the Adminis3 trator shall issue a statement providing a jus4 tification for issuance of an order instead of 

5 promulgating a rule or entering into a testing 

6 consent agreement. 

7 ‘‘(B) CONTENTS.—The statement de8 scribed in subparagraph (A) shall contain a dis9 cussion of— 

10 ‘‘(i) information that is readily acces11 sible to the Administrator, including infor12 mation submitted under any other provi13 sion of law; 

14 ‘‘(ii) the extent to which the Adminis15 trator has obtained or attempted to obtain 

16 the information through voluntary submis17 sions; and 

18 ‘‘(iii) any information relied on in 

19 safety assessments for other chemical sub20 stances relevant to the chemical substances 

21 that would be the subject of the order. 

22 ‘‘(c) REDUCTION OF TESTING ON MAMMALS.— 

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

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1 mals in testing of chemical substances or mixtures, 

2 by— 

3 ‘‘(A) encouraging and facilitating— 

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

5 testing and assessment strategies; 

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

7 in existence on the date on which the test 

8 is conducted; 

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

10 eliminate or reduce the use of mammals 

11 while providing information of high sci12 entific quality; 

13 ‘‘(iv) the grouping of 2 or more chem14 ical substances into scientifically appro15 priate categories in cases where testing of 

16 a chemical substance would provide reliable 

17 and useful information on others in the 

18 category; 

19 ‘‘(v) the formation of industry con20 sortia to jointly conduct testing to avoid 

21 unnecessary duplication of tests; and 

22 ‘‘(vi) the submission of information 

23 from animal-based studies and emerging 

24 methods and models; and 


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1 ‘‘(B) funding research and validation stud2 ies to reduce, refine, and replace the use of ani3 mal tests in accordance with this subsection. 

4 ‘‘(2) IMPLEMENTATION OF ALTERNATIVE TEST5 ING METHODS.—To promote the development and 

6 timely incorporation of new testing methods that are 

7 not based on mammals, the Administrator shall— 

8 ‘‘(A) after providing an opportunity for 

9 public comment, develop a strategic plan to pro10 mote the development and implementation of al11 ternative test methods and testing strategies to 

12 generate information used in safety assessments 

13 and determinations under section 6 that can re14 duce, refine, or replace the use of mammals, in15 cluding toxicity pathway-based risk assessment, 

16 in vitro studies, systems biology, computational 

17 toxicology, bioinformatics, and high-throughput 

18 screening; 

19 ‘‘(B) beginning on the date that is 5 years 

20 after the date of enactment of the Alan 

21 Reinstein and Trevor Schaefer Toxic Chemical 

22 Protection Act and every 5 years thereafter, 

23 submit to Congress a report that describes the 

24 progress made in implementing this subsection 


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1 and goals for future alternative test methods 

2 implementation; and 

3 ‘‘(C) to the extent practicable, fund and 

4 carry out research, development, performance 

5 assessment, and translational studies to accel6 erate the development of test methods and test7 ing strategies that reduce, refine, or replace the 

8 use of mammals in any safety assessment or de9 termination made under section 6. 

10 ‘‘(d) TESTING REQUIREMENTS.— 

11 ‘‘(1) IN GENERAL.—The Administrator may re12 quire the following persons to develop information: 

13 ‘‘(A) Manufacturers and processors of the 

14 chemical substance or mixture. 

15 ‘‘(B) Persons who begin to manufacture or 

16 process such chemical substance or mixture— 

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

18 rule, testing consent agreement, or order; 

19 but 

20 ‘‘(ii) subject to paragraph (3), not 

21 later than 180 days after the completion of 

22 the period for submitting information spec23 ified under subsection (a)(4)(A)(iv). 

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

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1 paragraphs (A) and (B) of paragraph (1) to des2 ignate a person or a qualified third party— 

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

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

5 of the persons making the designation. 

6 ‘‘(3) EXEMPTIONS.— 

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

8 subject to a rule, testing consent agreement, or 

9 order under this section may submit to the Ad10 ministrator an application for an exemption on 

11 the basis that the information is being devel12 oped by a person designated under paragraph 

13 (2). 

14 ‘‘(B) FAIR AND EQUITABLE REIMBURSE15 MENT TO DESIGNEE.— 

16 ‘‘(i) IN GENERAL.—If the Adminis17 trator accepts an application submitted 

18 under subparagraph (A), the Adminis19 trator shall direct the applicant to provide 

20 to the person designated under paragraph 

21 (2) fair and equitable reimbursement, as 

22 agreed to between the applicant and the 

23 person designated. 

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

25 and a person designated under paragraph 


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1 (2) cannot reach agreement on the amount 

2 of fair and equitable reimbursement, the 

3 amount shall be determined by arbitration. 

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

5 exemption under this paragraph, the Adminis6 trator determines that no person has complied 

7 with the rule, testing consent agreement, or 

8 order, the Administrator shall— 

9 ‘‘(i) by order terminate the exemption; 

10 and 

11 ‘‘(ii) notify in writing each person who 

12 received an exemption of the requirements 

13 with respect to which the exemption was 

14 granted. 

15 ‘‘(e) TRANSPARENCY.—Subject to section 14, the Ad16 ministrator shall make available to the public all testing 

17 consent agreements and orders under this section.’’. 

18 (b) CONFORMING AMENDMENTS.—Section 

19 104(i)(5)(A) of the Comprehensive Environmental Re20 sponse, Compensation, and Liability Act of 1980 (42 

21 U.S.C. 9604(i)(5)(A)) is amended by striking ‘‘section 

22 4(e)’’ and inserting ‘‘section 4(f)’’. 

23 SEC. 105. PRIORITIZATION SCREENING. 

24 The Toxic Substances Control Act (15 U.S.C. 2601 

25 et seq.) is amended by adding after section 4 the following: 


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1 ‘‘SEC. 4A. PRIORITIZATION SCREENING. 

2 ‘‘(a) PRIORITIZATION SCREENING.— 

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

4 the date of enactment of the Alan Reinstein and 

5 Trevor Schaefer Toxic Chemical Protection Act, the 

6 Administrator shall by rule establish a screening 

7 process and criteria for identifying existing chemical 

8 substances that are— 

9 ‘‘(A) a high priority for a safety assess10 ment and safety determination under section 6, 

11 to be known as ‘high-priority substances’; and 

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

13 and safety determination, to be known as ‘low14 priority substances’. 

15 ‘‘(2) INITIAL LIST OF HIGH PRIORITY SUB16 STANCES.—Prior to promulgation of the rule estab17 lished under paragraph (1) and not later than 6 

18 months after the date of enactment of the Alan 

19 Reinstein and Trevor Schaefer Toxic Chemical Pro20 tection Act, the Administrator shall consider and 

21 publish an initial list of high priority substances, 

22 which shall contain not less than 15 chemical sub23 stances, and pursuant to sections 6(a) and 6(b)(2), 

24 initiate or continue safety assessments and safety 

25 determinations for such substances. 


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1 ‘‘(3) ADDITIONS TO PRIORITY LIST.—Starting 1 

2 year after publication of the initial priority list under 

3 paragraph (2) and at 1 year intervals thereafter for 

4 the following 4 years, the Administrator shall add at 

5 least 15 high-priority substances to the list and, pur6 suant to sections 6(a) and 6(b)(2), initiate or con7 tinue safety assessments and safety determinations 

8 for those substances. 

9 ‘‘(4) WORKPLAN AND ACTION PLAN CHEMI10 CALS.—The Administration may list as high-priority 

11 substances under paragraphs (2) and (3) those 

12 chemical substances or categories of chemical sub13 stances that are included in the Administrator’s 

14 March 2012 Workplan (as updated in October 2014 

15 and by subsequent updates) or are the subject of 

16 Existing Chemical Action Plans published by the 

17 Administrator before the date of enactment of the 

18 Alan Reinstein and Trevor Schaefer Toxic Chemical 

19 Protection Act without providing further justifica20 tion for listing or meeting the requirements of this 

21 section. 

22 ‘‘(5) IMPLEMENTATION.— 

23 ‘‘(A) CONSIDERATION OF ACTIVE AND IN24 ACTIVE SUBSTANCES.— 


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1 ‘‘(i) CONSIDERATION OF ACTIVE SUB2 STANCES.—In implementing the process 

3 described in paragraph (1), the Adminis4 trator shall consider active substances, as 

5 determined under section 8, which may in6 clude substances on the interim list of ac7 tive substances established under that sec8 tion. 

9 ‘‘(ii) CONSIDERATION OF INACTIVE

10 SUBSTANCES.—In implementing the proc11 ess described in paragraph (1), the Admin12 istrator may consider inactive substances, 

13 as determined under section 8, that the 

14 Administrator determines— 

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

16 a regulatory or other enforceable ac17 tion by the Administrator to ban or 

18 phase out the substance; and 

19 ‘‘(bb) have the potential for high 

20 hazard and widespread exposure; or 

21 ‘‘(II)(aa) have been subject to a 

22 regulatory or other enforceable action 

23 by the Administrator to ban or phase 

24 out the substance; and 


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1 ‘‘(bb) there is the potential for 

2 residual high hazards or widespread 

3 exposures not otherwise addressed by 

4 the regulatory or other action. 

5 ‘‘(iii) REPOPULATION.—Upon the 

6 completion of a safety determination under 

7 section 6 for a chemical substance, the Ad8 ministrator shall remove the substance 

9 from the list of high-priority substances. 

10 The Administrator shall add not less than 

11 1 chemical substance to the list of high12 priority substances for each chemical sub13 stance removed from the list, until a safety 

14 assessment and safety determination is 

15 completed for all active substances, except 

16 that not less than 3 chemical substances 

17 shall be added for each chemical substance 

18 removed from the list, subject to section 

19 21, when fees are in place. 

20 ‘‘(B) TIMELY COMPLETION OF

21 PRIORITIZATION SCREENING PROCESS.— 

22 ‘‘(i) IN GENERAL.—In addition to the 

23 decisions required by paragraphs (1) and 

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1 graph (1), the Administrator shall begin 

2 the prioritization screening process. 

3 ‘‘(ii) DECISIONS ON SUBSTANCES SUB4 JECT TO TESTING FOR PRIORITIZATION

5 PURPOSES.—Not later than 120 days after 

6 receipt of the information complying with a 

7 rule, testing consent agreement, or order 

8 issued under section 4(a)(2), the Adminis9 trator shall designate the substance as ei10 ther a high or low priority. 

11 ‘‘(iii) CONSIDERATION.—The Admin12 istrator shall screen substances, taking 

13 into consideration the requirement to meet 

14 the deadlines under section 6 of this Act. 

15 ‘‘(iv) ANNUAL GOAL.—The Adminis16 trator shall publish an annual goal for the 

17 number of substances to be subject to the 

18 prioritization screening process. 

19 ‘‘(C) SCREENING OF CATEGORIES OF SUB20 STANCES.—The Administrator may screen cat21 egories of chemical substances to ensure an effi22 cient prioritization screening process to allow 

23 for timely and adequate safety assessments and 

24 determinations. 


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1 ‘‘(D) PUBLICATION OF LIST OF CHEMICAL

2 SUBSTANCES.—Not less frequently than annu3 ally, the Administrator shall— 

4 ‘‘(i) publish a list of chemical sub5 stances being considered in the 

6 prioritization screening process and their 

7 status in the prioritization process, includ8 ing those substances for which a 

9 prioritization decision has been deferred; 

10 and 

11 ‘‘(ii) publish a list of those substances 

12 designated as high-priority and low-priority 

13 substances and the basis for the designa14 tions. 

15 ‘‘(6) CRITERIA.—The criteria described in para16 graph (1) shall include— 

17 ‘‘(A) the recommendation of a Governor of 

18 a State or a State agency with responsibility for 

19 protecting health or the environment from 

20 chemical substances appropriate for 

21 prioritization screening, and the recommenda22 tions of the public; 

23 ‘‘(B) the hazard of the chemical substance 

24 (or category of substances), including specific 


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1 scientific classifications and designations by au2 thoritative governmental entities; 

3 ‘‘(C) the intended or reasonably foreseeable 

4 conditions of use of a chemical substance or sig5 nificant changes in the intended or reasonably 

6 foreseeable conditions of use of the chemical 

7 substance; 

8 ‘‘(D) evidence and indicators of exposure 

9 and potential exposure to humans or the envi10 ronment from the chemical substance including 

11 potentially exposed or susceptible populations; 

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

13 manufactured or processed, and past and an14 ticipated future changes in volume; 

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

16 substance as reported under a regulation issued 

17 under section 8(a) has significantly increased or 

18 decreased since a previous report or since the 

19 date on which a notice has been submitted 

20 under section 5(a) for that chemical substance; 

21 ‘‘(G) the availability of information about 

22 potential hazards and exposures needed for con23 ducting a safety assessment or determination, 

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1 formation shall not be a sufficient basis for fail2 ing to designate a substance as a high priority; 

3 ‘‘(H) the potential threat the chemical sub4 stance poses to drinking water supplies, based 

5 on hazard, exposure, or exposure potential (in6 cluding whether the chemical substance is 

7 stored near sources of drinking water); 

8 ‘‘(I) the extent to which a chemical sub9 stance accumulates in the human body; and 

10 ‘‘(J) other relevant criteria identified by 

11 the Administrator. 

12 ‘‘(b) PRIORITIZATION SCREENING PROCESS AND DE13 CISIONS.— 

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

15 process developed under subsection (a) shall include 

16 a requirement that the Administrator— 

17 ‘‘(A) identify the chemicals being consid18 ered for prioritization; 

19 ‘‘(B) request interested persons to supply 

20 information on the substances being considered; 

21 ‘‘(C) apply the criteria identified in sub22 section (a)(5); and 

23 ‘‘(D) subject to paragraph (4) and using 

24 the information available to the Administrator 

25 at the time of the decision, identify a chemical 


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1 substance as a high-priority substance or a low2 priority substance. 

3 ‘‘(2) IDENTIFICATION OF HIGH-PRIORITY SUB4 STANCES.—The Administrator— 

5 ‘‘(A) shall identify as a high-priority sub6 stance a chemical substance that the Adminis7 trator determines has, or has the potential for, 

8 significant hazard and significant or substantial 

9 exposure; 

10 ‘‘(B) may identify as a high-priority sub11 stance a chemical substance that the Adminis12 trator determines has, or has the potential for, 

13 significant hazard or significant or substantial 

14 exposure; 

15 ‘‘(C) may identify as a high-priority sub16 stance an inactive substance, as determined 

17 under section 8(b), that the Administrator de18 termines warrants a safety assessment and de19 termination under section 6; and 

20 ‘‘(D) may identify as a high-priority sub21 stance a chemical substance that accumulates 

22 in the body. 

23 ‘‘(3) IDENTIFICATION OF LOW-PRIORITY SUB24 STANCES.—The Administrator shall identify as a 


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1 low-priority substance a chemical substance if the 

2 Administrator— 

3 ‘‘(A) concludes that sufficient hazard and 

4 exposure information is available for an in5 formed evaluation of the substance’s risks to 

6 human health and the environment; 

7 ‘‘(B) determines, based on a review of the 

8 information available, that the substance is like9 ly to meet the safety standard under the in10 tended or reasonably foreseeable conditions of 

11 use; and 

12 ‘‘(C) identifies the information on which 

13 the determination is based and describes the 

14 Administrator’s analysis of this information. 

15 ‘‘(4) DEFERRING A DECISION.—If the Adminis16 trator determines that additional information is 

17 needed to establish the priority of a chemical sub18 stance, the Administrator may defer the 

19 prioritization screening decision for a reasonable pe20 riod to— 

21 ‘‘(A) allow for the submission and evalua22 tion of additional information by an interested 

23 person; or 


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1 ‘‘(B) require the development of informa2 tion pursuant to a rule, testing consent agree3 ment, or order issued under section 4(a)(2). 

4 ‘‘(5) DEADLINES FOR SUBMISSION OF INFOR5 MATION.—If the Administrator requests the develop6 ment or submission of information under this sec7 tion, the Administrator shall establish a deadline for 

8 submission of such information, which deadline shall 

9 be of reasonable duration. 

10 ‘‘(6) NOTICE AND COMMENT.—Except as pro11 vided in subsection (a)(4), the Administrator shall 

12 publish the proposed decisions made under para13 graphs (2), (3) and (4) and the basis for the deci14 sions, and provide an opportunity for public com15 ment. 

16 ‘‘(7) REVISION BASED ON NEW INFORMA17 TION.—The Administrator may, at any time, revise 

18 the designation of a chemical substance as a high19 priority or a low-priority substance based on new in20 formation made available to the Administrator after 

21 the date of the determination under paragraph (2) 

22 or (3), following the procedures in this section. 

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

24 every 5 years after the date on which the process 

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1 trator shall review the process on the basis of experi2 ence and consider the resources available to effi3 ciently and effectively screen and prioritize sub4 stances, and if necessary modify the prioritization 

5 screening process in a manner that complies with 

6 this Act. 

7 ‘‘(9) EFFECT.—Subject to section 18, a deci8 sion by the Administrator under this subsection with 

9 respect to a chemical substance shall not be con10 strued to affect the manufacture, processing, dis11 tribution, use, or disposal of the chemical substance, 

12 or regulation of those activities. 

13 ‘‘(c) FINAL AGENCY ACTION.—Except for the des14 ignation of a substance as low priority under subsection 

15 (b)(3), any action by the Administrator under this section 

16 shall not be— 

17 ‘‘(1) considered to be a final agency action; or 

18 ‘‘(2) subject to judicial review.’’. 

