49–006 

114TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 1st Session 114–176 

TSCA MODERNIZATION ACT OF 2015 

JUNE 23, 2015.—Committed to the Committee of the Whole House on the State of 

the Union and ordered to be printed 

Mr. UPTON, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

[To accompany H.R. 2576] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 2576) to modernize the Toxic Substances Control Act, 

and for other purposes, having considered the same, report favorably thereon with an amendment and recommend that the bill as 

amended do pass. 

CONTENTS 

Page 

Purpose and Summary ............................................................................................ 12 

Background and Need for Legislation .................................................................... 12 

Hearings ................................................................................................................... 13 

Committee Consideration ........................................................................................ 13 

Committee Votes ...................................................................................................... 14 

Committee Oversight Findings ............................................................................... 16 

Statement of General Performance Goals and Objectives .................................... 16 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 16 

Earmark, Limited Tax Benefits, and Limited Tariff Benefits ............................. 16 

Committee Cost Estimate ....................................................................................... 16 

Congressional Budget Office Estimate ................................................................... 16 

Federal Mandates Statement ................................................................................. 21 

Duplication of Federal Programs ............................................................................ 21 

Disclosure of Directed Rule Makings ..................................................................... 22 

Advisory Committee Statement .............................................................................. 22 

Applicability to Legislative Branch ........................................................................ 22 

Section-by-Section Analysis of the Legislation ...................................................... 22 

Changes in Existing Law Made by the Bill, as Reported ..................................... 34 

The amendment is as follows: 

Strike all after the enacting clause and insert the following: 


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SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

(a) SHORT TITLE.—This Act may be cited as the ‘‘TSCA Modernization Act of 

2015’’. 

(b) TABLE OF CONTENTS.—The table of contents of this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Definitions. 

Sec. 3. Testing of chemical substances and mixtures. 

Sec. 4. Regulation of hazardous chemical substances and mixtures. 

Sec. 5. Relationship to other Federal laws. 

Sec. 6. Disclosure of data. 

Sec. 7. Effect on State law. 

Sec. 8. Administration of the Act. 

Sec. 9. Conforming amendments. 

SEC. 2. DEFINITIONS. 

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

(1) by redesignating paragraphs (7) through (14) as paragraphs (8) through 

(10) and (12) through (16), respectively; 

(2) by inserting after paragraph (6) the following: 

‘‘(7) The term ‘intended conditions of use’ means the circumstances under which 

a chemical substance is intended, known, or reasonably foreseeable to be manufactured, processed, distributed in commerce, used, and disposed of.’’; and 

(3) by inserting after paragraph (10), as so redesignated, the following: 

‘‘(11) The term ‘potentially exposed subpopulation’ means a group of individuals 

within the general population who, due to either greater susceptibility or greater potential exposure, are likely to be at greater risk than the general population of adverse health effects from exposure to a chemical substance.’’. 

SEC. 3. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES. 

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

(1) in subsection (a)(1)— 

(A) in subparagraph (A)(iii), by striking ‘‘; or’’ and inserting a semicolon; 

(B) in subparagraph (B)(iii), by striking ‘‘; and’’ and inserting ‘‘; or’’; and 

(C) by adding at the end the following: 

‘‘(C) testing of a chemical substance is necessary to conduct a risk evaluation 

under section 6(b); and’’; 

(2) in the matter following subsection (a)(2), by inserting ‘‘, order, or consent 

agreement’’ after ‘‘by rule’’; and 

(3) in subsection (b)(5), by striking ‘‘paragraph (1)(A) or (1)(B)’’ and inserting 

‘‘paragraph (1)(A), (1)(B), or (1)(C)’’. 

SEC. 4. REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND MIXTURES. 

(a) SCOPE OF REGULATION.—Section 6(a) of the Toxic Substances Control Act (15 

U.S.C. 2605(a)) is amended— 

(1) by striking ‘‘finds that there is a reasonable basis to conclude’’ and inserting ‘‘determines under subsection (b)’’; 

(2) by inserting ‘‘or designates a chemical substance under subsection (i)(2),’’ 

before ‘‘the Administrator shall by rule’’; and 

(3) 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 or will present an unreasonable risk, including an identified unreasonable risk to a potentially exposed subpopulation’’. 

(b) RISK EVALUATIONS.—Section 6(b) of the Toxic Substances Control Act (15 

U.S.C. 2605(b)) is amended to read as follows: 

‘‘(b) RISK EVALUATIONS.— 

‘‘(1) IN GENERAL.—The Administrator shall conduct risk evaluations pursuant 

to this subsection to determine whether or not a chemical substance presents 

or will present, in the absence of requirements under subsection (a), an unreasonable risk of injury to health or the environment. 

‘‘(2) APPLYING REQUIREMENTS.—The Administrator shall apply requirements 

with respect to a chemical substance through a rule under subsection (a) only 

if the Administrator determines through a risk evaluation under this subsection 

that the chemical substance presents or will present, in the absence of such requirements, an unreasonable risk of injury to health or the environment. 

‘‘(3) CONDUCTING RISK EVALUATION.— 

‘‘(A) REQUIRED RISK EVALUATIONS.—The Administrator shall conduct and 

publish the results of a risk evaluation under this subsection for a chemical 

substance if— 

‘‘(i) the Administrator determines that the chemical substance may 

present an unreasonable risk of injury to health or the environment because of potential hazard and a potential route of exposure under the 

intended conditions of use; or 


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‘‘(ii) a manufacturer of the chemical substance requests such a risk 

evaluation. 

‘‘(B) TSCA WORK PLAN CHEMICALS.—The Administrator may, without 

making a determination under subparagraph (A)(i), conduct and publish the 

results of a risk evaluation under this subsection for a chemical substance 

that, on the date of enactment of the TSCA Modernization Act of 2015, is 

listed in the TSCA Work Plan for Chemical Assessments published by the 

Administrator. 

‘‘(4) REQUIREMENTS.—In conducting a risk evaluation under this subsection, 

the Administrator shall— 

‘‘(A) integrate and assess information on hazards and exposures for all of 

the intended 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 subpopulations; 

‘‘(B) not consider information on cost and other factors not directly related 

to health or the environment; 

‘‘(C) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the intended conditions of use of 

the chemical substance; 

‘‘(D) describe the weight of the scientific evidence for identified hazard 

and exposure; 

‘‘(E) consider whether the weight of the scientific evidence supports the 

identification of doses of the chemical substance below which no adverse effects can be expected to occur; and 

‘‘(F) in the case of a risk evaluation requested by a manufacturer under 

paragraph (3)(A)(ii), ensure that the costs to the Environmental Protection 

Agency, including contractor costs, of conducting the risk evaluation are 

paid for by the manufacturer. 

‘‘(5) DEADLINES.— 

‘‘(A) RISK EVALUATIONS.—The Administrator shall conduct and publish a 

risk evaluation under this subsection for a chemical substance as soon as 

reasonably possible, subject to the availability of resources, but not later 

than 3 years after the date on which— 

‘‘(i) the Administrator— 

‘‘(I) makes a determination under paragraph (3)(A)(i); or 

‘‘(II) begins the risk evaluation under paragraph (3)(B); or 

‘‘(ii) a manufacturer requests the risk evaluation under paragraph 

(3)(A)(ii). 

‘‘(B) SUBSECTION (a) RULES.—If, based on a risk evaluation conducted 

under this subsection, the Administrator determines that a chemical substance presents or will present, in the absence of a rule under subsection 

(a), an unreasonable risk of injury to health or the environment, the Administrator shall— 

‘‘(i) propose a rule under subsection (a) for the chemical substance not 

later than 90 days after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A); and 

‘‘(ii) publish in the Federal Register a final rule not later than 180 

days after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A). 

‘‘(C) EXTENSION.—If the Administrator determines that additional information is necessary to make a risk evaluation determination under this 

subsection, the Administrator may extend the deadline under subparagraph 

(A) accordingly, except that the deadline may not be extended to a date that 

is later than— 

‘‘(i) 90 days after receipt of such additional information; or 

‘‘(ii) 2 years after the original deadline. 

‘‘(6) DETERMINATIONS OF NO UNREASONABLE RISK.— 

‘‘(A) NOTICE AND COMMENT.—Not later than 30 days before publishing a 

final determination under this subsection that a chemical substance does 

not and will not present an unreasonable risk of injury to health or the environment, the Administrator shall make a preliminary determination to 

such effect and provide public notice of, and an opportunity for comment 

regarding, such preliminary determination. 

‘‘(B) POTENTIALLY EXPOSED SUBPOPULATIONS.—The Administrator shall 

not make a determination under this subsection that a chemical substance 

will not present an unreasonable risk of injury to health or the environment 

if the Administrator determines that the chemical substance, under the intended conditions of use, presents or will present an unreasonable risk of 

injury to 1 or more potentially exposed subpopulations. 


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‘‘(C) FINAL ACTION.—A final determination under this subsection that a 

chemical substance will not present an unreasonable risk of injury to health 

or the environment shall be considered a final agency action. 

‘‘(7) MINIMUM NUMBER.—Subject to the availability of appropriations, the Administrator shall initiate 10 or more risk evaluations under paragraphs (3)(A)(i) 

or (3)(B) in each fiscal year beginning in the fiscal year of the date of enactment 

of the TSCA Modernization Act of 2015.’’. 

(c) PROMULGATION OF SUBSECTION (a) RULES.—Section 6(c) of the Toxic Substances Control Act (15 U.S.C. 2605(c)) is amended— 

(1) by amending paragraph (1) to read as follows: 

‘‘(1) REQUIREMENTS FOR RULE.—In promulgating any rule under subsection (a) 

with respect to a chemical substance or mixture, the Administrator shall— 

‘‘(A) consider and publish a statement 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 the 

chemical substance or mixture; 

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

economy, small business, technological innovation, the environment, 

and public health; 

‘‘(B) impose requirements under the rule that the Administrator determines, consistent with the information published under subparagraph (A), 

are cost-effective, except where the Administrator determines that additional or different requirements described in subsection (a) are necessary to 

protect against the identified risk; 

‘‘(C) based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific use of a chemical substance or mixture and in setting an 

appropriate transition period for such action, determine 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) exempt replacement parts designed prior to the date of publication 

in the Federal Register of the rule unless the Administrator finds such replacement parts contribute significantly to the identified risk, including 

identified risk to identified potentially exposed subpopulations; and 

‘‘(E) in selecting among prohibitions and other restrictions to address an 

identified risk, apply prohibitions or other restrictions to articles on the 

basis of a chemical substance or mixture contained in the article only to the 

extent necessary to protect against the identified risk.’’; 

(2) in paragraph (2)— 

(A) by inserting ‘‘PROCEDURES.—’’ before ‘‘When prescribing a rule’’; 

(B) by striking ‘‘provide an opportunity for an informal hearing in accordance with paragraph (3); (D)’’; 

(C) by striking ‘‘, and (E)’’ and inserting ‘‘; and (D)’’; and 

(D) by moving such paragraph 2 ems to the right; 

(3) by striking paragraphs (3) and (4) and redesignating paragraph (5) as 

paragraph (3); and 

(4) in paragraph (3) (as so redesignated)— 

(A) by striking ‘‘Paragraphs (1), (2), (3), and (4)’’ and inserting ‘‘APPLICATION.—Paragraphs (1) and (2)’’; and 

(B) by moving such paragraph 2 ems to the right. 

(d) EFFECTIVE DATE.—Section 6(d)(2)(B) of the Toxic Substances Control Act (15 

U.S.C. 2605(d)(2)(B)) is amended by adding at the end the following: ‘‘Any rule promulgated under subsection (a) shall provide for a reasonable transition period.’’. 

(e) NON-RISK FACTORS; CRITICAL USE EXEMPTIONS; PBT CHEMICALS.—Section 6 of 

the Toxic Substances Control Act (15 U.S.C. 2605) is amended by adding at the end 

the following: 

‘‘(g) NON-RISK FACTORS.—The Administrator shall not consider costs or other nonrisk factors when deciding whether to initiate a rulemaking under subsection (a). 

‘‘(h) CRITICAL USE EXEMPTIONS.— 


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‘‘(1) CRITERIA FOR EXEMPTION.—The Administrator may grant an exemption 

from a requirement of a subsection (a) rule for a specific use of a chemical substance or mixture, if— 

‘‘(A) the requirement is not cost-effective with respect to the specific use, 

as determined by the Administrator pursuant to subsection (c)(1)(B); and 

‘‘(B) the Administrator finds that— 

‘‘(i) the specific use is a critical or essential use; or 

‘‘(ii) the requirement, as applied with respect to the specific use, 

would significantly disrupt the national economy, national security, or 

critical infrastructure. 

‘‘(2) PROCEDURE.—An exemption granted under paragraph (1) shall be— 

‘‘(A) supported by clear and convincing evidence; 

‘‘(B) preceded by public notice of the proposed exemption and an opportunity for comment; and 

‘‘(C) followed by notice of the granted exemption— 

‘‘(i) to the public, by the Administrator; and 

‘‘(ii) to known commercial purchasers of the chemical substance or 

mixture with respect to which the exemption applies, by the manufacturers and processors of such chemical substance or mixture. 

‘‘(3) PERIOD OF EXEMPTION.—An exemption granted under paragraph (1) shall 

expire after a period not to exceed 5 years, but may be renewed for one or more 

additional 5-year periods if the Administrator finds that the requirements of 

paragraph (1) continue to be met. 

‘‘(4) CONDITIONS.—The Administrator shall impose conditions on any use for 

which an exemption is granted under paragraph (1) to reduce risk from the 

chemical substance or mixture to the greatest extent feasible. 

‘‘(i) CHEMICALS THAT ARE PERSISTENT, BIOACCUMULATIVE, AND TOXIC.— ‘‘(1) IDENTIFICATION.—Not later than 9 months after the date of enactment of 

the TSCA Modernization Act of 2015, the Administrator shall publish a list of 

those chemical substances that the Administrator has a reasonable basis to conclude are persistent, bioaccumulative, and toxic, not including any chemical 

substance that is a metal, a metal compound, or subject to subsection (e). 

‘‘(2) CONFIRMATION OF CONCERN.—Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015, the Administrator shall designate as a PBT chemical of concern each chemical substance on the list published under paragraph (1)— 

‘‘(A) that, with respect to persistence and bioaccumulation, scores 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; and 

‘‘(B) exposure to which is likely to the general population or to a potentially exposed subpopulation identified by the Administrator. 

‘‘(3) EXPEDITED ACTION.—Notwithstanding subsection (b)(2), subject to the 

availability of appropriations, not later than 2 years after designating a chemical substance under paragraph (2), the Administrator shall promulgate a rule 

under subsection (a) with respect to the chemical substance to reduce likely exposure to the extent practicable. 

‘‘(4) RELATIONSHIP TO SUBSECTION (b).—If, at any time prior to the date that 

is 90 days after the date on which the Administrator publishes the list under 

paragraph (1), the Administrator makes a finding under subsection (b)(3)(A)(i), 

or a manufacturer requests a risk evaluation under subsection (b)(3)(A)(ii), with 

respect to a chemical substance, such chemical substance shall not be subject 

to this subsection.’’. 

SEC. 5. RELATIONSHIP TO OTHER FEDERAL LAWS. 

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

(1) by striking ‘‘The Administrator shall coordinate’’ and inserting ‘‘(1) The 

Administrator shall coordinate’’; and 

(2) 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 the relevant risks, 

and compare 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.’’. 

SEC. 6. DISCLOSURE OF DATA. 

Section 14 of the Toxic Substances Control Act (15 U.S.C. 2613) is amended— 

(1) in subsection (a)— 


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(A) by striking ‘‘or’’ at the end of paragraph (3); 

(B) by striking the period at the end of paragraph (4) and inserting a 

semicolon; and 

(C) by adding after paragraph (4) the following new paragraphs: 

‘‘(5) may be disclosed to a State, local, or tribal government official upon request of the official for the purpose of administration or enforcement of a law; 

and 

‘‘(6) shall be disclosed upon request— 

‘‘(A) to a health or environmental professional employed by a Federal or 

State agency in response to an environmental release; or 

‘‘(B) to a treating physician or other health care professional to assist in 

the diagnosis or treatment of 1 or more individuals.’’; 

(2) in subsection (b)(1), in the matter following subparagraph (B)— 

(A) by striking ‘‘data which discloses’’ and inserting ‘‘data that disclose 

formulas (including molecular structures) of a chemical substance or mixture,’’; 

(B) by striking ‘‘mixture or,’’ and inserting ‘‘mixture, or,’’; and 

(C) by striking ‘‘the release of data disclosing’’; 

(3) in subsection (c)— 

(A) by striking the subsection heading and inserting ‘‘DESIGNATING AND

SUBSTANTIATING CONFIDENTIALITY.—’’; 

(B) by amending paragraph (1) to read as follows: ‘‘(1)(A) In submitting 

information under this Act after date of enactment of the TSCA Modernization Act of 2015, a manufacturer, processor, or distributor in commerce 

shall designate the information which such person believes is entitled to 

protection under this section, and submit such designated information separately from other information submitted under this Act. A designation 

under this subparagraph shall be made in writing and in such manner as 

the Administrator may prescribe, and shall include— 

‘‘(i) justification for each designation of confidentiality; 

‘‘(ii) a certification that the information is not otherwise publicly available; and 

‘‘(iii) separate copies of all submitted information, with 1 copy containing 

and 1 copy excluding the information to which the request applies. 

‘‘(B) Designations made under subparagraph (A) after the date of enactment 

of the TSCA Modernization Act of 2015 shall expire after 10 years, at which 

time the information shall be made public unless the manufacturer, processor, 

or distributor in commerce has reasserted the claim for protection, in writing 

and in such manner as the Administrator may prescribe, including all of the 

elements required for the initial submission. 

‘‘(C) Not later than 60 days prior to making information public under subparagraph (B), the Administrator shall notify, as appropriate and practicable, 

the manufacturer, processor, or distributor in commerce who designated the information under subparagraph (A) of the date on which such information will 

be made public unless a request for renewal is granted under subparagraph 

(B).’’; and 

(C) in paragraph (2)— 

(i) in subparagraph (A), by inserting ‘‘, for a reason other than the 

expiration of such designation pursuant to paragraph (1)(B),’’ before 

‘‘proposes to release’’; and 

(ii) in subparagraph (B)(i), by striking ‘‘or (4)’’ and inserting ‘‘(4), or 

(6)’’; and 

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

‘‘(f) PROHIBITION.—No person who receives information as permitted under subsection (a) may use such information for any purpose not specified in such subsection, nor disclose such information to any person not authorized to receive such 

information. 

‘‘(g) SAVINGS.—Nothing in this section shall be construed to affect the applicability 

of State or Federal rules of evidence or procedure in any judicial proceeding.’’. 

SEC. 7. EFFECT ON STATE LAW. 

(a) IN GENERAL.—Section 18(a) of the Toxic Substances Control Act (15 U.S.C. 

2617(a)) is amended— 

(1) in paragraph (2)(A), by striking ‘‘; and’’ and inserting a semicolon; 

(2) by striking paragraph (2)(B) and inserting the following: 

‘‘(B) if the Administrator makes a final determination under section 6(b) that 

a chemical substance will not present an unreasonable risk of injury to health 

or the environment under the intended condition of use, no State or political 

subdivision may, after the date of publication of such determination, establish 


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or continue in effect any requirement that applies to such chemical substance 

under the intended conditions of use considered by the Administrator in the 

risk evaluation under section 6(b), and is designed to protect against exposure 

to such chemical substance under the intended conditions of use, unless the requirement of the State or political subdivision— 

‘‘(i) is adopted under the authority of a Federal law; or 

‘‘(ii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made 

by the Administrator under this title, actually conflicts with the requirement; and 

‘‘(C) if the Administrator imposes a requirement, through a rule or order 

under section 5 or 6, that applies to a chemical substance or mixture (other 

than a requirement described in section 6(a)(6)) and is designed to protect 

against a risk of injury to health or the environment associated with such chemical substance or mixture, no State or political subdivision may, after the effective date of such requirement, establish or continue in effect any requirement 

that applies to such chemical substance or mixture (including a requirement 

that applies to an article because the article contains the chemical substance 

or mixture) and is designed to protect against exposure to the chemical substance or mixture either under the intended conditions of use considered by the 

Administrator in the risk evaluation under section 6(b) or from a use identified 

in a notice received by the Administrator under section 5(a), or, in the case of 

a requirement imposed pursuant to section 6(i), is designed to protect against 

a risk of injury considered by the Administrator in imposing such requirement, 

unless the requirement of the State or political subdivision— 

‘‘(i) is identical to the requirement imposed by the Administrator; 

‘‘(ii) is adopted under the authority of a Federal law; or 

‘‘(iii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made 

by the Administrator under this title, actually conflicts with the requirement.’’; and 

(3) by adding at the end the following: 

‘‘(3) In the case of an identical requirement described in paragraph (2)(C)(i)— 

‘‘(A) a State may not assess a penalty for a specific violation for which the 

Administrator has assessed a penalty under section 16; and 

‘‘(B) if 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 and the 

Administrator combined to exceed the maximum amount that may be assessed 

for that violation by the Administrator under section 16.’’. 

(b) SAVINGS.—Section 18 of the Toxic Substances Control Act (15 U.S.C. 2617) is 

amended by adding at the end the following: 

‘‘(c) SAVINGS.— 

‘‘(1) PRIOR STATE ACTIONS.—Nothing in this title, nor any risk evaluation, 

rule, order, standard, or requirement completed or implemented under this title, 

shall 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 before August 1, 2015, under the authority of a State law that prohibits or otherwise restricts the manufacturing, processing, distribution in commerce, use, or disposal 

of a chemical substance, or any action taken pursuant to a State law that was 

in effect on August 31, 2003, unless an action or determination made by the 

Administrator under this title actually conflicts with the action taken pursuant 

to such a State law. 

‘‘(2) TORT AND CONTRACT LAW.—Nothing in this title, nor any risk evaluation, 

rule, order, standard, or requirement completed or implemented under this title, 

shall be construed to preempt or otherwise affect either Federal or State tort 

law or the law governing the interpretation of contracts of any State, including 

any remedy for civil relief, whether under statutory or common law, including 

a remedy for civil damages, and 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 relating to tort law. 

‘‘(3) INTENT OF CONGRESS.—It is not the intent of Congress that this title, or 

rules, regulations, or orders issued pursuant to this title, be interpreted as influencing, in either a plaintiff’s or defendant’s favor, the disposition of any civil 

action for damages in a State court, or the authority of any court to make a 

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spect to the admissibility of evidence, unless a provision of this title actually 

conflicts with the State court action. 

‘‘(4) APPLICATION.—For purposes of this title, the term ‘requirements’ does not 

include civil tort actions for damages under State law.’’. 

(c) EFFECT OF ACTIONS BY ADMINISTRATOR.—Nothing in this Act, or the amendments made by this Act, shall be construed as changing the preemptive effect of an 

action taken by the Administrator prior to the date of enactment of this Act or 

under section 6(e). 

SEC. 8. 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 inserting ‘‘of a fee that is sufficient and not more than reasonably 

necessary’’ after ‘‘section 4 or 5’’; 

(C) by inserting ‘‘, or who requests a risk evaluation under section 

6(b)(3)(A)(ii),’’ before ‘‘to defray the cost’’; 

(D) by striking ‘‘this Act’’ and inserting ‘‘the provision of this title for 

which such fee is collected’’; and 

(E) 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 inserting ‘‘Such rules shall provide for lower fees for small business concerns.’’; 

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

‘‘(3) FUND.— 

‘‘(A) ESTABLISHMENT.—There is established in the Treasury of the United 

States a revolving 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.—The Administrator shall collect the 

fees described in paragraph (1) and deposit those fees in the Fund. 

‘‘(C) CREDITING AND AVAILABILITY OF FEES.—On request by the Administrator, 

the Secretary of the Treasury shall transfer from the Fund to the Administrator 

amounts appropriated to pay or recover the full costs incurred by the Environmental Protection Agency, including contractor costs, in carrying out the provisions of this title for which the fees are collected under paragraph (1). 

‘‘(D) USE OF FUNDS BY ADMINISTRATOR.—Amounts equivalent to fees collected 

by the Administrator and deposited in the Fund under this section shall be 

available without fiscal year limitation to the Administrator, subject to the 

availability of appropriations, for use only in administering the provisions of 

this title for which the fees are collected. 

‘‘(E) 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, 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 the title for which the fees are collected; and 

‘‘(cc) the number of requests for a risk evaluation made by manufacturers under section 6(b)(3)(A)(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.’’; and 


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(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 

consider, as applicable— 

‘‘(1) the extent to which the scientific and technical procedures, measures, 

methods, or models employed to generate the information are reasonable for 

and consistent with the 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, 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, 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 all notices, determinations, findings, rules, and orders 

of the Administrator under this title. 

‘‘(k) POLICIES, PROCEDURES, AND GUIDANCE.— 

‘‘(1) DEVELOPMENT.—Not later than 2 years after the date of enactment of the 

TSCA Modernization Act of 2015, 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 TSCA Modernization Act of 2015. 

‘‘(2) REVIEW.—Not later than 5 years after the date of enactment of the TSCA 

Modernization Act of 2015, 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 

‘‘(B) revise such policies, procedures, and guidance as the Administrator 

determines necessary to reflect new scientific developments or understandings. 

‘‘(l) REPORT TO CONGRESS.— 

‘‘(1) INITIAL REPORT.—Not later than 6 months after the date of enactment of 

the TSCA Modernization Act of 2015, 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 subparagraphs (A)(i) and (B) of section 

6(b)(3), and the resources necessary to initiate the minimum number of risk 

evaluations required under section 6(b)(7); 

‘‘(B) the capacity of the Environmental Protection Agency to conduct and 

publish risk evaluations under section 6(b)(3)(A)(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 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.’’. 

SEC. 9. CONFORMING AMENDMENTS. 

(a) 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), 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’’; 


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(C) in paragraph (3), by striking ‘‘rule’’ each place it appears and inserting ‘‘rule, order, or consent agreement’’; 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 data 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, order, or consent agreement’’; 

(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’’. 

