PUBLIC LAW 114–182—JUNE 22, 2016 

FRANK R. LAUTENBERG CHEMICAL SAFETY 

FOR THE 21ST CENTURY ACT 


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130 STAT. 448 PUBLIC LAW 114–182—JUNE 22, 2016 

Public Law 114–182 

114th Congress 

An Act 

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

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

(a) SHORT TITLE.—This Act may be cited as the ‘‘Frank R. 

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

(b) TABLE OF CONTENTS.—The table of contents of this Act 

is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—CHEMICAL SAFETY 

Sec. 2. Findings, policy, and intent. 

Sec. 3. Definitions. 

Sec. 4. Testing of chemical substances and mixtures. 

Sec. 5. Manufacturing and processing notices. 

Sec. 6. Prioritization, risk evaluation, and regulation of chemical substances and 

mixtures. 

Sec. 7. Imminent hazards. 

Sec. 8. Reporting and retention of information. 

Sec. 9. Relationship to other Federal laws. 

Sec. 10. Exports of elemental mercury. 

Sec. 11. Confidential information. 

Sec. 12. Penalties. 

Sec. 13. State-Federal relationship. 

Sec. 14. Judicial review. 

Sec. 15. Citizens’ civil actions. 

Sec. 16. Studies. 

Sec. 17. Administration of the Act. 

Sec. 18. State programs. 

Sec. 19. Conforming amendments. 

Sec. 20. No retroactivity. 

Sec. 21. Trevor’s Law. 

TITLE II—RURAL HEALTHCARE CONNECTIVITY 

Sec. 201. Short title. 

Sec. 202. Telecommunications services for skilled nursing facilities. 

TITLE I—CHEMICAL SAFETY 

SEC. 2. FINDINGS, POLICY, AND INTENT. 

Section 2(c) of the Toxic Substances Control Act (15 U.S.C. 

2601(c)) is amended by striking ‘‘proposes to take’’ and inserting 

‘‘proposes as provided’’. 

SEC. 3. DEFINITIONS. 

Section 3 of the Toxic Substances Control Act (15 U.S.C. 2602) 

is amended— 

Frank R. 

Lautenberg 

Chemical Safety 

for the 21st 

Century Act. 

15 USC 2601 

note. 

June 22, 2016 

[H.R. 2576] 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 449 

(1) by redesignating paragraphs (4) through (14) as paragraphs (5), (6), (8), (9), (10), (11), (13), (14), (15), (16), and 

(17), respectively; 

(2) by inserting after paragraph (3) the following: 

‘‘(4) The term ‘conditions of use’ means the circumstances, 

as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.’’; 

(3) by inserting after paragraph (6), as so redesignated, 

the following: 

‘‘(7) The term ‘guidance’ means any significant written guidance 

of general applicability prepared by the Administrator.’’; and 

(4) by inserting after paragraph (11), as so redesignated, 

the following: 

‘‘(12) The term ‘potentially exposed or susceptible subpopulation’ means a group of individuals within the general population 

identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general 

population of adverse health effects from exposure to a chemical 

substance or mixture, such as infants, children, pregnant women, 

workers, or the elderly.’’. 

SEC. 4. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES. 

Section 4 of the Toxic Substances Control Act (15 U.S.C. 2603) 

is amended— 

(1) by striking ‘‘standards’’ each place it appears and 

inserting ‘‘protocols and methodologies’’; 

(2) in subsection (a)— 

(A) by striking ‘‘If the Administrator finds’’ and 

inserting ‘‘(1) If the Administrator finds’’; 

(B) in paragraph (1), as so designated— 

(i) by striking ‘‘(1)(A)(i)’’ and inserting ‘‘(A)(i)(I)’’; 

(ii) by striking ‘‘(ii)’’ each place it appears and 

inserting ‘‘(II)’’; 

(iii) by striking ‘‘are insufficient data’’ and 

inserting ‘‘is insufficient information’’ each place it 

appears; 

(iv) by striking ‘‘(iii)’’ each place it appears and 

inserting ‘‘(III)’’; 

(v) by striking ‘‘such data’’ and inserting ‘‘such 

information’’ each place it appears; 

(vi) by striking ‘‘(B)(i)’’ and inserting ‘‘(ii)(I)’’; 

(vii) by striking ‘‘(I)’’ and inserting ‘‘(aa)’’; 

(viii) by striking ‘‘(II)’’ and inserting ‘‘(bb)’’; 

(ix) by striking ‘‘(2)’’ and inserting ‘‘(B)’’; and 

(x) in the matter following subparagraph (B), as 

so redesignated— 

(I) by inserting ‘‘, or, in the case of a chemical 

substance or mixture described in subparagraph 

(A)(i), by rule, order, or consent agreement,’’ after 

‘‘rule’’; 

(II) by striking ‘‘data’’ each place it appears 

and inserting ‘‘information’’; and 

(III) by striking ‘‘and which are relevant’’ and 

inserting ‘‘and which is relevant’’; and 

(C) by adding at the end the following: 


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130 STAT. 450 PUBLIC LAW 114–182—JUNE 22, 2016 

‘‘(2) ADDITIONAL TESTING AUTHORITY.—In addition to the 

authority provided under paragraph (1), the Administrator may, 

by rule, order, or consent agreement— 

‘‘(A) require the development of new information 

relating to a chemical substance or mixture if the Administrator determines that the information is necessary— 

‘‘(i) to review a notice under section 5 or to perform 

a risk evaluation under section 6(b); 

‘‘(ii) to implement a requirement imposed in a 

rule, order, or consent agreement under subsection 

(e) or (f) of section 5 or in a rule promulgated under 

section 6(a); 

‘‘(iii) at the request of a Federal implementing 

authority under another Federal law, to meet the regulatory testing needs of that authority with regard to 

toxicity and exposure; or 

‘‘(iv) pursuant to section 12(a)(2); and 

‘‘(B) require the development of new information for 

the purposes of prioritizing a chemical substance under 

section 6(b) only if the Administrator determines that such 

information is necessary to establish the priority of the 

substance, subject to the limitations that— 

‘‘(i) not later than 90 days after the date of receipt 

of information regarding a chemical substance complying with a rule, order, or consent agreement under 

this subparagraph, the Administrator shall designate 

the chemical substance as a high-priority substance 

or a low-priority substance; and 

‘‘(ii) information required by the Administrator 

under this subparagraph shall not be required for the 

purposes of establishing or implementing a minimum 

information requirement of broader applicability. 

‘‘(3) STATEMENT OF NEED.—When requiring the development of new information relating to a chemical substance or 

mixture under paragraph (2), the Administrator shall identify 

the need for the new information, describe how information 

reasonably available to the Administrator was used to inform 

the decision to require new information, explain the basis for 

any decision that requires the use of vertebrate animals, and, 

as applicable, explain why issuance of an order is warranted 

instead of promulgating a rule or entering into a consent agreement. 

‘‘(4) TIERED TESTING.—When requiring the development of 

new information under this subsection, the Administrator shall 

employ a tiered screening and testing process, under which 

the results of screening-level tests or assessments of available 

information inform the decision as to whether 1 or more additional tests are necessary, unless information available to the 

Administrator justifies more advanced testing of potential 

health or environmental effects or potential exposure without 

first conducting screening-level testing.’’; 

(3) in subsection (b)— 

(A) in paragraph (1)— 

(i) in subparagraph (B), by striking ‘‘test data’’ 

and inserting ‘‘information’’; 

(ii) in subparagraph (C), by striking ‘‘data’’ and 

inserting ‘‘information’’; and 

Deadline. 

Review. 

Notice. 

Evaluation. 

Determination. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 451 

(iii) in the matter following subparagraph (C), by 

striking ‘‘data’’ and inserting ‘‘information’’; 

(B) in paragraph (2)— 

(i) in subparagraph (A)— 

(I) by striking ‘‘test data’’ and inserting 

‘‘information’’; 

(II) by inserting ‘‘Protocols and methodologies 

for the development of information may also be 

prescribed for the assessment of exposure or exposure potential to humans or the environment.’’ 

after the first sentence; and 

(III) by striking ‘‘hierarchical tests’’ and 

inserting ‘‘tiered testing’’; and 

(ii) in subparagraph (B), by striking ‘‘data’’ and 

inserting ‘‘information’’; 

(C) in paragraph (3)— 

(i) by striking ‘‘data’’ each place it appears and 

inserting ‘‘information’’; 

(ii) in subparagraph (A), by inserting ‘‘or (C), as 

applicable,’’ after ‘‘subparagraph (B)’’; 

(iii) by striking ‘‘(a)(1)(A)(ii) or (a)(1)(B)(ii)’’ each 

place it appears in subparagraph (B) and inserting 

‘‘(a)(1)(A)(i)(II) or (a)(1)(A)(ii)(II)’’; 

(iv) in subparagraph (B), in the matter before 

clause (i), by striking ‘‘subsection (a)’’ and inserting 

‘‘subsection (a)(1)’’; and 

(v) by adding at the end the following: 

‘‘(C) A rule or order under paragraph (1) or (2) of subsection 

(a) may require the development of information by any person 

who manufactures or processes, or intends to manufacture or 

process, a chemical substance or mixture subject to the rule or 

order.’’; 

(D) in paragraph (4)— 

(i) by striking ‘‘of data’’ each place it appears and 

inserting ‘‘of information’’; and 

(ii) by striking ‘‘test data’’ each place it appears 

and inserting ‘‘information’’; and 

(E) by striking paragraph (5); 

(4) in subsection (c)— 

(A) in paragraph (1), by striking ‘‘data’’ and inserting 

‘‘information’’; 

(B) in paragraph (2), by striking ‘‘data’’ each place 

it appears and inserting ‘‘information’’; 

(C) in paragraph (3)— 

(i) by striking ‘‘test data’’ each place it appears 

and inserting ‘‘information’’; and 

(ii) by striking ‘‘such data’’ each place it appears 

and inserting ‘‘such information’’; and 

(D) in paragraph (4) by striking ‘‘test data’’ each place 

it appears and inserting ‘‘information’’; 

(5) in subsection (d)— 

(A) by striking ‘‘test data’’ each place it appears and 

inserting ‘‘information’’; 

(B) by striking ‘‘such data’’ each place it appears and 

inserting ‘‘such information’’; and 

(C) by striking ‘‘for which data have’’ and inserting 

‘‘for which information has’’; 


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130 STAT. 452 PUBLIC LAW 114–182—JUNE 22, 2016 

(6) in subsection (e)— 

(A) in paragraph (1)— 

(i) in subparagraph (A)— 

(I) by striking ‘‘promulgation of a rule’’ and 

inserting ‘‘development of information’’; and 

(II) by striking ‘‘data’’ each place it appears 

and inserting ‘‘information’’; and 

(ii) in subparagraph (B), by striking ‘‘either initiate 

a rulemaking proceeding under subsection (a) or if 

such a proceeding is not initiated within such period, 

publish in the Federal Register the Administrator’s 

reason for not initiating such a proceeding’’ and insert 

‘‘issue an order, enter into a consent agreement, or 

initiate a rulemaking proceeding under subsection (a), 

or, if such an order or consent agreement is not issued 

or such a proceeding is not initiated within such period, 

publish in the Federal Register the Administrator’s 

reason for not issuing such an order, entering into 

such a consent agreement, or initiating such a proceeding’’; and 

(B) in paragraph (2)(A)— 

(i) by striking ‘‘eight members’’ and inserting ‘‘ten 

members’’; and 

(ii) by adding at the end the following: 

‘‘(ix) One member appointed by the Chairman of the Consumer Product Safety Commission from Commissioners or 

employees of the Commission. 

‘‘(x) One member appointed by the Commissioner of Food 

and Drugs from employees of the Food and Drug Administration.’’; 

(7) in subsection (f)— 

(A) in paragraph (1), by striking ‘‘test data’’ and 

inserting ‘‘information’’; and 

(B) in the matter following paragraph (2)— 

(i) by striking ‘‘or will present’’; 

(ii) by striking ‘‘from cancer, gene mutations, or 

birth defects’’; 

(iii) by striking ‘‘data or’’; 

(iv) by striking ‘‘appropriate’’ and inserting 

‘‘applicable’’; and 

(v) by inserting ‘‘, made without consideration of 

costs or other nonrisk factors,’’ after ‘‘publish in the 

Federal Register a finding’’; 

(8) in subsection (g)— 

(A) by amending the subsection heading to read as 

follows: ‘‘PETITION FOR PROTOCOLS AND METHODOLOGIES

FOR THE DEVELOPMENT OF INFORMATION’’; 

(B) by striking ‘‘test data’’ each place it appears and 

inserting ‘‘information’’; and 

(C) by striking ‘‘submit data’’ and inserting ‘‘submit 

information’’; and 

(9) by adding at the end the following: 

‘‘(h) REDUCTION OF TESTING ON VERTEBRATES.— 

‘‘(1) IN GENERAL.—The Administrator shall reduce and 

replace, to the extent practicable, scientifically justified, and 

consistent with the policies of this title, the use of vertebrate 

Federal Register, 

publication. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 453 

animals in the testing of chemical substances or mixtures under 

this title by— 

‘‘(A) prior to making a request or adopting a requirement for testing using vertebrate animals, and in accordance with subsection (a)(3), taking into consideration, as 

appropriate and to the extent practicable and scientifically 

justified, reasonably available existing information, 

including— 

‘‘(i) toxicity information; 

‘‘(ii) computational toxicology and bioinformatics; 

and 

‘‘(iii) high-throughput screening methods and the 

prediction models of those methods; and 

‘‘(B) encouraging and facilitating— 

‘‘(i) the use of scientifically valid test methods and 

strategies that reduce or replace the use of vertebrate 

animals while providing information of equivalent or 

better scientific quality and relevance that will support 

regulatory decisions under this title; 

‘‘(ii) the grouping of 2 or more chemical substances 

into scientifically appropriate categories in cases in 

which testing of a chemical substance would provide 

scientifically valid and useful information on other 

chemical substances in the category; and 

‘‘(iii) the formation of industry consortia to jointly 

conduct testing to avoid unnecessary duplication of 

tests, provided that such consortia make all information from such testing available to the Administrator. 

‘‘(2) IMPLEMENTATION OF ALTERNATIVE TESTING METHODS.— 

To promote the development and timely incorporation of new 

scientifically valid test methods and strategies that are not 

based on vertebrate animals, the Administrator shall— 

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

of the Frank R. Lautenberg Chemical Safety for the 21st 

Century Act, develop a strategic plan to promote the 

development and implementation of alternative test 

methods and strategies to reduce, refine, or replace 

vertebrate animal testing and provide information of 

equivalent or better scientific quality and relevance for 

assessing risks of injury to health or the environment of 

chemical substances or mixtures through, for example— 

‘‘(i) computational toxicology and bioinformatics; 

‘‘(ii) high-throughput screening methods; 

‘‘(iii) testing of categories of chemical substances; 

‘‘(iv) tiered testing methods; 

‘‘(v) in vitro studies; 

‘‘(vi) systems biology; 

‘‘(vii) new or revised methods identified by validation bodies such as the Interagency Coordinating Committee on the Validation of Alternative Methods or 

the Organization for Economic Co-operation and 

Development; or 

‘‘(viii) industry consortia that develop information 

submitted under this title; 

‘‘(B) as practicable, ensure that the strategic plan developed under subparagraph (A) is reflected in the development of requirements for testing under this section; 

Deadline. 

Strategic plan. 


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130 STAT. 454 PUBLIC LAW 114–182—JUNE 22, 2016 

‘‘(C) include in the strategic plan developed under 

subparagraph (A) a list, which the Administrator shall 

update on a regular basis, of particular alternative test 

methods or strategies the Administrator has identified that 

do not require new vertebrate animal testing and are scientifically reliable, relevant, and capable of providing 

information of equivalent or better scientific reliability and 

quality to that which would be obtained from vertebrate 

animal testing; 

‘‘(D) provide an opportunity for public notice and comment on the contents of the plan developed under subparagraph (A), including the criteria for considering scientific 

reliability and relevance of the test methods and strategies 

that may be identified pursuant to subparagraph (C); 

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

date of enactment of the Frank R. Lautenberg Chemical 

Safety for the 21st Century Act, and every 5 years thereafter, submit to Congress a report that describes the 

progress made in implementing the plan developed under 

subparagraph (A) and goals for future alternative test 

methods and strategies implementation; and 

‘‘(F) prioritize and, to the extent consistent with available resources and the Administrator’s other responsibilities under this title, carry out performance assessment, 

validation, and translational studies to accelerate the 

development of scientifically valid test methods and strategies that reduce, refine, or replace the use of vertebrate 

animals, including minimizing duplication, in any testing 

under this title. 

‘‘(3) VOLUNTARY TESTING.— 

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

for submission under this title on a voluntary basis and 

not pursuant to any request or requirement by the Administrator shall first attempt to develop the information by 

means of an alternative test method or strategy identified 

by the Administrator pursuant to paragraph (2)(C), if the 

Administrator has identified such a test method or strategy 

for the development of such information, before conducting 

new vertebrate animal testing. 

‘‘(B) EFFECT OF PARAGRAPH.—Nothing in this paragraph shall, under any circumstance, limit or restrict the 

submission of any existing information to the Administrator. 

‘‘(C) RELATIONSHIP TO OTHER LAW.—A violation of this 

paragraph shall not be a prohibited act under section 15. 

‘‘(D) REVIEW OF MEANS.—This paragraph authorizes, 

but does not require, the Administrator to review the means 

by which a person conducted testing described in subparagraph (A).’’. 

SEC. 5. MANUFACTURING AND PROCESSING NOTICES. 

Section 5 of the Toxic Substances Control Act (15 U.S.C. 2604) 

is amended— 

(1) in subsection (a)— 

(A) in paragraph (1)— 

Assessment. 

Effective date. 

Deadlines. 

Reports. 

Public 

information. 

List. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 455 

(i) by striking ‘‘Except as provided in’’ and inserting 

‘‘(A) Except as provided in subparagraph (B) of this 

paragraph and’’; 

(ii) by redesignating subparagraphs (A) and (B) 

as clauses (i) and (ii), respectively; 

(iii) by striking all that follows ‘‘significant new 

use’’ and inserting a period; and 

(iv) by adding at the end the following: 

‘‘(B) A person may take the actions described in subparagraph (A) if— 

‘‘(i) such person submits to the Administrator, at least 

90 days before such manufacture or processing, a notice, 

in accordance with subsection (d), of such person’s intention 

to manufacture or process such substance and such person 

complies with any applicable requirement of, or imposed 

pursuant to, subsection (b), (e), or (f); and 

‘‘(ii) the Administrator— 

‘‘(I) conducts a review of the notice; and 

‘‘(II) makes a determination under subparagraph 

(A), (B), or (C) of paragraph (3) and takes the actions 

required in association with that determination under 

such subparagraph within the applicable review 

period.’’; and 

(B) by adding at the end the following new paragraphs: 

‘‘(3) REVIEW AND DETERMINATION.—Within the applicable 

review period, subject to section 18, the Administrator shall 

review such notice and determine— 

‘‘(A) that the relevant chemical substance or significant 

new use presents an unreasonable risk of injury to health 

or the environment, without consideration of costs or other 

nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as 

relevant by the Administrator under the conditions of use, 

in which case the Administrator shall take the actions 

required under subsection (f); 

‘‘(B) that— 

‘‘(i) the information available to the Administrator 

is insufficient to permit a reasoned evaluation of the 

health and environmental effects of the relevant chemical substance or significant new use; or 

‘‘(ii)(I) in the absence of sufficient information to 

permit the Administrator to make such an evaluation, 

the manufacture, processing, distribution in commerce, 

use, or disposal of such substance, or any combination 

of such activities, may present an unreasonable risk 

of injury to health or the environment, without consideration of costs or other nonrisk factors, including an 

unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the 

Administrator; or 

‘‘(II) such substance is or will be produced in 

substantial quantities, and such substance either 

enters or may reasonably be anticipated to enter the 

environment in substantial quantities or there is or 

may be significant or substantial human exposure to 

the substance, 

Determination. 

Review. 

Deadline. 


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130 STAT. 456 PUBLIC LAW 114–182—JUNE 22, 2016 

in which case the Administrator shall take the actions 

required under subsection (e); or 

‘‘(C) that the relevant chemical substance or significant 

new use is not likely to present an unreasonable risk 

of injury to health or the environment, without consideration of costs or other nonrisk factors, including an 

unreasonable risk to a potentially exposed or susceptible 

subpopulation identified as relevant by the Administrator 

under the conditions of use, in which case the submitter 

of the notice may commence manufacture of the chemical 

substance or manufacture or processing for a significant 

new use. 

‘‘(4) FAILURE TO RENDER DETERMINATION.— ‘‘(A) FAILURE TO RENDER DETERMINATION.—If the 

Administrator fails to make a determination on a notice 

under paragraph (3) by the end of the applicable review 

period and the notice has not been withdrawn by the submitter, the Administrator shall refund to the submitter 

all applicable fees charged to the submitter for review 

of the notice pursuant to section 26(b), and the Administrator shall not be relieved of any requirement to make 

such determination. 

‘‘(B) LIMITATIONS.—(i) A refund of applicable fees under 

subparagraph (A) shall not be made if the Administrator 

certifies that the submitter has not provided information 

required under subsection (b) or has otherwise unduly 

delayed the process such that the Administrator is unable 

to render a determination within the applicable review 

period. 

‘‘(ii) A failure of the Administrator to render a decision 

shall not be deemed to constitute a withdrawal of the 

notice. 

‘‘(iii) Nothing in this paragraph shall be construed 

as relieving the Administrator or the submitter of the 

notice from any requirement of this section. 