19 SEC. 106. NEW CHEMICALS AND SIGNIFICANT NEW USES. 

20 Section 5 (15 U.S.C. 2604) is amended— 

21 (1) by striking the section designation and 

22 heading and inserting the following: 

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

24 (2) in subsection (a)(1), in the matter following 

25 subparagraph (B)— 


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1 (A) by striking ‘‘subsection (d)’’ and in2 serting ‘‘subsection (b)’’; and 

3 (B) by striking ‘‘and such person complies 

4 with any applicable requirement of subsection 

5 (b)’’; 

6 (3) by striking subsection (b); 

7 (4) by redesignating subsection (d) as sub8 section (b) and moving the subsection so as to ap9 pear after subsection (a); 

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

11 (A) by striking paragraph (1) and insert12 ing the following: 

13 ‘‘(1) IN GENERAL.—The notice required under 

14 subsection (a) shall include, with respect to a chem15 ical substance— 

16 ‘‘(A) the information required by sections 

17 720.45 and 720.50 of title 40, Code of Federal 

18 Regulations (or successor regulations); and 

19 ‘‘(B) information regarding intended or 

20 reasonably foreseeable conditions of use and 

21 reasonably foreseeable exposures.’’; 

22 (B) in paragraph (2)— 

23 (i) in the matter preceding subpara24 graph (A), by striking ‘‘or of data under 

25 subsection (b)’’; 


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

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

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

4 ‘‘; and’’ and inserting a period; and 

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

6 (C) in paragraph (3), by striking ‘‘, (b),’’; 

7 (6) by striking subsection (c) and inserting the 

8 following: 

9 ‘‘(c) REVIEW OF NOTICE.— 

10 ‘‘(1) INITIAL REVIEW.— 

11 ‘‘(A) IN GENERAL.—Subject to subpara12 graph (B), not later than 90 days after the date 

13 of receipt of a notice submitted under sub14 section (a), the Administrator shall— 

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

16 notice; 

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

18 the relevant chemical substance and the 

19 potential for exposure to humans and the 

20 environment; and 

21 ‘‘(iii) make any necessary determina22 tion under paragraph (3). 

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

24 paragraph (5), the Administrator may extend 

25 the period described in subparagraph (A) for 


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

2 which shall be not more than 90 days. 

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

4 notice under paragraph (1), the Administrator shall 

5 take into consideration— 

6 ‘‘(A) any relevant information identified in 

7 subsection (b)(1); and 

8 ‘‘(B) any other relevant information avail9 able to, or submitted to, the Administrator. 

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

11 applicable period for review under paragraph (1), 

12 and based on the information described in paragraph 

13 (2), the Administrator shall determine that— 

14 ‘‘(A) the relevant chemical substance or a 

15 significant new use is not likely to meet the 

16 safety standard, in which case the Adminis17 trator shall take appropriate action under para18 graph (5); 

19 ‘‘(B) the relevant chemical substance or 

20 significant new use is likely to meet the safety 

21 standard, in which case the Administrator shall 

22 allow the review period to expire without addi23 tional restrictions; or 

24 ‘‘(C) additional information is necessary in 

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1 graph (A) or (B), in which case the Adminis2 trator shall take appropriate action under para3 graph (5). 

4 ‘‘(4) RESTRICTIONS.— 

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

6 makes a determination under paragraph (3)(A) 

7 or (C) with respect to a notice submitted under 

8 subsection (a), the Administrator shall before 

9 the end of the applicable period for review 

10 under paragraph (1) and by consent agreement 

11 or order, as appropriate, prohibit or restrict the 

12 manufacture, processing, use, distribution in 

13 commerce, or disposal (as applicable) of the 

14 chemical substance, or of the substance for a 

15 significant new use without compliance with the 

16 restrictions specified in the consent agreement 

17 or order that the Administrator determines are 

18 sufficient to ensure that the chemical substance 

19 or significant new use is likely to meet the safe20 ty standard. 

21 ‘‘(B) RULEMAKING.—Not later than 90 

22 days after issuing a consent agreement or order 

23 under subparagraph (A), the Administrator 

24 shall— 


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1 ‘‘(i) consider whether to promulgate a 

2 rule under subsection (a)(2) that identifies 

3 as a significant new use any manufac4 turing, processing, use, distribution in 

5 commerce, or disposal of the chemical sub6 stance, or of the chemical substance for a 

7 new use that is not in compliance with the 

8 restrictions imposed by the consent agree9 ment or order; and 

10 ‘‘(ii)(I) initiate such rulemaking; or 

11 ‘‘(II) publish a statement of the Ad12 ministrator’s reasons for not initiating 

13 such action. 

14 ‘‘(C) INCLUSIONS.—A prohibition, restric15 tion, or requirement under subparagraph (A) 

16 shall include, as appropriate, 1 or more of the 

17 following requirements: 

18 ‘‘(i) A requirement that a chemical 

19 substance or mixture or article containing 

20 the substance be marked with, or accom21 panied by, clear and adequate warnings 

22 and instructions with respect to use, dis23 tribution in commerce, or disposal, or any 

24 combination of those activities, with the 

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1 structions to be prescribed by the Adminis2 trator. 

3 ‘‘(ii) A requirement that manufactur4 ers or processors, as applicable, of the 

5 chemical substance or mixture make and 

6 retain records of the processes used to 

7 manufacture or process the chemical sub8 stance. 

9 ‘‘(iii) A requirement that manufactur10 ers or processors, as applicable, monitor or 

11 conduct such additional tests as are rea12 sonably necessary to address potential 

13 risks from the manufacture, processing, 

14 distribution in commerce, use, or disposal 

15 of the chemical substance, subject to sec16 tion 4. 

17 ‘‘(iv) A restriction on the quantity of 

18 the chemical substance or a mixture or ar19 ticle containing the substance that may be 

20 manufactured, processed, or distributed in 

21 commerce. 

22 ‘‘(v) A restriction on the quantity of 

23 the chemical substance or a mixture or ar24 ticle containing the substance that may be 


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1 manufactured, processed, or distributed in 

2 commerce— 

3 ‘‘(I) for a particular use; or 

4 ‘‘(II) for a particular use in a 

5 concentration in excess of a level spec6 ified by the Administrator in the con7 sent agreement or order imposing the 

8 requirement. 

9 ‘‘(vi) A prohibition or other regulation 

10 of the manufacture, processing, or dis11 tribution in commerce of the chemical sub12 stance or a mixture or article containing 

13 the substance for a significant new use. 

14 ‘‘(vii) A prohibition or other regula15 tion of any manner or method of commer16 cial use of the chemical substance or a 

17 mixture or article containing the sub18 stance. 

19 ‘‘(viii) A prohibition or other regula20 tion of any manner or method of disposal 

21 of or environmental release of the chemical 

22 substance or a mixture or article con23 taining the substance, by its manufacturer 

24 or processor or by any other person who 


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1 uses, or disposes of it, for commercial pur2 poses. 

3 ‘‘(ix) A prohibition or other appro4 priate restriction or requirement on the 

5 manufacture, processing, or distribution in 

6 commerce of the chemical substance or a 

7 mixture or article containing the sub8 stance. 

9 ‘‘(x) A prohibition or other appro10 priate restriction or requirement on the 

11 manufacture, processing, or distribution in 

12 commerce of the chemical substance or a 

13 mixture or article containing the substance 

14 for a particular use. 

15 ‘‘(D) RULE OF CONSTRUCTION.—The re16 quirement, warning, or instruction required 

17 under subparagraph (C) does not establish a 

18 uniform national standard for the purpose of 

19 supplanting, displacing, or preempting State 

20 law. 

21 ‘‘(E) WORKPLACE EXPOSURES.—The Ad22 ministrator shall consult with the Assistant Sec23 retary of Labor for Occupational Safety and 

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1 striction adopted under this subsection to ad2 dress workplace exposures. 

3 ‘‘(5) ADDITIONAL INFORMATION.—If the Ad4 ministrator determines under paragraph (3)(C) that 

5 additional information is needed in order to conduct 

6 a review under this subsection, the Administrator— 

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

8 submitter of the notice to submit such addi9 tional information; 

10 ‘‘(B) may, by agreement with the sub11 mitter, extend the review period for a reason12 able time to allow the development and submis13 sion of the additional information; 

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

15 testing consent agreement, or issue an order 

16 under section 4 to require the development of 

17 the information; and 

18 ‘‘(D) shall, after receiving information the 

19 Administrator finds supports the determination 

20 under paragraph (3), promptly make the deter21 mination. 

22 ‘‘(6) REGULATION PENDING DEVELOPMENT OF

23 INFORMATION.—Subject to paragraph (4)(B), the 

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1 ditional information, subject to compliance with any 

2 restrictions under paragraph (4) determined by the 

3 Administrator to be sufficient to ensure that the 

4 chemical substance is likely to meet the safety stand5 ard. 

6 ‘‘(7) COMMENCEMENT OF MANUFACTURE.— 

7 Subject to paragraphs (4), (5), and (6), at the end 

8 of the applicable period for review under paragraph 

9 (1)(A) the submitter of a notice under subsection (a) 

10 may commence manufacture for commercial pur11 poses a chemical substance, or a chemical substance 

12 for a significant new use.’’; 

13 (7) by striking subsections (e) through (g) and 

14 inserting the following: 

15 ‘‘(d) NOTICE OF COMMENCEMENT.— 

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

17 after the date on which a manufacturer or processor 

18 that has submitted a notice under subsection (a) 

19 commences nonexempt commercial manufacture of a 

20 chemical substance, the manufacturer or processor 

21 shall submit to the Administrator a notice of com22 mencement that identifies— 

23 ‘‘(A) the name of the manufacturer or 

24 processor; 


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1 ‘‘(B) the initial date of nonexempt com2 mercial manufacture; and 

3 ‘‘(C) additional information specified in 

4 section 720.102(c)(1) of title 40, Code of Fed5 eral Regulations (or successor regulations). 

6 ‘‘(2) WITHDRAWAL.—A manufacturer or proc7 essor that has submitted a notice under subsection 

8 (a), but that has not commenced nonexempt com9 mercial manufacture or processing of the chemical 

10 substance, may withdraw the notice. 

11 ‘‘(e) FURTHER EVALUATION.—The Administrator 

12 may screen a chemical substance under section 4A or re13 quire testing under section 4 at any time after the Admin14 istrator receives— 

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

16 substance under subsection (d); or 

17 ‘‘(2) new information regarding the chemical 

18 substance. 

19 ‘‘(f) TRANSPARENCY.—Subject to section 14, the Ad20 ministrator shall make available to the public all notices, 

21 determinations, consent agreements, rules and orders of 

22 the Administrator issued under this section.’’; 

23 (8) by redesignating subsections (h) and (i) as 

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

25 (9) in subsection (g) (as so redesignated)— 


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1 (A) in paragraph (1), in the matter pre2 ceding subparagraph (A), by striking ‘‘or (b)’’; 

3 (B) by striking paragraph (2); 

4 (C) by redesignating paragraphs (3) 

5 through (6) as paragraphs (2) through (5), re6 spectively; 

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

8 by striking ‘‘subsections (a) and (b)’’ and in9 serting ‘‘subsection (a)’’; 

10 (E) in paragraph (3) (as so redesignated), 

11 in the first sentence, by striking ‘‘will not 

12 present an unreasonable risk of injury to health 

13 or the environment’’ and inserting ‘‘will meet 

14 the safety standard’’; 

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

16 by striking ‘‘subsections (a) and (b)’’ and in17 serting ‘‘subsection (a)’’; and 

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

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

20 or (5)’’ and inserting ‘‘paragraph (1) or (4),’’; 

21 and 

22 (10) by inserting after subsection (h) (as so re23 designated) the following: 

24 ‘‘(i) PRIOR ACTIONS.—Nothing in this section re25 quires the Administrator to modify or withdraw any rule 


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1 or order promulgated under section 5 of this title prior 

2 to the enactment of the Alan Reinstein and Trevor Schae3 fer Toxic Chemical Protection Act.’’. 

4 SEC. 107. SAFETY ASSESSMENTS AND DETERMINATIONS. 

5 Section 6 (15 U.S.C. 2605) is amended— 

6 (1) by striking the section designation and 

7 heading and inserting the following: 

8 ‘‘SEC. 6. SAFETY ASSESSMENTS AND DETERMINATIONS.’’; 

9 (2) by redesignating subsection (b) as sub10 section (m) and moving the subsection so as to ap11 pear after subsection (l) (as added by paragraph 

12 (6)); 

13 (3) in subsection (m) (as so redesignated), by 

14 striking ‘‘unreasonable’’ each place it appears and 

15 inserting ‘‘significant’’; 

16 (4) by striking subsections (a), (c) and (d) and 

17 inserting in lieu thereof the following, and by redes18 ignating subsection (b) as subsection (i): 

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

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

21 make a safety determination of each high-priority 

22 substance designated under section 4A in accordance 

23 with subsections (b) and (c); 

24 ‘‘(2) shall, when a safety determination con25 cludes that a substance does not meet the safety 


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1 standard, establish restrictions pursuant to sub2 section (d); 

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

4 safety determination not later than 2 years after the 

5 date on which a substance is designated as a high 

6 priority; 

7 ‘‘(4) shall promulgate a final rule pursuant to 

8 subsection (d) not later than 2 years after the date 

9 on which the safety determination is completed; and 

10 ‘‘(5) may extend any deadline under this sub11 section for a reasonable period of time after an ade12 quate public justification, subject to the condition 

13 that the aggregate length of all extensions of dead14 lines under paragraphs (3) and (4) of this sub15 section and any deferrals under subsection (c)(2) 

16 does not exceed 2 years. 

17 ‘‘(b) SAFETY ASSESSMENTS AND DETERMINA18 TIONS.— 

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

20 conduct a risk-based safety assessment and make a 

21 risk-based safety determination of each high-priority 

22 substance. 

23 ‘‘(2) ALREADY INITIATED ASSESSMENTS.— 

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

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1 ty assessments and safety determinations of 

2 chemical substances, or from continuing or 

3 completing safety assessments and safety deter4 minations initiated prior to the date of enact5 ment of the Alan Reinstein and Trevor Schaefer 

6 Toxic Chemical Protection Act, prior to the 

7 date on which the policies and procedures the 

8 Administrator is directed to establish under sec9 tion 3A and 4A are effective. 

10 ‘‘(B) INTEGRATION.—As policies and pro11 cedures under section 3A and 4A are estab12 lished, the Administrator shall integrate them 

13 into ongoing assessments and determinations to 

14 the maximum extent practicable. 

15 ‘‘(3) ACTIONS COMPLETED PRIOR TO COMPLE16 TION OF POLICIES AND PROCEDURES.—Nothing in 

17 this Act requires the Administrator to revise or with18 draw a completed safety assessment, safety deter19 mination, or rule merely because such action was 

20 completed prior to the completion of a policy or pro21 cedure established under section 3A or 4A, and the 

22 validity of such assessment, determination, or rule 

23 shall not be determined based on the content of such 

24 policy or procedure. 

25 ‘‘(c) SAFETY DETERMINATIONS.— 


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

2 information before the Administrator, including 

3 draft safety assessments, if any, submitted by inter4 ested persons, the Administrator shall determine 

5 that— 

6 ‘‘(A) the relevant chemical substance meets 

7 the safety standard; 

8 ‘‘(B) the relevant chemical substance does 

9 not meet the safety standard, in which case the 

10 Administrator shall by rule under subsection 

11 (d) impose restrictions necessary to assure that 

12 the substance meets the safety standard under 

13 the intended or reasonably foreseeable condi14 tions of use, or, where the safety standard can15 not be met with the application of restrictions, 

16 to ban or phase out the substance, as appro17 priate; or 

18 ‘‘(C) additional information is necessary in 

19 order to make a safety determination under 

20 subparagraph (A) or (B), in which case the Ad21 ministrator shall take appropriate action under 

22 paragraph (2). 

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

25 needed in order to carry out a safety assessment and 


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1 safety determination for a high-priority substance, 

2 the Administrator— 

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

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

7 testing consent agreement, or issue an order 

8 under section 4 to require the development of 

9 the information; 

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

11 that complies with the deadlines in subsection 

12 (a), a safety assessment and determination 

13 until after receipt of the information; and 

14 ‘‘(D) in compliance with the deadlines in 

15 subsection (a), shall, upon receipt of informa16 tion the Administrator finds supports the as17 sessment and determination, make a determina18 tion under paragraph (1). 

19 ‘‘(3) DEADLINE FOR SUBMISSION OF INFORMA20 TION.—When requesting the development or submis21 sion of information under this section the Adminis22 trator shall establish a deadline for the submission 

23 of such information, which deadline shall be of rea24 sonable duration and shall comply with the deadlines 

25 under subsection (a). 


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1 ‘‘(d) RULE.— 

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

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

4 with respect to a chemical substance, the Adminis5 trator shall promulgate a rule establishing restric6 tions necessary to ensure that the chemical sub7 stance meets the safety standard. 

8 ‘‘(2) SCOPE.—A rule promulgated under this 

9 subsection— 

10 ‘‘(A) may— 

11 ‘‘(i) apply to a mixture or article con12 taining the chemical substance, as appro13 priate; and 

14 ‘‘(ii) exempt a replacement part man15 ufactured prior to the applicable compli16 ance deadline; and 

17 ‘‘(B) shall include dates by which compli18 ance is mandatory, which shall be as soon as 

19 feasible and may vary for different affected per20 sons, as the Administrator determines to be ap21 propriate, but which shall be no later than 2 

22 years after the date on which the rule is pro23 mulgated. 

24 ‘‘(3) WORKPLACE EXPOSURES.—The Adminis25 trator shall consult with the Assistant Secretary of 


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1 Labor for Occupational Safety and Health prior to 

2 adopting any prohibition or restriction adopted 

3 under this subsection to address workplace expo4 sures. 

5 ‘‘(4) RESTRICTIONS.—A restriction under para6 graph (1) shall include, as appropriate, 1 or more of 

7 the following requirements: 

8 ‘‘(A) A requirement that a chemical sub9 stance or a mixture or article containing the 

10 substance be marked with, or accompanied by, 

11 clear and adequate warnings and instructions 

12 with respect to use, distribution in commerce, 

13 or disposal, or any combination of those activi14 ties, with the form and content of the warnings 

15 and instructions to be prescribed by the Admin16 istrator. 