(b) 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)— 

(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)— 

(i) by striking ‘‘rule promulgated’’ and inserting ‘‘rule or order’’; and 

(ii) by striking ‘‘the date of the submission in accordance with such 

rule’’ and inserting ‘‘the required date of submission’’; and 

(C) in paragraph (2)(A)(ii), by striking ‘‘rule promulgated’’ and inserting 

‘‘rule, order, or consent agreement’’; 

(2) in subsection (d)(2)(C), by striking ‘‘rule’’ and inserting ‘‘rule, order, or consent agreement’’; and 

(3) in subsection (h)(4), by striking ‘‘paragraphs (2) and (3) of section 6(c)’’ and 

inserting ‘‘paragraph (2) of section 6(c)’’. 

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

is amended— 

(1) in subsection (d)(2)(B)— 

(A) by striking ‘‘, provide reasonable opportunity, in accordance with 

paragraphs (2) and (3) of subsection (c), for a hearing on such rule,’’ and 

inserting ‘‘in accordance with paragraph (2) of subsection (c),’’; and 

(B) by striking ‘‘; and if such a hearing is requested’’ and all that follows 

through ‘‘or revoke it.’’ and inserting a period; and 

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

(c)’’ and inserting ‘‘paragraph (2) of subsection (c)’’. 

(d) SECTION 7.—Section 7(a)(1) of the Toxic Substances Control Act (15 U.S.C. 

2606(a)(1)) is amended, 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 insertVerDate Sep 11 2014 23:42 Jun 25, 2015 Jkt 049006 PO 00000 Frm 00010 Fmt 6659 Sfmt 6621 E:\HR\OC\HR176.XXX HR176

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ing ‘‘a rule under section 4, 5, or 6 or title IV, an order under section 4 or 5 or title 

IV, or a consent agreement under section 4’’. 

(e) SECTION 8.—Section 8(a)(3)(A)(ii)(I) of the Toxic Substances Control Act (15 

U.S.C. 2607(a)(3)(A)(ii)(I)) is amended 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’’. 

(f) SECTION 9.—Section 9(a) of the Toxic Substances Control Act (15 U.S.C. 

2608(a)) is amended by striking ‘‘section 6’’ each place it appears and inserting ‘‘section 6(a)’’. 

(g) SECTION 11.—Section 11(b)(2)(E) of the Toxic Substances Control Act (15 

U.S.C. 2610(b)(2)(E)) is amended by striking ‘‘rule promulgated’’ and inserting ‘‘rule 

promulgated, order issued, or consent agreement entered into’’. 

(h) 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’’. 

(i) SECTION 18.—Section 18(a)(2)(A) of the Toxic Substances Control Act (15 U.S.C. 

2617(a)(2)(A)) is amended— 

(1) by striking ‘‘rule promulgated’’ and inserting ‘‘rule, order, or consent agreement’’; and 

(2) by striking ‘‘such rule’’ each place it appears and inserting ‘‘such rule, 

order, or consent agreement’’. 

(j) 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 ‘‘(A) Not later than 60 days after the date of the promulgation of a rule’’ and inserting ‘‘Not later than 60 days after the 

date on which a rule is promulgated’’; 

(ii) by inserting ‘‘or the date on which an order is issued under section 4,’’ before ‘‘any person’’; 

(iii) by striking ‘‘such rule’’ and inserting ‘‘such rule or order’’; and 

(iv) by striking ‘‘such a rule’’ and inserting ‘‘such a rule or order’’; 

(B) by striking paragraph (1)(B); 

(C) in paragraph (2), by striking ‘‘the rule’’ and inserting ‘‘the rule or 

order’’; and 

(D) in paragraph (3)— 

(i) in subparagraph (A), by striking ‘‘the rule’’ and inserting ‘‘the rule 

or order’’; 

(ii) in subparagraph (B), by striking ‘‘a rule under section 4(a)’’ and 

inserting ‘‘a rule or order under section 4(a)’’; 

(iii) in subparagraph (C), by striking ‘‘such rule’’ and inserting ‘‘such 

rule or order’’; 

(iv) in subparagraph (D), by striking ‘‘such rule’’ and inserting ‘‘such 

rule or order’’; and 

(v) in subparagraph (E)— 

(I) by striking ‘‘to such rule’’ and inserting ‘‘to such rule or 

order’’; and 

(II) by striking ‘‘the date of the promulgation of such rule’’ and 

inserting ‘‘the date on which such rule is promulgated or such 

order is issued’’; 

(2) in subsection (b)— 

(A) by striking ‘‘review a rule’’ and inserting ‘‘review a rule, or an order 

under section 4,’’; 

(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 an order under 

section 4’’; and 

(II) by striking ‘‘such rule’’ and inserting ‘‘such rule or order’’; 

and 

(ii) in subparagraph (B)— 

(I) in the matter preceding clause (i), by striking ‘‘a rule’’ and inserting ‘‘a rule or order’’; 


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(II) in clause (i)— 

(aa) by inserting ‘‘or an order under section 4,’’ before ‘‘the 

standard for review’’; 

(bb) by striking ‘‘such rule’’ and inserting ‘‘such rule or 

order’’; 

(cc) by striking ‘‘the rule’’ and inserting ‘‘the rule or order’’; 

and 

(dd) by striking the semicolon and inserting ‘‘; and’’; and 

(III) by striking clause (ii) and redesignating clause (iii) as clause 

(ii); and 

(B) in paragraph (2), by striking ‘‘any rule’’ and inserting ‘‘any rule or 

order’’. 

(k) 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’’. 

(l) 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)’’; 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)’’; 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)’’; 

(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 ‘‘or an order under section 6(b)(2)’’. 

(m) 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). 

(n) SECTION 27.—Section 27(a) of the Toxic Substances Control Act (15 U.S.C. 

2626(a)) is amended by striking ‘‘rules promulgated’’ and inserting ‘‘rules, orders, or 

consent agreements’’. 

(o) 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’’. 

PURPOSE AND SUMMARY

To modernize the Toxic Substances Control Act of 1976, to identify and control unreasonable risks of injury to health or the environment from the manufacture, processing, distribution in commerce, use, and disposal of chemical substances, facilitate interstate commerce, and for other purposes. 

BACKGROUND AND NEED FOR LEGISLATION

In 1971, the President’s Council on Environmental Quality proposed comprehensive Federal legislation to identify and control potentially dangerous chemicals in U.S. commerce that were not adequately regulated under other Federal environmental statutes. 

President Ford signed the Toxic Substances Control Act (TSCA) (15 

U.S.C. 2601 et seq.) into law on October 11, 1976. 

Under TSCA, the Environmental Protection Agency (EPA) is responsible for identifying, testing, and regulating chemical substances in U.S. commerce whose manufacture, processing, distribution in commerce, use, and disposal present or will present an unreasonable risk of injury to health or the environment. 

In the nearly four decades since its enactment and particularly 

during the last decade, there have been persistent concerns about 

the pace of EPA’s work under TSCA, the ability of the Agency to 


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use its existing authority, and whether the statute prevents certain 

regulatory efforts. 

A variety of factors, including EPA’s slow pace in regulating 

chemicals already on the market, has led to several new State 

chemical control statutes—ranging from specific chemical restrictions to general chemical control programs—and retailer-based systems to identify and promote products that were considered safer 

for consumers. Ultimately, public confusion about chemical-specific 

claims, a perceived lack of expeditious action by EPA, and a domestic and foreign marketplace that has become increasingly uneven, 

unpredictable, and incompatible with economic and regulatory realities led Congress to examine TSCA and how it can operate more 

effectively in the 21st century. 

Oversight by the Committee yielded two conclusions about TSCA 

modernization. First, not every part of TSCA needs to be rewritten—and those that do are places where there is widespread agreement. Second, not every problem with TSCA is a statutory problem. 

EPA may, if it chooses, use existing authority to remedy these concerns. 

In light of these conclusions, the Committee on Energy and Commerce focused on giving the Agency more direct tools to obtain testing information on chemical substances, restructuring the way existing chemicals are evaluated and regulated, clarifying the treatment and availability of trade secrets submitted to EPA, updating 

the collection of fees needed to support EPA’s implementation of 

TSCA, assuring high quality science is used by the Agency, and organizing the Federal-State regulatory relationship in a way that 

makes sense for promoting interstate and global commerce, but 

also recognizes non-conflicting efforts taken by several States. 

HEARINGS

The Subcommittee on Environment and the Economy held a 

hearing entitled ‘‘H.R. ll, the TSCA Modernization Act’’ on April 

14, 2015. The Subcommittee received testimony from: 

• Jim Jones, Assistant Administrator, Office of Chemical Safety 

and Pollution Prevention, U.S. Environmental Protection Agency; 

• Michael P. Walls, Vice President of Regulatory and Technical 

Affairs, American Chemistry Council; 

• Beth Bosley, President, Boron Specialties, LLC, on behalf of 

the Society of Chemical Manufacturers and Affiliates; 

• Jennifer Thomas, Senior Director, Federal Government Affairs, 

Alliance of Automobile Manufacturers; and 

• Andy Igrejas, Director, Safer Chemicals, Healthy Families. 

COMMITTEE CONSIDERATION

On May 14, 2015, the Subcommittee on Environment and the 

Economy met in open markup session and forwarded a Committee 

Print entitled the ‘‘TSCA Modernization Act’’ to the full Committee, 

as amended, by a record vote of 21 yeas and 0 nays. On June 2 

and June 3, 2015, the Committee on Energy and Commerce met in 

open markup session and ordered H.R. 2576, the ‘‘TSCA Modernization Act,’’ reported to the House, as amended, by a recorded 

vote of 47 yeas and 0 nays, and 1 present. 


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COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion 

to report legislation and amendments thereto. A motion by Mr. 

Upton to order H.R. 2576 reported to the House, with amendment, 

was agreed to by a record vote of 47 ayes and 0 nays, and 1 

present. The following reflects the record votes taken during the 

Committee consideration: 


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COMMITTEE OVERSIGHT FINDINGS

Pursuant to clause 3(c)(1) of rule XIII of the Rules of the House 

of Representatives, the Committee held a hearing and made findings that are reflected in this report. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

To better permit the Administrator of the Environmental Protection Agency to identify and control unreasonable risks of injury to 

health or the environment from the manufacture, processing, distribution in commerce, use, and disposal of chemical substances, 

mixture, and articles containing a chemical substance; to facilitate 

interstate commerce; to increase access to information about chemicals for necessary responses while protecting legitimate trade secrets; to increase consumer confidence; and for other purposes. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

In compliance with clause 3(c)(2) of rule XIII of the Rules of the 

House of Representatives, the Committee finds that H.R. 2576, 

would result in no new or increased budget authority, entitlement 

authority, or tax expenditures or revenues. 

EARMARK, LIMITED TAX BENEFITS, AND LIMITED TARIFF BENEFITS

In compliance with clause 9(e), 9(f), and 9(g) of rule XXI of the 

Rules of the House of Representatives, the Committee finds that 

H.R. 2576 contains no earmarks, limited tax benefits, or limited 

tariff benefits. 

COMMITTEE COST ESTIMATE

The Committee adopts as its own the cost estimate prepared by 

the Director of the Congressional Budget Office pursuant to section 

402 of the Congressional Budget Act of 1974. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House 

of Representatives, the following is the cost estimate provided by 

the Congressional Budget Office pursuant to section 402 of the 

Congressional Budget Act of 1974: 

U.S. CONGRESS, CONGRESSIONAL BUDGET OFFICE, Washington, DC, June 23, 2015. 

Hon. FRED UPTON, 

Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 2576, the TSCA Modernization Act of 2015. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Susanne S. Mehlman. 

Sincerely, 

KEITH HALL. 


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Enclosure. 

H.R. 2576—TSCA Modernization Act of 2015 

Summary: H.R. 2576 would modify the Toxic Substances Control 

Act (TSCA), the law that regulates the manufacture, importation, 

and processing of chemicals, with the aim of strengthening the Environmental Protection Agency’s (EPA’s) ability to evaluate and 

regulate potentially hazardous chemicals. 

CBO estimates that EPA would incur additional costs to conduct 

safety evaluations of chemical substances over the 2016–2020 period in order to meet the new requirements imposed by H.R. 2576; 

we estimate that implementing this legislation would cost $64 million over the next five years and $143 million over the 2016–2025 

period, assuming appropriation actions consistent with the bill. 

Under the legislation, EPA would be authorized to charge two 

types of fees for some of its work under the legislation. Those fees 

would have different budgetary treatments. One fee would be classified as a mandatory offsetting receipt and the other would be 

classified as a revenue. Based on information provided by the agency, CBO estimates that enacting the legislation would increase offsetting receipts, which are treated as reductions in direct spending, 

by $115 million over the 2016–2025 period; revenues would increase by $121 million over the same period, net of income and 

payroll tax offsets. Pay-as-you-go procedures apply because the bill 

would affect direct spending and revenues. 

H.R. 2576 would impose intergovernmental and private-sector 

mandates, as defined in the Unfunded Mandates Reform Act 

(UMRA), on manufacturers, processors, importers, and users of 

chemical substances. CBO estimates that the aggregate cost of 

those mandates would fall below the annual thresholds established 

in UMRA for intergovernmental and private-sector mandates ($77 

million and $154 million in 2015, respectively, adjusted annually 

for inflation). 

Major provisions: The bill’s major provisions would: 

• Require EPA to develop policies, procedures, guidance, and 

rules to implement the bill; 

• Authorize EPA to obtain new information from manufacturers 

and processors necessary to conduct risk evaluations on chemical 

substances; 

• Require EPA to initiate at least 10 risk evaluations annually 

on chemical substances the agency determines may present an unreasonable risk of injury to human health or the environment; 

• Require EPA to publish a list of chemicals that are considered 

to be persistent, bioaccumulative and toxic (PBTs) and to designate 

any such PBTs as a ‘‘chemical of concern’’ for which EPA can take 

regulatory action; 

• Require EPA to review any renewed requests from manufacturers and processors to keep certain information confidential beginning 10 years after the original designations concerning confidentiality are made; 

• Address when federal actions under TSCA preempt requirements of state and local governments related to restricting and 

banning chemical substances; and 

• Require EPA to establish a new schedule for charging fees to 

chemical manufacturers who are required to submit data to the 


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agency or who request that EPA assess certain chemicals that are 

not yet prioritized for review by EPA. 

Estimated cost to the Federal Government: The estimated budgetary impact of H.R. 2576 is shown in the following table. The costs 

of this legislation fall within budget function 300 (natural resources 

and environment). 

By fiscal year, in millions of dollars— 

2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2016– 

2020 

2016– 

2025 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Administrative Expenses 

under TSCA: 

Estimated Authorization Level .............. 15 15 15 15 15 15 16 16 17 17 75 156 

Estimated Outlays .... 6 13 15 15 15 15 15 16 16 17 64 143 

CHANGES IN DIRECT SPENDING 

PMN Fee Collections: 

Estimated Budget 

Authority ............... 0 ¥7 ¥10 ¥14 ¥14 ¥14 ¥14 ¥14 ¥14 ¥14 ¥45 ¥115 

Estimated Outlays .... 0 ¥7 ¥10 ¥14 ¥14 ¥14 ¥14 ¥14 ¥14 ¥14 ¥45 ¥115 

CHANGES IN REVENUES 

Estimated Revenues .......... 2 7 7 15 15 15 15 15 15 15 46 121 

NET INCREASE OR DECREASE (¥) IN THE DEFICIT FROM CHANGES IN DIRECT SPENDING AND REVENUES 

Net Change in the Deficit ¥2 ¥14 ¥17 ¥29 ¥29 ¥29 ¥29 ¥29 ¥29 ¥29 ¥91 ¥236 

Notes: TSCA = Toxic Substances Control Act; PMN = Premanufacturing Notice. 

For direct spending, a negative number in indicates a decrease in outlays; for revenue, a positive number indicates an increase in revenues. 

Basis of estimate: For this estimate, CBO assumes that H.R. 

2576 will be enacted near the end of 2015 and that the necessary 

amounts will be appropriated each year. 

Spending subject to appropriation 

CBO estimates that implementing H.R. 2576 would cost $64 million over the 2016–2020 period, subject to appropriation of the necessary amounts. While some of the requirements in H.R. 2576 are 

similar to activities currently performed by EPA under TSCA, CBO 

estimates that implementing this legislation would increase EPA’s 

administrative workload for regulating chemical safety by about 25 

percent each year. That estimate is based on historical information 

about how other large regulatory programs have been implemented 

by EPA and on estimates that were provided by the agency of the 

additional workload under the bill. According to EPA, the agency 

currently requires, on average, an appropriation of about $58 million annually to implement and enforce EPA’s Chemical Risk Review and Reduction program under TSCA. That funding supports 

roughly 245 employees. Subject to appropriation of the necessary 

amounts, CBO estimates that EPA would require about $15 million 

annually over the next five years to cover the costs of additional 

personnel, contractors, and other administrative activities associated with meeting the new requirements of H.R. 2576. 

H.R. 2576 also specifies that all additional fees collected by EPA 

under the bill would be available for spending on the safety analysis of individual chemicals, subject to appropriation of those 

amounts. (A more detailed discussion of the fees is provided below.) 


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Direct spending and revenues 

Enacting this legislation would affect one existing fee and would 

authorize EPA to collect a new fee. Those fees would be recorded 

differently in the budget, as discussed below. CBO estimates that 

the gross collections would total $108 million over the 2016–2020 

period, and would be available for spending on chemical safety 

evaluations, subject to appropriation of those amounts. 

Premanufacturing Notice (PMN) Fees. Under the legislation the 

statutory cap in TSCA on the amount EPA can charge manufacturers and processors for premanufacturing notices would be eliminated. (Manufacturers or processors who plan to use a new chemical substance for a non-exempt commercial purpose are required 

to provide EPA with notice before initiating the activity. EPA then 

performs a risk assessment on the new chemical substance.) PMN 

fees are currently classified in the budget as offsetting receipts (a 

reduction in direct spending). CBO estimates that by eliminating 

the cap, EPA would begin collecting additional fees in 2017 and 

that such collections would total $7 million in that year. By 2019, 

we estimate that as more chemicals are reviewed by EPA, collections would reach $14 million annually. In total CBO estimates 

that direct spending would be reduced by $45 million over the next 

five years and by $115 million over the next 10 years. 

Manufacturing/Processor Requested Assessment Fees. In addition, under H.R. 2576 EPA could charge fees to manufacturers and 

processors who request that EPA initiate risk evaluations for 

chemicals that have not been designated a priority for further assessment. Those new fees would be classified as revenues because 

their payment would be compulsory, enforced by the federal government’s sovereign authority. CBO estimates that EPA would 

begin collecting additional fees in 2016 and that by 2019 such revenue would total $20 million annually. We estimate that gross revenues would total $63 million over the next five years and $163 

million over the next ten years. Such amounts would be available 

for spending on risk evaluations, subject to future appropriation action. However, the amount of revenue attributable to this bill 

would be approximately 25 percent less to account for income and 

payroll tax offsets. Net of those offsets, CBO estimates that enacting H.R. 2576 would increase revenues by $121 million over the 

2016–2025 period. 

Enacting H.R. 2576 also could affect direct spending and revenues because this bill would establish new authority for EPA to assess civil and criminal penalties against persons who receive confidential business information and then improperly use or disclose 

such information. Criminal penalties are recorded as revenues, 

then deposited in the Crime Victims Fund, and later spent; civil 

penalties are recorded as revenues. CBO estimates that any increase in criminal or civil penalties under the bill would not be significant. 

Pay-as-You-Go considerations: The Statutory Pay-As-You-Go Act 

of 2010 establishes budget-reporting and enforcement procedures 

for legislation affecting direct spending or revenues. CBO estimates 

that any fee collections over the 2016–2025 period would result in 

a decrease in direct spending and an increase in revenues as shown 

in the following table. 


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CBO ESTIMATE OF PAY-AS-YOU-GO EFFECTS FOR H.R. 2576, AS ORDERED REPORTED BY THE 

HOUSE COMMITTEE ON ENERGY AND COMMERCE ON JUNE 3, 2015 

By fiscal year, in millions of dollars— 

2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2015– 

2020 

2015– 

2025 

NET INCREASE OR DECREASE (¥) IN THE DEFICIT 

Statutory Pay-AsYou-Go Impact ... 0 ¥2 ¥14 ¥17 ¥29 ¥29 ¥29 ¥29 ¥29 ¥29 ¥29 ¥91 ¥236 

Memorandum: 

Changes in 

Outlays ...... 0 0 ¥7 ¥10 ¥14 ¥14 ¥14 ¥14 ¥14 ¥14 ¥14 ¥45 ¥115 

Changes in 

Revenues ... 0 2 7 7 15 15 15 15 15 15 15 46 121 

Intergovernmental and private-sector impact: H.R. 2576 would 

impose intergovernmental and private-sector mandates, as defined 

in UMRA, on manufacturers, processors, importers, and users of 

chemical substances. CBO estimates that the aggregate cost of 

those mandates would fall below the annual thresholds established 

in UMRA for intergovernmental and private-sector mandates ($77 

million and $154 million in 2015, respectively, adjusted annually 

for inflation). 

Mandates that apply to both public and private entities 

H.R. 2576 would modify the standard used to determine whether 

a chemical substance presents an unreasonable risk to human 

health or the environment and would allow EPA to regulate the 

manufacture, processing, distribution, use, and disposal of chemical 

substances to ensure the standard is met. If EPA determines that 

some chemical substances do not meet the standard and issues regulations for those substances, the bill would impose an intergovernmental and private-sector mandate. The bill also would impose an 

intergovernmental and private-sector mandate if EPA uses its authority under the bill to expedite the regulation of any chemical 

substance determined to be persistent, bioaccumulative, and toxic. 

EPA would have the authority to adopt a range of regulatory options to address risks from chemical substances. For example, EPA 

could limit the amount manufactured or require manufacturers to 

put warning labels on selected chemicals. EPA also could require 

users of chemicals, such as public and private universities conducting research, to handle or dispose of selected chemicals in a 

certain way. Based on information from industry experts, CBO expects that the annual cost of any restriction would not be substantial. Also, because of the amount of time involved in evaluating the 

risk of each chemical, any restrictions imposed would apply to few 

chemicals in the first five years the mandate is in effect. Therefore, 

CBO estimates that the cost of the mandate would be small for 

both public and private entities during that time. 

Mandates that apply to public entities only 

The bill would impose an intergovernmental mandate by preempting state regulations that conflict with the federal regulation 

of chemicals, but that preemption would impose no duty on states 

that would result in additional spending or a loss of revenues. 


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Mandates that apply to private entities only 

The bill would impose additional private-sector mandates on 

manufacturers, importers, and processors of chemical substances. 

By removing the cap on fees assessed by EPA when manufacturers 

and importers submit premanufacture notices, the bill would increase the cost of an existing mandate to pay those fees. CBO estimates that the increase in fees would start in 2017 and would 

reach $14 million annually beginning in 2019. The bill also would 

require manufacturers and processors of chemical substances to 

submit data to EPA for use in carrying out risk evaluations. Manufacturers and processors also would have to include additional information along with any data to substantiate a request that EPA 

protect their data as confidential business information. Based on 

information from industry experts, CBO expects that the cost to 

submit those data would not be substantial. 

Previous CBO estimate: On June 5, 2015, CBO transmitted a 

cost estimate for S. 697, the Frank R. Lautenberg Chemical Safety 

for the 21st Century Act, as ordered reported by the Senate Committee on Environment and Public Works on April 28, 2015. Both 

S. 697 and H.R. 2576 would increase EPA’s administrative workload by roughly equivalent amounts to meet new requirements 

under TSCA and both bills would enable EPA to charge fees to 

chemical manufacturers and processors for certain activities, 

though the types of fees charged and the amounts collected would 

vary between the two bills. Furthermore, because the classification 

of fees under the two bills differs, collections under the bills would 

have different budgetary implications. Under S. 697 the fees collected would be classified as offsetting collections and would more 

than offset the additional discretionary spending estimated under 

S. 697. In contrast, the fees collected under H.R. 2576 would result 

in a reduction in direct spending and an increase in revenues. The 

cost estimates for the two bills reflect the different budgetary treatment. 

Estimate prepared by: Federal spending: Susanne Mehlman; impact on state, local, and tribal governments: Jon Sperl; impact on 

the private sector: Amy Petz. 

Estimate approved by: Theresa Gullo, Assistant Director for 

Budget Analysis. 

FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of Federal mandates prepared by the Director of the Congressional Budget Office 

pursuant to section 423 of the Unfunded Mandates Reform Act. 

DUPLICATION OF FEDERAL PROGRAMS

No provision of H.R. 2576 establishes or reauthorizes a program 

of the Federal Government known to be duplicative of another Federal program, a program that was included in any report from the 

Government Accountability Office to Congress pursuant to section 

21 of Public Law 111–139, or a program related to a program identified in the most recent Catalog of Federal Domestic Assistance. 


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DISCLOSURE OF DIRECTED RULE MAKINGS

The Committee estimates that enacting H.R. 2576 specifically directs to be completed at least 4 rule makings within the meaning 

of 5 U.S.C. 551. 

ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the 

Federal Advisory Committee Act were created by this legislation. 

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that the legislation does not relate to the 

terms and conditions of employment or access to public services or 

accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title; table of contents 

Section 1 provides the short title of ‘‘TSCA Modernization Act of 

2015.’’ 

Section 2. Definitions 

The legislation amends TSCA section 3 to add two new definitions to the law. First, the legislation defines the use of the term 

‘‘intended conditions of use’’ to mean the circumstances under 

which a chemical substance is intended, known, or reasonably foreseeable to be manufactured, processed, distributed in commerce, 

used, and disposed. The Committee expects that the Agency will 

generally interpret this to mean intended by the manufacturer, 

known by the manufacturer or the public, or reasonably foreseeable 

by the manufacturer or the Administrator. 

The section also defines ‘‘potentially exposed subpopulations’’ to 

mean a group or a number of individuals within the general population who, due to greater susceptibility or greater potential exposure, are likely to be at greater risk than the general populations 

of adverse health effects from exposure to the chemical substance. 

