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Donate NowH.R.5820 - Toxic Chemicals Safety Act of 2010
To amend the Toxic Substances Control Act to ensure that the public and the environment are protected from risks of chemical exposure, and for other purposes.

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HR 5820 IHCommentsClose CommentsPermalink
111th CONGRESSCommentsClose CommentsPermalink
2d SessionCommentsClose CommentsPermalink
H. R. 5820CommentsClose CommentsPermalink
To amend the Toxic Substances Control Act to ensure that the public and the environment are protected from risks of chemical exposure, and for other purposes.CommentsClose CommentsPermalink
IN THE HOUSE OF REPRESENTATIVESCommentsClose CommentsPermalink
July 22, 2010CommentsClose CommentsPermalink
July 22, 2010CommentsClose CommentsPermalink
Mr. RUSH (for himself, Mr. WAXMAN, Ms. CASTOR of Florida, Ms. DEGETTE, Ms. SCHAKOWSKY, and Mr. SARBANES) introduced the following bill; which was referred to the Committee on Energy and CommerceCommentsClose CommentsPermalink
A BILLCommentsClose CommentsPermalink
To amend the Toxic Substances Control Act to ensure that the public and the environment are protected from risks of chemical exposure, and for other purposes.CommentsClose CommentsPermalink
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘Toxic Chemicals Safety Act of 2010’.CommentsClose CommentsPermalink
SEC. 2. FINDINGS, POLICY, AND GOAL.
(a) Findings, Policy, and Goal- Section 2 of the Toxic Substances Control Act (
(1) by striking ‘intent’ in the section heading and inserting ‘goal’; andCommentsClose CommentsPermalink
(2) by striking subsections (a) through (c) and inserting the following:CommentsClose CommentsPermalink
‘(a) Findings- Congress finds that--CommentsClose CommentsPermalink
‘(1) the chemical industry is an important part of the United States economy and provides valuable products that are used in diverse manufacturing industries and other commercial, institutional, and consumer applications;CommentsClose CommentsPermalink
‘(2) more than 3 decades after the enactment of the Toxic Substances Control Act, the public and the environment in the United States are still exposed to thousands of chemicals whose safety has not been adequately reviewed;CommentsClose CommentsPermalink
‘(3) biomonitoring reveals that people in the United States have many hazardous chemicals in their bodies;CommentsClose CommentsPermalink
‘(4) the potential for adverse effects from chemical exposures is modulated by developmental changes in metabolism, physiology, and pathways of exposure, with increased potential for adverse effects from exposures that occur in utero, during infancy, and during other critical periods of development;CommentsClose CommentsPermalink
‘(5) there is significant global trade in the chemical sector and many of the companies that conduct business in the United States must also comply with chemical safety regulatory programs in other countries, and the data that are generated to comply with these other regulatory programs may be useful in understanding the hazards of and exposures to chemicals in the United States; andCommentsClose CommentsPermalink
‘(6) a revised policy on the safety of chemicals will assist in renewing the manufacturing sector of the United States, create new and safer jobs, spur innovations in green chemistry, restore confidence domestically and internationally in the safety of products of the United States, and ensure that products of the United States remain competitive in the global market.CommentsClose CommentsPermalink
‘(b) Policy- It is the policy of the United States--CommentsClose CommentsPermalink
‘(1) to protect the health of children, workers, consumers, and the public, and to protect the environment from adverse effects of exposures to chemicals;CommentsClose CommentsPermalink
‘(2) to promote the use of safer alternatives and other actions that reduce use of and exposure to hazardous chemicals and reward innovation in developing safer chemicals, processes, and products;CommentsClose CommentsPermalink
‘(3) to require that all chemicals in commerce meet a risk-based safety standard that protects disproportionately vulnerable and affected populations and the environment;CommentsClose CommentsPermalink
‘(4) to require manufacturers and processors to provide sufficient health and environmental information for the chemicals which they manufacture or process as a condition of allowing distribution of such chemicals in commerce;CommentsClose CommentsPermalink
‘(5) to improve the quality of information on chemical safety and use;CommentsClose CommentsPermalink
‘(6) to guarantee the right of the public and workers to know about the risks associated with chemicals that they may be exposed to by maximizing public access to information on such chemicals;CommentsClose CommentsPermalink
‘(7) to strengthen cooperation between and among the Federal Government and State, municipal, tribal, and foreign governments;CommentsClose CommentsPermalink
‘(8) to ensure the Administrator has the authority to develop sufficient information to assess chemical safety, and to act effectively when the Administrator obtains information that indicates there are risks of harmful chemical exposure; andCommentsClose CommentsPermalink
‘(9) to replace, reduce, and refine testing on animals by promoting and funding the development of more efficient test methods and strategies.CommentsClose CommentsPermalink
‘(c) Goal- It is the goal of the United States to protect health and the environment by addressing exposure to harmful chemicals distributed in commerce, including exposure of vulnerable or disproportionately affected populations, by--CommentsClose CommentsPermalink
‘(1) determining whether all chemicals in commerce meet the safety standard under this title;CommentsClose CommentsPermalink
‘(2) restricting the manufacture, processing, use, distribution in commerce, or disposal of a chemical, where warranted; andCommentsClose CommentsPermalink
‘(3) encouraging the replacement of harmful chemicals and processes with safer alternatives.’.CommentsClose CommentsPermalink
(b) Conforming Amendment- The table of contents for the Toxic Substances Control Act is amended by amending the item relating to section 2 to read as follows:CommentsClose CommentsPermalink
‘Sec. 2. Findings, policy, and goal.’.CommentsClose CommentsPermalink
SEC. 3. DEFINITIONS AND DETERMINATIONS.
(a) Definitions and Determinations- Section 3 of the Toxic Substances Control Act (
(1) by striking--CommentsClose CommentsPermalink
‘SEC. 3. DEFINITIONS.
‘As used in this Act:’ and inserting the following:CommentsClose CommentsPermalink
‘SEC. 3. DEFINITIONS AND DETERMINATIONS.
‘(a) Definitions- As used in this Act:’;CommentsClose CommentsPermalink
(2) in subsection (a), (relating to definitions, as designated by paragraph (1))--CommentsClose CommentsPermalink
(A) in paragraph (2)--CommentsClose CommentsPermalink
(i) in subparagraph (A)--CommentsClose CommentsPermalink
(I) by striking ‘Except as provided in subparagraph (B), the term’ and inserting ‘The term’;CommentsClose CommentsPermalink
(II) in clause (i), by striking ‘and’ after ‘nature,’;CommentsClose CommentsPermalink
(III) in clause (ii), by striking the period at the end and inserting ‘, and’; andCommentsClose CommentsPermalink
(IV) by adding at the end the following new clause:CommentsClose CommentsPermalink
‘(iii) any form of a substance determined by the Administrator to be a chemical substance under subsection (b)(1).’; andCommentsClose CommentsPermalink
(ii) in subparagraph (B)--CommentsClose CommentsPermalink
(I) by striking clause (ii) and inserting the following:CommentsClose CommentsPermalink
‘(ii) any alcoholic beverage (as defined in section 214 of the Federal Alcohol Administration Act),’;CommentsClose CommentsPermalink
(II) in clause (iii), by striking ‘product,’ inserting ‘product (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act), and’; andCommentsClose CommentsPermalink
(III) by striking clauses (v) and (vi) and the matter following clause (vi);CommentsClose CommentsPermalink
(B) in paragraph (4)--CommentsClose CommentsPermalink
(i) by striking ‘or’ after ‘or article;’; andCommentsClose CommentsPermalink
(ii) by inserting ‘; or to export or offer for export the substance, mixture, or article, except for demonstrated use solely as a pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act), food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) and including poultry, poultry products, meat, meat food products (as defined in section 1(j) of the Federal Meat Inspection Act), eggs, and egg products (as defined in section 4 of the Egg Products Inspection Act)’ after ‘article after its introduction into commerce’;CommentsClose CommentsPermalink
(C) in paragraph (5), by inserting ‘ambient and indoor’ after ‘includes water,’;CommentsClose CommentsPermalink
(D) in paragraph (7), by inserting ‘, except for demonstrated use solely as a pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act), food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) and including poultry, poultry products, meat, meat food products (as defined in section 1(j) of the Federal Meat Inspection Act), eggs, and egg products (as defined in section 4 of the Egg Products Inspection Act)’ after ‘produce, or manufacture’;CommentsClose CommentsPermalink
(E) in paragraph (9), by striking ‘which is not included in the chemical substance list compiled and published under section 8(b)’ and inserting ‘for which no declaration has been submitted under section 8(a)(2), except that, with respect to the first year after the date of enactment of the Toxic Chemicals Safety Act of 2010, such term shall not include a chemical substance distributed in commerce as of such date of enactment’;CommentsClose CommentsPermalink
(F) in paragraph (10), after subparagraph (B), by adding the following:CommentsClose CommentsPermalink
‘Except such term shall not include preparation for demonstrated use solely as a pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act), food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) and including poultry, poultry products, meat, meat food products (as defined in section 1(j) of the Federal Meat Inspection Act), eggs, and egg products (as defined in section 4 of the Egg Products Inspection Act). Relabeling or redistributing a container holding a chemical substance or mixture where no repackaging of the chemical substance or mixture occurs does not constitute processing of the chemical substance or mixture. Relabeling, redistributing, or repackaging an article containing a chemical substance or mixture, including incorporating the article into another article, does not constitute processing of the chemical substance or mixture.’.CommentsClose CommentsPermalink