17 ‘‘(B) A requirement that manufacturers 

18 and processors of the chemical substance or a 

19 mixture or article containing the substance— 

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

21 processes used to manufacture or process 

22 the chemical substance; 

23 ‘‘(ii) describe and apply the relevant 

24 quality control procedures followed in the 


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1 manufacturing or processing of the sub2 stance; and 

3 ‘‘(iii) monitor or conduct tests which 

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

6 under this subsection. 

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

8 chemical substance or a mixture or article con9 taining the substance that may be manufac10 tured, processed, or distributed in commerce. 

11 ‘‘(D) A requirement to ban or phase out or 

12 other regulation on the manufacture, proc13 essing, distribution in commerce, use, or dis14 posal of the chemical substance or a mixture or 

15 article containing the substance— 

16 ‘‘(i) for a particular use; 

17 ‘‘(ii) for a particular use at a con18 centration in excess of a level specified by 

19 the Administrator; or 

20 ‘‘(iii) for all uses. 

21 ‘‘(E) A restriction on the quantity of the 

22 chemical substance or mixture or article con23 taining the substance that may be manufac24 tured, processed, or distributed in commerce— 

25 ‘‘(i) for a particular use; or 


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1 ‘‘(ii) for a particular use at a con2 centration in excess of a level specified by 

3 the Administrator. 

4 ‘‘(F) A requirement to restrict, ban, or 

5 phase out or other regulation of any manner or 

6 method of commercial use or environmental re7 lease of the chemical substance or mixture or 

8 article containing the substance. 

9 ‘‘(G) A requirement to restrict, ban, or 

10 phase out or other regulation of any manner or 

11 method of disposal of the chemical substance or 

12 any mixture or article containing the chemical 

13 substance, by its manufacturer or processor or 

14 by any person who uses, or disposes of it, for 

15 commercial purposes, provided that such a re16 quirement may not require any person to take 

17 any action that would be in violation of any law 

18 or requirement of, or in effect for, a State or 

19 political subdivision, and that such a require20 ment shall require each person subject to the 

21 requirement to notify each State and political 

22 subdivision in which a required disposal may 

23 occur of such disposal. 

24 ‘‘(H) A requirement directing manufactur25 ers or processors of the chemical substance or 


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1 mixture or article containing the substance to 

2 give notice of significant risks of harm (without 

3 taking into consideration cost or other non-risk 

4 factors) to distributors in commerce of the 

5 chemical substance and, to the extent reason6 ably ascertainable, to other persons in the chain 

7 of commerce in possession of the chemical sub8 stance or mixture, and to give public notice of 

9 such significant risks of harm. 

10 ‘‘(5) RULE OF CONSTRUCTION.—The require11 ment, warning, or instruction, under paragraph (4) 

12 does not establish a uniform national standard for 

13 the purpose of supplanting, displacing, or pre14 empting State law. 

15 ‘‘(6) ANALYSIS FOR RULEMAKING.— 

16 ‘‘(A) IN GENERAL.—Where the Adminis17 trator determines that a rule under paragraph 

18 (1) is likely to have an annual effect on the 

19 economy of more than $100,000,000, then 

20 when deciding which restrictions to impose 

21 under paragraph (3) as part of developing a 

22 rule under paragraph (1) to ensure that a 

23 chemical substance meets the safety standard, 

24 the Administrator shall consider, to the extent 

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1 mation, the quantifiable and non-quantifiable 

2 costs and benefits of the proposed regulatory 

3 action and of the primary alternative regulatory 

4 action or actions that the Administrator deter5 mines will ensure that the substance meets the 

6 safety standard. As part of the analysis, the 

7 Administrator shall review such technically and 

8 economically feasible alternative or alternatives 

9 to the chemical substance that the Adminis10 trator determines are relevant to the rule11 making. 

12 ‘‘(B) PUBLIC DISCLOSURE OF ANALYSIS.— 

13 When proposing a rule under paragraph (1), 

14 the Administrator shall make publicly available 

15 any analysis conducted under subparagraph 

16 (A). 

17 ‘‘(C) CONSIDERATION OF ANALYSIS.— 

18 When making final a rule under paragraph (1), 

19 the Administrator shall include a statement de20 scribing how the analysis considered under sub21 paragraph (A) was taken into account. 

22 ‘‘(7) EXEMPTIONS.— 

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

24 part of a rulemaking under this subsection— 


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1 ‘‘(i) may exempt a use of a chemical 

2 substance from any restriction in a rule 

3 promulgated under paragraph (1) if the 

4 Administrator determines, based on rea5 sonably available information, that the rule 

6 cannot be complied with without— 

7 ‘‘(I) harming national security; 

8 ‘‘(II) causing significant disrup9 tion in the national economy due to 

10 the lack of availability of a chemical 

11 substance for the exempted use; or 

12 ‘‘(III) interfering with a critical 

13 or essential use for which no tech14 nically and economically feasible safer 

15 alternative is available, considering 

16 hazard and exposure; and 

17 ‘‘(ii) may exempt a particular use of a 

18 chemical substance from a restriction in a 

19 rule issued under paragraph (1) if avail20 able information demonstrates that the 

21 risks to health or the environment from 

22 continued use of the substance are sub23 stantially lower than the risks to health or 

24 the environment of replacing that use of 


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1 the substance with reasonably available al2 ternatives. 

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

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

8 the need for such exemption. 

9 ‘‘(C) CONSIDERATION OF ANALYSIS.— 

10 When making final a rule under paragraph (1) 

11 that includes an exemption under this para12 graph, the Administrator shall include a state13 ment describing how the analysis was taken 

14 into account. 

15 ‘‘(D) CONDITIONS.—As part of a rule 

16 issued under paragraph (1), the Administrator 

17 shall include conditions in any exemption estab18 lished under this paragraph, including reason19 able recordkeeping, monitoring, and reporting 

20 requirements, to the extent that the Adminis21 trator determines the conditions are necessary 

22 to protect human health and the environment 

23 while achieving the purposes of the exemption. 

24 ‘‘(E) DURATION.— 


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

2 shall, as part of a rule under paragraph 

3 (1) that contains an exemption under this 

4 paragraph, set a time limit on any exemp5 tion not to exceed 5 years. 

6 ‘‘(ii) EXTENSION.—The Administrator 

7 may, by rule, extend, modify, or eliminate 

8 the exemption when the Administrator de9 termines, on the basis of reasonably avail10 able information and after adequate public 

11 justification, the exemption warrants ex12 tension or is no longer necessary. 

13 ‘‘(iii) CONSIDERATION FOR EXTEN14 SION.—The Administrator shall issue ex15 emptions and establish time periods under 

16 this subparagraph by considering factors 

17 determined by the Administrator as rel18 evant to the goals of fostering innovation 

19 and the development of alternatives that 

20 meet the safety standard. 

21 ‘‘(iv) EXCEPTION FOR RULE REQUIR22 ING BAN OR PHASE OUT.—Any renewal of 

23 an exemption in the case of a rule requir24 ing the ban or phase out of a chemical 

25 substance shall not exceed 5 years. 


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

2 declare a proposed rule under subsection (d) of this section 

3 to be effective upon publication of the proposed rule in 

4 the Federal Register and until the effective date of a final 

5 action taken respecting such rule if— 

6 ‘‘(1) the Administrator determines that— 

7 ‘‘(A) the manufacture, processing, distribu8 tion in commerce, use, or disposal of the chem9 ical substance or mixture subject to such pro10 posed rule or any combination of such activities 

11 is likely to result in a significant risk of serious 

12 or widespread injury (without taking into con13 sideration cost or other non-risk factors) to 

14 health or the environment before such effective 

15 date; and 

16 ‘‘(B) making the proposed rule effective is 

17 necessary to protect the public interest; and 

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

19 the manufacture, processing, or distribution of a 

20 chemical substance or mixture because of the risk 

21 determined under paragraph (1)(A), a court has in 

22 an action under section 7 of this title granted relief 

23 with respect to the risk associated with the sub24 stance or mixture. 

25 ‘‘(f) EXPEDITED ACTION ON PBTS.— 


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1 ‘‘(1) LIST OF PBTS.—In addition to carrying 

2 out section 4A, not later than 180 days after the 

3 date of enactment of the Alan Reinstein and Trevor 

4 Schaefer Toxic Chemical Protection Act, the Admin5 istrator shall publish a list of chemical substances 

6 that the Administrator determines are persistent, 

7 bio-accumulative, and toxic and have the potential 

8 for high or widespread exposure (referred to in this 

9 subsection as ‘PBTs’). 

10 ‘‘(2) USE AND EXPOSURE ASSESSMENT.— 

11 ‘‘(A) IN GENERAL.—Not later than 60 

12 days after publishing the PBT list required 

13 under paragraph (1), the Administrator shall 

14 require by order the submission by manufactur15 ers or processors of chemical substances in16 cluded in the list of any additional information 

17 the Administrator determines to be necessary to 

18 conduct an expedited assessment of the in19 tended, known, or reasonably foreseeable uses 

20 of, and exposures to, such chemical substances. 

21 ‘‘(B) PUBLICATION.—Not later than 1 

22 year after receiving the information which man23 ufacturers and processors are required to sub24 mit under subparagraph (A), the Administrator 

25 shall complete and publish an identification and 


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1 assessment of the intended or reasonably fore2 seeable conditions of use of, and exposures to, 

3 substances on the PBT list. 

4 ‘‘(3) EXPOSURE REDUCTION.— 

5 ‘‘(A) RULE.—As soon as practicable, but 

6 not later than 2 years after the date on which 

7 the Administrator completes the use and expo8 sure assessment required under paragraph (2), 

9 the Administrator shall impose, by rule, restric10 tions that the Administrator determines to be 

11 necessary to achieve the maximum practicable 

12 reduction in human or environmental exposure 

13 to chemical substances included in the PBT 

14 list. 

15 ‘‘(B) CONTENTS OF RULES.—A rule pro16 mulgated under subparagraph (A) may include 

17 any of the restrictions on manufacturing, proc18 essing, use, distribution in commerce, and dis19 posal described in subsection (d)(4) which the 

20 Administrator determines are necessary to 

21 achieve maximum practicable reduction in expo22 sure to the listed PBT substance. 

23 ‘‘(C) EFFECTIVE DATE.—A rule promul24 gated under subparagraph (A) shall include an 

25 effective date in accordance with subsection 


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1 (d)(2)(B) and may be made effective upon pub2 lication of a proposed rule in accordance with 

3 subsection (f). 

4 ‘‘(4) EXEMPTIONS.— 

5 ‘‘(A) SCOPE AND BASIS.—A rule imposing 

6 a restriction on a listed PBT substance in ac7 cordance with subparagraph (3) may exempt a 

8 use of the substance from such restriction upon 

9 a showing satisfactory to the Administrator 

10 that the use meets the exemption criteria in 

11 subsection (d)(7). 

12 ‘‘(B) CONDITIONS.—The Administrator 

13 shall include conditions in any exemption estab14 lished under this paragraph, including reason15 able recordkeeping, monitoring, and reporting 

16 requirements, to the extent necessary to protect 

17 health or the environment while achieving the 

18 purposes of the exemption. 

19 ‘‘(C) DURATION.—An exemption estab20 lished under this paragraph shall be in effect 

21 for a period determined by the Administrator 

22 but not to exceed 5 years and, after public no23 tice and an opportunity for comment, may be 

24 renewed by the Administrator for 1 or more pe25 riods not exceeding a total of 5 years by order 


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1 following submission of an application justifying 

2 the continuing need for the exemption and con3 taining such information as the Administrator 

4 may require. 

5 ‘‘(g) REPORT ON PUBLIC BUILDINGS.—Not later 

6 than 6 months after the date of enactment of the Alan 

7 Reinstein and Trevor Schaefer Toxic Chemical Protection 

8 Act, the Administrator shall submit to Congress a report 

9 on how data on exposure in public buildings will be gath10 ered to carry out subsection (f) and on what testing is 

11 necessary to protect the public from exposures to chemical 

12 substances identified under subsection (f) in public build13 ings. 

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

15 ‘‘(1) a safety determination, together with the 

16 associated safety assessment, for a substance that 

17 the Administrator determines under subsection (c) 

18 meets the safety standard, shall be considered to be 

19 a final agency action on the date of the final safety 

20 determination; and 

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

22 (d), together with the associated safety assessment 

23 and safety determination that a substance does not 

24 meet the safety standard, shall be considered to be 


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1 final agency action on the date of promulgation of 

2 the final rule.’’; 

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

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

5 (6) in subsection (i) (as so redesignated)— 

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

7 (B) by redesignating paragraph (5) as 

8 paragraph (4); and 

9 (7) by inserting after subsection (j) (as so re10 designated) the following: 

11 ‘‘(k) PRIOR ACTIONS.—Nothing in this section shall 

12 be construed as requiring the Administrator to modify or 

13 withdraw any rule or order promulgated under section 6 

14 of this title promulgated prior to the enactment of the 

15 Alan Reinstein and Trevor Schaefer Toxic Chemical Pro16 tection Act.’’. 

17 ‘‘(l) ASBESTOS.— 

18 ‘‘(1) LISTING.—The Administrator shall include 

19 all forms of asbestos as 1 high-priority chemical sub20 stance under section 4A(a)(2) in accordance with 

21 section 4A(a)(4). 

22 ‘‘(2) SCHEDULE.—Notwithstanding paragraphs 

23 (3), (4) and (5) of subsection (a), the Administrator 

24 shall— 


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1 ‘‘(A) complete a safety assessment and 

2 safety determination of all forms of asbestos 

3 not later than 2 years after the date of enact4 ment of the Alan Reinstein and Trevor Schaefer 

5 Toxic Chemical Protection Act; and 

6 ‘‘(B) promulgate a final rule not later than 

7 3 years after the date of enactment of that 

8 Act.’’. 

9 SEC. 108. IMMINENT HAZARDS. 

10 Section 7 (15 U.S.C. 2606) is amended— 

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

12 following: 

13 ‘‘(a) CIVIL ACTIONS.— 

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

15 commence a civil action in an appropriate district 

16 court of the United States for— 

17 ‘‘(A) seizure of an imminently hazardous 

18 chemical substance or mixture or any article 

19 containing the substance or mixture; 

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

21 (b)) against any person who manufactures, 

22 processes, distributes in commerce, uses, or dis23 poses of an imminently hazardous chemical sub24 stance or mixture or any article containing the 

25 substance or mixture; or 


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

3 (B). 

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

5 A civil action may be commenced under this sub6 section notwithstanding— 

7 ‘‘(A) the existence of— 

8 ‘‘(i) a decision by the Administrator 

9 under section 4, 5(c)(6), 6(c)(2) or 6(h); or 

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

12 6(d), or title IV; or 

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

14 judicial proceeding under any provision of this 

15 Act.’’; 

16 (2) in subsection (b)(1), by striking ‘‘unreason17 able’’; 

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

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

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

21 striking ‘‘and unreasonable’’. 

22 SEC. 109. INFORMATION COLLECTION AND REPORTING. 

23 Section 8 (15 U.S.C. 2607) is amended— 

24 (1) in subsection (a), by adding at the end the 

25 following: 


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1 ‘‘(4) REGULATIONS.— 

2 ‘‘(A) DEADLINE.— 

3 ‘‘(i) IN GENERAL.—Not later than 2 

4 years after the date of enactment of the 

5 Alan Reinstein and Trevor Schaefer Toxic 

6 Chemical Protection Act, the Adminis7 trator shall promulgate rules requiring the 

8 maintenance of records and the reporting 

9 of information known by, or reasonably as10 certainable by, the person making the re11 port, including rules requiring processors 

12 to report information, so that the Adminis13 trator has the information necessary to 

14 carry out sections 4 and 6. 

15 ‘‘(ii) PRIOR REGULATIONS.—In car16 rying out this subparagraph, the Adminis17 trator may modify, as appropriate, the reg18 ulations promulgated prior to the date of 

19 enactment of the Alan Reinstein and 

20 Trevor Schaefer Toxic Chemical Protection 

21 Act. 

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

23 under subparagraph (A)— 


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1 ‘‘(i) may impose different reporting 

2 and record retention requirements on man3 ufacturers and processors; 

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

5 necessary to be reported, including the 

6 manner by which use and exposure infor7 mation may be reported; and 

8 ‘‘(iii) shall require reporting of infor9 mation or maintenance of records where 

10 the Administrator determines the submis11 sion of reports would assist in the effective 

12 implementation of this Act. 

13 ‘‘(C) ADMINISTRATION.—In implementing 

14 this paragraph, the Administrator shall take 

15 measures to— 

16 ‘‘(i) limit the potential for duplication 

17 in reporting requirements; 

18 ‘‘(ii) minimize the impact of the rules 

19 on small manufacturers and processors; 

20 and 

21 ‘‘(iii) apply any reporting require22 ments to those persons likely to have infor23 mation relevant to the effective implemen24 tation of this title. 


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

3 to be reported under a rule promulgated under this 

4 subsection.’’; 

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

6 following: 

7 ‘‘(3) CHEMICAL SUBSTANCES IN COMMERCE.— 

8 ‘‘(A) RULE.— 

9 ‘‘(i) IN GENERAL.—Not later than 1 

10 year after the date of enactment of the 

11 Alan Reinstein and Trevor Schaefer Toxic 

12 Chemical Protection Act, the Adminis13 trator shall by rule require manufacturers 

14 and processors to notify the Administrator, 

15 not later than 180 days after the date of 

16 promulgation of the rule, of each chemical 

17 substance on the list published under para18 graph (1) that the manufacturer or proc19 essor, as applicable, has manufactured or 

20 processed for a nonexempt commercial pur21 pose during the 10-year period prior to the 

22 date of enactment of the Alan Reinstein 

23 and Trevor Schaefer Toxic Chemical Pro24 tection Act. 