As this term does not specify any particular group, the Administrator may focus attention on persons whose settings or physical 

attributes predispose them to adverse health consequences based 

upon exposure to the chemical substance. This term may include, 

among others, workers, infants, children, pregnant women, and the 

elderly. It is the Committee’s intention that the Administrator be 

clear about who is being identified and the basis for such a decision 

when invoking provisions involving subpopulations. 

Section 3. Testing of chemical substances and mixtures 

Section 3 amends TSCA section 4 to improve EPA’s ability to develop hazard and exposure data about chemicals in commerce to inform decisions required by the updated law. 

First, in addition to rulemaking authority, this section authorizes 

EPA to enter into a consent agreement or use order authority to 

require the development of health and environmental effects data 

on a chemical substance or mixture. 


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Second, this section allows EPA to require testing of a chemical 

substance when necessary to complete a risk evaluation of that 

chemical under section 6(b). The Committee intends ‘‘necessary’’ to 

mean that this grant of authority only be employed to fill a gap in 

the Agency’s existing data on the chemical substance that otherwise precludes a determination on a chemical substance. 

The increased testing authority in H.R. 2576 reflects the Committee consensus that EPA should have the information necessary 

to fill knowledge gaps before making regulatory decisions. Curiosity 

alone is insufficient to compel new testing. The Committee believes 

that the broader and simpler manner of requiring new test information by order or consent agreement, the new authority given to 

EPA to compel the creation of new data under section 4(a)(1)(C), 

and the Agency’s existing authority under section 8 will enable 

EPA to close knowledge gaps. 

Section 4. Regulation of hazardous chemical substances and mixtures 

To help the Agency function more effectively in dealing with existing chemicals, the Committee reorganized TSCA section 6 to 

specify what is expected of the Administrator in making discrete 

decisions. 

Section 4 makes substantive, clarifying, and structural changes 

to TSCA section 6. For example, where existing TSCA section 6(a) 

combines three undertakings—the finding of unreasonable risk, the 

standard for regulation, and the control measures available under 

any regulation, H.R. 2576 splits these actions into two separate 

subsections with distinct functions: section 6(a) establishes the 

standard for issuing regulations and the universe of available control measures for existing chemical substances and mixtures, and 

section 6(b) establishes a separate risk evaluation process for determining whether a chemical substance presents or will present an 

unreasonable risk of injury. If the Administrator makes such a determination, then a regulation to address that risk is warranted 

under section 6(a), and the Administrator must proceed to section 

6(a) rulemaking. 

Section 4(a) repeals the requirements in TSCA section 6(a) that 

a rule restricting a chemical substance or mixture apply the least 

burdensome requirements, be predicated upon the Administrator 

finding a ‘‘reasonable basis to conclude’’ an unreasonable risk is 

present or will be present, and ‘‘protect adequately’’ against the unreasonable risk. Instead, section 6(a) obliges the Administrator to 

apply requirements on a chemical substance or mixture to the extent necessary so that the chemical substance or mixture no longer 

presents or will present an unreasonable risk, including an identified unreasonable risk, to a potentially exposed subpopulation. 

The restrictions that the Administrator is authorized to impose 

are not changed by the TSCA Modernization Act. Because a chemical substance’s intended conditions of use are important in defining the risk it presents, the Committee expects that the Administrator, in applying any requirements, will address identified circumstances of manufacturing, processing, distribution in commerce, 

use, or disposal of a chemical substance or mixture that presents 

or will present an unreasonable risk of injury to health or the environment that require control. 


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Section 4(b) replaces TSCA section (6)(b) (Quality Control) with 

a new section 6(b) to determine whether, based upon a scientific 

risk evaluation of a chemical substance, the substance presents or 

will present, in the absence of new requirements under TSCA section 6(a), an unreasonable risk of injury to human health or the environment. New section 6(b) generally prohibits EPA from restricting a chemical substance before making this determination based 

on the findings of the risk evaluation. 

A risk evaluation under section 6(b) is initiated in one of two 

ways. Under subsection (b)(3)(A)(i), the Administrator is required 

to conduct and publish the results of a risk evaluation of a chemical substances already in commerce when the Administrator determines that it may present an unreasonable risk of injury to human 

health or the environment because of a combination of potential 

hazard from and a potential route of exposure to the chemical 

under its intended conditions of use. The standard for making this 

determination is broad and flexible because its application precedes 

the detailed scientific risk evaluation that it triggers. 

Subsection (b)(3)(B) also allows the Administrator, without making the determination in (b)(3)(A)(i), to conduct and publish the results of a risk evaluation for a chemical listed on the TSCA Work 

Plan for Chemical Assessments as of the date of enactment of the 

TSCA Modernization Act. 

The Committee understands that the TSCA Work Plan represents the Agency’s current priorities for risk review and potential 

risk management under TSCA. Nothing in this bill is intended to 

require the Agency to change or revise those priorities. The Committee expects that many, if not all, of the Agency’s selections for 

Agency initiated risk evaluations in the first years after enactment 

will come from the Work Plan and that risk evaluations for Work 

Plan chemicals will be completed in the first years. 

Subsection (b)(3)(A)(ii) provides that the Administrator must also 

perform a risk evaluation if a manufacturer requests it. 

Section 4(b) establishes new section 6(b)(4) and imposes six requirements on the Administrator for conducting a risk evaluation. 

First, the Administrator must integrate and assess information on 

hazards and exposures for all of the intended conditions of use of 

the chemical substance, including information relevant to specific 

risks of injury to health or the environment and information on potentially exposed subpopulations. 

The Committee expects that the Administrator will consider existing Federal or State risk reduction measures (e.g., existing State 

labeling requirements) as part of its exposure calculation. 

Second, the Administrator is barred from considering information 

on costs and other factors not related to health or the environment 

when performing section 6(b) risk evaluations. Thus, EPA’s determination whether the chemical presents an unreasonable risk of injury and requires regulation should be strictly risk-based. 

Third, the Administrator must take into account, where relevant, 

the likely duration, intensity frequency, and number of exposures 

under the intended conditions of use of the chemical substance. 

Fourth, the Administrator must describe the weight of the scientific evidence for identified exposure and hazard. 

Fifth, the Administrator must consider whether the weight of the 

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ical substance below which no adverse effects can be expected to 

occur. The Committee does not intend to suggest when such doses 

can be expected to occur. 

And sixth, when a risk evaluation is requested by a manufacturer pursuant to paragraph 3(A)(ii), the Administrator is required 

to ensure that the costs to the Environmental Protection Agency of 

conducting the risk evaluation are paid by the manufacturer, including contractor costs. 

New section 6(b)(5) imposes deadlines on the Administrator when 

conducting risk evaluations under section 6(b) and promulgating 

rules pursuant to subsection (a). Under new paragraph (5)(A), the 

Administrator must conduct and publish the results of a risk evaluation as soon as reasonably possible, subject to the availability of 

resources, but no later than three years after making a determination under paragraph (3)(A)(i), beginning the risk evaluation under 

paragraph (3)(B), or after a manufacturer requests a risk evaluation under (3)(a)(ii). New paragraph (5)(C) provides that if the Administrator determines that additional information is needed to 

complete a risk evaluation, the Administrator may extend the 

deadline to no later than ninety days after receipt of such additional information, or two years after the original deadline. 

New paragraph (5)(B) provides deadlines for rules issued under 

section 6(a). If, based on a risk evaluation conducted under section 

6(b), the Administrator determines that in the absence of a new 

rule a chemical presents or will present an unreasonable risk of injury to health or the environment, the Administrator must propose 

a rule under subsection (a) for the chemical substance within ninety days of publishing the risk evaluation regarding such chemical 

substance. Additionally, new paragraph (5)(B) requires the Administrator to publish a final rule in the Federal Register no later than 

180 days after publishing the risk evaluation regarding such chemical substance. 

New paragraph 6 of TSCA section 6(b) requires the Administrator, no later than thirty days before publishing a final determination that a chemical substance does not and will not present 

an unreasonable risk of injury to health or the environment, to 

make a preliminary determination to such effect and to provide 

public notice of and an opportunity for comment regarding such 

preliminary determination. 

New section 6(b)(6)(B) prevents the Administrator from making 

a determination that a chemical substance will not present an unreasonable risk of injury to health or the environment if, under the 

intended conditions of use, the chemical substance presents or will 

present an unreasonable risk of injury to one or more potentially 

exposed subpopulations. A final determination under subsection (b) 

that a chemical substance will not present an unreasonable risk of 

injury to health or the environment is designated a final agency action. 

Finally, new section 6(b)(7) of section 4 of H.R. 2576 requires the 

Administrator, beginning in the fiscal year of the date of enactment, to initiate at least ten risk evaluations under paragraphs 

(3)(A)(i) or (3)(B), subject to the availability of appropriations. 

Section 4(c) makes changes to TSCA section 6(c), which contains 

requirements for promulgating a section 6(a) rule. The existing section 6(c)(1) requirements for the Administrator to consider and 


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publish a statement about the impacts of the chemical substance 

or mixture are largely retained in new section 6(c)(1)(A), with the 

consideration of substitutes moved to section 6(c)(1)(C) and the requirements for addressing chemical risks under other statutes administered by the Agency now in section 9(b). Under new TSCA 

subsection (c)(1)(B), the Administrator must impose requirements 

under the rule that, consistent with information published under 

subparagraph (A), are cost-effective, unless the Administrator determines that additional or different requirements described in 

subsection (a) are necessary to protect against the identified risk. 

The Committee chose this process to ensure that the universe of 

data from which the Administrator would be making a cost-effectiveness decision would be limited to only that information provided and considered as part of the rulemaking record. The Committee does not expect EPA to analyze the cost-effectiveness of an 

open-ended group of possible requirements, but to focus on those 

that meet the subsection (a) purpose of controlling an unreasonable 

risk of injury. The Administrator need not test each control measure in a rulemaking for its cost-effectiveness. While the Committee’s preference is that selected requirements be cost-effective, if no 

restriction is available that the Administrator determines cost-effective in managing the risk, the identified unreasonable risk must 

still be addressed. 

New subsection (c)(1)(C) requires the Administrator, in deciding 

whether to prohibit or substantially restrict a specific use of a 

chemical substance or mixture and in setting an appropriate transition period for such action, to determine whether a technically 

and economically feasible alternative to a chemical that benefits 

health or the environment, compared to the use proposed to be prohibited or restricted, will be reasonably available as a substitute 

when the proposed prohibition or restriction takes effect. 

New subsection (c)(1)(D) exempts replacement parts if they are 

designed prior to publication of the section 6(a) risk management 

rule in the Federal Register, unless the Administrator finds that 

they contribute significantly to the identified risk, including identified risks to identified potentially exposed subpopulations. Subsection (c)(1)(E) instructs the Administrator, when applying prohibitions or other restrictions to address an unreasonable risk of injury, to apply such prohibitions or restrictions to an article, on the 

basis of a chemical substance or mixture contained in that article, 

only to the extent necessary to protect against the unreasonable 

risk of injury from that article. 

Section 4(c) repeals the requirement for informal hearings, including cross examination of witnesses, found in TSCA section 

6(c)(3) and repeals the availability of compensation of attorney’s 

fees, expert witness fees, and other costs of participating in a proceeding for the promulgation of a subsection (a) rule found in TSCA 

paragraph 6(c)(4). 

Further, Section 4(d) adds a requirement at the end of section 

6(d)(2)(B) providing for a reasonable transition period for any rule 

promulgated under section 6(a). 

Section 4(e) of the TSCA Modernization Act adds three new subsections to the end of TSCA section 6 to address three distinct 

areas. 


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First, under section 4(e), new section 6(g) bars the Administrator 

from considering costs and other non-health factors when deciding 

whether to initiate a rulemaking under subsection (a). The intention of the Committee is to ensure that the decision whether a regulation under 6(a) is required be limited to whether a chemical 

substance presents or will present an unreasonable risk as determined in section 6(b). The Committee intends that decisions applying the standard of regulation in section 6(a) and selecting any control measures to achieve that standard are made in the context of 

the economic, practical, and other considerations set out in section 

6(c)(1). 

Second, section 4(e) adds a new TSCA section 6(h) for cases in 

which the Administrator might find that any requirements to prevent a chemical substance or mixture from presenting an unreasonable risk are not cost-effective, but that a specific use of the chemical substance is critical or essential to prevent disruption to the 

national economy, national security, or critical infrastructure. 

Section 6(h) allows the Administrator to grant a renewable exemption from such a requirement for a specific use for up to five 

years. To obtain an exemption, the Administrator must determine, 

pursuant to section 6(c)(1)(B), that the requirement is not cost-effective with respect to a specific use and must find that either the 

specific use is critical or essential, or the requirement as applied 

with respect to the specific use would significantly disrupt the national economy, national security, or critical infrastructure. An exemption must be preceded by a notice and comment period and 

supported by clear and convincing evidence. If the exemption is 

granted, EPA must then provide notice of the exemption, and the 

manufacturer or processor must notify known commercial purchasers. The Administrator is required to impose conditions on any 

use for which an exemption is granted in order to reduce risk from 

the chemical substance or mixture to the greatest extent feasible. 

Finally, section 4(e) adds a new TSCA section 6(i) regarding Persistent, Bioaccumulative, and Toxic Chemicals (PBTs). First, new 

section 6(i) instructs the Administrator to publish a list, not later 

than nine months after the date of enactment, of chemicals the Administrator has a reasonable basis to conclude are persistent, bioaccumulative, and toxic. Subsection (i) excludes the placement on 

this list of metals, metal compounds, or chemical substances already regulated under TSCA section 6(e). The Committee hopes the 

Administrator will rely on its TSCA Work Plan Chemicals Methods 

Document published in February 2012 in identifying PBT candidate substances for listing. Upon its publication, either the Administrator or a chemical substance’s manufacturer has ninety 

days to decide whether to initiate a risk evaluation under TSCA 

section 6(b) rather than further evaluation under section 6(i). 

Second, no later than two years after the date of enactment, the 

Administrator is to designate as a PBT chemical of concern any 

chemical substance on the list: (1) that scores ‘‘high’’ for persistence 

or bioaccumulation and ‘‘high’’ or ‘‘moderate’’ in regard to the other, 

using the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012, and (2) where exposure is likely to the general population or a potentially exposed 

subpopulation identified by the Administrator. Last, the Administrator, subject to availability of appropriations, within two years of 


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designating a chemical substance a PBT chemical of concern, must 

promulgate a rule under section 6(a), and in keeping with the rest 

of the factors in sections 6 and 9, to reduce, to the extent practicable, likely exposure to that PBT chemical. 

These reforms to section 6 are intended to permit the Agency to 

identify unreasonable risks and address them effectively. To many 

members of the Committee, an important measure of TSCA reform 

proposals has been whether the proposal would enable EPA to take 

broader regulatory action to protect against unreasonable risks 

from asbestos. The Committee expects this legislation to enable 

that regulatory action. 

Finally, while the phrase ‘‘unreasonable risk of injury’’ is not 

amended, it must be read in the context of the changes to section 

6, including the functions and purposes delineated in subsections 

(a), (b), and (c). 

Section 5. Relationship to other Federal laws 

H.R. 2576 reinforces TSCA’s original purpose of filling gaps in 

Federal law that otherwise did not protect against the unreasonable risks presented by chemicals. The Joint Explanatory Statement of the Committee of Conference for the legislation, which is 

now Title I of TSCA, clearly states that ‘‘[t]he conferees have 

drawn from both the Senate bill and the House amendment to assure that overlapping or duplicative regulation is avoided’’ and: 

If the Administrator determines that a risk to health or 

the environment associated with a substance or mixture 

could be eliminated or reduced to a sufficient extent by actions taken under authorities contained in other Federal 

laws, then the Administrator shall use such other authorities, unless the Administrator determines . . . it is in the 

public interest to use this Act. 

This section adds a new paragraph to TSCA section 9(b) to help 

the Administrator decide whether using TSCA Title I or another 

Federal authority provided to the Administrator is ‘‘in the public 

interest.’’ Specifically, the new paragraph requires the Administrator to consider the relevant aspects of the risks posed by the 

chemical substance and compare the estimated costs of actions 

taken under Title I of TSCA or another Federal law with the relative efficiencies of protecting against the risk presented through 

actions taken under such laws. This new paragraph reflects language in section 6 current law that is removed by section 4 of the 

bill. 

The Committee believes the added language will help to focus 

the Administrator’s exercise of discretion regarding which statute 

to apply and to encourage decisions that avoid confusion, complication, and duplication. For example, if the Administrator determines 

that a risk to health or the environment associated with disposal 

of a chemical substance could be eliminated or reduced to a sufficient extent under the Solid Waste Disposal Act, the Administrator 

should use those authorities to protect against the risk. Likewise, 

while section 5 makes no amendment to TSCA section 9(a), the 

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tional safety. Specifically, the Committee does not intend for the 

implementation of TSCA to conflict with or disregard Occupational 

Safety and Health Administration’s hierarchy of controls. 

Section 6. Disclosure of data 

Section 6 makes a number of changes to the way TSCA section 

14 operates. 

First, it authorizes three new classes of persons to receive information submitted to EPA and protected as confidential business information (CBI). These are State and local governments and tribal 

officials who request it for the purpose of administering or enforcing a law; Federal or State environmental professionals when responding to a release of a contaminant to the environment; and a 

treating physician or other health care professional for the purpose 

of diagnosing and treating an ailing person. 

Second, the legislation requires persons receiving protected CBI 

to use the information only for the purpose for which it was obtained. Additionally, the legislation prohibits the disclosure of CBI 

to any person not authorized to receive it. Section 9 of the legislation, Conforming Amendments, makes a violation of these two requirements punishable through civil or criminal penalties or both. 

These sanctions are similar to penalties for unauthorized disclosure 

by Federal employees and Federal information protection laws that 

apply to the private sector, including the Health Insurance Portability and Accountability Act (42 USC 1320d–5). 

Third, H.R. 2576 requires any manufacturer, processor, or distributor in commerce when submitting information to the Administrator to designate the information it believes qualifies for protection under the law. This designation, which applies only to information submitted to the Administrator after the date of enactment, 

must be made in writing and include: (1) a justification for each 

designation of confidentiality; (2) a certification that the information is not otherwise publically available; and (3) copies of all submitted information, one with the claimed CBI redacted and one 

with no redactions. In addition, information protected from public 

disclosure pursuant to these new requirements is required to be 

made public ten years after its initial grant of protection unless the 

requester submits a written renewal request that contains the necessary elements of the initial CBI protection request submission. 

H.R. 2576 does not extend these same requirements to information protected under TSCA section 14 as in effect before the date 

of enactment of this legislation. Notwithstanding the Committee’s 

concern that a retrospective requirement could have been burdensome for both the Agency and for small businesses as both try to 

implement all the new requirements of this legislation, the Committee supports ensuring that only legitimate CBI is protected. 

The Committee is aware that EPA has undertaken a significant 

effort in recent years to review past CBI claims using authority 

under current law. Nothing in this bill is intended to restrict that 

authority under current law or prevent the Agency from continuing 

to review past CBI claims. Similarly, nothing in this bill is intended to restrict the Agency’s ability to challenge, deny, or modify 

designations of information as CBI under this section. 

Fourth, the legislation requires EPA, sixty days before publicly 

releasing any information protected by TSCA section 14 or the 


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amendments made by this legislation, to notify the respective manufacturer, processor, or distributor in commerce of the date on 

which the information will be made public unless EPA prior to that 

date receives a valid request for protection. The Committee understands that in some cases it may be difficult for EPA to find the 

appropriate person with rightful claim to the CBI. The Committee 

inserted the requirement that EPA efforts be ‘‘appropriate and 

practicable’’ to ensure that the Agency makes a good faith effort to 

contact the proper party, but not engage in an endless search. 

Fifth, the legislation clarifies that while health and safety studies about a specific chemical substance or mixture are not eligible 

for protection as CBI, those studies cannot reveal data that would 

disclose formulas, including molecular structures, for chemical substances and mixtures whose protection as confidential has been justified to EPA. The Committee expects that redactions or the use of 

approved generic names or unique identifiers will be employed to 

meaningfully inform the public without comprising trade secrets. 

Last, this section creates a savings clause in a new TSCA section 

14(g) that states that nothing in TSCA section 14 shall be construed to affect the applicability of State or Federal rules of evidence or procedure in any judicial proceeding. 

Section 7. Effect on State law 

As amended by section 7, section 18 describes three instances in 

which an action by the Administrator would preempt State law. 

As in current law, section 18(a)(2)(A), continues to provide that 

if the Administrator requires testing of a chemical substance or 

mixture under TSCA section 4, no State or political subdivision 

may, after the effective date of the Administrator’s testing requirement, establish or continue in effect a requirement for testing of 

such substance or mixture for similar purposes. 

Section 18(a)(2)(B) is a new paragraph to reflect changes in how 

TSCA operates under new section 6(b). It provides that if the Administrator makes a final determination under section 6(b) that a 

chemical substance will not present an unreasonable risk of injury 

to health or the environment under the intended conditions of use, 

no State or political subdivision of a State may, after the date the 

determination is published, establish or continue in effect any requirement that applies to such chemical substance under the conditions of use and is designed to protect against exposure to such 

chemical substance under the intended conditions of use considered 

by the Administrator in the chemical’s risk evaluation under section 6(b). 

However, if a requirement of a State or political subdivision of 

a State is adopted under the authority of a Federal law or is adopted pursuant to a State or local requirement that protects air or 

water quality or is related to waste treatment or waste disposal, 

Federal preemption does not apply unless the requirement of a 

State or political subdivision of a State actually conflicts with a 

provision of Title I of TSCA or an action or determination made by 

the Administrator under TSCA Title I. 

Section 18(a)(2)(C) replaces TSCA section 18(a)(2)(B), which provides that if the Administrator applies a requirement under section 

5 or 6 to a chemical substance or mixture designed to protect 

against a risk of injury to health or the environment associated 


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with such chemical substance or mixture, no State or political subdivision of a State may, after the effective date of such requirement, establish or continue in effect any requirement that applies 

to such chemical substance or mixture (including a requirement 

that applies to an article because the article contains the chemical 

substance or mixture) and is designed to protect against exposure 

to the substance or mixture either under the intended conditions 

of use considered by the Administrator in the risk evaluation under 

section 6(b) or from a use identified in a notice received by the Administrator under section 5(a) or, in the case of a requirement imposed pursuant to section 6(i), is designed to protect against a risk 

of injury considered by the Administrator in imposing such a requirement, unless the State or political subdivision requirement is 

identical to the requirement imposed by the Administrator, is 

adopted under authority of a Federal law, or is adopted to protect 

air or water quality or is related to waste treatment or waste disposal. These exceptions do not apply if a provision of Title I of 

TSCA or an action or determination by the Administrator under 

Title I of TSCA actually conflicts with the requirement. Because 

State monitoring, information reporting, and disclosure requirements often are intended to detect leaks or other problems, inform 

regulatory agencies, or serve communities’ right to know, but not 

to protect against exposure to a chemical substance, the Committee 

expects that these type of requirements generally would fall outside 

the scope of preemption. 

In the case of an identical State requirement, section 7 adds a 

new TSCA section 18(a)(2)(i), which precludes a State from assessing a penalty for a specific violation for which the Administrator 

has assessed a penalty under TSCA section 16, Penalties. If 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 Federal and State penalties to exceed 

the maximum amount that may be assessed for that violation 

under TSCA section 16. 

Section 7 does not amend subsection 18(b) of TSCA, but adds a 

new subsection 18(c) to preserve certain State actions. First, nothing in Title I is to be construed to preempt enforcement of any action taken before August 1, 2015, under a requirement of a State 

or political subdivision of a State that prohibits or otherwise restricts the manufacture, processing, distribution in commerce, use 

or disposal of a chemical substance or any action taken pursuant 

to any State law in effect on August 31, 2003, unless an action or 

determination of the Administrator under TSCA title I actually 

conflicts with the State action. 

New section 18(c)(2) also preserves Federal and State tort law 

and State law governing interpretation of contracts. 

New section 18(c)(3) expresses Congressional intent that Title I 

of TSCA not be interpreted as influencing civil actions for damages 

in State court, or the admissibility of evidence under State law unless a provision of TSCA Title I actually conflicts with the State 

court action. 

New section (c)(4) clarifies that the term ‘‘requirements’’ when 

used in TSCA Title I does not include civil tort actions for damages 

under State law. 


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Finally, section 7(c) states that nothing in TSCA, or the amendments made to it by the TSCA Modernization Act, shall be construed as changing the preemptive effect of actions taken by the 

Administrator under TSCA before the date of enactment of the 

TSCA Modernization Act or under TSCA section 6(e). This simply 

means that an action taken by the Administrator under TSCA before enactment of the TSCA Modernization Act, and any action 

taken under section 6(e) after enactment will have the same preemptive effect that it would have had if the TSCA Modernization 

Act were not enacted. 

The Committee has heard concerns that courts may read in conflicts between Federal rules and State laws where none exist. The 

phrase ‘‘actually conflicts’’ is not included to invoke a particular 

precedent. The Committee does not expect conflicts to be found 

broadly or frequently. 

Section 8. Administration of the Act 

This section adds or makes changes to three parts of TSCA section 26. 

First, the legislation changes the fee provisions in TSCA section 

26(b). Specifically, it replaces the cap on fees for data submission 

under sections 4 (for new test data) and 5 (data about a new chemical or new use of a chemical)—currently set at $2,500 or $100 for 

small businesses—with a requirement that fees be ‘‘sufficient and 

not more than reasonably necessary.’’ The legislation also mandates that fees for small businesses be lower. The Committee expects that EPA will publish for notice and comment any regulations, policies, and procedures for setting, adjusting, and charging 

fees. The Committee is sympathetic to claims that EPA needs an 

updated fee structure reflective of today’s marketplace in order to 

operate a modernized TSCA. The Committee expects EPA to act 

prudently with this new authority. The Committee believes this 

new authority strikes the right balance for matching resources to 

needs. 

This section creates a ‘‘TSCA Service Fee Fund,’’ to be operated 

by the U.S. Treasury, where those user fees collected for sections 

4 and 5 and for risk evaluations requested by the manufacturer of 

a chemical substance under section 6(b) would be deposited. Funds 

deposited are made available to EPA only for use in administering 

the provisions of law for which they were collected. The legislation 

requires biannual EPA reports to Congress on fee income and disbursements, as well as annual TSCA Service Fee Fund audits by 

the EPA Inspector General to examine fee reasonableness, Fund 

management, and the Fund’s financial stability. 