(G) by striking paragraph (12) and redesignating paragraphs (13) and (14) as paragraphs (12) and (13), respectively; andCommentsClose CommentsPermalink
(H) by adding at the end the following new paragraphs:CommentsClose CommentsPermalink
‘(14) The term ‘adverse effect’ means a chemical or biochemical change, anatomic change, or functional impairment, or a known precursor to such a change or impairment, that--CommentsClose CommentsPermalink
‘(A) has the potential to impair the performance of an anatomic structure of a vital system of an organism or progeny of an organism;CommentsClose CommentsPermalink
‘(B) causes irreversible change in the homeostasis of an organism;CommentsClose CommentsPermalink
‘(C) increases the susceptibility of an organism or progeny of an organism to other chemical or biological stressors or reduces the ability of an organism or progeny of an organism to respond to additional health or environmental challenges; orCommentsClose CommentsPermalink
‘(D) affects, alters, or harms the environment such that the health of humans or other organisms is directly or indirectly threatened.CommentsClose CommentsPermalink
In order to reflect best available science, the Administrator may, by rule, revise the definition of such term for purposes of this Act in such a way that reflects the state of the science and provides for equal or greater protection of health and the environment.CommentsClose CommentsPermalink
‘(15) The term ‘aggregate exposure’ means all exposure from--CommentsClose CommentsPermalink
‘(A) manufacture, processing, distribution, use, and disposal;CommentsClose CommentsPermalink
‘(B) manufacturing or processing of the substance for use as a pesticide, food, food additive, drug, cosmetic, or device;CommentsClose CommentsPermalink
‘(C) contamination of food, air, water, soil, house dust, and any other environmental media from current or prior uses or activity;CommentsClose CommentsPermalink
‘(D) permitted sources of pollution;CommentsClose CommentsPermalink
‘(E) nonpoint sources of pollution; andCommentsClose CommentsPermalink
‘(F) documented background levels from natural and anthropogenic sources.CommentsClose CommentsPermalink
‘(16) The term ‘bioaccumulative’ means, with respect to a chemical substance or mixture, that the chemical substance or mixture, as determined by the Administrator, can significantly accumulate in biota, as indicated through monitoring data, or is highly likely to accumulate in biota, as indicated by other evidence. In order to reflect best available science, the Administrator may, by rule, revise the definition of such term for purposes of this Act in such a way that reflects the state of the science and provides for equal or greater protection of health and the environment.CommentsClose CommentsPermalink
‘(17) The term ‘chemical identity’ means, with respect to a chemical substance--CommentsClose CommentsPermalink
‘(A) each common and trade name of the chemical substance;CommentsClose CommentsPermalink
‘(B) the name of the chemical substance appearing in International Union of Pure and Applied Chemistry nomenclature and 9th Collective Index format;CommentsClose CommentsPermalink
‘(C) the Chemical Abstracts Service registration number of the chemical substance; andCommentsClose CommentsPermalink
‘(D) the molecular structure and the molecular identity of the chemical substance.CommentsClose CommentsPermalink
‘(18) The term ‘cumulative exposure’ means the sum of aggregate exposure to--CommentsClose CommentsPermalink
‘(A) each of the chemical substances that are known or, where supported by scientific consensus, suspected to contribute appreciably to the risk of the same adverse effect; andCommentsClose CommentsPermalink
‘(B) mixtures containing chemical substances described in subparagraph (A).CommentsClose CommentsPermalink
‘(19) The term ‘Federal agency’ means any department, agency, or other instrumentality of the Federal Government, any independent agency or establishment of the Federal Government including any Government corporation, and the Government Printing Office.CommentsClose CommentsPermalink
‘(20) The term ‘importer’ means any person who imports a chemical substance or mixture, or any article containing a chemical substance or mixture, for distribution in commerce.CommentsClose CommentsPermalink
‘(21) The term ‘persistent’ means, with respect to a chemical substance or mixture, that the chemical substance or mixture, as determined by the Administrator, significantly persists in 1 or more environmental media, as indicated by monitoring data or other evidence. In order to reflect best available science, the Administrator may, by rule, revise the definition of such term for purposes of this Act in such a way that reflects the state of the science and provides for equal or greater protection of health and the environment.CommentsClose CommentsPermalink
‘(22) The term ‘substance characteristic’ means, with respect to a particular chemical substance, the physical and chemical characteristics that may vary for such substance, and whose variation may bear on the toxicological properties or the exposure potential of the substance, including--CommentsClose CommentsPermalink
‘(A) structure and composition;CommentsClose CommentsPermalink
‘(B) size or size distribution;CommentsClose CommentsPermalink
‘(C) shape;CommentsClose CommentsPermalink
‘(D) surface structure;CommentsClose CommentsPermalink
‘(E) reactivity; andCommentsClose CommentsPermalink
‘(F) other characteristics and properties that may bear on toxicological properties or exposure potential.CommentsClose CommentsPermalink
‘(23) The term ‘toxic’, with respect to a chemical substance or mixture, means that the chemical substance or mixture, or a metabolite or degradation product of such substance or mixture, has a toxicological property--CommentsClose CommentsPermalink
‘(A) that causes an adverse effect that has been demonstrated in humans or other organisms; orCommentsClose CommentsPermalink
‘(B) for which the weight of evidence (such as demonstration of such an adverse effect as described in subparagraph (A) in laboratory studies or data for a chemical from the same chemical class that exhibits such an adverse effect) demonstrates the potential for an adverse effect in humans or other organisms.CommentsClose CommentsPermalink
‘(24) The term ‘toxicological property’ means established toxicity, adverse effects, or established precursors to such toxicity or adverse effects, including effects of exposure to a chemical substance or mixture on--CommentsClose CommentsPermalink
‘(A) mortality;CommentsClose CommentsPermalink
‘(B) morbidity, including carcinogenesis;CommentsClose CommentsPermalink
‘(C) genetics, including mutagenicity, genotoxicity, and epigenetics;CommentsClose CommentsPermalink
‘(D) reproduction;CommentsClose CommentsPermalink
‘(E) growth and development;CommentsClose CommentsPermalink
‘(F) the immune system;CommentsClose CommentsPermalink
‘(G) the endocrine system;CommentsClose CommentsPermalink
‘(H) the brain or nervous system;CommentsClose CommentsPermalink
‘(I) other organ systems; orCommentsClose CommentsPermalink
‘(J) any other biological functions in humans or other organisms.CommentsClose CommentsPermalink
‘(25) The term ‘use’ means any utilization of a chemical substance or mixture that is not otherwise covered by the terms manufacture or process, and may include--CommentsClose CommentsPermalink
‘(A) any composition of the chemical substance with other chemical substances;CommentsClose CommentsPermalink
‘(B) any group of utilizations determined by the Administrator to be a single use under subsection (b)(2).CommentsClose CommentsPermalink
Relabeling or redistributing a container holding a chemical substance or mixture where no repackaging of the chemical substance or mixture occurs does not constitute use of the chemical substance or mixture.CommentsClose CommentsPermalink
‘(26) The term ‘vulnerable population’ means a population that is subject to a disproportionate exposure to, or potential for a disproportionate adverse effect from exposure to, a chemical substance or mixture, including--CommentsClose CommentsPermalink
‘(A) infants, children, and adolescents;CommentsClose CommentsPermalink
‘(B) pregnant women (including effects on fetal development);CommentsClose CommentsPermalink
‘(C) the elderly;CommentsClose CommentsPermalink
‘(D) individuals with preexisting medical conditions;CommentsClose CommentsPermalink
‘(E) workers; andCommentsClose CommentsPermalink
‘(F) members of any other appropriate population identified by the Administrator based on consideration of--CommentsClose CommentsPermalink
‘(i) socioeconomic status;CommentsClose CommentsPermalink
‘(ii) racial or ethnic background;CommentsClose CommentsPermalink
‘(iii) culturally influenced dietary or other practices or factors; orCommentsClose CommentsPermalink
‘(iv) other similar factors identified by the Administrator.’; andCommentsClose CommentsPermalink
(3) by adding at the end the following new subsection:CommentsClose CommentsPermalink
‘(b) Determinations-CommentsClose CommentsPermalink
‘(1) The Administrator may determine different forms of a chemical substance with a particular molecular identity to be different chemical substances for purposes of this Act, based on variations in the substance characteristics. New forms of existing chemical substances so determined shall be considered new chemical substances for purposes of this Act.CommentsClose CommentsPermalink
‘(2) The Administrator may determine different uses of a chemical substance or mixture to be the same use for purposes of this Act, based on industry classification systems or factors determined by the Administrator to indicate similarity in use and exposure, provided that such systems or factors ensure that the different uses treated as the same use under this paragraph do not involve materially different patterns, pathways, or degrees of exposure.’.CommentsClose CommentsPermalink
(b) Conforming Amendment- The table of contents for the Toxic Substances Control Act is amended by amending the item relating to section 3 to read as follows:CommentsClose CommentsPermalink
‘Sec. 3. Definitions and Determinations.’.CommentsClose CommentsPermalink
SEC. 4. MINIMUM DATA SET AND TESTING OF CHEMICAL SUBSTANCES AND MIXTURES.