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1 ‘‘(ii) CONSIDERATION AS ACTIVE SUB2 STANCE.—The Administrator shall con3 sider chemical substances for which notices 

4 are received under clause (i) to be active 

5 substances and shall, pursuant to para6 graph (4)(C), designate the chemical sub7 stance as an active substance on the list 

8 published under paragraph (1). 

9 ‘‘(B) CONFIDENTIAL CHEMICAL SUB10 STANCES.— 

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

12 shall maintain the list under paragraph 

13 (1), which shall include a confidential por14 tion and a nonconfidential portion con15 sistent with this section and section 14. 

16 ‘‘(ii) EXISTING CLAIM OF CONFIDEN17 TIALITY.—The rule promulgated under 

18 subparagraph (A) shall require a manufac19 turer or processor that is submitting a no20 tice pursuant to subparagraph (A) for a 

21 chemical substance on the confidential por22 tion of the list published under paragraph 

23 (1) to indicate in the notice whether the 

24 manufacturer or processor seeks to main25 tain any existing claim for protection 


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1 against disclosure of the specific identity of 

2 the substance as confidential pursuant to 

3 section 14. 

4 ‘‘(iii) SUBSTANTIATION.—The rule 

5 promulgated under subparagraph (A) shall 

6 require the substantiation of a claim de7 scribed in clause (ii) pursuant to section 

8 14 and in accordance with the review plan 

9 described in subparagraph (C). 

10 ‘‘(C) REVIEW PLAN AND REQUIRE11 MENTS.— 

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

13 year after the date on which the Adminis14 trator compiles the initial list of active sub15 stances pursuant to subparagraph (A), the 

16 Administrator shall develop a plan to re17 view all claims to protect the specific iden18 tity of a chemical substance on the con19 fidential portion of the list published under 

20 paragraph (1) that is identified as an ac21 tive substance in a report submitted pursu22 ant to subparagraph (A) or identified as 

23 active substances under paragraph (4)(A). 


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1 ‘‘(ii) CONTENTS.—The plan shall de2 scribe how the Administrator will carry out 

3 the requirements of this subparagraph. 

4 ‘‘(iii) REQUIREMENTS.—The Adminis5 trator shall— 

6 ‘‘(I) require, at a time deter7 mined by the Administrator, all man8 ufacturers or processors asserting a 

9 claim under subparagraph (B) to sub10 stantiate each such claim unless the 

11 manufacturer or processor has sub12 stantiated the claim in a submission 

13 made to the Administrator within 5 

14 years of the date of the Administra15 tor’s request; 

16 ‘‘(II) in accordance with the re17 quirements of section 14— 

18 ‘‘(aa) review each substan19 tiation— 

20 ‘‘(AA) submitted pursu21 ant to subclause (I) to deter22 mine if the claim warrants 

23 protection from disclosure; 

24 and 


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1 ‘‘(BB) submitted pre2 viously by a manufacturer or 

3 processor and relied on in 

4 lieu of the substantiation re5 quired pursuant to subclause 

6 (I), if such substantiation 

7 has not been previously re8 viewed by the Administrator, 

9 to determine if the claim 

10 warrants protection from 

11 disclosure; 

12 ‘‘(bb) approve, modify or 

13 deny each claim; and 

14 ‘‘(cc) except as provided in 

15 this section and section 14, pro16 tect from disclosure information 

17 for which the Administrator ap18 proves such a claim for a period 

19 of 10 years unless— 

20 ‘‘(AA) prior to the expi21 ration of the period, the per22 son notifies the Adminis23 trator that the person is 

24 withdrawing the confiden25 tiality claim, in which case, 


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1 the Administrator shall 

2 promptly make the informa3 tion available to the public; 

4 or 

5 ‘‘(BB) prior to the ex6 piration of the period, the 

7 Administrator otherwise be8 comes aware that the need 

9 for protection from disclo10 sure can no longer be sub11 stantiated, in which case the 

12 Administrator shall take the 

13 actions described in sub14 section (g)(2); and 

15 ‘‘(III) encourage manufacturers 

16 and processors that have previously 

17 made claims to protect the specific 

18 identities of chemical substances iden19 tified as inactive pursuant to para20 graph (4)(B) to review and either 

21 withdraw or substantiate such claims. 

22 ‘‘(D) TIMELINE FOR COMPLETION OF RE23 VIEWS.— 

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

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1 fied in subparagraph (C) not later than 5 

2 years after the date on which the Adminis3 trator compiles the initial list of active sub4 stances pursuant to subparagraph (A). 

5 ‘‘(ii) EXTENSION.—The Administrator 

6 may extend the deadline for completion of 

7 the reviews described in subparagraph (C) 

8 for up to a maximum of 2 additional years, 

9 after an adequate public justification, if 

10 the Administrator finds the extension is 

11 necessary based on the number of such 

12 claims needing review and the available re13 sources. 

14 ‘‘(iii) ANNUAL GOAL.—The Adminis15 trator shall publish an annual goal for the 

16 number of reviews to be completed over the 

17 course of implementation of the plan. 

18 ‘‘(E) NO CONFIDENTIALITY FOR UNLISTED

19 CHEMICALS.—The specific identity of any chem20 ical that is not on the confidential portion of 

21 the list published under paragraph (1) or subse22 quently added to the confidential portion of the 

23 list pursuant to section 14 shall not be eligible 

24 for protection from disclosure. 


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1 ‘‘(F) CERTIFICATION.—The Administrator 

2 shall require a manufacturer or processor— 

3 ‘‘(i) to certify the accuracy of each re4 port submitted or record maintained under 

5 this section; and 

6 ‘‘(ii) to retain documentation sup7 porting certification under clause (i) for a 

8 period of 5 years beginning on the last day 

9 of the submission period. 

10 ‘‘(4) ACTIVE AND INACTIVE SUBSTANCES.— 

11 ‘‘(A) ACTIVE SUBSTANCES.—For the pur12 poses of this section, the term ‘active substance’ 

13 means a chemical substance that— 

14 ‘‘(i) has been manufactured or proc15 essed for a nonexempt commercial purpose 

16 at any point during the 10-year period 

17 prior to the date of enactment of the Alan 

18 Reinstein and Trevor Schaefer Toxic 

19 Chemical Protection Act; or 

20 ‘‘(ii) that is added to the list pub21 lished under paragraph (1) after the date 

22 of enactment of the Alan Reinstein and 

23 Trevor Schaefer Toxic Chemical Protection 

24 Act. 


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1 ‘‘(B) INACTIVE SUBSTANCES.—For pur2 poses of this section, the term ‘inactive sub3 stance’ means a chemical substance on the list 

4 published under paragraph (1) that does not 

5 meet any of the criteria in subparagraph (A). 

6 ‘‘(C) LIST OF DESIGNATIONS.—The Ad7 ministrator shall maintain and keep current 

8 designations of active and inactive substances 

9 on the list published under paragraph (1). 

10 ‘‘(D) UPDATE.—The Administrator shall 

11 update the list of chemicals designated as active 

12 as soon as practicable following the publication 

13 of the most recent data reported under part 

14 711 of title 40, Code of Federal Regulations, 

15 and the rule promulgated under subsection 

16 (a)(4). 

17 ‘‘(E) CHANGE TO ACTIVE STATUS.— 

18 ‘‘(i) IN GENERAL.—Any person who 

19 intends to manufacture or process for a 

20 nonexempt commercial purpose a chemical 

21 substance that is designated as an inactive 

22 substance shall notify the Administrator 

23 not less than 90 days before the date on 

24 which the substance is manufactured or 

25 processed. 


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1 ‘‘(ii) CONFIDENTIAL CHEMICAL IDEN2 TITY CLAIMS.— 

3 ‘‘(I) IN GENERAL.—If a person 

4 submitting a notice under clause (i) 

5 for an inactive chemical substance on 

6 the confidential portion of the list 

7 published under paragraph (1) seeks 

8 to maintain an existing claim for pro9 tection against disclosure of the spe10 cific identity of the substance as con11 fidential, the person shall— 

12 ‘‘(aa) in the notice sub13 mitted under clause (i), assert 

14 the claim; and 

15 ‘‘(bb) substantiate the claim. 

16 ‘‘(II) NO CONFIDENTIALITY FOR

17 UNLISTED CHEMICALS.—The specific 

18 identity of any inactive chemical that 

19 is not on the confidential portion of 

20 the list published under paragraph (1) 

21 or subsequently added to the confiden22 tial portion of the list pursuant to sec23 tion 14 shall not be eligible for protec24 tion from disclosure. 


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1 ‘‘(iii) ACTIVE STATUS.—After receiv2 ing notification under clause (i), the Ad3 ministrator shall— 

4 ‘‘(I) designate the chemical sub5 stance as an active substance; 

6 ‘‘(II) pursuant to section 14, 

7 promptly review any claim and associ8 ated substantiation submitted pursu9 ant to clause (ii) for protection 

10 against disclosure of the specific iden11 tity of the substance and approve, 

12 modify, or deny the claim; 

13 ‘‘(III) except as provided in this 

14 section and section 14, protect from 

15 disclosure information for which the 

16 Administrator approves a claim under 

17 subclause (II) for a period of 10 years 

18 unless— 

19 ‘‘(aa) prior to the expiration 

20 of the 10-year period, the person 

21 notifies the Administrator that 

22 the person is withdrawing the 

23 confidentiality claim, in which 

24 case, the Administrator shall 


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1 promptly make the information 

2 available to the public; or 

3 ‘‘(bb) prior to the expiration 

4 of the 10-year period, the Admin5 istrator otherwise becomes aware 

6 that the need for protection from 

7 disclosure can no longer be sub8 stantiated, in which case the Ad9 ministrator shall take the actions 

10 described in subsection (g)(2); 

11 and 

12 ‘‘(IV) pursuant to section 4A, re13 view the priority of the chemical sub14 stance as the Administrator deter15 mines necessary. 

16 ‘‘(F) CATEGORY STATUS.—The list of inac17 tive chemical substances shall not be considered 

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

19 ‘‘(5) INTERIM LIST OF ACTIVE SUBSTANCES.— 

20 Prior to the promulgation of the rule required under 

21 this subsection, the Administrator shall designate 

22 those substances reported under part 711 of title 40, 

23 Code of Federal Regulations, during the reporting 

24 period that most closely preceded the date of enact25 ment of the Alan Reinstein and Trevor Schaefer 


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1 Toxic Chemical Protection Act, as the initial list of 

2 active substances for the purposes of section 4A. 

3 ‘‘(6) PUBLIC PARTICIPATION.—The Adminis4 trator shall make available to the public— 

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

6 substance on the nonconfidential portion of the 

7 list published under paragraph (1) that the Ad8 ministrator has designated as an active sub9 stance; 

10 ‘‘(B) the specific identity of each chemical 

11 substance on the nonconfidential portion of the 

12 list published under paragraph (1) that the Ad13 ministrator has designated as an inactive sub14 stance; 

15 ‘‘(C) the accession number, generic name, 

16 and, if applicable, premanufacture notice case 

17 number for each chemical substance on the con18 fidential portion of the list published under 

19 paragraph (1) for which a claim of confiden20 tiality was received and approved by the Admin21 istrator pursuant to section 14; 

22 ‘‘(D) subject to section 14, the specific 

23 identity of any active substance— 


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1 ‘‘(i) for which no claim of protection 

2 against disclosure of the specific identity 

3 pursuant to this subsection was received; 

4 ‘‘(ii) for which a claim for protection 

5 against disclosure of the specific identity of 

6 the substance has been denied by the Ad7 ministrator; or 

8 ‘‘(iii) for which the time period for 

9 protection against disclosure of the specific 

10 identity of the substance has expired; and 

11 ‘‘(E) any substance previously classified as 

12 an inactive substance that has been reclassified 

13 as an active substance.’’; and 

14 (3) in subsection (e)— 

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

16 the following: 

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

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

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

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

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

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


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1 SEC. 110. RELATIONSHIP TO OTHER FEDERAL LAWS. 

2 Section 9 (15 U.S.C. 2608) is amended— 

3 (1) in subsection (a)— 

4 (A) in the first sentence of paragraph 

5 (1)— 

6 (i) by striking ‘‘presents or will 

7 present an unreasonable risk to health or 

8 the environment’’ and inserting ‘‘does not 

9 meet the safety standard’’; and 

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

11 place it appears and inserting ‘‘the risk 

12 posed by the substance or mixture’’; 

13 (B) in paragraph (2), in the matter fol14 lowing subparagraph (B), by striking ‘‘section 6 

15 or 7’’ and inserting ‘‘subsections (b) or (c) of 

16 section 6, or section 7’’; and 

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

18 6 or 7’’ and inserting ‘‘section 6(d) or section 

19 7’’; and 

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

21 striking ‘‘Health, Education, and Welfare’’ and in22 serting ‘‘Health and Human Services’’. 


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1 SEC. 111. RESEARCH, DEVELOPMENT, COLLECTION, DIS2 SEMINATION, AND UTILIZATION OF DATA. 

3 Section 10 (15 U.S.C. 2609) is amended by striking 

4 ‘‘Health, Education, and Welfare’’ each place it appears 

5 and inserting ‘‘Health and Human Services’’. 

6 SEC. 112. EXPORTS. 

7 Section 12 (15 U.S.C. 2611) is amended— 

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

9 and inserting the following: 

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

11 apply to any chemical substance, mixture, or article 

12 that the Administrator determines— 

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

14 the safety standard; or 

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

16 safety standard. 

17 ‘‘(3) WAIVERS.—For a mixture or article con18 taining a chemical substance described in paragraph 

19 (2), the Administrator may— 

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

21 not apply to the mixture or article if the Ad22 ministrator finds that the chemical substance as 

23 contained in the mixture or article will meet the 

24 safety standard; and 

25 ‘‘(B) establish a threshold concentration of 

26 the chemical substance in a mixture or article 


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1 at which paragraph (1) shall not apply if the 

2 Administrator finds that at or below this con3 centration the substance as contained in the ar4 ticle or mixture will meet the safety standard. 

5 ‘‘(4) TESTING.—The Administrator may re6 quire testing under section 4 of any chemical sub7 stance or mixture exempted from this Act by para8 graph (1) for the purpose of determining whether or 

9 not the substance or mixture meets the safety stand10 ard within the United States.’’; 

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

12 following: 

13 ‘‘(b) NOTICE.— 

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

15 Administrator that the person is exporting or in16 tends to export to a foreign country— 

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

18 containing a chemical substance that the Ad19 ministrator has determined under section 5 is 

20 not likely to meet the safety standard and for 

21 which a notification, prohibition, or restriction 

22 has been proposed or established under that 

23 section; 

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

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1 ministrator has determined under section 6 

2 does not meet the safety standard and for 

3 which a notification, prohibition, or restriction 

4 has been proposed or established under that 

5 section; 

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

7 United States is obligated by treaty to provide 

8 export notification; 

9 ‘‘(D) a chemical substance or mixture sub10 ject to a prohibition or restriction pursuant to 

11 a rule, order, or consent agreement in effect 

12 under this Act; 

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

14 which the submission of information is required 

15 under section 4; or 

16 ‘‘(F) a chemical substance or mixture con17 taining a chemical substance with respect to 

18 which an action is pending, or relief has been 

19 granted under section 7. 

20 ‘‘(2) REGULATIONS.— 

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

22 shall promulgate regulations to carry out para23 graph (1). 

24 ‘‘(B) CONTENTS.—The regulations pro25 mulgated under subparagraph (A) shall include 


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1 any exemptions the Administrator determines 

2 to be appropriate, which may include exemp3 tions identified under section 5(g). 

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

5 submit to the government of each country to which 

6 a chemical substance or mixture is exported— 

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

8 described in paragraph (1)(E), a notice of avail9 ability of the information on the chemical sub10 stance or mixture submitted to the Adminis11 trator; 

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

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

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

15 rule, order, consent agreement, requirement, 

16 designation, action, or relief; and 

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

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

21 (3) in subsection (c)— 

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

23 (B) by redesignating paragraphs (4) 

24 through (6) as paragraphs (3) through (5), re25 spectively. 


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1 SEC. 113. IMPORTS. 

2 Section 13 (15 U.S.C. 2612) is amended to read as 

3 follows: 

4 ‘‘SEC. 13. IMPORTS. 

5 ‘‘(a) REFUSAL OF ENTRY.— 

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

7 Security shall refuse entry into the customs territory 

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

9 to the Harmonized Tariff Schedule of the United 

10 States) any chemical substance, mixture, or article 

11 containing a chemical substance or mixture offered 

12 for entry if— 

13 ‘‘(A) the Administrator— 

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

15 that the chemical substance, mixture or ar16 ticle does not meet the safety standard; 

17 and 

18 ‘‘(ii) has promulgated a rule under 

19 section 6(d) banning the chemical sub20 stance, mixture, or article, as of the effec21 tive date of the rule; 

22 ‘‘(B) the chemical substance— 

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

24 section 8(b)(1); and 

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1 tion 8(b)(1) by this title or a rule issued 

2 by the Administrator under this title; or 

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

4 any article containing the chemical substance or 

5 mixture fails to comply with any requirement in 

6 effect under this Act or is offered for entry in 

7 violation of a rule, consent agreement, or order 

8 in effect under this Act or an order issued in 

9 a civil action brought under section 7 or title 

10 IV. 

11 ‘‘(2) PROCEDURE.— 

12 ‘‘(A) IN GENERAL.—Subject to subpara13 graph (B), if a chemical substance, mixture, or 

14 article containing a chemical substance or mix15 ture is refused entry under paragraph (1), the 

16 Secretary of Homeland Security— 

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

18 entry of the refusal; 

19 ‘‘(ii) shall not release the chemical 

20 substance or mixture to the consignee; and 

21 ‘‘(iii) shall cause the disposal or stor22 age of the chemical substance or mixture 

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1 signee in the 90-day period beginning on 

2 the date of receipt of the notice of the re3 fused entry. 