Second, the legislation requires EPA, when making science-based 

decisions in sections 4, 5, and 6, to consider the quality of the 

science it is using. The Committee believes that high quality 

science is the foundation of good public policy. 

The criteria in new TSCA section 26(h) are drawn from EPA’s 

June 2003 ‘‘A summary of General Assessment Factors for Evaluating the Quality of Scientific and Technical Information.’’ The 

Committee believes this is a good baseline for the Agency to use 

in making scientific evaluations for the provisions of TSCA Title I. 

These factors relate to the soundness of the means used to generate information, its appropriateness for its intended use, the relVerDate Sep 11 2014 01:34 Jun 26, 2015 Jkt 049006 PO 00000 Frm 00032 Fmt 6659 Sfmt 6602 E:\HR\OC\HR176.XXX HR176

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evance of the information to the question being asked, the degree 

of the data’s clarity and completeness, the extent of variability and 

uncertainty in the underlying data, methods, or analysis of the 

data, and the use of independent verification, reliable study methods, and peer review. 

In addition to these information quality guidelines, the legislation creates a new TSCA section 26(i), which requires the Administrator to make decisions based upon the weight of the scientific evidence. The term ‘‘weight of evidence’’ refers to a systematic review 

method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate 

each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and 

appropriate based upon strengths, limitations, and relevance. This 

requirement is not intended to prevent the Agency from considering academic studies, or any other category of study. The Committee expects that when EPA makes a weight of the evidence decision it will fully describe its use and methods. 

Third, this section requires the Administrator, not later than two 

years after the date of enactment of this legislation, to develop any 

policies, procedures, and guidance that are necessary to implement 

the new provisions added to TSCA by this legislation. The language 

also mandates that EPA review the adequacy of these policies, procedures, and guidance, including as it relates to using animal testing and non-animal alternatives for assessing and determining risk 

every five years. After completing this review, EPA must make 

changes to the policies and guidance if necessary to reflect new scientific developments or understandings. The Committee does not 

intend for this language to require updates to these documents 

every five years, but expects the Agency to update them as needed 

to reflect generally accepted scientific and risk assessment practices. 

Last, this section requires the Administrator to report to Congress on the Agency’s capacity to conduct and publish risk evaluations under section 6 and to issue related or required rulemakings 

(as well as the resources needed to carry out section 6), and what 

needs to be done to ensure future capacity exists to meet future 

section 6 demands. 

Section 9. Conforming amendments 

This section makes technical and conforming amendments to 

Title I of TSCA to effectuate the two changes made in the other 

parts of this legislation. The first conforming amendment relates to 

the addition of authority for EPA to order testing under TSCA section 4 using orders or consent agreements. The other conforming 

amendment strikes the references to parts of existing TSCA section 

6 that no longer apply. 

The legislation made a single conforming change to TSCA section 

8. When H.R. 2576 was ordered reported, the Committee was 

aware of five specific issues about which regulated stakeholders 

recommended legislative language in H.R. 2576 to improve the implementation of some portions of TSCA section 8. These issues are: 

(1) resetting the TSCA section 8(b) inventory, (2) updating the 

standards for determining what constitutes a small manufacturer 

or processor for purposes of section 8(a) reporting, (3) limiting secVerDate Sep 11 2014 23:42 Jun 25, 2015 Jkt 049006 PO 00000 Frm 00033 Fmt 6659 Sfmt 6602 E:\HR\OC\HR176.XXX HR176

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tion 8(a) reporting requirements for byproducts if EPA already has 

that information and if the reporting discourages recycling, (4) requiring that EPA under section 8(b) consider chemical substances 

with multiple nomenclature conventions as a single inventory listing for both existing and new chemical substances, and (5) getting 

quicker and clearer responses from EPA on petitions for partial exemption from TSCA section 8(a) reporting due to a designation as 

a ‘‘low current interest’’ under 40 C.F.R. 711.6(b)(2)(iv). The exclusion of these items from H.R. 2576 should not be interpreted as a 

lack of interest by the Committee in the issues. Rather, the omission from H.R. 2576 is predicated on the understanding of the 

Committee that these are matters that EPA already has administrative authority under TSCA to address, and new or amended 

legal authority may not be required to accomplish these improvements under section 8. If the Administrator fails to promptly and 

adequately address these concerns, the Committee will work with 

other Members of Congress and with the Administration to consider legislative remedies. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, 

and existing law in which no change is proposed is shown in 

roman): 

TOXIC SUBSTANCES CONTROL ACT 

TITLE I—CONTROL OF TOXIC SUBSTANCES 

* * * * * * * 

SEC. 3. DEFINITIONS. 

As used in this Act: 

(1) The term ‘‘Administrator’’ means the Administrator of the Environmental Protection Agency. 

(2)(A) Except as provided in subparagraph (B), the term ‘‘chemical substance’’ means any organic or inorganic substance of a particular molecular identity, including— 

(i) any combination of such substances occurring in whole or 

in part as a result of a chemical reaction or occurring in nature, and 

(ii) any element or uncombined radical. 

(B) Such term does not include— 

(i) any mixture, 

(ii) any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or 

distributed in commerce for use as a pesticide, 

(iii) tobacco or any tobacco product, 

(iv) any source material, special nuclear material, or byproduct material (as such terms are defined in the Atomic Energy 

Act of 1954 and regulations issued under such Act), 

(v) any article the sale of which is subject to the tax imposed 

by section 4181 of the Internal Revenue Code of 1954 (determined without regard to any exemptions from such tax proVerDate Sep 11 2014 23:42 Jun 25, 2015 Jkt 049006 PO 00000 Frm 00034 Fmt 6659 Sfmt 6602 E:\HR\OC\HR176.XXX HR176

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vided by section 4182 or 4221 or any other provision of such 

Code), and 

(vi) any food, food additive, drug, cosmetic, or device (as such 

terms are defined in section 201 of the Federal Food, Drug, 

and Cosmetic Act) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. 

The term ‘‘food’’ as used in clause (vi) of this subparagraph includes 

poultry and poultry products (as defined in sections 4(e) and 4(f) 

of the Poultry Products Inspection Act), meat and meat food products (as defined in section 1(j) of the Federal Meat Inspection Act), 

and eggs and egg products (as defined in section 4 of the Egg Products Inspection Act). 

(3) The term ‘‘commerce’’ means trade, traffic, transportation, or 

other commerce (A) between a place in a State and any place outside of such State, or (B) which affects trade, traffic, transportation, or commerce described in clause (A). 

(4) The terms ‘‘distribute in commerce’’ and ‘‘distribution in commerce’’ when used to describe an action taken with respect to a 

chemical substance or mixture or article containing a substance or 

mixture mean to sell, or the sale of, the substance, mixture, or article in commerce; to introduce or deliver for introduction into commerce, or the introduction or delivery for introduction into commerce of, the substance, mixture, or article; or to hold, or the holding of, the substance, mixture, or article after its introduction into 

commerce. 

(5) The term ‘‘environment’’ includes water, air, and land and the 

interrelationship which exists among and between water, air, and 

land and all living things. 

(6) The term ‘‘health and safety study’’ means any study of any 

effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological 

studies, studies of occupational exposure to a chemical substance or 

mixture, toxicological, clinical, and ecological studies of a chemical 

substance or mixture, and any test performed pursuant to this Act. 

(7) The term ‘‘intended conditions of use’’ means the circumstances under which a chemical substance is intended, known, 

or reasonably foreseeable to be manufactured, processed, distributed 

in commerce, used, and disposed of. 

ø(7)¿ (8) The term ‘‘manufacture’’ means to import into the customs territory of the United States (as defined in general note 2 

of the Harmonized Tariff Schedules of the United States), produce, 

or manufacture. 

ø(8)¿ (9) The term ‘‘mixture’’ means any combination of two or 

more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except that such term does include any combination which occurs, in whole or in part, as a result of a chemical reaction if none 

of the chemical substances comprising the combination is a new 

chemical substance and if the combination could have been manufactured for commercial purposes without a chemical reaction at 

the time the chemical substances comprising the combination were 

combined. 


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ø(9)¿ (10) The term ‘‘new chemical substance’’ means any chemical substance which is not included in the chemical substance list 

compiled and published under section 8(b). 

(11) The term ‘‘potentially exposed subpopulation’’ means a group 

of individuals within the general population who, due to either 

greater susceptibility or greater potential exposure, are likely to be 

at greater risk than the general population of adverse health effects 

from exposure to a chemical substance. 

ø(10)¿ (12) The term ‘‘process’’ means the preparation of a chemical substance or mixture, after its manufacture, for distribution in 

commerce— 

(A) in the same form or physical state as, or in a different 

form or physical state from, that in which it was received by 

the person so preparing such substance or mixture, or 

(B) as part of an article containing the chemical substance 

or mixture. 

ø(11)¿ (13) The term ‘‘processor’’ means any person who processes a chemical substance or mixture. 

ø(12)¿ (14) The term ‘‘standards for the development of test data’’ 

means a prescription of— 

(A) the— 

(i) health and environmental effects, and 

(ii) information relating to toxicity, persistence, and 

other characteristics which affect health and the environment, 

for which test data for a chemical substance or mixture are to 

be developed and any analysis that is to be performed on such 

data, and 

(B) to the extent necessary to assure that data respecting 

such effects and characteristics are reliable and adequate— 

(i) the manner in which such data are to be developed, 

(ii) the specification of any test protocol or methodology 

to be employed in the development of such data, and 

(iii) such other requirements as are necessary to provide 

such assurance. 

ø(13)¿ (15) The term ‘‘State’’ means any State of the United 

States, the District of Columbia, the Commonwealth of Puerto Rico, 

the Virgin Islands, Guam, the Canal Zone, American Samoa, the 

Northern Mariana Islands, or any other territory or possession of 

the United States. 

ø(14)¿ (16) The term ‘‘United States’’, when used in the geographic sense, means all of the States. 

SEC. 4. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES. 

(a) TESTING REQUIREMENTS.—If the Administrator finds that— 

(1)(A)(i) the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or 

that any combination of such activities, may present an unreasonable risk of injury to health or the environment, 

(ii) there are insufficient data and experience upon which the 

effects of such manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any 

combination of such activities on health or the environment 

can reasonably be determined or predicted, and 

(iii) testing of such substance or mixture with respect to such 

effects is necessary to develop such dataø; or¿; 


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(B)(i) a chemical substance or mixture is or will be produced 

in substantial quantities, and (I) it enters or may reasonably 

be anticipated to enter the environment in substantial quantities or (II) there is or may be significant or substantial 

human exposure to such substance or mixture, 

(ii) there are insufficient data and experience upon which the 

effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any 

combination of such activities on health or the environment 

can reasonably be determined or predicted, and 

(iii) testing of such substance or mixture with respect to such 

effects is necessary to develop such dataø; and¿; or 

(C) testing of a chemical substance is necessary to conduct a 

risk evaluation under section 6(b); and 

(2) in the case of a mixture, the effects which the mixture’s 

manufacture, distribution in commerce, processing, use, or disposal or any combination of such activities may have on health 

or the environment may not be reasonably and more efficiently 

determined or predicted by testing the chemical substances 

which comprise the mixture; 

the Administrator shall by rule, order, or consent agreement require 

that testing be conducted on such substance or mixture to develop 

data with respect to the health and environmental effects for which 

there is an insufficiency of data and experience and which are relevant to a determination that the manufacture, distribution in 

commerce, processing, use, or disposal of such substance or mixture, or that any combination of such activities, does or does not 

present an unreasonable risk of injury to health or the environment. 

(b)(1) TESTING REQUIREMENT RULE.—A ørule¿ rule, order, or consent agreement under subsection (a) shall include— 

(A) identification of the chemical substance or mixture for 

which testing is required under the ørule¿ rule, order, or consent agreement, (B) standards for the development of test data for such substance or mixture, and 

(C) with respect to chemical substances which are not new 

chemical substances and to mixtures, a specification of the period (which period may not be of unreasonable duration) within 

which the persons required to conduct the testing shall submit 

to the Administrator data developed in accordance with the 

standards referred to in subparagraph (B). 

In determining the standards and period to be included, pursuant 

to subparagraphs (B) and (C), in a ørule¿ rule, order, or consent 

agreement under subsection (a), the Administrator’s considerations 

shall include the relative costs of the various test protocols and 

methodologies which may be required under the ørule¿ rule, order, 

or consent agreement and the reasonably foreseeable availability of 

the facilities and personnel needed to perform the testing required 

under the ørule¿ rule, order, or consent agreement. Any such ørule¿ 

rule, order, or consent agreement may require the submission to the 

Administrator of preliminary data during the period prescribed 

under subparagraph (C). 

(2)(A) The health and environmental effects for which standards 

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genesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synergistic effects, and any other effect which may present 

an unreasonable risk of injury to health or the environment. The 

characteristics of chemical substances and mixtures for which such 

standards may be prescribed include persistence, acute toxicity, 

subacute toxicity, chronic toxicity, and any other characteristic 

which may present such a risk. The methodologies that may be 

prescribed in such standards include epidemiologic studies, serial 

or hierarchical tests, in vitro tests, and whole animal tests, except 

that before prescribing epidemiologic studies of employees, the Administrator shall consult with the Director of the National Institute 

for Occupational Safety and Health. 

(B) From time to time, but not less than once each 12 months, 

the Administrator shall review the adequacy of the standards for 

development of data prescribed in ørules¿ rules, orders, and consent agreements under subsection (a) and shall, if necessary, institute proceedings to make appropriate revisions of such standards. 

(3)(A) A ørule¿ rule, order, or consent agreement under subsection 

(a) respecting a chemical substance or mixture shall require the 

persons described in subparagraph (B) to conduct tests and submit 

data to the Administrator on such substance or mixture, except 

that the Administrator may permit two or more of such persons to 

designate one such person or a qualified third party to conduct 

such tests and submit such data on behalf of the persons making 

the designation. 

(B) The following persons shall be required to conduct tests and 

submit data on a chemical substance or mixture subject to a ørule¿ 

rule, order, or consent agreement under subsection (a): 

(i) Each person who manufactures or intends to manufacture 

such substance or mixture if the Administrator makes a finding described in subsection (a)(1)(A)(ii) or (a)(1)(B)(ii) with respect to the manufacture of such substance or mixture. 

(ii) Each person who processes or intends to process such 

substance or mixture if the Administrator makes a finding described in subsection (a)(1)(A)(ii) or (a)(1)(B)(ii) with respect to 

the processing of such substance or mixture. 

(iii) Each person who manufactures or processes or intends 

to manufacture or process such substance or mixture if the Administrator makes a finding described in subsection (a)(1)(A)(ii) 

or (a)(1)(B)(ii) with respect to the distribution in commerce, 

use, or disposal of such substance or mixture. 

(4) Any ørule under subsection (a)¿ rule, order, or consent agreement under subsection (a) requiring the testing of and submission 

of data for a particular chemical substance or mixture shall expire 

at the end of the reimbursement period (as defined in subsection 

(c)(3)(B)) which is applicable to test data for such substance or mixture unless the Administrator ørepeals the rule¿ repeals the rule or 

order or modifies the consent agreement to terminate the requirement before such date; and a ørule under subsection (a)¿ rule, 

order, or consent agreement under subsection (a) requiring the testing of and submission of data for a category of chemical substances 

or mixtures shall expire with respect to a chemical substance or 

mixture included in the category at the end of the reimbursement 

period (as so defined) which is applicable to test data for such substance or mixture unless the Administrator before such date øreVerDate Sep 11 2014 23:42 Jun 25, 2015 Jkt 049006 PO 00000 Frm 00038 Fmt 6659 Sfmt 6602 E:\HR\OC\HR176.XXX HR176

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peals the application of the rule¿ repeals or modifies the application of the rule, order, or consent agreement to such substance or 

mixture or ørepeals the rule¿ repeals the rule or order or modifies 

the consent agreement to terminate the requirement. 

(5) Rules issued under subsection (a) (and any substantive 

amendment thereto or repeal thereof) shall be promulgated pursuant to section 553 of title 5, United States Code, except that (A) 

the Administrator shall give interested persons an opportunity for 

the oral presentation of data, views, or arguments, in addition to 

an opportunity to make written submission; (B) a transcript shall 

be made of any oral presentation; and (C) the Administrator shall 

make and publish with the rule the findings described in øparagraph (1)(A) or (1)(B)¿ paragraph (1)(A), (1)(B), or (1)(C) of subsection (a) and, in the case of a rule respecting a mixture, the finding described in paragraph (2) of such subsection. 

(c) EXEMPTION.—(1) Any person required by a ørule¿ rule or 

order under subsection (a) to conduct tests and submit data on a 

chemical substance or mixture may apply to the Administrator (in 

such form and manner as the Administrator shall prescribe) for an 

exemption from such requirement. 

(2) If, upon receipt of an application under paragraph (1), the Administrator determines that— 

(A) the chemical substance or mixture with respect to which 

such application was submitted is equivalent to a chemical 

substance or mixture for which data has been submitted to the 

Administrator in accordance with øa rule under subsection (a) 

or for which data is being developed pursuant to such a rule¿ 

a rule, order, or consent agreement under subsection (a) or for 

which data is being developed pursuant to such a rule, order, 

or consent agreement, and 

(B) submission of data by the applicant on such substance or 

mixture would be duplicative of data which has been submitted 

to the Administrator in accordance with øsuch rule or which is 

being developed pursuant to such rule¿ such rule, order, or 

consent agreement or which is being developed pursuant to such 

rule, order, or consent agreement, 

the Administrator shall exempt, in accordance with paragraph (3) 

or (4), the applicant from conducting tests and submitting data on 

such substance or mixture under øthe rule¿ the rule or order with 

respect to which such application was submitted. 

(3)(A) If the exemption under paragraph (2) of any person from 

the requirement to conduct tests and submit test data on a chemical substance or mixture is granted on the basis of the existence 

of previously submitted test data and if such exemption is granted 

during the reimbursement period for such test data (as prescribed 

by subparagraph (B)), then (unless such person and the persons referred to in clauses (i) and (ii) agree on the amount and method 

of reimbursement) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in 

an amount determined under rules of the Administrator)— 

(i) to the person who previously submitted such test data, for 

a portion of the costs incurred by such person in complying 

with the requirement to submit such data, and 


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(ii) to any other person who has been required under this 

subparagraph to contribute with respect to such costs, for a 

portion of the amount such person was required to contribute. 

In promulgating rules for the determination of fair and equitable 

reimbursement to the persons described in clauses (i) and (ii) for 

costs incurred with respect to a chemical substance or mixture, the 

Administrator shall, after consultation with the Attorney General 

and the Federal Trade Commission, consider all relevant factors, 

including the effect on the competitive position of the person required to provide reimbursement in relation to the person to be reimbursed and the share of the market for such substance or mixture of the person required to provide reimbursement in relation to 

the share of such market of the persons to be reimbursed. An order 

under this subparagraph shall, for purposes of judicial review, be 

considered final agency action. 

(B) For purposes of subparagraph (A), the reimbursement period 

for any test data for a chemical substance or mixture is a period— 

(i) beginning on the date such data is submitted in accordance with a ørule promulgated¿ rule, order, or consent agreement under subsection (a), and 

(ii) ending— 

(I) five years after the date referred to in clause (i), or 

(II) at the expiration of a period which begins on the 

date referred to in clause (i) and which is equal to the period which the Administrator determines was necessary to 

develop such data, 

whichever is later. 

(4)(A) If the exemption under paragraph (2) of any person from 

the requirement to conduct tests and submit test data on a chemical substance or mixture is granted on the basis of the fact that 

test data is being developed by one or more persons pursuant to a 

ørule promulgated¿ rule, order, or consent agreement under subsection (a), then (unless such person and the persons referred to in 

clauses (i) and (ii) agree on the amount and method of reimbursement) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the Administrator)— 

(i) to each such person who is developing such test data, for 

a portion of the costs incurred by each such person in complying with øsuch rule¿ such rule, order, or consent agreement, 

and 

(ii) to any other person who has been required under this 

subparagraph to contribute with respect to the costs of complying with øsuch rule¿ such rule, order, or consent agreement, 

for a portion of the amount such person was required to contribute. 

In promulgating rules for the determination of fair and equitable 

reimbursement to the persons described in clauses (i) and (ii) for 

costs incurred with respect to a chemical substance or mixture, the 

Administrator shall, after consultation with the Attorney General 

and the Federal Trade Commission, consider the factors described 

in the second sentence of paragraph (3)(A). An order under this 

subparagraph shall, for purposes of judicial review, be considered 

final agency action. 


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(B) If any exemption is granted under paragraph (2) on the basis 

of the fact that one or more persons are developing test data pursuant to a ørule promulgated¿ rule, order, or consent agreement 

under subsection (a) and if after such exemption is granted the Administrator determines that no such person has complied with 

øsuch rule¿ such rule, order, or consent agreement, the Administrator shall (i) after providing written notice to the person who 

holds such exemption and an opportunity for a hearing, by order 

terminate such exemption, and (ii) notify in writing such person of 

the requirements of øthe rule¿ the rule, order, or consent agreement 

with respect to which such exemption was granted. 

(d) NOTICE.—Upon the receipt of any test data pursuant to a 

ørule¿ rule, order, or consent agreement under subsection (a), the 

Administrator shall publish a notice of the receipt of such data in 

the Federal Register within 15 days of its receipt. Subject to section 

14, each such notice shall (1) identify the chemical substance or 

mixture for which data have been received; (2) list the uses or intended uses of such substance or mixture and the information required by the applicable standards for the development of test 

data; and (3) describe the nature of the test data developed. Except 

as otherwise provided in section 14, such data shall be made available by the Administrator for examination by any person. 

(e) PRIORITY LIST.—(1)(A) There is established a committee to 

make recommendations to the Administrator respecting the chemical substances and mixtures to which the Administrator should 

give priority consideration for the promulgation of a rule under 

subsection (a). In making such a recommendation with respect to 

any chemical substance or mixture, the committee shall consider 

all relevant factors, including— 

(i) the quantities in which the substance or mixture is or will 

be manufactured, 

(ii) the quantities in which the substance or mixture enters 

or will enter the environment, 

(iii) the number of individuals who are or will be exposed to 

the substance or mixture in their places of employment and 

the duration of such exposure, 

(iv) the extent to which human beings are or will be exposed 

to the substance or mixture, 

(v) the extent to which the substance or mixture is closely related to a chemical substance or mixture which is known to 

present an unreasonable risk of injury to health or the environment, 

(vi) the existence of data concerning the effects of the substance or mixture on health or the environment, 

(vii) the extent to which testing of the substance or mixture 

may result in the development of data upon which the effects 

of the substance or mixture on health or the environment can 

reasonably be determined or predicted, and 

(viii) the reasonably foreseeable availability of facilities and 

personnel for performing testing on the substance or mixture. 

The recommendations of the committee shall be in the form of a 

list of chemical substances and mixtures which shall be set forth, 

either by individual substance or mixture or by groups of substances or mixtures, in the order in which the committee determines the Administrator should take action under subsection (a) 


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with respect to the substances and mixtures. In establishing such 

list, the committee shall give priority attention to those chemical 

substances and mixtures which are known to cause or contribute 

to or which are suspected of causing or contributing to cancer, gene 

mutations, or birth defects. The committee shall designate chemical 

substances and mixtures on the list with respect to which the committee determines the Administrator should, within 12 months of 

the date on which such substances and mixtures are first designated, initiate a proceeding under subsection (a). The total number of chemical substances and mixtures on the list which are designated under the preceding sentence may not, at any time, exceed 

50. 

(B) As soon as practicable but not later than nine months after 

the effective date of this Act, the committee shall publish in the 

Federal Register and transmit to the Administrator the list and 

designations required by subparagraph (A) together with the reasons for the committee’s inclusion of each chemical substance or 

mixture on the list. At least every six months after the date of the 

transmission to the Administrator of the list pursuant to the 

preceeding sentence, the committee shall make such revisions in 

the list as it determines to be necessary and shall transmit them 

to the Administrator together with the committee’s reasons for the 

revisions. Upon receipt of any such revision, the Administrator 

shall publish in the Federal Register the list with such revision, 

the reasons for such revision, and the designations made under 

subparagraph (A). The Administrator shall provide reasonable opportunity to any interested person to file with the Administrator 

written comments on the committee’s list, any revision of such list 

by the committee, and designations made by the committee, and 

shall make such comments available to the public. Within the 12- 

month period beginning on the date of the first inclusion on the list 

of a chemical substance or mixture designated by the committee 

under subparagraph (A) the Administrator shall with respect to 

such chemical substance or mixture 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. 

(2)(A) The committee established by paragraph (1)(A) shall consist of eight members as follows: 

(i) One member appointed by the Administrator from the Environmental Protection Agency. 

(ii) One member appointed by the Secretary of Labor from officers or employees of the Department of Labor engaged in the 

Secretary’s activities under the Occupational Safety and 

Health Act of 1970. 

(iii) One member appointed by the Chairman of the Council 

on Environmental Quality from the Council or its officers or 

employees. 

(iv) One member appointed by the Director of the National 

Institute for Occupational Safety and Health from officers or 

employees of the Institute. 

(v) One member appointed by the Director of the National 

Institute of Environmental Health Sciences from officers or 

employees of the Institute. 


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(vi) One member appointed by the Director of the National 

Cancer Institute from officers or employees of the Institute. 

(vii) One member appointed by the Director of the National 

Science Foundation from officers or employees of the Foundation. 

(viii) One member appointed by the Secretary of Commerce 

from officers or employees of the Department of Commerce. 

(B)(i) An appointed member may designate an individual to serve 

on the committee on the member’s behalf. Such a designation may 

be made only with the approval of the applicable appointing authority and only if the individual is from the entity from which the 

member was appointed. 

(ii) No individual may serve as a member of the committee for 

more than four years in the aggregate. If any member of the committee leaves the entity from which the member was appointed, 

such member may not continue as a member of the committee, and 

the member’s position shall be considered to be vacant. A vacancy 

in the committee shall be filled in the same manner in which the 

original appointment was made. 