Section 4 of the Toxic Substances Control Act (
(1) By amending subsection (a) to read as follows:CommentsClose CommentsPermalink
‘(a) Minimum Data Set-CommentsClose CommentsPermalink
‘(1) Not later than 1 year after the date of enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall establish, by rule, the data that constitute the minimum data set for substances described in paragraph (2). The rule shall--CommentsClose CommentsPermalink
‘(A) require manufacturers and processors to submit a minimum data set that the Administrator determines will be useful in conducting safety standard determinations pursuant to section 6(b) or carrying out any provision of this Act, and shall include information on--CommentsClose CommentsPermalink
‘(i) chemical identity;CommentsClose CommentsPermalink
‘(ii) substance characteristics;CommentsClose CommentsPermalink
‘(iii) biological and environmental fate and transport;CommentsClose CommentsPermalink
‘(iv) toxicological properties;CommentsClose CommentsPermalink
‘(v) volume manufactured, processed, or imported;CommentsClose CommentsPermalink
‘(vi) intended uses; andCommentsClose CommentsPermalink
‘(vii) exposures from all stages of the chemical substance or mixture’s lifecycle that are known or reasonably foreseeable to the party submitting the data set;CommentsClose CommentsPermalink
‘(B) provide for varied or tiered testing;CommentsClose CommentsPermalink
‘(C) establish requirements for manufacturers and processors to update their minimum data set submissions, as appropriate; andCommentsClose CommentsPermalink
‘(D) be updated by the Administrator not less often than once every 5 years.CommentsClose CommentsPermalink
‘(2) Except as provided in paragraph (3), the manufacturers and processors of a chemical substance or mixture shall submit the minimum data set established by the rule under paragraph (1), accompanied by the certification described in section 8(i), to the Administrator--CommentsClose CommentsPermalink
‘(A) for an existing chemical substance or mixture, not later than the earlier of--CommentsClose CommentsPermalink
‘(i) 18 months after the date on which the Administrator lists the chemical substance or mixture on the priority list under section 6(a); orCommentsClose CommentsPermalink
‘(ii) for chemical substances produced--CommentsClose CommentsPermalink
‘(I) at high volumes, as determined by the Administrator, 3 years after the date of enactment of the Toxic Chemicals Safety Act of 2010;CommentsClose CommentsPermalink
‘(II) at moderate volumes, as determined by the Administrator, 4 years after the date of enactment of the Toxic Chemicals Safety Act of 2010; orCommentsClose CommentsPermalink
‘(III) at low volumes, as determined by the Administrator, 5 years after the date of enactment of the Toxic Chemicals Safety Act of 2010; orCommentsClose CommentsPermalink
‘(B) for a new chemical substance, the date on which the notice required under section 5(a)(1)(A) is submitted.CommentsClose CommentsPermalink
‘(3) No minimum data set shall be required to be submitted by manufacturers and processors of a chemical substance listed under section 6(a)(1)(A) or exempted from the requirement pursuant to section 39 or section 32 or for a safer alternative approved pursuant to section 35.CommentsClose CommentsPermalink
‘(4) If a manufacturer or processor is in violation of paragraph (2), the Administrator may impose penalties, pursuant to section 16, on such manufacturer or processor, or, by order, impose conditions, including prohibitions, on the manufacture, processing, or distribution in commerce of the chemical substance, or any mixture or article containing the chemical substance, by such manufacturer or processor.’.CommentsClose CommentsPermalink
(2) In subsection (b)--CommentsClose CommentsPermalink
(A) by redesignating paragraphs (2) and (3) as paragraphs (4) and (5), respectively;CommentsClose CommentsPermalink
(B) by redesignating paragraphs (4) and (5) as paragraphs (7) and (8), respectively;CommentsClose CommentsPermalink
(C) in paragraph (1)--CommentsClose CommentsPermalink
(i) by striking ‘A rule under subsection (a) shall include’ and all that follows through ‘during the period prescribed under subparagraph (C)’; andCommentsClose CommentsPermalink
(D) by striking the following:CommentsClose CommentsPermalink
‘(b)(1) Testing requirement rule- ’ and inserting the following:CommentsClose CommentsPermalink
‘(b) Testing Rules and Orders-CommentsClose CommentsPermalink
‘(1) The Administrator may, by rule or order, after notice and opportunity for comment, require testing in addition to the requirements for the minimum data set under subsection (a) with respect to any chemical substance or mixture and the submission of test results by a specified date, as necessary for making a safety standard determination under section 6(b) or carrying out any provision of this Act.CommentsClose CommentsPermalink
‘(2) If a manufacturer or processor is in violation of paragraph (1), the Administrator may impose penalties, pursuant to section 16, on such manufacturer or processor, or, by order, impose conditions, including prohibitions, on the manufacture, processing, or distribution in commerce of the chemical substance, or any mixture or article containing the chemical substance, by such manufacturer or processor.CommentsClose CommentsPermalink
‘(3) A rule or order under paragraph (1) shall include--CommentsClose CommentsPermalink
‘(A) identification of the chemical substance or mixture for which testing is required;CommentsClose CommentsPermalink
‘(B) the testing required and justification for such testing, and may specify test protocols and methodology for testing for such substance or mixture in accordance with section 34(c); andCommentsClose CommentsPermalink
‘(C) 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 a methodology referred to in subparagraph (B).CommentsClose CommentsPermalink
In determining the testing, test protocols, and methodology, and period to be included, pursuant to subparagraphs (B) and (C), in a rule or order under paragraph (1), the Administrator shall consider the relative costs of the various test protocols and methodologies which may be required under the rule or order and the reasonably foreseeable availability of the facilities and personnel needed to perform the testing required under the rule or order. Any such rule or order may require the submission to the Administrator of preliminary data during the period prescribed under subparagraph (C).’;CommentsClose CommentsPermalink
(E) by amending paragraph (4), as redesignated by subparagraph (A) of this paragraph, to read as follows:CommentsClose CommentsPermalink
‘(4)(A)(i) The health and environmental effects for which testing may be prescribed include any toxicological property and any other adverse effect which may be considered in a safety standard determination under section 6(b).CommentsClose CommentsPermalink
‘(ii) The exposure information for which testing may be prescribed includes biological or environmental fate and transport, monitoring for the presence of the chemical substance or mixture (or a metabolite or degradation byproduct of the chemical substance or mixture) in animal or human biological media or environmental media, and any other exposure information which may be considered in a safety standard determination under section 6(b).CommentsClose CommentsPermalink
‘(iii) The characteristics of chemical substances and mixtures for which testing may be prescribed include persistence, bioaccumulation, and any other relevant substance characteristic which may be considered in a safety standard determination under section 6(b).CommentsClose CommentsPermalink
‘(B) The methodologies that may be prescribed in testing include epidemiologic studies, industrial hygiene surveys, biomonitoring studies, serial or hierarchical tests, in vitro tests, and whole animal tests consistent with section 34, except that before prescribing epidemiologic studies or industrial hygiene surveys of employees, the Administrator shall consult with the Director of the National Institute for Occupational Safety and Health.CommentsClose CommentsPermalink
‘(C) From time to time, but not less than once each 12 months, the Administrator shall review the adequacy of the methodology for testing prescribed in rules or orders under paragraph (1) and shall, if necessary, institute proceedings to make appropriate revisions of such methodology.’;CommentsClose CommentsPermalink
(F) in paragraph (5), as redesignated by subparagraph (A) of this paragraph--CommentsClose CommentsPermalink
(i) by striking subparagraph (B);CommentsClose CommentsPermalink
(ii) by striking ‘(A) A rule under subsection (a) respecting a chemical substance or mixture shall require the persons described in subparagraph (B)’ and inserting ‘A rule or order under paragraph (1) respecting a chemical substance or mixture shall specify the persons required’; andCommentsClose CommentsPermalink
(iii) by inserting ‘in which case all parties remain individually liable for the testing requirements’ after ‘on behalf of the persons making the designation’;CommentsClose CommentsPermalink
(G) by inserting after paragraph (5), as redesignated by subparagraph (A) of this paragraph, the following new paragraph:CommentsClose CommentsPermalink
‘(6) Any biomonitoring study of the public regarding a chemical substance or any metabolite or degradation byproduct of such substance shall be conducted by the Director of the Centers for Disease Control and Prevention in collaboration with the Administrator, at the expense of the manufacturers and processors of the chemical substance. Any biomonitoring study of employees regarding a chemical substance or any metabolite or degradation byproduct of such substance may be conducted by the relevant employer, at the expense of the manufacturers and processors of the chemical substance, in collaboration with the Director of the National Institute of Occupational Safety and Health and the Administrator.’;CommentsClose CommentsPermalink
(H) in paragraph (7), as redesignated by subparagraph (B) of this paragraph--CommentsClose CommentsPermalink
(i) by striking ‘under subsection (a)’ in both places it appears and inserting ‘or order under paragraph (1)’;CommentsClose CommentsPermalink
(ii) by striking ‘repeals the rule’ in both places it appears and inserting ‘withdraws the rule or order’; andCommentsClose CommentsPermalink
(iii) by striking ‘repeals the application of the rule’ and inserting ‘withdraws the rule or order as applied’; andCommentsClose CommentsPermalink
(I) by amending paragraph (8), as redesignated by subparagraph (B) of this paragraph, to read as follows:CommentsClose CommentsPermalink
‘(8) Rules issued under subsection (a) and paragraph (1) (and any substantive amendment thereto or repeal thereof) shall be promulgated pursuant to
section 553 of title 5, United States Code .’.CommentsClose CommentsPermalink
(3) In subsection (c)--CommentsClose CommentsPermalink
(A) in paragraph (1)--CommentsClose CommentsPermalink
(i) by inserting ‘or order’ after ‘rule’; andCommentsClose CommentsPermalink
(ii) by striking ‘subsection (a)’ and inserting ‘subsection (a) or (b)(1)’;CommentsClose CommentsPermalink
(B) in paragraph (2)--CommentsClose CommentsPermalink
(i) by striking ‘under subsection (a)’ and inserting ‘under subsection (b)(1)’; andCommentsClose CommentsPermalink
(ii) by inserting ‘or order’ after ‘rule’ each place it appears;CommentsClose CommentsPermalink
(C) in paragraph (3)(B)(i), by striking ‘promulgated under subsection (a)’ and inserting ‘or order issued under subsection (b)(1)’;CommentsClose CommentsPermalink
(D) in paragraph (4)--CommentsClose CommentsPermalink
(i) in subparagraph (A)--CommentsClose CommentsPermalink
(I) by striking ‘promulgated under subsection (a)’ and inserting ‘issued under subsection (b)(1)’; andCommentsClose CommentsPermalink
(II) by inserting ‘or order’ after ‘rule’ each place it appears; andCommentsClose CommentsPermalink
(ii) in subparagraph (B)--CommentsClose CommentsPermalink
(I) by striking ‘promulgated under subsection (a)’ and inserting ‘or order issued under subsection (b)(1)’; andCommentsClose CommentsPermalink
(II) by inserting ‘or order’ after ‘such rule’; andCommentsClose CommentsPermalink
(III) by inserting ‘or order’ after ‘requirements of the rule’; andCommentsClose CommentsPermalink
(E) by adding at the end the following new paragraph:CommentsClose CommentsPermalink
‘(5) If a manufacturer or processor has submitted a declaration of permanent cessation of manufacture or processing under section 8(a)(3) for a chemical substance or mixture, the manufacturer or processor shall be exempted from the requirements of this section with regard to such chemical substance or mixture.’.CommentsClose CommentsPermalink
(4) In subsection (d)--CommentsClose CommentsPermalink
(A) by striking ‘under subsection (a)’ and inserting ‘or order issued under subsection (a) or (b)(1)’;CommentsClose CommentsPermalink
(B) by inserting ‘Such notice shall not be interpreted as meeting the requirements of the rule or order, unless otherwise indicated.’ before ‘Subject to section 14, each notice shall’; andCommentsClose CommentsPermalink