4 ‘‘(B) EXCEPTION.— 

5 ‘‘(i) IN GENERAL.—The Secretary of 

6 Homeland Security may, pending a review 

7 by the Administrator, release to the con8 signee the chemical substance or mixture if 

9 the consignee— 

10 ‘‘(I) executes a bond for the 

11 amount of the full invoice of the 

12 chemical substance or mixture (as set 

13 forth in the customs entry); and 

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

15 substance or mixture. 

16 ‘‘(ii) ADMINISTRATION.—If a con17 signee fails to return a chemical substance 

18 or mixture released to that consignee 

19 under clause (i) for any cause to the cus20 tody of the Secretary of Homeland Secu21 rity when demanded, the consignee shall be 

22 liable to the United States for liquidated 

23 damages equal to the full amount of the 

24 bond. 


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

2 cartage, and labor on and for the disposal of a 

3 chemical substance or mixture that is refused 

4 entry or released under this subsection shall be 

5 paid by the owner or consignee, and a default 

6 on that payment shall constitute a lien against 

7 any future entry made by the owner or con8 signee. 

9 ‘‘(b) CERTIFICATION.— 

10 ‘‘(1) IN GENERAL.—A person offering a chem11 ical substance or mixture subject to this Act for 

12 entry into the customs territory of the United States 

13 shall certify to the Secretary of Homeland Security 

14 that the chemical substance or mixture is in compli15 ance with any applicable rule, consent agreement, or 

16 order under section 5 or 6, and that the chemical 

17 substance— 

18 ‘‘(A) is included on the list under section 

19 8(b)(1); or 

20 ‘‘(B) is exempt from any requirement to be 

21 included on the list under section 8(b)(1) by 

22 this title or a rule issued by the Administrator 

23 under this title. 

24 ‘‘(2) ARTICLES.—The Administrator may, by 

25 rule, require certification under paragraph (1) for an 


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1 article containing a chemical substance or mixture 

2 that is subject to regulation under section 5 or 6. 

3 ‘‘(3) CONTENT OF CERTIFICATION RULE.—In 

4 determining the need for and content of a certifi5 cation rule under this subsection, the Administrator 

6 may consider— 

7 ‘‘(A) the utility of such certification to the 

8 enforcement of the applicable rule, consent 

9 agreement, or order under section 5 or 6; 

10 ‘‘(B) the frequency of the certification re11 quirement; and 

12 ‘‘(C) if applicable, specification of the con13 centration of a chemical substance in an article 

14 that would subject the article to the certifi15 cation requirement. 

16 ‘‘(4) PUBLIC INFORMATION.—For purposes of 

17 this section, the Administrator shall provide publicly 

18 accessible information on the identity of a chemical 

19 substance or mixture subject to regulation under 

20 this Act that would be readily understood in import 

21 transactions. 

22 ‘‘(c) NOTICE.—A person offering a chemical sub23 stance for entry into the customs territory of the United 

24 States shall notify the Secretary of Homeland Security 

25 if— 


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1 ‘‘(1) the chemical substance or chemical sub2 stance in a mixture is a high-priority substance; 

3 ‘‘(2) the chemical substance or chemical sub4 stance in a mixture is one for which the United 

5 States is obligated to provide export notification by 

6 treaty; or 

7 ‘‘(3) the chemical substance or chemical sub8 stance in a mixture is the subject of a safety assess9 ment and safety determination conducted pursuant 

10 to section 6(d) and has been found not to meet the 

11 safety standard. 

12 ‘‘(d) RULES.— 

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

14 Security, after consultation with the Administrator, 

15 shall issue rules for the administration of this sec16 tion. 

17 ‘‘(2) CONTENT.—A rule issued under para18 graph (1) may tailor the application of any require19 ment in this section, as appropriate for the efficient 

20 and effective implementation of this Act.’’. 

21 SEC. 114. CONFIDENTIAL INFORMATION. 

22 Section 14 (15 U.S.C. 2613) is amended— 

23 (1) by striking the heading ‘‘DISCLOSURE OF

24 DATA’’ and inserting ‘‘CONFIDENTIAL INFORMA25 TION’’; 


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1 (2) by striking subsection (c) and redesignating 

2 subsection (b) as subsection (c); 

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

4 following: 

5 ‘‘SEC. 14. CONFIDENTIAL INFORMATION. 

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

7 this section, the Administrator shall not disclose informa8 tion that is exempt from disclosure pursuant to section 

9 552 of title 5, United States Code, under subsection (b)(4) 

10 of that section— 

11 ‘‘(1) that is reported to, or otherwise obtained 

12 by, the Administrator under this Act; and 

13 ‘‘(2) for which the requirements of subsection 

14 (d) are met. 

15 ‘‘(b) INFORMATION GENERALLY PROTECTED FROM

16 DISCLOSURE.— 

17 ‘‘(1) IN GENERAL.—The information described 

18 in paragraph (2) specific to and submitted by a 

19 manufacturer, processor, or distributor that meets 

20 the requirements of subsection (d) shall be protected 

21 from disclosure, except that— 

22 ‘‘(A) such information may be disclosed in 

23 accordance with subsection (e); 


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1 ‘‘(B) such information is subject to the re2 view and substantiation requirements in sub3 section (f)(2); and 

4 ‘‘(C) nothing in this Act shall operate to 

5 prohibit the disclosure of such information 

6 through discovery, subpoena, other court or7 ders, or any other judicial process otherwise al8 lowed under applicable State or Federal laws. 

9 ‘‘(2) PROTECTED INFORMATION.—Information 

10 subject to paragraph (1) shall include— 

11 ‘‘(A) specific information describing the 

12 processes used in manufacture or processing of 

13 a chemical substance, mixture, or article; 

14 ‘‘(B) marketing and sales plans and strate15 gies; 

16 ‘‘(C) information identifying suppliers or 

17 customers; 

18 ‘‘(D) the percentages of the components of 

19 a mixture; 

20 ‘‘(E) specific information about the use, 

21 function, or application of a chemical substance 

22 or mixture in a process, mixture, or product; 

23 ‘‘(F) specific production or import volumes 

24 of the manufacturer, and specific aggregated 

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1 trator determines that disclosure of the specific 

2 aggregated volumes would reveal confidential 

3 information; and 

4 ‘‘(G) except as otherwise provided in this 

5 section, the specific identity of a chemical sub6 stance prior to the date on which it was in7 cluded on the list under section 8(b)(1), includ8 ing the chemical name, molecular formula, 

9 Chemical Abstracts Service number, and other 

10 information that would identify a specific chem11 ical substance, if— 

12 ‘‘(i) the specific identity was claimed 

13 as confidential information at the time it 

14 was submitted to the Administrator in a 

15 notice under section 5; 

16 ‘‘(ii) the claim has not subsequently 

17 been withdrawn or found by the Adminis18 trator not to warrant protection as con19 fidential information under subsection (e), 

20 (f)(2), or (g); and 

21 ‘‘(iii) the substance is not an active 

22 substance under section 8(b)(4) of this 

23 Act.’’; 

24 (4) by striking the heading ‘‘DATA FROM

25 HEALTH AND SAFETY STUDIES’’ in subsection (c) 


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1 (as so redesignated) and inserting ‘‘INFORMATION

2 NOT PROTECTED FROM DISCLOSURE.—Notwith3 standing subsections (a) and (b), the following infor4 mation shall not be protected from disclosure:’’; 

5 (5) by inserting at the end of subsection (c) (as 

6 so redesignated) the following: 

7 ‘‘(3) OTHER INFORMATION NOT PROTECTED

8 FROM DISCLOSURE.—Information shall not be pro9 tected from disclosure under this section if it is— 

10 ‘‘(A) for information submitted after the 

11 date of enactment of the Alan Reinstein and 

12 Trevor Schaefer Toxic Chemical Protection Act, 

13 the specific identity of a chemical substance as 

14 of the date on which it is included on the list 

15 under section 8(b)(1), if the person submitting 

16 the information does not meet the requirements 

17 of subsection (d); 

18 ‘‘(B) a safety assessment developed or a 

19 safety determination made under section 6; 

20 ‘‘(C) general information describing the 

21 manufacturing volumes, expressed as specific 

22 aggregated volumes or, when the Administrator 

23 determines that disclosure of specific aggre24 gated volumes would reveal confidential infor25 mation, expressed in ranges; or 


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1 ‘‘(D) general descriptions of the processes 

2 used in manufacture or processing and indus3 trial, commercial, or consumer functions and 

4 uses of a chemical substance, mixture, or article 

5 containing a chemical substance or mixture, in6 cluding information specific to an industry or 

7 industry sector that would be customarily 

8 shared with the general public or within an in9 dustry or industry sector. 

10 ‘‘(4) EXCEPTION.—Information elements that 

11 are otherwise eligible for protection under this sec12 tion that are contained in submissions of informa13 tion described in paragraph (1) shall be protected 

14 from disclosure if the submitter complies with sub15 section (d), but information in such submissions de16 scribed in paragraph (1) that is not eligible for pro17 tection against disclosure shall be disclosed. 

18 ‘‘(5) NO CONFIDENTIALITY FOR UNLISTED

19 CHEMICALS.—Except as provided in the second sen20 tence of paragraph (1), the specific identity of any 

21 chemical that is not on the confidential portion of 

22 the list published under section 8(b)(1) or subse23 quently added to the confidential portion of the list 

24 pursuant to this section shall not be eligible for pro25 tection from disclosure. 


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1 ‘‘(6) BAN OR PHASE-OUT.—If the Adminis2 trator promulgates a rule pursuant to section 6(d) 

3 that establishes a ban or phase out on the manufac4 ture, processing, or distribution in commerce of a 

5 chemical substance, any protection from disclosure 

6 provided under section 14 applicable for information 

7 on the chemical substance shall no longer apply and 

8 the Administrator shall promptly make the informa9 tion public. 

10 ‘‘(d) REQUIREMENTS FOR CONFIDENTIALITY

11 CLAIMS.— 

12 ‘‘(1) ASSERTION OF CLAIMS.— 

13 ‘‘(A) IN GENERAL.—A person seeking to 

14 protect any information submitted under this 

15 Act from disclosure (including information de16 scribed in subsection (b)) shall assert a claim 

17 for such protection to the Administrator at the 

18 time of the submission of the information, pur19 suant to rules applicable to a claim for protec20 tion from disclosure that the Administrator has 

21 promulgated under this title. 

22 ‘‘(B) CONTENTS OF CLAIM.—An assertion 

23 of a claim under subparagraph (A) shall include 

24 a statement that the person has— 


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1 ‘‘(i) taken reasonable measures to pro2 tect the confidentiality of the information; 

3 ‘‘(ii) determined that the information 

4 is not required to be disclosed, or otherwise 

5 made available, to the public under any 

6 other Federal law in connection with 1 or 

7 more uses subject to this Act; 

8 ‘‘(iii) a reasonable basis to conclude 

9 that disclosure of the information is likely 

10 to cause substantial harm to the competi11 tive position of the person; and 

12 ‘‘(iv) a reasonable basis to believe that 

13 the information is not readily otherwise 

14 publicly available or discoverable through 

15 reverse engineering. 

16 ‘‘(C) SPECIFIC CHEMICAL IDENTITY.—In 

17 the case of a claim under subparagraph (A) for 

18 protection against disclosure of a specific chem19 ical identity, the claim shall include a struc20 turally descriptive generic name for the chem21 ical substance that the Administrator may dis22 close to the public, subject to the conditions 

23 that— 


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1 ‘‘(i) the generic name conforms with 

2 guidance prescribed by the Administrator 

3 under paragraph (3)(A); and 

4 ‘‘(ii) describes the chemical structure 

5 of the substance as specifically as possible 

6 while protecting those features of the 

7 chemical structure that are considered con8 fidential and the disclosure of which would 

9 potentially harm the competitive position 

10 of the person. 

11 ‘‘(2) ADDITIONAL REQUIREMENTS FOR CON12 FIDENTIALITY CLAIMS.—Except for information de13 scribed in subsection (b)(2), a person asserting a 

14 claim to protect information from disclosure under 

15 this Act shall, in accordance with the rules promul16 gated and guidance issued by the Administrator, 

17 substantiate that the information meets the require18 ments for protection pursuant to section 552 of title 

19 5, United States Code, under subsection (b)(4) of 

20 that section. 

21 ‘‘(3) GUIDANCE.—The Administrator shall de22 velop guidance on— 

23 ‘‘(A) the determination of structurally de24 scriptive generic names, in the case of claims 


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1 for the protection against disclosure of specific 

2 chemical identity; and 

3 ‘‘(B) the content and form of the state4 ments of need and agreements required under 

5 paragraphs (4), (5) and (6) of subsection (e). 

6 ‘‘(4) CERTIFICATION.—An authorized official of 

7 the person described in paragraph (1)(A) shall cer8 tify that the statements and information included in 

9 assertions and substantiations of claims for protec10 tion submitted under this subsection are true and 

11 correct. 

12 ‘‘(e) EXCEPTIONS TO PROTECTION FROM DISCLO13 SURE.—Information described in subsection (a) (including 

14 information subject to subsection (b)) shall be disclosed 

15 if— 

16 ‘‘(1) the information is to be disclosed to an of17 ficer or employee of the United States in connection 

18 with the official duties of that person under any law 

19 for the protection of human health or the environ20 ment or for specific law enforcement purposes; 

21 ‘‘(2) the information is to be disclosed to a con22 tractor with the United States and employees of that 

23 contractor if, in the opinion of the Administrator, 

24 the disclosure is necessary for the satisfactory per25 formance by the contractor of a contract with the 


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1 United States for the performance of work in con2 nection with this Act and under such conditions as 

3 the Administrator shall specify; 

4 ‘‘(3) the Administrator determines that disclo5 sure is necessary to protect human health or the en6 vironment; 

7 ‘‘(4) the information is to be disclosed to a 

8 State or political subdivision of a State, on written 

9 request, for the purpose of development, administra10 tion, or enforcement of a law, if— 

11 ‘‘(A) 1 or more applicable agreements with 

12 the Administrator that conform with the guid13 ance issued under subsection (d)(3)(B) ensure 

14 that the recipient government will take appro15 priate steps, and has adequate authority, to 

16 maintain the confidentiality of the information 

17 in accordance with procedures comparable to 

18 those which the Administrator uses to safe19 guard the information; and 

20 ‘‘(B) the Administrator notifies the person 

21 who submitted the information that the infor22 mation has been disclosed to a State or political 

23 subdivision of a State; 

24 ‘‘(5) a health or environmental professional em25 ployed by a Federal or State agency or a treating 


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1 physician or nurse in a nonemergency situation pro2 vides a written statement of need and agrees to sign 

3 a written confidentiality agreement with the Admin4 istrator that conforms with the guidance issued 

5 under subsection (d)(3)(B), subject to the conditions 

6 that— 

7 ‘‘(A) the written statement of need is a 

8 statement that the person has a reasonable 

9 basis to suspect that— 

10 ‘‘(i) the information is necessary for 

11 or will assist in diagnosis or treatment of 

12 1 or more individuals or in responding to 

13 an environmental release or exposure; and 

14 ‘‘(ii) 1 or more individuals being diag15 nosed or treated have been exposed to the 

16 chemical substance concerned, or an envi17 ronmental release or exposure has oc18 curred; and 

19 ‘‘(B) the confidentiality agreement pro20 vides that the person will not use the informa21 tion for any purpose other than the health or 

22 environmental needs asserted in the statement 

23 of need, except as may otherwise be authorized 

24 by the terms of the agreement or by the person 

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1 trator, except that nothing in this Act shall op2 erate to prohibit the disclosure of such informa3 tion through discovery, subpoena, and other 

4 court orders, or any other judicial process oth5 erwise allowed under applicable State or Fed6 eral laws; 

7 ‘‘(6) in the event of an emergency, a treating 

8 physician, nurse, agent of a poison control center, 

9 public health or environmental official of a State or 

10 political subdivision of a State, or first responder re11 quests the information, subject to the conditions 

12 that— 

13 ‘‘(A) the treating physician, nurse, agent, 

14 public health or environmental official of a 

15 State or a political subdivision of a State, or 

16 first responder has a reasonable basis to sus17 pect that— 

18 ‘‘(i) a medical or public health or en19 vironmental emergency exists; 

20 ‘‘(ii) the information is necessary for 

21 or will assist in emergency or first-aid di22 agnosis or treatment; and 

23 ‘‘(iii) 1 or more individuals being di24 agnosed or treated have likely been ex25 posed to the chemical substance concerned, 


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1 or a serious environmental release of or ex2 posure to the chemical substance con3 cerned has occurred; and 

4 ‘‘(B) if requested by the person submitting 

5 the information to the Administrator, the treat6 ing physician, nurse, agent, public health or en7 vironmental official of a State or a political sub8 division of a State, or first responder provides 

9 a written statement of need and agrees to sign 

10 a confidentiality agreement as described in 

11 paragraph (5); and 

12 ‘‘(C) the written confidentiality agreement 

13 or statement of need is submitted as soon as 

14 practicable, but not necessarily before the infor15 mation is disclosed; 

16 ‘‘(7) the Administrator determines that disclo17 sure is relevant in a proceeding under this Act, sub18 ject to the condition that the disclosure is made in 

19 such a manner as to preserve confidentiality to the 

20 maximum extent practicable without impairing the 

21 proceeding; 

22 ‘‘(8) the information is to be disclosed, on writ23 ten request of any duly authorized committee of the 

24 Congress, to that committee; 

25 ‘‘(9) the information is publicly available; or 


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1 ‘‘(10) the information is required to be dis2 closed or otherwise made public under any other 

3 Federal law. 

4 ‘‘(f) DURATION OF PROTECTION FROM DISCLO5 SURE.— 

6 ‘‘(1) IN GENERAL.— 

7 ‘‘(A) INFORMATION PROTECTED FROM DIS8 CLOSURE.—Subject to paragraph (2) and ex9 cept as allowed under subsection (e), the Ad10 ministrator shall protect from disclosure infor11 mation that meets the requirements of sub12 section (d) for a period of 10 years, unless— 

13 ‘‘(i) prior to the expiration of the 10- 

14 year period, the person notifies the Admin15 istrator that the person is withdrawing the 

16 confidentiality claim, in which case, the 

17 Administrator shall promptly make the in18 formation available to the public; 

19 ‘‘(ii) prior to the expiration of the 10- 

20 year period, the Administrator otherwise 

21 becomes aware that the need for protection 

22 from disclosure can no longer be substan23 tiated, in which case the Administrator 

24 shall take the actions described in sub25 section (g)(2); or 


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1 ‘‘(iii) the Administrator denies the 

2 claim under subsection (g)(1). 