‘‘(5) ARTICLE CONSIDERATION.—The Administrator may 

require notification under this section for the import or processing of a chemical substance as part of an article or category 

of articles under paragraph (1)(A)(ii) if the Administrator makes 

an affirmative finding in a rule under paragraph (2) that the 

reasonable potential for exposure to the chemical substance 

through the article or category of articles subject to the rule 

justifies notification.’’; 

(2) in subsection (b)— 

(A) in the subsection heading, by striking ‘‘TEST DATA’’ 

and inserting ‘‘INFORMATION’’; 

(B) in paragraph (1)— 

(i) in subparagraph (A)— 

(I) by striking ‘‘test data’’ and inserting 

‘‘information’’; and 

(II) by striking ‘‘such data’’ and inserting ‘‘such 

information’’; and 

(ii) in subparagraph (B)— 

(I) by striking ‘‘test data’’ and inserting 

‘‘information’’; 

(II) by striking ‘‘subsection (a)(1)(A)’’ and 

inserting ‘‘subsection (a)(1)(A)(i)’’; and 

Refund. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 457 

(III) by striking ‘‘subsection (a)(1)(B)’’ and 

inserting ‘‘subsection (a)(1)(A)(ii)’’; 

(C) in paragraph (2)— 

(i) in subparagraph (A)— 

(I) by striking ‘‘test data’’ in clause (ii) and 

inserting ‘‘information’’; 

(II) by striking ‘‘shall’’ and inserting ‘‘may’’; 

and 

(III) by striking ‘‘data prescribed’’ and 

inserting ‘‘information prescribed’’; and 

(ii) in subparagraph (B)— 

(I) by striking ‘‘Data’’ and inserting ‘‘Information’’; 

(II) by striking ‘‘data’’ both places it appears 

and inserting ‘‘information’’; 

(III) by striking ‘‘show’’ and inserting ‘‘shows’’; 

(IV) by striking ‘‘subsection (a)(1)(A)’’ in clause 

(i) and inserting ‘‘subsection (a)(1)(A)(i)’’; and 

(V) by striking ‘‘subsection (a)(1)(B)’’ in clause 

(ii) and inserting ‘‘subsection (a)(1)(A)(ii)’’; 

(D) in paragraph (3)— 

(i) by striking ‘‘Data’’ and inserting ‘‘Information’’; 

and 

(ii) by striking ‘‘paragraph (1) or (2)’’ and inserting 

‘‘paragraph (1) or (2) of this subsection or under subsection (e)’’; and 

(E) in paragraph (4)— 

(i) in subparagraph (A)(i), by inserting ‘‘, without 

consideration of costs or other nonrisk factors’’ after 

‘‘health or the environment’’; and 

(ii) in subparagraph (C), by striking ‘‘, except that’’ 

and all that follows through ‘‘subparagraph (A)’’; 

(3) in subsection (c)— 

(A) in the subsection heading, by striking ‘‘NOTICE’’ 

and inserting ‘‘REVIEW’’; and 

(B) by striking ‘‘before which’’ and all that follows 

through ‘‘subsection may begin’’; 

(4) in subsection (d)— 

(A) by striking ‘‘test data’’ in paragraph (1)(B) and 

inserting ‘‘information’’; 

(B) by striking ‘‘data’’ each place it appears in paragraph (1)(C) and paragraph (2) and inserting ‘‘information’’; 

(C) in paragraph (2)(B), by striking ‘‘uses or intended 

uses of such substance’’ and inserting ‘‘uses of such substance identified in the notice’’; and 

(D) in paragraph (3)— 

(i) by striking ‘‘for which the notification period 

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

‘‘for which the applicable review period’’; and 

(ii) by striking ‘‘such notification period’’ and 

inserting ‘‘such period’’; 

(5) in subsection (e)— 

(A) in paragraph (1)(A)— 

(i) in clause (i), by striking ‘‘; and’’ and inserting 

‘‘; or’’; 

(ii) in clause (ii)(I), by inserting ‘‘without consideration of costs or other nonrisk factors, including an 


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130 STAT. 458 PUBLIC LAW 114–182—JUNE 22, 2016 

unreasonable risk to a potentially exposed subpopulation identified as relevant by the Administrator under 

the conditions of use;’’ after ‘‘health or the environment,’’; and 

(iii) in the matter after clause (ii)(II)— 

(I) by striking ‘‘may issue a proposed order’’ 

and inserting ‘‘shall issue an order’’; 

(II) by striking ‘‘notification period applicable 

to the manufacturing or processing of such substance under subsection (a), (b), (c)’’ and inserting 

‘‘applicable review period’’; and 

(III) by inserting ‘‘to the extent necessary to 

protect against an unreasonable risk of injury to 

health or the environment, without consideration 

of costs or other nonrisk factors, including an 

unreasonable risk to a potentially exposed or 

susceptible subpopulation identified as relevant by 

the Administrator under the conditions of use, and 

the submitter of the notice may commence manufacture of the chemical substance, or manufacture 

or processing of the chemical substance for a 

significant new use, including while any required 

information is being developed, only in compliance 

with the order’’ before the period at the end; 

(B) in paragraph (1)(B)— 

(i) by striking ‘‘A proposed order’’ and inserting 

‘‘An order’’; 

(ii) by striking ‘‘notification period applicable to 

the manufacture or processing of such substance under 

subsection (a), (b), (c)’’ and inserting ‘‘applicable review 

period’’; and 

(iii) by striking ‘‘of the proposed order’’ and 

inserting ‘‘of the order’’; 

(C) by striking paragraph (1)(C); and 

(D) by striking paragraph (2); 

(6) in subsection (f)— 

(A) in paragraph (1)— 

(i) by striking ‘‘finds that there is a reasonable 

basis to conclude that the manufacture, processing, 

distribution in commerce, use, or disposal of a chemical 

substance with’’ and inserting ‘‘determines that a 

chemical substance or significant new use with’’; 

(ii) by striking ‘‘, or that any combination of such 

activities,’’; 

(iii) by striking ‘‘or will present’’; 

(iv) by striking ‘‘before a rule promulgated under 

section 6 can protect against such risk,’’ and inserting 

‘‘, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially 

exposed subpopulation identified as relevant by the 

Administrator under the conditions of use,’’; and 

(v) by striking ‘‘notification period applicable under 

subsection (a), (b), or (c) to the manufacturing or processing of such substance’’ and inserting ‘‘applicable 

review period’’; 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 459 

(B) in paragraph (2), the matter following subparagraph (C), by striking ‘‘Section 6(d)(2)(B)’’ and inserting 

‘‘Section 6(d)(3)(B)’’; 

(C) in paragraph (3)— 

(i) in subparagraph (A)— 

(I) by striking ‘‘Administrator may’’ and all 

that follows through ‘‘issue a proposed order to 

prohibit the’’ and inserting ‘‘Administrator may 

issue an order to prohibit or limit the’’; and 

(II) by striking ‘‘under paragraph (1)’’ and all 

that follows through ‘‘processing of such substance.’’ and inserting ‘‘under paragraph (1). Such 

order shall take effect on the expiration of the 

applicable review period.’’; 

(ii) by striking subparagraph (B) and redesignating 

subparagraph (C) as subparagraph (B); 

(iii) in subparagraph (B), as so redesignated— 

(I) by striking ‘‘subparagraphs (B) and (C)’’ 

and inserting ‘‘subparagraph (B)’’; 

(II) by striking ‘‘clause (i) of’’; and 

(III) by striking ‘‘; and the provisions of 

subparagraph (C) of subsection (e)(2) shall apply 

with respect to an injunction issued under 

subparagraph (B)’’; and 

(iv) by striking subparagraph (D); and 

(D) by adding at the end the following: 

‘‘(4) TREATMENT OF NONCONFORMING USES.—Not later than 

90 days after taking an action under paragraph (2) or (3) 

or issuing an order under subsection (e) relating to a chemical 

substance with respect to which the Administrator has made 

a determination under subsection (a)(3)(A) or (B), the Administrator shall consider whether to promulgate a rule pursuant 

to subsection (a)(2) that identifies as a significant new use 

any manufacturing, processing, use, distribution in commerce, 

or disposal of the chemical substance that does not conform 

to the restrictions imposed by the action or order, and, as 

applicable, initiate such a rulemaking or publish a statement 

describing the reasons of the Administrator for not initiating 

such a rulemaking. 

‘‘(5) WORKPLACE EXPOSURES.—To the extent practicable, 

the Administrator shall consult with the Assistant Secretary 

of Labor for Occupational Safety and Health prior to adopting 

any prohibition or other restriction relating to a chemical substance with respect to which the Administrator has made a 

determination under subsection (a)(3)(A) or (B) to address workplace exposures.’’; 

(7) by amending subsection (g) to read as follows: 

‘‘(g) STATEMENT ON ADMINISTRATOR FINDING.—If the Administrator finds in accordance with subsection (a)(3)(C) that a chemical 

substance or significant new use is not likely to present an 

unreasonable risk of injury to health or the environment, then 

notwithstanding any remaining portion of the applicable review 

period, the submitter of the notice may commence manufacture 

of the chemical substance or manufacture or processing for the 

significant new use, and the Administrator shall make public a 

statement of the Administrator’s finding. Such a statement shall 

be submitted for publication in the Federal Register as soon as 

Federal Register, 

publication. 

Public 

information. 

Consultation. 

Deadline. 

Regulations. 

Publication. 


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130 STAT. 460 PUBLIC LAW 114–182—JUNE 22, 2016 

is practicable before the expiration of such period. Publication of 

such statement in accordance with the preceding sentence is not 

a prerequisite to the manufacturing or processing of the substance 

with respect to which the statement is to be published.’’; 

(8) in subsection (h)— 

(A) in paragraph (1)(A), by inserting ‘‘, including an 

unreasonable risk to a potentially exposed or susceptible 

subpopulation identified by the Administrator for the specific conditions of use identified in the application’’ after 

‘‘health or the environment’’; 

(B) in paragraph (2), by striking ‘‘data’’ each place 

it appears and inserting ‘‘information’’; and 

(C) in paragraph (4), by striking ‘‘. A rule promulgated’’ 

and all that follows through ‘‘section 6(c)’’ and inserting 

‘‘, including an unreasonable risk to a potentially exposed 

or susceptible subpopulation identified by the Administrator under the conditions of use’’; and 

(9) by amending subsection (i) to read as follows: 

‘‘(i) DEFINITIONS.—(1) For purposes of this section, the terms 

‘manufacture’ and ‘process’ mean manufacturing or processing for 

commercial purposes. 

‘‘(2) For purposes of this Act, the term ‘requirement’ as used 

in this section shall not displace any statutory or common law. 

‘‘(3) For purposes of this section, the term ‘applicable review 

period’ means the period starting on the date the Administrator 

receives a notice under subsection (a)(1) and ending 90 days after 

that date, or on such date as is provided for in subsection (b)(1) 

or (c).’’. 

SEC. 6. PRIORITIZATION, RISK EVALUATION, AND REGULATION OF 

CHEMICAL SUBSTANCES AND MIXTURES. 

Section 6 of the Toxic Substances Control Act (15 U.S.C. 2605) 

is amended— 

(1) by striking the section heading and inserting 

‘‘PRIORITIZATION, RISK EVALUATION, AND REGULATION OF

CHEMICAL SUBSTANCES AND MIXTURES’’; 

(2) in subsection (a)— 

(A) by striking ‘‘finds that there is a reasonable basis 

to conclude’’ and inserting ‘‘determines in accordance with 

subsection (b)(4)(A)’’; 

(B) by striking ‘‘or will present’’; 

(C) by inserting ‘‘and subject to section 18, and in 

accordance with subsection (c)(2),’’ after ‘‘shall by rule’’; 

(D) by striking ‘‘to protect adequately against such 

risk using the least burdensome requirements’’ and 

inserting ‘‘so that the chemical substance or mixture no 

longer presents such risk’’; 

(E) by inserting ‘‘or otherwise restricting’’ after ‘‘prohibiting’’ in paragraphs (1)(A) and (2)(A); 

(F) by inserting ‘‘minimum’’ before ‘‘warnings’’ both 

places it appears in paragraph (3); 

(G) by striking ‘‘and monitor or conduct tests’’ and 

inserting ‘‘or monitor or conduct tests’’ in paragraph (4); 

and 

(H) in paragraph (7)— 

(i) by striking ‘‘such unreasonable risk of injury’’ 

and inserting ‘‘such determination’’; and 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 461 

(ii) by striking ‘‘such risk of injury’’ and inserting 

‘‘such determination’’; 

(3) by amending subsection (b) to read as follows: 

‘‘(b) RISK EVALUATIONS.— 

‘‘(1) PRIORITIZATION FOR RISK EVALUATIONS.— 

‘‘(A) ESTABLISHMENT OF PROCESS.—Not later than 1 

year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the 

Administrator shall establish, by rule, a risk-based 

screening process, including criteria for designating chemical substances as high-priority substances for risk evaluations or low-priority substances for which risk evaluations 

are not warranted at the time. The process to designate 

the priority of chemical substances shall include a consideration of the hazard and exposure potential of a chemical 

substance or a category of chemical substances (including 

consideration of persistence and bioaccumulation, potentially exposed or susceptible subpopulations and storage 

near significant sources of drinking water), the conditions 

of use or significant changes in the conditions of use of 

the chemical substance, and the volume or significant 

changes in the volume of the chemical substance manufactured or processed. 

‘‘(B) IDENTIFICATION OF PRIORITIES FOR RISK EVALUATION.— 

‘‘(i) HIGH-PRIORITY SUBSTANCES.—The Administrator shall designate as a high-priority substance a 

chemical substance that the Administrator concludes, 

without consideration of costs or other nonrisk factors, 

may present an unreasonable risk of injury to health 

or the environment because of a potential hazard and 

a potential route of exposure under the conditions of 

use, including an unreasonable risk to a potentially 

exposed or susceptible subpopulation identified as relevant by the Administrator. 

‘‘(ii) LOW-PRIORITY SUBSTANCES.—The Administrator shall designate a chemical substance as a lowpriority substance if the Administrator concludes, 

based on information sufficient to establish, without 

consideration of costs or other nonrisk factors, that 

such substance does not meet the standard identified 

in clause (i) for designating a chemical substance a 

high-priority substance. 

‘‘(C) INFORMATION REQUEST AND REVIEW AND PROPOSED

AND FINAL PRIORITIZATION DESIGNATION.—The rulemaking 

required in subparagraph (A) shall ensure that the time 

required to make a priority designation of a chemical substance be no shorter than nine months and no longer 

than 1 year, and that the process for such designations 

includes— 

‘‘(i) a requirement that the Administrator request 

interested persons to submit relevant information on 

a chemical substance that the Administrator has initiated the prioritization process on, before proposing a 

priority designation for the chemical substance, and 

provide 90 days for such information to be provided; 

Time periods. 

Deadline. 

Criteria. 


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130 STAT. 462 PUBLIC LAW 114–182—JUNE 22, 2016 

‘‘(ii) a requirement that the Administrator publish 

each proposed designation of a chemical substance as 

a high- or low-priority substance, along with an identification of the information, analysis, and basis used 

to make the proposed designations, and provide 90 

days for public comment on each such proposed designation; and 

‘‘(iii) a process by which the Administrator may 

extend the deadline in clause (i) for up to three months 

in order to receive or evaluate information required 

to be submitted in accordance with section 4(a)(2)(B), 

subject to the limitation that if the information available to the Administrator at the end of such an extension remains insufficient to enable the designation of 

the chemical substance as a low-priority substance, 

the Administrator shall designate the chemical substance as a high-priority substance. 

‘‘(2) INITIAL RISK EVALUATIONS AND SUBSEQUENT DESIGNATIONS OF HIGH- AND LOW-PRIORITY SUBSTANCES.— 

‘‘(A) INITIAL RISK EVALUATIONS.—Not later than 180 

days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the 

Administrator shall ensure that risk evaluations are being 

conducted on 10 chemical substances drawn from the 2014 

update of the TSCA Work Plan for Chemical Assessments 

and shall publish the list of such chemical substances 

during the 180 day period. 

‘‘(B) ADDITIONAL RISK EVALUATIONS.—Not later than 

three and one half years after the date of enactment of 

the Frank R. Lautenberg Chemical Safety for the 21st 

Century Act, the Administrator shall ensure that risk 

evaluations are being conducted on at least 20 high-priority 

substances and that at least 20 chemical substances have 

been designated as low-priority substances, subject to the 

limitation that at least 50 percent of all chemical substances on which risk evaluations are being conducted by 

the Administrator are drawn from the 2014 update of the 

TSCA Work Plan for Chemical Assessments. 

‘‘(C) CONTINUING DESIGNATIONS AND RISK EVALUATIONS.—The Administrator shall continue to designate priority substances and conduct risk evaluations in accordance 

with this subsection at a pace consistent with the ability 

of the Administrator to complete risk evaluations in accordance with the deadlines under paragraph (4)(G). 

‘‘(D) PREFERENCE.—In designating high-priority substances, the Administrator shall give preference to— 

‘‘(i) chemical substances that are listed in the 2014 

update of the TSCA Work Plan for Chemical Assessments as having a Persistence and Bioaccumulation 

Score of 3; and 

‘‘(ii) chemical substances that are listed in the 

2014 update of the TSCA Work Plan for Chemical 

Assessments that are known human carcinogens and 

have high acute and chronic toxicity. 

‘‘(E) METALS AND METAL COMPOUNDS.—In identifying 

priorities for risk evaluation and conducting risk evaluations of metals and metal compounds, the Administrator 

Deadline. 

Deadline. 

Publication. 

Lists. 

Time period. 

Publication. 

Public 

information. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 463 

shall use the Framework for Metals Risk Assessment of 

the Office of the Science Advisor, Risk Assessment Forum, 

and dated March 2007, or a successor document that 

addresses metals risk assessment and is peer reviewed 

by the Science Advisory Board. 

‘‘(3) INITIATION OF RISK EVALUATIONS; DESIGNATIONS.— 

‘‘(A) RISK EVALUATION INITIATION.—Upon designating 

a chemical substance as a high-priority substance, the 

Administrator shall initiate a risk evaluation on the substance. 

‘‘(B) REVISION.—The Administrator may revise the designation of a low-priority substance based on information 

made available to the Administrator. 

‘‘(C) ONGOING DESIGNATIONS.—The Administrator shall 

designate at least one high-priority substance upon the 

completion of each risk evaluation (other than risk evaluations for chemical substances designated under paragraph 

(4)(C)(ii)). 

‘‘(4) RISK EVALUATION PROCESS AND DEADLINES.— 

‘‘(A) IN GENERAL.—The Administrator shall conduct 

risk evaluations pursuant to this paragraph to determine 

whether a chemical substance presents an unreasonable 

risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an 

unreasonable risk to a potentially exposed or susceptible 

subpopulation identified as relevant to the risk evaluation 

by the Administrator, under the conditions of use. 

‘‘(B) ESTABLISHMENT OF PROCESS.—Not later than 1 

year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the 

Administrator shall establish, by rule, a process to conduct 

risk evaluations in accordance with subparagraph (A). 

‘‘(C) REQUIREMENT.—The Administrator shall conduct 

and publish risk evaluations, in accordance with the rule 

promulgated under subparagraph (B), for a chemical substance— 

‘‘(i) that has been identified under paragraph (2)(A) 

or designated under paragraph (1)(B)(i); and 

‘‘(ii) subject to subparagraph (E), that a manufacturer of the chemical substance has requested, in a 

form and manner and using the criteria prescribed 

by the Administrator in the rule promulgated under 

subparagraph (B), be subjected to a risk evaluation. 

‘‘(D) SCOPE.—The Administrator shall, not later than 

6 months after the initiation of a risk evaluation, publish 

the scope of the risk evaluation to be conducted, including 

the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider, and, for each designation of 

a high-priority substance, ensure not less than 12 months 

between the initiation of the prioritization process for the 

chemical substance and the publication of the scope of 

the risk evaluation for the chemical substance, and for 

risk evaluations conducted on chemical substances that 

have been identified under paragraph (2)(A) or selected 

under subparagraph (E)(iv)(II) of this paragraph, ensure 

Deadlines. 

Publications. 

Publication. 

Deadline. 

Determination. 


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130 STAT. 464 PUBLIC LAW 114–182—JUNE 22, 2016 

not less than 3 months before the Administrator publishes 

the scope of the risk evaluation. 

‘‘(E) LIMITATION AND CRITERIA.— 

‘‘(i) PERCENTAGE REQUIREMENTS.—The Administrator shall ensure that, of the number of chemical 

substances that undergo a risk evaluation under clause 

(i) of subparagraph (C), the number of chemical substances undergoing a risk evaluation under clause (ii) 

of subparagraph (C) is— 

‘‘(I) not less than 25 percent, if sufficient 

requests are made under clause (ii) of subparagraph (C); and 

‘‘(II) not more than 50 percent. 

‘‘(ii) REQUESTED RISK EVALUATIONS.—Requests for 

risk evaluations under subparagraph (C)(ii) shall be 

subject to the payment of fees pursuant to section 

26(b), and the Administrator shall not expedite or 

otherwise provide special treatment to such risk 

evaluations. 

‘‘(iii) PREFERENCE.—In deciding whether to grant 

requests under subparagraph (C)(ii), the Administrator 

shall give preference to requests for risk evaluations 

on chemical substances for which the Administrator 

determines that restrictions imposed by 1 or more 

States have the potential to have a significant impact 

on interstate commerce or health or the environment. 

‘‘(iv) EXCEPTIONS.—(I) Chemical substances for 

which requests have been granted under subparagraph 

(C)(ii) shall not be subject to section 18(b). 

‘‘(II) Requests for risk evaluations on chemical substances which are made under subparagraph (C)(ii) 

and that are drawn from the 2014 update of the TSCA 

Work Plan for Chemical Assessments shall be granted 

at the discretion of the Administrator and not be subject to clause (i)(II). 