(C) by inserting ‘and be added to the public database established pursuant to section 8(d)’ after ‘Administrator for examination by any person’.CommentsClose CommentsPermalink
(5) In subsection (e)--CommentsClose CommentsPermalink
(A) in the subsection heading, by striking ‘Priority List’ and inserting ‘Interagency Testing Committee’;CommentsClose CommentsPermalink
(B) in paragraph (1)--CommentsClose CommentsPermalink
(i) in subparagraph (A)--CommentsClose CommentsPermalink
(I) by striking ‘for the promulgation of a rule under subsection (a)’ and inserting ‘for listing under section 6(a)(1) and promulgation of testing rules or orders under subsection (b)(1)’;CommentsClose CommentsPermalink
(II) in clause (v), by striking ‘an unreasonable’ and inserting ‘a substantial’; andCommentsClose CommentsPermalink
(III) in the matter following clause (viii)--CommentsClose CommentsPermalink
(aa) by striking ‘cancer, gene mutations, or birth defects’ and inserting ‘adverse effects on health or the environment’;CommentsClose CommentsPermalink
(bb) by striking ‘under subsection (a)’ each place it appears and inserting ‘under subsection (b)(1)’; andCommentsClose CommentsPermalink
(cc) by striking ‘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.’; andCommentsClose CommentsPermalink
(ii) in subparagraph (B), by striking ‘rulemaking proceeding under subsection (a)’ and inserting ‘proceeding to promulgate a rule or issue an order under subsection (b)(1)’; andCommentsClose CommentsPermalink
(C) in paragraph (2)(A)--CommentsClose CommentsPermalink
(i) by striking ‘eight members’ and inserting ‘10 members’; andCommentsClose CommentsPermalink
(ii) by adding at the end the following new clauses:CommentsClose CommentsPermalink
‘(ix) One member appointed by the Commissioner of the Food and Drug Administration from officers or employees of the Administration.CommentsClose CommentsPermalink
‘(x) One member appointed by the Chairman of the Consumer Product Safety Commission from officers or employees of the Commission.’.CommentsClose CommentsPermalink
(6) By amending subsection (f) to read as follows:CommentsClose CommentsPermalink
‘(f) Requests From Other Federal Agencies for Additional Information or Testing-CommentsClose CommentsPermalink
‘(1) IN GENERAL- If a Federal agency determines that information relating to a chemical substance or mixture, including data derived from new testing or monitoring, would assist such agency in carrying out duties or exercising authority of such agency, but such information is not available to the agency, such agency may request the Administrator to seek such information on its behalf.CommentsClose CommentsPermalink
‘(2) DUTY OF ADMINISTRATOR- Not later than 60 days after the date of receipt of a request under paragraph (1), the Administrator shall--CommentsClose CommentsPermalink
‘(A) if in possession of the requested data, make such data available to the requesting agency, subject to section 14;CommentsClose CommentsPermalink
‘(B) issue an order, under section 8(b)(1), requiring the submission of existing data to the requesting agency and to the Administrator;CommentsClose CommentsPermalink
‘(C) issue a rule or order, under subsection (b), to develop such data, and require such data be furnished to the requesting agency and to the Administrator; orCommentsClose CommentsPermalink
‘(D) publish in the Federal Register the reason for not taking any of the actions described in subparagraphs (A) through (C).’.CommentsClose CommentsPermalink
(7) By striking subsection (g).CommentsClose CommentsPermalink
SEC. 5. MANUFACTURING AND PROCESSING NOTICES.
Section 5 of the Toxic Substances Control Act (
(1) By amending subsection (a) to read as follows:CommentsClose CommentsPermalink
‘(a) New Chemical Substances and Mixtures and New Uses of Chemical Substances and Mixtures-CommentsClose CommentsPermalink
‘(1) Except as provided in subsection (d), no person may manufacture or process a new chemical substance or mixture, or manufacture or process any chemical substance or mixture for a use which the Administrator has determined, in accordance with paragraph (2), is a new use, unless--CommentsClose CommentsPermalink
‘(A) such person submits to the Administrator, at least 90 days before such manufacture or processing, a notice, in accordance with subsection (c) and section 8(i), of such person’s intention to manufacture or process such chemical substance or mixture and such person complies with any applicable requirement of subsection (b); andCommentsClose CommentsPermalink
‘(B) the Administrator finds that--CommentsClose CommentsPermalink
‘(i) such use is a critical use as determined pursuant to section 6(e);CommentsClose CommentsPermalink
‘(ii) in the case of a chemical substance or mixture that has not already been determined to meet the safety standard under section 6(b), the chemical substance or mixture meets the safety standard under section 6(b), with or without conditions; orCommentsClose CommentsPermalink
‘(iii) in the case of a chemical substance or mixture that has already been determined to meet the safety standard under section 6(b) without inclusion of the proposed new use, the chemical substance or mixture continues to meet the safety standard under section 6 for all intended uses including the new use, with or without conditions.CommentsClose CommentsPermalink
‘(2) A use shall be determined by the Administrator to be new if--CommentsClose CommentsPermalink
‘(A) the chemical substance or mixture has already received a safety standard determination under section 6(b) which did not include the use; orCommentsClose CommentsPermalink
‘(B) the proposed use will result in manufacturing or processing of the chemical substance or mixture at a significantly increased volume, as determined by the Administrator, above that considered in the safety standard determination under section 6(b).CommentsClose CommentsPermalink
‘(3) Not later than 30 days after the date on which a manufacturer or processor commences manufacturing or processing of a new chemical substance or mixture or commences manufacturing or processing of a chemical substance or mixture for a new use, the manufacturer or processor shall submit to the Administrator a notice of commencement of manufacture or processing.’.CommentsClose CommentsPermalink
(2) By amending subsection (b) to read as follows:CommentsClose CommentsPermalink
‘(b) Submission of Data for Uses and Manufacturers or Processors Not Previously Declared-CommentsClose CommentsPermalink
‘(1) For a chemical substance or mixture which is not new that has not yet received a safety standard determination under section 6(b), any manufacturer or processor who manufactures, processes, or distributes in commerce the chemical substance or mixture for a use that has not previously been declared under section 8(a), shall submit the declaration required by section 8(a) within 6 months of initiating manufacture, processing, or distribution, for that use.CommentsClose CommentsPermalink
‘(2) Any manufacturer or processor who manufactures, processes, or distributes in commerce a chemical substance for a use that the particular manufacturer or processor has not previously declared under section 8(a), even where such use has previously been declared by another party, shall submit the declaration required by section 8(a) within 6 months of initiating manufacture, processing, or distribution for that use.CommentsClose CommentsPermalink
‘(3) For any chemical substance subject to a Significant New Use Rule pursuant to part 721 of title 40, Code of Federal Regulations, as of the date of enactment of the Toxic Chemicals Safety Act of 2010, the requirements of that rule shall apply to all manufacturers and processors of the chemical substance whether or not the Administrator determines a use to be new pursuant to subsection (a), unless and until the chemical substance receives a safety standard determination and, if appropriate, conditions or prohibitions are imposed pursuant to section 6, after which the Significant New Use Rule shall cease to apply.CommentsClose CommentsPermalink
‘(4) For a chemical substance or mixture that is subject to a rule or order under section 4, the manufacturer or processor of such chemical for any use which has not previously been declared under section 8 shall submit to the Administrator any data required in accordance with such rule or order with the notice under subsection (a)(1)(A) or the declaration under this subsection, as appropriate.CommentsClose CommentsPermalink
‘(5) Not later than 90 days after submission of a notice under subsection (a)(1)(A), and data under paragraph (4), if required, the Administrator shall determine, pursuant to subsection (a)(1)(B), whether the use is a critical use or whether a safety standard determination is required by that paragraph. Not later than 9 months after the date of such determination, the Administrator shall complete any such required safety standard determination. The Administrator’s failure to make a determination pursuant to this paragraph in a timely manner shall not be deemed to satisfy subsection (a)(1)(B).’.CommentsClose CommentsPermalink
(3) By striking subsection (c) and redesignating subsection (d) as subsection (c).CommentsClose CommentsPermalink
(4) By amending subsection (c), as redesignated by paragraph (3) of this section, to read as follows:CommentsClose CommentsPermalink
‘(c) Content of Notice; Publications- The notice required by subsection (a)(1)(A) shall include--CommentsClose CommentsPermalink
‘(1) the declaration under section 8(a)(2);CommentsClose CommentsPermalink
‘(2) the minimum data set, as defined pursuant to section 4(a); andCommentsClose CommentsPermalink
‘(3) a statement that the chemical substance or mixture is reasonably anticipated to meet or continue to meet the safety standard under section 6(b), and a justification for such statement.CommentsClose CommentsPermalink
Such a notice shall be made available, subject to section 14, in the public database established pursuant to section 8(d).’;CommentsClose CommentsPermalink
(5) By striking subsections (e), (f), and (g), and redesignating subsections (h) and (i) as subsections (d) and (e), respectively.CommentsClose CommentsPermalink
(6) In subsection (d), as redesignated by paragraph (5) of this section--CommentsClose CommentsPermalink
(A) by redesignating paragraphs (1) through (3) as paragraphs (3) through (5), respectively;CommentsClose CommentsPermalink
(B) by redesignating paragraphs (5) and (6) as paragraphs (6) and (7), respectively;CommentsClose CommentsPermalink
(C) by striking paragraph (4);CommentsClose CommentsPermalink
(D) by inserting, before paragraph (3), as redesignated by subparagraph (A) of this paragraph, the following new paragraphs:CommentsClose CommentsPermalink
‘(1) Any new chemical substance or new use of a chemical substance or mixture approved pursuant to section 35 as a safer alternative shall be exempt from the requirements of this section.CommentsClose CommentsPermalink
‘(2) The Administrator may exempt any new chemical substance or new use of a chemical substance or mixture from the requirements of this section pursuant to section 39.’;CommentsClose CommentsPermalink
(E) in paragraph (3), as redesignated by subparagraph (A) of this paragraph--CommentsClose CommentsPermalink
(i) by inserting ‘and by order,’ after ‘upon application,’; andCommentsClose CommentsPermalink
(ii) by striking ‘any unreasonable’ and inserting ‘a substantial’;CommentsClose CommentsPermalink
(F) in paragraph (4), as redesignated by subparagraph (A) of this paragraph--CommentsClose CommentsPermalink
(i) by amending subparagraph (A) to read as follows:CommentsClose CommentsPermalink
‘(A) The Administrator shall exempt any person from the requirement to submit data for a chemical substance or mixture pursuant to subsection (b)(4), if upon receipt of an application from such person, the Administrator determines that--CommentsClose CommentsPermalink
‘(i) 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 as required by this Act; andCommentsClose CommentsPermalink
‘(ii) 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 subsection (b)(4).CommentsClose CommentsPermalink
No exemption which is granted under this subparagraph with respect to the submission of data for a chemical substance or mixture may take effect before the beginning of the reimbursement period applicable to such data.’; andCommentsClose CommentsPermalink
(ii) in subparagraph (B), by striking ‘subsection (b)(2)’ each place it appears and inserting ‘subsection (b)(4)’;CommentsClose CommentsPermalink
(G) in paragraph (6), as redesignated by subparagraph (B) or this paragraph, by inserting ‘, including occupational exposure’ after ‘human or environmental exposure’; andCommentsClose CommentsPermalink
(H) in paragraph (7), as redesignated by subparagraph (B) of this paragraph, by striking ‘(1) or (5)’ and inserting ‘(3) or (6)’.CommentsClose CommentsPermalink
SEC. 6. PRIORITIZATION, SAFETY STANDARD DETERMINATION, AND RISK MANAGEMENT.