3 ‘‘(B) EXTENSIONS.— 

4 ‘‘(i) IN GENERAL.—Not less than 60 

5 days prior to the expiration of the period 

6 described in subparagraph (A), the Admin7 istrator shall provide notice of the impend8 ing expiration of the period to the person 

9 who asserted the claim. 

10 ‘‘(ii) SUBMISSION TO REASSERT A

11 CLAIM.—Not less than 30 days prior to ex12 piration of the period described in subpara13 graph (A), the person reasserting the claim 

14 shall submit a statement substantiating, in 

15 accordance with subsection (d)(2), the 

16 need to extend the period. 

17 ‘‘(iii) REVIEW.—Not later than 30 

18 days of receipt of the statement described 

19 in clause (ii), the Administrator shall— 

20 ‘‘(I) review the request and make 

21 a determination as to whether the in22 formation for which the request is 

23 made continues to meet the relevant 

24 criteria established in this section; and 


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1 ‘‘(II)(aa) grant an extension not 

2 to exceed 10 years; or 

3 ‘‘(bb) deny the claim. 

4 ‘‘(C) LIMIT ON NUMBER OF EXTEN5 SIONS.—There shall be no limit on the number 

6 of extensions granted under subparagraph (B) 

7 as long as the Administrator finds that the sub8 stantiation establishes the need to extend the 

9 period and meets the requirements established 

10 by the Administrator, and that the length of 

11 any extension does not exceed 10 years. 

12 ‘‘(2) REVIEW AND RESUBSTANTIATION.— 

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

14 may at any time review a claim for protection 

15 against disclosure under subsection (a) for in16 formation submitted to the Administrator on a 

17 chemical substance (including information de18 scribed in subsection (b)(2)), and may require 

19 any person who has claimed protection for that 

20 information, whether before or after the date of 

21 enactment of the Alan Reinstein and Trevor 

22 Schaefer Toxic Chemical Protection Act, to 

23 withdraw or reassert and substantiate or re24 substantiate the claim in conformance with the 

25 requirements of this section— 


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1 ‘‘(i) after the chemical substance is 

2 identified as a high-priority substance 

3 under section 4A; 

4 ‘‘(ii) for any chemical substance for 

5 which the Administrator has made a deter6 mination under section 6(c)(1) (B) or (C); 

7 ‘‘(iii) for any inactive chemical sub8 stance identified pursuant to section 

9 8(b)(4); 

10 ‘‘(iv) if the Administrator determines 

11 that disclosure of certain information cur12 rently protected from disclosure would as13 sist the Administrator in conducting safety 

14 assessments and determinations under sec15 tion 6 (b) and (c) or promulgating rules 

16 under section 6(d); 

17 ‘‘(v) if necessary to comply with a re18 quest for information the Administrator re19 ceives pursuant to section 552 of title 5, 

20 United States Code; 

21 ‘‘(vi) if information available to the 

22 Administrator provides a basis that the re23 quirements of subsection (b)(4) of section 

24 552 of title 5, United States Code, are no 

25 longer met; or 


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1 ‘‘(vii) for information contained in a 

2 notice of substantial risk submitted under 

3 section 8(e). 

4 ‘‘(B) RESUBSTANTIATION.—If the Admin5 istrator makes a request under subparagraph 

6 (A), the person receiving the request shall— 

7 ‘‘(i) resubstantiate the claim; or 

8 ‘‘(ii) withdraw the claim. 

9 ‘‘(C) EXTENSION.—Protection from disclo10 sure of the information subject to a claim that 

11 is reviewed and approved by the Administrator 

12 under this paragraph shall be extended for a 

13 period of 10 years from the date of approval, 

14 subject to any subsequent request by the Ad15 ministrator under this paragraph. 

16 ‘‘(3) UNIQUE IDENTIFIER.—The Administrator 

17 shall— 

18 ‘‘(A) develop a system to assign a unique 

19 identifier to each specific chemical identity for 

20 which the Administrator approves a request for 

21 protection from disclosure, other than a specific 

22 chemical identity or structurally descriptive ge23 neric term, and apply such identifier consist24 ently to all information relevant to such sub25 stance; 


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1 ‘‘(B) annually publish and update a list of 

2 substances for which claims to protect specific 

3 chemical identity from disclosure have been ap4 proved, referred to by unique identifier, includ5 ing the expiration date for each such claim; 

6 ‘‘(C) ensure that any nonconfidential infor7 mation received by the Administrator with re8 spect to such a substance during the period of 

9 protection from disclosure is made public and 

10 identifies the substance using the unique identi11 fier; and 

12 ‘‘(D) for each claim for protection of spe13 cific chemical identity that has been denied by 

14 the Administrator, upon expiration of the pe15 riod for appeal under subsection (g)(3), that 

16 has expired, or that has been withdrawn by the 

17 submitter, provide public access to the specific 

18 chemical identity clearly linked to all noncon19 fidential information received by the Adminis20 trator with respect to the substance. 

21 ‘‘(g) DUTIES OF THE ADMINISTRATOR.— 

22 ‘‘(1) DETERMINATION.— 

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

24 subsection (b), the Administrator shall, subject 

25 to subparagraph (C), not later than 90 days 


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1 after the receipt of a claim under subsection 

2 (d), and not later than 30 days after the receipt 

3 of a request for extension of a claim under sub4 section (f), review and approve, modify, or deny 

5 the claim or request. 

6 ‘‘(B) DENIAL OR MODIFICATION.— 

7 ‘‘(i) IN GENERAL.—Except as pro8 vided in subsections (c) and (f), the Ad9 ministrator shall deny a claim to protect a 

10 chemical identity from disclosure only if 

11 the person who has submitted the claim 

12 fails to meet the requirements of sub13 sections (a) and (d). 

14 ‘‘(ii) REASONS FOR DENIAL OR MODI15 FICATION.—The Administrator shall pro16 vide to the person who has submitted the 

17 claim a written statement of the reasons 

18 for the denial or modification of the claim. 

19 ‘‘(C) SUBSETS.—The Administrator 

20 shall— 

21 ‘‘(i) except for claims described in 

22 subsection (b)(7), review all claims under 

23 this section for the protection against dis24 closure of the specific identity of a chem25 ical substance; and 


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1 ‘‘(ii) review a representative subset, 

2 comprising at least 25 percent, of all other 

3 claims for protection against disclosure. 

4 ‘‘(D) EFFECT OF FAILURE TO ACT.—The 

5 failure of the Administrator to make a decision 

6 on a claim for protection against disclosure or 

7 extension under this section shall not be the 

8 basis for denial or elimination of a claim for 

9 protection against disclosure. 

10 ‘‘(2) NOTIFICATION.— 

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

12 subparagraph (B) and subsections (c), (e), and 

13 (f), if the Administrator denies or modifies a 

14 claim under paragraph (1), the Administrator 

15 shall notify, in writing and by certified mail, the 

16 person who submitted the claim of the intent of 

17 the Administrator to release the information. 

18 ‘‘(B) RELEASE OF INFORMATION.— 

19 ‘‘(i) IN GENERAL.—Except as pro20 vided in clause (ii), the Administrator shall 

21 not release information under this sub22 section until the date that is 30 days after 

23 the date on which the person who sub24 mitted the request receives notification 

25 under subparagraph (A). 


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1 ‘‘(ii) EXCEPTIONS.— 

2 ‘‘(I) IN GENERAL.—For informa3 tion under paragraph (3) or (8) of 

4 subsection (e), the Administrator shall 

5 not release that information until the 

6 date that is 15 days after the date on 

7 which the person who submitted the 

8 claim receives a notification, unless 

9 the Administrator determines that re10 lease of the information is necessary 

11 to protect against an imminent and 

12 substantial harm to human health or 

13 the environment, in which case, no 

14 prior notification is necessary. 

15 ‘‘(II) NO NOTIFICATION.—For 

16 information under paragraph (1), (2), 

17 (6), (7), (9) or (10) of subsection (e), 

18 no prior notification is necessary. 

19 ‘‘(3) APPEALS.— 

20 ‘‘(A) IN GENERAL.—A person who receives 

21 a notification under paragraph (2) may, if the 

22 person believes disclosure of the information is 

23 prohibited under subsection (a), before the date 

24 on which the information is to be released, 


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1 bring an action to restrain disclosure of the in2 formation in— 

3 ‘‘(i) the district court of the United 

4 States in the district in which the com5 plainant resides or has the principal place 

6 of business; or 

7 ‘‘(ii) the United States District Court 

8 for the District of Columbia. 

9 ‘‘(B) NO DISCLOSURE.—The Adminis10 trator shall not disclose any information that is 

11 the subject of an appeal under this section prior 

12 to the date on which the applicable court rules 

13 on an action under subparagraph (A). 

14 ‘‘(4) ADMINISTRATION.—In carrying out this 

15 subsection, the Administrator shall employ the pro16 cedures in part 2 of title 40, Code of Federal Regu17 lations (or successor regulations). 

18 ‘‘(h) CRIMINAL PENALTY FOR WRONGFUL DISCLO19 SURE.— 

20 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

21 any officer or employee of the United States or 

22 former officer or employee of the United States 

23 who— 

24 ‘‘(A) by virtue of that employment or offi25 cial position has obtained possession of, or has 


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1 access to, material the disclosure of which is 

2 prohibited by subsection (a); and 

3 ‘‘(B) knowing that disclosure of that mate4 rial is prohibited by subsection (a), willfully dis5 closes the material in any manner to any person 

6 not entitled to receive that material, shall be 

7 guilty of a misdemeanor and fined under title 

8 18, United States Code, imprisoned for not 

9 more than 1 year, or both. 

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 the purposes of this 

16 subsection, any contractor of the United States who 

17 is furnished information in accordance with sub18 section (e)(2), including any employee of that con19 tractor, shall be considered to be an employee of the 

20 United States. 

21 ‘‘(i) APPLICABILITY.— 

22 ‘‘(1) Except as otherwise provided by this sec23 tion, section 8, or any other Federal law, the Admin24 istrator shall have no authority— 


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1 ‘‘(A) to require the substantiation or re2 substantiation of a claim for the protection 

3 from disclosure of information submitted to the 

4 Administrator under this Act prior to the date 

5 of enactment of the Alan Reinstein and Trevor 

6 Schaefer Toxic Chemical Protection Act; or 

7 ‘‘(B) to impose substantiation or re8 substantiation requirements under this Act that 

9 are more extensive than those required under 

10 this section. 

11 ‘‘(2) PRIOR ACTIONS.—Nothing in this Act pre12 vents the Administrator from reviewing, requiring 

13 substantiation or resubstantiation for, or approving, 

14 modifying or denying any claim for the protection 

15 from disclosure of information prior to the effective 

16 date of rules applicable to such claims that the Ad17 ministrator may promulgate after the date of enact18 ment of the Alan Reinstein and Trevor Schaefer 

19 Toxic Chemical Protection Act. 

20 ‘‘(j) DEFINITION OF FIRST RESPONDER.—For the 

21 purposes of this section, the term ‘first responder’ means 

22 a person duly authorized by a State or political subdivision 

23 of a State or a Federal agency, trained in urgent medical 

24 care or other emergency procedures, including a police of25 ficer, firefighter, or emergency medical technician.’’. 


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1 SEC. 115. PROHIBITED ACTS. 

2 Section 15 (15 U.S.C. 2614) is amended by striking 

3 paragraph (1) and inserting the following: 

4 ‘‘(1) fail or refuse to comply with— 

5 ‘‘(A) any rule promulgated, consent agree6 ment entered into, or order issued under section 

7 4; 

8 ‘‘(B) any requirement prescribed by section 

9 5 or 6; 

10 ‘‘(C) any rule promulgated, consent agree11 ment entered into, or order issued under section 

12 5 or 6; 

13 ‘‘(D) any requirement of title II or any 

14 rule promulgated or order issued under title II; 

15 or 

16 ‘‘(E) any requirement of title VI or any 

17 rule promulgated or order issued under title 

18 VI;’’. 

19 SEC. 116. PENALTIES. 

20 Section 16 (15 U.S.C. 2615) is amended— 

21 (1) in subsection (a)— 

22 (A) in paragraph (1)— 

23 (i) in the first sentence— 

24 (I) by inserting ‘‘this Act or a 

25 rule or order promulgated or issued 


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1 pursuant to this Act, as described in’’ 

2 after ‘‘a provision of’’; and 

3 (II) by striking ‘‘$25,000’’ and 

4 inserting ‘‘$37,500’’; and 

5 (ii) in the second sentence, by striking 

6 ‘‘violation of section 15 or 409’’ and in7 serting ‘‘violation of this Act’’; and 

8 (2) in subsection (b)— 

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

10 the following: 

11 ‘‘(1) IN GENERAL.—Any person’’; 

12 (B) by striking ‘‘section 15 or 409’’ and 

13 inserting ‘‘this Act’’; 

14 (C) by striking ‘‘$25,000’’ and inserting 

15 ‘‘$50,000’’; and 

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

17 ‘‘(2) IMMINENT DANGER OF DEATH OR SERIOUS

18 BODILY INJURY.—Any person who knowingly or will19 fully violates any provision of this Act, and who 

20 knows at the time of the violation that the violation 

21 places another person in imminent danger of death 

22 or serious bodily injury shall be subject, upon convic23 tion, to a fine of not more than $250,000, imprison24 ment for not more than 15 years, or both. Any per25 son committing such violation which is an organizaVerDate Sep 11 2014 04:07 Mar 18, 2015 Jkt 049200 PO 00000 Frm 00129 Fmt 6652 Sfmt 6201 E:\BILLS\S725.IS S725

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1 tion shall, upon conviction under this paragraph, be 

2 subject to a fine of not more than $1,000,000 for 

3 each violation. 

4 ‘‘(3) KNOWLEDGE OF IMMINENT DANGER OR

5 INJURY.—In determining whether a defendant knew 

6 that the violation placed another person in imminent 

7 danger of death or serious bodily injury, the defend8 ant is responsible only for actual awareness or ac9 tual belief possessed, and knowledge possessed by 

10 another person that is not the defendant may not be 

11 attributed to the defendant.’’. 

12 SEC. 117. PREEMPTION. 

13 Section 18 (15 U.S.C. 2617) is amended— 

14 (1) in subsection (a)(1), by striking ‘‘(1) Except 

15 as provided in paragraph (2), nothing’’ and inserting 

16 ‘‘Nothing’’; 

17 (2) by striking subsection (a)(2); and 

18 (3) by striking subsection (b) and inserting the 

19 following: 

20 ‘‘(b) SAVINGS.— 

21 ‘‘(1) NO PREEMPTION OF COMMON LAW OR

22 STATUTORY CAUSES OF ACTION FOR CIVIL RELIEF

23 OR CRIMINAL CONDUCT.—Nothing in this Act, nor 

24 any amendment made by this Act, nor any regula25 tion, requirement, standard of performance, safety 


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1 determination, or scientific assessment implemented 

2 pursuant to this Act, shall be construed to preempt, 

3 displace, or supplant any State or Federal common 

4 law rights or any State or Federal statute creating 

5 a remedy for civil relief, including those for civil 

6 damage, or a penalty for a criminal conduct. 

7 ‘‘(2) CLARIFICATION OF NO PREEMPTION.— 

8 Notwithstanding any other provision in this Act, 

9 nothing in this Act, nor any amendments made by 

10 this Act, shall preempt or preclude any cause of ac11 tion for personal injury, wrongful death, property 

12 damage, or other injury based on negligence, strict 

13 liability, products liability, failure to warn, or any 

14 other legal theory of liability under any State, mari15 time, or Federal common law or statutory theory. 

16 ‘‘(3) NO EFFECT ON PRIVATE REMEDIES.— 

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

18 nor any amendments made by this Act, nor any 

19 rules, regulations, requirements, safety assess20 ments, safety determinations, scientific assess21 ments, or orders issued pursuant to this Act 

22 shall be interpreted as, in either the plaintiff’s 

23 or defendant’s favor, dispositive in any civil ac24 tion. 


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1 ‘‘(B) NO EFFECT ON AUTHORITY OF

2 COURT.—This Act does not affect the authority 

3 of any court to make a determination in an ad4 judicatory proceeding under applicable State or 

5 Federal law with respect to the admission into 

6 evidence or any other use of this Act or rules, 

7 regulations, requirements, standards of per8 formance, safety assessments, scientific assess9 ments, or orders issued pursuant to this Act. 

10 ‘‘(4) NO PREEMPTION OF STATE LAWS.—Noth11 ing in this Act, nor any amendment made by this 

12 Act, nor any regulation, requirement, standard of 

13 performance, safety determination, or scientific as14 sessment implemented pursuant to this Act, shall af15 fect the right of a State or a political subdivision of 

16 a State to adopt or enforce any regulation, require17 ment, standard of performance, safety determina18 tion, scientific assessment, or any protection for 

19 public health or the environment that is different 

20 from, or in addition to, any regulation, requirement, 

21 standard of performance, safety determination, or 

22 scientific assessment implemented pursuant to this 

23 Act.’’. 

24 SEC. 118. JUDICIAL REVIEW. 

25 Section 19 (15 U.S.C. 2618) is amended— 


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1 (1) in subsection (a)— 

2 (A) in subparagraph (1)(A), by striking 

3 ‘‘section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 8, 

4 or under title II or IV’’ and inserting ‘‘section 

5 4(a), 5(c)(4), 6(d), or 8’’; 

6 (B) in subparagraph (1)(B), by striking 

7 ‘‘subparagraph (A)’’ and inserting ‘‘paragraph 

8 (1)’’; and 

9 (C) by striking paragraph (3); and 

10 (2) in subsection (c)— 

11 (A) in subparagraph (1)(B), by striking 

12 clauses (i) and (ii) and the last sentence of the 

13 subparagraph; 

14 (B) by redesignating paragraph (1)(B)(iii) 

15 as paragraph (1)(B)(i); and 

16 (C) in paragraph (1)(B)(i) as so redesig17 nated), by striking ‘‘(I) any statement required 

18 to be made pursuant to section 6(c)(1) of this 

19 title, or (II)’’. 