‘‘(F) REQUIREMENTS.—In conducting a risk evaluation 

under this subsection, the Administrator shall— 

‘‘(i) integrate and assess available information on 

hazards and exposures for the conditions of use of 

the chemical substance, including information that is 

relevant to specific risks of injury to health or the 

environment and information on potentially exposed 

or susceptible subpopulations identified as relevant by 

the Administrator; 

‘‘(ii) describe whether aggregate or sentinel exposures to a chemical substance under the conditions 

of use were considered, and the basis for that consideration; 

‘‘(iii) not consider costs or other nonrisk factors; 

‘‘(iv) take into account, where relevant, the likely 

duration, intensity, frequency, and number of exposures under the conditions of use of the chemical substance; and 

‘‘(v) describe the weight of the scientific evidence 

for the identified hazard and exposure. 

‘‘(G) DEADLINES.—The Administrator— 

Assessment. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 465 

‘‘(i) shall complete a risk evaluation for a chemical 

substance as soon as practicable, but not later than 

3 years after the date on which the Administrator 

initiates the risk evaluation under subparagraph (C); 

and 

‘‘(ii) may extend the deadline for a risk evaluation 

for not more than 6 months. 

‘‘(H) NOTICE AND COMMENT.—The Administrator shall 

provide no less than 30 days public notice and an opportunity for comment on a draft risk evaluation prior to 

publishing a final risk evaluation.’’; 

(4) by amending subsection (c) to read as follows: 

‘‘(c) PROMULGATION OF SUBSECTION (a) RULES.— 

‘‘(1) DEADLINES.—If the Administrator determines that a 

chemical substance presents an unreasonable risk of injury 

to health or the environment in accordance with subsection 

(b)(4)(A), the Administrator— 

‘‘(A) shall propose in the Federal Register a rule under 

subsection (a) for the chemical substance not later than 

1 year after the date on which the final risk evaluation 

regarding the chemical substance is published; 

‘‘(B) shall publish in the Federal Register a final rule 

not later than 2 years after the date on which the final 

risk evaluation regarding the chemical substance is published; and 

‘‘(C) may extend the deadlines under this paragraph 

for not more than 2 years, subject to the condition that 

the aggregate length of extensions under this subparagraph 

and subsection (b)(4)(G)(ii) does not exceed 2 years, and 

subject to the limitation that the Administrator may not 

extend a deadline for the publication of a proposed or 

final rule regarding a chemical substance drawn from the 

2014 update of the TSCA Work Plan for Chemical Assessments or a chemical substance that, with respect to persistence and bioaccumulation, scores high for 1 and either 

high or moderate for the other, pursuant to the TSCA 

Work Plan Chemicals Methods Document published by the 

Administrator in February 2012 (or a successor scoring 

system), without adequate public justification that demonstrates, following a review of the information reasonably 

available to the Administrator, that the Administrator 

cannot complete the proposed or final rule without additional information regarding the chemical substance. 

‘‘(2) REQUIREMENTS FOR RULE.— 

‘‘(A) STATEMENT OF EFFECTS.—In proposing and 

promulgating a rule under subsection (a) with respect to 

a chemical substance or mixture, the Administrator shall 

consider and publish a statement based on reasonably 

available information with respect to— 

‘‘(i) the effects of the chemical substance or mixture 

on health and the magnitude of the exposure of human 

beings to the chemical substance or mixture; 

‘‘(ii) the effects of the chemical substance or mixture on the environment and the magnitude of the 

exposure of the environment to such substance or mixture; 

Publication. 

Determination. 

Federal Register, 

publication. 

Time period. 


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130 STAT. 466 PUBLIC LAW 114–182—JUNE 22, 2016 

‘‘(iii) the benefits of the chemical substance or mixture for various uses; and 

‘‘(iv) the reasonably ascertainable economic consequences of the rule, including consideration of— 

‘‘(I) the likely effect of the rule on the national 

economy, small business, technological innovation, 

the environment, and public health; 

‘‘(II) the costs and benefits of the proposed 

and final regulatory action and of the 1 or more 

primary alternative regulatory actions considered 

by the Administrator; and 

‘‘(III) the cost effectiveness of the proposed 

regulatory action and of the 1 or more primary 

alternative regulatory actions considered by the 

Administrator. 

‘‘(B) SELECTING REQUIREMENTS.—In selecting among 

prohibitions and other restrictions, the Administrator shall 

factor in, to the extent practicable, the considerations under 

subparagraph (A) in accordance with subsection (a). 

‘‘(C) CONSIDERATION OF ALTERNATIVES.—Based on the 

information published under subparagraph (A), in deciding 

whether to prohibit or restrict in a manner that substantially prevents a specific condition of use of a chemical 

substance or mixture, and in setting an appropriate transition period for such action, the Administrator shall consider, to the extent practicable, whether technically and 

economically feasible alternatives that benefit health or 

the environment, compared to the use so proposed to be 

prohibited or restricted, will be reasonably available as 

a substitute when the proposed prohibition or other restriction takes effect. 

‘‘(D) REPLACEMENT PARTS.— 

‘‘(i) IN GENERAL.—The Administrator shall exempt 

replacement parts for complex durable goods and complex consumer goods that are designed prior to the 

date of publication in the Federal Register of the rule 

under subsection (a), unless the Administrator finds 

that such replacement parts contribute significantly 

to the risk, identified in a risk evaluation conducted 

under subsection (b)(4)(A), to the general population 

or to an identified potentially exposed or susceptible 

subpopulation. 

‘‘(ii) DEFINITIONS.—In this subparagraph— 

‘‘(I) the term ‘complex consumer goods’ means 

electronic or mechanical devices composed of multiple manufactured components, with an intended 

useful life of 3 or more years, where the product 

is typically not consumed, destroyed, or discarded 

after a single use, and the components of which 

would be impracticable to redesign or replace; and 

‘‘(II) the term ‘complex durable goods’ means 

manufactured goods composed of 100 or more 

manufactured components, with an intended useful life of 5 or more years, where the product 

is typically not consumed, destroyed, or discarded 

after a single use. 

Exemption. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 467 

‘‘(E) ARTICLES.—In selecting among prohibitions and 

other restrictions, the Administrator shall apply such 

prohibitions or other restrictions to an article or category 

of articles containing the chemical substance or mixture 

only to the extent necessary to address the identified risks 

from exposure to the chemical substance or mixture from 

the article or category of articles so that the substance 

or mixture does not present an unreasonable risk of injury 

to health or the environment identified in the risk evaluation conducted in accordance with subsection (b)(4)(A). 

‘‘(3) PROCEDURES.—When prescribing a rule under subsection (a) the Administrator shall proceed in accordance with 

section 553 of title 5, United States Code (without regard 

to any reference in such section to sections 556 and 557 of 

such title), and shall also— 

‘‘(A) publish a notice of proposed rulemaking stating 

with particularity the reason for the proposed rule; 

‘‘(B) allow interested persons to submit written data, 

views, and arguments, and make all such submissions publicly available; 

‘‘(C) promulgate a final rule based on the matter in 

the rulemaking record; and 

‘‘(D) make and publish with the rule the determination 

described in subsection (a).’’; 

(5) in subsection (d)— 

(A) by redesignating paragraph (2) as paragraph (3); 

(B) by striking paragraph (1) and inserting the following: 

‘‘(1) IN GENERAL.—In any rule under subsection (a), the 

Administrator shall— 

‘‘(A) specify the date on which it shall take effect, 

which date shall be as soon as practicable; 

‘‘(B) except as provided in subparagraphs (C) and (D), 

specify mandatory compliance dates for all of the requirements under a rule under subsection (a), which shall be 

as soon as practicable, but not later than 5 years after 

the date of promulgation of the rule, except in a case 

of a use exempted under subsection (g); 

‘‘(C) specify mandatory compliance dates for the start 

of ban or phase-out requirements under a rule under subsection (a), which shall be as soon as practicable, but not 

later than 5 years after the date of promulgation of the 

rule, except in the case of a use exempted under subsection 

(g); 

‘‘(D) specify mandatory compliance dates for full 

implementation of ban or phase-out requirements under 

a rule under subsection (a), which shall be as soon as 

practicable; and 

‘‘(E) provide for a reasonable transition period. 

‘‘(2) VARIABILITY.—As determined by the Administrator, 

the compliance dates established under paragraph (1) may vary 

for different affected persons.’’; and 

(C) in paragraph (3), as so redesignated by subparagraph (A) of this paragraph— 

(i) in subparagraph (A)— 

(I) by striking ‘‘upon its publication’’ and all 

that follows through ‘‘respecting such rule if’’ and 

Determination. 

Compliance 

dates. 

Deadline. 

Effective date. 

Publication. 

Public 

information. 

Publication. 

Notice. 

Applicability. 


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130 STAT. 468 PUBLIC LAW 114–182—JUNE 22, 2016 

inserting ‘‘, and compliance with the proposed 

requirements to be mandatory, upon publication 

in the Federal Register of the proposed rule and 

until the compliance dates applicable to such 

requirements in a final rule promulgated under 

section 6(a) or until the Administrator revokes 

such proposed rule, in accordance with subparagraph (B), if’’; and 

(II) in clause (i)(I), by inserting ‘‘without 

consideration of costs or other non-risk factors’’ 

after ‘‘effective date’’; and 

(ii) in subparagraph (B), by striking ‘‘, provide 

reasonable opportunity’’ and all that follows through 

the period at the end and inserting ‘‘in accordance 

with subsection (c), and either promulgate such rule 

(as proposed or with modifications) or revoke it.’’; 

(6) in subsection (e)(4), by striking ‘‘paragraphs (2), (3), 

and (4)’’ and inserting ‘‘paragraph (3)’’; and 

(7) by adding at the end the following new subsections: 

‘‘(g) EXEMPTIONS.— 

‘‘(1) CRITERIA FOR EXEMPTION.—The Administrator may, 

as part of a rule promulgated under subsection (a), or in a 

separate rule, grant an exemption from a requirement of a 

subsection (a) rule for a specific condition of use of a chemical 

substance or mixture, if the Administrator finds that— 

‘‘(A) the specific condition of use is a critical or essential 

use for which no technically and economically feasible safer 

alternative is available, taking into consideration hazard 

and exposure; 

‘‘(B) compliance with the requirement, as applied with 

respect to the specific condition of use, would significantly 

disrupt the national economy, national security, or critical 

infrastructure; or 

‘‘(C) the specific condition of use of the chemical substance or mixture, as compared to reasonably available 

alternatives, provides a substantial benefit to health, the 

environment, or public safety. 

‘‘(2) EXEMPTION ANALYSIS AND STATEMENT.—In proposing 

an exemption under this subsection, the Administrator shall 

analyze the need for the exemption, and shall make public 

the analysis and a statement describing how the analysis was 

taken into account. 

‘‘(3) PERIOD OF EXEMPTION.—The Administrator shall establish, as part of a rule under this subsection, a time limit 

on any exemption for a time to be determined by the Administrator as reasonable on a case-by-case basis, and, by rule, 

may extend, modify, or eliminate an exemption if the Administrator determines, on the basis of reasonably available information and after adequate public justification, the exemption warrants extension or modification or is no longer necessary. 

‘‘(4) CONDITIONS.—As part of a rule promulgated under 

this subsection, the Administrator shall include conditions, 

including reasonable recordkeeping, monitoring, and reporting 

requirements, to the extent that the Administrator determines 

the conditions are necessary to protect health and the environment while achieving the purposes of the exemption. 

Records. 

Reports. 

Determination. 

Determination. 

Public 

information. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 469 

‘‘(h) CHEMICALS THAT ARE PERSISTENT, BIOACCUMULATIVE, AND

TOXIC.— 

‘‘(1) EXPEDITED ACTION.—Not later than 3 years after the 

date of enactment of the Frank R. Lautenberg Chemical Safety 

for the 21st Century Act, the Administrator shall propose rules 

under subsection (a) with respect to chemical substances identified in the 2014 update of the TSCA Work Plan for Chemical 

Assessments— 

‘‘(A) that the Administrator has a reasonable basis 

to conclude are toxic and that with respect to persistence 

and bioaccumulation score high for one and either high 

or moderate for the other, pursuant to the TSCA Work 

Plan Chemicals Methods Document published by the 

Administrator in February 2012 (or a successor scoring 

system), and are not a metal or a metal compound, and 

for which the Administrator has not completed a Work 

Plan Problem Formulation, initiated a review under section 

5, or entered into a consent agreement under section 4, 

prior to the date of enactment of the Frank R. Lautenberg 

Chemical Safety for the 21st Century Act; and 

‘‘(B) exposure to which under the conditions of use 

is likely to the general population or to a potentially 

exposed or susceptible subpopulation identified by the 

Administrator, or the environment, on the basis of an exposure and use assessment conducted by the Administrator. 

‘‘(2) NO RISK EVALUATION REQUIRED.—The Administrator 

shall not be required to conduct risk evaluations on chemical 

substances that are subject to paragraph (1). 

‘‘(3) FINAL RULE.—Not later than 18 months after proposing 

a rule pursuant to paragraph (1), the Administrator shall 

promulgate a final rule under subsection (a). 

‘‘(4) SELECTING RESTRICTIONS.—In selecting among prohibitions and other restrictions promulgated in a rule under subsection (a) pursuant to paragraph (1), the Administrator shall 

address the risks of injury to health or the environment that 

the Administrator determines are presented by the chemical 

substance and shall reduce exposure to the substance to the 

extent practicable. 

‘‘(5) RELATIONSHIP TO SUBSECTION (b).—If, at any time prior 

to the date that is 90 days after the date of enactment of 

the Frank R. Lautenberg Chemical Safety for the 21st Century 

Act, the Administrator makes a designation under subsection 

(b)(1)(B)(i), or receives a request under subsection (b)(4)(C)(ii), 

such chemical substance shall not be subject to this subsection, 

except that in selecting among prohibitions and other restrictions promulgated in a rule pursuant to subsection (a), the 

Administrator shall both ensure that the chemical substance 

meets the rulemaking standard under subsection (a) and reduce 

exposure to the substance to the extent practicable. 

‘‘(i) FINAL AGENCY ACTION.—Under this section and subject 

to section 18— 

‘‘(1) a determination by the Administrator under subsection 

(b)(4)(A) that a chemical substance does not present an 

unreasonable risk of injury to health or the environment shall 

be issued by order and considered to be a final agency action, 

effective beginning on the date of issuance of the order; and 

Determination. 

Effective date. 

Time period. 

Deadline. 

Deadline. 


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130 STAT. 470 PUBLIC LAW 114–182—JUNE 22, 2016 

‘‘(2) a final rule promulgated under subsection (a), including 

the associated determination by the Administrator under subsection (b)(4)(A) that a chemical substance presents an 

unreasonable risk of injury to health or the environment, shall 

be considered to be a final agency action, effective beginning 

on the date of promulgation of the final rule. 

‘‘(j) DEFINITION.—For the purposes of this Act, the term ‘requirement’ as used in this section shall not displace statutory or common 

law.’’. 

SEC. 7. IMMINENT HAZARDS. 

Section 7 of the Toxic Substances Control Act (15 U.S.C. 2606) 

is amended— 

(1) in subsection (b)(1), by inserting ‘‘(as identified by the 

Administrator without consideration of costs or other nonrisk 

factors)’’ after ‘‘from the unreasonable risk’’; and 

(2) in subsection (f), by inserting ‘‘, without consideration 

of costs or other nonrisk factors’’ after ‘‘widespread injury to 

health or the environment’’. 

SEC. 8. REPORTING AND RETENTION OF INFORMATION. 

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

Act (15 U.S.C. 2607) is amended— 

(1) in subsection (a)— 

(A) in paragraph (2), by striking the matter that follows 

subparagraph (G); 

(B) in paragraph (3), by adding at the end the following: 

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

the Frank R. Lautenberg Chemical Safety for the 21st Century 

Act, and not less frequently than once every 10 years thereafter, 

the Administrator, after consultation with the Administrator of 

the Small Business Administration, shall— 

‘‘(i) review the adequacy of the standards prescribed under 

subparagraph (B); and 

‘‘(ii) after providing public notice and an opportunity for 

comment, make a determination as to whether revision of the 

standards is warranted.’’; and 

(C) by adding at the end the following: 

‘‘(4) CONTENTS.—The rules promulgated pursuant to paragraph (1)— 

‘‘(A) may impose differing reporting and recordkeeping 

requirements on manufacturers and processors; and 

‘‘(B) shall include the level of detail necessary to be 

reported, including the manner by which use and exposure 

information may be reported. 

‘‘(5) ADMINISTRATION.—In carrying out this section, the 

Administrator shall, to the extent feasible— 

‘‘(A) not require reporting which is unnecessary or 

duplicative; 

‘‘(B) minimize the cost of compliance with this section 

and the rules issued thereunder on small manufacturers 

and processors; and 

‘‘(C) apply any reporting obligations to those persons 

likely to have information relevant to the effective 

implementation of this title. 

‘‘(6) NEGOTIATED RULEMAKING.—(A) The Administrator 

shall enter into a negotiated rulemaking pursuant to subchapter 

III of chapter 5 of title 5, United States Code, to develop 

Publications. 

Applicability. 

Public 

information. 

Determination. 

Review. 

Time period. 

Consultation. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 471 

and publish, not later than 3 years after the date of enactment 

of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, a proposed rule providing for limiting the reporting 

requirements, under this subsection, for manufacturers of any 

inorganic byproducts, when such byproducts, whether by the 

byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed. 

‘‘(B) Not later than 3 and one-half years after such date 

of enactment, the Administrator shall publish a final rule 

resulting from such negotiated rulemaking.’’; and 

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

‘‘(3) NOMENCLATURE.— 

‘‘(A) IN GENERAL.—In carrying out paragraph (1), the 

Administrator shall— 

‘‘(i) maintain the use of Class 2 nomenclature in 

use on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act; 

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

Association Nomenclature System, published in March 

1978 by the Administrator in section 1 of addendum 

III of the document entitled ‘Candidate List of Chemical Substances’, and further described in the appendix 

A of volume I of the 1985 edition of the Toxic Substances Control Act Substances Inventory (EPA Document No. EPA–560/7–85–002a); and 

‘‘(iii) treat the individual members of the categories 

of chemical substances identified by the Administrator 

as statutory mixtures, as defined in Inventory descriptions established by the Administrator, as being 

included on the list established under paragraph (1). 

‘‘(B) MULTIPLE NOMENCLATURE LISTINGS.—If a manufacturer or processor demonstrates to the Administrator 

that a chemical substance appears multiple times on the 

list published under paragraph (1) under different CAS 

numbers, the Administrator may recognize the multiple 

listings as a single chemical substance. 

‘‘(4) CHEMICAL SUBSTANCES IN COMMERCE.— 

‘‘(A) RULES.— 

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

date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator, 

by rule, shall require manufacturers, and may require 

processors, subject to the limitations under subsection 

(a)(5)(A), to notify the Administrator, by not later than 

180 days after the date on which the final rule is 

published in the Federal Register, of each chemical 

substance on the list published under paragraph (1) 

that the manufacturer or processor, as applicable, has 

manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the 

day before the date of enactment of the Frank R. 

Lautenberg Chemical Safety for the 21st Century Act. 

‘‘(ii) ACTIVE SUBSTANCES.—The Administrator shall 

designate chemical substances for which notices are 

received under clause (i) to be active substances on 

the list published under paragraph (1). 

Notification. 

Federal Register, 

publication. 

Time period. 


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130 STAT. 472 PUBLIC LAW 114–182—JUNE 22, 2016 

‘‘(iii) INACTIVE SUBSTANCES.—The Administrator 

shall designate chemical substances for which no 

notices are received under clause (i) to be inactive 

substances on the list published under paragraph (1). 

‘‘(iv) LIMITATION.—No chemical substance on the 

list published under paragraph (1) shall be removed 

from such list by reason of the implementation of this 

subparagraph, or be subject to section 5(a)(1)(A)(i) by 

reason of a change to active status under paragraph 

(5)(B). 

‘‘(B) CONFIDENTIAL CHEMICAL SUBSTANCES.—In promulgating a rule under subparagraph (A), the Administrator 

shall— 

‘‘(i) maintain the list under paragraph (1), which 

shall include a confidential portion and a nonconfidential portion consistent with this section and section 

14; 

‘‘(ii) require any manufacturer or processor of a 

chemical substance on the confidential portion of the 

list published under paragraph (1) that seeks to maintain an existing claim for protection against disclosure 

of the specific chemical identity of the chemical substance as confidential pursuant to section 14 to submit 

a notice under subparagraph (A) that includes such 

request; 

‘‘(iii) require the substantiation of those claims 

pursuant to section 14 and in accordance with the 

review plan described in subparagraph (C); and 

‘‘(iv) move any active chemical substance for which 

no request was received to maintain an existing claim 

for protection against disclosure of the specific chemical 

identity of the chemical substance as confidential from 

the confidential portion of the list published under 

paragraph (1) to the nonconfidential portion of that 

list. 

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

date on which the Administrator compiles the initial list 

of active substances pursuant to subparagraph (A), the 

Administrator shall promulgate a rule that establishes a 

plan to review all claims to protect the specific chemical 

identities of chemical substances on the confidential portion 

of the list published under paragraph (1) that are asserted 

pursuant to subparagraph (B). 

‘‘(D) REQUIREMENTS OF REVIEW PLAN.—In establishing 

the review plan under subparagraph (C), the Administrator 

shall— 

‘‘(i) require, at a time specified by the Administrator, all manufacturers or processors asserting claims 

under subparagraph (B) to substantiate the claim, in 

accordance with section 14, unless the manufacturer 

or processor has substantiated the claim in a submission made to the Administrator during the 5-year 

period ending on the last day of the of the time period 

specified by the Administrator; and 

‘‘(ii) in accordance with section 14— 

‘‘(I) review each substantiation— 

Time period. 

Claims. 

Regulations. 

Notice. 

List. 