(iii) Initial appointments to the committee shall be made not 

later than the 60th day after the effective date of this Act. Not 

later than the 90th day after such date the members of the committee shall hold a meeting for the selection of a chairperson from 

among their number. 

(C)(i) No member of the committee, or designee of such member, 

shall accept employment or compensation from any person subject 

to any requirement of this Act or of any rule promulgated or order 

issued thereunder, for a period of at least 12 months after termination of service on the committee. 

(ii) No person, while serving as a member of the committee, or 

designee of such member, may own any stocks or bonds, or have 

any pecuniary interest, of substantial value in any person engaged 

in the manufacture, processing, or distribution in commerce of any 

chemical substance or mixture subject to any requirement of this 

Act or of any rule promulgated or order issued thereunder. 

(iii) The Administrator, acting through attorneys of the Environmental Protection Agency, or the Attorney General may bring an 

action in the appropriate district court of the United States to restrain any violation of this subparagraph. 

(D) The Administrator shall provide the committee such administrative support services as may be necessary to enable the committee to carry out its function under this subsection. 

(f) REQUIRED ACTIONS.—Upon the receipt of— 

(1) any test data required to be submitted under this Act, or 

(2) any other information available to the Administrator, 

which indicates to the Administrator that there may be a reasonable basis to conclude that a chemical substance or mixture presents or will present a significant risk of serious or widespread 

harm to human beings from cancer, gene mutations, or birth defects, the Administrator shall, within the 180-day period beginning 

on the date of the receipt of such data or information, initiate appropriate action under section 5, 6, or 7 to prevent or reduce to a 

sufficient extent such risk or publish in the Federal Register a finding that such risk is not unreasonable. For good cause shown the 

Administrator may extend such period for an additional period of 


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not more than 90 days. The Administrator shall publish in the Federal Register notice of any such extension and the reasons therefor. 

A finding by the Administrator that a risk is not unreasonable 

shall be considered agency action for purposes of judicial review 

under chapter 7 of title 5, United States Code. This subsection 

shall not take effect until two years after the effective date of this 

Act. 

(g) PETITION FOR STANDARDS FOR THE DEVELOPMENT OF TEST

DATA.—A person intending to manufacture or process a chemical 

substance for which notice is required under section 5(a) and who 

is not required under a ørule¿ rule, order, or consent agreement 

under subsection (a) to conduct tests and submit data on such substance may petition the Administrator to prescribe standards for 

the development of test data for such substance. The Administrator 

shall by order either grant or deny any such petition within 60 

days of its receipt. If the petition is granted, the Administrator 

shall prescribe such standards for such substance within 75 days 

of the date the petition is granted. If the petition is denied, the Administrator shall publish, subject to section 14, in the Federal Register the reasons for such denial. 

SEC. 5. MANUFACTURING AND PROCESSING NOTICES. 

(a) IN GENERAL.—(1) Except as provided in subsection (h), no 

person may— 

(A) manufacture a new chemical substance on or after the 

30th day after the date on which the Administrator first publishes the list required by section 8(b), or 

(B) manufacture or process any chemical substance for a use 

which the Administrator has determined, in accordance with 

paragraph (2), is a significant new use, 

unless 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 subsection (b). 

(2) A determination by the Administrator that a use of a chemical substance is a significant new use with respect to which notification is required under paragraph (1) shall be made by a rule promulgated after a consideration of all relevant factors, including— 

(A) the projected volume of manufacturing and processing of 

a chemical substance, 

(B) the extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance, 

(C) the extent to which a use increases the magnitude and 

duration of exposure of human beings or the environment to a 

chemical substance, and 

(D) the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal 

of a chemical substance. 

(b) SUBMISSION OF TEST DATA.—(1)(A) If (i) a person is required 

by subsection (a)(1) to submit a notice to the Administrator before 

beginning the manufacture or processing of a chemical substance, 

and (ii) such person is required to submit test data for such substance pursuant to a ørule promulgated¿ rule, order, or consent 

agreement under section 4 before the submission of such notice, 


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such person shall submit to the Administrator such data in accordance with øsuch rule¿ such rule, order, or consent agreement at the 

time notice is submitted in accordance with subsection (a)(1). 

(B) If— 

(i) a person is required by subsection (a)(1) to submit a notice 

to the Administrator, and 

(ii) such person has been granted an exemption under section 4(c) from the requirements of a ørule promulgated¿ rule 

or order under section 4 before the submission of such notice, 

such person may not, before the expiration of the 90-day period 

which begins on øthe date of the submission in accordance with 

such rule¿ the required date of submission of the test data the submission or development of which was the basis for the exemption, 

manufacture such substance if such person is subject to subsection 

(a)(1)(A) or manufacture or process such substance for a significant 

new use if the person is subject to subsection (a)(1)(B). 

(2)(A) If a person— 

(i) is required by subsection (a)(1) to submit a notice to the 

Administrator before beginning the manufacture or processing 

of a chemical substance listed under paragraph (4), and 

(ii) is not required by a ørule promulgated¿ rule, order, or 

consent agreement under section 4 before the submission of 

such notice to submit test data for such substance, 

such person shall submit to the Administrator data prescribed by 

subparagraph (B) at the time notice is submitted in accordance 

with subsection (a)(1). 

(B) Data submitted pursuant to subparagraph (A) shall be data 

which the person submitting the data believes show that— 

(i) in the case of a substance with respect to which notice is 

required under subsection (a)(1)(A), the manufacture, processing, distribution in commerce, use, and disposal of the 

chemical substance or any combination of such activities will 

not present an unreasonable risk of injury to health or the environment, or 

(ii) in the case of a chemical substance with respect to which 

notice is required under subsection (a)(1)(B), the intended significant new use of the chemical substance will not present an 

unreasonable risk of injury to health or the environment. 

(3) Data submitted under paragraph (1) or (2) shall be made 

available, subject to section 14, for examination by interested persons. 

(4)(A)(i) The Administrator may, by rule, compile and keep current a list of chemical substances with respect to which the Administrator finds that the manufacture, processing, distribution in 

commerce, use, or disposal, or any combination of such activities, 

presents or may present an unreasonable risk of injury to health 

or the environment. 

(ii) In making a finding under clause (i) that the manufacture, 

processing, distribution in commerce, use, or disposal of a chemical 

substance or any combination of such activities presents or may 

present an unreasonable risk of injury to health or the environment, the Administrator shall consider all relevant factors, including— 

(I) the effects of the chemical substance on health and the 

magnitude of human exposure to such substance; and 


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(II) the effects of the chemical substance on the environment 

and the magnitude of environmental exposure to such substance. 

(B) The Administrator shall, in prescribing a rule under subparagraph (A) which lists any chemical substance, identify those uses, 

if any, which the Administrator determines, by rule under subsection (a)(2), would constitute a significant new use of such substance. 

(C) Any rule under subparagraph (A), and any substantive 

amendment or repeal of such a rule, shall be promulgated pursuant 

to the procedures specified in section 553 of title 5, United States 

Code, except that (i) the Administrator shall give interested persons an opportunity for the oral presentation of data, views, or arguments, in addition to an opportunity to make written submissions, (ii) a transcript shall be kept of any oral presentation, and 

(iii) the Administrator shall make and publish with the rule the 

finding described in subparagraph (A). 

(c) EXTENSION OF NOTICE PERIOD.—The Administrator may for 

good cause extend for additional periods (not to exceed in the aggregate 90 days) the period, prescribed by subsection (a) or (b) before which the manufacturing or processing of a chemical substance 

subject to such subsection may begin. Subject to section 14, such 

an extension and the reasons therefor shall be published in the 

Federal Register and shall constitute a final agency action subject 

to judicial review. 

(d) CONTENT OF NOTICE; PUBLICATIONS IN THE FEDERAL REGISTER.—(1) The notice required by subsection (a) shall include— 

(A) insofar as known to the person submitting the notice or 

insofar as reasonably ascertainable, the information described 

in subparagraphs (A), (B), (C), (D), (F), and (G) of section 

8(a)(2), and 

(B) in such form and manner as the Administrator may prescribe, any test data in the possession or control of the person 

giving such notice which are related to the effect of any manufacture, processing, distribution in commerce, use, or disposal 

of such substance or any article containing such substance, or 

of any combination of such activities, on health or the environment, and 

(C) a description of any other data concerning the environmental and health effects of such substance, insofar as known 

to the person making the notice or insofar as reasonably ascertainable. 

Such a notice shall be made available, subject to section 14, for examination by interested persons. 

(2) Subject to section 14, not later than five days (excluding Saturdays, Sundays and legal holidays) after the date of the receipt of 

a notice under subsection (a) or of data under subsection (b), the 

Administrator shall publish in the Federal Register a notice 

which— 

(A) identifies the chemical substance for which notice or data 

has been received; 

(B) lists the uses or intended uses of such substance; and 

(C) in the case of the receipt of data under subsection (b), describes the nature of the tests performed on such substance 


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and any data which was developed pursuant to subsection (b) 

or a ørule¿ rule, order, or consent agreement under section 4. 

A notice under this paragraph respecting a chemical substance 

shall identify the chemical substance by generic class unless the 

Administrator determines that more specific identification is required in the public interest. 

(3) At the beginning of each month the Administrator shall publish a list in the Federal Register of (A) each chemical substance 

for which notice has been received under subsection (a) and for 

which the notification period prescribed by subsection (a), (b), or (c) 

has not expired, and (B) each chemical substance for which such 

notification period has expired since the last publication in the Federal Register of such list. 

(e) REGULATION PENDING DEVELOPMENT OF INFORMATION.—(1)(A) 

If the Administrator determines that— 

(i) the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of a chemical substance with respect to 

which notice is required by subsection (a); and 

(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, 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, 

the Administrator may issue a proposed order, to take effect on the 

expiration of the notification period applicable to the manufacturing or processing of such substance under subsection (a), (b), or 

(c), to prohibit or limit the manufacture, processing, distribution in 

commerce, use, or disposal of such substance or to prohibit or limit 

any combination of such activities. 

(B) A proposed order may not be issued under subparagraph (A) 

respecting a chemical substance (i) later than 45 days before the 

expiration of the notification period applicable to the manufacture 

or processing of such substance under subsection (a), (b), or (c), and 

(ii) unless the Administrator has, on or before the issuance of the 

proposed order, notified, in writing, each manufacturer or processor, as the case may be, of such substance of the determination 

which underlies such order. 

(C) If a manufacturer or processor of a chemical substance to be 

subject to a proposed order issued under subparagraph (A) files 

with the Administrator (within the 30-day period beginning on the 

date such manufacturer or processor received the notice required 

by subparagraph (B)(ii)) objections specifying with particularity the 

provisions of the order deemed objectionable and stating the 

grounds therefor, the proposed order shall not take effect. 

(2)(A)(i) Except as provided in clause (ii), if with respect to a 

chemical substance with respect to which notice is required by subsection (a), the Administrator makes the determination described 

in paragraph (1)(A) and if— 


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(I) the Administrator does not issue a proposed order under 

paragraph (1) respecting such substance, or 

(II) the Administrator issues such an order respecting such 

substance but such order does not take effect because objections were filed under paragraph (1)(C) with respect to it, 

the Administrator, through attorneys of the Environmental Protection Agency, shall apply to the United States District Court for the 

District of Columbia or the United States district court for the judicial district in which the manufacturer or processor, as the case 

may be, of such substance is found, resides, or transacts business 

for an injunction to prohibit or limit the manufacture, processing, 

distribution in commerce, use, or disposal of such substance (or to 

prohibit or limit any combination of such activities). 

(ii) If the Administrator issues a proposed order under paragraph 

(1)(A) respecting a chemical substance but such order does not take 

effect because objections have been filed under paragraph (1)(C) 

with respect to it, the Administrator is not required to apply for an 

injunction under clause (i) respecting such substance if the Administrator determines, on the basis of such objections, that the determinations under paragraph (1)(A) may not be made. 

(B) A district court of the United States which receives an application under subparagraph (A)(i) for an injunction respecting a 

chemical substance shall issue such injunction if the court finds 

that— 

(i) the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of a chemical substance with respect to 

which notice is required by subsection (a); and 

(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, 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. 

(C) Pending the completion of a proceeding for the issuance of an 

injunction under subparagraph (B) respecting a chemical substance, the court may, upon application of the Administrator made 

through attorneys of the Environmental Protection Agency, issue a 

temporary restraining order or a preliminary injunction to prohibit 

the manufacture, processing, distribution in commerce, use, or disposal of such a substance (or any combination of such activities) if 

the court finds that the notification period applicable under subsection (a), (b), or (c) to the manufacturing or processing of such 

substance may expire before such proceeding can be completed. 

(D) After the submission to the Administrator of test data sufficient to evaluate the health and environmental effects of a chemical substance subject to an injunction issued under subparagraph 

(B) and the evaluation of such data by the Administrator, the district court of the United States which issued such injunction shall, 

upon petition, dissolve the injunction unless the Administrator has 

initiated a proceeding for the issuance of a rule under section 6(a) 


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respecting the substance. If such a proceeding has been initiated, 

such court shall continue the injunction in effect until the effective 

date of the rule promulgated in such proceeding or, if such proceeding is terminated without the promulgation of a rule, upon the 

termination of the proceeding, whichever occurs first. 

(f) PROTECTION AGAINST UNREASONABLE RISKS.—(1) If the Administrator finds that there is a reasonable basis to conclude that 

the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance with respect to which notice is required by subsection (a), or that any combination of such activities, 

presents or will present an unreasonable risk of injury to health or 

environment before a rule promulgated under section 6 can protect 

against such risk, the Administrator shall, before the expiration of 

the notification period applicable under subsection (a), (b), or (c) to 

the manufacturing or processing of such substance, take the action 

authorized by paragraph (2) or (3) to the extent necessary to protect against such risk. 

(2) The Administrator may issue a proposed rule under section 

6(a) to apply to a chemical substance with respect to which a finding was made under paragraph (1)— 

(A) a requirement limiting the amount of such substance 

which may be manufactured, processed, or distributed in commerce, 

(B) a requirement described in paragraph (2), (3), (4), (5), (6), 

or (7) of section 6(a), or 

(C) any combination of the requirements referred to in subparagraph (B). 

Such a proposed rule shall be effective upon its publication in the 

Federal Register. Section 6(d)(2)(B) shall apply with respect to such 

rule. 

(3)(A) The Administrator may— 

(i) issue a proposed order to prohibit the manufacture, processing, or distribution in commerce of a substance with respect 

to which a finding was made under paragraph (1), or 

(ii) apply, through attorneys of the Environmental Protection 

Agency, to the United States District Court for the District of 

Columbia or the United States district court for the judicial 

district in which the manufacturer, or processor, as the case 

may be, of such substance, is found, resides, or transacts business for an injunction to prohibit the manufacture, processing, 

or distribution in commerce of such substance. 

A proposed order issued under clause (i) respecting a chemical substance shall take effect on the expiration of the notification period 

applicable under subsection (a), (b), or (c) to the manufacture or 

processing of such substance. 

(B) If the district court of the United States to which an application has been made under subparagraph (A)(ii) finds that there is 

a reasonable basis to conclude that the manufacture, processing, 

distribution in commerce, use, or disposal of the chemical substance with respect to which such application was made, or that 

any combination of such activities, presents or will present an unreasonable risk of injury to health or the environment before a rule 

promulgated under section 6 can protect against such risk, the 

court shall issue an injunction to prohibit the manufacture, procVerDate Sep 11 2014 23:42 Jun 25, 2015 Jkt 049006 PO 00000 Frm 00049 Fmt 6659 Sfmt 6602 E:\HR\OC\HR176.XXX HR176

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essing or distribution in commerce of such substance or to prohibit 

any combination of such activities. 

(C) The provisions of subparagraphs (B) and (C) of subsection 

(e)(1) shall apply with respect to an order issued under clause (i) 

of subparagraph (A); and the provisions of subparagraph (C) of subsection (e)(2) shall apply with respect to an injunction issued under 

subparagraph (B). 

(D) If the Administrator issues an order pursuant to subparagraph (A)(i) respecting a chemical substance and objections are 

filed in accordance with subsection (e)(1)(C), the Administrator 

shall seek an injunction under subparagraph (A)(ii) respecting such 

substance unless the Administrator determines, on the basis of 

such objections, that such substance does not or will not present an 

unreasonable risk of injury to health or the environment. 

(g) STATEMENT OF REASONS FOR NOT TAKING ACTION.—If the Administrator has not initiated any action under this section or section 6 or 7 to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance, 

with respect to which notification or data is required by subsection 

(a)(1)(B) or (b), before the expiration of the notification period applicable to the manufacturing or processing of such substance, the 

Administrator shall publish a statement of the Administrator’s reasons for not initiating such action. Such a statement shall be published in the Federal Register 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. 

(h) EXEMPTIONS.—(1) The Administrator may, upon application, 

exempt any person from any requirement of subsection (a) or (b) 

to permit such person to manufacture or process a chemical substance for test marketing purposes— 

(A) upon a showing by such person satisfactory to the Administrator that the manufacture, processing, distribution in 

commerce, use, and disposal of such substance, and that any 

combination of such activities, for such purposes will not 

present any unreasonable risk of injury to health or the environment, and 

(B) under such restrictions as the Administrator considers 

appropriate. 

(2)(A) The Administrator may, upon application, exempt any person from the requirement of subsection (b)(2) to submit data for a 

chemical substance. If, upon receipt of an application under the 

preceding sentence, the Administrator determines that— 

(i) the chemical substance with respect to which such application was submitted is equivalent to a chemical substance for 

which data has been submitted to the Administrator as required by subsection (b)(2), and 

(ii) submission of data by the applicant on such substance 

would be duplicative of data which has been submitted to the 

Administrator in accordance with such subsection, 

the Administrator shall exempt the applicant from the requirement 

to submit such data on such substance. No exemption which is 

granted under this subparagraph with respect to the submission of 


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data for a chemical substance may take effect before the beginning 

of the reimbursement period applicable to such data. 

(B) If the Administrator exempts any person, under subparagraph (A), from submitting data required under subsection (b)(2) 

for a chemical substance because of the existence of previously submitted data and if such exemption is granted during the reimbursement period for such data, then (unless such person and the persons referred to in clauses (i) and (ii) agree on the amount and 

method of reimbursement) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the Administrator)— 

(i) to the person who previously submitted the data on which 

the exemption was based, for a portion of the costs incurred by 

such person in complying with the requirement under subsection (b)(2) to submit such data, and 

(ii) to any other person who has been required under this 

subparagraph to contribute with respect to such costs, for a 

portion of the amount such person was required to contribute. 

In promulgating rules for the determination of fair and equitable 

reimbursement to the persons described in clauses (i) and (ii) for 

costs incurred with respect to a chemical substance, the Administrator shall, after consultation with the Attorney General and the 

Federal Trade Commission, consider all relevant factors, including 

the effect on the competitive position of the person required to provide reimbursement in relation to the persons to be reimbursed 

and the share of the market for such substance of the person required to provide reimbursement in relation to the share of such 

market of the persons to be reimbursed. For purposes of judicial review, an order under this subparagraph shall be considered final 

agency action. 

(C) For purposes of this paragraph, the reimbursement period for 

any previously submitted data for a chemical substance is a period— 

(i) beginning on the date of the termination of the prohibition, imposed under this section, on the manufacture or processing of such substance by the person who submitted such 

data to the Administrator, and 

(ii) ending— 

(I) five years after the date referred to in clause (i), or 

(II) at the expiration of a period which begins on the 

date referred to in clause (i) and is equal to the period 

which the Administrator determines was necessary to develop such data, 

whichever is later. 

(3) The requirements of subsections (a) and (b) do not apply with 

respect to the manufacturing or processing of any chemical substance which is manufactured or processed, or proposed to be manufactured or processed, only in small quantities (as defined by the 

Administrator by rule) solely for purposes of— 

(A) scientific experimentation or analysis, or 

(B) chemical research on, or analysis of such substance or 

another substance, including such research or analysis for the 

development of a product, 


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if all persons engaged in such experimentation, research, or analysis for a manufacturer or processor are notified (in such form and 

manner as the Administrator may prescribe) of any risk to health 

which the manufacturer, processor, or the Administrator has reason to believe may be associated with such chemical substance. 

(4) The Administrator may, upon application and by rule, exempt 

the manufacturer of any new chemical substance from all or part 

of the requirements of this section if the Administrator determines 

that the manufacture, processing, distribution in commerce, use, or 

disposal of such chemical substance, or that any combination of 

such activities, will not present an unreasonable risk of injury to 

health or the environment. A rule promulgated under this paragraph (and any substantive amendment to, or repeal of, such a 

rule) shall be promulgated in accordance with øparagraphs (2) and 

(3) of section 6(c)¿ paragraph (2) of section 6(c). 

(5) The Administrator may, upon application, make the requirements of subsections (a) and (b) inapplicable with respect to the 

manufacturing or processing of any chemical substance (A) which 

exists temporarily as a result of a chemical reaction in the manufacturing or processing of a mixture or another chemical substance, 

and (B) to which there is no, and will not be, human or environmental exposure. 

(6) Immediately upon receipt of an application under paragraph 

(1) or (5) the Administrator shall publish in the Federal Register 

notice of the receipt of such application. The Administrator shall 

give interested persons an opportunity to comment upon any such 

application and shall, within 45 days of its receipt, either approve 

or deny the application. The Administrator shall publish in the 

Federal Register notice of the approval or denial of such an application. 

(i) DEFINITION.—For purposes of this section, the terms ‘‘manufacture’’ and ‘‘process’’ mean manufacturing or processing for commercial purposes. 

SEC. 6. REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND 

MIXTURES. 

(a) SCOPE OF REGULATION.—If the Administrator øfinds that 

there is a reasonable basis to conclude¿ determines under subsection (b) that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that 

any combination of such activities, presents, or will present an unreasonable risk of injury to health or the environment, or designates a chemical substance under subsection (i)(2), the Administrator shall by rule apply one or more of the following requirements 

to such substance or mixture to the extent necessary øto protect 

adequately against such risk using the least burdensome requirements¿ so that the chemical substance or mixture no longer presents 

or will present an unreasonable risk, including an identified unreasonable risk to a potentially exposed subpopulation: 

(1) A requirement (A) prohibiting the manufacturing, processing, or distribution in commerce of such substance or mixture, or (B) limiting the amount of such substance or mixture 

which may be manufactured, processed, or distributed in commerce. 

(2) A requirement— 


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(A) prohibiting the manufacture, processing, or distribution in commerce of such substance or mixture for (i) a 

particular use or (ii) a particular use in a concentration in 

excess of a level specified by the Administrator in the rule 

imposing the requirement, or 

(B) limiting the amount of such substance or mixture 

which may be manufactured, processed, or distributed in 

commerce for (i) a particular use or (ii) a particular use in 

a concentration in excess of a level specified by the Administrator in the rule imposing the requirement. 

(3) A requirement that such substance or mixture or any article containing such substance or mixture be marked with or 

accompanied by clear and adequate warnings and instructions 

with respect to its use, distribution in commerce, or disposal or 

with respect to any combination of such activities. The form 

and content of such warnings and instructions shall be prescribed by the Administrator. 

(4) A requirement that manufacturers and processors of such 

substance or mixture make and retain records of the processes 

used to manufacture or process such substance or mixture and 

monitor or conduct tests which are reasonable and necessary 

to assure compliance with the requirements of any rule applicable under this subsection. 

(5) A requirement prohibiting or otherwise regulating any 

manner or method of commercial use of such substance or mixture. 

(6)(A) A requirement prohibiting or otherwise regulating any 

manner or method of disposal of such substance or mixture, or 

of any article containing such substance or mixture, by its 

manufacturer or processor or by any other person who uses, or 

disposes of, it for commercial purposes. 

(B) A requirement under subparagraph (A) may not require 

any person to take any action which would be in violation of 

any law or requirement of, or in effect for, a State or political 

subdivision, and shall require each person subject to it to notify each State and political subdivision in which a required 

disposal may occur of such disposal. 

(7) A requirement directing manufacturers or processors of 

such substance or mixture (A) to give notice of such unreasonable risk of injury to distributors in commerce of such substance or mixture and, to the extent reasonably ascertainable, 

to other persons in possession of such substance or mixture or 

exposed to such substance or mixture, (B) to give public notice 

of such risk of injury, and (C) to replace or repurchase such 

substance or mixture as elected by the person to which the requirement is directed. 

Any requirement (or combination of requirements) imposed under 

this subsection may be limited in application to specified geographic areas. 

ø(b) QUALITY CONTROL.—If the Administrator has a reasonable 

basis to conclude that a particular manufacturer or processor is 

manufacturing or processing a chemical substance or mixture in a 

manner which unintentionally causes the chemical substance or 

mixture to present or which will cause it to present an unreasonable risk of injury to health or the environment— 


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ø(1) the Administrator may by order require such manufacturer or processor to submit a description of the relevant quality control procedures followed in the manufacturing or processing of such chemical substance or mixture; and 

ø(2) if the Administrator determines— 

ø(A) that such quality control procedures are inadequate 

to prevent the chemical substance or mixture from presenting such risk of injury, the Administrator may order 

the manufacturer or processor to revise such quality control procedures to the extent necessary to remedy such inadequacy; or 

ø(B) that the use of such quality control procedures has 

resulted in the distribution in commerce of chemical substances or mixtures which present an unreasonable risk of 

injury to health or the environment, the Administrator 

may order the manufacturer or processor to (i) give notice 

of such risk to processors or distributors in commerce of 

any such substance or mixture, or to both, and, to the extent reasonably ascertainable, to any other person in possession of or exposed to any such substance, (ii) to give 

public notice of such risk, and (iii) to provide such replacement or repurchase of any such substance or mixture as 

is necessary to adequately protect health or the environment. 

A determination under subparagraph (A) or (B) of paragraph (2) 

shall be made on the record after opportunity for hearing in accordance with section 554 of title 5, United States Code. Any manufacturer or processor subject to a requirement to replace or repurchase 

a chemical substance or mixture may elect either to replace or repurchase the substance or mixture and shall take either such action in the manner prescribed by the Administrator.¿ 

(b) RISK EVALUATIONS.— 

(1) IN GENERAL.—The Administrator shall conduct risk evaluations pursuant to this subsection to determine whether or not 

a chemical substance presents or will present, in the absence of 

requirements under subsection (a), an unreasonable risk of injury to health or the environment. 