20 SEC. 119. CITIZENS’ PETITIONS. 

21 Section 21 (15 U.S.C. 2620) is amended— 

22 (1) in subsection (a), by striking ‘‘an order 

23 under section 5(e)’’ and inserting ‘‘an order under 

24 section 4, 5(c),’’; and 

25 (2) in subsection (b)— 


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1 (A) in paragraph (1), by striking ‘‘an 

2 order under section 5(e)’’ and inserting ‘‘an 

3 order under section 4, 5(c),’’; and 

4 (B) in paragraph (4), by striking subpara5 graph (B) and inserting the following: 

6 ‘‘(B) DE NOVO PROCEEDING.— 

7 ‘‘(i) IN GENERAL.—In an action 

8 under subparagraph (A) to initiate a pro9 ceeding to issue a rule under section 4, 

10 5(c), 6(d), or 8 or an order issued under 

11 section 4 or 5(c), the petitioner shall be 

12 provided an opportunity to have the peti13 tion considered by the court in a de novo 

14 proceeding. 

15 ‘‘(ii) DEMONSTRATION.— 

16 ‘‘(I) IN GENERAL.—The court 

17 shall order the Administrator to ini18 tiate the action requested by the peti19 tioner if the petitioner demonstrates 

20 to the satisfaction of the court by a 

21 preponderance of the evidence that— 

22 ‘‘(aa) in the case of a peti23 tion to initiate a proceeding for 

24 the issuance of a rule or order 

25 under section 4, the information 


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1 available to the Administrator is 

2 insufficient for the Administrator 

3 to perform an action described in 

4 section 4, 4A, or 6(b); 

5 ‘‘(bb) in the case of a peti6 tion to issue an order under sec7 tion 5(c), there is a reasonable 

8 basis to conclude that the sub9 stance is not likely to meet the 

10 safety standard; 

11 ‘‘(cc) in the case of a peti12 tion to initiate a proceeding for 

13 the issuance of a rule under sec14 tion 6(d), there is a reasonable 

15 basis to conclude that the sub16 stance will not meet the safety 

17 standard; or 

18 ‘‘(dd) in the case of a peti19 tion to initiate a proceeding for 

20 the issuance of a rule under sec21 tion 8, there is a reasonable basis 

22 to conclude that the rule is nec23 essary to require reporting or 

24 recordkeeping to obtain informa25 tion relevant to determining 


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1 whether a substance or mixture 

2 may fail to meet the safety 

3 standard. 

4 ‘‘(II) DEFERMENT.—The court 

5 may permit the Administrator to defer 

6 initiating the action requested by the 

7 petitioner until such time as the court 

8 prescribes if the court finds that— 

9 ‘‘(aa) the extent of the risk 

10 to human health or the environ11 ment alleged by the petitioner is 

12 less than the extent of risks to 

13 human health or the environment 

14 with respect to which the Admin15 istrator is taking action under 

16 this Act; and 

17 ‘‘(bb) there are insufficient 

18 resources available to the Admin19 istrator to take the action re20 quested by the petitioner.’’. 

21 SEC. 120. STUDIES. 

22 Section 25 (15 U.S.C. 2624) is repealed. 

23 SEC. 121. ADMINISTRATION. 

24 Section 26(e) (15 U.S.C. 2625(e)) is amended— 


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1 (1) by striking ‘‘Health, Education, and Wel2 fare’’ each place it appears and inserting ‘‘Health 

3 and Human Services’’; and 

4 (2) by striking subsection (b) and inserting— 

5 ‘‘(b) FEES.— 

6 ‘‘(1) IN GENERAL.—The Administrator shall, 

7 by rule, require manufacturers of chemical sub8 stances to pay reasonable fees to defray the costs of 

9 administering this title, including but not limited to 

10 costs resulting from— 

11 ‘‘(A) issuing rules and orders to conduct 

12 testing under section 4 and reviewing data sub13 mitted under these requirements; 

14 ‘‘(B) developing the priority list and desig15 nating substances as high-priority under section 

16 4A; 

17 ‘‘(C) reviewing notices submitted under 

18 section 5; 

19 ‘‘(D) conducting safety assessments and 

20 making safety determinations under section 6; 

21 ‘‘(E) promulgating rules and issuing orders 

22 to restrict chemical substances under section 6; 

23 ‘‘(F) promulgating rules and issuing orders 

24 to report information and data and maintain 

25 records under section 8; and 


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1 ‘‘(G) reviewing confidentiality claims under 

2 section 14. 

3 ‘‘(2) APPORTIONMENT.— 

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

5 shall apportion fees among individual manufac6 turers in relation to the costs of administering 

7 this title which are attributable to each manu8 facturer’s production or importation of chemical 

9 substances subject to action under sections 4, 

10 4A, 5, 6 and 8. 

11 ‘‘(B) MULTIPLE MANUFACTURERS.—If 

12 there is more than 1 manufacturer of such sub13 stance, the Administrator shall provide for the 

14 sharing of fees in proportion to each manufac15 turer’s contribution to total production of such 

16 substance, unless there is some other basis for 

17 apportionment that better reflects consider18 ations of hazard and exposure. 

19 ‘‘(3) SMALL BUSINESS CONCERNS.—The rule 

20 promulgated under paragraph (1) may set separate 

21 fees for manufacturers of chemical substances that 

22 are small business concerns based on their ability to 

23 pay. 

24 ‘‘(4) LIMITATION.—Fees collected under this 

25 subsection shall only be used to defray the costs of 


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1 administering this title and not for any other pur2 pose.’’. 

3 ‘‘(5) LEVEL OF FEES.—The Administrator shall 

4 ensure that fees are set at a level sufficient to enable 

5 the Administrator to perform all of the responsibil6 ities described in paragraph (1) and add not less 

7 than 3 chemical substances to the list of high-pri8 ority substances for each chemical substance re9 moved from the list under section 4A(a)(5)(iii) and 

10 to complete safety assessments and determinations 

11 and any necessary rulemaking for these high-priority 

12 substances in accordance with section 6(a).’’. 

13 SEC. 122. DEVELOPMENT AND EVALUATION OF TEST METH14 ODS. 

15 Section 27(a) (15 U.S.C. 2626(a)) is amended by 

16 striking ‘‘Health, Education, and Welfare’’ and inserting 

17 ‘‘Health and Human Services’’. 

18 SEC. 123. STATE PROGRAMS. 

19 Section 28 (15 U.S.C. 2627) is amended by striking 

20 subsections (c) and (d). 

21 SEC. 124. AUTHORIZATION OF APPROPRIATIONS. 

22 Section 29 (15 U.S.C. 2628) is repealed. 

23 SEC. 125. ANNUAL REPORT. 

24 Section 30 (15 U.S.C. 2629) is amended by striking 

25 paragraph (2) and inserting the following: 


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1 ‘‘(2)(A) the number of notices received during 

2 each year under section 5; and 

3 ‘‘(B) the number of the notices described in 

4 subparagraph (A) for chemical substances subject to 

5 a rule, testing consent agreement, or order under 

6 section 4;’’. 

7 TITLE II—STRENGTHENING PRO8 TECTIONS FOR CHILDREN 

9 AND COMMUNITIES FROM 

10 DISEASE CLUSTERS 

11 SEC. 201. PURPOSES. 

12 The purposes of this title are— 

13 (1) to provide to the Administrator the author14 ity to help conduct investigations into the potential 

15 for environmental pollutants or toxic substances to 

16 cause disease clusters; 

17 (2) to ensure that the Administrator has the 

18 authority to undertake actions to help address exist19 ing and potential environmental pollution and toxic 

20 substances that may contribute to the creation of 

21 disease clusters; and 

22 (3) to enable the Administrator to integrate and 

23 work in conjunction with other Federal, State, and 

24 local agencies, institutions of higher education, and 


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1 the public in investigating and helping to address 

2 the possible causes of disease clusters. 

3 SEC. 202. DEFINITIONS. 

4 In this title: 

5 (1) ADMINISTRATOR.—The term ‘‘Adminis6 trator’’ means the Administrator of the Environ7 mental Protection Agency. 

8 (2) AGENCY.—The term ‘‘Agency’’ means the 

9 Environmental Protection Agency. 

10 (3) DIRECTOR.—The term ‘‘Director’’ means 

11 the Director of the National Institute of Environ12 mental Health Sciences. 

13 (4) DISEASE CLUSTER.—The term ‘‘disease 

14 cluster’’ means— 

15 (A) the occurrence of a greater-than-ex16 pected number of cases of a particular disease 

17 within a group of individuals, a geographical 

18 area, or a period of time; or 

19 (B) the occurrence of a particular disease 

20 in such number of cases, or meeting such other 

21 criteria, as the Administrator, in consultation 

22 with the Administrator of the Agency for Toxic 

23 Substances and Disease Registry and the Direc24 tor, may determine. 


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1 (5) ENVIRONMENTAL POLLUTANTS OR TOXIC

2 SUBSTANCES.—The term ‘‘environmental pollutants 

3 or toxic substances’’ includes the substances de4 scribed in paragraph (7). 

5 (6) FEDERAL AGENCY.—The term ‘‘Federal 

6 agency’’ means— 

7 (A) any department, agency, or other in8 strumentality of the Federal Government; 

9 (B) any independent agency or establish10 ment of the Federal Government (including any 

11 Government corporation); and 

12 (C) the Government Publishing Office. 

13 (7) POTENTIAL CAUSES OF A DISEASE CLUS14 TER.—The term ‘‘potential causes of a disease clus15 ter’’ includes environmental and public health fac16 tors that could increase the possibility of disease 

17 clusters, including environmental pollutants or toxic 

18 substances and sources of those pollutants and sub19 stances, including— 

20 (A) emissions of air pollutants that are 

21 regulated under the Clean Air Act (42 U.S.C. 

22 7401 et seq.); 

23 (B) water pollutants that are regulated 

24 under the Federal Water Pollution Control Act 

25 (33 U.S.C. 1251 et seq.); 


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1 (C) a contaminant, as that term is defined 

2 in section 1401 of the Safe Drinking Water Act 

3 (42 U.S.C. 300f); 

4 (D) a hazardous substance, as that term is 

5 defined in section 101 of the Comprehensive 

6 Environmental Response, Compensation, and 

7 Liability Act (42 U.S.C. 9601); 

8 (E) solid waste and hazardous waste, as 

9 those terms are defined in section 1004 of the 

10 Solid Waste Disposal Act (42 U.S.C. 6903); 

11 (F) a chemical substance, as that term is 

12 defined in section 3 of the Toxic Substances 

13 Control Act (15 U.S.C. 2602); 

14 (G) a substance that is regulated under 

15 the Emergency Planning and Community 

16 Right-To-Know Act of 1986 (42 U.S.C. 11001 

17 et seq.); and 

18 (H) any other form of environmental pollu19 tion or toxic substance that is a known or po20 tential cause of an adverse health effect, includ21 ing a developmental, reproductive, neurotoxic, 

22 or carcinogenic effect. 

23 (8) REGIONAL RESPONSE CENTER.—The term 

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1 ease Cluster Information and Response Center es2 tablished under section 204. 

3 (9) RESPONSE TEAM.—The term ‘‘Response 

4 Team’’ means a Regional Disease Cluster Informa5 tion and Response Team established under section 

6 204. 

7 (10) SECRETARY.—The term ‘‘Secretary’’ 

8 means the Secretary of Health and Human Services. 

9 SEC. 203. GUIDELINES FOR ENVIRONMENTAL INVESTIGA10 TIONS OF DISEASE CLUSTERS. 

11 (a) ESTABLISHMENT.— 

12 (1) IN GENERAL.—The Administrator, in con13 sultation with the Administrator of the Agency for 

14 Toxic Substances and Disease Registry, the Sec15 retary, and the Director, shall develop, publish, and 

16 periodically update guidelines that describe a sys17 tematic, integrated approach that uses the best 

18 available science to investigate— 

19 (A) 1 or more suspected or potential dis20 ease clusters; 

21 (B) environmental pollutants or toxic sub22 stances associated with 1 or more suspected or 

23 potential disease clusters; or 

24 (C) potential causes of 1 or more disease 

25 clusters. 


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1 (2) COORDINATION.—The Administrator shall 

2 ensure that the Office of Children’s Health Protec3 tion, in consultation with appropriate advisory com4 mittees, such as the Children’s Health Protection 

5 Advisory Committee, has a prominent role on behalf 

6 of the Agency in developing and updating guidelines 

7 under paragraph (1). 

8 (b) REQUIREMENTS.—Guidelines developed under 

9 this section shall include— 

10 (1) definitions of key concepts and actions; 

11 (2) disease cluster identification and reporting 

12 protocols; 

13 (3) standardized methods of reviewing and cat14 egorizing data, including from health surveillance 

15 systems and disease cluster reports; 

16 (4) guidance for using, in a health-protective 

17 way, an appropriate epidemiological, statistical, or 

18 other approach for the circumstances of an inves19 tigation; 

20 (5) procedures for peer review of key documents 

21 by individuals who have no direct or indirect conflict 

22 of interest; and 

23 (6) a description of roles and responsibilities of 

24 the Administrator and the Administrator of the 

25 Agency for Toxic Substances and Disease Registry 


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1 in conducting investigations described in those 

2 guidelines, in accordance with this title. 

3 (c) TIMING.— 

4 (1) IN GENERAL.—Draft guidelines developed 

5 under this section shall be available for public review 

6 and comment for a period of not less than 60 days. 

7 (2) FINAL GUIDELINES.—Not later than 1 year 

8 after the date of enactment of this Act, the Adminis9 trator, in consultation with the Administrator of the 

10 Agency for Toxic Substances and Disease Registry, 

11 the Secretary, and the Director, shall publish in the 

12 Federal Register final guidelines under this section. 

13 SEC. 204. ENHANCED SUPPORT FOR ENVIRONMENTAL IN14 VESTIGATIONS OF DISEASE CLUSTERS. 

15 (a) ESTABLISHMENT OF REGIONAL DISEASE CLUS16 TER INFORMATION AND RESPONSE CENTERS AND

17 TEAMS.— 

18 (1) ESTABLISHMENT.— 

19 (A) IN GENERAL.—The Administrator, in 

20 consultation with the Administrator of the 

21 Agency for Toxic Substances and Disease Reg22 istry, the Secretary, and the Director, and other 

23 appropriate Federal agencies, shall establish 

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1 tion and Response Centers and Regional Dis2 ease Cluster Information and Response Teams. 

3 (B) PRINCIPAL RESPONSIBILITY.—The Ad4 ministrator shall be principally responsible for 

5 directing, coordinating, and approving Federal 

6 efforts and assistance authorized under this 

7 section. 

8 (2) COORDINATION.— 

9 (A) IN GENERAL.—The Administrator 

10 shall ensure that the Office of Children’s 

11 Health Protection, in consultation with appro12 priate advisory committees, such as the Chil13 dren’s Health Protection Advisory Committee, 

14 has a prominent role on behalf of the Agency 

15 in establishing and operating the Regional Re16 sponse Centers and the Response Teams. 

17 (B) GRANTS AND COOPERATIVE AGREE18 MENTS.— 

19 (i) IN GENERAL.—The Administrator 

20 shall provide support (including research, 

21 program implementation, and operational 

22 support activities) to individuals on Re23 sponse Teams described in subsection (b) 

24 and Community Disease Cluster Advisory 

25 Committees described in subsection (c) 


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1 through grants and cooperative agreements 

2 with institutions of higher education that 

3 have programs or individuals with dem4 onstrated expertise in research, training, 

5 studies, and technical assistance. 

6 (ii) AUTHORIZATION OF APPROPRIA7 TIONS.—There are authorized to be appro8 priated to carry out this subparagraph 

9 such sums as are necessary. 

10 (3) TIMING.—Not later than 1 year after the 

11 date of enactment of this Act, the Administrator 

12 shall establish at least— 

13 (A) 2 Regional Response Centers; and 

14 (B) 2 Response Teams. 

15 (b) RESPONSE TEAMS.— 

16 (1) MEMBERSHIP.—Each Response Team shall 

17 include individuals who— 

18 (A) have expertise in epidemiology, 

19 toxicogenomics, molecular biology, toxicology, 

20 pollution control requirements, data analysis, 

21 environmental health and disease surveillance, 

22 exposure assessment, pediatric health, commu23 nity outreach and involvement, and other rel24 evant fields; and 


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1 (B) have no direct or indirect conflict of 

2 interest. 

3 (2) LEADERSHIP.—Each Response Team shall 

4 have— 

5 (A) an individual who is the leader of the 

6 Response Team and who reports to the Admin7 istrator, the Administrator of the Agency for 

8 Toxic Substances and Disease Registry, and the 

9 Director; and 

10 (B) an individual who has the skills or ex11 perience necessary to carry out community out12 reach and involvement activities, including— 

13 (i) the establishment of Community 

14 Disease Cluster Advisory Committees 

15 under subsection (c); and 

16 (ii) the facilitation of activities of 

17 those Committees. 

18 (3) ACTIVITIES.— 

19 (A) IN GENERAL.—The Administrator, in 

20 consultation with the Administrator of the 

21 Agency for Toxic Substances and Disease Reg22 istry and the Director, shall establish the scope 

23 of activities for Response Teams to ensure that 

24 the activities are consistent with achieving the 

25 purposes of this title. 