Claims. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 473 

‘‘(aa) submitted pursuant to clause (i) to 

determine if the claim qualifies for protection 

from disclosure; and 

‘‘(bb) submitted previously by a manufacturer or processor and relied on in lieu of 

the substantiation required pursuant to clause 

(i), if the substantiation has not been previously reviewed by the Administrator, to 

determine if the claim warrants protection 

from disclosure; 

‘‘(II) approve, approve in part and deny in 

part, or deny each claim; and 

‘‘(III) except as provided in this section and 

section 14, protect from disclosure information for 

which the Administrator approves such a claim 

for a period of 10 years, unless, prior to the expiration of the period— 

‘‘(aa) the person notifies the Administrator 

that the person is withdrawing the claim, in 

which case the Administrator shall not protect 

the information from disclosure; or 

‘‘(bb) the Administrator otherwise becomes 

aware that the information does not qualify 

for protection from disclosure, in which case 

the Administrator shall take the actions 

described in section 14(g)(2). 

‘‘(E) TIMELINE FOR COMPLETION OF REVIEWS.— 

‘‘(i) IN GENERAL.—The Administrator shall implement the review plan so as to complete reviews of 

all claims specified in subparagraph (C) not later than 

5 years after the date on which the Administrator 

compiles the initial list of active substances pursuant 

to subparagraph (A). 

‘‘(ii) CONSIDERATIONS.— 

‘‘(I) IN GENERAL.—The Administrator may 

extend the deadline for completion of the reviews 

for not more than 2 additional years, after an 

adequate public justification, if the Administrator 

determines that the extension is necessary based 

on the number of claims needing review and the 

available resources. 

‘‘(II) ANNUAL REVIEW GOAL AND RESULTS.—At 

the beginning of each year, the Administrator shall 

publish an annual goal for reviews and the number 

of reviews completed in the prior year. 

‘‘(5) ACTIVE AND INACTIVE SUBSTANCES.— 

‘‘(A) IN GENERAL.—The Administrator shall keep designations of active substances and inactive substances on 

the list published under paragraph (1) current. 

‘‘(B) CHANGE TO ACTIVE STATUS.— 

‘‘(i) IN GENERAL.—Any person that intends to 

manufacture or process for a nonexempt commercial 

purpose a chemical substance that is designated as 

an inactive substance shall notify the Administrator 

before the date on which the inactive substance is 

manufactured or processed. 

Notification. 

Publication. 

Determination. 

Claims. 

Notification. 

Time period. 

Determination. 


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130 STAT. 474 PUBLIC LAW 114–182—JUNE 22, 2016 

‘‘(ii) CONFIDENTIAL CHEMICAL IDENTITY.—If a person submitting a notice under clause (i) for an inactive 

substance on the confidential portion of the list published under paragraph (1) seeks to maintain an 

existing claim for protection against disclosure of the 

specific chemical identity of the inactive substance as 

confidential, the person shall, consistent with the 

requirements of section 14— 

‘‘(I) in the notice submitted under clause (i), 

assert the claim; and 

‘‘(II) by not later than 30 days after providing 

the notice under clause (i), substantiate the claim. 

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

under clause (i), the Administrator shall— 

‘‘(I) designate the applicable chemical substance as an active substance; 

‘‘(II) pursuant to section 14, promptly review 

any claim and associated substantiation submitted 

pursuant to clause (ii) for protection against disclosure of the specific chemical identity of the chemical substance and approve, approve in part and 

deny in part, or deny the claim; 

‘‘(III) except as provided in this section and 

section 14, protect from disclosure the specific 

chemical identity of the chemical substance for 

which the Administrator approves a claim under 

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

prior to the expiration of the period— 

‘‘(aa) the person notifies the Administrator 

that the person is withdrawing the claim, in 

which case the Administrator shall not protect 

the information from disclosure; or 

‘‘(bb) the Administrator otherwise becomes 

aware that the information does not qualify 

for protection from disclosure, in which case 

the Administrator shall take the actions 

described in section 14(g)(2); and 

‘‘(IV) pursuant to section 6(b), review the priority of the chemical substance as the Administrator determines to be necessary. 

‘‘(C) CATEGORY STATUS.—The list of inactive substances 

shall not be considered to be a category for purposes of 

section 26(c). 

‘‘(6) INTERIM LIST OF ACTIVE SUBSTANCES.—Prior to the 

promulgation of the rule required under paragraph (4)(A), the 

Administrator shall designate the chemical substances reported 

under part 711 of title 40, Code of Federal Regulations (as 

in effect on the date of enactment of the Frank R. Lautenberg 

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

period that most closely preceded the date of enactment of 

the Frank R. Lautenberg Chemical Safety for the 21st Century 

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

of section 6(b). 

‘‘(7) PUBLIC INFORMATION.—Subject to this subsection and 

section 14, the Administrator shall make available to the 

public— 

Review. 

Notification. 

Time period. 

Review. 

Claims. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 475 

‘‘(A) each specific chemical identity on the nonconfidential portion of the list published under paragraph (1) along 

with the Administrator’s designation of the chemical substance as an active or inactive substance; 

‘‘(B) the unique identifier assigned under section 14, 

accession number, generic name, and, if applicable, 

premanufacture notice case number for each chemical substance on the confidential portion of the list published 

under paragraph (1) for which a claim of confidentiality 

was received; and 

‘‘(C) the specific chemical identity of any active substance for which— 

‘‘(i) a claim for protection against disclosure of 

the specific chemical identity of the active substance 

was not asserted, as required under this subsection 

or section 14; 

‘‘(ii) all claims for protection against disclosure 

of the specific chemical identity of the active substance 

have been denied by the Administrator; or 

‘‘(iii) the time period for protection against disclosure of the specific chemical identity of the active substance has expired. 

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

this subsection or section 14 for protection from disclosure 

of a specific chemical identity of any active or inactive substance 

for which a notice is received under paragraph (4)(A)(i) or 

(5)(B)(i) that is not on the confidential portion of the list published under paragraph (1). 

‘‘(9) CERTIFICATION.—Under the rules promulgated under 

this subsection, manufacturers and processors, as applicable, 

shall be required— 

‘‘(A) to certify that each notice or substantiation the 

manufacturer or processor submits complies with the 

requirements of the rule, and that any confidentiality 

claims are true and correct; and 

‘‘(B) to retain a record documenting compliance with 

the rule and supporting confidentiality claims for a period 

of 5 years beginning on the last day of the submission 

period.’’. 

(b) MERCURY INVENTORY.—Section 8(b) of the Toxic Substances 

Control Act (15 U.S.C. 2607(b)) (as amended by subsection (a)) 

is further amended by adding at the end the following: 

‘‘(10) MERCURY.— 

‘‘(A) DEFINITION OF MERCURY.—In this paragraph, notwithstanding section 3(2)(B), the term ‘mercury’ means— 

‘‘(i) elemental mercury; and 

‘‘(ii) a mercury compound. 

‘‘(B) PUBLICATION.—Not later than April 1, 2017, and 

every 3 years thereafter, the Administrator shall carry 

out and publish in the Federal Register an inventory of 

mercury supply, use, and trade in the United States. 

‘‘(C) PROCESS.—In carrying out the inventory under 

subparagraph (B), the Administrator shall— 

‘‘(i) identify any manufacturing processes or products that intentionally add mercury; and 

Federal Register, 

publication. 

Records. 

Time period. 

Effective date. 


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130 STAT. 476 PUBLIC LAW 114–182—JUNE 22, 2016 

‘‘(ii) recommend actions, including proposed revisions of Federal law or regulations, to achieve further 

reductions in mercury use. 

‘‘(D) REPORTING.— ‘‘(i) IN GENERAL.—To assist in the preparation of 

the inventory under subparagraph (B), any person who 

manufactures mercury or mercury-added products or 

otherwise intentionally uses mercury in a manufacturing process shall make periodic reports to the 

Administrator, at such time and including such 

information as the Administrator shall determine by 

rule promulgated not later than 2 years after the date 

of enactment of this paragraph. 

‘‘(ii) COORDINATION.—To avoid duplication, the 

Administrator shall coordinate the reporting under this 

subparagraph with the Interstate Mercury Education 

and Reduction Clearinghouse. 

‘‘(iii) EXEMPTION.—Clause (i) shall not apply to 

a person engaged in the generation, handling, or 

management of mercury-containing waste, unless that 

person manufactures or recovers mercury in the 

management of that waste.’’. 

SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS. 

Section 9 of the Toxic Substances Control Act (15 U.S.C. 2608) 

is amended— 

(1) in subsection (a)— 

(A) in paragraph (1)— 

(i) by striking ‘‘has reasonable basis to conclude’’ 

and inserting ‘‘determines’’; 

(ii) by striking ‘‘or will present’’; and 

(iii) by inserting ‘‘, without consideration of costs 

or other nonrisk factors, including an unreasonable 

risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator, under 

the conditions of use,’’ after ‘‘or the environment’’; 

(B) in paragraph (2)— 

(i) in subparagraph (A), by inserting ‘‘, within the 

time period specified by the Administrator in the 

report,’’ after ‘‘issues an order’’; and 

(ii) in subparagraph (B), by inserting ‘‘responds 

within the time period specified by the Administrator 

in the report and’’ before ‘‘initiates, within 90’’; 

(C) by redesignating paragraph (3) as paragraph (6); 

and 

(D) by inserting after paragraph (2) the following: 

‘‘(3) The Administrator shall take the actions described in paragraph (4) if the Administrator makes a report under paragraph 

(1) with respect to a chemical substance or mixture and the agency 

to which the report was made does not— 

‘‘(A) issue the order described in paragraph (2)(A) within 

the time period specified by the Administrator in the report; 

or 

‘‘(B)(i) respond under paragraph (1) within the timeframe 

specified by the Administrator in the report; and 

‘‘(ii) initiate action within 90 days of publication in the 

Federal Register of the response described in clause (i). 

Reports. 

Time period. 

Deadline. 

Determination. 

Regulations. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 477 

‘‘(4) If an agency to which a report is submitted under paragraph (1) does not take the actions described in subparagraph 

(A) or (B) of paragraph (3), the Administrator shall— 

‘‘(A) initiate or complete appropriate action under section 

6; or 

‘‘(B) take any action authorized or required under section 

7, as applicable. 

‘‘(5) This subsection shall not relieve the Administrator of any 

obligation to take any appropriate action under section 6(a) or 

7 to address risks from the manufacture, processing, distribution 

in commerce, use, or disposal of a chemical substance or mixture, 

or any combination of those activities, that are not identified in 

a report issued by the Administrator under paragraph (1).’’; 

(2) in subsection (b)— 

(A) by striking ‘‘The Administrator shall coordinate’’ 

and inserting ‘‘(1) The Administrator shall coordinate’’; and 

(B) by adding at the end the following: 

‘‘(2) In making a determination under paragraph (1) that it 

is in the public interest for the Administrator to take an action 

under this title with respect to a chemical substance or mixture 

rather than under another law administered in whole or in part 

by the Administrator, the Administrator shall consider, based on 

information reasonably available to the Administrator, all relevant 

aspects of the risk described in paragraph (1) and a comparison 

of the estimated costs and efficiencies of the action to be taken 

under this title and an action to be taken under such other law 

to protect against such risk.’’; and 

(3) by adding at the end the following: 

‘‘(e) EXPOSURE INFORMATION.—In addition to the requirements 

of subsection (a), if the Administrator obtains information related 

to exposures or releases of a chemical substance or mixture that 

may be prevented or reduced under another Federal law, including 

a law not administered by the Administrator, the Administrator 

shall make such information available to the relevant Federal 

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

SEC. 10. EXPORTS. 

(a) IN GENERAL.—Section 12(a)(2) of the Toxic Substances Control Act (15 U.S.C. 2611(a)(2)) is amended by striking ‘‘will present’’ 

and inserting ‘‘presents’’. 

(b) PROHIBITION ON EXPORT OF CERTAIN MERCURY COMPOUNDS.—Section 12(c) of the Toxic Substances Control Act (15 

U.S.C. 2611(c)) is amended— 

(1) in the subsection heading, by inserting ‘‘AND MERCURY

COMPOUNDS’’ after ‘‘MERCURY’’; and 

(2) by adding at the end the following: 

‘‘(7) PROHIBITION ON EXPORT OF CERTAIN MERCURY COMPOUNDS.— 

‘‘(A) IN GENERAL.—Effective January 1, 2020, the 

export of the following mercury compounds is prohibited: 

‘‘(i) Mercury (I) chloride or calomel. 

‘‘(ii) Mercury (II) oxide. 

‘‘(iii) Mercury (II) sulfate. 

‘‘(iv) Mercury (II) nitrate. 

‘‘(v) Cinnabar or mercury sulphide. 

‘‘(vi) Any mercury compound that the Administrator adds to the list published under subparagraph 

Effective date. 

Determination. 


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130 STAT. 478 PUBLIC LAW 114–182—JUNE 22, 2016 

(B) by rule, on determining that exporting that mercury 

compound for the purpose of regenerating elemental 

mercury is technically feasible. 

‘‘(B) PUBLICATION.—Not later than 90 days after the 

date of enactment of the Frank R. Lautenberg Chemical 

Safety for the 21st Century Act, and as appropriate thereafter, the Administrator shall publish in the Federal Register a list of the mercury compounds that are prohibited 

from export under this paragraph. 

‘‘(C) PETITION.—Any person may petition the Administrator to add a mercury compound to the list published 

under subparagraph (B). 

‘‘(D) ENVIRONMENTALLY SOUND DISPOSAL.—This paragraph does not prohibit the export of mercury compounds 

on the list published under subparagraph (B) to member 

countries of the Organization for Economic Co-operation 

and Development for environmentally sound disposal, on 

the condition that no mercury or mercury compounds so 

exported are to be recovered, recycled, or reclaimed for 

use, or directly reused, after such export. 

‘‘(E) REPORT.—Not later than 5 years after the date 

of enactment of the Frank R. Lautenberg Chemical Safety 

for the 21st Century Act, the Administrator shall evaluate 

any exports of mercury compounds on the list published 

under subparagraph (B) for disposal that occurred after 

such date of enactment and shall submit to Congress a 

report that— 

‘‘(i) describes volumes and sources of mercury compounds on the list published under subparagraph (B) 

exported for disposal; 

‘‘(ii) identifies receiving countries of such exports; 

‘‘(iii) describes methods of disposal used after such 

export; 

‘‘(iv) identifies issues, if any, presented by the 

export of mercury compounds on the list published 

under subparagraph (B); 

‘‘(v) includes an evaluation of management options 

in the United States for mercury compounds on the 

list published under subparagraph (B), if any, that 

are commercially available and comparable in cost and 

efficacy to methods being utilized in such receiving 

countries; and 

‘‘(vi) makes a recommendation regarding whether 

Congress should further limit or prohibit the export 

of mercury compounds on the list published under 

subparagraph (B) for disposal. 

‘‘(F) EFFECT ON OTHER LAW.—Nothing in this paragraph shall be construed to affect the authority of the 

Administrator under the Solid Waste Disposal Act (42 

U.S.C. 6901 et seq.).’’. 

(c) TEMPORARY GENERATOR ACCUMULATION.—Section 5 of the 

Mercury Export Ban Act of 2008 (42 U.S.C. 6939f) is amended— 

(1) in subsection (a)(2), by striking ‘‘2013’’ and inserting 

‘‘2019’’; 

(2) in subsection (b)— 

(A) in paragraph (1)— 

Recommendation. 

Evaluation. 

Deadline. 

Federal Register, 

publication. 

List. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 479 

(i) by redesignating subparagraphs (A), (B), and 

(C), as clauses (i), (ii), and (iii), respectively and 

indenting appropriately; 

(ii) in the first sentence, by striking ‘‘After consultation’’ and inserting the following: 

‘‘(A) ASSESSMENT AND COLLECTION.—After consultation’’; 

(iii) in the second sentence, by striking ‘‘The 

amount of such fees’’ and inserting the following: 

‘‘(B) AMOUNT.—The amount of the fees described in 

subparagraph (A)’’; 

(iv) in subparagraph (B) (as so designated)— 

(I) in clause (i) (as so redesignated), by striking 

‘‘publically available not later than October 1, 

2012’’ and inserting ‘‘publicly available not later 

than October 1, 2018’’; 

(II) in clause (ii) (as so redesignated), by 

striking ‘‘and’’; 

(III) in clause (iii) (as so redesignated), by 

striking the period at the end and inserting ‘‘, 

subject to clause (iv); and’’; and 

(IV) by adding at the end the following: 

‘‘(iv) for generators temporarily accumulating elemental mercury in a facility subject to subparagraphs 

(B) and (D)(iv) of subsection (g)(2) if the facility designated in subsection (a) is not operational by January 

1, 2019, shall be adjusted to subtract the cost of the 

temporary accumulation during the period in which 

the facility designated under subsection (a) is not operational.’’; and 

(v) by adding at the end the following: 

‘‘(C) CONVEYANCE OF TITLE AND PERMITTING.—If the 

facility designated in subsection (a) is not operational by 

January 1, 2020, the Secretary— 

‘‘(i) shall immediately accept the conveyance of 

title to all elemental mercury that has accumulated 

in facilities in accordance with subsection (g)(2)(D), 

before January 1, 2020, and deliver the accumulated 

mercury to the facility designated under subsection 

(a) on the date on which the facility becomes operational; 

‘‘(ii) shall pay any applicable Federal permitting 

costs, including the costs for permits issued under section 3005(c) of the Solid Waste Disposal Act (42 U.S.C. 

6925(c)); and 

‘‘(iii) shall store, or pay the cost of storage of, 

until the time at which a facility designated in subsection (a) is operational, accumulated mercury to 

which the Secretary has title under this subparagraph 

in a facility that has been issued a permit under section 

3005(c) of the Solid Waste Disposal Act (42 U.S.C. 

6925(c)).’’; and 

(B) in paragraph (2), in the first sentence, by striking 

‘‘paragraph (1)(C)’’ and inserting ‘‘paragraph (1)(B)(iii)’’; and 

(3) in subsection (g)(2)— 

(A) in the undesignated material at the end, by striking 

‘‘This subparagraph’’ and inserting the following: 

Deadline. 


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130 STAT. 480 PUBLIC LAW 114–182—JUNE 22, 2016 

‘‘(C) Subparagraph (B)’’; 

(B) in subparagraph (C) (as designated by subparagraph (A)), by inserting ‘‘of that subparagraph’’ before the 

period at the end; and 

(C) by adding at the end the following: 

‘‘(D) A generator producing elemental mercury incidentally from the beneficiation or processing of ore or related 

pollution control activities may accumulate the mercury 

produced onsite that is destined for a facility designated 

by the Secretary under subsection (a) for more than 90 

days without a permit issued under section 3005(c) of the 

Solid Waste Disposal Act (42 U.S.C. 6925(c)), and shall 

not be subject to the storage prohibition of section 3004(j) 

of that Act (42 U.S.C. 6924(j)), if— 

‘‘(i) the Secretary is unable to accept the mercury 

at a facility designated by the Secretary under subsection (a) for reasons beyond the control of the generator; 

‘‘(ii) the generator certifies in writing to the Secretary that the generator will ship the mercury to 

a designated facility when the Secretary is able to 

accept the mercury; 

‘‘(iii) the generator certifies in writing to the Secretary that the generator is storing only mercury the 

generator has produced or recovered onsite and will 

not sell, or otherwise place into commerce, the mercury; 

and 

‘‘(iv) the generator has obtained an identification 

number under section 262.12 of title 40, Code of Federal Regulations, and complies with the requirements 

described in paragraphs (1) through (4) of section 

262.34(a) of title 40, Code of Federal Regulations (as 

in effect on the date of enactment of this subparagraph). 

‘‘(E) MANAGEMENT STANDARDS FOR TEMPORARY STOR- AGE.—Not later than January 1, 2017, the Secretary, after 

consultation with the Administrator of the Environmental 

Protection Agency and State agencies in affected States, 

shall develop and make available guidance that establishes 

procedures and standards for the management and shortterm storage of elemental mercury at a generator covered 

under subparagraph (D), including requirements to ensure 

appropriate use of flasks or other suitable containers. Such 

procedures and standards shall be protective of health and 

the environment and shall ensure that the elemental mercury is stored in a safe, secure, and effective manner. 

A generator may accumulate mercury in accordance with 

subparagraph (D) immediately upon enactment of this 

subparagraph, and notwithstanding that guidance called 

for by this paragraph has not been developed or made 

available.’’. 

(d) INTERIM STATUS.—Section 5(d)(1) of the Mercury Export 

Ban Act of 2008 (42 U.S.C. 6939f(d)(1)) is amended— 

(1) in the fourth sentence, by striking ‘‘in existence on 

or before January 1, 2013,’’; and 

(2) in the last sentence, by striking ‘‘January 1, 2015’’ 

and inserting ‘‘January 1, 2020’’. 

Deadline. 

Consultation. 

Guidance. 

Procedures. 

Compliance. 

Time period. 

Certification. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 481 

SEC. 11. CONFIDENTIAL INFORMATION. 

Section 14 of the Toxic Substances Control Act (15 U.S.C. 

2613) is amended to read as follows: 

‘‘SEC. 14. CONFIDENTIAL INFORMATION. 

‘‘(a) IN GENERAL.—Except as provided in this section, the 

Administrator shall not disclose information that is exempt from 

disclosure pursuant to subsection (a) of section 552 of title 5, United 

States Code, by reason of subsection (b)(4) of that section— 

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

Administrator under this Act; and 

‘‘(2) for which the requirements of subsection (c) are met. 

In any proceeding under section 552(a) of title 5, United States 

Code, to obtain information the disclosure of which has been denied 

because of the provisions of this subsection, the Administrator 

may not rely on section 552(b)(3) of such title to sustain the 

Administrator’s action. 

‘‘(b) INFORMATION NOT PROTECTED FROM DISCLOSURE.— 

‘‘(1) MIXED CONFIDENTIAL AND NONCONFIDENTIAL INFORMATION.—Information that is protected from disclosure under this 

section, and which is mixed with information that is not protected from disclosure under this section, does not lose its 

protection from disclosure notwithstanding that it is mixed 

with information that is not protected from disclosure. 

