II 

113TH CONGRESS 

1ST SESSION S. 1009 

To reauthorize and modernize the Toxic Substances Control Act, and for 

other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 22, 2013 

Mr. LAUTENBERG (for himself, Mr. VITTER, Mrs. GILLIBRAND, Mr. CRAPO, 

Mr. DURBIN, Mr. ALEXANDER, Mr. SCHUMER, Mr. INHOFE, Mr. UDALL

of New Mexico, Ms. COLLINS, Ms. LANDRIEU, Mr. RUBIO, Mr. MANCHIN, 

Mr. BOOZMAN, Mr. MENENDEZ, Mr. HOEVEN, and Mr. BEGICH) introduced the following bill; which was read twice and referred to the Committee on Environment and Public Works 

A BILL 

To reauthorize and modernize 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; REF4 ERENCES. 

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

6 ‘‘Chemical Safety Improvement Act’’. 

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

8 this Act is as follows: 


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Sec. 1. Short title; table of contents; references. 

Sec. 2. Findings, policy, and intent. 

Sec. 3. Definitions. 

Sec. 4. Chemical assessment framework; prioritization screening; testing. 

Sec. 5. New chemicals and significant new uses. 

Sec. 6. Safety assessments and determinations. 

Sec. 7. Imminent hazards. 

Sec. 8. Information collection and reporting. 

Sec. 9. Relationship to other Federal laws. 

Sec. 10. Research, development, collection, dissemination, and utilization of 

data. 

Sec. 11. Exports. 

Sec. 12. Imports. 

Sec. 13. Confidential information. 

Sec. 14. Prohibited acts. 

Sec. 15. Preemption. 

Sec. 16. Judicial review. 

Sec. 17. Citizens’ petitions. 

Sec. 18. Studies. 

Sec. 19. Administration. 

Sec. 20. Development and evaluation of test methods. 

Sec. 21. State programs. 

Sec. 22. Authorization of appropriations. 

Sec. 23. Annual report. 

1 (c) REFERENCES.—Except as otherwise expressly 

2 provided, wherever in this Act an amendment or repeal 

3 is expressed in terms of an amendment to, or repeal of, 

4 a section or other provision, the reference shall be consid5 ered to be made to a section or other provision of the Toxic 

6 Substances Control Act (15 U.S.C. 2601 et seq.). 

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

8 (a) PURPOSES.—The purposes of this Act are— 

9 (1) to improve the safety of consumers in the 

10 United States; and 

11 (2) to ensure that risks from chemical sub12 stances are adequately understood and managed by 

13 modernizing title I of the Toxic Substances Control 

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


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1 (b) FINDINGS, POLICY, AND INTENT.—Section 2 (15 

2 U.S.C. 2601) is amended by striking subsections (a) 

3 through (c) and inserting the following: 

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

5 ‘‘(1) chemicals should be safe for the intended 

6 use of the chemicals; 

7 ‘‘(2) the unmanaged risks of chemical sub8 stances may pose a danger to human health and the 

9 environment; 

10 ‘‘(3) public confidence in the Federal chemical 

11 regulatory program has diminished over time; 

12 ‘‘(4) scientific understanding of chemicals and 

13 the possible risks of the chemicals has evolved great14 ly since 1976, requiring that Congress update the 

15 law to ensure that chemical regulation in the United 

16 States reflects modern science, technology and 

17 knowledge; 

18 ‘‘(5) this Act should be modernized to create a 

19 robust Federal system for assessing and managing 

20 chemical risks; 

21 ‘‘(6) chemicals are used in diverse manufac22 turing industries and other valuable commercial, in23 stitutional, and consumer applications that have ben24 efitted society; 


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1 ‘‘(7) for the purposes of promoting uniform 

2 protections through regulation of chemical sub3 stances in commerce, to minimize undue burdens on 

4 commerce, and to minimize burdens on States, speci5 fied actions by the Administrator should preempt re6 quirements by States and political subdivisions of 

7 States that relate to the effects of or exposure to a 

8 chemical substance under the intended conditions of 

9 use; and 

10 ‘‘(8) innovation in the development of new 

11 chemical substances, especially safer chemical sub12 stances, should be encouraged to reduce risk, provide 

13 improved products, stimulate the economy, create 

14 jobs, and protect interstate commerce. 

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

16 that— 

17 ‘‘(1) this Act— 

18 ‘‘(A) should protect the health of people 

19 and the environment from the unmanaged risks 

20 of chemical substances; and 

21 ‘‘(B) should be modernized to build public 

22 confidence in the ability of the Federal regu23 latory system to protect health and the environ24 ment, promote innovation, and sustain a globVerDate Mar 15 2010 00:35 May 29, 2013 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1009.IS S1009

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1 ally competitive chemical industry in the United 

2 States; 

3 ‘‘(2) the Administrator— 

4 ‘‘(A) should have the appropriate hazard, 

5 use, and exposure information necessary to 

6 make safety determinations; 

7 ‘‘(B) should minimize the use of animal 

8 testing through the use of scientifically reliable 

9 and relevant test methods, where appropriate; 

10 ‘‘(C) should encourage the use of best lab11 oratory practices to ensure high quality, rel12 evant, and reliable results from test methods 

13 and studies; 

14 ‘‘(D) should have the authority to share 

15 confidential business information with States 

16 and political subdivisions of the States, subject 

17 to appropriate safeguards against inappropriate 

18 disclosure; 

19 ‘‘(E) should have the resources and tools 

20 necessary to implement this Act; and 

21 ‘‘(F) should implement this Act in a man22 ner that promotes transparency of information 

23 and decisionmaking, protects substantiated con24 fidential business information, and promotes in25 novation, including innovation in chemical subVerDate Mar 15 2010 00:35 May 29, 2013 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1009.IS S1009

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1 stances that have reduced hazard, exposure, 

2 and risk patterns; 

3 ‘‘(3) adequate data and information should be 

4 available with respect to the effect of and exposure 

5 to chemical substances and mixtures on health and 

6 the environment, to the extent necessary for safety 

7 assessments and determinations, and that, where 

8 necessary, the development of such test data and in9 formation should be the primary responsibility of 

10 those who manufacture or process such chemical 

11 substances and mixtures; and 

12 ‘‘(4) States have an important role in pro13 tecting health and the environment from the 

14 unmanaged risks of chemical substances in com15 merce, particularly in recommending priorities for 

16 Federal assessment and regulation, providing safety 

17 assessment information, and fostering programs to 

18 protect consumers. 

19 ‘‘(c) INTENT OF CONGRESS.—It is the intent of Con20 gress that the Administrator shall— 

21 ‘‘(1) rely on robust scientific evidence to imple22 ment this Act in a way that balances the mutual 

23 goals of promoting the safety of American con24 sumers and preventing harm to American innova25 tion, manufacturing, and the economy; and 


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1 ‘‘(2) implement this Act to protect the health of 

2 the people of the United States and the environment 

3 in such a manner as not to unduly impede commerce 

4 or create unnecessary economic barriers to techno5 logical innovation, including safer chemistry.’’. 

6 SEC. 3. DEFINITIONS. 

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

8 (1) by redesignating paragraphs (2) through 

9 (6), (7) through (11), and (12) through (14) as 

10 paragraphs (3) through (7), (9) through (13), and 

11 (17) through (19), respectively; 

12 (2) by inserting after paragraph (1) the fol13 lowing: 

14 ‘‘(2) BEST AVAILABLE SCIENCE.—The term 

15 ‘best available science’ means science that— 

16 ‘‘(A) maximizes the quality, objectivity, 

17 and integrity of information, including statis18 tical information; 

19 ‘‘(B) uses peer-reviewed and publically 

20 available data; and 

21 ‘‘(C) clearly documents and communicates 

22 risks and uncertainties in the scientific basis for 

23 decisions.’’; 

24 (3) by inserting after paragraph (7) (as so re25 designated) the following: 


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1 ‘‘(8) INTENDED CONDITIONS OF USE.—The 

2 term ‘intended conditions of use’ means the cir3 cumstances under which a chemical substance is in4 tended or reasonably anticipated to be manufac5 tured, processed, distributed in commerce, used, and 

6 disposed of.’’; and 

7 (4) by inserting after paragraph (13) (as so re8 designated) the following: 

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

10 assessment’ means a risk-based assessment of the 

11 safety of a chemical substance that— 

12 ‘‘(A) integrates hazard; use; and exposure 

13 information about a chemical substance; and 

14 ‘‘(B) includes— 

15 ‘‘(i) an assessment of exposure under 

16 the intended conditions of use; and 

17 ‘‘(ii) reference parameters that may 

18 be appropriate with regard to a specific 

19 chemical substance (such as a margin of 

20 exposure). 

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

22 ‘safety determination’ means a determination by the 

23 Administrator as to whether a chemical substance 

24 meets the safety standard under the intended condi25 tions of use. 


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

2 standard’ means a standard that ensures that no 

3 unreasonable risk of harm to human health or the 

4 environment will result from exposure to a chemical 

5 substance.’’. 

6 SEC. 4. CHEMICAL ASSESSMENT FRAMEWORK; 

7 PRIORITIZATION SCREENING; TESTING. 

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

9 amended— 

10 (1) in the heading, by striking ‘‘TESTING OF

11 CHEMICAL SUBSTANCES AND MIXTURES’’ and 

12 inserting ‘‘CHEMICAL ASSESSMENT FRAME13 WORK; PRIORITIZATION SCREENING; TEST14 ING’’. 

15 (2) by redesignating subsection (e) as sub16 section (l); 

17 (3) in subsection (l) (as so redesignated)— 

18 (A) by striking ‘‘rule’’ each place it ap19 pears and inserting ‘‘rule, testing consent 

20 agreement, or order’’; 

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

22 each place it appears and inserting ‘‘under this 

23 subsection’’; and 

24 (C) in paragraph (1)(B), by striking ‘‘rule25 making’’; and 


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1 (4) by striking subsections (a) through (d), (f), 

2 and (g) and inserting the following: 

3 ‘‘(a) CHEMICAL ASSESSMENT FRAMEWORK.— 

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

5 develop a framework in accordance with subsection 

6 (e) and sections 5 and 6 for evaluating the safety of 

7 chemical substances in commerce that shall employ 

8 the best available science and risk assessment prin9 ciples in existence at the time the Administrator is 

10 developing the framework. 

11 ‘‘(2) POLICIES AND PROCEDURES.— 

12 ‘‘(A) IN GENERAL.—After the date of en13 actment of the Chemical Safety Improvement 

14 Act, the Administrator shall promptly develop 

15 appropriate policies and procedures for imple16 menting the framework, including procedures 

17 on the collection, evaluation, and development 

18 of data and information. 

19 ‘‘(B) CONTENTS.—The policies and proce20 dures shall require— 

21 ‘‘(i) the collection of existing data and 

22 information from manufacturers and proc23 essors of chemical substances and other 

24 sources, including the use of voluntary 


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1 agreements to provide the data and infor2 mation; 

3 ‘‘(ii) an evaluation of the quality of 

4 existing data and information; 

5 ‘‘(iii) an analysis of data and informa6 tion; 

7 ‘‘(iv) a determination of the need for 

8 additional data and information, including 

9 information related to the exposures of dif10 ferent subpopulations; and 

11 ‘‘(v) subject to section 14, trans12 parency of data and information consid13 ered by the Administrator, including both 

14 positive and negative findings. 

15 ‘‘(3) TRANSPARENCY AND VALIDITY.—The Ad16 ministrator shall ensure that the evaluation frame17 work described in subsection (a)(1)— 

18 ‘‘(A) is transparent; 

19 ‘‘(B) assures that data and information 

20 are valid; 

21 ‘‘(C) addresses the strengths and limita22 tions of— 

23 ‘‘(i) the design of the framework, 

24 ‘‘(ii) the reliability of the test meth25 ods; and 


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1 ‘‘(iii) the quality of the data and in2 formation; and 

3 ‘‘(D) pursues the goal of maximizing the 

4 quality, objectivity, utility, and integrity of the 

5 data and information. 

6 ‘‘(b) DATA AND INFORMATION QUALITY.— 

7 ‘‘(1) IN GENERAL.—The Administrator shall es8 tablish and publish scientifically sound criteria for 

9 evaluating all of the data and information, including 

10 the results of animal and nonanimal testing, regard11 less of affiliation or funding source, on which the 

12 Administrator relies in making a decision under this 

13 Act. 

14 ‘‘(2) DISCLOSURE OF SOURCES OF FUNDING.— 

15 The Administrator shall require that the submitter 

16 of any health and safety study disclose to the Ad17 ministrator and to the public the sources of any 

18 funding used for the study or publication of the 

19 study received by the researcher who conducted the 

20 study, to the extent reasonably ascertainable. 

21 ‘‘(3) TEST DATA.—For test data developed 

22 under this Act, the Administrator shall encourage 

23 the use of good laboratory practices, peer review, sci24 entifically reliable and relevant test methods, stand25 ardized protocols, and other methods to ensure sciVerDate Mar 15 2010 00:35 May 29, 2013 Jkt 029200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S1009.IS S1009

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1 entific quality for all data and information sub2 mitted under this Act. 

3 ‘‘(4) DATA AND INFORMATION THAT DO NOT

4 MEET CRITERIA.— 

5 ‘‘(A) IN GENERAL.—Nothing in this sub6 section shall preclude the Administrator from 

7 considering data and information which do not 

8 meet the quality criteria established under 

9 paragraph (1). 

10 ‘‘(B) IDENTIFICATION.—The Adminis11 trator shall— 

12 ‘‘(i) identify any data and information 

13 described in subparagraph (A) on which 

14 the Administrator relies; 

15 ‘‘(ii) describe the quality of the data 

16 and information described in subparagraph 

17 (A) and the extent to which the data and 

18 information depart from those criteria; 

19 ‘‘(iii) indicate any limitations on the 

20 usefulness of the data and information de21 scribed in subparagraph (A); and 

22 ‘‘(iv) explain how the data and infor23 mation described in subparagraph (A) was 

24 used and the basis for reliance on the data 

25 and information. 


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1 ‘‘(5) EVALUATIVE FRAMEWORK FOR DECISION2 MAKING.— 

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

4 shall develop and use a structured evaluative 

5 framework consisting of science-based criteria, 

6 consistent with the protection of human health 

7 and the environment, for making any decision 

8 under this Act, and for determining the rel9 evance, quality, and reliability of data and in10 formation. 

11 ‘‘(B) CONTENTS.—The framework de12 scribed in subparagraph (A) shall, at a min13 imum— 

14 ‘‘(i) use sound and objective scientific 

15 practices in assessing risks; 

16 ‘‘(ii) consider the current best avail17 able science (including peer-reviewed stud18 ies); 

19 ‘‘(iii) when consistent with the under20 lying data, consider, for both cancer and 

21 noncancer endpoints, whether available 

22 data support or do not support the identi23 fication of threshold doses of a chemical 

24 substance below which no adverse effects 

25 can be expected to occur; and 


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1 ‘‘(iv) include a description of the 

2 weight of the scientific evidence concerning 

3 risks, including mechanistic information 

4 (such as appropriate modes of action). 