(2) APPLYING REQUIREMENTS.—The Administrator shall apply 

requirements with respect to a chemical substance through a 

rule under subsection (a) only if the Administrator determines 

through a risk evaluation under this subsection that the chemical substance presents or will present, in the absence of such 

requirements, an unreasonable risk of injury to health or the 

environment. 

(3) CONDUCTING RISK EVALUATION.— 

(A) REQUIRED RISK EVALUATIONS.—The Administrator 

shall conduct and publish the results of a risk evaluation 

under this subsection for a chemical substance if— 

(i) the Administrator determines that the chemical 

substance may present an unreasonable risk of injury 

to health or the environment because of potential hazard and a potential route of exposure under the intended conditions of use; or 

(ii) a manufacturer of the chemical substance requests such a risk evaluation. 


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(B) TSCA WORK PLAN CHEMICALS.—The Administrator 

may, without making a determination under subparagraph 

(A)(i), conduct and publish the results of a risk evaluation 

under this subsection for a chemical substance that, on the 

date of enactment of the TSCA Modernization Act of 2015, 

is listed in the TSCA Work Plan for Chemical Assessments 

published by the Administrator. 

(4) REQUIREMENTS.—In conducting a risk evaluation under 

this subsection, the Administrator shall— 

(A) integrate and assess information on hazards and exposures for all of the intended 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 subpopulations; 

(B) not consider information on cost and other factors not 

directly related to health or the environment; 

(C) take into account, where relevant, the likely duration, 

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

(D) describe the weight of the scientific evidence for identified hazard and exposure; 

(E) consider whether the weight of the scientific evidence 

supports the identification of doses of the chemical substance below which no adverse effects can be expected to 

occur; and 

(F) in the case of a risk evaluation requested by a manufacturer under paragraph (3)(A)(ii), ensure that the costs to 

the Environmental Protection Agency, including contractor 

costs, of conducting the risk evaluation are paid for by the 

manufacturer. 

(5) DEADLINES.— (A) RISK EVALUATIONS.—The Administrator shall conduct and publish a risk evaluation under this subsection 

for a chemical substance as soon as reasonably possible, 

subject to the availability of resources, but not later than 3 

years after the date on which— 

(i) the Administrator— 

(I) makes a determination under paragraph 

(3)(A)(i); or 

(II) begins the risk evaluation under paragraph 

(3)(B); or 

(ii) a manufacturer requests the risk evaluation 

under paragraph (3)(A)(ii). 

(B) SUBSECTION (a) RULES.—If, based on a risk evaluation conducted under this subsection, the Administrator determines that a chemical substance presents or will present, 

in the absence of a rule under subsection (a), an unreasonable risk of injury to health or the environment, the Administrator shall— 

(i) propose a rule under subsection (a) for the chemical substance not later than 90 days after the date on 

which the risk evaluation regarding such chemical substance is published under subparagraph (A); and 

(ii) publish in the Federal Register a final rule not 

later than 180 days after the date on which the risk 


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evaluation regarding such chemical substance is published under subparagraph (A). 

(C) EXTENSION.—If the Administrator determines that 

additional information is necessary to make a risk evaluation determination under this subsection, the Administrator 

may extend the deadline under subparagraph (A) accordingly, except that the deadline may not be extended to a 

date that is later than— 

(i) 90 days after receipt of such additional information; or 

(ii) 2 years after the original deadline. 

(6) DETERMINATIONS OF NO UNREASONABLE RISK.— 

(A) NOTICE AND COMMENT.—Not later than 30 days before publishing a final determination under this subsection 

that a chemical substance does not and will not present an 

unreasonable risk of injury to health or the environment, 

the Administrator shall make a preliminary determination 

to such effect and provide public notice of, and an opportunity for comment regarding, such preliminary determination. 

(B) POTENTIALLY EXPOSED SUBPOPULATIONS.—The Administrator shall not make a determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment if the 

Administrator determines that the chemical substance, 

under the intended conditions of use, presents or will 

present an unreasonable risk of injury to 1 or more potentially exposed subpopulations. 

(C) FINAL ACTION.—A final determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment shall 

be considered a final agency action. 

(7) MINIMUM NUMBER.—Subject to the availability of appropriations, the Administrator shall initiate 10 or more risk evaluations under paragraphs (3)(A)(i) or (3)(B) in each fiscal year 

beginning in the fiscal year of the date of enactment of the 

TSCA Modernization Act of 2015. 

(c) PROMULGATION OF SUBSECTION (a) RULES.—ø(1) In promulgating any rule under subsection (a) with respect to a chemical 

substance or mixture, the Administrator shall consider and publish 

a statement with respect to— 

ø(A) the effects of such substance or mixture on health and 

the magnitude of the exposure of human beings to such substance or mixture, 

ø(B) the effects of such substance or mixture on the environment and the magnitude of the exposure of the environment to 

such substance or mixture, 

ø(C) the benefits of such substance or mixture for various 

uses and the availability of substitutes for such uses, and 

ø(D) the reasonably ascertainable economic consequences of 

the rule, after consideration of the effect on the national economy, small business, technological innovation, the environment, and public health. 

If the Administrator determines that a risk of injury to health or 

the environment could be eliminated or reduced to a sufficient exVerDate Sep 11 2014 23:42 Jun 25, 2015 Jkt 049006 PO 00000 Frm 00056 Fmt 6659 Sfmt 6602 E:\HR\OC\HR176.XXX HR176

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tent by actions taken under another Federal law (or laws) administered in whole or in part by the Administrator, the Administrator 

may not promulgate a rule under subsection (a) to protect against 

such risk of injury unless the Administrator finds, in the Administrator’s discretion, that it is in the public interest to protect against 

such risk under this Act. In making such a finding the Administrator shall consider (i) all relevant aspects of the risk, as determined by the Administrator in the Administrator’s discretion, (ii) 

a comparison of the estimated costs of complying with actions 

taken under this Act and under such law (or laws), and (iii) the relative efficiency of actions under this Act and under such law (or 

laws) to protect against such risk of injury.¿ 

(1) REQUIREMENTS FOR RULE.—In promulgating any rule 

under subsection (a) with respect to a chemical substance or 

mixture, the Administrator shall— 

(A) consider and publish a statement 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 the chemical substance or mixture; 

(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 the 

likely effect of the rule on the national economy, small 

business, technological innovation, the environment, 

and public health; 

(B) impose requirements under the rule that the Administrator determines, consistent with the information published under subparagraph (A), are cost-effective, except 

where the Administrator determines that additional or different requirements described in subsection (a) are necessary to protect against the identified risk; 

(C) based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a 

manner that substantially prevents a specific use of a 

chemical substance or mixture and in setting an appropriate transition period for such action, determine 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) exempt replacement parts designed prior to the date 

of publication in the Federal Register of the rule unless the 

Administrator finds such replacement parts contribute significantly to the identified risk, including identified risk to 

identified potentially exposed subpopulations; and 

(E) in selecting among prohibitions and other restrictions 

to address an identified risk, apply prohibitions or other restrictions to articles on the basis of a chemical substance or 


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mixture contained in the article only to the extent necessary 

to protect against the identified risk. 

(2) 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) 

øprovide an opportunity for an informal hearing in accordance 

with paragraph (3); (D)¿ promulgate, if appropriate, a final 

rule based on the matter in the rulemaking record (as defined 

in section 19(a))ø, and (E)¿; and (D) make and publish with the 

rule the finding described in subsection (a). 

ø(3) Informal hearings required by paragraph (2)(C) shall be conducted by the Administrator in accordance with the following requirements: 

ø(A) Subject to subparagraph (B), an interested person is entitled— 

ø(i) to present such person’s position orally or by documentary submissions (or both), and 

ø(ii) if the Administrator determines that there are disputed issues of material fact it is necessary to resolve, to 

present such rebuttal submissions and to conduct (or have 

conducted under subparagraph (B)(ii)) such cross-examination of persons as the Administrator determines (I) to be 

appropriate, and (II) to be required for a full and true disclosure with respect to such issues. 

ø(B) The Administrator may prescribe such rules and make 

such rulings concerning procedures in such hearings to avoid 

unnecessary costs or delay. Such rules or rulings may include 

(i) the imposition of reasonable time limits on each interested 

person’s oral presentations, and (ii) requirements that any 

cross-examination to which a person may be entitled under 

subparagraph (A) be conducted by the Administrator on behalf 

of that person in such manner as the Administrator determines (I) to be appropriate, and (II) to be required for a full 

and true disclosure with respect to disputed issues of material 

fact. 

ø(C)(i) Except as provided in clause (ii), if a group of persons 

each of whom under subparagraphs (A) and (B) would be entitled to conduct (or have conducted) cross-examination and who 

are determined by the Administrator to have the same or similar interests in the proceeding cannot agree upon a single representative of such interests for purposes of cross-examination, 

the Administrator may make rules and rulings (I) limiting the 

representation of such interest for such purposes, and (II) governing the manner in which such cross-examination shall be 

limited. 

ø(ii) When any person who is a member of a group with respect to which the Administrator has made a determination 

under clause (i) is unable to agree upon group representation 

with the other members of the group, then such person shall 

not be denied under the authority of clause (i) the opportunity 


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to conduct (or have conducted) cross-examination as to issues 

affecting the person’s particular interests if (I) the person satisfies the Administrator that the person has made a reasonable 

and good faith effort to reach agreement upon group representation with the other members of the group and (II) the Administrator determines that there are substantial and relevant 

issues which are not adequately presented by the group representative. 

ø(D) A verbatim transcript shall be taken of any oral presentation made, and cross-examination conducted in any informal 

hearing under this subsection. Such transcript shall be available to the public. 

ø(4)(A) The Administrator may, pursuant to rules prescribed by 

the Administrator, provide compensation for reasonable attorneys’ 

fees, expert witness fees, and other costs of participating in a rulemaking proceeding for the promulgation of a rule under subsection 

(a) to any person— 

ø(i) who represents an interest which would substantially 

contribute to a fair determination of the issues to be resolved 

in the proceeding, and 

ø(ii) if— 

ø(I) the economic interest of such person is small in comparison to the costs of effective participation in the proceeding by such person, or 

ø(II) such person demonstrates to the satisfaction of the 

Administrator that such person does not have sufficient resources adequately to participate in the proceeding without 

compensation under this subparagraph. 

In determining for purposes of clause (i) if an interest will substantially contribute to a fair determination of the issues to be resolved 

in a proceeding, the Administrator shall take into account the number and complexity of such issues and the extent to which representation of such interest will contribute to widespread public 

participation in the proceeding and representation of a fair balance 

of interests for the resolution of such issues. 

ø(B) In determining whether compensation should be provided to 

a person under subparagraph (A) and the amount of such compensation, the Administrator shall take into account the financial 

burden which will be incurred by such person in participating in 

the rulemaking proceeding. The Administrator shall take such action as may be necessary to ensure that the aggregate amount of 

compensation paid under this paragraph in any fiscal year to all 

persons who, in rulemaking proceedings in which they receive compensation, are persons who either— 

ø(i) would be regulated by the proposed rule, or 

ø(ii) represent persons who would be so regulated, 

may not exceed 25 per centum of the aggregate amount paid as 

compensation under this paragraph to all persons in such fiscal 

year.¿ 

ø(5) Paragraphs (1), (2), (3), and (4)¿ (3) APPLICATION.— 

Paragraphs (1) and (2) of this subsection apply to the promulgation of a rule repealing, or making a substantive amendment 

to, a rule promulgated under subsection (a). 


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(d) EFFECTIVE DATE.—(1) The Administrator shall specify in any 

rule under subsection (a) the date on which it shall take effect, 

which date shall be as soon as feasible. 

(2)(A) The Administrator may declare a proposed rule under subsection (a) to be effective upon its publication in the Federal Register and until the effective date of final action taken, in accordance 

with subparagraph (B), respecting such rule if— 

(i) the Administrator determines that— 

(I) the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance or mixture subject to such proposed rule or any combination of 

such activities is likely to result in an unreasonable risk 

of serious or widespread injury to health or the environment before such effective date; and 

(II) making such proposed rule so effective is necessary 

to protect the public interest; and 

(ii) in the case of a proposed rule to prohibit the manufacture, processing, or distribution of a chemical substance or 

mixture because of the risk determined under clause (i)(I), a 

court has in an action under section 7 granted relief with respect to such risk associated with such substance or mixture. 

Such a proposed rule which is made so effective shall not, for purposes of judicial review, be considered final agency action. 

(B) If the Administrator makes a proposed rule effective upon its 

publication in the Federal Register, the Administrator shall, as expeditiously as possible, give interested persons prompt notice of 

such actionø, provide reasonable opportunity, in accordance with 

paragraphs (2) and (3) of subsection (c), for a hearing on such 

rule,¿ in accordance with paragraph (2) of subsection (c), and either 

promulgate such rule (as proposed or with modifications) or revoke 

itø; and if such a hearing is requested, the Administrator shall 

commence the hearing within five days from the date such request 

is made unless the Administrator and the person making the request agree upon a later date for the hearing to begin, and after 

the hearing is concluded the Administrator shall, within ten days 

of the conclusion of the hearing, either promulgate such rule (as 

proposed or with modifications) or revoke it.¿. Any rule promulgated under subsection (a) shall provide for a reasonable transition 

period. 

(e) POLYCHLORINATED BIPHENYLS.—(1) Within six months after 

the effective date of this Act the Administrator shall promulgate 

rules to— 

(A) prescribe methods for the disposal of polychlorinated 

biphenyls, and 

(B) require polychlorinated biphenyls to be marked with 

clear and adequate warnings, and instructions with respect to 

their processing, distribution in commerce, use, or disposal or 

with respect to any combination of such activities. 

Requirements prescribed by rules under this paragraph shall be 

consistent with the requirements of paragraphs (2) and (3). 

(2)(A) Except as provided under subparagraph (B), effective one 

year after the effective date of this Act no person may manufacture, process, or distribute in commerce or use any polychlorinated 

biphenyl in any manner other than in a totally enclosed manner. 


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(B) The Administrator may by rule authorize the manufacture, 

processing, distribution in commerce or use (or any combination of 

such activities) of any polychlorinated biphenyl in a manner other 

than in a totally enclosed manner if the Administrator finds that 

such manufacture, processing, distribution in commerce, or use (or 

combination of such activities) will not present an unreasonable 

risk of injury to health or the environment. 

(C) For the purposes of this paragraph, the term ‘‘totally enclosed 

manner’’ means any manner which will ensure that any exposure 

of human beings or the environment by the polychlorinated 

biphenyl will be insignificant as determined by the Administrator 

by rule. 

(3)(A) Except as provided in subparagraphs (B), (C), and (D)— 

(i) no person may manufacture any polychlorinated biphenyl 

after two years after the effective date of this Act, and 

(ii) no person may process or distribute in commerce any polychlorinated biphenyl after two and one-half years after such 

date. 

(B) Any person may petition the Administrator for an exemption 

from the requirements of subparagraph (A), and the Administrator 

may grant by rule such an exemption if the Administrator finds 

that— 

(i) an unreasonable risk of injury to health or environment 

would not result, and 

(ii) good faith efforts have been made to develop a chemical 

substance which does not present an unreasonable risk of injury to health or the environment and which may be substituted for such polychlorinated biphenyl. 

An exemption granted under this subparagraph shall be subject to 

such terms and conditions as the Administrator may prescribe and 

shall be in effect for such period (but not more than 1 year from 

the date it is granted, except as provided in subparagraph (D)) as 

the Administrator may prescribe. 

(C) Subparagraph (A) shall not apply to the distribution in commerce of any polychlorinated biphenyl if such polychlorinated 

biphenyl was sold for purposes other than resale before two and 

one-half years after the date of enactment of this Act. 

(D) The Administrator may extend an exemption granted pursuant to subparagraph (B) that has not yet expired for a period not 

to exceed 60 days for the purpose of authorizing the Secretary of 

Defense and the Secretaries of the military departments to provide 

for the transportation into the customs territory of the United 

States of polychlorinated biphenyls generated by or under the control of the Department of Defense for purposes of their disposal, 

treatment, or storage in the customs territory of the United States 

if those polychlorinated biphenyls are already in transit from their 

storage locations but the Administrator determines, in the sole discretion of the Administrator, they would not otherwise arrive in the 

customs territory of the United States within the period of the 

original exemption. The Administrator shall promptly publish notice of such extension in the Federal Register. 

(4) Any rule under paragraph (1), (2)(B), or (3)(B) shall be promulgated in accordance with øparagraphs (2), (3), and (4) of subsection (c)¿ paragraph (2) of subsection (c). 


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(5) This subsection does not limit the authority of the Administrator, under any other provision of this Act or any other Federal 

law, to take action respecting any polychlorinated biphenyl. 

(f) MERCURY.— 

(1) PROHIBITION ON SALE, DISTRIBUTION, OR TRANSFER OF

ELEMENTAL MERCURY BY FEDERAL AGENCIES.—Except as provided in paragraph (2), effective beginning on the date of enactment of this subsection, no Federal agency shall convey, 

sell, or distribute to any other Federal agency, any State or 

local government agency, or any private individual or entity 

any elemental mercury under the control or jurisdiction of the 

Federal agency. 

(2) EXCEPTIONS.—Paragraph (1) shall not apply to— 

(A) a transfer between Federal agencies of elemental 

mercury for the sole purpose of facilitating storage of mercury to carry out this Act; or 

(B) a conveyance, sale, distribution, or transfer of coal. 

(3) LEASES OF FEDERAL COAL.—Nothing in this subsection 

prohibits the leasing of coal. 

(g) NON-RISK FACTORS.—The Administrator shall not consider 

costs or other non-risk factors when deciding whether to initiate a 

rulemaking under subsection (a). 

(h) CRITICAL USE EXEMPTIONS.— 

(1) CRITERIA FOR EXEMPTION.—The Administrator may grant 

an exemption from a requirement of a subsection (a) rule for a 

specific use of a chemical substance or mixture, if— 

(A) the requirement is not cost-effective with respect to the 

specific use, as determined by the Administrator pursuant 

to subsection (c)(1)(B); and 

(B) the Administrator finds that— 

(i) the specific use is a critical or essential use; or 

(ii) the requirement, as applied with respect to the 

specific use, would significantly disrupt the national 

economy, national security, or critical infrastructure. 

(2) PROCEDURE.—An exemption granted under paragraph (1) 

shall be— 

(A) supported by clear and convincing evidence; 

(B) preceded by public notice of the proposed exemption 

and an opportunity for comment; and 

(C) followed by notice of the granted exemption— 

(i) to the public, by the Administrator; and 

(ii) to known commercial purchasers of the chemical 

substance or mixture with respect to which the exemption applies, by the manufacturers and processors of 

such chemical substance or mixture. 

(3) PERIOD OF EXEMPTION.—An exemption granted under 

paragraph (1) shall expire after a period not to exceed 5 years, 

but may be renewed for one or more additional 5-year periods 

if the Administrator finds that the requirements of paragraph 

(1) continue to be met. 

(4) CONDITIONS.—The Administrator shall impose conditions 

on any use for which an exemption is granted under paragraph 

(1) to reduce risk from the chemical substance or mixture to the 

greatest extent feasible. 


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(i) CHEMICALS THAT ARE PERSISTENT, BIOACCUMULATIVE, AND

TOXIC.— 

(1) IDENTIFICATION.—Not later than 9 months after the date 

of enactment of the TSCA Modernization Act of 2015, the Administrator shall publish a list of those chemical substances 

that the Administrator has a reasonable basis to conclude are 

persistent, bioaccumulative, and toxic, not including any chemical substance that is a metal, a metal compound, or subject to 

subsection (e). 

(2) CONFIRMATION OF CONCERN.—Not later than 2 years after 

the date of enactment of the TSCA Modernization Act of 2015, 

the Administrator shall designate as a PBT chemical of concern 

each chemical substance on the list published under paragraph 

(1)— 

(A) that, with respect to persistence and bioaccumulation, 

scores 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; and 

(B) exposure to which is likely to the general population 

or to a potentially exposed subpopulation identified by the 

Administrator. 

(3) EXPEDITED ACTION.—Notwithstanding subsection (b)(2), 

subject to the availability of appropriations, not later than 2 

years after designating a chemical substance under paragraph 

(2), the Administrator shall promulgate a rule under subsection 

(a) with respect to the chemical substance to reduce likely exposure to the extent practicable. 

(4) RELATIONSHIP TO SUBSECTION (B).—If, at any time prior 

to the date that is 90 days after the date on which the Administrator publishes the list under paragraph (1), the Administrator 

makes a finding under subsection (b)(3)(A)(i), or a manufacturer requests a risk evaluation under subsection (b)(3)(A)(ii), 

with respect to a chemical substance, such chemical substance 

shall not be subject to this subsection. 

SEC. 7. IMMINENT HAZARDS. 

(a) ACTIONS AUTHORIZED AND REQUIRED.—(1) The Administrator 

may commence a civil action in an appropriate district court of the 

United States— 

(A) for seizure of an imminently hazardous chemical substance or mixture or any article containing such a substance 

or mixture, 

(B) for relief (as authorized by subsection (b)) against any 

person who manufactures, processes, distributes in commerce, 

or uses, or disposes of, an imminent hazardous chemical substance or mixture or any article containing such a substance 

or mixture, or 

(C) for both such seizure and relief. 

A civil action may be commenced under this paragraph notwithstanding the existence of øa rule under section 4, 5, 6, or title IV 

or an order under section 5 or title IV¿ a rule under section 4, 5, 

or 6 or title IV, an order under section 4 or 5 or title IV, or a consent agreement under section 4, and notwithstanding the pendency 

of any administrative or judicial proceeding under any provision of 

this Act. 


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(2) If the Administrator has not made a rule under section 6(a) 

immediately effective (as authorized by subsection 6(d)(2)(A)(i)) 

with respect to an imminently hazardous chemical substance or 

mixture, the Administrator shall commence in a district court of 

the United States with respect to such substance or mixture or article containing such substance or mixture a civil action described 

in subparagraph (A), (B), or (C) of paragraph (1). 

(b) RELIEF AUTHORIZED.—(1) The district court of the United 

States in which an action under subsection (a) is brought shall 

have jurisdiction to grant such temporary or permanent relief as 

may be necessary to protect health or the environment from the 

unreasonable risk associated with the chemical substance, mixture, 

or article involved in such action. 

(2) In the case of an action under subsection (a) brought against 

a person who manufactures, processes, or distributes in commerce 

a chemical substance or mixture or an article containing a chemical 

substance or mixture, the relief authorized by paragraph (1) may 

include the issuance of a mandatory order requiring (A) in the case 

of purchasers of such substance, mixture, or article known to the 

defendant, notification to such purchasers of the risk associated 

with it; (B) public notice of such risk; (C) recall; (D) the replacement or repurchase of such substance, mixture, or article; or (E) 

any combination of the actions described in the preceding clauses. 

(3) In the case of an action under subsection (a) against a chemical substance, mixture, or article, such substance, mixture, or article may be proceeded against by process of libel for its seizure and 

condemnation. Proceedings in such an action shall conform as nearly as possible to proceedings in rem in admiralty. 

(c) VENUE AND CONSOLIDATION.—(1)(A) An action under subsection (a) against a person who manufactures, processes, or distributes a chemical substance or mixture or an article containing 

a chemical substance or mixture may be brought in the United 

States District Court for the District of Columbia or for any judicial 

district in which any of the defendants is found, resides, or transacts business; and process in such an action may be served on a 

defendant in any other district in which such defendant resides or 

may be found. An action under subsection (a) against a chemical 

substance, mixture, or article may be brought in any United States 

district court within the jurisdiction of which the substance, mixture, or article is found. 

(B) In determining the judicial district in which an action may 

be brought under subsection (a) in instances in which such action 

may be brought in more than one judicial district, the Administrator shall take into account the convenience of the parties. 

(C) Subpoenas requiring attendance of witnesses in an action 

brought under subsection (a) may be served in any judicial district. 

(2) Whenever proceedings under subsection (a) involving identical 

chemical substances, mixtures, or articles are pending in courts in 

two or more judicial districts, they shall be consolidated for trial by 

order of any such court upon application reasonably made by any 

party in interest, upon notice to all parties in interest. 

(d) ACTION UNDER SECTION 6.—Where appropriate, concurrently 

with the filing of an action under subsection (a) or as soon thereafter as may be practicable, the Administrator shall initiate a proceeding for the promulgation of a rule under section 6(a). 


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(e) REPRESENTATION.—Notwithstanding any other provision of 

law, in any action under subsection (a), the Administrator may direct attorneys of the Environmental Protection Agency to appear 

and represent the Administrator in such an action. 

(f) DEFINITION.—For the purposes of subsection (a), the term ‘‘imminently hazardous chemical substance or mixture’’ means a chemical substance or mixture which presents an imminent and unreasonable risk of serious or widespread injury to health or the environment. Such a risk to health or the environment shall be considered imminent if it is shown that the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance 

or mixture, or that any combination of such activities, is likely to 

result in such injury to health or the environment before a final 

rule under section 6 can protect against such risk. 

SEC. 8. REPORTING AND RETENTION OF INFORMATION. 

(a) REPORTS.—(1) The Administrator shall promulgate rules 

under which— 

(A) each person (other than a small manufacturer or processor) who manufactures or processes or proposes to manufacture or process a chemical substance (other than a chemical 

substance described in subparagraph (B)(ii) shall maintain 

such records, and shall submit to the Administrator such reports, as the Administrator may reasonably require, and 

(B) each person (other than a small manufacturer or processor) who manufactures or processes or proposes to manufacture or process— 

(i) a mixture, or 

(ii) a chemical substance in small quantities (as defined 

by the Administrator by rule) solely for purposes of scientific experimentation or analysis or chemical research 

on, or analysis of, such substance or another substance, including any such research or analysis for the development 

of a product, 

shall maintain records and submit to the Administrator reports 

but only to the extent the Administrator determines the maintenance of records or submission of reports, or both, is necessary for the effective enforcement of this Act. 