‘‘(2) INFORMATION FROM HEALTH AND SAFETY STUDIES.— 

Subsection (a) does not prohibit the disclosure of— 

‘‘(A) any health and safety study which is submitted 

under this Act with respect to— 

‘‘(i) any chemical substance or mixture which, on 

the date on which such study is to be disclosed has 

been offered for commercial distribution; or 

‘‘(ii) any chemical substance or mixture for which 

testing is required under section 4 or for which notification is required under section 5; and 

‘‘(B) any information reported to, or otherwise obtained 

by, the Administrator from a health and safety study which 

relates to a chemical substance or mixture described in 

clause (i) or (ii) of subparagraph (A). 

This paragraph does not authorize the disclosure of any 

information, including formulas (including molecular structures) of a chemical substance or mixture, that discloses processes used in the manufacturing or processing of a chemical 

substance or mixture or, in the case of a mixture, the portion 

of the mixture comprised by any of the chemical substances 

in the mixture. 

‘‘(3) OTHER INFORMATION NOT PROTECTED FROM DISCLOSURE.—Subsection (a) does not prohibit the disclosure of— 

‘‘(A) any general information describing the manufacturing volumes, expressed as specific aggregated volumes 

or, if the Administrator determines that disclosure of specific aggregated volumes would reveal confidential information, expressed in ranges; or 

‘‘(B) a general description of a process used in the 

manufacture or processing and industrial, commercial, or 

consumer functions and uses of a chemical substance, mixture, or article containing a chemical substance or mixture, 

including information specific to an industry or industry 

Determination. 


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130 STAT. 482 PUBLIC LAW 114–182—JUNE 22, 2016 

sector that customarily would be shared with the general 

public or within an industry or industry sector. 

‘‘(4) BANS AND PHASE-OUTS.— 

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

a rule pursuant to section 6(a) that establishes a ban 

or phase-out of a chemical substance or mixture, the protection from disclosure of any information under this section 

with respect to the chemical substance or mixture shall 

be presumed to no longer apply, subject to subsection 

(g)(1)(E) and subparagraphs (B) and (C) of this paragraph. 

‘‘(B) LIMITATIONS.— ‘‘(i) CRITICAL USE.—In the case of a chemical substance or mixture for which a specific condition of 

use is subject to an exemption pursuant to section 

6(g), if the Administrator establishes a ban or phaseout described in subparagraph (A) with respect to the 

chemical substance or mixture, the presumption 

against protection under such subparagraph shall only 

apply to information that relates solely to any conditions of use of the chemical substance or mixture to 

which the exemption does not apply. 

‘‘(ii) EXPORT.—In the case of a chemical substance 

or mixture for which there is manufacture, processing, 

or distribution in commerce that meets the conditions 

of section 12(a)(1), if the Administrator establishes a 

ban or phase-out described in subparagraph (A) with 

respect to the chemical substance or mixture, the 

presumption against protection under such subparagraph shall only apply to information that relates solely 

to any other manufacture, processing, or distribution 

in commerce of the chemical substance or mixture for 

the conditions of use subject to the ban or phaseout, unless the Administrator makes the determination 

in section 12(a)(2). 

‘‘(iii) SPECIFIC CONDITIONS OF USE.—In the case 

of a chemical substance or mixture for which the 

Administrator establishes a ban or phase-out described 

in subparagraph (A) with respect to a specific condition 

of use of the chemical substance or mixture, the 

presumption against protection under such subparagraph shall only apply to information that relates solely 

to the condition of use of the chemical substance or 

mixture for which the ban or phase-out is established. 

‘‘(C) REQUEST FOR NONDISCLOSURE.— 

‘‘(i) IN GENERAL.—A manufacturer or processor of 

a chemical substance or mixture subject to a ban or 

phase-out described in this paragraph may submit to 

the Administrator, within 30 days of receiving a 

notification under subsection (g)(2)(A), a request, 

including documentation supporting such request, that 

some or all of the information to which the notice 

applies should not be disclosed or that its disclosure 

should be delayed, and the Administrator shall review 

the request under subsection (g)(1)(E). 

‘‘(ii) EFFECT OF NO REQUEST OR DENIAL.—If no 

request for nondisclosure or delay is submitted to the 

Administrator under this subparagraph, or the 

Deadline. 

Records. 

Review. 

Applicability. 

Applicability. 

Regulation. 

Applicability. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 483 

Administrator denies such a request under subsection 

(g)(1)(A), the information shall not be protected from 

disclosure under this section. 

‘‘(5) CERTAIN REQUESTS.—If a request is made to the 

Administrator under section 552(a) of title 5, United States 

Code, for information reported to or otherwise obtained by 

the Administrator under this Act that is not protected from 

disclosure under this subsection, the Administrator may not 

deny the request on the basis of section 552(b)(4) of title 5, 

United States Code. 

‘‘(c) REQUIREMENTS FOR CONFIDENTIALITY CLAIMS.— 

‘‘(1) ASSERTION OF CLAIMS.— 

‘‘(A) IN GENERAL.—A person seeking to protect from 

disclosure any information that person submits under this 

Act (including information described in paragraph (2)) shall 

assert to the Administrator a claim for protection from 

disclosure concurrent with submission of the information, 

in accordance with such rules regarding a claim for protection from disclosure as the Administrator has promulgated 

or may promulgate pursuant to this title. 

‘‘(B) INCLUSION.—An assertion of a claim under 

subparagraph (A) shall include a statement that the person 

has— 

‘‘(i) taken reasonable measures to protect the confidentiality of the information; 

‘‘(ii) determined that the information is not 

required to be disclosed or otherwise made available 

to the public under any other Federal law; 

‘‘(iii) a reasonable basis to conclude that disclosure 

of the information is likely to cause substantial harm 

to the competitive position of the person; and 

‘‘(iv) a reasonable basis to believe that the information is not readily discoverable through reverse 

engineering. 

‘‘(C) ADDITIONAL REQUIREMENTS FOR CLAIMS

REGARDING CHEMICAL IDENTITY INFORMATION.—In the case 

of a claim under subparagraph (A) for protection from 

disclosure of a specific chemical identity, the claim shall 

include a structurally descriptive generic name for the 

chemical substance that the Administrator may disclose 

to the public, subject to the condition that such generic 

name shall— 

‘‘(i) be consistent with guidance developed by the 

Administrator under paragraph (4)(A); and 

‘‘(ii) describe the chemical structure of the chemical 

substance as specifically as practicable while protecting 

those features of the chemical structure— 

‘‘(I) that are claimed as confidential; and 

‘‘(II) the disclosure of which would be likely 

to cause substantial harm to the competitive position of the person. 

‘‘(2) INFORMATION GENERALLY NOT SUBJECT TO SUBSTANTIATION REQUIREMENTS.—Subject to subsection (f), the following 

information shall not be subject to substantiation requirements 

under paragraph (3): 


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130 STAT. 484 PUBLIC LAW 114–182—JUNE 22, 2016 

‘‘(A) Specific information describing the processes used 

in manufacture or processing of a chemical substance, mixture, or article. 

‘‘(B) Marketing and sales information. 

‘‘(C) Information identifying a supplier or customer. 

‘‘(D) In the case of a mixture, details of the full composition of the mixture and the respective percentages of 

constituents. 

‘‘(E) Specific information regarding the use, function, 

or application of a chemical substance or mixture in a 

process, mixture, or article. 

‘‘(F) Specific production or import volumes of the manufacturer or processor. 

‘‘(G) Prior to the date on which a chemical substance 

is first offered for commercial distribution, the specific 

chemical identity of the chemical substance, including the 

chemical name, molecular formula, Chemical Abstracts 

Service number, and other information that would identify 

the specific chemical substance, if the specific chemical 

identity was claimed as confidential at the time it was 

submitted in a notice under section 5. 

‘‘(3) SUBSTANTIATION REQUIREMENTS.—Except as provided 

in paragraph (2), a person asserting a claim to protect information from disclosure under this section shall substantiate the 

claim, in accordance with such rules as the Administrator has 

promulgated or may promulgate pursuant to this section. 

‘‘(4) GUIDANCE.—The Administrator shall develop guidance 

regarding— 

‘‘(A) the determination of structurally descriptive 

generic names, in the case of claims for the protection 

from disclosure of specific chemical identity; and 

‘‘(B) the content and form of the statements of need 

and agreements required under paragraphs (4), (5), and 

(6) of subsection (d). 

‘‘(5) CERTIFICATION.—An authorized official of a person 

described in paragraph (1)(A) shall certify that the statement 

required to assert a claim submitted pursuant to paragraph 

(1)(B), and any information required to substantiate a claim 

submitted pursuant to paragraph (3), are true and correct. 

‘‘(d) EXCEPTIONS TO PROTECTION FROM DISCLOSURE.—Information described in subsection (a)— 

‘‘(1) shall be disclosed to an officer or employee of the 

United States— 

‘‘(A) in connection with the official duties of that person 

under any Federal law for the protection of health or the 

environment; or 

‘‘(B) for a specific Federal law enforcement purpose; 

‘‘(2) shall be disclosed to a contractor of the United States 

and employees of that contractor— 

‘‘(A) if, in the opinion of the Administrator, the disclosure is necessary for the satisfactory performance by the 

contractor of a contract with the United States for the 

performance of work in connection with this Act; and 

‘‘(B) subject to such conditions as the Administrator 

may specify; 

‘‘(3) shall be disclosed if the Administrator determines that 

disclosure is necessary to protect health or the environment 

Determination. 

Contracts. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 485 

against an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, 

including an unreasonable risk to a potentially exposed or 

susceptible subpopulation identified as relevant by the Administrator under the conditions of use; 

‘‘(4) shall be disclosed to a State, political subdivision of 

a State, or tribal government, on written request, for the purpose of administration or enforcement of a law, if such entity 

has 1 or more applicable agreements with the Administrator 

that are consistent with the guidance developed under subsection (c)(4)(B) and ensure that the entity will take appropriate 

measures, and has adequate authority, to maintain the confidentiality of the information in accordance with procedures 

comparable to the procedures used by the Administrator to 

safeguard the information; 

‘‘(5) shall be disclosed to a health or environmental professional employed by a Federal or State agency or tribal government or a treating physician or nurse in a nonemergency situation if such person provides a written statement of need and 

agrees to sign a written confidentiality agreement with the 

Administrator, subject to the conditions that— 

‘‘(A) the statement of need and confidentiality agreement are consistent with the guidance developed under 

subsection (c)(4)(B); 

‘‘(B) the statement of need shall be a statement that 

the person has a reasonable basis to suspect that— 

‘‘(i) the information is necessary for, or will assist 

in— 

‘‘(I) the diagnosis or treatment of 1 or more 

individuals; or 

‘‘(II) responding to an environmental release 

or exposure; and 

‘‘(ii) 1 or more individuals being diagnosed or 

treated have been exposed to the chemical substance 

or mixture concerned, or an environmental release of 

or exposure to the chemical substance or mixture concerned has occurred; and 

‘‘(C) the person will not use the information for any 

purpose other than the health or environmental needs 

asserted in the statement of need, except as otherwise 

may be authorized by the terms of the agreement or by 

the person who has a claim under this section with respect 

to the information; 

‘‘(6) shall be disclosed in the event of an emergency to 

a treating or responding physician, nurse, agent of a poison 

control center, public health or environmental official of a State, 

political subdivision of a State, or tribal government, or first 

responder (including any individual duly authorized by a Federal agency, State, political subdivision of a State, or tribal 

government who is trained in urgent medical care or other 

emergency procedures, including a police officer, firefighter, 

or emergency medical technician) if such person requests the 

information, subject to the conditions that such person shall— 

‘‘(A) have a reasonable basis to suspect that— 

‘‘(i) a medical, public health, or environmental 

emergency exists; 


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130 STAT. 486 PUBLIC LAW 114–182—JUNE 22, 2016 

‘‘(ii) the information is necessary for, or will assist 

in, emergency or first-aid diagnosis or treatment; or 

‘‘(iii) 1 or more individuals being diagnosed or 

treated have likely been exposed to the chemical substance or mixture concerned, or a serious environmental release of or exposure to the chemical substance 

or mixture concerned has occurred; and 

‘‘(B) if requested by a person who has a claim with 

respect to the information under this section— 

‘‘(i) provide a written statement of need and agree 

to sign a confidentiality agreement, as described in 

paragraph (5); and 

‘‘(ii) submit to the Administrator such statement 

of need and confidentiality agreement as soon as practicable, but not necessarily before the information is 

disclosed; 

‘‘(7) may be disclosed if the Administrator determines that 

disclosure is relevant in a proceeding under this Act, subject 

to the condition that the disclosure is made in such a manner 

as to preserve confidentiality to the extent practicable without 

impairing the proceeding; 

‘‘(8) shall be disclosed if the information is required to 

be made public under any other provision of Federal law; and 

‘‘(9) shall be disclosed as required pursuant to discovery, 

subpoena, other court order, or any other judicial process otherwise allowed under applicable Federal or State law. 

‘‘(e) DURATION OF PROTECTION FROM DISCLOSURE.— 

‘‘(1) IN GENERAL.—Subject to paragraph (2), subsection 

(f)(3), and section 8(b), the Administrator shall protect from 

disclosure information described in subsection (a)— 

‘‘(A) in the case of information described in subsection 

(c)(2), until such time as— 

‘‘(i) the person that asserted the claim notifies 

the Administrator that the person is withdrawing the 

claim, in which case the information shall not be protected from disclosure under this section; or 

‘‘(ii) the Administrator becomes aware that the 

information does not qualify for protection from disclosure under this section, in which case the Administrator shall take any actions required under subsections (f) and (g); and 

‘‘(B) in the case of information other than information 

described in subsection (c)(2)— 

‘‘(i) for a period of 10 years from the date on 

which the person asserts the claim with respect to 

the information submitted to the Administrator; or 

‘‘(ii) if applicable before the expiration of such 10- 

year period, until such time as— 

‘‘(I) the person that asserted the claim notifies 

the Administrator that the person is withdrawing 

the claim, in which case the information shall not 

be protected from disclosure under this section; 

or 

‘‘(II) the Administrator becomes aware that 

the information does not qualify for protection from 

disclosure under this section, in which case the 

Notification. 

Time period. 

Notification. 

Determination. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 487 

Administrator shall take any actions required 

under subsections (f) and (g). 

‘‘(2) EXTENSIONS.— 

‘‘(A) IN GENERAL.—In the case of information other 

than information described in subsection (c)(2), not later 

than the date that is 60 days before the expiration of 

the period described in paragraph (1)(B)(i), the Administrator shall provide to the person that asserted the claim 

a notice of the impending expiration of the period. 

‘‘(B) REQUEST.— ‘‘(i) IN GENERAL.—Not later than the date that 

is 30 days before the expiration of the period described 

in paragraph (1)(B)(i), a person reasserting the relevant 

claim shall submit to the Administrator a request for 

extension substantiating, in accordance with subsection 

(c)(3), the need to extend the period. 

‘‘(ii) ACTION BY ADMINISTRATOR.—Not later than 

the date of expiration of the period described in paragraph (1)(B)(i), the Administrator shall, in accordance 

with subsection (g)(1)— 

‘‘(I) review the request submitted under clause 

(i); 

‘‘(II) make a determination regarding whether 

the claim for which the request was submitted 

continues to meet the relevant requirements of 

this section; and 

‘‘(III)(aa) grant an extension of 10 years; or 

‘‘(bb) deny the request. 

‘‘(C) NO LIMIT ON NUMBER OF EXTENSIONS.—There shall 

be no limit on the number of extensions granted under 

this paragraph, if the Administrator determines that the 

relevant request under subparagraph (B)(i)— 

‘‘(i) establishes the need to extend the period; and 

‘‘(ii) meets the requirements established by the 

Administrator. 

‘‘(f) REVIEW AND RESUBSTANTIATION.— 

‘‘(1) DISCRETION OF ADMINISTRATOR.—The Administrator 

may require any person that has claimed protection for information from disclosure under this section, whether before, on, 

or after the date of enactment of the Frank R. Lautenberg 

Chemical Safety for the 21st Century Act, to reassert and 

substantiate or resubstantiate the claim in accordance with 

this section— 

‘‘(A) after the chemical substance is designated as a 

high-priority substance under section 6(b); 

‘‘(B) for any chemical substance designated as an active 

substance under section 8(b)(5)(B)(iii); or 

‘‘(C) if the Administrator determines that disclosure 

of certain information currently protected from disclosure 

would be important to assist the Administrator in conducting risk evaluations or promulgating rules under section 6. 

‘‘(2) REVIEW REQUIRED.—The Administrator shall review 

a claim for protection of information from disclosure under 

this section and require any person that has claimed protection 

for that information, whether before, on, or after the date 

of enactment of the Frank R. Lautenberg Chemical Safety 

Determination. 

Determination. 

Determination. 

Review. 

Notice. 

Deadlines. 


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130 STAT. 488 PUBLIC LAW 114–182—JUNE 22, 2016 

for the 21st Century Act, to reassert and substantiate or resubstantiate the claim in accordance with this section— 

‘‘(A) as necessary to determine whether the information 

qualifies for an exemption from disclosure in connection 

with a request for information received by the Administrator under section 552 of title 5, United States Code; 

‘‘(B) if the Administrator has a reasonable basis to 

believe that the information does not qualify for protection 

from disclosure under this section; or 

‘‘(C) for any chemical substance the Administrator 

determines under section 6(b)(4)(A) presents an unreasonable risk of injury to health or the environment. 

‘‘(3) PERIOD OF PROTECTION.—If the Administrator requires 

a person to reassert and substantiate or resubstantiate a claim 

under this subsection, and determines that the claim continues 

to meet the relevant requirements of this section, the Administrator shall protect the information subject to the claim from 

disclosure for a period of 10 years from the date of such determination, subject to any subsequent requirement by the 

Administrator under this subsection. 

‘‘(g) DUTIES OF ADMINISTRATOR.— 

‘‘(1) DETERMINATION.— 

‘‘(A) IN GENERAL.—Except for claims regarding 

information described in subsection (c)(2), the Administrator shall, subject to subparagraph (C), not later than 

90 days after the receipt of a claim under subsection (c), 

and not later than 30 days after the receipt of a request 

for extension of a claim under subsection (e) or a request 

under subsection (b)(4)(C), review and approve, approve 

in part and deny in part, or deny the claim or request. 

‘‘(B) REASONS FOR DENIAL.—If the Administrator denies 

or denies in part a claim or request under subparagraph 

(A) the Administrator shall provide to the person that 

asserted the claim or submitted the request a written statement of the reasons for the denial or denial in part of 

the claim or request. 

‘‘(C) SUBSETS.—The Administrator shall— 

‘‘(i) except with respect to information described 

in subsection (c)(2)(G), review all claims or requests 

under this section for the protection from disclosure 

of the specific chemical identity of a chemical substance; and 

‘‘(ii) review a representative subset, comprising at 

least 25 percent, of all other claims or requests for 

protection from disclosure under this section. 

‘‘(D) EFFECT OF FAILURE TO ACT.—The failure of the 

Administrator to make a decision regarding a claim or 

request for protection from disclosure or extension under 

this section shall not have the effect of denying or eliminating a claim or request for protection from disclosure. 

‘‘(E) DETERMINATION OF REQUESTS UNDER SUBSECTION

(b)(4)(C).—With respect to a request submitted under subsection (b)(4)(C), the Administrator shall, with the objective 

of ensuring that information relevant to the protection 

of health and the environment is disclosed to the extent 

practicable, determine whether the documentation provided 

by the person rebuts what shall be the presumption of 

Claims. 

Deadlines. 

Claims. 

Determination. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 489 

the Administrator that the public interest in the disclosure 

of the information outweighs the public or proprietary 

interest in maintaining the protection for all or a portion 

of the information that the person has requested not be 

disclosed or for which disclosure be delayed. 

‘‘(2) NOTIFICATION.— 

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

(B) and subsections (b), (d), and (e), if the Administrator 

denies or denies in part a claim or request under paragraph 

(1), concludes, in accordance with this section, that the 

information does not qualify for protection from disclosure, 

intends to disclose information pursuant to subsection (d), 

or promulgates a rule under section 6(a) establishing a 

ban or phase-out with respect to a chemical substance 

or mixture, the Administrator shall notify, in writing, the 

person that asserted the claim or submitted the request 

of the intent of the Administrator to disclose the information or not protect the information from disclosure under 

this section. The notice shall be furnished by certified mail 

(return receipt requested), by personal delivery, or by other 

means that allows verification of the fact and date of 

receipt. 

‘‘(B) DISCLOSURE OF INFORMATION.—Except as provided 

in subparagraph (C), the Administrator shall not disclose 

information under this subsection until the date that is 

30 days after the date on which the person that asserted 

the claim or submitted the request receives notification 

under subparagraph (A). 

‘‘(C) EXCEPTIONS.— 

‘‘(i) FIFTEEN DAY NOTIFICATION.—For information 

the Administrator intends to disclose under subsections 

(d)(3), (d)(4), (d)(5), and (j), the Administrator shall 

not disclose the information until the date that is 15 

days after the date on which the person that asserted 

the claim or submitted the request receives notification 

under subparagraph (A), except that, with respect to 

information to be disclosed under subsection (d)(3), 

if the Administrator determines that disclosure of the 

information is necessary to protect against an 

imminent and substantial harm to health or the 

environment, no prior notification shall be necessary. 

‘‘(ii) NOTIFICATION AS SOON AS PRACTICABLE.—For 

information the Administrator intends to disclose 

under paragraph (6) of subsection (d), the Administrator shall notify the person that submitted the 

information that the information has been disclosed 

as soon as practicable after disclosure of the information. 

‘‘(iii) NO NOTIFICATION REQUIRED.—Notification 

shall not be required— 

‘‘(I) for the disclosure of information under 

paragraphs (1), (2), (7), or (8) of subsection (d); 

or 

‘‘(II) for the disclosure of information for 

which— 

Determination. 