5 ‘‘(c) DATA AND INFORMATION SOURCES.—In making 

6 any decision with respect to a chemical substance under 

7 subsection (e) and sections 5 and 6, the Administrator 

8 shall consider data and information relevant to the sub9 stance that are reasonably available to the Administrator 

10 at that time, including data and information that are— 

11 ‘‘(1) submitted to the Administrator by— 

12 ‘‘(A) manufacturers and processors of the 

13 substance; 

14 ‘‘(B) the public; or 

15 ‘‘(C) a Governor of a State or a State 

16 agency with responsibility for protecting health 

17 or the environment; 

18 ‘‘(2) submitted to a governmental body in an19 other jurisdiction under a governmental requirement 

20 relating to the protection of human health and the 

21 environment, if the information is accessible to the 

22 Administrator; 

23 ‘‘(3) derived through the application of scientif24 ically reliable and relevant structure-activity rela25 tionship, or other methods or models to estimate the 


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1 environmental and human health effects, environ2 mental and biological fate and behavior, and expo3 sure potential for the substance; 

4 ‘‘(4) inferred based on the degree of structural 

5 similarity or properties of the substance, or cat6 egories of substances, to those of 1 or more other 

7 chemical substances for which reliable information 

8 exists that is relevant to predicting the potential en9 vironmental or human health effects, environmental 

10 or biological fate and behavior, or exposure potential 

11 for the chemical substance; and 

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

13 Administrator of information sources that are pub14 licly available or otherwise accessible to the Adminis15 trator. 

16 ‘‘(d) TRANSPARENCY.— 

17 ‘‘(1) IN GENERAL.—Subject to section 14, the 

18 data and information considered by the Adminis19 trator in taking action under this Act shall be avail20 able to the public. 

21 ‘‘(2) TYPES OF INFORMATION AVAILABLE TO

22 THE PUBLIC.—The Administrator shall make avail23 able to the public the guidance, procedures, and 

24 tools used in evaluating data and information under 


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1 this section, including models, studies, and, as ap2 propriate, the data underlying any study. 

3 ‘‘(3) GUIDANCE.—Any written guidance of gen4 eral applicability prepared by the Administrator 

5 under this Act shall be subject to public notice and 

6 an opportunity for comment. 

7 ‘‘(e) PRIORITIZATION SCREENING PROCESS.— 

8 ‘‘(1) IN GENERAL.— 

9 ‘‘(A) PROCESS.—Not later than 1 year 

10 after the date of enactment of the Chemical 

11 Safety Improvement Act, the Administrator 

12 shall establish a risk-based screening process 

13 for identifying existing chemical substances that 

14 are— 

15 ‘‘(i) a high priority for a safety as16 sessment and determination under section 

17 6, to be known as ‘high-priority sub18 stances’; and 

19 ‘‘(ii) a low priority for a safety assess20 ment and determination, to be known as 

21 ‘low-priority substances’. 

22 ‘‘(B) CONSIDERATION OF ACTIVE AND IN23 ACTIVE SUBSTANCES.— 

24 ‘‘(i) CONSIDERATION OF ACTIVE SUB25 STANCES.—In implementing the process 


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1 described in subparagraph (A), the Admin2 istrator shall only consider active sub3 stances, as determined under section 

4 8(b)(6), as either high-priority substances 

5 or low-priority substances. 

6 ‘‘(ii) CONSIDERATION OF INACTIVE

7 SUBSTANCES.—In implementing the proc8 ess described in subparagraph (A), the Ad9 ministrator shall only consider inactive 

10 substances, as determined under section 

11 8(b)(7), that the Administrator deter12 mines, on the basis of credible scientific 

13 evidence that— 

14 ‘‘(I) have not been subject to a 

15 regulatory or other enforceable action 

16 by the Administrator to ban or phase 

17 out the substances; and 

18 ‘‘(II) demonstrate high hazard 

19 and high exposure. 

20 ‘‘(C) TIMELY COMPLETION OF

21 PRIORITIZATION PROCESS.— 

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

23 shall make every effort to complete the 

24 prioritization of all active substances in a 

25 timely manner. 


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1 ‘‘(ii) CONSIDERATION.—The Adminis2 trator shall prioritize substances taking 

3 into consideration the ability of the Admin4 istrator to schedule and complete safety as5 sessments and determinations under sec6 tion 6 in a timely manner. 

7 ‘‘(D) USE OF DATA.—In making a decision 

8 under the prioritization screening process, the 

9 Administrator shall use reasonably available 

10 data and information concerning the hazard, 

11 exposure, and use characteristics of chemical 

12 substances on the list developed by the Admin13 istrator under section 8(b)(1) at the time the 

14 decision is made. 

15 ‘‘(E) SCREENING OF CATEGORIES OR

16 CLASSES OF SUBSTANCES.—The Administrator 

17 may screen categories or classes of chemical 

18 substances to ensure an efficient prioritization 

19 screening process to allow for timely and ade20 quate safety assessments and determinations. 

21 ‘‘(F) PUBLICATION OF LIST OF CHEMICAL

22 SUBSTANCES.—From time to time the Adminis23 trator shall— 


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1 ‘‘(i) publish a list of chemical sub2 stances being considered in the 

3 prioritization screening process; and 

4 ‘‘(ii) request the submission of data 

5 and information on the chemical sub6 stances. 

7 ‘‘(2) PROPOSED PROCESS.— 

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

9 shall— 

10 ‘‘(i) publish for public comment a pro11 posed prioritization screening process; and 

12 ‘‘(ii) establish criteria for determining 

13 whether a substance is a high or low pri14 ority for a safety assessment and deter15 mination. 

16 ‘‘(B) INITIAL LIST.— 

17 ‘‘(i) IN GENERAL.—The proposal shall 

18 include an initial list of chemical sub19 stances that includes, at a minimum, those 

20 substances prioritized by the Administrator 

21 before the date of enactment of the Chem22 ical Safety Improvement Act and for which 

23 assessments or safety determinations have 

24 not been completed, and proposed 


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1 prioritization outcomes based on the pro2 posed criteria. 

3 ‘‘(ii) CONTENTS.—The initial list shall 

4 contain as many chemical substances as 

5 the Administrator determines appropriate. 

6 ‘‘(iii) MODIFICATION.—The Adminis7 trator may modify the initial list on the 

8 basis of comments received on the pro9 posed process and criteria. 

10 ‘‘(C) CRITERIA.—The criteria described in 

11 subparagraph (A) shall consider— 

12 ‘‘(i) the recommendation of a Gov13 ernor of a State or a State agency with re14 sponsibility for protecting health or the en15 vironment from chemical substances appro16 priate for prioritization screening; 

17 ‘‘(ii) the hazard and exposure poten18 tial of the chemical substance (or category 

19 or class of substances), including specific 

20 scientific classifications and designations 

21 by authoritative governmental entities; 

22 ‘‘(iii) the intended conditions of use or 

23 significant changes in the conditions of use 

24 of the chemical substance; 


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1 ‘‘(iv) evidence and indicators of expo2 sure potential to humans or the environ3 ment from the chemical substance; 

4 ‘‘(v) the volume of a chemical sub5 stance manufactured or processed; 

6 ‘‘(vi) whether the volume of a chem7 ical substance as reported under a regula8 tion issued under section 8(a) (as in effect 

9 on the date on which the criteria are pro10 posed) has significantly increased or de11 creased since a previous report or since the 

12 date on which a notice has been submitted 

13 under section 5(a); 

14 ‘‘(vii) the availability of information 

15 about potential hazards and exposures 

16 needed for conducting a safety assessment 

17 or determination, with limited availability 

18 of relevant data and information to be a 

19 factor in designating a substance as a high 

20 priority; and 

21 ‘‘(viii) the extent of Federal or State 

22 regulation of the chemical substance or the 

23 extent of the impact of State regulation of 

24 the chemical substance on the United 

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1 ulation of any uses evaluated in the 

2 prioritization screening process as a factor 

3 in designating a chemical substance to be 

4 a low priority. 

5 ‘‘(3) PRIORITIZATION SCREENING DECISIONS.— 

6 ‘‘(A) IN GENERAL.—For the chemical sub7 stances considered for prioritization screening, 

8 the Administrator shall apply the criteria iden9 tified in paragraph (2), using the information 

10 identified in subsection (c), to identify a chem11 ical substance as a high-priority substance or a 

12 low-priority substance. 

13 ‘‘(B) ADDITIONAL TEST DATA.—If the Ad14 ministrator determines that additional test data 

15 and information are needed to establish the pri16 ority of a chemical substance, the Administrator 

17 shall provide an opportunity for interested per18 sons to submit data and information to the ex19 tent that it is reasonably ascertainable. 

20 ‘‘(C) DEFERRING A DECISION.—If the Ad21 ministrator determines that it is appropriate, 

22 the Administrator may defer a prioritization 

23 screening decision for a chemical substance 

24 under subparagraph (A) for a reasonable period 


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1 to allow for the submission and evaluation of 

2 additional data and information. 

3 ‘‘(D) INTEGRATION OF DATA AND INFOR4 MATION.—During the prioritization screening of 

5 a chemical substance, the Administrator shall 

6 integrate any hazard and exposure data and in7 formation related to a chemical substance avail8 able to the Administrator. 

9 ‘‘(E) IDENTIFICATION OF HIGH-PRIORITY

10 SUBSTANCES.—The Administrator— 

11 ‘‘(i) shall identify as a high-priority 

12 substance a chemical substance that, rel13 ative to other substances, has the potential 

14 for high hazard and high exposure; 

15 ‘‘(ii) may identify as a high-priority 

16 substance a chemical substance that, rel17 ative to other substances, has the potential 

18 for high hazard or high exposure; and 

19 ‘‘(iii) may identify as a high-priority 

20 substance an inactive substance, as deter21 mined under section 8(b)(7), that the Ad22 ministrator determines, on the basis of 

23 credible scientific evidence that— 

24 ‘‘(I) has not been subject to a 

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1 trator to ban or phase out the sub2 stance; and 

3 ‘‘(II) demonstrates high hazard 

4 and high exposure. 

5 ‘‘(F) IDENTIFICATION OF LOW-PRIORITY

6 SUBSTANCES.—The Administrator shall identify 

7 as a low-priority substance a chemical sub8 stance that the Administrator on the basis of 

9 the available information determines is likely to 

10 meet the safety standard under the intended 

11 conditions of use. 

12 ‘‘(G) NOTICE AND COMMENT.—The identi13 fications made under subparagraphs (E) and 

14 (F) shall be subject to notice and an oppor15 tunity for comment. 

16 ‘‘(H) ORDER OF SAFETY ASSESSMENTS.— 

17 ‘‘(i) HIGH-PRIORITY SUBSTANCES.— 

18 The Administrator— 

19 ‘‘(I) shall determine the order for 

20 performing safety assessments on 

21 high-priority substances under section 

22 6; and 

23 ‘‘(II) may revise the order as the 

24 Administrator determines appropriate. 


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1 ‘‘(ii) LOW-PRIORITY SUBSTANCE.— 

2 The Administrator shall not perform safety 

3 assessments on low-priority substances, un4 less a low-priority substance is redesig5 nated under subparagraph (I). 

6 ‘‘(I) REVISION BASED ON NEW DATA.— 

7 ‘‘(i) IN GENERAL.—Subject to sub8 paragraph (D), at any time the Adminis9 trator may revise the identification of a 

10 chemical substance as a high-priority sub11 stance or a low-priority substance based on 

12 consideration of data or information made 

13 available to the Administrator after the 

14 date on which the Administrator makes the 

15 identification under subparagraphs (E) 

16 and (F). 

17 ‘‘(ii) REEVALUATION.— 

18 ‘‘(I) IN GENERAL.—The Admin19 istrator shall evaluate the data or in20 formation described in clause (i) on a 

21 high-priority substance or a low-pri22 ority substance for possible reevalua23 tion of the priority of the substance. 

24 ‘‘(II) LIMITED AVAILABILITY.—If 

25 limited availability of relevant data 


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1 and information was a factor in the 

2 original identification of a chemical 

3 substance as a high-priority sub4 stance, the Administrator shall re5 evaluate the prioritization screening of 

6 the substance on receiving the rel7 evant data and information. 

8 ‘‘(J) PUBLICATION OF A LIST OF HIGH9 PRIORITY AND LOW-PRIORITY SUBSTANCES.— 

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

11 shall publish and keep current a list of 

12 high-priority substances and a list of low13 priority substances. 

14 ‘‘(ii) JUSTIFICATION.—Whenever the 

15 Administrator places a chemical substance 

16 on one of the lists described in clause (i) 

17 or changes the priority of the chemical 

18 substance, the Administrator shall include 

19 a justification for the decision in accord20 ance with paragraph (2)(C). 

21 ‘‘(K) REMOVAL.—The Administrator shall 

22 remove a chemical substance from the list of 

23 high-priority substances on the date on which a 

24 safety determination for the chemical substance 

25 is published. 


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1 ‘‘(L) EFFECT.—Subject to section 18, a 

2 decision by the Administrator under this para3 graph with respect to a chemical substance 

4 shall not affect the manufacture, processing, 

5 distribution, use, or disposal of the chemical 

6 substance, or regulation of those activities. 

7 ‘‘(4) EXPEDITED PRIORITIZATION SCREEN8 ING.— 

9 ‘‘(A) IN GENERAL.—Not later than 180 

10 days after the date on which the Administrator 

11 receives a recommendation and relevant data 

12 and information from a Governor of a State or 

13 a State agency with responsibility for protecting 

14 health and the environment that an active 

15 chemical substance be identified as a high-pri16 ority or low-priority substance, the Adminis17 trator shall make a prioritization screening de18 cision for the substance. 

19 ‘‘(B) NOTICE AND COMMENT.—The public 

20 shall be provided notice and an opportunity to 

21 comment on the recommendation described in 

22 subparagraph (A). 

23 ‘‘(C) EXPLANATION OF REASONS.—The 

24 Administrator shall— 


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1 ‘‘(i) make available to the Governor or 

2 the appropriate State agency, as applica3 ble, and to the public a brief explanation of 

4 reasons for identifying a chemical sub5 stance recommended by the Governor or 

6 the agency for prioritization screening as 

7 either a high-priority substance or a low8 priority substance; and 

9 ‘‘(ii) identify the information relied 

10 upon in making that identification. 

11 ‘‘(5) FINAL AGENCY ACTION.—Any action by 

12 the Administrator under this subsection shall not 

13 be— 

14 ‘‘(A) considered to be a final agency ac15 tion; or 

16 ‘‘(B) subject to judicial review. 

17 ‘‘(f) DEVELOPMENT OF NEW TEST DATA AND IN18 FORMATION.— 

19 ‘‘(1) IN GENERAL.—The Administrator may re20 quire the development of new test data and informa21 tion related to a chemical substance or mixture in 

22 accordance with this section if the Administration 

23 determines that the data and information are need24 ed— 

25 ‘‘(A) to perform a safety assessment; 


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1 ‘‘(B) to make a safety determination; or 

2 ‘‘(C) to meet the testing needs of the im3 plementing authority under another Federal 

4 statute. 

5 ‘‘(2) FORM.—The Administrator may require 

6 the development of test data and information de7 scribed in paragraph (1) by— 

8 ‘‘(A) promulgating a rule; 

9 ‘‘(B) entering into a testing consent agree10 ment; or 

11 ‘‘(C) issuing an order. 