(a) Safety Standard Determination- Section 6 of the Toxic Substances Control Act (
(1) By amending the section heading to read as follows: ‘prioritization, safety standard determination, and risk management’.CommentsClose CommentsPermalink
(2) By striking subsection (d).CommentsClose CommentsPermalink
(3) By redesignating subsections (e) and (f) as subsections (f) and (g), respectively.CommentsClose CommentsPermalink
(4) By redesignating subsections (a) through (c) as subsections (c) through (e), respectively.CommentsClose CommentsPermalink
(5) By inserting before subsection (c), as redesignated by paragraph (4) of this subsection, the following new subsections:CommentsClose CommentsPermalink
‘(a) Priority List for Safety Standard Determinations-CommentsClose CommentsPermalink
‘(1) ESTABLISHMENT OF LIST-CommentsClose CommentsPermalink
‘(A) As of the date of enactment of the Toxic Chemicals Safety Act of 2010, there shall be established a list of chemical substances for which safety standard determinations under this section shall first be made, which shall consist of the following chemical substances:CommentsClose CommentsPermalink
‘(i) Bisphenol A.CommentsClose CommentsPermalink
‘(ii) Formaldehyde.CommentsClose CommentsPermalink
‘(iii) N-Hexane.CommentsClose CommentsPermalink
‘(iv) Hexavalent chromium.CommentsClose CommentsPermalink
‘(v) Methylene chloride.CommentsClose CommentsPermalink
‘(vi) Trichloroethylene.CommentsClose CommentsPermalink
‘(vii) Vinyl chloride.CommentsClose CommentsPermalink
‘(viii) The following phthalates:CommentsClose CommentsPermalink
‘(I) Benzylbutyl phthalate.CommentsClose CommentsPermalink
‘(II) Dibutyl phthalate.CommentsClose CommentsPermalink
‘(III) Diethylhexyl phthalate.CommentsClose CommentsPermalink
‘(IV) Di-isodecyl phthalate.CommentsClose CommentsPermalink
‘(V) Di-isononyl phthalate.CommentsClose CommentsPermalink
‘(VI) Di-n-hexyl phthalate.CommentsClose CommentsPermalink
‘(VII) Di-n-octyl phthalate.CommentsClose CommentsPermalink
‘(ix) Perchlorate.CommentsClose CommentsPermalink
‘(x) Tetrachloroethylene.CommentsClose CommentsPermalink
‘(xi) Tris (1,3-dichloro-2-propyl) phosphate.CommentsClose CommentsPermalink
‘(xii) Tris (2-chloroethyl) phosphate.CommentsClose CommentsPermalink
‘(xiii) Tris (2,3-dibromopropyl) phosphate.CommentsClose CommentsPermalink
‘(B) Not later than 12 months after the date of enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall update the list established in subparagraph (A) and publish in the Federal Register, after notice and opportunity for comment, the updated list which shall consist of not fewer than 300 chemical substances, along with a justification for such listing. Chemical substances shall be listed at the Administrator’s discretion, based on available scientific evidence and consideration of their hazard, exposure, or risk relative to other chemical substances, aggregate or cumulative exposure, evidence of exposure to humans including presence in human or animal biological and environmental media including in the workplace, use, volume of manufacture, toxicological properties, persistence, bioaccumulation, or other properties indicating risk.CommentsClose CommentsPermalink
‘(2) UPDATING OF LIST- The Administrator shall--CommentsClose CommentsPermalink
‘(A) remove a chemical substance from the list under paragraph (1) only after the safety standard determination has been made for such chemical substance pursuant to subsection (b); andCommentsClose CommentsPermalink
‘(B) add chemical substances to the list periodically so that the number of chemical substances on the list will not be fewer than 300 at any given time, until such time as all chemical substances manufactured, processed, or distributed in commerce have been listed, have received a safety standard determination, or have been exempted from the requirement to receive a safety standard determination pursuant to section 35 or section 39. Additions to the list shall be consistent with paragraph (1) and, to the extent practicable, based on consideration of hazard, exposure, or risk relative to listed chemical substances. Such additions to the list may be made in response to petitions under section 21 or recommendations from the Interagency Testing Committee under section 4(e).CommentsClose CommentsPermalink
‘(3) MIXTURES- The Administrator may add a mixture to the priority list based on available scientific evidence and the considerations for listing described in paragraph (1).CommentsClose CommentsPermalink
‘(b) Safety Standard Determinations-CommentsClose CommentsPermalink
‘(1) SAFETY STANDARD-CommentsClose CommentsPermalink
‘(A) The Administrator shall apply, as the safety standard under this title, a standard that takes into account aggregate exposure to a chemical substance or mixture and ensures that, for all intended uses--CommentsClose CommentsPermalink
‘(i) with regard to public health, there is a reasonable certainty that no harm will result, including to vulnerable populations; andCommentsClose CommentsPermalink
‘(ii) the public welfare is protected.CommentsClose CommentsPermalink
‘(B) In making a determination under this subsection, the Administrator shall consider, among other relevant factors---CommentsClose CommentsPermalink
‘(i) the lifecycle of the chemical substance or mixture; andCommentsClose CommentsPermalink
‘(ii) available information concerning the cumulative effects of exposure to chemical substances or mixtures.CommentsClose CommentsPermalink
‘(2) BURDEN OF PROOF- The manufacturers and processors of a chemical substance or mixture shall bear the burden of proving that the chemical substance or mixture meets the safety standard.CommentsClose CommentsPermalink
‘(3) DETERMINATION-CommentsClose CommentsPermalink
‘(A) For each chemical substance or mixture listed under subsection (a), the Administrator shall determine whether the chemical substance or mixture meets the safety standard, taking into account any existing conditions or controls already in effect, or can be made to meet the safety standard through the imposition of additional conditions under subsection (c), and whether intended uses that do not meet the safety standard are critical. In making this determination, the Administrator may consider exposures associated with known or foreseeable uses that are not intended uses identified by the manufacturers and processors of the substance or mixture.CommentsClose CommentsPermalink
‘(B) The determination under subparagraph (A) shall be made in keeping with standards for assessment developed under paragraph (4).CommentsClose CommentsPermalink
‘(C) Except as provided in subparagraph (D), the determination under subparagraph (A) shall be completed and published not later than 30 months after the date on which the chemical substance or mixture is placed on the priority list, or, for a chemical substance listed in subsection (a)(1)(A), not later than 18 months after the date of enactment of the Toxic Chemicals Safety Act of 2010.CommentsClose CommentsPermalink
‘(D) In assessing risk to make the determination under subparagraph (A), the Administrator may require the submission of additional information by the manufacturer or processor. If additional information is required, the determination shall be completed and published not later than 12 months after the submission of all required information. Failure to submit required information in the period specified in section 4(b)(3)(C), as applicable, or by such other reasonable deadlines as the Administrator shall establish shall constitute grounds for determining that the chemical substance or mixture does not meet the safety standard.CommentsClose CommentsPermalink
‘(4) STANDARDS FOR ASSESSMENT OF DATA-CommentsClose CommentsPermalink
‘(A) Not later than 18 months after the date of enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall, after providing for notice and opportunity for comment, develop and publish guidance regarding the use of science in making determinations under this subsection. In developing such guidance, the Administrator shall rely upon the recommendations of the National Academy of Sciences report entitled ‘Science and Decisions’.CommentsClose CommentsPermalink
‘(B) Not later than 5 years after the date of enactment of the Toxic Chemicals Safety Act of 2010, and not less often than once every 5 years thereafter, the Administrator shall review the guidance under this paragraph and may revise the guidance to reflect new scientific developments or understanding.CommentsClose CommentsPermalink
‘(5) PUBLICATION- The Administrator shall make publicly available, and enter into the public database established pursuant to section 8(d), the determination made pursuant to paragraph (3) with a list of allowed uses and any conditions on those uses necessary to ensure that the safety standard is met.CommentsClose CommentsPermalink
‘(6) RENEWAL AND REDETERMINATION- The determination made pursuant to paragraph (3) regarding a chemical substance or mixture shall remain in effect for 15 years, except that the Administrator shall make a redetermination pursuant to paragraph (3) if a new use of such chemical substance or mixture is proposed under section 5, or new information related to such chemical substance or mixture raises a credible question as to whether the chemical substance or mixture continues to meet the safety standard. The Administrator may renew a determination made pursuant to paragraph (3) for additional 15 year periods. The burden of proof for renewal of a determination or redetermination shall remain with the manufacturers and processors of each chemical substance or mixture.CommentsClose CommentsPermalink
‘(7) FAILURE TO MEET DEADLINES- If the Administrator fails to publish or renew a determination or publish a redetermination by the applicable deadline pursuant to this subsection, the Administrator shall promptly publish notice of such failure in the Federal Register, identifying the chemical substance or mixture and any information gaps that have impeded the determination, shall prohibit new manufacturers or processors or new uses of the chemical substance or mixture until the determination is published, and shall require manufacturers and processors of the chemical substance or mixture to provide, within a reasonable timeframe as determined by the Administrator, written notice to the public, their employees and their commercial customers that a safety standard determination of the chemical substance or mixture is pending.’.CommentsClose CommentsPermalink
(6) By amending subsection (c), as redesignated by paragraph (4) of this subsection, to read as follows:CommentsClose CommentsPermalink
‘(c) Risk Management-CommentsClose CommentsPermalink