Deadline. 

Claims. 


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130 STAT. 490 PUBLIC LAW 114–182—JUNE 22, 2016 

‘‘(aa) the Administrator has provided to 

the person that asserted the claim a notice 

under subsection (e)(2)(A); and 

‘‘(bb) such person does not submit to the 

Administrator a request under subsection 

(e)(2)(B) on or before the deadline established 

in subsection (e)(2)(B)(i). 

‘‘(D) APPEALS.— 

‘‘(i) ACTION TO RESTRAIN DISCLOSURE.—If a person 

receives a notification under this paragraph and 

believes the information is protected from disclosure 

under this section, before the date on which the 

information is to be disclosed pursuant to subparagraph (B) or (C) the person may bring an action to 

restrain disclosure of the information in— 

‘‘(I) the United States district court of the district in which the complainant resides or has the 

principal place of business; or 

‘‘(II) the United States District Court for the 

District of Columbia. 

‘‘(ii) NO DISCLOSURE.— 

‘‘(I) IN GENERAL.—Subject to subsection (d), 

the Administrator shall not disclose information 

that is the subject of an appeal under this paragraph before the date on which the applicable court 

rules on an action under clause (i). 

‘‘(II) EXCEPTION.—Subclause (I) shall not apply 

to disclosure of information described under subsections (d)(4) and (j). 

‘‘(3) REQUEST AND NOTIFICATION SYSTEM.—The Administrator, in consultation with the Director of the Centers for 

Disease Control and Prevention, shall develop a request and 

notification system that, in a format and language that is 

readily accessible and understandable, allows for expedient and 

swift access to information disclosed pursuant to paragraphs 

(5) and (6) of subsection (d). 

‘‘(4) UNIQUE IDENTIFIER.—The Administrator shall— 

‘‘(A)(i) develop a system to assign a unique identifier 

to each specific chemical identity for which the Administrator approves a request for protection from disclosure, 

which shall not be either the specific chemical identity 

or a structurally descriptive generic term; and 

‘‘(ii) apply that identifier consistently to all information 

relevant to the applicable chemical substance; 

‘‘(B) annually publish and update a list of chemical 

substances, referred to by their unique identifiers, for which 

claims to protect the specific chemical identity from disclosure have been approved, including the expiration date 

for each such claim; 

‘‘(C) ensure that any nonconfidential information 

received by the Administrator with respect to a chemical 

substance included on the list published under subparagraph (B) while the specific chemical identity of the chemical substance is protected from disclosure under this section identifies the chemical substance using the unique 

identifier; and 

Deadline. 

Publication. 

List. 

Applicability. 

Consultation. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 491 

‘‘(D) for each claim for protection of a specific chemical 

identity that has been denied by the Administrator or 

expired, or that has been withdrawn by the person who 

asserted the claim, and for which the Administrator has 

used a unique identifier assigned under this paragraph 

to protect the specific chemical identity in information that 

the Administrator has made public, clearly link the specific 

chemical identity to the unique identifier in such information to the extent practicable. 

‘‘(h) CRIMINAL PENALTY FOR WRONGFUL DISCLOSURE.— ‘‘(1) INDIVIDUALS SUBJECT TO PENALTY.— ‘‘(A) IN GENERAL.—Subject to subparagraph (C) and 

paragraph (2), an individual described in subparagraph 

(B) shall be fined under title 18, United States Code, or 

imprisoned for not more than 1 year, or both. 

‘‘(B) DESCRIPTION.—An individual referred to in 

subparagraph (A) is an individual who— 

‘‘(i) pursuant to this section, obtained possession 

of, or has access to, information protected from disclosure under this section; and 

‘‘(ii) knowing that the information is protected from 

disclosure under this section, willfully discloses the 

information in any manner to any person not entitled 

to receive that information. 

‘‘(C) EXCEPTION.—This paragraph shall not apply to 

any medical professional (including an emergency medical 

technician or other first responder) who discloses any 

information obtained under paragraph (5) or (6) of subsection (d) to a patient treated by the medical professional, 

or to a person authorized to make medical or health care 

decisions on behalf of such a patient, as needed for the 

diagnosis or treatment of the patient. 

‘‘(2) OTHER LAWS.—Section 1905 of title 18, United States 

Code, shall not apply with respect to the publishing, divulging, 

disclosure, or making known of, or making available, information reported to or otherwise obtained by the Administrator 

under this Act. 

‘‘(i) APPLICABILITY.— 

‘‘(1) IN GENERAL.—Except as otherwise provided in this 

section, section 8, or any other applicable Federal law, the 

Administrator shall have no authority— 

‘‘(A) to require the substantiation or resubstantiation 

of a claim for the protection from disclosure of information 

reported to or otherwise obtained by the Administrator 

under this Act prior to the date of enactment of the Frank 

R. Lautenberg Chemical Safety for the 21st Century Act; 

or 

‘‘(B) to impose substantiation or resubstantiation 

requirements, with respect to the protection of information 

described in subsection (a), under this Act that are more 

extensive than those required under this section. 

‘‘(2) ACTIONS PRIOR TO PROMULGATION OF RULES.—Nothing 

in this Act prevents the Administrator from reviewing, 

requiring substantiation or resubstantiation of, or approving, 

approving in part, or denying any claim for the protection 

from disclosure of information before the effective date of such 

rules applicable to those claims as the Administrator may 


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130 STAT. 492 PUBLIC LAW 114–182—JUNE 22, 2016 

promulgate after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. 

‘‘(j) ACCESS BY CONGRESS.—Notwithstanding any limitation contained in this section or any other provision of law, all information 

reported to or otherwise obtained by the Administrator (or any 

representative of the Administrator) under this Act shall be made 

available, upon written request of any duly authorized committee 

of the Congress, to such committee.’’. 

SEC. 12. PENALTIES. 

Section 16 of the Toxic Substances Control Act (15 U.S.C. 

2615) is amended— 

(1) in subsection (a)(1), by striking ‘‘$25,000’’ and inserting ‘‘$37,500’’; and 

(2) in subsection (b)— 

(A) by striking ‘‘Any person’’ and inserting the following: 

‘‘(1) IN GENERAL.—Any person’’; (B) by striking ‘‘$25,000’’ and inserting ‘‘$50,000’’; and 

(C) by adding at the end the following: 

‘‘(2) IMMINENT DANGER OF DEATH OR SERIOUS BODILY

INJURY.— 

‘‘(A) IN GENERAL.—Any person who knowingly and willfully violates any provision of section 15 or 409, and who 

knows at the time of the violation that the violation places 

an individual in imminent danger of death or serious bodily 

injury, shall be subject on conviction to a fine of not more 

than $250,000, or imprisonment for not more than 15 years, 

or both. 

‘‘(B) ORGANIZATIONS.—Notwithstanding the penalties 

described in subparagraph (A), an organization that commits a knowing violation described in subparagraph (A) 

shall be subject on conviction to a fine of not more than 

$1,000,000 for each violation. 

‘‘(C) INCORPORATION OF CORRESPONDING PROVISIONS.— Subparagraphs (B) through (F) of section 113(c)(5) of the 

Clean Air Act (42 U.S.C. 7413(c)(5)(B)–(F)) shall apply to 

the prosecution of a violation under this paragraph.’’. 

SEC. 13. STATE-FEDERAL RELATIONSHIP. 

Section 18 of the Toxic Substances Control Act (15 U.S.C. 

2617) is amended— 

(1) by amending subsection (a) to read as follows: 

‘‘(a) IN GENERAL.— ‘‘(1) ESTABLISHMENT OR ENFORCEMENT.—Except as otherwise provided in subsections (c), (d), (e), (f), and (g), and subject 

to paragraph (2), no State or political subdivision of a State 

may establish or continue to enforce any of the following: 

‘‘(A) DEVELOPMENT OF INFORMATION.—A statute or 

administrative action to require the development of 

information about a chemical substance or category of 

chemical substances that is reasonably likely to produce 

the same information required under section 4, 5, or 6 

in— 

‘‘(i) a rule promulgated by the Administrator; 

‘‘(ii) a consent agreement entered into by the 

Administrator; or 

‘‘(iii) an order issued by the Administrator. 

Applicability. 


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‘‘(B) CHEMICAL SUBSTANCES FOUND NOT TO PRESENT

AN UNREASONABLE RISK OR RESTRICTED.—A statute, 

criminal penalty, or administrative action to prohibit or 

otherwise restrict the manufacture, processing, or distribution in commerce or use of a chemical substance— 

‘‘(i) for which the determination described in section 6(i)(1) is made, consistent with the scope of the 

risk evaluation under section (6)(b)(4)(D); or 

‘‘(ii) for which a final rule is promulgated under 

section 6(a), after the effective date of the rule issued 

under section 6(a) for the chemical substance, consistent with the scope of the risk evaluation under 

section (6)(b)(4)(D). 

‘‘(C) SIGNIFICANT NEW USE.—A statute or administrative action requiring the notification of a use of a chemical 

substance that the Administrator has specified as a significant new use and for which the Administrator has required 

notification pursuant to a rule promulgated under section 

5. 

‘‘(2) EFFECTIVE DATE OF PREEMPTION.—Under this subsection, Federal preemption of statutes and administrative 

actions applicable to specific chemical substances shall not occur 

until the effective date of the applicable action described in 

paragraph (1) taken by the Administrator.’’; 

(2) by amending subsection (b) to read as follows: 

‘‘(b) NEW STATUTES, CRIMINAL PENALTIES, OR ADMINISTRATIVE

ACTIONS CREATING PROHIBITIONS OR OTHER RESTRICTIONS.— 

‘‘(1) IN GENERAL.—Except as provided in subsections (c), 

(d), (e), (f), and (g), beginning on the date on which the Administrator defines the scope of a risk evaluation for a chemical 

substance under section 6(b)(4)(D) and ending on the date on 

which the deadline established pursuant to section 6(b)(4)(G) 

for completion of the risk evaluation expires, or on the date 

on which the Administrator publishes the risk evaluation under 

section 6(b)(4)(C), whichever is earlier, no State or political 

subdivision of a State may establish a statute, criminal penalty, 

or administrative action prohibiting or otherwise restricting 

the manufacture, processing, distribution in commerce, or use 

of such chemical substance that is a high-priority substance 

designated under section 6(b)(1)(B)(i). 

‘‘(2) EFFECT OF SUBSECTION.—This subsection does not 

restrict the authority of a State or political subdivision of a 

State to continue to enforce any statute enacted, criminal penalty assessed, or administrative action taken, prior to the date 

on which the Administrator defines and publishes the scope 

of a risk evaluation under section 6(b)(4)(D).’’; and 

(3) by adding at the end the following: 

‘‘(c) SCOPE OF PREEMPTION.—Federal preemption under subsections (a) and (b) of statutes, criminal penalties, and administrative actions applicable to specific chemical substances shall apply 

only to— 

‘‘(1) with respect to subsection (a)(1)(A), the chemical substances or category of chemical substances subject to a rule, 

order, or consent agreement under section 4, 5, or 6; 

‘‘(2) with respect to subsection (b), the hazards, exposures, 

risks, and uses or conditions of use of such chemical substances 

Applicability. 

Time period. 


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130 STAT. 494 PUBLIC LAW 114–182—JUNE 22, 2016 

included in the scope of the risk evaluation pursuant to section 

6(b)(4)(D); 

‘‘(3) with respect to subsection (a)(1)(B), the hazards, exposures, risks, and uses or conditions of use of such chemical 

substances included in any final action the Administrator takes 

pursuant to section 6(a) or 6(i)(1); or 

‘‘(4) with respect to subsection (a)(1)(C), the uses of such 

chemical substances that the Administrator has specified as 

significant new uses and for which the Administrator has 

required notification pursuant to a rule promulgated under 

section 5. 

‘‘(d) EXCEPTIONS.— ‘‘(1) NO PREEMPTION OF STATUTES AND ADMINISTRATIVE

ACTIONS.— 

‘‘(A) IN GENERAL.—Nothing in this Act, nor any amendment made by the Frank R. Lautenberg Chemical Safety 

for the 21st Century Act, nor any rule, standard of performance, risk evaluation, or scientific assessment implemented 

pursuant to this Act, shall affect the right of a State 

or a political subdivision of a State to adopt or enforce 

any rule, standard of performance, risk evaluation, scientific assessment, or any other protection for public health 

or the environment that— 

‘‘(i) is adopted or authorized under the authority 

of any other Federal law or adopted to satisfy or obtain 

authorization or approval under any other Federal law; 

‘‘(ii) implements a reporting, monitoring, or other 

information obligation for the chemical substance not 

otherwise required by the Administrator under this 

Act or required under any other Federal law; 

‘‘(iii) is adopted pursuant to authority under a 

law of the State or political subdivision of the State 

related to water quality, air quality, or waste treatment 

or disposal, except to the extent that the action— 

‘‘(I) imposes a restriction on the manufacture, 

processing, distribution in commerce, or use of a 

chemical substance; and 

‘‘(II)(aa) addresses the same hazards and exposures, with respect to the same conditions of use 

as are included in the scope of the risk evaluation 

published pursuant to section 6(b)(4)(D), but is 

inconsistent with the action of the Administrator; 

or 

‘‘(bb) would cause a violation of the applicable 

action by the Administrator under section 5 or 

6; or 

‘‘(iv) subject to subparagraph (B), is identical to 

a requirement prescribed by the Administrator. 

‘‘(B) IDENTICAL REQUIREMENTS.— 

‘‘(i) IN GENERAL.—The penalties and other sanctions applicable under a law of a State or political 

subdivision of a State in the event of noncompliance 

with the identical requirement shall be no more stringent than the penalties and other sanctions available 

to the Administrator under section 16 of this Act. 

‘‘(ii) PENALTIES.—In the case of an identical 

requirement— 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 495 

‘‘(I) a State or political subdivision of a State 

may not assess a penalty for a specific violation 

for which the Administrator has assessed an adequate penalty under section 16; and 

‘‘(II) if a State or political subdivision of a 

State has assessed a penalty for a specific violation, the Administrator may not assess a penalty 

for that violation in an amount that would cause 

the total of the penalties assessed for the violation 

by the State or political subdivision of a State 

and the Administrator combined to exceed the 

maximum amount that may be assessed for that 

violation by the Administrator under section 16. 

‘‘(2) APPLICABILITY TO CERTAIN RULES OR ORDERS.— ‘‘(A) PRIOR RULES AND ORDERS.—Nothing in this section 

shall be construed as modifying the preemptive effect under 

this section, as in effect on the day before the effective 

date of the Frank R. Lautenberg Chemical Safety for the 

21st Century Act, of any rule or order promulgated or 

issued under this Act prior to that effective date. 

‘‘(B) CERTAIN CHEMICAL SUBSTANCES AND MIXTURES.— 

With respect to a chemical substance or mixture for which 

any rule or order was promulgated or issued under section 

6 prior to the effective date of the Frank R. Lautenberg 

Chemical Safety for the 21st Century Act with respect 

to manufacturing, processing, distribution in commerce, 

use, or disposal of the chemical substance or mixture, 

nothing in this section shall be construed as modifying 

the preemptive effect of this section as in effect prior to 

the enactment of the Frank R. Lautenberg Chemical Safety 

for the 21st Century Act of any rule or order that is 

promulgated or issued with respect to such chemical substance or mixture under section 6 after that effective date, 

unless the latter rule or order is with respect to a chemical 

substance or mixture containing a chemical substance and 

follows a designation of that chemical substance as a highpriority substance under section 6(b)(1)(B)(i), the identification of that chemical substance under section 6(b)(2)(A), 

or the selection of that chemical substance for risk evaluation under section 6(b)(4)(E)(iv)(II). 

‘‘(e) PRESERVATION OF CERTAIN LAWS.— 

‘‘(1) IN GENERAL.—Nothing in this Act, subject to subsection 

(g) of this section, shall— 

‘‘(A) be construed to preempt or otherwise affect the 

authority of a State or political subdivision of a State 

to continue to enforce any action taken or requirement 

imposed or requirement enacted relating to a specific chemical substance before April 22, 2016, under the authority 

of a law of the State or political subdivision of the State 

that prohibits or otherwise restricts manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance; or 

‘‘(B) be construed to preempt or otherwise affect any 

action taken pursuant to a State law that was in effect 

on August 31, 2003. 

‘‘(2) EFFECT OF SUBSECTION.—This subsection does not 

affect, modify, or alter the relationship between Federal law 


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130 STAT. 496 PUBLIC LAW 114–182—JUNE 22, 2016 

and laws of a State or political subdivision of a State pursuant 

to any other Federal law. 

‘‘(f) WAIVERS.— 

‘‘(1) DISCRETIONARY EXEMPTIONS.—Upon application of a 

State or political subdivision of a State, the Administrator 

may, by rule, exempt from subsection (a), under such conditions 

as may be prescribed in the rule, a statute, criminal penalty, 

or administrative action of that State or political subdivision 

of the State that relates to the effects of exposure to a chemical 

substance under the conditions of use if the Administrator 

determines that— 

‘‘(A) compelling conditions warrant granting the waiver 

to protect health or the environment; 

‘‘(B) compliance with the proposed requirement of the 

State or political subdivision of the State would not unduly 

burden interstate commerce in the manufacture, processing, distribution in commerce, or use of a chemical substance; 

‘‘(C) compliance with the proposed requirement of the 

State or political subdivision of the State would not cause 

a violation of any applicable Federal law, rule, or order; 

and 

‘‘(D) in the judgment of the Administrator, the proposed 

requirement of the State or political subdivision of the 

State is designed to address a risk of a chemical substance, 

under the conditions of use, that was identified— 

‘‘(i) consistent with the best available science; 

‘‘(ii) using supporting studies conducted in accordance with sound and objective scientific practices; and 

‘‘(iii) based on the weight of the scientific evidence. 

‘‘(2) REQUIRED EXEMPTIONS.—Upon application of a State 

or political subdivision of a State, the Administrator shall 

exempt from subsection (b) a statute or administrative action 

of a State or political subdivision of a State that relates to 

the effects of exposure to a chemical substance under the conditions of use if the Administrator determines that— 

‘‘(A)(i) compliance with the proposed requirement of 

the State or political subdivision of the State would not 

unduly burden interstate commerce in the manufacture, 

processing, distribution in commerce, or use of a chemical 

substance; 

‘‘(ii) compliance with the proposed requirement of the 

State or political subdivision of the State would not cause 

a violation of any applicable Federal law, rule, or order; 

and 

‘‘(iii) the State or political subdivision of the State 

has a concern about the chemical substance or use of 

the chemical substance based in peer-reviewed science; or 

‘‘(B) no later than the date that is 18 months after 

the date on which the Administrator has initiated the 

prioritization process for a chemical substance under the 

rule promulgated pursuant to section 6(b)(1)(A), or the 

date on which the Administrator publishes the scope of 

the risk evaluation for a chemical substance under section 

6(b)(4)(D), whichever is sooner, the State or political subdivision of the State has enacted a statute or proposed 

or finalized an administrative action intended to prohibit 

Deadline. 

Determination. 

Determination. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 497 

or otherwise restrict the manufacture, processing, distribution in commerce, or use of the chemical substance. 

‘‘(3) DETERMINATION OF A WAIVER REQUEST.—The duty of 

the Administrator to grant or deny a waiver application shall 

be nondelegable and shall be exercised— 

‘‘(A) not later than 180 days after the date on which 

an application under paragraph (1) is submitted; and 

‘‘(B) not later than 110 days after the date on which 

an application under paragraph (2) is submitted. 

‘‘(4) FAILURE TO MAKE A DETERMINATION.—If the Administrator fails to make a determination under paragraph (3)(B) 

during the 110-day period beginning on the date on which 

an application under paragraph (2) is submitted, the statute 

or administrative action of the State or political subdivision 

of the State that was the subject of the application shall not 

be considered to be an existing statute or administrative action 

for purposes of subsection (b) by reason of the failure of the 

Administrator to make a determination. 

‘‘(5) NOTICE AND COMMENT.—Except in the case of an 

application approved under paragraph (9), the application of 

a State or political subdivision of a State under this subsection 

shall be subject to public notice and comment. 

‘‘(6) FINAL AGENCY ACTION.—The decision of the Administrator on the application of a State or political subdivision 

of a State shall be— 

‘‘(A) considered to be a final agency action; and 

‘‘(B) subject to judicial review. 

‘‘(7) DURATION OF WAIVERS.—A waiver granted under paragraph (2) or approved under paragraph (9) shall remain in 

effect until such time as the Administrator publishes the risk 

evaluation under section 6(b). 

‘‘(8) JUDICIAL REVIEW OF WAIVERS.—Not later than 60 days 

after the date on which the Administrator makes a determination on an application of a State or political subdivision of 

a State under paragraph (1) or (2), any person may file a 

petition for judicial review in the United States Court of 

Appeals for the District of Columbia Circuit, which shall have 

exclusive jurisdiction over the determination. 

‘‘(9) APPROVAL.— 

‘‘(A) AUTOMATIC APPROVAL.—If the Administrator fails 

to meet the deadline established under paragraph (3)(B), 

the application of a State or political subdivision of a State 

under paragraph (2) shall be automatically approved, effective on the date that is 10 days after the deadline. 

‘‘(B) REQUIREMENTS.—Notwithstanding paragraph (6), 

approval of a waiver application under subparagraph (A) 

for failure to meet the deadline under paragraph (3)(B) 

shall not be considered final agency action or be subject 

to judicial review or public notice and comment. 

‘‘(g) SAVINGS.— 

‘‘(1) NO PREEMPTION OF COMMON LAW OR STATUTORY CAUSES

OF ACTION FOR CIVIL RELIEF OR CRIMINAL CONDUCT.— 

‘‘(A) IN GENERAL.—Nothing in this Act, nor any amendment made by the Frank R. Lautenberg Chemical Safety 

for the 21st Century Act, nor any standard, rule, requirement, standard of performance, risk evaluation, or scientific 

assessment implemented pursuant to this Act, shall be 

Effective date. 