The Administrator may not require in a rule promulgated under 

this paragraph the maintenance of records or the submission of reports with respect to changes in the proportions of the components 

of a mixture unless the Administrator finds that the maintenance 

of such records or the submission of such reports, or both, is necessary for the effective enforcement of this Act. For purposes of the 

compilation of the list of chemical substances required under subsection (b), the Administrator shall promulgate rules pursuant to 

this subsection not later than 180 days after the effective date of 

this Act. 

(2) The Administrator may require under paragraph (1) maintenance of records and reporting with respect to the following insofar 

as known to the person making the report or insofar as reasonably 

ascertainable: 

(A) The common or trade name, the chemical identity, and 

molecular structure of each chemical substance or mixture for 

which such a report is required. 


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(B) The categories or proposed categories of use of each such 

substance or mixture. 

(C) The total amount of each substance and mixture manufactured or processed, reasonable estimates of the total amount 

to be manufactured or processed, the amount manufactured or 

processed for each of its categories of use, and reasonable estimates of the amount to be manufactured or processed for each 

of its categories of use or proposed categories of use. 

(D) A description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or 

mixture. 

(E) All existing data concerning the environmental and 

health effects of such substance or mixture. 

(F) The number of individuals exposed, and reasonable estimates of the number who will be exposed, to such substance 

or mixture in their places of employment and the duration of 

such exposure. 

(G) In the initial report under paragraph (1) on such substance or mixture, the manner or method of its disposal, and 

in any subsequent report on such substance or mixture, any 

change in such manner or method. 

To the extent feasible, the Administrator shall not require under 

paragraph (1), any reporting which is unnecessary or duplicative. 

(3)(A)(i) The Administrator may by rule require a small manufacturer or processor of a chemical substance to submit to the Administrator such information respecting the chemical substance as the 

Administrator may require for publication of the first list of chemical substances required by subsection (b). 

(ii) The Administrator may by rule require a small manufacturer 

or processor of a chemical substance or mixture— 

(I) subject to a rule proposed or promulgated under section 

4, 5(b)(4), or 6, øor an order in effect under section 5(e)¿, an 

order in effect under section 4 or 5(e), or a consent agreement 

under section 4, or 

(II) with respect to which relief has been granted pursuant 

to a civil action brought under section 5 or 7, 

to maintain such records on such substance or mixture, and to submit to the Administrator such reports on such substance or mixture, as the Administrator may reasonably require. A rule under 

this clause requiring reporting may require reporting with respect 

to the matters referred to in paragraph (2). 

(B) The Administrator, after consultation with the Administrator 

of the Small Business Administration, shall by rule prescribe 

standards for determining the manufacturers and processors which 

qualify as small manufacturers and processors for purposes of this 

paragraph and paragraph (1). 

(b) INVENTORY.—(1) The Administrator shall compile, keep current, and publish a list of each chemical substance which is manufactured or processed in the United States. Such list shall at least 

include each chemical substance which any person reports, under 

section 5 or subsection (a) of this section, is manufactured or processed in the United States. Such list may not include any chemical 

substance which was not manufactured or processed in the United 

States within three years before the effective date of the rules promulgated pursuant to the last sentence of subsection (a)(1). In the 


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case of a chemical substance for which a notice is submitted in accordance with section 5, such chemical substance shall be included 

in such list as of the earliest date (as determined by the Administrator) on which such substance was manufactured or processed in 

the United States. The Administrator shall first publish such a list 

not later than 315 days after the effective date of this Act. The Administrator shall not include in such list any chemical substance 

which is manufactured or processed only in small quantities (as defined by the Administrator by rule) solely for purposes of scientific 

experimentation or analysis or chemical research on, or analysis of, 

such substance or another substance, including such research or 

analysis for the development of a product. 

(2) To the extent consistent with the purposes of this Act, the Administrator may, in lieu of listing, pursuant to paragraph (1), a 

chemical substance individually, list a category of chemical substances in which such substance is included. 

(c) RECORDS.—Any person who manufactures, processes, or distributes in commerce any chemical substance or mixture shall 

maintain records of significant adverse reactions to health or the 

environment, as determined by the Administrator by rule, alleged 

to have been caused by the substance or mixture. Records of such 

adverse reactions to the health of employees shall be retained for 

a period of 30 years from the date such reactions were first reported to or known by the person maintaining such records. Any 

other record of such adverse reactions shall be retained for a period 

of five years from the date the information contained in the record 

was first reported to or known by the person maintaining the 

record. Records required to be maintained under this subsection 

shall include records of consumer allegations of personal injury or 

harm to health, reports of occupational disease or injury, and reports or complaints of injury to the environment submitted to the 

manufacturer, processor, or distributor in commerce from any 

source. Upon request of any duly designated representative of the 

Administrator, each person who is required to maintain records 

under this subsection shall permit the inspection of such records 

and shall submit copies of such records. 

(d) HEALTH AND SAFETY STUDIES.—The Administrator shall promulgate rules under which the Administrator shall require any 

person who manufactures, processes, or distributes in commerce or 

who proposes to manufacture, process, or distribute in commerce 

any chemical substance or mixture (or with respect to paragraph 

(2), any person who has possession of a study) to submit to the Administrator— 

(1) lists of health and safety studies (A) conducted or initiated by or for such person with respect to such substance or 

mixture at any time, (B) known to such person, or (C) reasonably ascertainable by such person, except that the Administrator may exclude certain types or categories of studies from 

the requirements of this subsection if the Administrator finds 

that submission of lists of such studies are unnecessary to 

carry out the purposes of this Act; and 

(2) copies of any study contained on a list submitted pursuant to paragraph (1) or otherwise known by such person. 

(e) NOTICE TO ADMINISTRATOR OF SUBSTANTIAL RISKS.—Any person who manufactures, processes, or distributes in commerce a 


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chemical substance or mixture and who obtains information which 

reasonably supports the conclusion that such substance or mixture 

presents a substantial risk of injury to health or the environment 

shall immediately inform the Administrator of such information 

unless such person has actual knowledge that the Administrator 

has been adequately informed of such information. 

(f) DEFINITIONS.—For purposes of this section, the terms ‘‘manufacture’’ and ‘‘process’’ mean manufacture or process for commercial 

purposes. 

SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS. 

(a) LAWS NOT ADMINISTERED BY THE ADMINISTRATOR.—(1) If the 

Administrator has reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a 

chemical substance or mixture, or that any combination of such activities, presents or will present an unreasonable risk of injury to 

health or the environment and determines, in the Administrator’s 

discretion, that such risk may be prevented or reduced to a sufficient extent by action taken under a Federal law not administered 

by the Administrator, the Administrator shall submit to the agency 

which administers such law a report which describes such risk and 

includes in such description a specification of the activity or combination of activities which the Administrator has reason to believe 

so presents such risk. Such report shall also request such agency— 

(A)(i) to determine if the risk described in such report may 

be prevented or reduced to a sufficient extent by action taken 

under such law, and 

(ii) if the agency determines that such risk may be so prevented or reduced, to issue an order declaring whether or not 

the activity or combination of activities specified in the description of such risk presents such risk; and 

(B) to respond to the Administrator with respect to the matters described in subparagraph (A). 

Any report of the Administrator shall include a detailed statement 

of the information on which it is based and shall be published in 

the Federal Register. The agency receiving a request under such a 

report shall make the requested determination, issue the requested 

order, and make the requested response within such time as the 

Administrator specifies in the request, but such time specified may 

not be less than 90 days from the date the request was made. The 

response of an agency shall be accompanied by a detailed statement of the findings and conclusions of the agency and shall be 

published in the Federal Register. 

(2) If the Administrator makes a report under paragraph (1) with 

respect to a chemical substance or mixture and the agency to which 

such report was made either— 

(A) issues an order declaring that the activity or combination 

of activities specified in the description of the risk described in 

the report does not present the risk described in the report, or 

(B) initiates, within 90 days of the publication in the Federal 

Register of the response of the agency under paragraph (1), action under the law (or laws) administered by such agency to 

protect against such risk associated with such activity or combination of activities, 

the Administrator may not take any action under øsection 6¿ section 6(a) or 7 with respect to such risk. 


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(3) If the Administrator has initiated action under øsection 6¿ 

section 6(a) or 7 with respect to a risk associated with a chemical 

substance or mixture which was the subject of a report made to an 

agency under paragraph (1), such agency shall before taking action 

under the law (or laws) administered by it to protect against such 

risk consult with the Administrator for the purpose of avoiding duplication of Federal action against such risk. 

(b) LAWS ADMINISTERED BY THE ADMINISTRATOR.—øThe Administrator shall coordinate¿ (1) The Administrator shall coordinate actions taken under this Act with actions taken under other Federal 

laws administered in whole or in part by the Administrator. If the 

Administrator determines that a risk to health or the environment 

associated with a chemical substance or mixture could be eliminated or reduced to a sufficient extent by actions taken under the 

authorities contained in such other Federal laws, the Administrator 

shall use such authorities to protect against such risk unless the 

Administrator determines, in the Administrator’s discretion, that it 

is in the public interest to protect against such risk by actions 

taken under this Act. This subsection shall not be construed to relieve the Administrator of any requirement imposed on the Administrator by such other Federal laws. 

(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 the relevant risks, and 

compare 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. 

(c) OCCUPATIONAL SAFETY AND HEALTH.—In exercising any authority under this Act, the Administrator shall not, for purposes of 

section 4(b)(1) of the Occupational Safety and Health Act of 1970, 

be deemed to be exercising statutory authority to prescribe or enforce standards or regulations affecting occupational safety and 

health. 

(d) COORDINATION.—In administering this Act, the Administrator 

shall consult and coordinate with the Secretary of Health, Education, and Welfare and the heads of any other appropriate Federal 

executive department or agency, any relevant independent regulatory agency, and any other appropriate instrumentality of the 

Federal Government for the purpose of achieving the maximum enforcement of this Act while imposing the least burdens of duplicative requirements on those subject to the Act and for other purposes. The Administrator shall, in the report required by section 

30, report annually to the Congress on actions taken to coordinate 

with such other Federal departments, agencies, or instrumentalities, and on actions taken to coordinate the authority under this 

Act with the authority granted under other Acts referred to in subsection (b). 

* * * * * * * 

SEC. 11. INSPECTIONS AND SUBPOENAS. 

(a) IN GENERAL.—For purposes of administering this Act, the Administrator, and any duly designated representative of the Administrator, may inspect any establishment, facility, or other premises 


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in which chemical substances, mixtures, or products subject to title 

IV are manufactured, processed, stored, or held before or after 

their distribution in commerce and any conveyance being used to 

transport chemical substances, mixtures, such products, or such articles in connection with distribution in commerce. Such an inspection may only be made upon the presentation of appropriate credentials and of a written notice to the owner, operator, or agent in 

charge of the premises or conveyance to be inspected. A separate 

notice shall be given for each such inspection, but a notice shall not 

be required for each entry made during the period covered by the 

inspection. Each such inspection shall be commenced and completed with reasonable promptness and shall be conducted at reasonable times, within reasonable limits, and in a reasonable manner. 

(b) SCOPE.—(1) Except as provided in paragraph (2), an inspection conducted under subsection (a) shall extend to all things within the premises or conveyance inspected (including records, files, 

papers, processes, controls, and facilities) bearing on whether the 

requirements of this Act applicable to the chemical substances, 

mixtures, or products subject to title IV within such premises or 

conveyance have been complied with. 

(2) No inspection under subsection (a) shall extend to— 

(A) financial data, 

(B) sales data (other than shipment data), 

(C) pricing data, 

(D) personnel data, or 

(E) research data (other than data required by this Act or 

under a ørule promulgated¿ rule promulgated, order issued, or 

consent agreement entered into thereunder), 

unless, the nature and extent of such data are described with reasonable specificity in the written notice required by subsection (a) 

for such inspection. 

(c) SUBPOENAS.—In carrying out this Act, the Administrator may 

by subpoena require the attendance and testimony of witnesses 

and the production of reports, papers, documents, answers to questions, and other information that the Administrator deems necessary. Witnesses shall be paid the same fees and mileage that are 

paid witnesses in the courts of the United States. In the event of 

contumacy, failure, or refusal of any person to obey any such subpoena, any district court of the United States in which venue is 

proper shall have jurisdiction to order any such person to comply 

with such subpoena. Any failure to obey such an order of the court 

is punishable by the court as a contempt thereof. 

* * * * * * * 

SEC. 14. DISCLOSURE OF DATA. 

(a) IN GENERAL.—Except as provided by subsection (b), any information reported to, or otherwise obtained by, the Administrator (or 

any representative of the Administrator) under this Act, which is 

exempt from disclosure pursuant to subsection (a) of section 552 of 

title 5, United States Code, by reason of subsection (b)(4) of such 

section, shall, notwithstanding the provisions of any other section 

of this Act, not be disclosed by the Administrator or by any officer 

or employee of the United States, except that such information— 


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(1) shall be disclosed to any officer or employee of the United 

States— 

(A) in connection with the official duties of such officer 

or employee under any law for the protection of health or 

the environment, or 

(B) for specific law enforcement purposes; 

(2) shall be disclosed to contractors with the United States 

and employees of such contractors if in the opinion of the Administrator such disclosure is necessary for the satisfactory 

performance by the contractor of a contract with the United 

States entered into on or after the date of enactment of this 

Act for the performance of work in connection with this Act 

and under such conditions as the Administrator may specify; 

(3) shall be disclosed if the Administrator determines it necessary to protect health or the environment against an unreasonable risk of injury to health or the environment; øor¿ 

(4) may be disclosed when relevant in any proceeding under 

this Act, except that disclosure in such a proceeding shall be 

made in such manner as to preserve confidentiality to the extent practicable without impairing the proceedingø.¿; 

(5) may be disclosed to a State, local, or tribal government official upon request of the official for the purpose of administration or enforcement of a law; and 

(6) shall be disclosed upon request— 

(A) to a health or environmental professional employed 

by a Federal or State agency in response to an environmental release; or 

(B) to a treating physician or other health care professional to assist in the diagnosis or treatment of 1 or more 

individuals. 

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) DATA FROM HEALTH AND SAFETY STUDIES.—(1) 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 data 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 release of any ødata which 

discloses¿ data that disclose formulas (including molecular structures) of a chemical substance or mixture, processes used in the 

manufacturing or processing of a chemical substance or ømixture 

or,¿ mixture, or, in the case of a mixture, øthe release of data disVerDate Sep 11 2014 23:42 Jun 25, 2015 Jkt 049006 PO 00000 Frm 00071 Fmt 6659 Sfmt 6602 E:\HR\OC\HR176.XXX HR176

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closing¿ the portion of the mixture comprised by any of the chemical substances in the mixture. 

(2) If a request is made to the Administrator under subsection 

(a) of section 552 of title 5, United States Code, for information 

which is described in the first sentence of paragraph (1) and which 

is not information described in the second sentence of such paragraph, the Administrator may not deny such request on the basis 

of subsection (b)(4) of such section. 

(c) øDESIGNATION AND RELEASE OF CONFIDENTIAL DATA.—¿ DES- IGNATING AND SUBSTANTIATING CONFIDENTIALITY.—ø(1) In submitting data under this Act, a manufacturer, processor, or distributor 

in commerce may (A) designate the data which such person believes is entitled to confidential treatment under subsection (a), 

and (B) submit such designated data separately from other data 

submitted under this Act. A designation under this paragraph shall 

be made in writing and in such manner as the Administrator may 

prescribe.¿ (1)(A) In submitting information under this Act after 

date of enactment of the TSCA Modernization Act of 2015, a manufacturer, processor, or distributor in commerce shall designate the 

information which such person believes is entitled to protection 

under this section, and submit such designated information separately from other information submitted under this Act. A designation under this subparagraph shall be made in writing and in such 

manner as the Administrator may prescribe, and shall include— 

(i) justification for each designation of confidentiality; 

(ii) a certification that the information is not otherwise publicly available; and 

(iii) separate copies of all submitted information, with 1 copy 

containing and 1 copy excluding the information to which the 

request applies. 

(B) Designations made under subparagraph (A) after the date of 

enactment of the TSCA Modernization Act of 2015 shall expire after 

10 years, at which time the information shall be made public unless 

the manufacturer, processor, or distributor in commerce has reasserted the claim for protection, in writing and in such manner as 

the Administrator may prescribe, including all of the elements required for the initial submission. 

(C) Not later than 60 days prior to making information public 

under subparagraph (B), the Administrator shall notify, as appropriate and practicable, the manufacturer, processor, or distributor 

in commerce who designated the information under subparagraph 

(A) of the date on which such information will be made public unless a request for renewal is granted under subparagraph (B). 

(2)(A) Except as provided by subparagraph (B), if the Administrator, for a reason other than the expiration of such designation 

pursuant to paragraph (1)(B), proposes to release for inspection 

data which has been designated under paragraph (1)(A), the Administrator shall notify, in writing and by certified mail, the manufacturer, processor, or distributor in commerce who submitted such 

data of the intent to release such data. If the release of such data 

is to be made pursuant to a request made under section 552(a) of 

title 5, United States Code, such notice shall be given immediately 

upon approval of such request by the Administrator. The Administrator may not release such data until the expiration of 30 days 

after the manufacturer, processor, or distributor in commerce subVerDate Sep 11 2014 23:42 Jun 25, 2015 Jkt 049006 PO 00000 Frm 00072 Fmt 6659 Sfmt 6602 E:\HR\OC\HR176.XXX HR176

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mitting such data has received the notice required by this subparagraph. 

(B)(i) Subparagraph (A) shall not apply to the release of information under paragraph (1), (2), (3), øor (4)¿ (4), or (6) of subsection 

(a), except that the Administrator may not release data under 

paragraph (3) of subsection (a) unless the Administrator has notified each manufacturer, processor, and distributor in commerce 

who submitted such data of such release. Such notice shall be 

made in writing by certified mail at least 15 days before the release 

of such data, except that if the Administrator determines that the 

release of such data is necessary to protect against an imminent, 

unreasonable risk of injury to health or the environment, such notice may be made by such means as the Administrator determines 

will provide notice at least 24 hours before such release is made. 

(ii) Subparagraph (A) shall not apply to the release of information described in subsection (b)(1) other than information described 

in the second sentence of such subsection. 

(d) CRIMINAL PENALTY FOR WRONGFUL DISCLOSURE.—(1) Any officer or employee of the United States or former officer or employee 

of the United States, who by virtue of such employment or official 

position has obtained possession of, or has access to, material the 

disclosure of which is prohibited by subsection (a), and who knowing that disclosure of such material is prohibited by such subsection, willfully disclosures the material in any manner to any 

person not entitled to receive it, shall be guilty of a misdemeanor 

and fined not more than $5,000 or imprisoned for not more than 

one year, or both. Section 1905 of title 18, United States Code, does 

not apply with respect to the publishing, divulging, disclosure, or 

making known of, or making available, information reported or otherwise obtained under this Act. 

(2) For the purposes of paragraph (1), any contractor with the 

United States who is furnished information as authorized by subsection (a)(2), and any employee of any such contractor, shall be 

considered to be an employee of the United States. 

(e) 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. 

(f) PROHIBITION.—No person who receives information as permitted under subsection (a) may use such information for any purpose not specified in such subsection, nor disclose such information 

to any person not authorized to receive such information. 

(g) SAVINGS.—Nothing in this section shall be construed to affect 

the applicability of State or Federal rules of evidence or procedure 

in any judicial proceeding. 

SEC. 15. PROHIBITED ACTS. 

It shall be unlawful for any person to— 

(1) fail or refuse to comply with ø(A) any rule promulgated 

or order issued under section 4,¿ ø(B) any requirement prescribed by section 5 or 6,¿ ø(C) any rule promulgated or order 

issued under section 5 or 6, or¿ ø(D)¿ any requirement of this 

title or any rule promulgated, order issued, or consent agreeVerDate Sep 11 2014 23:42 Jun 25, 2015 Jkt 049006 PO 00000 Frm 00073 Fmt 6659 Sfmt 6602 E:\HR\OC\HR176.XXX HR176

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ment entered into under this title, or any requirement of title 

II or any rule promulgated or order issued under title II; 

(2) use for commercial purposes a chemical substance or mixture which such person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of 

section 5 or 6, a rule or order under section 5 or 6, or an order 

issued in action brought under section 5 or 7; 

(3) fail or refuse to (A) establish or maintain records, (B) submit reports, notices, or other information, or (C) permit access 

to or copying of records, as required by this Act or a rule thereunder; or 

(4) fail or refuse to permit entry or inspection as required by 

section 11. 

* * * * * * * 

SEC. 18. PREEMPTION. 

(a) EFFECT ON STATE LAW.—(1) Except as provided in paragraph 

(2), nothing in this Act shall affect the authority of any State or 

political subdivision of a State to establish or continue in effect regulation of any chemical substance, mixture, or article containing a 

chemical substance or mixture. 

(2) Except as provided in subsection (b)— 

(A) if the Administrator requires by a ørule promulgated¿ 

rule, order, or consent agreement under section 4 the testing of 

a chemical substance or mixture, no State or political subdivision may, after the effective date of øsuch rule¿ such rule, 

order, or consent agreement, establish or continue in effect a requirement for the testing of such substance or mixture for purposes similar to those for which testing is required under 

øsuch rule¿ such rule, order, or consent agreement ø; and¿; 

ø(B) if the Administrator prescribes a rule or order under 

section 5 or 6 (other than a rule imposing a requirement described in subsection (a)(6) of section 6) which is applicable to 

a chemical substance or mixture, and which is designed to protect against a risk of injury to health or the environment associated with such substance or mixture, no State or political 

subdivision of a State may, after the effective date of such requirement, establish or continue in effect, any requirement 

which is applicable to such substance or mixture, or an article 

containing such substance or mixture, and which is designed 

to protect against such risk unless such requirement (i) is identical to the requirement prescribed by the Administrator, (ii) is 

adopted under the authority of the Clean Air Act or any other 

Federal law, or (iii) prohibits the use of such substance or mixture in such State or political subdivision (other than its use 

in the manufacture or processing of other substances or mixtures).¿ 

(B) if the Administrator makes a final determination under 

section 6(b) that a chemical substance will not present an unreasonable risk of injury to health or the environment under the 

intended condition of use, no State or political subdivision may, 

after the date of publication of such determination, establish or 

continue in effect any requirement that applies to such chemical 

substance under the intended conditions of use considered by 

the Administrator in the risk evaluation under section 6(b), and 


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is designed to protect against exposure to such chemical substance under the intended conditions of use, unless the requirement of the State or political subdivision— 

(i) is adopted under the authority of a Federal law; or 

(ii) is adopted to protect air or water quality or is related 

to waste treatment or waste disposal, except that this clause 

does not apply to such a requirement if a provision of this 

title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement; and 

(C) if the Administrator imposes a requirement, through a 

rule or order under section 5 or 6, that applies to a chemical 

substance or mixture (other than a requirement described in 

section 6(a)(6)) and is designed to protect against a risk of injury to health or the environment associated with such chemical 

substance or mixture, no State or political subdivision may, 

after the effective date of such requirement, establish or continue in effect any requirement that applies to such chemical 

substance or mixture (including a requirement that applies to 

an article because the article contains the chemical substance or 

mixture) and is designed to protect against exposure to the 

chemical substance or mixture either under the intended conditions of use considered by the Administrator in the risk evaluation under section 6(b) or from a use identified in a notice received by the Administrator under section 5(a), or, in the case 

of a requirement imposed pursuant to section 6(i), is designed 

to protect against a risk of injury considered by the Administrator in imposing such requirement, unless the requirement of 

the State or political subdivision— 

(i) is identical to the requirement imposed by the Administrator; 

(ii) is adopted under the authority of a Federal law; or 

(iii) is adopted to protect air or water quality or is related 

to waste treatment or waste disposal, except that this clause 

does not apply to such a requirement if a provision of this 

title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement. 

(3) In the case of an identical requirement described in paragraph 

(2)(C)(i)— 

(A) a State may not assess a penalty for a specific violation 

for which the Administrator has assessed a penalty under section 16; and 

(B) if 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 and the Administrator combined to exceed the maximum amount that may be assessed for 

that violation by the Administrator under section 16. 

(b) EXEMPTION.—Upon application of a State or political subdivision of a State the Administrator may by rule exempt from subsection (a)(2), under such conditions as may be prescribed in such 

rule, a requirement of such State or political subdivision designed 

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sociated with a chemical substance, mixture, or article containing 

a chemical substance or mixture if— 

(1) compliance with the requirement would not cause the 

manufacturing, processing, distribution in commerce, or use of 

the substance, mixture, or article to be in violation of the applicable requirement under this Act described in subsection (a)(2), 

and 

(2) the State or political subdivision requirement (A) provides a significantly higher degree of protection from such risk 

than the requirement under this Act described in subsection 

(a)(2) and (B) does not, through difficulties in marketing, distribution, or other factors, unduly burden interstate commerce. 

(c) SAVINGS.— (1) PRIOR STATE ACTIONS.—Nothing in this title, nor any risk 

evaluation, rule, order, standard, or requirement completed or 

implemented under this title, shall 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 before August 

1, 2015, under the authority of a State law that prohibits or 

otherwise restricts the manufacturing, processing, distribution 

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

action taken pursuant to a State law that was in effect on August 31, 2003, unless an action or determination made by the 

Administrator under this title actually conflicts with the action 

taken pursuant to such a State law. 

(2) TORT AND CONTRACT LAW.—Nothing in this title, nor any 

risk evaluation, rule, order, standard, or requirement completed 

or implemented under this title, shall be construed to preempt 

or otherwise affect either Federal or State tort law or the law 

governing the interpretation of contracts of any State, including 

any remedy for civil relief, whether under statutory or common 

law, including a remedy for civil damages, and 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 relating to tort 

law. 

(3) INTENT OF CONGRESS.—It is not the intent of Congress 

that this title, or rules, regulations, or orders issued pursuant 

to this title, be interpreted as influencing, in either a plaintiff’s 

or defendant’s favor, the disposition of any civil action for damages in a State court, or the authority of any court to make a 

determination in an adjudicatory proceeding under applicable 

State law with respect to the admissibility of evidence, unless 

a provision of this title actually conflicts with the State court 

action. 