‘(1) CHEMICAL SUBSTANCES AND MIXTURES DETERMINED TO MEET THE SAFETY STANDARD WITHOUT CONDITIONS- A chemical substance or mixture, for which the Administrator has determined, pursuant to subsection (b)(3), that the chemical substance or mixture meets the safety standard without imposition of conditions under this subsection, may be manufactured, processed, and distributed in commerce for uses identified and included in the safety standard determination. The Administrator may make such determination contingent on the continuation of conditions or controls already in effect, if any.CommentsClose CommentsPermalink
‘(2) CHEMICAL SUBSTANCES AND MIXTURES DETERMINED TO MEET THE SAFETY STANDARD WITH CONDITIONS- Except as the Administrator determines pursuant to subsection (e), a chemical substance or mixture, for which the Administrator has determined, pursuant to subsection (b)(3), that imposition of conditions under this subsection is required to ensure that the chemical substance or mixture meets the safety standard, shall be subject to conditions on manufacture, processing, use, distribution in commerce, or disposal, as specified by the Administrator. Such conditions shall be identified in a manner that ensures effective and efficient protection of health and the environment and may include:CommentsClose CommentsPermalink
‘(A) A requirement--CommentsClose CommentsPermalink
‘(i) prohibiting the manufacturing, processing, or distribution in commerce of such substance or mixture; orCommentsClose CommentsPermalink
‘(ii) limiting the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce.CommentsClose CommentsPermalink
‘(B) A requirement--CommentsClose CommentsPermalink
‘(i) prohibiting the manufacture, processing, or distribution in commerce of such substance or mixture for--CommentsClose CommentsPermalink
‘(I) a particular use; orCommentsClose CommentsPermalink
‘(II) a particular use in a concentration in excess of a level specified by the Administrator in the safety standard determination; orCommentsClose CommentsPermalink
‘(ii) limiting the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce for--CommentsClose CommentsPermalink
‘(I) a particular use; orCommentsClose CommentsPermalink
‘(II) a particular use in a concentration in excess of a level specified by the Administrator in the safety standard determination.CommentsClose CommentsPermalink
‘(C) 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 or by the appropriate agency as determined under section 9, and shall be consistent with the Globally Harmonized System of Labeling and Classification of Chemicals.CommentsClose CommentsPermalink
‘(D) 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, or any article containing 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 paragraph.CommentsClose CommentsPermalink
‘(E) A requirement prohibiting or otherwise regulating any manner or method of manufacturing, processing, distribution in commerce or commercial use of such substance or mixture.CommentsClose CommentsPermalink
‘(F) A requirement that prescribes specific control measures to reduce occupational exposures shall reflect the industrial hygiene hierarchy of controls.CommentsClose CommentsPermalink
‘(G)(i) 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.CommentsClose CommentsPermalink
‘(ii) A requirement under clause (i) 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 or tribe in which a required disposal may occur of such disposal.CommentsClose CommentsPermalink
‘(H) A requirement that the manufacturers and processors of such chemical substance or mixture, or article containing such chemical substance or mixture, develop a risk reduction management plan to achieve a risk reduction specified by the Administrator. For all cases in which a risk reduction management plan requires a reduction in occupational exposure, the specified level or risk reduction is to be achieved through application of the industrial hygiene hierarchy of controls.CommentsClose CommentsPermalink
Where the Administrator determines that conditions under this subsection are necessary to ensure that a chemical substance or mixture meets the safety standard, the Administrator shall require that such conditions be met within one year after publication of the determination under subsection (b), or as quickly as feasible and in no case later than 3 years after such publication. The Administrator, in determining the deadline for compliance with conditions pursuant to this subsection, shall consider human health and the environment as the primary and paramount concern, and shall also consider the technological feasibility of compliance, the economic impact of compliance, the benefits of earlier compliance, and other relevant considerations. After the date or dates on which conditions become effective, no person shall manufacture, process, use for commercial purposes, distribute in commerce, or dispose of the chemical substance or mixture, or any article containing such substance or mixture, unless the applicable conditions of the determination are met with respect to that person’s activities.CommentsClose CommentsPermalink
‘(3) CHEMICAL SUBSTANCES AND MIXTURES DETERMINED NOT TO MEET THE SAFETY STANDARD- Except as the Administrator determines pursuant to subsection (e):CommentsClose CommentsPermalink
‘(A) If the Administrator determines that an existing chemical substance or mixture has not been proven to meet the safety standard, pursuant to subsection (b)(3), effective 1 year after publication of that determination, or as quickly as feasible and in no case later than 3 years after such publication, no person shall manufacture, process, use for commercial purposes or distribute in commerce the chemical substance or mixture. The Administrator, in determining the deadline for compliance with this subsection, shall consider human health and the environment as the primary and paramount concern, and shall also consider the technological feasibility of compliance, the economic impact of compliance, and other relevant considerations.CommentsClose CommentsPermalink
‘(B) If the Administrator determines that a new chemical substance or mixture has not been proven to meet the safety standard, no person shall manufacture, process, or distribute in commerce the new chemical substance or mixture.CommentsClose CommentsPermalink
‘(C) If the Administrator determines that an existing chemical substance or mixture has not been proven to meet the safety standard for a new use, no person shall manufacture, process, use, or distribute in commerce the existing chemical substance or mixture for the new use.’.CommentsClose CommentsPermalink
(7) In subsection (d), as redesignated by paragraph (4) of this subsection, by striking ‘present an unreasonable’ each place it appears and inserting ‘present a significant’.CommentsClose CommentsPermalink
(8) By amending subsection (e), as redesignated by paragraph (4) of this subsection, to read as follows:CommentsClose CommentsPermalink
‘(e) Critical Use Exemptions-CommentsClose CommentsPermalink
‘(1) Exemptions from restrictions on manufacture, processing, use, distribution in commerce, or disposal imposed under subsection (c) may be requested for a specific use by a manufacturer or processor of a chemical substance or mixture, and may be granted by the Administrator, after providing public notice and opportunity for comment, if the Administrator determines that the manufacturer or processor has demonstrated by clear and convincing evidence that--CommentsClose CommentsPermalink
‘(A)(i) an exemption for the specific use is in the paramount interest of national security as determined under section 22;CommentsClose CommentsPermalink
‘(ii) the restriction would significantly disrupt the national economy; orCommentsClose CommentsPermalink
‘(iii) the specific use is a critical or essential use; andCommentsClose CommentsPermalink
‘(B)(i) no feasible safer alternative for the specified use is available; orCommentsClose CommentsPermalink
‘(ii) the specified use of the chemical substance or mixture provides a net benefit to health or the environment when compared to all available alternatives.CommentsClose CommentsPermalink
‘(2) Exemptions 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 use continues to meet the requirements of paragraph (1).CommentsClose CommentsPermalink
‘(3) Notice of any exemption granted under this subsection shall be provided--CommentsClose CommentsPermalink
‘(A) to known commercial purchasers by the manufacturers and processors of the subject chemical substance or mixture; andCommentsClose CommentsPermalink
‘(B) to the public by the Administrator.CommentsClose CommentsPermalink
‘(4) The Administrator shall impose conditions on any use receiving an exemption under this subsection to reduce risk from the chemical substance or mixture to the greatest extent feasible. Such conditions shall take effect upon the granting of such exemption under paragraph (1). For cases in which such conditions are related to occupational exposure, exposure shall be controlled through application of the industrial hygiene hierarchy of controls.’.CommentsClose CommentsPermalink
(9) In subsection (f), as redesignated by paragraph (3) of this subsection--CommentsClose CommentsPermalink
(A) in paragraph (2), by striking ‘an unreasonable risk of injury to health or the environment’ and inserting ‘a substantial risk of injury to health or the environment, and will comply with section 37 and any regulations prescribed thereunder’;CommentsClose CommentsPermalink
(B) in paragraph (3)(B)--CommentsClose CommentsPermalink
(i) in clause (i)--CommentsClose CommentsPermalink
(I) by striking ‘an unreasonable’ and inserting ‘a substantial’; andCommentsClose CommentsPermalink
(II) by striking ‘, and’ and inserting a semicolon;CommentsClose CommentsPermalink
(ii) in clause (ii)--CommentsClose CommentsPermalink
(I) by striking ‘which does not present an unreasonable risk of injury to health or the environment’ and inserting ‘that meets the safety standard under subsection (b)’; andCommentsClose CommentsPermalink
(II) by inserting ‘and’ after ‘biphenyl;’; andCommentsClose CommentsPermalink
(iii) by adding at the end the following new clause:CommentsClose CommentsPermalink
‘(iii) the terms of the exemption will comply with section 37 and any regulations prescribed thereunder.’;CommentsClose CommentsPermalink
(C) by striking paragraph (4); andCommentsClose CommentsPermalink
(D) by redesignating paragraph (5) as paragraph (4).CommentsClose CommentsPermalink
(b) Conforming Amendment- The table of contents for the Toxic Substances Control Act is amended by amending the item relating to section 6 to read as follows:CommentsClose CommentsPermalink
‘Sec. 6. Prioritization, safety standard determination, and risk management.’.CommentsClose CommentsPermalink
SEC. 7. IMMINENT HAZARDS.