12 ‘‘(3) REQUIREMENTS.— 

13 ‘‘(A) IN GENERAL.—In promulgating a 

14 rule, adopting a testing consent agreement, or 

15 issuing an order described in paragraph (2), the 

16 Administrator shall require the use of— 

17 ‘‘(i) an evaluation framework that, 

18 prior to requiring additional testing of 

19 vertebrate animals, integrates relevant in20 formation from multiple sources, including, 

21 to the extent reliable— 

22 ‘‘(I) toxicity information; 

23 ‘‘(II) computational toxicology; 

24 ‘‘(III) bioinformatics; 


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1 ‘‘(IV) high-throughput screening 

2 methods; and 

3 ‘‘(V) scientifically reliable and 

4 relevant alternatives to vertebrate ani5 mal tests; and 

6 ‘‘(ii) tiered testing in accordance with 

7 subsection (h), wherein the results of a 

8 screening level tier of tests relating to a 

9 toxicity pathway or target organ or target 

10 system inform the decision of the Adminis11 trator as to whether tests from a higher 

12 tier related to that pathway or organ or 

13 system are necessary. 

14 ‘‘(B) STATEMENT TO THE PUBLIC.—The 

15 Administrator shall explain the basis for a deci16 sion made in subparagraph (A)(ii) in a state17 ment made available to the public. 

18 ‘‘(4) CONTENTS.— 

19 ‘‘(A) IN GENERAL.—A rule, testing con20 sent agreement, or order issued under para21 graph (2) shall include— 

22 ‘‘(i) identification of the chemical sub23 stance or mixture for which testing is re24 quired; 


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1 ‘‘(ii) identification of the persons re2 quired to conduct the testing; 

3 ‘‘(iii) procedures for the development 

4 of test data and information for the chem5 ical substance or mixture, including spe6 cific reference to reliable nonanimal test 

7 procedures; and 

8 ‘‘(iv) specification of the period within 

9 which persons required to conduct the test10 ing shall submit to the Administrator test 

11 data and information developed in accord12 ance with the procedures described in 

13 clause (iii). 

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

15 subparagraph (A)(iv) shall not be of an unrea16 sonable duration. 

17 ‘‘(C) CONSIDERATIONS.—In determining 

18 the procedures and period to be required under 

19 subparagraph (A), the Administrator shall con20 sider— 

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

22 test protocols and methodologies that may 

23 be required; and 


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

3 perform the testing. 

4 ‘‘(g) STATEMENT OF NEED.— 

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

7 an order for development of additional data and in8 formation (including information on exposure or ex9 posure potential) under subsection (f)(2), the Ad10 ministrator shall issue a statement— 

11 ‘‘(A) identifying the need intended to be 

12 met by the rule, agreement, or order; 

13 ‘‘(B) explaining why existing data and in14 formation reasonably available to the Adminis15 trator at that time are inadequate to meet that 

16 need; and 

17 ‘‘(C) encouraging, to the extent possible, 

18 the use of nonanimal test methods to develop 

19 additional data and information. 

20 ‘‘(2) CONTENTS OF STATEMENT IN CASE OF

21 ORDER.— 

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

23 issues an order, the statement described in 

24 paragraph (1) shall explain why good cause ex25 ists for issuance of an order instead of promulVerDate Mar 15 2010 00:35 May 29, 2013 Jkt 029200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6201 E:\BILLS\S1009.IS S1009

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1 gating a rule or entering into a testing consent 

2 agreement. 

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

4 in subparagraph (A) shall contain a discussion 

5 of— 

6 ‘‘(i) data and information that are 

7 readily accessible to the Administrator, in8 cluding data and information submitted 

9 under any other provision of law; 

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

12 the data and information through vol13 untary submissions; 

14 ‘‘(iii) the extent to which the Adminis15 trator may use available data and informa16 tion for structurally related substances 

17 (grouping or read-across), or use valid 

18 structure-activity relationship models or 

19 nonanimal test alternatives; and 

20 ‘‘(iv) safety assessments, and the data 

21 and information relied on in the assess22 ments, on other chemical substances to the 

23 extent relevant to the chemical substances 

24 that would be the subject of the rule or 

25 order. 


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1 ‘‘(h) TIERED TOXICITY TESTING AND EVALUA2 TION.— 

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

4 develop an evidence-based review system for con5 ducting consistent evaluations of the relevance and 

6 reliability of studies of chemical substances and their 

7 exposure (including exposure pathways), and a 

8 structured evaluative framework to provide a sys9 tematic and transparent approach for assessing the 

10 overall weight of the evidence for observed biological 

11 or other effects, mechanistic information, and expo12 sure. 

13 ‘‘(2) TIERS.—Subject to subsections (b) and 

14 (c), the framework shall have 2 tiers. 

15 ‘‘(A) TIER 1.— 

16 ‘‘(i) IN GENERAL.—Tier 1 shall in17 clude both a screening level exposure as18 sessment, including modeling if appro19 priate, and screening tests for hazard. 

20 ‘‘(ii) USES OF SCREENING TESTS AND

21 MODELING.—Screening tests for hazard 

22 (which may include, as appropriate, sci23 entifically reliable and relevant in silico, in 

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1 sure information and modeling shall be 

2 used— 

3 ‘‘(I) to screen chemical sub4 stances or mixtures for major toxic ef5 fects (including acute toxicity, sub6 chronic toxicity, chronic toxicity, car7 cinogenicity, genotoxicity, develop8 mental toxicity, and neurotoxicity); 

9 and 

10 ‘‘(II) to direct planning for more 

11 complex and targeted testing in tier 2, 

12 if necessary. 

13 ‘‘(B) TIER 2.—If the Administrator deter14 mines that additional testing is necessary, 

15 based on the results of tier 1 testing and mod16 eling and any other available relevant informa17 tion, tier 2 shall include— 

18 ‘‘(i) an exposure assessment and tests 

19 for specific endpoints triggered on the 

20 basis of biologically based decisions; and 

21 ‘‘(ii) an assessment of potential expo22 sure using scientifically valid approaches. 

23 ‘‘(3) GUIDANCE.—The Administrator shall pre24 pare guidance for implementing this subsection and 


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1 review that guidance not less than once every 5 

2 years thereafter. 

3 ‘‘(i) REDUCTION OF ANIMAL-BASED TESTING.— 

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

5 minimize the use of animals in testing of chemical 

6 substances or mixtures, including by— 

7 ‘‘(A) encouraging and facilitating, to the 

8 maximum extent practicable— 

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

10 testing and assessment strategies; 

11 ‘‘(ii) the use of data and information 

12 of sufficient scientific quality in existence 

13 on the date on which the test is conducted; 

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

15 eliminate or reduce the use of animals 

16 while providing test data and information 

17 of high scientific quality; 

18 ‘‘(iv) the grouping of 2 or more chem19 ical substances into scientifically appro20 priate categories in cases in which testing 

21 of a chemical substance would provide reli22 able and useful test data and information 

23 on others in the category; 


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

3 unnecessary duplication of tests; 

4 ‘‘(vi) the submission of test data and 

5 information from animal-based studies and 

6 from emerging methods and models; and 

7 ‘‘(vii) the use of exposure potential as 

8 a factor in decisions to require new testing; 

9 and 

10 ‘‘(B) funding research and validation stud11 ies to reduce, refine, and replace the use of ani12 mal tests in accordance with this subsection. 

13 ‘‘(2) IMPLEMENTATION OF ALTERNATIVE TEST14 ING METHODS.—To promote the development and 

15 timely incorporation of new testing methods that are 

16 not laboratory animal-based, the Administrator 

17 shall— 

18 ‘‘(A) after providing an opportunity for 

19 public comment, develop a strategic plan to pro20 mote the development and implementation of al21 ternative test methods and testing strategies to 

22 generate information used for any safety-stand23 ard determination made that reduce, refine, or 

24 replace the use of laboratory animals, including 

25 toxicity pathway-based risk assessment, in vitro 


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1 studies, systems biology, computational toxi2 cology, bioinformatics, and high-throughput 

3 screening; 

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

5 after the date of enactment of the Chemical 

6 Safety Improvement Act and every 5 years 

7 thereafter, submit to Congress a report that de8 scribes the progress made in implementing this 

9 section; and 

10 ‘‘(C) fund and carry out research, develop11 ment, performance assessment, and translation12 al studies to accelerate the development of test 

13 methods and testing strategies that reduce, re14 fine, or replace the use of laboratory animals in 

15 any safety-standard determination made under 

16 this section. 

17 ‘‘(3) CRITERIA FOR ADAPTING OR WAIVING ANI18 MAL TESTING REQUIREMENTS.—On request from a 

19 manufacturer or processor that is required to con20 duct animal-based testing of a chemical substance or 

21 mixture under this title, the Administrator may 

22 adapt or waive the animal-testing requirement if the 

23 Administrator determines that— 

24 ‘‘(A) there is sufficient evidence from sev25 eral independent sources of information to supVerDate Mar 15 2010 00:35 May 29, 2013 Jkt 029200 PO 00000 Frm 00039 Fmt 6652 Sfmt 6201 E:\BILLS\S1009.IS S1009

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1 port a conclusion that a chemical substance or 

2 mixture has, or does not have, a particular 

3 property if the information from each individual 

4 source alone is insufficient to support the con5 clusion; 

6 ‘‘(B) because of one or more physical or 

7 chemical properties of the chemical substance 

8 or mixture or other toxicokinetic consider9 ations— 

10 ‘‘(i) the material cannot be absorbed; 

11 or 

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

13 technically not practicable to conduct; or 

14 ‘‘(C) a chemical substance or mixture can15 not be tested in animals at concentrations that 

16 do not result in significant pain or distress, be17 cause of physical or chemical properties of the 

18 chemical substance or mixture, such as a poten19 tial to cause severe corrosion or severe irritation 

20 to the tissues of the animal. 

21 ‘‘(j) TESTING REQUIREMENTS.— 

22 ‘‘(1) PERSONS REQUIRED TO DEVELOP TEST

23 DATA AND INFORMATION.— 


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

2 may require the following persons to develop 

3 test data and information: 

4 ‘‘(i) Manufacturers and processors of 

5 the chemical substance or mixture identi6 fied in subsection (f)(4)(A)(i). 

7 ‘‘(ii) Persons who begin to manufac8 ture or process such chemical substance or 

9 mixture— 

10 ‘‘(I) after the effective date of 

11 the rule, testing consent agreement, 

12 or order; but 

13 ‘‘(II) subject to subparagraph 

14 (C), before the period ending 180 

15 days after the end of the period iden16 tified in subsection (f)(4)(A)(iv). 

17 ‘‘(B) DESIGNATION.—The Administrator 

18 may permit 2 or more of the persons identified 

19 in subparagraph (A) to designate a person or a 

20 qualified third party— 

21 ‘‘(i) to develop the data and informa22 tion; and 

23 ‘‘(ii) to submit the data and informa24 tion on behalf of the persons making the 

25 designation. 


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1 ‘‘(C) EXEMPTIONS.— 

2 ‘‘(i) IN GENERAL.—A person other3 wise subject to a rule, testing consent 

4 agreement, or order under subsection (f) 

5 may submit to the Administrator an appli6 cation for an exemption on the basis that 

7 the data and information are being devel8 oped by a person designated under sub9 paragraph (B). 

10 ‘‘(ii) FAIR AND EQUITABLE REIM11 BURSEMENT TO DESIGNEE.— 

12 ‘‘(I) IN GENERAL.—If the Ad13 ministrator accepts an application 

14 submitted under clause (i), the Ad15 ministrator shall direct the applicant 

16 to provide to the person designated 

17 under subparagraph (B) fair and eq18 uitable reimbursement, as agreed to 

19 between the applicant and the person 

20 designated. 

21 ‘‘(II) ARBITRATION.—If the ap22 plicant and a person designated under 

23 subparagraph (B) cannot reach agree24 ment on the amount of fair and equiVerDate Mar 15 2010 00:35 May 29, 2013 Jkt 029200 PO 00000 Frm 00042 Fmt 6652 Sfmt 6201 E:\BILLS\S1009.IS S1009

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1 table reimbursement, the amount shall 

2 be determined by arbitration. 

3 ‘‘(iii) TERMINATION.—If, after grant4 ing an exemption under this subparagraph, 

5 the Administrator determines that no per6 son has complied with the rule, testing 

7 consent agreement, or order, the Adminis8 trator shall— 

9 ‘‘(I) by order terminate the ex10 emption; and 

11 ‘‘(II) notify in writing each per12 son who received an exemption of the 

13 requirements with respect to which 

14 the exemption was granted. 

15 ‘‘(2) TYPES OF HEALTH AND ENVIRONMENTAL

16 DATA AND INFORMATION.— 

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

18 may prescribe guidelines for the development of 

19 test data and information under subsection (f) 

20 for health and environmental information, in21 cluding— 

22 ‘‘(i) test data pertaining to acute tox23 icity, subchronic toxicity, chronic toxicity, 

24 carcinogenicity, genotoxicity, developmental 


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1 toxicity, and neurotoxicity that may be in2 dicative of an adverse effect; 

3 ‘‘(ii) test data and information per4 taining to exposure to the chemical sub5 stance or mixture, including information 

6 regarding bioaccumulation, persistence, 

7 and the presence of the chemical substance 

8 or mixture in human blood, fluids, or tis9 sue; and 

10 ‘‘(iii) information pertaining to aggre11 gate exposure, or other effects that may be 

12 considered in a safety assessment. 

13 ‘‘(B) METHODOLOGIES.— 

14 ‘‘(i) IN GENERAL.—The Adminis15 trator— 

16 ‘‘(I) may prescribe methodologies 

17 in guidelines for the development of 

18 data and information; and 

19 ‘‘(II) shall encourage the use of 

20 nonanimal methodologies. 

21 ‘‘(ii) DEVELOPMENT OF GUIDE22 LINES.—The Administrator may develop 

23 guidelines for evaluating data from bio24 monitoring studies. 


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1 ‘‘(iii) REQUIREMENT.—Prior to pre2 scribing epidemiologic studies of employ3 ees, the Administrator shall coordinate 

4 with the Director of the National Institute 

5 for Occupational Safety and Health. 

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

7 frequently than once every 5 years, the Admin8 istrator shall— 

9 ‘‘(i) review the adequacy of the guide10 lines for development of data and informa11 tion prescribed under subparagraph (B); 

12 ‘‘(ii) if necessary, institute pro13 ceedings to make appropriate revisions of 

14 the guidelines; and 

15 ‘‘(iii) revise the guidelines as appro16 priate, particularly to— 

17 ‘‘(I) reflect the availability of sci18 entifically reliable and relevant non19 animal test methods; and 

20 ‘‘(II) eliminate obsolete meth21 odologies that do not produce reliable 

22 and relevant results. 

23 ‘‘(k) TRANSPARENCY.—Subject to section 14, the Ad24 ministrator shall make available to the public all testing 


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1 consent agreements and orders and all data and informa2 tion submitted under this section.’’. 

3 (b) CONFORMING AMENDMENTS.—Section 

4 104(i)(5)(A) of the Comprehensive Environmental Re5 sponse, Compensation, and Liability Act of 1980 (42 

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

7 4(e)’’ and inserting ‘‘section 4(l)’’. 