Deadline. 

Time period. 

Deadlines. 


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130 STAT. 498 PUBLIC LAW 114–182—JUNE 22, 2016 

construed to preempt, displace, or supplant any State or 

Federal common law rights or any State or Federal statute 

creating a remedy for civil relief, including those for civil 

damage, or a penalty for a criminal conduct. 

‘‘(B) CLARIFICATION OF NO PREEMPTION.—Notwithstanding any other provision of this Act, nothing in this 

Act, nor any amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, shall preempt or preclude any cause of action for personal injury, 

wrongful death, property damage, or other injury based 

on negligence, strict liability, products liability, failure to 

warn, or any other legal theory of liability under any State 

law, maritime law, or Federal common law or statutory 

theory. 

‘‘(2) NO EFFECT ON PRIVATE REMEDIES.— 

‘‘(A) IN GENERAL.—Nothing in this Act, nor any amendments made by the Frank R. Lautenberg Chemical Safety 

for the 21st Century Act, nor any rules, regulations, 

requirements, risk evaluations, scientific assessments, or 

orders issued pursuant to this Act shall be interpreted 

as, in either the plaintiff’s or defendant’s favor, dispositive 

in any civil action. 

‘‘(B) AUTHORITY OF COURTS.—This Act does not affect 

the authority of any court to make a determination in 

an adjudicatory proceeding under applicable State or Federal law with respect to the admission into evidence or 

any other use of this Act or rules, regulations, requirements, standards of performance, risk evaluations, scientific assessments, or orders issued pursuant to this Act.’’. 

SEC. 14. JUDICIAL REVIEW. 

Section 19(a) of the Toxic Substances Control Act (15 U.S.C. 

2618(a)) is amended— 

(1) in paragraph (1), by adding at the end the following: 

‘‘(C)(i) Not later than 60 days after the publication of a 

designation under section 6(b)(1)(B)(ii), any person may commence a civil action to challenge the designation. 

‘‘(ii) The United States Court of Appeals for the District 

of Columbia Circuit shall have exclusive jurisdiction over a 

civil action filed under this subparagraph.’’; and 

(2) by striking paragraph (3). 

SEC. 15. CITIZENS’ CIVIL ACTIONS. 

Section 20(b) of the Toxic Substances Control Act (15 U.S.C. 

2619(b)) is amended— 

(1) in paragraph (1)(B), by striking ‘‘or’’ at the end; and 

(2) in paragraph (2), by striking the period at the end 

and inserting the following: ‘‘, except that no prior notification 

shall be required in the case of a civil action brought to compel 

a decision by the Administrator pursuant to section 18(f)(3)(B); 

or 

‘‘(3) in the case of a civil action brought to compel a decision 

by the Administrator pursuant to section 18(f)(3)(B), after the 

date that is 60 days after the deadline specified in section 

18(f)(3)(B).’’. 

Time period. 

Deadline. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 499 

SEC. 16. STUDIES. 

Section 25 of the Toxic Substances Control Act (15 U.S.C. 

2624) is repealed. 

SEC. 17. ADMINISTRATION OF THE ACT. 

Section 26 of the Toxic Substances Control Act (15 U.S.C. 

2625) is amended— 

(1) in subsection (b)(1)— 

(A) by striking ‘‘of a reasonable fee’’; 

(B) by striking ‘‘data under section 4 or 5 to defray 

the cost of administering this Act’’ and inserting ‘‘information under section 4 or a notice or other information to 

be reviewed by the Administrator under section 5, or who 

manufactures or processes a chemical substance that is 

the subject of a risk evaluation under section 6(b), of a 

fee that is sufficient and not more than reasonably necessary to defray the cost related to such chemical substance 

of administering sections 4, 5, and 6, and collecting, processing, reviewing, and providing access to and protecting 

from disclosure as appropriate under section 14 information 

on chemical substances under this title, including contractor costs incurred by the Administrator’’; 

(C) by striking ‘‘Such rules shall not provide for any 

fee in excess of $2,500 or, in the case of a small business 

concern, any fee in excess of $100.’’; and 

(D) by striking ‘‘submit the data and the cost to the 

Administrator of reviewing such data’’ and inserting ‘‘pay 

such fee and the cost to the Administrator of carrying 

out the activities described in this paragraph’’; 

(2) in subsection (b)— 

(A) in paragraph (2), by striking ‘‘paragraph (1)’’ and 

inserting ‘‘paragraph (4)’’; and 

(B) by adding at the end the following: 

‘‘(3) FUND.— 

‘‘(A) ESTABLISHMENT.—There is established in the Treasury 

of the United States a fund, to be known as the TSCA Service 

Fee Fund (in this paragraph referred to as the ‘Fund’), consisting of such amounts as are deposited in the Fund under 

this paragraph. 

‘‘(B) COLLECTION AND DEPOSIT OF FEES.—Subject to the 

conditions of subparagraph (C), the Administrator shall collect 

the fees described in this subsection and deposit those fees 

in the Fund. 

‘‘(C) USE OF FUNDS BY ADMINISTRATOR.—Fees authorized 

under this section shall be collected and available for obligation 

only to the extent and in the amount provided in advance 

in appropriations Acts, and shall be available without fiscal 

year limitation for use in defraying the costs of the activities 

described in paragraph (1). 

‘‘(D) ACCOUNTING AND AUDITING.— 

‘‘(i) ACCOUNTING.—The Administrator shall biennially 

prepare and submit to the Committee on Environment 

and Public Works of the Senate and the Committee on 

Energy and Commerce of the House of Representatives 

a report that includes an accounting of the fees paid to 

the Administrator under this paragraph and amounts disbursed from the Fund for the period covered by the report, 

Deadline. 

Reports. 

Repeal. 


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130 STAT. 500 PUBLIC LAW 114–182—JUNE 22, 2016 

as reflected by financial statements provided in accordance 

with sections 3515 and 3521 of title 31, United States 

Code. 

‘‘(ii) AUDITING.— 

‘‘(I) IN GENERAL.—For the purpose of section 

3515(c) of title 31, United States Code, the Fund shall 

be considered a component of a covered executive 

agency. 

‘‘(II) COMPONENTS OF AUDIT.—The annual audit 

required in accordance with sections 3515 and 3521 

of title 31, United States Code, of the financial statements of activities carried out using amounts from 

the Fund shall include an analysis of— 

‘‘(aa) the fees collected and amounts disbursed 

under this subsection; 

‘‘(bb) the reasonableness of the fees in place 

as of the date of the audit to meet current and 

projected costs of administering the provisions of 

this title for which the fees may be used; and 

‘‘(cc) the number of requests for a risk evaluation made by manufacturers under section 

6(b)(4)(C)(ii). 

‘‘(III) FEDERAL RESPONSIBILITY.—The Inspector 

General of the Environmental Protection Agency shall 

conduct the annual audit described in subclause (II) 

and submit to the Administrator a report that describes 

the findings and any recommendations of the Inspector 

General resulting from the audit. 

‘‘(4) AMOUNT AND ADJUSTMENT OF FEES; REFUNDS.—In setting 

fees under this section, the Administrator shall— 

‘‘(A) prescribe lower fees for small business concerns, after 

consultation with the Administrator of the Small Business 

Administration; 

‘‘(B) set the fees established under paragraph (1) at levels 

such that the fees will, in aggregate, provide a sustainable 

source of funds to annually defray— 

‘‘(i) the lower of— 

‘‘(I) 25 percent of the costs to the Administrator 

of carrying out sections 4, 5, and 6, and of collecting, 

processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 

14 information on chemical substances under this title, 

other than the costs to conduct and complete risk 

evaluations under section 6(b); or 

‘‘(II) $25,000,000 (subject to adjustment pursuant 

to subparagraph (F)); and 

‘‘(ii) the costs of risk evaluations specified in subparagraph (D); 

‘‘(C) reflect an appropriate balance in the assessment of 

fees between manufacturers and processors, and allow the payment of fees by consortia of manufacturers or processors; 

‘‘(D) notwithstanding subparagraph (B)— 

‘‘(i) except as provided in clause (ii), for chemical substances for which the Administrator has granted a request 

from a manufacturer pursuant to section 6(b)(4)(C)(ii), 

establish the fee at a level sufficient to defray the full 

Consultation. 

Reports. 

Analysis. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 501 

costs to the Administrator of conducting the risk evaluation 

under section 6(b); 

‘‘(ii) for chemical substances for which the Administrator has granted a request from a manufacturer pursuant 

to section 6(b)(4)(C)(ii), and which are included in the 2014 

update of the TSCA Work Plan for Chemical Assessments, 

establish the fee at a level sufficient to defray 50 percent 

of the costs to the Administrator of conducting the risk 

evaluation under section 6(b); and 

‘‘(iii) apply fees collected pursuant to clauses (i) and 

(ii) only to defray the costs described in those clauses; 

‘‘(E) prior to the establishment or amendment of any fees 

under paragraph (1), consult and meet with parties potentially 

subject to the fees or their representatives, subject to the condition that no obligation under the Federal Advisory Committee 

Act (5 U.S.C. App.) or subchapter II of chapter 5 of title 5, 

United States Code, is applicable with respect to such meetings; 

‘‘(F) beginning with the fiscal year that is 3 years after 

the date of enactment of the Frank R. Lautenberg Chemical 

Safety for the 21st Century Act, and every 3 years thereafter, 

after consultation with parties potentially subject to the fees 

and their representatives pursuant to subparagraph (E), 

increase or decrease the fees established under paragraph (1) 

as necessary to adjust for inflation and to ensure that funds 

deposited in the Fund are sufficient to defray— 

‘‘(i) approximately but not more than 25 percent of 

the costs to the Administrator of carrying out sections 

4, 5, and 6, and of collecting, processing, reviewing, and 

providing access to and protecting from disclosure as appropriate under section 14 information on chemical substances 

under this title, other than the costs to conduct and complete risk evaluations requested under section 6(b)(4)(C)(ii); 

and 

‘‘(ii) the costs of risk evaluations specified in subparagraph (D); and 

‘‘(G) if a notice submitted under section 5 is not reviewed 

or such a notice is withdrawn, refund the fee or a portion 

of the fee if no substantial work was performed on the notice. 

‘‘(5) MINIMUM AMOUNT OF APPROPRIATIONS.—Fees may not be 

assessed for a fiscal year under this section unless the amount 

of appropriations for the Chemical Risk Review and Reduction 

program project of the Environmental Protection Agency for the 

fiscal year (excluding the amount of any fees appropriated for 

the fiscal year) are equal to or greater than the amount of appropriations for that program project for fiscal year 2014. 

‘‘(6) TERMINATION.—The authority provided by this subsection 

shall terminate at the conclusion of the fiscal year that is 10 

years after the date of enactment of the Frank R. Lautenberg 

Chemical Safety for the 21st Century Act unless otherwise reauthorized or modified by Congress.’’; and 

(3) by adding at the end the following: 

‘‘(h) SCIENTIFIC STANDARDS.—In carrying out sections 4, 5, and 

6, to the extent that the Administrator makes a decision based 

on science, the Administrator shall use scientific information, technical procedures, measures, methods, protocols, methodologies, or 

models, employed in a manner consistent with the best available 

science, and shall consider as applicable— 

Applicability. 

Notice. 

Effective date. 

Deadline. 

Consultation. 

Consultation. 

Applicability. 


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‘‘(1) the extent to which the scientific information, technical 

procedures, measures, methods, protocols, methodologies, or 

models employed to generate the information are reasonable 

for and consistent with the intended use of the information; 

‘‘(2) the extent to which the information is relevant for 

the Administrator’s use in making a decision about a chemical 

substance or mixture; 

‘‘(3) the degree of clarity and completeness with which 

the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented; 

‘‘(4) the extent to which the variability and uncertainty 

in the information, or in the procedures, measures, methods, 

protocols, methodologies, or models, are evaluated and 

characterized; and 

‘‘(5) the extent of independent verification or peer review 

of the information or of the procedures, measures, methods, 

protocols, methodologies, or models. 

‘‘(i) WEIGHT OF SCIENTIFIC EVIDENCE.—The Administrator shall 

make decisions under sections 4, 5, and 6 based on the weight 

of the scientific evidence. 

‘‘(j) AVAILABILITY OF INFORMATION.—Subject to section 14, the 

Administrator shall make available to the public— 

‘‘(1) all notices, determinations, findings, rules, consent 

agreements, and orders of the Administrator under this title; 

‘‘(2) any information required to be provided to the Administrator under section 4; 

‘‘(3) a nontechnical summary of each risk evaluation conducted under section 6(b); 

‘‘(4) a list of the studies considered by the Administrator 

in carrying out each such risk evaluation, along with the results 

of those studies; and 

‘‘(5) each designation of a chemical substance under section 

6(b), along with an identification of the information, analysis, 

and basis used to make the designations. 

‘‘(k) REASONABLY AVAILABLE INFORMATION.—In carrying out 

sections 4, 5, and 6, the Administrator shall take into consideration 

information relating to a chemical substance or mixture, including 

hazard and exposure information, under the conditions of use, that 

is reasonably available to the Administrator. 

‘‘(l) POLICIES, PROCEDURES, AND GUIDANCE.— 

‘‘(1) DEVELOPMENT.—Not later than 2 years after the date 

of enactment of the Frank R. Lautenberg Chemical Safety 

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

policies, procedures, and guidance the Administrator determines are necessary to carry out the amendments to this Act 

made by the Frank R. Lautenberg Chemical Safety for the 

21st Century Act. 

‘‘(2) REVIEW.—Not later than 5 years after the date of 

enactment of the Frank R. Lautenberg Chemical Safety for 

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

5 years thereafter, the Administrator shall— 

‘‘(A) review the adequacy of the policies, procedures, 

and guidance developed under paragraph (1), including 

with respect to animal, nonanimal, and epidemiological 

test methods and procedures for assessing and determining 

risk under this title; and 

Deadlines. 

List. 

Public 

information. 


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‘‘(B) revise such policies, procedures, and guidance as 

the Administrator determines necessary to reflect new scientific developments or understandings. 

‘‘(3) TESTING OF CHEMICAL SUBSTANCES AND MIXTURES.— 

The policies, procedures, and guidance developed under paragraph (1) applicable to testing chemical substances and mixtures shall— 

‘‘(A) address how and when the exposure level or exposure potential of a chemical substance or mixture would 

factor into decisions to require new testing, subject to the 

condition that the Administrator shall not interpret the 

lack of exposure information as a lack of exposure or exposure potential; and 

‘‘(B) describe the manner in which the Administrator 

will determine that additional information is necessary 

to carry out this title, including information relating to 

potentially exposed or susceptible populations. 

‘‘(4) CHEMICAL SUBSTANCES WITH COMPLETED RISK ASSESSMENTS.—With respect to a chemical substance listed in the 

2014 update to the TSCA Work Plan for Chemical Assessments 

for which the Administrator has published a completed risk 

assessment prior to the date of enactment of the Frank R. 

Lautenberg Chemical Safety for the 21st Century Act, the 

Administrator may publish proposed and final rules under section 6(a) that are consistent with the scope of the completed 

risk assessment for the chemical substance and consistent with 

other applicable requirements of section 6. 

‘‘(5) GUIDANCE.—Not later than 1 year after the date of 

enactment of the Frank R. Lautenberg Chemical Safety for 

the 21st Century Act, the Administrator shall develop guidance 

to assist interested persons in developing and submitting draft 

risk evaluations which shall be considered by the Administrator. The guidance shall, at a minimum, address the quality 

of the information submitted and the process to be followed 

in developing draft risk evaluations for consideration by the 

Administrator. 

‘‘(m) REPORT TO CONGRESS.— 

‘‘(1) INITIAL REPORT.—Not later than 6 months after the 

date of enactment of the Frank R. Lautenberg Chemical Safety 

for the 21st Century Act, the Administrator shall submit to 

the Committees on Energy and Commerce and Appropriations 

of the House of Representatives and the Committees on 

Environment and Public Works and Appropriations of the 

Senate a report containing an estimation of— 

‘‘(A) the capacity of the Environmental Protection 

Agency to conduct and publish risk evaluations under section 6(b)(4)(C)(i), and the resources necessary to conduct 

the minimum number of risk evaluations required under 

section 6(b)(2); 

‘‘(B) the capacity of the Environmental Protection 

Agency to conduct and publish risk evaluations under section 6(b)(4)(C)(ii), the likely demand for such risk evaluations, and the anticipated schedule for accommodating that 

demand; 

‘‘(C) the capacity of the Environmental Protection 

Agency to promulgate rules under section 6(a) as required 

Estimate. 

Deadline. 

Applicability. 


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130 STAT. 504 PUBLIC LAW 114–182—JUNE 22, 2016 

based on risk evaluations conducted and published under 

section 6(b); and 

‘‘(D) the actual and anticipated efforts of the Environmental Protection Agency to increase the Agency’s capacity 

to conduct and publish risk evaluations under section 6(b). 

‘‘(2) SUBSEQUENT REPORTS.—The Administrator shall 

update and resubmit the report described in paragraph (1) 

not less frequently than once every 5 years. 

‘‘(n) ANNUAL PLAN.— ‘‘(1) IN GENERAL.—The Administrator shall inform the 

public regarding the schedule and the resources necessary for 

the completion of each risk evaluation as soon as practicable 

after initiating the risk evaluation. 

‘‘(2) PUBLICATION OF PLAN.—At the beginning of each calendar year, the Administrator shall publish an annual plan 

that— 

‘‘(A) identifies the chemical substances for which risk 

evaluations are expected to be initiated or completed that 

year and the resources necessary for their completion; 

‘‘(B) describes the status of each risk evaluation that 

has been initiated but not yet completed; and 

‘‘(C) if the schedule for completion of a risk evaluation 

has changed, includes an updated schedule for that risk 

evaluation. 

‘‘(o) CONSULTATION WITH SCIENCE ADVISORY COMMITTEE ON

CHEMICALS.— 

‘‘(1) ESTABLISHMENT.—Not later than 1 year after the date 

of enactment of the Frank R. Lautenberg Chemical Safety 

for the 21st Century Act, the Administrator shall establish 

an advisory committee, to be known as the Science Advisory 

Committee on Chemicals (referred to in this subsection as 

the ‘Committee’). 

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

to provide independent advice and expert consultation, at the 

request of the Administrator, with respect to the scientific 

and technical aspects of issues relating to the implementation 

of this title. 

‘‘(3) COMPOSITION.—The Committee shall be composed of 

representatives of such science, government, labor, public 

health, public interest, animal protection, industry, and other 

groups as the Administrator determines to be advisable, 

including representatives that have specific scientific expertise 

in the relationship of chemical exposures to women, children, 

and other potentially exposed or susceptible subpopulations. 

‘‘(4) SCHEDULE.—The Administrator shall convene the Committee in accordance with such schedule as the Administrator 

determines to be appropriate, but not less frequently than 

once every 2 years. 

‘‘(p) PRIOR ACTIONS.— 

‘‘(1) RULES, ORDERS, AND EXEMPTIONS.—Nothing in the 

Frank R. Lautenberg Chemical Safety for the 21st Century 

Act eliminates, modifies, or withdraws any rule promulgated, 

order issued, or exemption established pursuant to this Act 

before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. 

‘‘(2) PRIOR-INITIATED EVALUATIONS.—Nothing in this Act 

prevents the Administrator from initiating a risk evaluation 

Deadline. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 505 

regarding a chemical substance, or from continuing or completing such risk evaluation, prior to the effective date of the 

policies, procedures, and guidance required to be developed 

by the Administrator pursuant to the amendments made by 

the Frank R. Lautenberg Chemical Safety for the 21st Century 

Act. 

‘‘(3) ACTIONS COMPLETED PRIOR TO COMPLETION OF POLICIES, 

PROCEDURES, AND GUIDANCE.—Nothing in this Act requires the 

Administrator to revise or withdraw a completed risk evaluation, determination, or rule under this Act solely because the 

action was completed prior to the development of a policy, 

procedure, or guidance pursuant to the amendments made by 

the Frank R. Lautenberg Chemical Safety for the 21st Century 

Act.’’. 

SEC. 18. STATE PROGRAMS. 

Section 28 of the Toxic Substances Control Act (15 U.S.C. 

2627) is amended by striking subsections (c) and (d). 

SEC. 19. CONFORMING AMENDMENTS. 

(a) TABLE OF CONTENTS.—The table of contents in section 1 

of the Toxic Substances Control Act is amended— 

(1) by striking the item relating to section 6 and inserting 

the following: 

‘‘Sec. 6. Prioritization, risk evaluation, and regulation of chemical substances and 

mixtures.’’; 

(2) by striking the item relating to section 10 and inserting 

the following: 

‘‘Sec. 10. Research, development, collection, dissemination, and utilization of information.’’; 

(3) by striking the item relating to section 14 and inserting 

the following: 

‘‘Sec. 14. Confidential information.’’; and 

(4) by striking the item relating to section 25. 

(b) SECTION 2.—Section 2(b)(1) of the Toxic Substances Control 

Act (15 U.S.C. 2601(b)(1)) is amended by striking ‘‘data’’ both places 

it appears and inserting ‘‘information’’. 

(c) SECTION 3.—Section 3 of the Toxic Substances Control Act 

(15 U.S.C. 2602) is amended— 

(1) in paragraph (8) (as redesignated by section 3 of this 

Act), by striking ‘‘data’’ and inserting ‘‘information’’; and 

(2) in paragraph (15) (as redesignated by section 3 of this 

Act)— 

(A) by striking ‘‘standards’’ and inserting ‘‘protocols 

and methodologies’’; 

(B) by striking ‘‘test data’’ both places it appears and 

inserting ‘‘information’’; and 

(C) by striking ‘‘data’’ each place it appears and 

inserting ‘‘information’’. 