Section 7 of the Toxic Substances Control Act (
(1) By amending subsection (a) to read as follows:CommentsClose CommentsPermalink
‘(a) Actions Authorized and Required-CommentsClose CommentsPermalink
‘(1) CIVIL ACTION- The Administrator may commence a civil action in an appropriate district court of the United States for--CommentsClose CommentsPermalink
‘(A) seizure of a chemical substance or mixture or any article containing such a substance or mixture, that may present an imminent and substantial endangerment to health or the environment;CommentsClose CommentsPermalink
‘(B) relief (as authorized by subsection (b)) against any person who manufactures, processes, distributes in commerce, uses, or disposes of, a chemical substance or mixture or any article containing such a substance or mixture, that may present an imminent and substantial endangerment to health or the environment; orCommentsClose CommentsPermalink
‘(C) both such seizure described in subparagraph (A) and relief described in subparagraph (B).CommentsClose CommentsPermalink
‘(2) OTHER ACTIONS- The Administrator may issue such orders as may be necessary to protect health or the environment from a chemical substance or mixture or article containing such substance or mixture that may present an imminent and substantial endangerment to health or the environment. Such orders may include any requirements on the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or article containing such substance or mixture, as the Administrator determines are necessary to protect health or the environment, including the conditions that may be imposed under section 6(c)(2) and the relief authorized in subsection (b) of this section.CommentsClose CommentsPermalink
‘(3) RELATIONSHIP TO EXISTING RULES, ORDERS, AND PROCEEDINGS- A civil action may be commenced under paragraph (1) or other action may be taken under paragraph (2), notwithstanding the existence of a rule or order under this Act and notwithstanding the pendency of any administrative or judicial proceeding under this Act.’.CommentsClose CommentsPermalink
(2) In subsection (b)--CommentsClose CommentsPermalink
(A) in paragraph (1)--CommentsClose CommentsPermalink
(i) by striking ‘subsection (a)’ and inserting ‘subsection (a)(1)’; andCommentsClose CommentsPermalink
(ii) by striking ‘unreasonable risk’ and inserting ‘imminent and substantial endangerment’;CommentsClose CommentsPermalink
(B) in paragraph (2)--CommentsClose CommentsPermalink
(i) by striking ‘subsection (a)’ and inserting ‘subsection (a)(1)’;CommentsClose CommentsPermalink
(ii) by striking ‘or distributes in commerce’ and inserting ‘distributes in commerce, uses, or disposes of’;CommentsClose CommentsPermalink
(iii) by striking ‘risk’ each place it appears and inserting ‘hazard’; andCommentsClose CommentsPermalink
(iv) by striking ‘or (E)’ and inserting ‘(E) conditions that may be imposed under section 6(c); or (F)’; andCommentsClose CommentsPermalink
(C) in paragraph (3), by striking ‘subsection (a)’ and inserting ‘subsection (a)(1)’.CommentsClose CommentsPermalink
(3) In subsection (c), by striking ‘subsection (a)’ each place it appears and inserting ‘subsection (a)(1)’.CommentsClose CommentsPermalink
(4) By amending subsection (d) to read as follows:CommentsClose CommentsPermalink
‘(d) Action Under Section 6- As appropriate, concurrently with the filing of an action under subsection (a)(1) or as soon thereafter as may be practicable, the Administrator shall add the subject chemical substance or mixture to the priority list under section 6(a) or initiate a redetermination of whether the subject chemical substance or mixture meets the safety standard under section 6(b).’.CommentsClose CommentsPermalink
(5) In subsection (e), by striking ‘subsection (a)’ and inserting ‘subsection (a)(1)’.CommentsClose CommentsPermalink
(6) By striking subsection (f).CommentsClose CommentsPermalink
SEC. 8. REPORTING AND RETENTION OF INFORMATION.
Section 8 of the Toxic Substances Control Act (
(1) by striking subsection (a) and redesignating subsection (b) as subsection (c);CommentsClose CommentsPermalink
(2) by redesignating subsection (e) as subsection (h);CommentsClose CommentsPermalink
(3) by redesignating subsection (c) as subsection (e);CommentsClose CommentsPermalink
(4) by striking subsection (d);CommentsClose CommentsPermalink
(5) by redesignating subsection (f) as subsection (j);CommentsClose CommentsPermalink
(6) by inserting before subsection (c), as redesignated by paragraph (1) of this section, the following new subsections:CommentsClose CommentsPermalink
‘(a) Declarations-CommentsClose CommentsPermalink
‘(1) IN GENERAL- (A) Each manufacturer or processor of a chemical substance distributed in commerce shall submit to the Administrator a declaration described in paragraph (2) or (3), accompanied by the certification described in subsection (i), not later than 1 year after the date of enactment of the Toxic Chemicals Safety Act of 2010 or 1 year after commencement of such manufacturing or processing, whichever is earlier.CommentsClose CommentsPermalink
‘(B) The Administrator may additionally require submission of a declaration described in paragraph (2) or (3), accompanied by the certification described in subsection (i), from any manufacturer or processor of a mixture determined by the Administrator to have substance characteristics different from the substance characteristics of the constituent chemical substances, in kind or degree.CommentsClose CommentsPermalink
‘(2) DECLARATION OF CURRENT MANUFACTURE OR PROCESSING- A declaration described in this paragraph is a statement that includes, for each chemical substance or mixture that is manufactured or processed by a manufacturer or processor--CommentsClose CommentsPermalink
‘(A) the chemical identity of the chemical substance or mixture;CommentsClose CommentsPermalink
‘(B) the name and location of each facility under the control of the manufacturer or processor at which the chemical substance or mixture is manufactured or processed or from which the chemical substance or mixture is distributed in commerce;CommentsClose CommentsPermalink
‘(C) 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;CommentsClose CommentsPermalink
‘(D) a list of health and safety studies conducted or initiated by or for, known to, or reasonably ascertainable by the manufacturer or processor with respect to the chemical substance or mixture, and copies of any such studies that have not previously been submitted to the Administrator by the manufacturer or processor; andCommentsClose CommentsPermalink
‘(E) all other information known to, in the possession or control of, or reasonably ascertainable by the manufacturer or processor that has not previously been submitted to the Administrator by the manufacturer or processor regarding--CommentsClose CommentsPermalink
‘(i) the physical, chemical, and toxicological properties of the chemical substance or mixture, including classification of the toxicity of the chemical in accordance with the Globally Harmonized System for Hazard Communication;CommentsClose CommentsPermalink
‘(ii) the categories or proposed categories of intended use of each such substance or mixture;CommentsClose CommentsPermalink
‘(iii) 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;CommentsClose CommentsPermalink
‘(iv) a description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or mixture;CommentsClose CommentsPermalink
‘(v) exposure information relating to the chemical substance or mixture;CommentsClose CommentsPermalink
‘(vi) any condition or conditions currently placed on the chemical substance or mixture due to regulation under any Federal law or due to voluntary action; andCommentsClose CommentsPermalink
‘(vii) for a processor of a chemical substance, any information indicating that a mixture including the chemical substance has substance characteristics that are different from the substance characteristics of the named chemical substances, in kind or degree.CommentsClose CommentsPermalink
To the extent feasible, the Administrator shall not require under paragraph (1), any reporting which is unnecessary or duplicative.CommentsClose CommentsPermalink
‘(3) DECLARATION OF PERMANENT CESSATION OF MANUFACTURING OR PROCESSING- A manufacturer or processor that permanently ceases manufacture or processing of a chemical substance or mixture shall file a declaration certifying that the manufacturer or processor has permanently ceased all manufacturing or processing of the chemical substance or mixture, not later than 180 days after cessation is complete. A declaration under this paragraph may be filed based on an intention to permanently cease manufacture or processing, in which case such cessation must be completed not later than 180 days after the declaration is filed.CommentsClose CommentsPermalink
‘(4) UPDATING OF DECLARATION- Each manufacturer or processor of a chemical substance or mixture that submits to the Administrator a declaration required under paragraph (2) shall submit an update of the previously submitted declaration to the Administrator, at a minimum, once every 3 years, and immediately, at any time at which there becomes known or available to, in the possession or control of, or reasonably ascertainable by the manufacturer or processor, significant new information regarding a physical, chemical, toxicological property or use of, or exposure to, the chemical substance or mixture, indicating a new potential adverse effect of the chemical substance or mixture, suggesting an adverse effect at a lower dose than previously demonstrated, or otherwise reasonably relevant to an analysis of whether the chemical substance or mixture meets the safety standard under section 6.CommentsClose CommentsPermalink
‘(5) RECORDS TO SUPPORT DECLARATIONS- Each manufacturer or processor of a chemical substance, substance, or mixture, as applicable, distributed in commerce shall maintain records of the information described in subparagraphs (A) through (E) of paragraph (2).CommentsClose CommentsPermalink
‘(6) PROHIBITION- The Administrator may impose penalties, pursuant to section 16, on a manufacturer or processor in violation of paragraphs (1) or (4), or, by order, prohibit, or otherwise impose conditions under section 6(c), on the manufacture, processing, or distribution in commerce of a chemical substance or mixture, or any article containing such chemical substance or mixture, by a manufacturer or processor in violation of such paragraphs.CommentsClose CommentsPermalink
‘(b) Recordkeeping and Reports-CommentsClose CommentsPermalink