8 SEC. 5. NEW CHEMICALS AND SIGNIFICANT NEW USES. 

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

10 (1) by striking the section designation and 

11 heading and inserting the following: 

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

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

14 subparagraph (B)— 

15 (A) by striking ‘‘subsection (d)’’ and in16 serting ‘‘subsection (b)’’; and 

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

18 with any applicable requirement of subsection 

19 (b)’’; 

20 (3) by striking subsection (b); 

21 (4) by redesignating subsection (d) as sub22 section (b) and moving the subsection so as to ap23 pear after subsection (a); 

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


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1 (A) by striking paragraph (1) and insert2 ing the following: 

3 ‘‘(1) IN GENERAL.—The notice required by sub4 section (a) shall include, with respect to a chemical 

5 substance— 

6 ‘‘(A) the information required by sections 

7 720.45 and 720.50 of title 40, Code of Federal 

8 Regulations (or successor regulations); and 

9 ‘‘(B) information regarding intended condi10 tions of use and reasonably anticipated expo11 sure.’’; 

12 (B) in paragraph (2)— 

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

15 subsection (b)’’; 

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

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

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

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

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

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

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

23 following: 

24 ‘‘(c) REVIEW OF NOTICE.— 

25 ‘‘(1) INITIAL REVIEW.— 


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1 ‘‘(A) IN GENERAL.—Subject to subpara2 graph (B), not later than 90 days after the date 

3 of receipt of a notice submitted under sub4 section (a), the Administrator shall— 

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

6 notice; 

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

8 the relevant chemical substance and the 

9 potential for exposure to humans and the 

10 environment; and 

11 ‘‘(iii) make any necessary determina12 tion under paragraph (4). 

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

14 paragraph (6), the Administrator may extend 

15 the period described in subparagraph (A) for 

16 good cause for one or more periods, the total of 

17 which shall be not more than 90 days. 

18 ‘‘(2) NOTICE OF COMMENCEMENT.—Unless the 

19 Administrator determines under paragraph (4)(A) 

20 that a chemical substance is not likely to meet the 

21 safety standard, at the end of the applicable period 

22 for review under paragraph (1), a chemical sub23 stance may be the subject of a notice of commence24 ment under subsection (d). 


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

2 notice under paragraph (1), the Administrator shall 

3 take into consideration— 

4 ‘‘(A) the information identified in section 

5 4(c); and 

6 ‘‘(B) any additional information provided 

7 by the submitter. 

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

9 applicable period for review under paragraph (1), 

10 based on the information described in paragraph (3), 

11 the Administrator shall determine that— 

12 ‘‘(A) the relevant chemical substance is not 

13 likely to meet the safety standard under the in14 tended conditions of use, in which case the Ad15 ministrator shall take appropriate action under 

16 paragraph (5); 

17 ‘‘(B) the relevant chemical substance is 

18 likely to meet the safety standard under the in19 tended conditions of use, in which case the Ad20 ministrator shall allow the review period to ex21 pire without additional restrictions; or 

22 ‘‘(C) additional information is necessary in 

23 order to make a determination under subpara24 graph (A) or (B), in which case the AdminisVerDate Mar 15 2010 00:35 May 29, 2013 Jkt 029200 PO 00000 Frm 00049 Fmt 6652 Sfmt 6201 E:\BILLS\S1009.IS S1009

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1 trator shall take appropriate action under para2 graph (6). 

3 ‘‘(5) PROHIBITIONS AND LIMITATIONS.— 

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

5 makes a determination under paragraph (4)(A) 

6 with respect to a notice, before the end of the 

7 applicable period for review under paragraph 

8 (1), the Administrator shall, by consent agree9 ment or order, as appropriate— 

10 ‘‘(i) prohibit manufacture of the 

11 chemical substance, or prohibit such manu12 facture without compliance with restric13 tions specified in a relevant consent agree14 ment or order; or 

15 ‘‘(ii) prohibit manufacture or proc16 essing of the chemical substance for a sig17 nificant new use, or prohibit such manu18 facture or processing without compliance 

19 with restrictions specified in a relevant 

20 consent agreement or order. 

21 ‘‘(B) INCLUSIONS.—A prohibition or limi22 tation under subparagraph (A) may include, as 

23 appropriate— 

24 ‘‘(i) a requirement that a chemical 

25 substance be marked with, or accompanied 


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1 by, clear and adequate warnings and in2 structions with respect to use, distribution 

3 in commerce, or disposal, or any combina4 tion of those activities, with the form and 

5 content of the warnings and instructions to 

6 be prescribed by the Administrator; 

7 ‘‘(ii) a requirement that manufactur8 ers or processors, as applicable, of the 

9 chemical substance make and retain 

10 records of the processes used to manufac11 ture or process the chemical substance; 

12 ‘‘(iii) a requirement that manufactur13 ers or processors, as applicable, monitor or 

14 conduct such additional tests as are rea15 sonably necessary to ensure compliance 

16 with this Act, subject to section 4(g); 

17 ‘‘(iv) a limitation on the quantity of 

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

21 ‘‘(v) a limitation on the quantity of 

22 the chemical substance that may be manu23 factured, processed, or distributed in com24 merce for a particular use; 


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1 ‘‘(vi) a prohibition or other regulation 

2 of the manufacture, processing, or dis3 tribution in commerce of the chemical sub4 stance for a significant new use; 

5 ‘‘(vii) a prohibition or other regulation 

6 of any method of commercial use of the 

7 chemical substance; 

8 ‘‘(viii) a prohibition or other regula9 tion of any method of disposal of the 

10 chemical substance; 

11 ‘‘(ix) a prohibition on the manufac12 ture, processing, or distribution in com13 merce of the chemical substance; 

14 ‘‘(x) a prohibition on the manufac15 ture, processing, or distribution in com16 merce of the chemical substance for a par17 ticular use; or 

18 ‘‘(xi) such other requirements as the 

19 Administrator determines to be necessary. 

20 ‘‘(6) ADDITIONAL DATA AND INFORMATION.—If 

21 the Administrator determines under paragraph 

22 (4)(C) that additional data and information (includ23 ing, for example, information on exposure or expo24 sure potential) are needed in order to conduct a re25 view under this subsection, the Administrator— 


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

2 submitter of the notice to submit such addi3 tional information; 

4 ‘‘(B) may, by agreement with the sub5 mitter, extend the review period for a reason6 able time to allow the development and submis7 sion of the additional information; 

8 ‘‘(C) on receipt of the information, shall 

9 promptly make a determination under para10 graph (4); and 

11 ‘‘(D) may take action under paragraph (5) 

12 pending receipt of the additional data and in13 formation, which may, as appropriate, permit 

14 the submitter of the notice to file a notice of 

15 commencement under subsection (d).’’; 

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

17 inserting the following: 

18 ‘‘(d) NOTICE OF COMMENCEMENT.— 

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

20 after the date on which a manufacturer or processor 

21 that has submitted a notice under subsection (a) 

22 commences nonexempt commercial manufacture of a 

23 chemical substance or nonexempt commercial manu24 facture or processing of a chemical substance for a 

25 significant new use, as applicable, the manufacturer 


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1 or processor shall submit to the Administrator a no2 tice of commencement that identifies— 

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

4 processor; and 

5 ‘‘(B) the initial date of nonexempt com6 mercial manufacture or nonexempt commercial 

7 manufacture or processing for a significant new 

8 use. 

9 ‘‘(2) WITHDRAWAL.—A manufacturer or proc10 essor that has submitted a notice under subsection 

11 (a), but that has not commenced nonexempt com12 mercial manufacture or processing of the chemical 

13 substance, may withdraw the notice. 

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

15 may review a chemical substance under section 4(e) at any 

16 time after the Administrator receives— 

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

18 substance under subsection (d); or 

19 ‘‘(2) significant new information regarding the 

20 chemical substance. 

21 ‘‘(f) TRANSPARENCY.—Subject to section 14, the Ad22 ministrator shall make available to the public all notices, 

23 rules and orders of the Administrator, and all data and 

24 information submitted or issued under this section.’’; 


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

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

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

4 (A) in paragraph (1), in the matter pre5 ceding subparagraph (A), by striking ‘‘or (b)’’; 

6 (B) by striking paragraph (2); 

7 (C) by redesignating paragraphs (3) 

8 through (6) as paragraphs (2) through (5), re9 spectively; 

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

11 by striking ‘‘subsections (a) and (b)’’ and in12 serting ‘‘subsection (a)’’; 

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

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

15 present an unreasonable risk of injury to health 

16 or the environment’’ and inserting ‘‘is expected 

17 to meet the safety standard under the intended 

18 conditions of use’’; 

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

20 by striking ‘‘subsections (a) and (b)’’ and in21 serting ‘‘subsection (a)’’; and 

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

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

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


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1 SEC. 6. SAFETY ASSESSMENTS AND DETERMINATIONS. 

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

3 (1) by striking the section designation and 

4 heading and inserting the following: 

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

6 (2) by striking subsections (a) through (d) and 

7 inserting the following: 

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

9 ‘‘(1) conduct a safety assessment of each high10 priority substance in accordance with subsection (b); 

11 ‘‘(2) make a safety determination for each high12 priority substance; and 

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

14 safety determination, establish requirements for risk 

15 management of a high-priority substance. 

16 ‘‘(b) SAFETY ASSESSMENTS.— 

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

18 conduct a risk-based safety assessment of each high19 priority substance, in accordance with such schedule 

20 as the Administrator establishes, to be based solely 

21 on considerations of risk to human health and the 

22 environment. 

23 ‘‘(2) PROCEDURAL RULES.— 

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

25 shall establish procedural rules for safety as26 sessments and determinations under this subVerDate Mar 15 2010 00:35 May 29, 2013 Jkt 029200 PO 00000 Frm 00056 Fmt 6652 Sfmt 6201 E:\BILLS\S1009.IS S1009

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1 section, including schedules for the submission 

2 of relevant data and information and the initi3 ation and completion of safety assessments and 

4 safety determinations. 

5 ‘‘(B) REQUIREMENTS.— 

6 ‘‘(i) IN GENERAL.—The rules under 

7 subparagraph (A) shall— 

8 ‘‘(I) identify the basis on which 

9 the Administrator shall decide which 

10 high-priority substances take prece11 dence in the safety assessment and 

12 determination process; 

13 ‘‘(II) require the Administrator 

14 to inform the public regarding— 

15 ‘‘(aa) the approximate order 

16 in which safety assessments and 

17 determinations will be performed; 

18 ‘‘(bb) the informational 

19 needs of the Administrator relat20 ing to the safety assessment and 

21 determination process; 

22 ‘‘(cc) the importance of ex23 peditiously completing safety as24 sessments and determinations 


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1 and the need for rigorous evalua2 tion of the data and information; 

3 ‘‘(dd) the schedule by which 

4 each assessment and determina5 tion will be conducted; and 

6 ‘‘(ee) subject to clause (ii), 

7 the deadline for the completion of 

8 each assessment and determina9 tion; 

10 ‘‘(III) allow interested persons, 

11 including States, to submit informa12 tion, including safety assessments, re13 garding high-priority substances that 

14 may facilitate the safety assessment 

15 and determination process; and 

16 ‘‘(IV) subject to section 14, re17 quire the Administrator— 

18 ‘‘(aa) to make available to 

19 the public the information taken 

20 into consideration in preparing 

21 each safety assessment and de22 termination; 

23 ‘‘(bb) to publish and provide 

24 an opportunity for comment on 


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1 proposed safety assessments and 

2 determinations; and 

3 ‘‘(cc) to publish final safety 

4 assessments and determinations. 

5 ‘‘(ii) DEADLINES.— 

6 ‘‘(I) IN GENERAL.—The rules de7 scribed in subparagraph (A) shall also 

8 include— 

9 ‘‘(aa) a schedule by which 

10 each safety assessment and de11 termination is expected to be con12 ducted; and 

13 ‘‘(bb) a deadline for the 

14 completion of each assessment 

15 and determination. 

16 ‘‘(II) FLEXIBILITY AND REASON17 ABLE EXTENSIONS.—The deadlines 

18 described in subclause (I)(bb)— 

19 ‘‘(aa) may vary among 

20 chemical substances to grant the 

21 Administrator flexibility; and 

22 ‘‘(bb) shall allow for reason23 able extensions after an adequate 

24 public justification. 


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1 ‘‘(C) INCLUSIONS IN FINAL ASSESS2 MENTS.—Each safety assessment under this 

3 subsection shall include— 

4 ‘‘(i) a weight-of-the evidence sum5 mary; and 

6 ‘‘(ii) a nontechnical summary explain7 ing what the relevant information dem8 onstrates in the context of the intended 

9 conditions of use and exposure patterns of 

10 the chemical substance. 

11 ‘‘(3) DATA AND INFORMATION SOURCES.—In 

12 conducting a safety assessment under this sub13 section, the Administrator shall, at a minimum, take 

14 into consideration— 

15 ‘‘(A) the information described in section 

16 4(c); and 

17 ‘‘(B) any additional information submitted 

18 under paragraph (5). 

19 ‘‘(4) METHODOLOGY.— 

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

21 shall— 

22 ‘‘(i) develop an appropriate science23 based methodology for conducting safety 

24 assessments under this subsection, which 

25 shall include consideration of the weight of 


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1 the evidence for observed effects, mecha2 nistic information, and exposure evalua3 tions; and 

4 ‘‘(ii) make the proposed methodology 

5 available for public comment and scientific 

6 peer review. 

7 ‘‘(B) REVIEW AND REVISIONS.—Not later 

8 than 5 years after the date of enactment of the 

9 Chemical Safety Improvement Act, and not less 

10 frequently than once every 5 years thereafter, 

11 the Administrator— 

12 ‘‘(i) shall review the methodology de13 veloped under subparagraph (A); and 

14 ‘‘(ii) may revise the methodology to 

15 reflect new scientific developments or un16 derstandings, in accordance with subpara17 graph (A). 

18 ‘‘(C) REQUIREMENTS.—The methodology 

19 shall apply scientifically recognized factors to 

20 address the following topics: 

21 ‘‘(i) Strengths and limitations of 

22 study design. 

23 ‘‘(ii) Reliability and relevance of test 

24 methods to human health and the environ25 ment. 


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1 ‘‘(iii) Quality of data. 

2 ‘‘(iv) Use of good laboratory practices. 

3 ‘‘(v) Peer review and peer review proc4 esses. 

5 ‘‘(vi) Use of standardized protocols. 

6 ‘‘(vii) Structured evaluative frame7 works to determine the overall weight of 

8 the evidence, based on a review of positive 

9 and negative findings. 

10 ‘‘(D) HAZARD, USE, AND EXPOSURE IN11 FORMATION.— 

12 ‘‘(i) IN GENERAL.—A safety assess13 ment under this subsection shall evaluate 

14 existing hazard, use, and exposure infor15 mation for the chemical substance under 

16 the intended conditions of use of the chem17 ical substance, including information sub18 mitted by interested persons. 

19 ‘‘(ii) EXPOSURE.—For purposes of 

20 evaluating exposure under clause (i), a 

21 safety assessment shall take into consider22 ation— 

23 ‘‘(I) exposures or significant sub24 sets of exposures; 


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1 ‘‘(II) exposure duration, inten2 sity, frequency, and number; and 

3 ‘‘(III) the vulnerability of ex4 posed subpopulations. 

5 ‘‘(E) BEST AVAILABLE SCIENCE.—The Ad6 ministrator shall use the best available science 

7 in conducting a safety assessment under this 

8 subsection. 