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1 (B) REQUIREMENTS.—The activities of the 

2 Response Teams shall include— 

3 (i) making guidelines, protocols, data, 

4 and other relevant information and exper5 tise available to State and local officials 

6 and the public to assist in efforts— 

7 (I) to investigate suspected or po8 tential disease clusters, environmental 

9 pollutants or toxic substances associ10 ated with those disease clusters, and 

11 potential causes of disease clusters; 

12 and 

13 (II) to address potential causes 

14 of disease clusters; 

15 (ii) responding rapidly to a petition 

16 described in subparagraph (C) from any 

17 person, including a State or local official, 

18 regarding the need— 

19 (I) to investigate suspected or po20 tential disease clusters, environmental 

21 pollutants or toxic substances associ22 ated with those disease clusters, and 

23 potential causes of disease clusters; 

24 and 


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1 (II) to address the potential 

2 causes of disease clusters; 

3 (iii) providing the best available envi4 ronmental sampling and laboratory equip5 ment to collect, analyze, and interpret 

6 monitoring, health surveillance, and other 

7 relevant information at scales and time8 lines appropriate to an action; 

9 (iv) involving community members, in 

10 accordance with established scientific 

11 methods and norms (including the preser12 vation of the confidentiality of individuals), 

13 in— 

14 (I) investigations of suspected or 

15 potential disease clusters, environ16 mental pollutants or toxic substances 

17 associated with those disease clusters, 

18 or potential causes of disease clusters, 

19 including through— 

20 (aa) environmental exposure 

21 assessments; 

22 (bb) biomonitoring activities; 

23 and 


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1 (cc) community-based par2 ticipatory research initiatives; 

3 and 

4 (II) other efforts to address the 

5 potential causes of disease clusters; 

6 (v) working with State and local agen7 cies— 

8 (I) to help make the use and 

9 management of integrated environ10 mental health data consistent and 

11 timely; and 

12 (II) to fill data gaps; and 

13 (vi) investigating suspected or poten14 tial disease clusters, environmental pollut15 ants or toxic substances associated with 

16 those disease clusters, and potential causes 

17 of disease clusters, and addressing the po18 tential causes of disease clusters that the 

19 Administrator determines State and local 

20 officials need assistance in investigating or 

21 addressing, or that the Administrator de22 termines should be investigated or ad23 dressed. 

24 (C) PETITION.— 


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1 (i) IN GENERAL.—Any person, includ2 ing a State or local official, may submit a 

3 petition referred to in subparagraph (B)(ii) 

4 to the Administrator, the Administrator of 

5 the Agency for Toxic Substances and Dis6 ease Registry, and the Director that re7 quests that a Response Team conduct an 

8 investigation or take other action to ad9 dress the potential causes of disease clus10 ters in accordance with this title. 

11 (ii) REQUIREMENTS.—Each petition 

12 submitted under clause (i) shall clearly de13 scribe the basis for the requested investiga14 tion or action, including any data sup15 porting the request. 

16 (iii) CONSIDERATION.—The Adminis17 trator, in consultation with the Adminis18 trator of the Agency for Toxic Substances 

19 and Disease Registry and the Director, 

20 shall establish criteria for the consideration 

21 of petitions submitted under this section 

22 using health-protective factors, including— 

23 (I) evidence of the release of en24 vironmental pollutants or toxic sub25 stances; 


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1 (II) the locations in which there 

2 appear to be potentially significant 

3 health threats from the potential 

4 causes of disease clusters; 

5 (III) cases in which existing data 

6 appear to be inadequate to fully as7 sess the potential risks to public 

8 health; and 

9 (IV) such other factors as the 

10 Administrator determines are nec11 essary. 

12 (iv) RESPONSE.—Not later than 60 

13 days after the date of receipt of a petition 

14 under clause (iii), the Administrator, in 

15 consultation with the Administrator of the 

16 Agency for Toxic Substances and Disease 

17 Registry and the Director, shall provide a 

18 written response that describes— 

19 (I) the investigation or actions 

20 that will be undertaken in response to 

21 the petition, including the timeline 

22 and basis for the investigation or ac23 tions; and 

24 (II) the reasons for any denial or 

25 deferral in providing such a response. 


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1 (v) TIMING OF ISSUANCE OF CRI2 TERIA.— 

3 (I) IN GENERAL.—The Adminis4 trator, in consultation with the Ad5 ministrator of the Agency for Toxic 

6 Substances and Disease Registry and 

7 the Director, shall provide for public 

8 notice of draft criteria established 

9 under this subparagraph for a period 

10 of not less than 60 days. 

11 (II) FINAL CRITERIA.—Not later 

12 than 1 year after the date of enact13 ment of this Act, the Administrator, 

14 in consultation with the Administrator 

15 of the Agency for Toxic Substances 

16 and Disease Registry and the Direc17 tor, shall publish in the Federal Reg18 ister final criteria required under this 

19 subparagraph. 

20 (4) USE OF PUBLICLY AVAILABLE REPORTS.— 

21 Response Team investigations and actions shall— 

22 (A) include publicly available reports pre23 pared by the Response Team that contain state24 ments of facts, findings, and recommendations 

25 for actions, to the extent appropriate; and 


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1 (B) be prepared in a manner that pre2 serves the confidentiality of individuals. 

3 (5) TRANSPARENCY AND ACCOUNTABILITY.— 

4 Response Team activities shall include measures to 

5 ensure— 

6 (A) transparency and accountability to po7 tentially affected individuals, State and local of8 ficials, the public, and other persons and agen9 cies, while preserving the confidentiality of indi10 viduals; 

11 (B) that consistent, accurate, and mean12 ingful information is provided to potentially af13 fected individuals, State and local officials, the 

14 public, and other persons and agencies through 

15 the use of comprehensive, community-based 

16 communications plans; and 

17 (C) accountability to meeting goals and 

18 timetables. 

19 (6) DATABASE.— 

20 (A) IN GENERAL.—The Administrator, in 

21 consultation with the Administrator of the 

22 Agency for Toxic Substances and Disease Reg23 istry, the Secretary, and the Director, shall 

24 compile and regularly update information in a 

25 comprehensive electronic database that— 


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1 (i) is publicly accessible through the 

2 Internet; 

3 (ii) provides a centralized location for 

4 information relating to— 

5 (I) disease cluster reports and in6 vestigations; 

7 (II) environmental pollutants or 

8 toxic substances that are associated 

9 with suspected or potential disease 

10 clusters; 

11 (III) illnesses associated with 

12 suspected or potential disease clusters, 

13 including locally generated informa14 tion; 

15 (IV) systematic tracking of envi16 ronmental pollutants or toxic sub17 stances and illnesses associated with 

18 suspected or potential disease clusters; 

19 (V) actions to help address the 

20 potential causes of disease clusters; 

21 and 

22 (VI) any other information that 

23 the Administrator determines to be 

24 necessary; and 


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1 (iii) facilitates the rapid reporting and 

2 analysis of information described in clause 

3 (ii). 

4 (B) CONFIDENTIALITY.—A database de5 scribed in subparagraph (A) shall be main6 tained in a manner that preserves the confiden7 tiality of individuals. 

8 (c) COMMUNITY DISEASE CLUSTER ADVISORY COM9 MITTEES.— 

10 (1) IN GENERAL.—The Administrator shall es11 tablish Community Disease Cluster Advisory Com12 mittees to provide oversight, guidance, and advice 

13 relating to— 

14 (A) the investigation of suspected and po15 tential disease clusters; 

16 (B) the investigation of environmental pol17 lutants or toxic substances associated with sus18 pected or potential disease clusters; 

19 (C) the investigation of potential causes of 

20 disease clusters; 

21 (D) efforts to address the potential causes 

22 of disease clusters; and 

23 (E) the most effective means of ensuring 

24 outreach to and involvement of community 

25 members. 


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1 (2) MEMBERSHIP.—Membership on Community 

2 Disease Cluster Advisory Committees shall be com3 prised of representatives that include— 

4 (A) individuals who are or may be im5 pacted by a suspected or potential disease clus6 ter, and the designee of such an individual who 

7 may participate with or in the place of such an 

8 individual; 

9 (B) State or local government health or 

10 environmental agencies; 

11 (C) at least 2 individuals, appointed by the 

12 Administrator in consultation with the Adminis13 trator of the Agency for Toxic Substances and 

14 Disease Registry and the Director, with dem15 onstrated knowledge of the activities described 

16 in paragraph (1); and 

17 (D) other appropriate individuals, as deter18 mined by the Administrator, in consultation 

19 with the Administrator of the Agency for Toxic 

20 Substances and Disease Registry and the Direc21 tor. 

22 (3) PROHIBITION.—No member of a Committee 

23 may have any direct or indirect conflict of interest. 

24 (4) TECHNICAL ASSISTANCE.— 


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1 (A) IN GENERAL.—The Administrator, in 

2 consultation with the Administrator of the 

3 Agency for Toxic Substances and Disease Reg4 istry and the Director, may make grants avail5 able to any group of individuals that may be af6 fected by a suspected or potential disease clus7 ter. 

8 (B) USE OF FUNDS.—Grants made avail9 able under subparagraph (A) may be used to 

10 facilitate active involvement in all aspects of 

11 Committee activities and to assist Committee 

12 members in obtaining technical assistance in in13 terpreting information with regard to— 

14 (i) the investigation of— 

15 (I) suspected or potential disease 

16 clusters; 

17 (II) environmental pollutants or 

18 toxic substances that are associated 

19 with suspected or potential disease 

20 clusters; and 

21 (III) the potential causes of dis22 ease clusters; 

23 (ii) addressing the potential causes of 

24 disease clusters; 


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1 (iii) understanding the health con2 cerns associated with suspected or poten3 tial disease clusters; and 

4 (iv) understanding other scientific and 

5 technical issues relating to the activities of 

6 a Regional Response Team and Commu7 nity Disease Cluster Advisory Committee, 

8 including the potential need for and inter9 pretation of any biomonitoring of individ10 uals in the area. 

11 (d) ENVIRONMENTAL RESEARCH AND ANALYSIS.— 

12 The Administrator, in consultation with the Administrator 

13 of the Agency for Toxic Substances and Disease Registry, 

14 the Secretary, and the Director, shall use available au15 thorities and programs to compile, research, and analyze 

16 information generated by actions authorized under this 

17 section, including by— 

18 (1) using those authorities to test environ19 mental pollutants or toxic substances identified 

20 under subsection (b)(6); and 

21 (2) incorporating environmental pollutants or 

22 toxic substances identified under subsection (b)(6) in 

23 appropriate national biomonitoring initiatives. 


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1 SEC. 205. FEDERAL REPORTS TO CONGRESS. 

2 (a) IN GENERAL.—Not later than 1 year after the 

3 date of enactment of this Act and annually thereafter, the 

4 Administrator, in consultation with the Administrator of 

5 the Agency for Toxic Substances and Disease Registry, 

6 the Secretary, and the Director, shall prepare a report 

7 that describes— 

8 (1) the status of activities under this title to in9 vestigate and address the suspected and potential 

10 causes of disease clusters; 

11 (2) environmental pollutants or toxic substances 

12 that are associated with suspected or potential dis13 ease clusters; 

14 (3) the potential causes of disease clusters; and 

15 (4) ways to address the potential causes of 

16 those disease clusters. 

17 (b) REQUIREMENTS.—The report shall include a de18 scription of— 

19 (1) outreach activities to State and local offi20 cials and communities; 

21 (2) actions that the Administrator has taken to 

22 prioritize the testing of environmental pollutants or 

23 toxic substances; 

24 (3) actions that the Administrator has taken to 

25 include environmental pollutants or toxic substances 


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1 identified under section 204(b)(7) in appropriate na2 tional biomonitoring initiatives; 

3 (4) actions that the Administrator is taking or 

4 plans to take to address problems in implementing 

5 this title; 

6 (5) actions that the Secretary is taking or plans 

7 to take to address problems in implementing this 

8 title; 

9 (6) actions that the Administrator of the Agen10 cy for Toxic Substances and Disease Registry has 

11 undertaken or is considering taking with respect to 

12 any disease clusters under subparagraphs (D) and 

13 (E) of section 104(i)(1) of Comprehensive Environ14 mental Response, Compensation, and Liability Act 

15 (42 U.S.C. 9604(i)(1)) and other provisions of that 

16 section; 

17 (7) actions that the Director is taking or plans 

18 to take to address problems in implementing this 

19 title; and 

20 (8) other relevant information. 

21 (c) SUBMISSION AND AVAILABILITY.—The Adminis22 trator shall— 

23 (1) submit the report under this subsection 

24 to— 


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1 (A) the Committees on Environment and 

2 Public Works and Health, Education, Labor, 

3 and Pensions of the Senate; and 

4 (B) the Committee on Energy and Com5 merce of the House of Representatives; and 

6 (2) make the report available to the public. 

7 SEC. 206. AUTHORIZATION OF APPROPRIATIONS. 

8 There are authorized to be appropriated such sums 

9 as are necessary to carry out this title. 

10 SEC. 207. EFFECT ON OTHER LAW. 

11 Nothing in this title modifies, limits, or otherwise af12 fects the application of, or obligation to comply with, any 

13 law, including any environmental or public health law. 

14 TITLE III—COMMUNITY DISEASE 

15 CLUSTER TECHNICAL ASSIST16 ANCE GRANTS 

17 SEC. 301. COMMUNITY DISEASE CLUSTER TECHNICAL AS18 SISTANCE GRANTS. 

19 (a) IN GENERAL.—The Administrator of the Envi20 ronmental Protection Agency (referred to in this title as 

21 the ‘‘Administrator’’), in coordination with the Secretary 

22 of Health and Human Services (referred to in this title 

23 as the ‘‘Secretary’’) may award grants in accordance with 

24 this title to any individual or group of individuals that may 


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1 be affected by a reported community-based disease clus2 ter— 

3 (1) to pay the Federal share of the technical as4 sistance described in subsection (d); 

5 (2) to protect public health and the environ6 ment; 

7 (3) to promote healthy and safe environments; 

8 and 

9 (4) to prevent and address harmful exposures 

10 to hazardous substances. 

11 (b) APPLICATION.— 

12 (1) IN GENERAL.—To be eligible for a grant 

13 under this title, an individual or group of individuals 

14 shall submit to the Administrator and the Secretary 

15 an application that contains a description of the— 

16 (A) need for technical assistance, including 

17 the need to procure independent technical advi18 sors to help grant recipients interpret the infor19 mation described in subsection (d); 

20 (B) expected outputs, including results, ef21 fects, or consequences that will occur from the 

22 technical assistance; and 

23 (C) expected outcomes, including activity, 

24 effort, or associated work products that will be 


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1 produced or provided over a period of time or 

2 by a specific date. 

3 (2) RESPONSE.—Not later than 120 days after 

4 the date on which an application is submitted under 

5 paragraph (1), the Administrator and the Secretary 

6 shall respond to each applicant in writing and de7 scribe whether the application is approved, denied, 

8 or will be considered after the applicant modifies the 

9 application. 

10 (3) CRITERIA.—The Administrator, in coordi11 nation with the Secretary, shall develop criteria that, 

12 if satisfied, would result in the Administrator and 

13 the Secretary accepting an application submitted 

14 under paragraph (1). 

15 (c) AMOUNT.— 

16 (1) IN GENERAL.—Except as provided in para17 graph (2), each grant awarded under this title shall 

18 not exceed $50,000. 

19 (2) WAIVER.—The Administrator, in coordina20 tion with the Secretary, may waive the limitation de21 scribed in paragraph (1) if the waiver is necessary 

22 to provide the technical assistance described in sub23 section (d). 


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1 (d) USE OF FUNDS.—Grants awarded under this title 

2 shall be used to obtain technical assistance in interpreting 

3 information regarding— 

4 (1) investigating reported community-based dis5 ease clusters associated with 1 or more hazardous 

6 chemicals; 

7 (2) the potential hazardous chemicals associated 

8 with a reported community-based disease cluster; 

9 (3) providing individuals or groups of individ10 uals with community-based tools to educate the indi11 viduals on the mitigation of hazardous chemicals as12 sociated with reported community-based disease 

13 clusters; or 

14 (4) other scientific and technical issues related 

15 to reported community-based disease clusters. 

16 (e) NUMBER OF GRANTS.—No individual or group of 

17 individuals shall be awarded more than 1 grant under this 

18 title. 

19 (f) NON-FEDERAL SHARE.— 

20 (1) IN GENERAL.—Except as provided in para21 graph (2), the non-Federal share for each grant 

22 awarded under this title is 20 percent. 

23 (2) WAIVER.—The Administrator, in coordina24 tion with the Secretary, may waive the non-Federal 

25 share described in paragraph (1) if— 


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1 (A) the recipient of the grant demonstrates 

2 financial need; and 

3 (B) the waiver is necessary to provide the 

4 technical assistance described in subsection (d). 

5 (g) RENEWAL OF GRANT.— 

6 (1) IN GENERAL.—Any grant awarded under 

7 this title may be renewed to facilitate technical as8 sistance to any group of individuals that may be af9 fected by a reported community-based disease clus10 ter. 

11 (2) CONDITIONS.—Each renewal of a grant 

12 awarded under this title is subject to the same con13 ditions that apply to an initial grant. 

14 (h) REPORTS.—Any recipient of a grant awarded 

15 under this title shall submit to the Administrator and the 

16 Secretary a report that describes the progress in address17 ing the needs and achieving the outputs and outcomes de18 scribed in subsection (b). 

19 SEC. 302. AUTHORIZATION OF APPROPRIATIONS. 

20 For each of fiscal years 2016 through 2021, there 

21 are authorized to be appropriated to the Administrator 

22 and the Secretary from any funds made available to the 

23 Administrator and the Secretary for the purpose of pro24 viding community members with technical assistance and 

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1 ardous Substance Superfund established under section 

2 9507 of the Internal Revenue Code of 1986 such sums 

3 as are necessary to carry out section 301. 

Æ 


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