(4) APPLICATION.—For purposes of this title, the term ‘‘requirements’’ does not include civil tort actions for damages 

under State law. 

SEC. 19. JUDICIAL REVIEW. 

(a) IN GENERAL.—(1)ø(A) Not later than 60 days after the date 

of the promulgation of a rule¿ Not later than 60 days after the date 

on which a rule is promulgated under section 4(a), 5(a)(2), 5(b)(4), 

6(a), 6(e), or 8, or under title II or IV, or the date on which an order 

is issued under section 4, any person may file a petition for judicial 

review of øsuch rule¿ such rule or order with the United States 


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Court of Appeals for the District of Columbia Circuit or for the circuit in which such person resides or in which such person’s principal place of business is located. Courts of appeals of the United 

States shall have exclusive jurisdiction of any action to obtain judicial review (other than in an enforcement proceeding) of øsuch a 

rule¿ such a rule or order if any district court of the United States 

would have had jurisdiction of such action but for this subparagraph. 

ø(B) Courts of appeals of the United States shall have exclusive 

jurisdiction of any action to obtain judicial review (other than in an 

enforcement proceeding) of an order issued under subparagraph (A) 

or (B) of section 6(b)(1) if any district court of the United States 

would have had jurisdiction of such action but for this subparagraph.¿ 

(2) Copies of any petition filed under paragraph (1)(A) shall be 

transmitted forthwith to the Administrator and to the Attorney 

General by the clerk of the court with which such petition was 

filed. The provisions of section 2112 of title 28, United States Code, 

shall apply to the filing of the rulemaking record of proceedings on 

which the Administrator based øthe rule¿ the rule or order being 

reviewed under this section and to the transfer of proceedings between United States courts of appeals. 

(3) For purposes of this section, the term ‘‘rulemaking record’’ 

means— 

(A) øthe rule¿ the rule or order being reviewed under this 

section; 

(B) in the case of øa rule under section 4(a)¿ a rule or order 

under section 4(a), the finding required by such section, in the 

case of a rule under section 5(b)(4), the finding required by 

such section, in the case of a rule under section 6(a) the finding 

required by section 5(f) or 6(a), as the case may be, in the case 

of a rule under section 6(a), the statement required by section 

6(c)(1), and in the case of a rule under section 6(e), the findings 

required by paragraph (2)(B) or (3)(B) of such section, as the 

case may be and in the case of a rule under title IV, the finding required for the issuance of such a rule; 

(C) any transcript required to be made of oral presentations 

made in proceedings for the promulgation of øsuch rule¿ such 

rule or order; 

(D) any written submission of interested parties respecting 

the promulgation of øsuch rule¿ such rule or order; and 

(E) any other information which the Administrator considers 

to be relevant øto such rule¿ to such rule or order and which 

the Administrator identified, on or before øthe date of the promulgation of such rule¿ the date on which such rule is promulgated or such order is issued, in a notice published in the Federal Register. 

(b) ADDITIONAL SUBMISSIONS AND PRESENTATIONS; MODIFICATIONS.—If in an action under this section to øreview a rule¿ review 

a rule, or an order under section 4, the petitioner or the Administrator applies to the court for leave to make additional oral submissions or written presentations respecting øsuch rule¿ such rule or 

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missions and presentations in the proceeding before the Administrator, the court may order the Administrator to provide additional 

opportunity to make such submissions and presentations. The Administrator may modify or set aside øthe rule¿ the rule or order 

being reviewed or make a ønew rule¿ new rule or order by reason 

of the additional submissions and presentations and shall file such 

modified or ønew rule¿ new rule or order with the return of such 

submissions and presentations. The court shall thereafter review 

such new or ømodified rule¿ modified rule or order. (c) STANDARD OF REVIEW.—(1)(A) Upon the filing of a petition 

under subsection (a)(1) for judicial review of øa rule¿ a rule, or an 

order under section 4, the court shall have jurisdiction (i) to grant 

appropriate relief, including interim relief, as provided in chapter 

7 of title 5, United States Code, and (ii) except as otherwise provided in subparagraph (B), to review øsuch rule¿ such rule or order 

in accordance with chapter 7 of title 5, United States Code. 

(B) Section 706 of title 5, United States Code, shall apply to review of øa rule¿ a rule or order under this section, except that— 

(i) in the case of review of a rule under section 4(a), 5(b)(4), 

6(a), or 6(e), or an order under section 4, 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 

øsuch rule¿ such rule or order if the court finds that øthe rule¿ 

the rule or order is not supported by substantial evidence in 

the rulemaking record (as defined in subsection (a)(3)) taken as 

a wholeø;¿; and 

ø(ii) in the case of review of a rule under section 6(a), the 

court shall hold unlawful and set aside such rule if it finds 

that— 

ø(I) a determination by the Administrator under section 

6(c)(3) that the petitioner seeking review of such rule is 

not entitled to conduct (or have conducted) cross-examination or to present rebuttal submissions, or 

ø(II) a rule of, or ruling by, the Administrator under section 6(c)(3) limiting such petitioner’s cross-examination or 

oral presentations, 

has precluded disclosure of disputed material facts which was 

necessary to a fair determination by the Administrator of the 

rulemaking proceeding taken as a whole; and section 706(2)(D) 

shall not apply with respect to a determination, rule, or ruling 

referred to in subclause (I) or (II); and¿ 

ø(iii)¿ (ii) the court may not review the contents and adequacy of— 

(I) any statement required to be made pursuant to section 6(c)(1), or 

(II) any statement of basis and purpose required by section 553(c) of title 5, United States Code, to be incorporated in the rule 

except as part of a review of the rulemaking record taken as 

a whole. 

The term ‘‘evidence’’ as used in clause (i) means any matter in the 

rulemaking record. 

(C) A determination, rule, or ruling of the Administrator described in subparagraph (B)(ii) may be reviewed only in an action 

under this section and only in accordance with such subparagraph. 


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(2) The judgment of the court affirming or setting aside, in whole 

or in part, øany rule¿ any rule or order reviewed in accordance 

with this section shall be final, subject to review by the Supreme 

Court of the United States upon certiorari or certification, as provided in section 1254 of title 28, United States Code. 

(d) FEES AND COSTS.—The decision of the court in an action commenced under subsection (a), or of the Supreme Court of the 

United States on review of such a decision, may include an award 

of costs of suit and reasonable fees for attorneys and expert witnesses if the court determines that such an award is appropriate. 

(e) OTHER REMEDIES.—The remedies as provided in this section 

shall be in addition to and not in lieu of any other remedies provided by law. 

SEC. 20. CITIZENS’ CIVIL ACTIONS. 

(a) IN GENERAL.—Except as provided in subsection (b), any person may commence a civil action— 

(1) against any person (including (A) the United States, and 

(B) any other governmental instrumentality or agency to the 

extent permitted by the eleventh amendment to the Constitution) who is alleged to be in violation of this Act or any rule 

promulgated under section 4, 5, or 6, or title II or IV, or øorder 

issued under section 5¿ order issued under section 4 or 5 or 

title II or IV to restrain such violation, or 

(2) against the Administrator to compel the Administrator to 

perform any act or duty under this Act which is not discretionary. 

Any civil action under paragraph (1) shall be brought in the United 

States district court for the district in which the alleged violation 

occurred or in which the defendant resides or in which the defendant’s principal place of business is located. Any action brought 

under paragraph (2) shall be brought in the United States District 

Court for the District of Columbia, or the United States district 

court for the judicial district in which the plaintiff is domiciled. The 

district courts of the United States shall have jurisdiction over 

suits brought under this section, without regard to the amount in 

controversy or the citizenship of the parties. In any civil action 

under this subsection process may be served on a defendant in any 

judicial district in which the defendant resides or may be found 

and subpoenas for witnesses may be served in any judicial district. 

(b) LIMITATION.—No civil action may be commenced— 

(1) under subsection (a)(1) to restrain a violation of this Act 

or rule or order under this Act— 

(A) before the expiration of 60 days after the plaintiff 

has given notice of such violation (i) to the Administrator, 

and (ii) to the person who is alleged to have committed 

such violation, or 

(B) if the Administrator has commenced and is diligently 

prosecuting a proceeding for the issuance of an order 

under section 16(a)(2) to require compliance with this Act 

or with such rule or order or if the Attorney General has 

commenced and is diligently prosecuting a civil action in 

a court of the United States to require compliance with 

this Act or with such rule or order, but if such proceeding 

or civil action is commenced after the giving of notice, any 


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person giving such notice may intervene as a matter of 

right in such proceeding or action; or 

(2) under subsection (a)(2) before the expiration of 60 days 

after the plaintiff has given notice to the Administrator of the 

alleged failure of the Administrator to perform an act or duty 

which is the basis for such action or, in the case of an action 

under such subsection for the failure of the Administrator to 

file an action under section 7, before the expiration of ten days 

after such notification. 

Notice under this subsection shall be given in such manner as the 

Administrator shall prescribe by rule. 

(c) GENERAL.—(1) In any action under this section, the Administrator, if not a party, may intervene as a matter of right. 

(2) The court, in issuing any final order in any action brought 

pursuant to subsection (a), may award costs of suit and reasonable 

fees for attorneys and expert witnesses if the court determines that 

such an award is appropriate. Any court, in issuing its decision in 

an action brought to review such an order, may award costs of suit 

and reasonable fees for attorneys if the court determines that such 

an award is appropriate. 

(3) Nothing in this section shall restrict any right which any person (or class of persons) may have under any statute or common 

law to seek enforcement of this Act or any rule or order under this 

Act or to seek any other relief. 

(d) CONSOLIDATION.—When two or more civil actions brought 

under subsection (a) involving the same defendant and the same 

issues or violations are pending in two or more judicial districts, 

such pending actions, upon application of such defendants to such 

actions which is made to a court in which any such action is 

brought, may, if such court in its discretion so decides, be consolidated for trial by order (issued after giving all parties reasonable 

notice and opportunity to be heard) of such court and tried in— 

(1) any district which is selected by such defendant and in 

which one of such actions is pending, 

(2) a district which is agreed upon by stipulation between all 

the parties to such actions and in which one of such actions is 

pending, or 

(3) a district which is selected by the court and in which one 

of such actions is pending. 

The court issuing such an order shall give prompt notification of 

the order to the other courts in which the civil actions consolidated 

under the order are pending. 

SEC. 21. CITIZENS’ PETITIONS. 

(a) IN GENERAL.—Any person may petition the Administrator to 

initiate a proceeding for the issuance, amendment, or repeal of a 

rule under section 4, 6, or 8 or an øorder under section 5(e) or 

(6)(b)(2)¿ order under section 4 or 5(e). 

(b) PROCEDURES.—(1) Such petition shall be filed in the principal 

office of the Administrator and shall set forth the facts which it is 

claimed establish that it is necessary to issue, amend, or repeal a 

rule under section 4, 6, or 8 or an øorder under section 5(e), 

6(b)(1)(A), or 6(b)(1)(B)¿ order under section 4 or 5(e). 

(2) The Administrator may hold a public hearing or may conduct 

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priate in order to determine whether or not such petition should be 

granted. 

(3) Within 90 days after filing of a petition described in paragraph (1), the Administrator shall either grant or deny the petition. 

If the Administrator grants such petition, the Administrator shall 

promptly commence an appropriate proceeding in accordance with 

section 4, 5, 6, or 8. If the Administrator denies such petition, the 

Administrator shall publish in the Federal Register the Administrator’s reasons for such denial. 

(4)(A) If the Administrator denies a petition filed under this section (or if the Administrator fails to grant or deny such petition 

within the 90-day period) the petitioner may commence a civil action in a district court of the United States to compel the Administrator to initiate a rulemaking proceeding as requested in the petition. Any such action shall be filed within 60 days after the Administrator’s denial of the petition or, if the Administrator fails to 

grant or deny the petition within 90 days after filing the petition, 

within 60 days after the expiration of the 90-day period. 

(B) In an action under subparagraph (A) respecting a petition to 

initiate a proceeding to issue a rule under section 4, 6, or 8 or an 

øorder under section 5(e) or 6(b)(2)¿ order under section 4 or 5(e), 

the petitioner shall be provided an opportunity to have such petition considered by the court in a de novo proceeding. If the petitioner demonstrates to the satisfaction of the court by a preponderance of the evidence that— 

(i) in the case of a petition to initiate a proceeding for the 

issuance of a rule under section 4 or an øorder under section 

5(e)¿ order under section 4 or 5(e)— 

(I) information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of the chemical substance to be subject 

to such rule or order; and 

(II) in the absence of such information, the substance 

may present an unreasonable risk to health or the environment, or the substance is or will be produced in substantial quantities and it 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 it; or 

(ii) in the case of a petition to initiate a proceeding for the 

issuance of a rule under section 6 or 8 øor 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; 

the court shall order the Administrator to initiate the action requested by the petitioner. If the court finds that the extent of the 

risk to health or the environment alleged by the petitioner is less 

than the extent of risks to health or the environment with respect 

to which the Administrator is taking action under this Act and 

there are insufficient resources available to the Administrator to 

take the action requested by the petitioner, the court may permit 

the Administrator to defer initiating the action requested by the 

petitioner until such time as the court prescribes. 


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(C) The court in issuing any final order in any action brought 

pursuant to subparagraph (A) may award costs of suit and reasonable fees for attorneys and expert witnesses if the court determines 

that such an award is appropriate. Any court, in issuing its decision in an action brought to review such an order, may award costs 

of suit and reasonable fees for attorneys if the court determines 

that such an award is appropriate. 

(5) The remedies under this section shall be in addition to, and 

not in lieu of, other remedies provided by law. 

* * * * * * * 

SEC. 24. EMPLOYMENT EFFECTS. 

(a) IN GENERAL.—The Administrator shall evaluate on a continuing basis the potential effects on employment (including reductions in employment or loss of employment from threatened plant 

closures) of— 

(1) the issuance of a rule or order under section 4, 5, or 6, 

or 

(2) a requirement of section 5 or 6. 

(b)(1) INVESTIGATIONS.—Any employee (or any representative of 

an employee) may request the Administrator to make an investigation of— 

(A) a discharge or layoff or threatened discharge or layoff of 

the employee, or 

(B) adverse or threatened adverse effects on the employee’s 

employment, 

allegedly resulting from a rule or order under section 4, 5, or 6 or 

a requirement of section 5 or 6. Any such request shall be made 

in writing, shall set forth with reasonable particularity the grounds 

for the request, and shall be signed by the employee, or representative of such employee, making the request. 

(2)(A) Upon receipt of a request made in accordance with paragraph (1) the Administrator shall (i) conduct the investigation requested, and (ii) if requested by any interested person, hold public 

hearings on any matter involved in the investigation unless the Administrator, by order issued within 45 days of the date such hearings are requested, denies the request for the hearings because the 

Administrator determines there are no reasonable grounds for 

holding such hearings. If the Administrator makes such a determination, the Administrator shall notify in writing the person requesting the hearing of the determination and the reasons therefor 

and shall publish the determination and the reasons therefor in the 

Federal Register. 

(B) If public hearings are to be held on any matter involved in 

an investigation conducted under this subsection— 

(i) at least five days’ notice shall be provided the person 

making the request for the investigation and any person identified in such request, and 

ø(ii) such hearings shall be held in accordance with section 

6(c)(3), and¿ 

ø(iii)¿ (ii) each employee who made or for whom was made 

a request for such hearings and the employer of such employee 

shall be required to present information respecting the applicable matter referred to in paragraph (1)(A) or (1)(B) together 

with the basis for such information. 


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(3) Upon completion of an investigation under paragraph (2), the 

Administrator shall make findings of fact, shall make such recommendations as the Administrator deems appropriate, and shall 

make available to the public such findings and recommendations. 

(4) This section shall not be construed to require the Administrator to amend or repeal any rule or order in effect under this Act. 

* * * * * * * 

SEC. 26. ADMINISTRATION OF THE ACT. 

(a) COOPERATION OF FEDERAL AGENCIES.—Upon request by the 

Administrator, each Federal department and agency is authorized— 

(1) to make its services, personnel, and facilities available 

(with or without reimbursement) to the Administrator to assist 

the Administrator in the administration of this Act; and 

(2) to furnish to the Administrator such information, data, 

estimates, and statistics, and to allow the Administrator access 

to all information in its possession as the Administrator may 

reasonably determine to be necessary for the administration of 

this Act. 

(b) FEES.—(1) The Administrator may, by rule, require the payment øof a reasonable fee¿ from any person required to submit 

data under section 4 or 5 of a fee that is sufficient and not more 

than reasonably necessary , or who requests a risk evaluation under 

section 6(b)(3)(A)(ii), to defray the cost of administering øthis Act¿ 

the provision of this title for which such fee is collected. øSuch 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.¿ Such rules 

shall provide for lower fees for small business concerns. In setting 

a fee under this paragraph, the Administrator shall take into account the ability to pay of the person required to submit the data 

and the cost to the Administrator of reviewing such data. Such 

rules may provide for sharing such a fee in any case in which the 

expenses of testing are shared under section 4 or 5. 

(2) The Administrator, after consultation with the Administrator 

of the Small Business Administration, shall by rule prescribe 

standards for determining the persons which qualify as small business concerns for purposes of paragraph (1). 

(3) FUND.— 

(A) ESTABLISHMENT.—There is established in the Treasury of 

the United States a revolving 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.—The Administrator 

shall collect the fees described in paragraph (1) and deposit 

those fees in the Fund. 

(C) CREDITING AND AVAILABILITY OF FEES.—On request by the 

Administrator, the Secretary of the Treasury shall transfer from 

the Fund to the Administrator amounts appropriated to pay or 

recover the full costs incurred by the Environmental Protection 

Agency, including contractor costs, in carrying out the provisions of this title for which the fees are collected under paragraph (1). 


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(D) USE OF FUNDS BY ADMINISTRATOR.—Amounts equivalent 

to fees collected by the Administrator and deposited in the Fund 

under this section shall be available without fiscal year limitation to the Administrator, subject to the availability of appropriations, for use only in administering the provisions of this 

title for which the fees are collected. 

(E) 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, 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 the title for 

which the fees are collected; and 

(cc) the number of requests for a risk evaluation 

made by manufacturers under section 

6(b)(3)(A)(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. 

(c) ACTION WITH RESPECT TO CATEGORIES.—(1) Any action authorized or required to be taken by the Administrator under any 

provision of this Act with respect to a chemical substance or mixture may be taken by the Administrator in accordance with that 

provision with respect to a category of chemical substances or mixtures. Whenever the Administrator takes action under a provision 

of this Act with respect to a category of chemical substances or 

mixtures, any reference in this Act to a chemical substance or mixture (insofar as it relates to such action) shall be deemed to be a 

reference to each chemical substance or mixture in such category. 

(2) For purposes of paragraph (1): 

(A) The term ‘‘category of chemical substances’’ means a 

group of chemical substances the members of which are similar 

in molecular structure, in physical, chemical, or biological 

properties, in use, or in mode of entrance into the human body 


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or into the environment, or the members of which are in some 

other way suitable for classification as such for purposes of this 

Act, except that such term does not mean a group of chemical 

substances which are grouped together solely on the basis of 

their being new chemical substances. 

(B) The term ‘‘category of mixtures’’ means a group of mixtures the members of which are similar in molecular structure, 

in physical, chemical, or biological 1properties, in use, or in the 

mode of entrance into the human body or into the environment, or the members of which are in some other way suitable 

for classification as such for purposes of this Act. 

(d) ASSISTANCE OFFICE.—The Administrator shall establish in 

the Environmental Protection Agency an identifiable office to provide technical and other nonfinancial assistance to manufacturers 

and processors of chemical substances and mixtures respecting the 

requirements of this Act applicable to such manufacturers and 

processors, the policy of the Agency respecting the application of 

such requirements to such manufacturers and processors, and the 

means and methods by which such manufacturers and processors 

may comply with such requirements. 

(e) FINANCIAL DISCLOSURES.—(1) Except as provided under paragraph (3), each officer or employee of the Environmental Protection 

Agency and the Department of Health, Education, and Welfare 

who— 

(A) performs any function or duty under this Act, and 

(B) has any known financial interest (i) in any person subject 

to this Act or any rule or order in effect under this Act, or (ii) 

in any person who applies for or receives any grant or contract 

under this Act, 

shall, on February 1, 1978, and on February 1 of each year thereafter, file with the Administrator or the Secretary of Health, Education, and Welfare (hereinafter in this subsection referred to as 

the ‘‘Secretary’’), as appropriate, a written statement concerning all 

such interests held by such officer or employee during the preceding calendar year. Such statement shall be made available to 

the public. 

(2) The Administrator and the Secretary shall— 

(A) act within 90 days of the effective date of this Act— 

(i) to define the term ‘‘known financial interests’’ for purposes of paragraph (1), and 

(ii) to establish the methods by which the requirement 

to file written statements specified in paragraph (1) will be 

monitored and enforced, including appropriate provisions 

for review by the Administrator and the Secretary of such 

statements; and 

(B) report to the Congress on June 1, 1978, and on June 1 

of each year thereafter with respect to such statements and the 

actions taken in regard thereto during the preceding calendar 

year. 

(3) The Administrator may by rule identify specific positions with 

the Environmental Protection Agency, and the Secretary may by 

rule identify specific positions with the Department of Health, Education, and Welfare, which are of a nonregulatory or nonpolicymaking nature, and the Administrator and the Secretary may by 


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rule provide that officers or employees occupying such positions 

shall be exempt from the requirements of paragraph (1). 

(4) This subsection does not supersede any requirement of chapter 11 of title 18, United States Code. 

(5) Any officer or employee who is subject to, and knowingly violates, this subsection or any rule issued thereunder, shall be fined 

not more than $2,500 or imprisoned not more than one year, or 

both. 

(f) STATEMENT OF BASIS AND PURPOSE.—Any final order issued 

under this Act shall be accompanied by a statement of its basis and 

purpose. The contents and adequacy of any such statement shall 

not be subject to judicial review in any respect. 

(g) ASSISTANT ADMINISTRATOR.—(1) The President, by and with 

the advice and consent of the Senate, shall appoint an Assistant 

Administrator for Toxic Substances of the Environmental Protection Agency. Such Assistant Administrator shall be a qualified individual who is, by reason of background and experience, especially 

qualified to direct a program concerning the effects of chemicals on 

human health and the environment. Such Assistant Administrator 

shall be responsible for (A) the collection of data, (B) the preparation of studies, (C) the making of recommendations to the Administrator for regulatory and other actions to carry out the purposes 

and to facilitate the administration of this Act, and (D) such other 

functions as the Administrator may assign or delegate. 

(2) The Assistant Administrator to be appointed under paragraph 

(1) shall be in addition to the Assistant Administrators of the Environmental Protection Agency authorized by section 1(d) of Reorganization Plan No. 3 of 1970. 

(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 consider, as applicable— 

(1) the extent to which the scientific and technical procedures, 

measures, methods, or models employed to generate the information are reasonable for and consistent with the 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, 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, 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 all notices, determinations, findings, rules, and orders of the Administrator under 

this title. 

(k) POLICIES, PROCEDURES, AND GUIDANCE.— 


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(1) DEVELOPMENT.—Not later than 2 years after the date of 

enactment of the TSCA Modernization Act of 2015, 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 TSCA Modernization Act of 2015. 

(2) REVIEW.—Not later than 5 years after the date of enactment of the TSCA Modernization Act of 2015, 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 

(B) revise such policies, procedures, and guidance as the 

Administrator determines necessary to reflect new scientific 

developments or understandings. 

(l) REPORT TO CONGRESS.— (1) INITIAL REPORT.—Not later than 6 months after the date 

of enactment of the TSCA Modernization Act of 2015, 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 subparagraphs (A)(i) and (B) of section 6(b)(3), and the resources 

necessary to initiate the minimum number of risk evaluations required under section 6(b)(7); 

(B) the capacity of the Environmental Protection Agency 

to conduct and publish risk evaluations under section 

6(b)(3)(A)(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 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. 

SEC. 27. DEVELOPMENT AND EVALUATION OF TEST METHODS. 

(a) IN GENERAL.—The Secretary of Health, Education, and Welfare in consultation with the Administrator and acting through the 

Assistant Secretary for Health, may conduct, and make grants to 

public and nonprofit private entities and enter into contracts with 

public and private entities for, projects for the development and 

evaluation of inexpensive and efficient methods (1) for determining 

and evaluating the health and environmental effects of chemical 

substances and mixtures, and their toxicity, persistence, and other 

characteristics which affect health and the environment, and (2) 


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which may be used for the development of test data to meet the 

requirements of ørules promulgated¿ rules, orders, or consent 

agreements under section 4. The Administrator shall consider such 

methods in prescribing under section 4 standards for the development of test data. 

(b) APPROVAL BY SECRETARY.—No grant may be made or contract 

entered into under subsection (a) unless an application therefor has 

been submitted to and approved by the Secretary. Such an application shall be submitted in such form and manner and contain such 

information as the Secretary may require. The Secretary may apply 

such conditions to grants and contracts under subsection (a) as the 

Secretary determines are necessary to carry out the purposes of 

such subsection. Contracts may be entered into under such subsection without regard to sections 3648 and 3709 of the Revised 

Statutes (31 U.S.C. 529; 41 U.S.C. 5). 

* * * * * * * 

SEC. 30. ANNUAL REPORT. 

The Administrator shall prepare and submit to the President and 

the Congress on or before January 1, 1978, and on or before January 1 of each succeeding year a comprehensive report on the administration of this Act during the preceding fiscal year. Such report shall include— 

(1) a list of the testing required under section 4 during the 

year for which the report is made and an estimate of the costs 

incurred during such year by the persons required to perform 

such tests; 

(2) the number of notices received during such year under 

section 5, the number of such notices received during such year 

under such section for chemical substances subject to a section 

4 ørule¿ rule, order, or consent agreement, and a summary of 

any action taken during such year under section 5(g); 

(3) a list of rules issued during such year under section 6; 

(4) a list, with a brief statement of the issues, of completed 

or pending judicial actions under this Act and administrative 

actions under section 16 during such year; 

(5) a summary of major problems encountered in the administration of this Act; and 

(6) such recommendations for additional legislation as the 

Administrator deems necessary to carry out the purposes of 

this Act. 

* * * * * * * 

Æ 


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