9 ‘‘(5) ADDITIONAL TEST INFORMATION.—If the 

10 Administrator determines that additional test infor11 mation is needed in order to make a safety assess12 ment for a high-priority substance, the Adminis13 trator— 

14 ‘‘(A) shall provide an opportunity for inter15 ested persons to submit the additional informa16 tion; 

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

18 testing consent agreement, or issue an order 

19 under section 4 to require the development of 

20 the information; and 

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

22 safety assessment until after receipt of the in23 formation. 

24 ‘‘(6) TREATMENT.—A safety assessment under 

25 this subsection— 


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1 ‘‘(A) shall not be considered to be a final 

2 agency action; and 

3 ‘‘(B) shall not be subject to judicial review. 

4 ‘‘(c) SAFETY DETERMINATION.— 

5 ‘‘(1) IN GENERAL.—As soon as possible after 

6 the date on which the safety assessment is com7 pleted for a high-priority substance under subsection 

8 (b), the Administrator shall determine whether the 

9 chemical substance meets the safety standard under 

10 the intended conditions of use of the chemical sub11 stance. 

12 ‘‘(2) DETERMINATIONS.—Based on a review of 

13 the information described in paragraph (3), the Ad14 ministrator shall determine, based solely on consid15 erations of risk to human health and the environ16 ment, that— 

17 ‘‘(A) the relevant chemical substance meets 

18 the safety standard under intended conditions 

19 of use; 

20 ‘‘(B) the relevant chemical substance does 

21 not meet the safety standard under intended 

22 conditions of use, in which case the Adminis23 trator shall impose additional restrictions, as 

24 appropriate, under paragraph (9); or 


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1 ‘‘(C) additional information is necessary in 

2 order to make a determination under subpara3 graph (A) or (B), in which case the Adminis4 trator shall take appropriate action under para5 graph (8). 

6 ‘‘(3) CONSIDERATIONS.—In making a safety de7 termination under this subsection, the Administrator 

8 shall take into consideration and publish a statement 

9 that includes, at a minimum— 

10 ‘‘(A) the safety assessment for the chem11 ical substance, including the uses considered in 

12 the assessment and any uses that are consid13 ered critical or essential; 

14 ‘‘(B) the range of exposure to the chemical 

15 substance under the intended conditions of use 

16 of the chemical substance and appropriate ref17 erence parameters; 

18 ‘‘(C) the weight of the evidence of risk 

19 posed by the chemical substance under the in20 tended conditions of use of the chemical sub21 stance; and 

22 ‘‘(D) the magnitude of the risk posed by 

23 the chemical substance under the intended con24 ditions of use of the chemical substance. 


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1 ‘‘(4) INFORMATION SOURCES.—In making a 

2 safety determination under this subsection, the Ad3 ministrator shall take into consideration, at a min4 imum— 

5 ‘‘(A) the information described in section 

6 4(c); and 

7 ‘‘(B) the safety assessment conducted with 

8 respect to the chemical substance under sub9 section (b). 

10 ‘‘(5) BEST AVAILABLE SCIENCE.—The Adminis11 trator shall use the best available science in making 

12 a safety determination under this subsection. 

13 ‘‘(6) NOTICE AND COMMENT.—Subject to sec14 tion 14, the Administrator shall provide notice and 

15 an opportunity for public comment on each proposed 

16 safety determination under this subsection. 

17 ‘‘(7) TRANSPARENCY.—Subject to section 14, 

18 the Administrator shall publish— 

19 ‘‘(A) each safety determination under this 

20 subsection, together with a summary of the in21 formation considered in the determination; 

22 ‘‘(B) a summary of the evaluation by the 

23 Administrator of the information; and 

24 ‘‘(C) an explanation of the reasons for the 

25 determination. 


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1 ‘‘(8) ADDITIONAL TEST DATA AND INFORMA2 TION.—If the Administrator determines that addi3 tional test data and information is needed in order 

4 to make a safety determination for a high-priority 

5 substance, the Administrator— 

6 ‘‘(A) shall provide an opportunity for inter7 ested persons to submit the additional data and 

8 information; 

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

10 testing consent agreement, or issue an order 

11 under section 4 to require the development of 

12 the data and information; 

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

14 safety determination until after receipt of the 

15 data and information; and 

16 ‘‘(D) on receipt of the data and informa17 tion, shall make a determination under para18 graph (2). 

19 ‘‘(9) ADDITIONAL RESTRICTIONS.— 

20 ‘‘(A) IN GENERAL.— 

21 ‘‘(i) DETERMINATION.—If the Admin22 istrator makes a determination under 

23 paragraph (2)(B) with respect to a chem24 ical substance, the Administrator shall pro25 mulgate a rule establishing necessary reVerDate Mar 15 2010 00:35 May 29, 2013 Jkt 029200 PO 00000 Frm 00067 Fmt 6652 Sfmt 6201 E:\BILLS\S1009.IS S1009

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1 strictions (based on the weight of the evi2 dence of risk and the magnitude of risk), 

3 including if appropriate, a ban or phase 

4 out of the manufacture, processing, or use 

5 of the chemical substance in accordance 

6 with subparagraph (C). 

7 ‘‘(ii) RULES.—Rules promulgated 

8 under this section may apply to mixtures 

9 containing the chemical substance, as ap10 propriate. 

11 ‘‘(B) INCLUSIONS.—A restriction under 

12 subparagraph (A) may include, as appro13 priate— 

14 ‘‘(i) a requirement that a chemical 

15 substance be marked with, or accompanied 

16 by, clear and adequate warnings and in17 structions with respect to use, distribution 

18 in commerce, or disposal, or any combina19 tion of those activities, with the form and 

20 content of the warnings and instructions to 

21 be prescribed by the Administrator; 

22 ‘‘(ii) a requirement that manufactur23 ers and processors of the chemical sub24 stance— 


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1 ‘‘(I) make and retain records of 

2 the processes used to manufacture or 

3 process the chemical substance; and 

4 ‘‘(II) subject to section 4(f), de5 velop test information that is reason6 ably necessary to ensure compliance 

7 with this Act; 

8 ‘‘(iii) a limitation on the quantity of 

9 the chemical substance that may be manu10 factured, processed, or distributed in com11 merce; 

12 ‘‘(iv) a requirement to ban or phase 

13 out or other regulation on the manufac14 ture, processing, or distribution in com15 merce of the chemical substance— 

16 ‘‘(I) for a particular use; or 

17 ‘‘(II) for a particular use at a 

18 concentration in excess of a level spec19 ified by the Administrator; 

20 ‘‘(v) a limitation on the quantity of 

21 the chemical substance that may be manu22 factured, processed, or distributed in com23 merce— 

24 ‘‘(I) for a particular use; or 


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1 ‘‘(II) for a particular use at a 

2 concentration in excess of a level spec3 ified by the Administrator; 

4 ‘‘(vi) a requirement to ban or phase 

5 out or other regulation of any method of 

6 commercial use of the chemical substance; 

7 ‘‘(vii) a requirement to ban or phase 

8 out or other regulation of any method of 

9 disposal of the chemical substance or any 

10 article containing the chemical substance; 

11 ‘‘(viii) a requirement directing manu12 facturers or processors of the chemical 

13 substance to give notice of unreasonable 

14 risks of harm to distributors in commerce 

15 of the chemical substance and, to the ex16 tent reasonably ascertainable, to other per17 sons in the chain of commerce in posses18 sion of the chemical substance; and 

19 ‘‘(ix) such other requirements as the 

20 Administrator determines to be necessary. 

21 ‘‘(C) BANS AND PHASE OUTS.—The Ad22 ministrator shall base a determination under 

23 subparagraph (A) that a ban or phase out of 

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1 ical substance is necessary on the consider2 ations described in subparagraph (D). 

3 ‘‘(D) DETERMINATION THAT CHEMICAL

4 SUBSTANCE DOES NOT MEET SAFETY STAND5 ARD.—If the Administrator determines that the 

6 chemical substance does not meet the safety 

7 standard under the intended conditions of use, 

8 the Administrator shall consider and publish a 

9 statement on— 

10 ‘‘(i) the availability of technically and 

11 economically feasible alternatives for the 

12 chemical substance under the intended 

13 conditions of use; 

14 ‘‘(ii) the risks posed by those alter15 natives as compared to those of the chem16 ical substance; 

17 ‘‘(iii) the economic and social costs 

18 and benefits of the proposed regulatory ac19 tion and options considered, and of poten20 tial alternatives; and 

21 ‘‘(iv) the economic and social benefits 

22 and costs of— 

23 ‘‘(I) the chemical substance; 

24 ‘‘(II) alternatives to the chemical 

25 substance; and 


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1 ‘‘(III) any necessary restrictions 

2 on the chemical substance or alter3 natives. 

4 ‘‘(10) EXEMPTIONS.—The Administrator may 

5 exempt the use of a chemical substance from any ad6 ditional restriction established under paragraph (9) 

7 if the Administrator determines that— 

8 ‘‘(A) the exemption is in the interest of na9 tional security; 

10 ‘‘(B) the lack of availability of the chemical 

11 substance would cause significant disruption in 

12 the national economy; 

13 ‘‘(C) the use for which the exemption is 

14 sought is a critical or essential use for which— 

15 ‘‘(i) no feasible alternative for the use 

16 would materially reduce risk to health or 

17 the environment; or 

18 ‘‘(ii) no feasible alternative for the use 

19 is economically, technically, or efficiently 

20 available; or 

21 ‘‘(D) the use, as compared to reasonably 

22 available alternatives, provides a net benefit to 

23 human health, the environment, or public safe24 ty. 


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1 ‘‘(11) FINAL AGENCY ACTION.—A safety deter2 mination under this subsection shall be— 

3 ‘‘(A) considered to be a final agency ac4 tion; and 

5 ‘‘(B) subject to judicial review, including 

6 review of the associated safety assessment 

7 under this subsection.’’; 

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

9 subsections (d) and (e), respectively; and 

10 (4) in subsection (d) (as so redesignated)— 

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

12 (B) by redesignating paragraph (5) as 

13 paragraph (4). 

14 SEC. 7. IMMINENT HAZARDS. 

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

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

17 following: 

18 ‘‘(a) CIVIL ACTIONS.— 

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

20 commence a civil action in an appropriate district 

21 court of the United States for— 

22 ‘‘(A) seizure of an imminently hazardous 

23 chemical substance or mixture or any article 

24 containing the substance or mixture; 


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

2 (b)) against any person who manufactures, 

3 processes, distributes in commerce, uses, or dis4 poses of, an imminently hazardous chemical 

5 substance or mixture or any article containing 

6 the substance or mixture; or 

7 ‘‘(C) both seizure described in subpara8 graph (A) and relief described in subparagraph 

9 (B). 

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

11 A civil action may be commenced under this para12 graph notwithstanding— 

13 ‘‘(A) the existence of— 

14 ‘‘(i) a decision by the Administrator 

15 under section 4(c)(3), 5(c)(4), or 6(c)(2); 

16 or 

17 ‘‘(ii) a rule, testing consent agree18 ment, or order under section 4(f), 5(g), 

19 6(b)(5), 6(c)(8), 6(c)(9), or 6(d); or 

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

21 judicial proceeding under any provision of this 

22 Act.’’; 

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

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


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

2 striking ‘‘and unreasonable’’. 

3 SEC. 8. INFORMATION COLLECTION AND REPORTING. 

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

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

6 following: 

7 ‘‘(4) REGULATIONS.— 

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

9 shall promulgate rules requiring the reporting 

10 of information known by, or reasonably ascer11 tainable by, the person making the report, in12 cluding rules requiring processors to report in13 formation, so that the Administrator has the in14 formation necessary to carry out sections 4 and 

15 6. 

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

17 under subparagraph (A)— 

18 ‘‘(i) may impose different reporting 

19 requirements on manufacturers and proc20 essors; 

21 ‘‘(ii) shall be limited to active sub22 stances or mixtures containing active sub23 stances as designated under subsection (b); 

24 and 


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1 ‘‘(iii) shall apply only to the extent the 

2 Administrator determines the submission 

3 of reports is necessary for the effective en4 forcement of this Act. 

5 ‘‘(5) GUIDANCE.—The Administrator shall de6 velop guidance relating to the information required 

7 to be reported under the rules promulgated under 

8 this subsection that— 

9 ‘‘(A) include the level of detail necessary to 

10 be reported; and 

11 ‘‘(B) describes the manner by which manu12 facturers and processors may report use and ex13 posure information on a voluntary basis.’’; 

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

15 following: 

16 ‘‘(3) NOMENCLATURE.— 

17 ‘‘(A) IN GENERAL.—In carrying out para18 graph (1), the Administrator shall— 

19 ‘‘(i) maintain the use of Class 2 no20 menclature in use on date of enactment of 

21 the Chemical Safety Improvement Act; 

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

23 Detergent Association Nomenclature Sys24 tem, published in March 1978 by the Ad25 ministrator in section 1 of addendum III 


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1 of the document entitled ‘Candidate List of 

2 Chemical Substances’, and further de3 scribed in the appendix A of volume I of 

4 the 1985 edition of the Toxic Substances 

5 Control Act Substances Inventory (EPA 

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

7 ‘‘(iii) treat all components of cat8 egories that are considered to be statutory 

9 mixtures under this Act as being included 

10 on the list published under paragraph (1) 

11 under the Chemical Abstracts Service 

12 numbers for the respective categories, in13 cluding, without limitation— 

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

15 CAS No. 65997–15–1; 

16 ‘‘(II) cement, alumina, chemicals, 

17 CAS No. 65997–16–2; 

18 ‘‘(III) glass, oxide, chemicals, 

19 CAS No. 65997–17–3; 

20 ‘‘(IV) frits, chemicals, CAS No. 

21 65997–18–4; 

22 ‘‘(V) steel manufacture, chemi23 cals, CAS No. 65997–19–5; and 


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1 ‘‘(VI) ceramic materials and 

2 wares, chemicals, CAS No. 66402– 

3 68–4. 

4 ‘‘(B) MULTIPLE NOMENCLATURE CONVEN5 TIONS.— 

6 ‘‘(i) IN GENERAL.—In the event that 

7 existing guidance allows for multiple no8 menclature conventions, the Administrator 

9 shall— 

10 ‘‘(I) maintain the nomenclature 

11 conventions for substances; and 

12 ‘‘(II) develop new guidance 

13 that— 

14 ‘‘(aa) establishes equivalency 

15 between the nomenclature con16 ventions for chemical substances 

17 on the list published under para18 graph (1); and 

19 ‘‘(bb) permits persons to 

20 rely on that new guidance for 

21 purposes of determining whether 

22 a chemical substance is on the 

23 list published under paragraph 

24 (1). 


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1 ‘‘(ii) MULTIPLE CAS NUMBERS.—For 

2 any chemical substance appearing multiple 

3 times on the list under different Chemical 

4 Abstracts Service numbers, the Adminis5 trator shall develop guidance recognizing 

6 the multiple listings as a single chemical 

7 substance. 