(d) SECTION 4.—Section 4 of the Toxic Substances Control Act 

(15 U.S.C. 2603) is amended— 

(1) in subsection (b)— 

(A) in paragraph (1)— 


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130 STAT. 506 PUBLIC LAW 114–182—JUNE 22, 2016 

(i) in the paragraph heading, by adding ‘‘, ORDER, 

OR CONSENT AGREEMENT’’ at the end; and 

(ii) by striking ‘‘rule’’ each place it appears and 

inserting ‘‘rule, order, or consent agreement’’; 

(B) in paragraph (2)(B), by striking ‘‘rules’’ and 

inserting ‘‘rules, orders, and consent agreements’’; 

(C) in paragraph (3)(A), by striking ‘‘rule’’ and inserting 

‘‘rule or order’’; and 

(D) in paragraph (4)— 

(i) by striking ‘‘rule under subsection (a)’’ each 

place it appears and inserting ‘‘rule, order, or consent 

agreement under subsection (a)’’; 

(ii) by striking ‘‘repeals the rule’’ each place it 

appears and inserting ‘‘repeals the rule or order or 

modifies the consent agreement to terminate the 

requirement’’; and 

(iii) by striking ‘‘repeals the application of the rule’’ 

and inserting ‘‘repeals or modifies the application of 

the rule, order, or consent agreement’’; 

(2) in subsection (c)— 

(A) in paragraph (1), by striking ‘‘rule’’ and inserting 

‘‘rule or order’’; 

(B) in paragraph (2)— 

(i) in subparagraph (A), by striking ‘‘a rule under 

subsection (a) or for which data is being developed 

pursuant to such a rule’’ and inserting ‘‘a rule, order, 

or consent agreement under subsection (a) or for which 

information is being developed pursuant to such a rule, 

order, or consent agreement’’; 

(ii) in subparagraph (B), by striking ‘‘such rule 

or which is being developed pursuant to such rule’’ 

and inserting ‘‘such rule, order, or consent agreement 

or which is being developed pursuant to such rule, 

order, or consent agreement’’; and 

(iii) in the matter following subparagraph (B), by 

striking ‘‘the rule’’ and inserting ‘‘the rule or order’’; 

(C) in paragraph (3)(B)(i), by striking ‘‘rule promulgated’’ and inserting ‘‘rule, order, or consent agreement’’; 

and 

(D) in paragraph (4)— 

(i) by striking ‘‘rule promulgated’’ each place it 

appears and inserting ‘‘rule, order, or consent agreement’’; 

(ii) by striking ‘‘such rule’’ each place it appears 

and inserting ‘‘such rule, order, or consent agreement’’; 

and 

(iii) in subparagraph (B), by striking ‘‘the rule’’ 

and inserting ‘‘the rule or order’’; 

(3) in subsection (d), by striking ‘‘rule’’ and inserting ‘‘rule, 

order, or consent agreement’’; and 

(4) in subsection (g), by striking ‘‘rule’’ and inserting ‘‘rule, 

order, or consent agreement’’. 

(e) SECTION 5.—Section 5 of the Toxic Substances Control Act 

(15 U.S.C. 2604) is amended— 

(1) in subsection (b)— 

(A) in paragraph (1)(A)— 


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(i) by striking ‘‘rule promulgated’’ and inserting 

‘‘rule, order, or consent agreement’’; and 

(ii) by striking ‘‘such rule’’ and inserting ‘‘such 

rule, order, or consent agreement’’; 

(B) in paragraph (1)(B), by striking ‘‘rule promulgated’’ 

and inserting ‘‘rule or order’’; and 

(C) in paragraph (2)(A)(ii), by striking ‘‘rule promulgated’’ and inserting ‘‘rule, order, or consent agreement’’; 

and 

(2) in subsection (d)(2)(C), by striking ‘‘rule’’ and inserting 

‘‘rule, order, or consent agreement’’. 

(f) SECTION 7.—Section 7(a) of the Toxic Substances Control 

Act (15 U.S.C. 2606(a)) is amended— 

(1) in paragraph (1), in the matter following subparagraph 

(C), by striking ‘‘a rule under section 4, 5, 6, or title IV or 

an order under section 5 or title IV’’ and inserting ‘‘a determination under section 5 or 6, a rule under section 4, 5, or 6 

or title IV, an order under section 4, 5, or 6 or title IV, 

or a consent agreement under section 4’’; and 

(2) in paragraph (2), by striking ‘‘subsection 6(d)(2)(A)(i)’’ 

and inserting ‘‘section 6(d)(3)(A)(i)’’. 

(g) SECTION 8.—Section 8(a) of the Toxic Substances Control 

Act (15 U.S.C. 2607(a)) is amended— 

(1) in paragraph (2)(E), by striking ‘‘data’’ and inserting 

‘‘information’’; and 

(2) in paragraph (3)(A)(ii)(I), by striking ‘‘or an order in 

effect under section 5(e)’’ and inserting ‘‘, an order in effect 

under section 4 or 5(e), or a consent agreement under section 

4’’. 

(h) SECTION 9.—Section 9 of the Toxic Substances Control Act 

(15 U.S.C. 2608) is amended— 

(1) in subsection (a), by striking ‘‘section 6’’ each place 

it appears and inserting ‘‘section 6(a)’’; and 

(2) in subsection (d), by striking ‘‘Health, Education, and 

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

(i) SECTION 10.—Section 10 of the Toxic Substances Control 

Act (15 U.S.C. 2609) is amended— 

(1) in the section heading, by striking ‘‘DATA’’ and inserting 

‘‘INFORMATION’’; 

(2) by striking ‘‘Health, Education, and Welfare’’ each place 

it appears and inserting ‘‘Health and Human Services’’; 

(3) in subsection (b)— 

(A) in the subsection heading, by striking ‘‘DATA’’ and 

inserting ‘‘INFORMATION’’; 

(B) by striking ‘‘data’’ and inserting ‘‘information’’ in 

paragraph (1); 

(C) by striking ‘‘data’’ and inserting ‘‘information’’ in 

paragraph (2)(A); and 

(D) by striking ‘‘a data’’ and inserting ‘‘an information’’ 

in paragraph (2)(B); and 

(4) in subsection (g), by striking ‘‘data’’ and inserting 

‘‘information’’. 

(j) SECTION 11.—Section 11(b)(2) of the Toxic Substances Control Act (15 U.S.C. 2610(b)(2)) is amended— 

(1) by striking ‘‘data’’ each place it appears and inserting 

‘‘information’’; and 


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(2) in subparagraph (E), by striking ‘‘rule promulgated’’ 

and inserting ‘‘rule promulgated, order issued, or consent agreement entered into’’. 

(k) SECTION 12.—Section 12(b)(1) of the Toxic Substances Control Act (15 U.S.C. 2611(b)(1)) is amended by striking ‘‘data’’ both 

places it appears and inserting ‘‘information’’. 

(l) SECTION 15.—Section 15(1) of the Toxic Substances Control 

Act (15 U.S.C. 2614(1)) is amended by striking ‘‘(A) any rule’’ 

and all that follows through ‘‘or (D)’’ and inserting ‘‘any requirement 

of this title or any rule promulgated, order issued, or consent 

agreement entered into under this title, or’’. 

(m) SECTION 19.—Section 19 of the Toxic Substances Control 

Act (15 U.S.C. 2618) is amended— 

(1) in subsection (a)— 

(A) in paragraph (1)(A)— 

(i) by striking ‘‘Not later than 60 days after the 

date of the promulgation of a rule under section 4(a), 

5(a)(2), 5(b)(4), 6(a), 6(e), or 8, or under title II or 

IV’’ and inserting ‘‘Except as otherwise provided in 

this title, not later than 60 days after the date on 

which a rule is promulgated under this title, title II, 

or title IV, or the date on which an order is issued 

under section 4, 5(e), 5(f), or 6(i)(1),’’; 

(ii) by striking ‘‘such rule’’ and inserting ‘‘such 

rule or order’’; and 

(iii) by striking ‘‘such a rule’’ and inserting ‘‘such 

a rule or order’’; 

(B) in paragraph (1)(B)— 

(i) by striking ‘‘Courts’’ and inserting ‘‘Except as 

otherwise provided in this title, courts’’; and 

(ii) by striking ‘‘subparagraph (A) or (B) of section 

6(b)(1)’’ and inserting ‘‘this title, other than an order 

under section 4, 5(e), 5(f), or 6(i)(1),’’; and 

(C) in paragraph (2)— 

(i) by striking ‘‘rulemaking record’’ and inserting 

‘‘record’’; and 

(ii) by striking ‘‘based the rule’’ and inserting 

‘‘based the rule or order’’; 

(2) in subsection (b)— 

(A) by striking ‘‘review a rule’’ and inserting ‘‘review 

a rule, or an order under section 4, 5(e), 5(f), or 6(i)(1),’’; 

(B) by striking ‘‘such rule’’ and inserting ‘‘such rule 

or order’’; 

(C) by striking ‘‘the rule’’ and inserting ‘‘the rule or 

order’’; 

(D) by striking ‘‘new rule’’ each place it appears and 

inserting ‘‘new rule or order’’; and 

(E) by striking ‘‘modified rule’’ and inserting ‘‘modified 

rule or order’’; and 

(3) in subsection (c)— 

(A) in paragraph (1)— 

(i) in subparagraph (A)— 

(I) by striking ‘‘a rule’’ and inserting ‘‘a rule 

or order’’; and 

(II) by striking ‘‘such rule’’ and inserting ‘‘such 

rule or order’’; 

(ii) in subparagraph (B)— 


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(I) in the matter preceding clause (i), by 

striking ‘‘a rule’’ and inserting ‘‘a rule or order’’; 

(II) by amending clause (i) to read as follows: 

‘‘(i) in the case of review of— 

‘‘(I) a rule under section 4(a), 5(b)(4), 6(a) (including 

review of the associated determination under section 

6(b)(4)(A)), or 6(e), the standard for review prescribed by 

paragraph (2)(E) of such section 706 shall not apply and 

the court shall hold unlawful and set aside such rule if 

the court finds that the rule is not supported by substantial 

evidence in the rulemaking record taken as a whole; and 

‘‘(II) an order under section 4, 5(e), 5(f), or 6(i)(1), 

the standard for review prescribed by paragraph (2)(E) 

of such section 706 shall not apply and the court shall 

hold unlawful and set aside such order if the court finds 

that the order is not supported by substantial evidence 

in the record taken as a whole; and’’; and 

(III) by striking clauses (ii) and (iii) and the 

matter after clause (iii) and inserting the following: 

‘‘(ii) the court may not review the contents and adequacy 

of any statement of basis and purpose required by section 

553(c) of title 5, United States Code, to be incorporated in 

the rule or order, except as part of the record, taken as a 

whole.’’; and 

(iii) by striking subparagraph (C); and 

(B) in paragraph (2), by striking ‘‘any rule’’ and 

inserting ‘‘any rule or order’’. 

(n) SECTION 20.—Section 20(a)(1) of the Toxic Substances Control Act (15 U.S.C. 2619(a)(1)) is amended by striking ‘‘order issued 

under section 5’’ and inserting ‘‘order issued under section 4 or 

5’’. 

(o) SECTION 21.—Section 21 of the Toxic Substances Control 

Act (15 U.S.C. 2620) is amended— 

(1) in subsection (a), by striking ‘‘order under section 5(e) 

or (6)(b)(2)’’ and inserting ‘‘order under section 4 or 5(e) or 

(f)’’; and 

(2) in subsection (b)— 

(A) in paragraph (1), by striking ‘‘order under section 

5(e), 6(b)(1)(A), or 6(b)(1)(B)’’ and inserting ‘‘order under 

section 4 or 5(e) or (f)’’; and 

(B) in paragraph (4)(B)— 

(i) in the matter preceding clause (i), by striking 

‘‘order under section 5(e) or 6(b)(2)’’ and inserting 

‘‘order under section 4 or 5(e) or (f)’’; 

(ii) in clause (i), by striking ‘‘order under section 

5(e)’’ and inserting ‘‘order under section 4 or 5(e)’’; 

and 

(iii) in clause (ii), by striking ‘‘section 6 or 8 or 

an order under section 6(b)(2), there is a reasonable 

basis to conclude that the issuance of such a rule 

or order is necessary to protect health or the environment against an unreasonable risk of injury to health 

or the environment’’ and inserting ‘‘section 6(a) or 8 

or an order under section 5(f), the chemical substance 

or mixture to be subject to such rule or order presents 

an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk 


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factors, including an unreasonable risk to a potentially 

exposed or susceptible subpopulation, under the conditions of use’’. 

(p) SECTION 24.—Section 24(b)(2)(B) of the Toxic Substances 

Control Act (15 U.S.C. 2623(b)(2)(B)) is amended— 

(1) by inserting ‘‘and’’ at the end of clause (i); 

(2) by striking clause (ii); and 

(3) by redesignating clause (iii) as clause (ii). 

(q) SECTION 26.—Section 26 of the Toxic Substances Control 

Act (15 U.S.C. 2625) is amended— 

(1) in subsection (e), by striking ‘‘Health, Education, and 

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

Human Services’’; and 

(2) in subsection (g)(1), by striking ‘‘data’’ and inserting 

‘‘information’’. 

(r) SECTION 27.—Section 27(a) of the Toxic Substances Control 

Act (15 U.S.C. 2626(a)) is amended— 

(1) by striking ‘‘Health, Education, and Welfare’’ and 

inserting ‘‘Health and Human Services’’; 

(2) by striking ‘‘test data’’ both places it appears and 

inserting ‘‘information’’; 

(3) by striking ‘‘rules promulgated’’ and inserting ‘‘rules, 

orders, or consent agreements’’; and 

(4) by striking ‘‘standards’’ and inserting ‘‘protocols and 

methodologies’’. 

(s) SECTION 30.—Section 30(2) of the Toxic Substances Control 

Act (15 U.S.C. 2629(2)) is amended by striking ‘‘rule’’ and inserting 

‘‘rule, order, or consent agreement’’. 

SEC. 20. NO RETROACTIVITY. 

Nothing in sections 1 through 19, or the amendments made 

by sections 1 through 19, shall be interpreted to apply retroactively 

to any State, Federal, or maritime legal action filed before the 

date of enactment of this Act. 

SEC. 21. TREVOR’S LAW. 

(a) PURPOSES.—The purposes of this section are— 

(1) to provide the appropriate Federal agencies with the 

authority to help conduct investigations into potential cancer 

clusters; 

(2) to ensure that Federal agencies have the authority 

to undertake actions to help address cancer clusters and factors 

that may contribute to the creation of potential cancer clusters; 

and 

(3) to enable Federal agencies to coordinate with other 

Federal, State, and local agencies, institutes of higher education, and the public in investigating and addressing cancer 

clusters. 

(b) DESIGNATION AND INVESTIGATION OF POTENTIAL CANCER

CLUSTERS.—Part P of title III of the Public Health Service Act 

(42 U.S.C. 280g et seq.) is amended by adding at the end the 

following: 

‘‘SEC. 399V–6. DESIGNATION AND INVESTIGATION OF POTENTIAL 

CANCER CLUSTERS. 

‘‘(a) DEFINITIONS.—In this section: 

‘‘(1) CANCER CLUSTER.—The term ‘cancer cluster’ means 

the incidence of a particular cancer within a population group, 

42 USC 280g–17. 

42 USC 280g–17 

note. 

15 USC 2601 

note. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 511 

a geographical area, and a period of time that is greater than 

expected for such group, area, and period. 

‘‘(2) PARTICULAR CANCER.—The term ‘particular cancer’ 

means one specific type of cancer or a type of cancers scientifically proven to have the same cause. 

‘‘(3) POPULATION GROUP.—The term ‘population group’ 

means a group, for purposes of calculating cancer rates, defined 

by factors such as race, ethnicity, age, or gender. 

‘‘(b) CRITERIA FOR DESIGNATION OF POTENTIAL CANCER CLUSTERS.— 

‘‘(1) DEVELOPMENT OF CRITERIA.—The Secretary shall 

develop criteria for the designation of potential cancer clusters. 

‘‘(2) REQUIREMENTS.—The criteria developed under paragraph (1) shall consider, as appropriate— 

‘‘(A) a standard for cancer cluster identification and 

reporting protocols used to determine when cancer 

incidence is greater than would be typically observed; 

‘‘(B) scientific screening standards that ensure that 

a cluster of a particular cancer involves the same type 

of cancer, or types of cancers; 

‘‘(C) the population in which the cluster of a particular 

cancer occurs by factors such as race, ethnicity, age, and 

gender, for purposes of calculating cancer rates; 

‘‘(D) the boundaries of a geographic area in which 

a cluster of a particular cancer occurs so as not to create 

or obscure a potential cluster by selection of a specific 

area; and 

‘‘(E) the time period over which the number of cases 

of a particular cancer, or the calculation of an expected 

number of cases, occurs. 

‘‘(c) GUIDELINES FOR INVESTIGATION OF POTENTIAL CANCER

CLUSTERS.—The Secretary, in consultation with the Council of State 

and Territorial Epidemiologists and representatives of State and 

local health departments, shall develop, publish, and periodically 

update guidelines for investigating potential cancer clusters. The 

guidelines shall— 

‘‘(1) recommend that investigations of cancer clusters— 

‘‘(A) use the criteria developed under subsection (b); 

‘‘(B) use the best available science; and 

‘‘(C) rely on a weight of the scientific evidence; 

‘‘(2) provide standardized methods of reviewing and categorizing data, including from health surveillance systems and 

reports of potential cancer clusters; and 

‘‘(3) provide guidance for using appropriate epidemiological 

and other approaches for investigations. 

‘‘(d) INVESTIGATION OF CANCER CLUSTERS.— 

‘‘(1) SECRETARY DISCRETION.—The Secretary— 

‘‘(A) in consultation with representatives of the relevant State and local health departments, shall consider 

whether it is appropriate to conduct an investigation of 

a potential cancer cluster; and 

‘‘(B) in conducting investigations shall have the discretion to prioritize certain potential cancer clusters, based 

on the availability of resources. 

‘‘(2) COORDINATION.—In investigating potential cancer clusters, the Secretary shall coordinate with agencies within the 

Consultation. 

Recommendation. 

Consultation. 

Publication. 


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130 STAT. 512 PUBLIC LAW 114–182—JUNE 22, 2016 

Department of Health and Human Services and other Federal 

agencies, such as the Environmental Protection Agency. 

‘‘(3) BIOMONITORING.—In investigating potential cancer 

clusters, the Secretary shall rely on all appropriate biomonitoring information collected under other Federal programs, such 

as the National Health and Nutrition Examination Survey. 

The Secretary may provide technical assistance for relevant 

biomonitoring studies of other Federal agencies. 

‘‘(e) DUTIES.—The Secretary shall— 

‘‘(1) ensure that appropriate staff of agencies within the 

Department of Health and Human Services are prepared to 

provide timely assistance, to the extent practicable, upon 

receiving a request to investigate a potential cancer cluster 

from a State or local health authority; 

‘‘(2) maintain staff expertise in epidemiology, toxicology, 

data analysis, environmental health and cancer surveillance, 

exposure assessment, pediatric health, pollution control, 

community outreach, health education, laboratory sampling and 

analysis, spatial mapping, and informatics; 

‘‘(3) consult with community members as investigations 

into potential cancer clusters are conducted, as the Secretary 

determines appropriate; 

‘‘(4) collect, store, and disseminate reports on investigations 

of potential cancer clusters, the possible causes of such clusters, 

and the actions taken to address such clusters; and 

‘‘(5) provide technical assistance for investigating cancer 

clusters to State and local health departments through existing 

programs, such as the Epi-Aids program of the Centers for 

Disease Control and Prevention and the Assessments of Chemical Exposures Program of the Agency for Toxic Substances 

and Disease Registry.’’. 

TITLE II—RURAL HEALTHCARE 

CONNECTIVITY 

SEC. 201. SHORT TITLE. 

This title may be cited as the ‘‘Rural Healthcare Connectivity 

Act of 2016’’. 

SEC. 202. TELECOMMUNICATIONS SERVICES FOR SKILLED NURSING 

FACILITIES. 

(a) IN GENERAL.—Section 254(h)(7)(B) of the Communications 

Act of 1934 (47 U.S.C. 254(h)(7)(B)) is amended— 

(1) in clause (vi), by striking ‘‘and’’ at the end; 

(2) by redesignating clause (vii) as clause (viii); 

(3) by inserting after clause (vi) the following: 

‘‘(vii) skilled nursing facilities (as defined in section 

1819(a) of the Social Security Act (42 U.S.C. 1395i– 

3(a))); and’’; and 

(4) in clause (viii), as redesignated, by striking ‘‘clauses 

(i) through (vi)’’ and inserting ‘‘clauses (i) through (vii)’’. 

(b) SAVINGS CLAUSE.—Nothing in subsection (a) shall be construed to affect the aggregate annual cap on Federal universal 

service support for health care providers under section 54.675 of 

title 47, Code of Federal Regulations, or any successor regulation. 

47 USC 254 note. 

47 USC 609 note. 

Rural Healthcare 

Connectivity Act 

of 2016. 


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PUBLIC LAW 114–182—JUNE 22, 2016 130 STAT. 513 

LEGISLATIVE HISTORY—H.R. 2576: 

HOUSE REPORTS: No. 114–176 (Comm. on Energy and Commerce). 

CONGRESSIONAL RECORD: 

Vol. 161 (2015): June 23, considered and passed House. 

Dec. 17, considered and passed Senate, amended. 

Vol. 162 (2016): May 24, House concurred in Senate amendment with an 

amendment. 

June 7, Senate concurred in House amendment. 

DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2016): 

June 22, Presidential remarks. 

Æ 

(c) EFFECTIVE DATE.—The amendments made by subsection 

(a) shall apply beginning on the date that is 180 days after the 

date of the enactment of this Act. 

Approved June 22, 2016. 

47 USC 254 note. 


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