8 ‘‘(4) CANDIDATE LIST OF ACTIVE SUBSTANCES

9 IN COMMERCE.— 

10 ‘‘(A) IN GENERAL.—Subject to section 14, 

11 the Administrator shall make publicly available 

12 a candidate list of active chemical substances, 

13 which shall include— 

14 ‘‘(i) any chemical substance reported 

15 under part 711 of title 40, Code of Federal 

16 Regulations, as in effect on the date of en17 actment of the Chemical Safety Improve18 ment Act, during the period beginning on 

19 the date that is 10 years before the date 

20 of enactment of the Chemical Safety Im21 provement Act and ending on the date of 

22 enactment of the Chemical Safety Improve23 ment Act; 


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1 ‘‘(ii) any chemical substance for which 

2 a notice of commencement of manufacture 

3 has been submitted; 

4 ‘‘(iii) any chemical substance for 

5 which a significant new use notice has 

6 been submitted; 

7 ‘‘(iv) any chemical substance for 

8 which an export notification has been sub9 mitted during the period beginning on the 

10 date that is 10 years before the date of en11 actment of the Chemical Safety Improve12 ment Act and ending on the date of enact13 ment of the Chemical Safety Improvement 

14 Act; and 

15 ‘‘(v) any other chemical substance 

16 identified by the Administrator as likely to 

17 qualify as active. 

18 ‘‘(B) RULE.—The Administrator shall, by 

19 rule, require manufacturers and processors to 

20 notify the Administrator that the manufacturer 

21 or processor, as applicable, has manufactured 

22 or processed a chemical substance on the list 

23 described in subparagraph (A), or the list pub24 lished under paragraph (1) for a nonexempt 

25 commercial purpose during the 5-year period 


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1 prior to the date of enactment of the Chemical 

2 Safety Improvement Act. 

3 ‘‘(C) GUIDANCE.—Before issuing a final 

4 rule under subparagraph (A), the Administrator 

5 shall make publicly available guidance relating 

6 to the rule for chemical substances on the con7 fidential portion of the candidate list of active 

8 substances and of the list published under para9 graph (1), including — 

10 ‘‘(i) accession numbers; 

11 ‘‘(ii) premanufacture notice case num12 bers, if applicable; and 

13 ‘‘(iii) generic names. 

14 ‘‘(D) CONFIDENTIAL CHEMICAL SUB15 STANCES.—The rule under subparagraph (B) 

16 shall require a manufacturer or processor that 

17 is reporting information relating to a chemical 

18 substance on the confidential portion of the list 

19 published under paragraph (1) to indicate 

20 whether the manufacturer or processor claims 

21 the specific identity of the substance as con22 fidential pursuant to section 14. 

23 ‘‘(E) CERTIFICATION.—The rule under 

24 subparagraph (B) shall require a manufacturer 

25 or processor— 


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1 ‘‘(i) to certify the accuracy of each re2 port of the manufacturer or processor car3 ried out under the rule; and 

4 ‘‘(ii) to retain a record supporting 

5 that certification for a period of 5 years 

6 beginning on the last day of the submis7 sion period. 

8 ‘‘(F) APPLICABILITY.—Nothing in this 

9 paragraph requires the resubstantiation of a 

10 claim for protection against disclosure for infor11 mation submitted to the Administrator prior to 

12 the date of enactment of the Chemical Safety 

13 Improvement Act. 

14 ‘‘(5) LIST.— 

15 ‘‘(A) IN GENERAL.—Based on the notifica16 tions received in response to the rule under 

17 paragraph (4), the Administrator shall des18 ignate each chemical substance that is on the 

19 list published under paragraph (1) on the date 

20 of enactment of the Chemical Safety Improve21 ment Act as active or inactive. 

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

23 update the list of chemicals designated as active 

24 or inactive as soon as practicable following the 

25 publication of the most recent data reported 


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1 under part 711 of title 40, Code of Federal 

2 Regulations. 

3 ‘‘(6) ACTIVE SUBSTANCES.—The Administrator 

4 shall designate as an active substance— 

5 ‘‘(A) a chemical substance that has been 

6 manufactured or processed for a nonexempt 

7 commercial purposes at any point during the 5- 

8 year period prior to the date of enactment of 

9 the Chemical Safety Improvement Act; 

10 ‘‘(B) a chemical substance that is added to 

11 the list published under paragraph (1) after the 

12 date of enactment of the Chemical Safety Im13 provement Act; 

14 ‘‘(C) a chemical substance for which a no15 tice is received under paragraph (7)(C); and 

16 ‘‘(D) a chemical substance reported under 

17 part 711 of title 40, Code of Federal Regula18 tions, after the date of enactment of the Chem19 ical Safety Improvement Act. 

20 ‘‘(7) INACTIVE SUBSTANCES.— 

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

22 shall designate as an inactive substance each 

23 chemical substance on the list published under 

24 paragraph (1) that has not been manufactured 

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1 pose in the 5-year period ending on the date of 

2 enactment of the Chemical Safety Improvement 

3 Act. 

4 ‘‘(B) TREATMENT.—Each inactive sub5 stance shall remain on the list published under 

6 paragraph (1). 

7 ‘‘(C) CHANGE TO ACTIVE STATUS.— 

8 ‘‘(i) IN GENERAL.—Any person who 

9 intends to manufacture or process for a 

10 nonexempt commercial purpose a chemical 

11 substance that is designated as an inactive 

12 substance shall notify the Administrator 

13 before the date on which the substance is 

14 manufactured or processed. 

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

16 notification under clause (i), the Adminis17 trator— 

18 ‘‘(I) shall designate the chemical 

19 substance as an active substance; and 

20 ‘‘(II) shall, pursuant to section 

21 4(e), review the priority of the chem22 ical substance as the Administrator 

23 determines necessary. 


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1 ‘‘(D) CATEGORY STATUS.—The list of in2 active chemical substances shall not be consid3 ered a category for purposes of section 26(c). 

4 ‘‘(8) PUBLIC PARTICIPATION.— 

5 ‘‘(A) IN GENERAL.—Subject to subpara6 graph (B), the Administrator shall make avail7 able to the public— 

8 ‘‘(i) the specific identity of each chem9 ical substance on the nonconfidential por10 tion of the list published under paragraph 

11 (5) that the Administrator has designated 

12 as an active substance; 

13 ‘‘(ii) the specific identity of each 

14 chemical substance on the nonconfidential 

15 portion of the list published under para16 graph (1) that the Administrator has des17 ignated as an inactive substance; 

18 ‘‘(iii) the accession number, generic 

19 name, and, if applicable, premanufacture 

20 notice case number for each chemical sub21 stance on the confidential portion of the 

22 list published under paragraph (1) for 

23 which a claim of confidentiality was re24 ceived; and 


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1 ‘‘(iv) the specific identity of any active 

2 or inactive substance on the confidential 

3 portion of the list published under para4 graph (1) for which no claim of confiden5 tiality was received, subject to the condi6 tion that, before revealing the specific iden7 tity of the substance, the Administrator 

8 shall— 

9 ‘‘(I) publish a notice in the Fed10 eral Register identifying the accession 

11 number, generic name, and, if applica12 ble, premanufacture notice case num13 ber for that substance; and 

14 ‘‘(II) provide an opportunity for 

15 any person— 

16 ‘‘(aa) to certify to the Ad17 ministrator that the person in18 tends to manufacture or process 

19 the substance at any point in the 

20 subsequent 4-year period; and 

21 ‘‘(bb) to claim confiden22 tiality for the specific identity of 

23 the substance. 

24 ‘‘(B) CONFIDENTIALITY.—Subject section 

25 14, the Administrator shall not make available 


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1 to the public the specific chemical identity of 

2 any substance for which the Administrator re3 ceives a notice under subparagraph (A)(iv).’’; 

4 and 

5 (3) in subsection (e)— 

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

7 the following: 

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

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

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

11 to the Administrator data and information reason12 ably supporting the conclusion that a chemical sub13 stance or mixture does not present a substantial risk 

14 of injury to health and the environment.’’. 

15 SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS. 

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

17 (1) in subsection (a)— 

18 (A) in the first sentence of paragraph 

19 (1)— 

20 (i) by striking ‘‘presents or will 

21 present an unreasonable risk to health or 

22 the environment’’ and inserting ‘‘does not 

23 meet the safety standard under the in24 tended conditions of use’’; and 


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

2 place it appears and inserting ‘‘the risk 

3 posed by the substance or mixture’’; 

4 (B) in paragraph (2), in the matter fol5 lowing subparagraph (B), by striking ‘‘section 6 

6 or 7’’ and inserting ‘‘paragraph (8) or (9) of 

7 subsection (c) of section 6 or section 7’’; and 

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

9 6 or 7’’ and inserting ‘‘paragraph (8) or (9) of 

10 subsection (c) of section 6 or section 7’’; and 

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

12 striking ‘‘Health, Education, and Welfare’’ and in13 serting ‘‘Health and Human Services’’. 

14 SEC. 10. RESEARCH, DEVELOPMENT, COLLECTION, DIS15 SEMINATION, AND UTILIZATION OF DATA. 

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

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

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

19 SEC. 11. EXPORTS. 

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

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

22 and inserting the following: 

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

24 apply to any chemical substance that the Adminis25 trator determines— 


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

2 the safety standard under the intended condi3 tions of use of the chemical substance; or 

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

5 safety standard under the intended conditions 

6 of use of the chemical substance. 

7 ‘‘(3) WAIVERS.—For a mixture or article con8 taining a chemical substance described in paragraph 

9 (2), the Administrator may— 

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

11 not apply to that mixture or article; and 

12 ‘‘(B) establish a threshold concentration in 

13 a mixture or article at which paragraph (1) 

14 shall not apply.’’; 

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

16 following: 

17 ‘‘(b) NOTICE.— 

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

19 Administrator that the person is exporting or in20 tends to export to a foreign country— 

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

22 containing a chemical substance that the Ad23 ministrator has determined under section 5 is 

24 not likely to meet the safety standard under the 


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1 intended conditions of use of the chemical sub2 stance; 

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

4 containing a chemical substance that the Ad5 ministrator has determined under section 6 

6 does not meet the safety standard under the in7 tended conditions of use of the chemical sub8 stance; or 

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

10 United States is obligated by treaty to provide 

11 export notification. 

12 ‘‘(2) REGULATIONS.— 

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

14 shall promulgate regulations to carry out para15 graph (1). 

16 ‘‘(B) CONTENTS.—The regulations pro17 mulgated under subparagraph (A) shall— 

18 ‘‘(i) include any exemptions the Ad19 ministrator determines to be appropriate, 

20 which may include exemptions identified 

21 under section 5(g); and 

22 ‘‘(ii) indicate whether or to what ex23 tent the regulations apply to articles con24 taining a chemical substance or mixture 

25 described in paragraph (1). 


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

2 submit to the government of each country to which 

3 a chemical substance or mixture is exported— 

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

5 described in subparagraph (A) or (B) of para6 graph (1), a notice that information on the 

7 chemical substance or mixture can be obtained 

8 from the Administrator, unless the Adminis9 trator determines that good cause exists not to 

10 provide the notice; and 

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

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

15 (3) in subsection (c)— 

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

17 (B) by redesignating paragraphs (4) 

18 through (6) as paragraphs (3) through (5), re19 spectively. 

20 SEC. 12. IMPORTS. 

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

22 follows: 


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1 ‘‘SEC. 13. IMPORTS. 

2 ‘‘(a) DEFINITION OF CHEMICAL SUBSTANCE OR MIX3 TURE.—In this section, the term ‘chemical substance or 

4 mixture’ includes— 

5 ‘‘(1) a mixture containing a chemical substance 

6 or mixture; and 

7 ‘‘(2) an article containing a chemical substance 

8 or mixture. 

9 ‘‘(b) REFUSAL OF ENTRY.— 

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

11 Security shall refuse entry into the customs territory 

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

13 to the Harmonized Tariff Schedule of the United 

14 States) any chemical substance or mixture offered 

15 for such entry if— 

16 ‘‘(A) the Administrator has determined 

17 under section 6(c) that the chemical substance 

18 or mixture does not meet the safety standard 

19 under the intended conditions of use of the 

20 chemical substance; or 

21 ‘‘(B) the chemical substance or mixture is 

22 offered for entry in violation of a rule or order 

23 in effect under this Act. 

24 ‘‘(2) PROCEDURE.— 

25 ‘‘(A) IN GENERAL.—Subject to subpara26 graph (B), if a chemical substance or mixture 


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1 is refused entry under paragraph (1), the Sec2 retary of Homeland Security— 

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

4 entry of the refusal; 

5 ‘‘(ii) shall not release the chemical 

6 substance or mixture to the consignee; and 

7 ‘‘(iii) shall cause the disposal or stor8 age of the chemical substance or mixture 

9 under such rules as the Secretary may pre10 scribe, if the chemical substance or mix11 ture has not been exported by the con12 signee in the 90-day period beginning on 

13 the date of receipt of the notice of the re14 fused entry. 

15 ‘‘(B) EXCEPTION.— 

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

17 Homeland Security may, pending a review 

18 by the Administrator, release to the con19 signee the chemical substance or mixture if 

20 the consignee— 

21 ‘‘(I) executes a bond for the 

22 amount of the full invoice of the 

23 chemical substance or mixture (as set 

24 forth in the customs entry); and 


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1 ‘‘(II) pays a duty on the chemical 

2 substance or mixture. 

3 ‘‘(ii) ADMINISTRATION.—If a con4 signee fails to return a chemical substance 

5 or mixture released to that consignee 

6 under clause (i) for any cause to the cus7 tody of the Secretary of Homeland Secu8 rity when demanded, the consignee shall be 

9 liable to the United States for liquidated 

10 damages equal to the full amount of the 

11 bond. 

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

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

14 chemical substance or mixture that is refused 

15 entry or released under this subsection shall be 

16 paid by the owner or consignee, and a default 

17 on that payment shall constitute a lien against 

18 any future entry made by the owner or con19 signee. 

20 ‘‘(c) NOTICE.— 

21 ‘‘(1) IN GENERAL.—A person offering a chem22 ical substance or mixture subject to this Act for 

23 entry into the customs territory of the United States 

24 shall— 


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1 ‘‘(A) certify to the Secretary of Homeland 

2 Security that, after reasonable inquiry and to 

3 the best knowledge and belief of the person, the 

4 chemical substance or mixture is— 

5 ‘‘(i) in compliance with any applicable 

6 rule, consent agreement, or order under 

7 section 5 or 6; and 

8 ‘‘(ii)(I) included on the list under sec9 tion 8(b); or 

10 ‘‘(II) exempt from any requirement to 

11 be included on that list; and 

12 ‘‘(B) provide to the Secretary of Homeland 

13 Security any notice required under paragraph 

14 (2). 

15 ‘‘(2) NOTICE.—A person offering a chemical 

16 substance or mixture for entry into the customs ter17 ritory of the United States shall notify the Secretary 

18 of Homeland Security if— 

19 ‘‘(A) the chemical substance is a high-pri20 ority substance; 

21 ‘‘(B) the chemical substance is a chemical 

22 for which the United States is obligated to pro23 vide export notification by treaty; or 


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1 ‘‘(C) the chemical substance or mixture or 

2 any article containing the substance or mix3 ture— 

4 ‘‘(i) is the subject of a safety assess5 ment and safety determination conducted 

6 pursuant to section 6 and has been found 

7 not to meet the safety standard; and 

8 ‘‘(ii) is identified in a rule promul9 gated by the Secretary of Homeland Secu10 rity pursuant to subsection (c) as meriting 

11 notification due to the potential impact of 

12 the chemical substance or mixture or any 

13 article containing the substance or mixture 

14 on human health or the environment. 

15 ‘‘(d) RULES.—The Secretary of Homeland Security, 

16 after consultation with the Administrator, shall issue rules 

17 for the administration of subsection (c), including wheth18 er, or to what extent, the provisions of subsections (b) and 

19 (c) apply.’’. 

20 SEC. 13. CONFIDENTIAL INFORMATION. 

21 Section 14 (15 U.S.C. 2613) is amended to read as 

22 follows: 


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1 ‘‘SEC. 14. CONFIDENTIAL INFORMATION. 

2 ‘‘(a) IN GENERAL.—Except as provided in sub3 sections (c) and (e), the Administrator shall not disclose 

4 information described in subsection (b)— 

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

6 by, the Administrator under this Act; and 

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

8 (d) are met. 

9 ‘‘(b) INFORMATION GENERALLY PROTECTED FROM

10 DISCLOSURE.— 

11 ‘‘(1) IN GENERAL.—Information referred to in 

12 subsection (a) includes confidential information that 

13 is exempt from disclosure pursuant to subsection (a) 

14 of section 552 of title 5, United States Code, under 

15 subsection (b)(4) of that section. 

16 ‘‘(2) PRESUMPTION OF PROTECTION.—The fol17 lowing information submitted by a manufacturer, 

18 processor, or distributor is presumed to be protected 

19 from disclosure: 

20 ‘‘(A) Specific information describing the 

21 manufacture, processing, or distribution in com22 merce of a chemical substance, mixture, or arti23 cle. 

24 ‘‘(B) Marketing and sales information. 

25 ‘‘(C) Information identifying suppliers or 

26 customers. 


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1 ‘‘(D) The identity of constituents in a mix2 ture and the respective percentages of those 

3 constituents. 

4 ‘‘(E) Specific information about the use, 

5 function, or application of a chemical substance 

6 or mixture in a process, mixture, or product. 

7 ‘‘(F) Specific production or import volumes 

8 of a manufacturer and specific volumes aggre9 gated across manufacturers if the Adminis10 trator determines that disclosure of the aggre11 gated data could reveal confidential informa12 tion. 

13 ‘‘(G) The specific identity of a chemical 

14 substance, including the chemical name, molec15 ular formula, Chemical Abstracts Service num16 ber, and other information that would identify 

17 a specific chemical substance, if— 

18 ‘‘(i) the specific identity was claimed 

19 as confidential information at the time it 

20 was submitted; and 

21 ‘‘(ii) the claim has not subsequently 

22 been withdrawn or found by the Adminis23 trator not to warrant protection as con24 fidential information under subsection (g). 


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1 ‘‘(c) INFORMATION NOT PROTECTED FROM DISCLO2 SURE.— 

3 ‘‘(1) IN GENERAL.—Notwithstanding sub4 sections (a) and (b), and except as provided in para5 graph (2), the following information shall not be 

6 protected from disclosure: 

7 ‘‘(A) For information submitted after the 

8 date of enactment of the Chemical Safety Im9 provement Act, the identity of a chemical sub10 stance if the person submitting the information 

11 does not meet the requirements of subsection 

12 (d). 

13 ‘‘(B) A safety assessment developed or a 

14 safety determination made under section 6. 

15 ‘‘(C) Health and safety data that are sub16 mitted under this Act with respect to a chem17 ical substance or mixture that has been offered 

18 for commercial distribution as of the date on 

19 which the study is to be disclosed or for which 

20 testing is required under section 4. 

21 ‘‘(D) Health and safety data in notices of 

22 substantial risk submitted under section 8(e) 

23 and in the underlying studies. 


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1 ‘‘(E) General information describing the 

2 manufacturing volumes, expressed in ranges 

3 would not reveal confidential information. 

4 ‘‘(F) General descriptions of industrial, 

5 commercial, or consumer functions and uses of 

6 a chemical substance or mixture. 

7 ‘‘(2) EXCEPTION.—Information elements con8 tained in submissions described in paragraph (1) 

9 that are otherwise eligible for protection under this 

10 section shall be protected from disclosure if the sub11 mitter complies with subsection (d). 

12 ‘‘(d) REQUIREMENTS FOR CONFIDENTIALITY

13 CLAIMS.— 

14 ‘‘(1) CLAIMS.— 

15 ‘‘(A) IN GENERAL.—For information to be 

16 protected from disclosure under this section, a 

17 person who submits information to the Admin18 istrator under this Act shall— 

19 ‘‘(i) indicate the information that the 

20 person believes is entitled to protection 

21 from disclosure under this section in a sub22 mission to the Administrator in such man23 ner and at such time as the Administrator 

24 shall prescribe; and 


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1 ‘‘(ii) except in the case of information 

2 described in subparagraphs (A) through 

3 (F) of subsection (b)(2), submit written 

4 documentation justifying why the informa5 tion qualifies for protection from disclo6 sure. 

7 ‘‘(B) CERTIFICATION.—An authorized offi8 cial of the person described in subparagraph 

9 (A) shall certify that the information that has 

10 been submitted is true and correct. 

11 ‘‘(2) ADDITIONAL REQUIREMENTS FOR CON12 FIDENTIALITY CLAIMS FOR CHEMICAL IDENTI13 TIES.—A person submitting information under this 

14 Act related to a chemical identity and who claims 

15 protection from disclosure for that identity shall pro16 vide the Administrator with— 

17 ‘‘(A) information establishing that— 

18 ‘‘(i) the person takes reasonable meas19 ures to protect the confidentiality of the 

20 chemical identity; 

21 ‘‘(ii) the chemical identity is not re22 quired to be disclosed, or otherwise made 

23 available, to the public under any other 

24 Federal law in connection with one or more 

25 uses subject to this Act; 


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1 ‘‘(iii) disclosure of the chemical iden2 tity is likely to cause substantial harm to 

3 the competitive position of the person; and 

4 ‘‘(iv) the chemical identity is not rea5 sonably believed to be readily discoverable 

6 through reverse engineering; 

7 ‘‘(B) the time period for which protection 

8 of the chemical identity from disclosure is nec9 essary; 

10 ‘‘(C) a generic name for the chemical sub11 stance that the Administrator may disclose to 

12 the public, subject to the condition that the ge13 neric name discloses a maximum amount of in14 formation on the chemical structure of the sub15 stance while protecting those features of the 

16 chemical structure that are considered confiden17 tial and the disclosure of which would poten18 tially harm the competitive position of the per19 son; and 

20 ‘‘(D) in the event the Administrator makes 

21 a request under subsection (f)— 

22 ‘‘(i) redocumentation and recertifi23 cation of the information submitted under 

24 subsection (a); or 


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1 ‘‘(ii) withdrawal of the claim for pro2 tection of the chemical identity from disclo3 sure. 

4 ‘‘(3) GUIDANCE.—The Administrator shall de5 velop guidance, after notice and opportunity to com6 ment, on the determination of generic names for 

7 confidential chemical identities. 

8 ‘‘(e) EXCEPTIONS TO PROTECTION FROM DISCLO9 SURE.—Subsection (a) shall not apply if— 

10 ‘‘(1) the information is to be disclosed to an of11 ficer or employee of the United States in connection 

12 with the official duties of that person under any law 

13 for the protection of human health or the environ14 ment or for specific law enforcement purposes; 

15 ‘‘(2) the information is to be disclosed to a con16 tractor with the United States and employees of that 

17 contractor if, in the opinion of the Administrator, 

18 the disclosure is necessary for the satisfactory per19 formance by the contractor of a contract with the 

20 United States for the performance of work in con21 nection with this Act and under such conditions as 

22 the Administrator shall specify; 

23 ‘‘(3) the Administrator determines that disclo24 sure is necessary to protect human health or the en25 vironment; 


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1 ‘‘(4) the information is to be disclosed to a 

2 State or political subdivision of a State, on written 

3 request, for the purpose of development, administra4 tion, or enforcement of a law, if— 

5 ‘‘(A) one or more applicable agreements 

6 with the Administrator ensure that the recipient 

7 government will take appropriate steps, and has 

8 adequate authority, to maintain the confiden9 tiality of the information in accordance with 

10 procedures as stringent as those which the Ad11 ministrator uses to safeguard the information; 

12 and 

13 ‘‘(B) the Administrator notifies the person 

14 who submitted the information that the infor15 mation has been disclosed to a State or political 

16 subdivision of a State; 

17 ‘‘(5) a health professional employed by a Fed18 eral or State agency or a treating physician or nurse 

19 in a nonemergency situation provides a written 

20 statement of need and a written confidentiality 

21 agreement, subject to the conditions that— 

22 ‘‘(A) the written statement of need is a 

23 statement that the person has a reasonable 

24 basis to suspect that— 


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1 ‘‘(i) the information is needed for pur2 poses of diagnosis or treatment of one or 

3 more individuals; 

4 ‘‘(ii) one or more individuals being di5 agnosed or treated have been exposed to 

6 the chemical substance concerned; and 

7 ‘‘(iii) knowledge of the specific chem8 ical identity of the chemical substance will 

9 assist in diagnosis or treatment; and 

10 ‘‘(B) the confidentiality agreement pro11 vides that the person will not use the specific 

12 chemical identity for any purpose other than 

13 the health needs asserted in the statement of 

14 need, except as may otherwise be authorized by 

15 the terms of the agreement or by the person 

16 submitting the specific chemical identity to the 

17 Administrator; 

18 ‘‘(6) a treating physician or nurse requests the 

19 information, subject to the conditions that— 

20 ‘‘(A) the treating physician or nurse deter21 mines that— 

22 ‘‘(i) a medical emergency exists; 

23 ‘‘(ii) the specific chemical identity of 

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1 essary for or will assist in emergency or 

2 first-aid diagnosis or treatment; and 

3 ‘‘(iii) the one or more individuals 

4 being diagnosed or treated have likely been 

5 exposed to the chemical substance con6 cerned; 

7 ‘‘(B) if requested by the person submitting 

8 the specific chemical identity to the Adminis9 trator, the treating physician or nurse provides 

10 a written statement of need and a confiden11 tiality agreement as described in paragraph (5); 

12 and 

13 ‘‘(C) the written confidentiality agreement 

14 or statement of need is submitted as soon as 

15 practicable, but not necessarily before the infor16 mation is disclosed; 

17 ‘‘(7) the Administrator determines that disclo18 sure is necessary in a proceeding under this Act, 

19 subject to the condition that the disclosure is made 

20 in such a manner as to preserve confidentiality to 

21 the maximum extent practicable without impairing 

22 the proceeding; or 

23 ‘‘(8) the information is to be disclosed, on writ24 ten request of any duly authorized committee of the 

25 Congress, to that committee. 


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1 ‘‘(f) DURATION OF PROTECTION FROM DISCLO2 SURE.— 

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

4 protect from disclosure information described in sub5 section (b) that meets the requirements of sub6 section (d)(2) for the period of time requested by the 

7 person submitting the claim or for such period of 

8 time as the Administrator, after reviewing the re9 quest for confidential treatment and the documenta10 tion, otherwise determines to be reasonable, unless— 

11 ‘‘(A) prior to the expiration of the period, 

12 the person notifies the Administrator that the 

13 person is withdrawing the confidentiality claim, 

14 in which case, the Administrator shall promptly 

15 make the information available to the public; or 

16 ‘‘(B) prior to the expiration of the period, 

17 the Administrator otherwise becomes aware 

18 that the need for protection from disclosure can 

19 no longer be substantiated, in which case the 

20 Administrator shall take the actions described 

21 in subsection (g)(2). 

22 ‘‘(2) REDOCUMENTATION.—The Administrator 

23 may request— 

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1 tity of a substance under subsection (d) to re2 document the confidentiality claim of the per3 son; and 

4 ‘‘(B) any person who has requested that 

5 confidential information be protected from dis6 closure under section 8(b) to reassert the con7 fidentiality claim of the person after the chem8 ical substance is identified as a high-priority 

9 substance under section 4(e). 

10 ‘‘(g) DUTIES OF THE ADMINISTRATOR.— 

11 ‘‘(1) DETERMINATION.— 

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

13 subsection (b)(2), the Administrator shall— 

14 ‘‘(i) review a request received under 

15 this section to maintain the confidentiality 

16 of information submitted under this Act; 

17 and 

18 ‘‘(ii) determine whether to approve, 

19 modify, or deny that request. 

20 ‘‘(B) DENIAL OR MODIFICATION.— 

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

22 shall deny a claim to protect a chemical 

23 identity from disclosure only if the person 

24 who has submitted the request fails to 

25 meet the requirements of subsection (d). 


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1 ‘‘(ii) REASONS FOR DENIAL OR MODI2 FICATION.—The Administrator shall pro3 vide to the person who has submitted the 

4 request a written statement of the reasons 

5 for the denial or modification of the claim. 

6 ‘‘(C) SUBSETS.—If it is not feasible for the 

7 Administrator to review each request under this 

8 section, the Administrator shall review a rep9 resentative subset. 

10 ‘‘(2) NOTIFICATION.— 

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

12 subsections (c) and (e), if the Administrator de13 nies a request under paragraph (1), the Admin14 istrator shall notify, in writing and by certified 

15 mail, the person who submitted the request of 

16 the intent of the Administrator to release the 

17 information. 

18 ‘‘(B) RELEASE OF INFORMATION.— 

19 ‘‘(i) IN GENERAL.—Except as pro20 vided in clause (ii), the Administrator may 

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 may 

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 request 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 (6) or 

17 (7) of subsection (e), no prior notifica18 tion is necessary. 

19 ‘‘(3) APPEALS.— 

20 ‘‘(A) IN GENERAL.—A person who receives 

21 notification under this subsection 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— 

5 ‘‘(I) the complainant resides or 

6 has the principal place of business; or 

7 ‘‘(II) the information is located; 

8 or 

9 ‘‘(ii) the United States District Court 

10 for the District of Columbia. 

11 ‘‘(B) NO DISCLOSURE.—The Adminis12 trator shall not disclose any information under 

13 this section prior to the date on which the ap14 plicable court rules on an action under subpara15 graph (A). 

16 ‘‘(4) ADMINISTRATION.—In carrying out this 

17 subsection, the Administrator shall employ the pro18 cedures in part 2 of title 40, Code of Federal Regu19 lations (or successor regulations). 

20 ‘‘(h) CRIMINAL PENALTY FOR WRONGFUL DISCLO21 SURE.— 

22 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

23 any officer or employee of the United States or 

24 former officer or employee of the United States, 

25 who— 


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1 ‘‘(A) by virtue of that employment or offi2 cial position has obtained possession of, or has 

3 access to, material the disclosure of which is 

4 prohibited by subsection (a); and 

5 ‘‘(B) knowing that disclosure of that mate6 rial is prohibited by subsection (a), willfully dis7 closes the material in any manner to any person 

8 not entitled to receive that material, shall be— 

9 ‘‘(i) guilty of a misdemeanor and 

10 fined under title 18, United States Code, 

11 imprisoned for not more than 1 year, or 

12 both; and 

13 ‘‘(ii) removed from office or employ14 ment. 

15 ‘‘(2) OTHER LAWS.—Section 1905 of title 18, 

16 United States Code, shall not apply with respect to 

17 the publishing, divulging, disclosure, making known 

18 of, or making available, information reported or oth19 erwise obtained under this Act. 

20 ‘‘(3) CONTRACTORS.—For the purposes of this 

21 subsection, any contractor of the United States who 

22 is furnished information in accordance with sub23 section (e)(2), including any employee of that con24 tractor, shall be considered to be an employee of the 

25 United States. 


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1 ‘‘(i) APPLICABILITY.—Except as otherwise provided 

2 in this section, the Administrator shall have no author3 ity— 

4 ‘‘(1) to require the documentation or redocu5 mentation of a claim for the protection from disclo6 sure of information submitted to the Administrator 

7 under this Act prior to the date of enactment of the 

8 Chemical Safety Improvement Act; or 

9 ‘‘(2) to impose redocumentation requirements 

10 under this Act that are more extensive than those 

11 required under this section.’’. 

12 SEC. 14. PROHIBITED ACTS. 

13 Section 15 (15 U.S.C. 2614) is amended by striking 

14 paragraph (1) and inserting the following: 

15 ‘‘(1) fail or refuse to comply with— 

16 ‘‘(A) any rule promulgated, consent agree17 ment entered into, or order issued under section 

18 4; 

19 ‘‘(B) any requirement prescribed by section 

20 5 or 6; 

21 ‘‘(C) any rule promulgated, consent agree22 ment entered into, or order issued under section 

23 5 or 6; 


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1 ‘‘(D) any requirement of title II or any 

2 rule promulgated or order issued under title II; 

3 or 

4 ‘‘(E) any requirement of title VII or any 

5 rule promulgated or order issued under title 

6 VII;’’. 

7 SEC. 15. PREEMPTION. 

8 Section 18 (15 U.S.C. 2617) is amended by striking 

9 subsections (a) and (b) and inserting the following: 

10 ‘‘(a) IN GENERAL.—Except as provided in sub11 sections (c) and (d), no State or political subdivision of 

12 a State may establish or continue to enforce— 

13 ‘‘(1) a requirement for the development of test 

14 data or information on a chemical substance or cat15 egory of substances that is reasonably likely to 

16 produce the same data and information required 

17 under section 4, 5, or 6 by— 

18 ‘‘(A) a rule promulgated by the Adminis19 trator; 

20 ‘‘(B) a consent agreement entered into by 

21 the Administrator; or 

22 ‘‘(C) an order issued by the Administrator; 

23 ‘‘(2) a prohibition or restriction on the manu24 facture, processing, or distribution in commerce or 

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1 pleted safety determination for a chemical substance 

2 under section 6, consistent with the scope of the re3 view and decisions addressed by the Administrator; 

4 or 

5 ‘‘(3) a requirement for the notification of a use 

6 of a chemical substance that the Administrator has 

7 specified as a significant new use and for which the 

8 Administrator has required notification pursuant to 

9 a rule promulgated under section 5. 

10 ‘‘(b) NEW PROHIBITIONS OR RESTRICTIONS.—Ex11 cept as provided in subsections (c) and (d), no State or 

12 political subdivision of a State may establish (after the 

13 date of enactment of the Chemical Safety Improvement 

14 Act)— 

15 ‘‘(1) a prohibition or restriction on the manu16 facture, processing, distribution in commerce or use 

17 of a chemical substance that is a high-priority sub18 stance identified under section 4(e)(3) (as of the 

19 date on which the Administrator publishes a sched20 ule under section 6(b)); or 

21 ‘‘(2) a prohibition or restriction on the manu22 facture, processing, distribution in commerce or use 

23 of a chemical substance that is a low-priority sub24 stance identified under section 4(e)(3). 


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1 ‘‘(c) EXCEPTIONS.—Subsections (a) and (b) shall not 

2 apply to a requirement, prohibition, or restriction of a 

3 State or a political subdivision of a State that— 

4 ‘‘(1) is adopted under the authority of any 

5 other Federal law; 

6 ‘‘(2) implements a reporting or information col7 lection requirement not otherwise required by the 

8 Administrator under this Act or required under any 

9 other Federal law; or 

10 ‘‘(3) is adopted pursuant to authority under a 

11 law of the State or political subdivision of the State 

12 related to water quality, air quality, or waste treat13 ment or disposal that— 

14 ‘‘(A) does not impose a restriction on the 

15 manufacture, processing, distribution in com16 merce, or use of a chemical substance; and 

17 ‘‘(B) is not otherwise required by or incon18 sistent with an action by the Administrator 

19 under section 5 or 6. 

20 ‘‘(d) STATE WAIVERS.—Upon application of a State 

21 or political subdivision of a State, the Administrator may 

22 provide a waiver from subsection (a) and subsection 

23 (b)(1), regarding a requirement of that State or political 

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1 sure to any chemical substance under the intended condi2 tions of use if— 

3 ‘‘(1)(A) the State or political subdivision of the 

4 State determines it cannot wait until the end of the 

5 period specified in the established schedule and 

6 deadline for the completion of a full safety assess7 ment and determination established under section 

8 6(b)(2)(B)(ii); and 

9 ‘‘(B) the Administrator determines that— 

10 ‘‘(i) compelling State or local conditions 

11 warrant granting the waiver to protect human 

12 health or the environment; 

13 ‘‘(ii) compliance with the proposed require14 ment of the State or political subdivision of the 

15 State does not unduly burden interstate and 

16 foreign commerce in the manufacture, proc17 essing, distribution in commerce, or use of a 

18 chemical substance; 

19 ‘‘(iii) compliance with the proposed re20 quirement of the State or political subdivision 

21 of the State would not cause a violation of any 

22 applicable Federal law, rule, or order; and 

23 ‘‘(iv) the proposed requirement of the 

24 State or political subdivision of the State is 


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1 based on the best available science and is sup2 ported by the weight of the evidence; or 

3 ‘‘(2)(A) the Administrator finds a safety assess4 ment or determination has been unreasonably de5 layed; and 

6 ‘‘(B) the State certifies that— 

7 ‘‘(i) the State has a compelling local inter8 est to protect human health or the environment; 

9 ‘‘(ii) compliance with the proposed require10 ment of the State does not unduly burden inter11 state and foreign commerce in the manufacture, 

12 processing, distribution in commerce, or use of 

13 a chemical substance; 

14 ‘‘(iii) compliance with the proposed re15 quirement would not cause a violation of any 

16 applicable Federal law, rule, or order; and 

17 ‘‘(iv) the proposed requirement is grounded 

18 in reasonable scientific concern. 

19 ‘‘(3) APPROVAL OF A STATE WAIVER RE20 QUEST.—The Administrator shall grant or deny a 

21 waiver application— 

22 ‘‘(A) not later than 180 days after the date 

23 on which an application under paragraph (1) is 

24 submitted; and 


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1 ‘‘(B) not later than 90 days after the date 

2 on which an application under paragraph (2) is 

3 submitted. 

4 ‘‘(4) NOTICE AND COMMENT.—The application 

5 of a State or political subdivision of the State shall 

6 be subject to public notice and comment. 

7 ‘‘(5) FINAL AGENCY ACTION.—The decision of 

8 the Administrator on the application of a State or 

9 political subdivision of the State shall be— 

10 ‘‘(A) considered to be a final agency ac11 tion; and 

12 ‘‘(B) subject to judicial review. 

13 ‘‘(6) DURATION OF STATE WAIVERS.—A State 

14 waiver— 

15 ‘‘(A) granted under paragraph (1) shall re16 main in effect unless the waiver is found to be 

17 in conflict with a completed safety assessment 

18 and determination; and 

19 ‘‘(B) granted under paragraph (2) shall re20 main in effect until such time as the safety as21 sessment and determination is completed. 

22 ‘‘(7) JUDICIAL REVIEW.—Not later than 60 

23 days after the date on which the Administrator 

24 makes a determination on an application of a State 

25 or political subdivision of the State under paragraph 


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1 (1), any person may file a petition for judicial review 

2 in the United States Court of Appeals for the Dis3 trict of Columbia Circuit, which shall have exclusive 

4 jurisdiction over the determination. 

5 ‘‘(e) EFFECT ON PRIVATE REMEDIES.— 

6 ‘‘(1) IN GENERAL.—If the Administrator com7 pletes a safety determination for a high-priority sub8 stance under section 6, the determination shall be 

9 admissible as evidence in any public or private ac10 tion in any court of the United States or State court 

11 for recovery of damages or for equitable relief relat12 ing to injury to human health or the environment 

13 from exposure to a chemical substance. 

14 ‘‘(2) SAFETY STANDARD.—The safety deter15 mination shall be determinative of whether the sub16 stance meets the safety standard under the condi17 tions of use addressed in the safety determination.’’. 

18 SEC. 16. JUDICIAL REVIEW. 

19 Section 19 (15 U.S.C. 2618) is amended— 

20 (1) in subsection (a)— 

21 (A) by striking paragraph (1) and insert22 ing the following: 

23 ‘‘(1) FILING OF PETITION.— 

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

25 days after the date of the promulgation of a 


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1 rule under section 4(f), 6(c), 6(e), or 8, any 

2 person may file a petition for judicial review of 

3 the rule in— 

4 ‘‘(i) the United States Court of Ap5 peals for the District of Columbia Circuit; 

6 ‘‘(ii) the circuit in which the person 

7 resides; or 

8 ‘‘(iii) the circuit in which the principal 

9 place of business of the person is located. 

10 ‘‘(B) EXCLUSIVE JURISDICTION OF

11 COURTS OF APPEALS.—The courts of appeals of 

12 the United States shall have exclusive jurisdic13 tion of any action to obtain judicial review 

14 (other than in an enforcement proceeding) 

15 under subparagraph (A) if any district court of 

16 the United States would have had jurisdiction 

17 of the action but for this paragraph.’’; 

18 (B) in paragraph (2), by striking ‘‘para19 graph (1)(A)’’ and inserting ‘‘paragraph (1)’’; 

20 and 

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

22 (2) in subsection (c)(1), by striking subpara23 graph (B) and inserting the following: 

24 ‘‘(B) APPLICABILITY OF SECTION 706 OF

25 TITLE 5, UNITED STATES CODE.— 


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1 ‘‘(i) DEFINITION OF EVIDENCE.—In 

2 this subparagraph, the term ‘evidence’ 

3 means any matter in the rulemaking 

4 record. 

5 ‘‘(ii) APPLICABILITY.—Section 706 of 

6 title 5, United States Code, shall apply to 

7 review of a rule under this section, except 

8 that— 

9 ‘‘(I) in the case of a rule under 

10 section 4(f), 6(c), or 6(e)— 

11 ‘‘(aa) the standard of review 

12 prescribed in section 706(2)(E) 

13 of title 5, United States Code, 

14 shall not apply; and 

15 ‘‘(bb) the court shall hold as 

16 unlawful and set aside the rule if 

17 the court finds that the rule is 

18 not supported by substantial evi19 dence in the rulemaking record; 

20 and 

21 ‘‘(II) the court shall not review 

22 the contents and adequacy of the 

23 statement of basis and purpose re24 quired by section 553(c) of title 5, 

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1 porated in the rule except as part of 

2 a review of the rulemaking record 

3 taken as a whole.’’. 

4 SEC. 17. CITIZENS’ PETITIONS. 

5 Section 21 (15 U.S.C. 2620) is amended— 

6 (1) in subsection (a), by striking ‘‘an order 

7 under section 5(e) or 6(b)(2)’’ and inserting ‘‘an 

8 order under section 4(f) or 5(c)’’; and 

9 (2) in subsection (b)— 

10 (A) in paragraph (1), by striking ‘‘an 

11 order under section 5(e), 6(b)(1)(A), or 

12 6(b)(1)(B)’’ and inserting ‘‘an order under sec13 tion 4(f) or 5(c)’’; and 

14 (B) by striking subparagraph (B) of para15 graph (4) and inserting the following: 

16 ‘‘(B) DE NOVO PROCEEDING.— 

17 ‘‘(i) IN GENERAL.—In an action 

18 under subparagraph (A) to initiate a pro19 ceeding to issue a rule under section 4(f), 

20 6(b), 6(c), 6(d), or 8 or an order issued 

21 under section 4(f) or 5(c), the petitioner 

22 shall be provided an opportunity to have 

23 the petition considered by the court in a de 

24 novo proceeding. 

25 ‘‘(ii) DEMONSTRATION.— 


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1 ‘‘(I) IN GENERAL.—The court 

2 shall order the Administrator to ini3 tiate the action requested by the peti4 tioner if the petitioner demonstrates 

5 to the satisfaction of the court by a 

6 preponderance of the evidence that— 

7 ‘‘(aa) in the case of a peti8 tion to initiate a proceeding for 

9 the issuance of a rule or order 

10 under section 4(f), the informa11 tion available to the Adminis12 trator is insufficient for the Ad13 ministrator to perform an action 

14 described in section 4(f), 6(b)(5), 

15 or 6(c)(8); 

16 ‘‘(bb) in the case of a peti17 tion to issue an order under sec18 tion 5(c), there is a reasonable 

19 basis to conclude that the sub20 stance is not likely to meet the 

21 safety standard under the in22 tended conditions of use; 

23 ‘‘(cc) in the case of a peti24 tion to initiate a proceeding for 

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1 tion 6(c)(9), there is a reasonable 

2 basis to conclude that the sub3 stance will not meet the safety 

4 standard under the intended con5 ditions of use; or 

6 ‘‘(dd) in the case of a peti7 tion to initiate a proceeding for 

8 the issuance of a rule under sec9 tion 6(b)(2), 6(d) or 8, there is a 

10 reasonable basis to conclude that 

11 the rule is necessary to protect 

12 human health or the environment 

13 from an unreasonable risk of 

14 harm to human health or the en15 vironment. 

16 ‘‘(II) DEFERMENT.—The court 

17 may permit the Administrator to defer 

18 initiating the action requested by the 

19 petitioner until such time as the court 

20 prescribes if the court finds that— 

21 ‘‘(aa) the extent of the risk 

22 to human health or the environ23 ment alleged by the petitioner is 

24 less than the extent of risks to 

25 human health or the environment 


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1 with respect to which the Admin2 istrator is taking action under 

3 this Act; and 

4 ‘‘(bb) there are insufficient 

5 resources available to the Admin6 istrator to take the action re7 quested by the petitioner.’’. 

8 SEC. 18. STUDIES. 

9 Section 25 (15 U.S.C. 2624) is repealed. 

10 SEC. 19. ADMINISTRATION. 

11 Section 26(e) (15 U.S.C. 2625(e)) is amended by 

12 striking ‘‘Health, Education, and Welfare’’ each place it 

13 appears and inserting ‘‘Health and Human Services’’. 

14 SEC. 20. DEVELOPMENT AND EVALUATION OF TEST METH15 ODS. 

16 Section 27(a) (15 U.S.C. 2626(a)) is amended by 

17 striking ‘‘Health, Education, and Welfare’’ and inserting 

18 ‘‘Health and Human Services’’. 

19 SEC. 21. STATE PROGRAMS. 

20 Section 28 (15 U.S.C. 2627) is amended by striking 

21 subsections (c) and (d). 

22 SEC. 22. AUTHORIZATION OF APPROPRIATIONS. 

23 Section 29 (15 U.S.C. 2628) is repealed. 


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1 SEC. 23. ANNUAL REPORT. 

2 Section 30 (15 U.S.C. 2629) is amended by striking 

3 paragraph (2) and inserting the following: 

4 ‘‘(2)(A) the number of notices received during 

5 each year under section 5; and 

6 ‘‘(B) the number of the notices described in 

7 subparagraph (A) for chemical substances subject to 

8 a rule, testing consent agreement, or order under 

9 section 4(f);’’. 

Æ 


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