‘(1) The Administrator may, by rule or order, require any person who manufactures, processes, distributes in commerce, uses for commercial purposes, repackages, or disposes of a chemical substance, mixture, or article containing such substance or mixture (other than as described in paragraph (2)) to maintain records of and submit reports by a specified date, to supply any information concerning the chemical substance, mixture, or article containing such substance or mixture that, in the judgment of the Administrator, would assist the Administrator in--CommentsClose CommentsPermalink
‘(A) making a safety standard determination with respect to a chemical substance or mixture under this title; orCommentsClose CommentsPermalink
‘(B) administering any other provision of this Act.CommentsClose CommentsPermalink
‘(2) With respect to the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture in small quantities (as defined by the Administrator by rule) solely for purposes of scientific experimentation or analysis or chemical research, including any such research or analysis for the development of a product, the Administrator may require a person to maintain records or submit a report under paragraph (1) 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.CommentsClose CommentsPermalink
‘(3) The Administrator may impose penalties, pursuant to section 16, on a person in violation of a requirement of a rule or order under paragraph (1) or, by order, prohibit, or otherwise impose conditions under section 6(c), on the manufacture, processing, or distribution in commerce of a chemical substance or mixture, or any article containing such chemical substance or mixture, by a person in violation of such a requirement.’;CommentsClose CommentsPermalink
(7) in subsection (c), as redesignated by paragraph (1) of this section--CommentsClose CommentsPermalink
(A) in the subsection heading, by inserting ‘and Categorization’ after ‘Inventory’;CommentsClose CommentsPermalink
(B) by amending paragraph (1) to read as follows:CommentsClose CommentsPermalink
‘(1) INVENTORY- The Administrator shall compile, keep current, publish and enter into the public database established pursuant to subsection (d) a list of each chemical substance, and each mixture for which a declaration is received, which is manufactured or processed in the United States. Such list shall at least include each such chemical substance or mixture which any person reports, under section 5 or subsection (a)(2) of this section, is manufactured or processed in the United States, but shall not include any chemical substance or mixture for which all manufacturers and processors have submitted declarations under subsection (a)(3). In the case of a chemical substance or mixture for which a notice is submitted in accordance with section 5, the date of such notice shall be included in the list under this section, in addition to the date on which the chemical substance or mixture was first added to the list. The Administrator shall first publish such a list not later than 24 months after the effective date of the Toxic Chemicals Safety Act of 2010. The Administrator shall not include in such list any chemical substance or mixture 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 mixture or another substance or mixture, including such research or analysis for the development of a product.’; andCommentsClose CommentsPermalink
(C) by amending paragraph (2) to read as follows:CommentsClose CommentsPermalink
‘(2) CATEGORIZED INVENTORY- Not later than 5 years after the date of enactment of the Toxic Chemicals Safety Act of 2010, and no less than every 3 years thereafter, the Administrator shall publish in the Federal Register and enter in the public database established pursuant to subsection (d) a list of all chemical substances and mixtures manufactured, processed, or distributed in commerce that categorizes the chemical substances and mixtures, based on existing information available to the Administrator, based upon health or environmental adverse effects, exposure, or other criteria that the Administrator determine appropriate.’;CommentsClose CommentsPermalink
(8) by inserting after subsection (c), as redesignated by paragraph (1) of this section, the following new subsection:CommentsClose CommentsPermalink
‘(d) Public Database and Access to Significant Information-CommentsClose CommentsPermalink
‘(1) PUBLIC DATABASE- Not later than 1 year after the date of the enactment of Toxic Chemicals Safety Act of 2010, the Administrator shall establish--CommentsClose CommentsPermalink
‘(A) an electronic database that is searchable, sortable, downloadable, and publicly accessible on the Internet for storing and sharing of information relating to the toxicity and use of, and exposure to, chemical substances and mixtures; andCommentsClose CommentsPermalink
‘(B) procedures for use in maintaining and updating the database.CommentsClose CommentsPermalink
‘(2) PUBLIC ACCESS TO SIGNIFICANT INFORMATION- Not later than 90 days after the date of any significant decision made by the Administrator or receipt by the Administrator of any significant information submitted pursuant to this title, the Administrator shall, subject to section 14, make available to the public on the public database established pursuant to paragraph (1) such significant decision made by the Administrator under this title or such significant information submitted pursuant to this title.’;CommentsClose CommentsPermalink
(9) in subsection (e), as redesignated by paragraph (3) of this section--CommentsClose CommentsPermalink
(A) in the subsection heading, by inserting ‘of Significant Adverse Reactions’ after ‘Records’; andCommentsClose CommentsPermalink
(B) by inserting ‘Such records shall be submitted to the Administrator on an annual basis, or immediately upon request by the Administrator.’ after the first sentence;CommentsClose CommentsPermalink
(10) by inserting after subsection (e), as redesignated by paragraph (3) of this section, the following new subsections:CommentsClose CommentsPermalink
‘(f) Disclosures to Commercial Purchasers- Effective 1 year after the date of enactment of the Toxic Chemicals Safety Act of 2010, all manufacturers and processors of chemical substances and mixtures subject to this section shall provide, with shipment or promptly thereafter and by request, to all known commercial purchasers of the chemical substances and mixtures they manufacture or process a disclosure, subject to section 14, of--CommentsClose CommentsPermalink
‘(1) the chemical identity of the chemical substance or, for mixtures, the chemical identity of all chemical ingredients;CommentsClose CommentsPermalink
‘(2) all information regarding toxicological properties of the chemical substance or mixture submitted to the Administrator under subsection (a);CommentsClose CommentsPermalink
‘(3) the list of health and safety studies submitted to the Administrator under subsection (a), with copies of the individual studies available upon request; andCommentsClose CommentsPermalink
‘(4) any records of significant adverse reactions submitted to the Administrator under subsection (e).CommentsClose CommentsPermalink
‘(g) Information in the Possession of Other Federal Agencies-CommentsClose CommentsPermalink
‘(1) The Administrator may request, and upon such request a Federal agency shall submit to the Administrator, any information in the possession or control of such Federal agency relating to a hazard of, use of, exposure to, or risk of a chemical substance or mixture, or a report, including copies of the data and records in the possession or control of such Federal agency that may be useful to the Administrator in carrying out the purposes of this Act.CommentsClose CommentsPermalink
‘(2) The Administrator shall specify the format, content, and level of detail of any report requested under paragraph (1).CommentsClose CommentsPermalink
‘(3) Each Federal agency shall make its initial submission to the Administrator within 60 days of receipt of the specification under paragraph (2).CommentsClose CommentsPermalink
‘(4) The Administrator shall issue a request pursuant to paragraph (1) to each Federal agency which the Administrator reasonably expects may have information on chemical substances or mixtures that would assist the Administrator in making a safety standard determination for a chemical substance or mixture under this title. Such requests shall be issued by the Administrator not later than 12 months after the date on which the Administrator lists a chemical substance or mixture on the priority list under section 6(a), or, for chemical substances identified in section 6(a)(1)(A), 12 months after enactment of the Toxic Chemicals Safety Act of 2010.’; andCommentsClose CommentsPermalink
(11) by inserting after subsection (h), as redesignated by paragraph (2) of this section, the following new subsection:CommentsClose CommentsPermalink
‘(i) Certification- Each submission required pursuant to this title, or pursuant to a rule or an order promulgated or issued by the Administrator under this title, other than a submission under subsection (g), shall be accompanied by a certification signed by a responsible official of the submitting party that each statement contained in the submission--CommentsClose CommentsPermalink
‘(1) is accurate and reliable; andCommentsClose CommentsPermalink
‘(2) includes all material facts known to, in the possession or control of, or reasonably ascertainable by the manufacturer or processor.’.CommentsClose CommentsPermalink
SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS.
Section 9(a)(1) of the Toxic Substances Control Act (
(1) by striking ‘the manufacture, processing, distribution in commerce, use, or disposal of’ after ‘If the Administrator has reasonable basis to conclude that’;CommentsClose CommentsPermalink
(2) by striking ‘, or that any combination of such activities, presents or will present an unreasonable risk of injury to health or the environment’ and inserting ‘does not meet the safety standard under section 6(b)’;CommentsClose CommentsPermalink
(3) by striking ‘such risk may be prevented’ and inserting ‘that the risk associated with the chemical substance or mixture may be prevented’;CommentsClose CommentsPermalink
(4) by striking ‘describes such risk’ and inserting ‘describes the risk associated with the chemical substance or mixture’; andCommentsClose CommentsPermalink
(5) in the matter following subparagraph (B)--CommentsClose CommentsPermalink
(A) by striking ‘Any report’ and inserting ‘Any such report’;CommentsClose CommentsPermalink
(B) by striking ‘information on which it is based and shall be published in the Federal Register’ and inserting ‘information on which it is based and shall be promptly published in the Federal Register and entered into the public database established pursuant to section 8(d)’;CommentsClose CommentsPermalink
(C) by inserting ‘and not more than 180 days’ after ‘but such time specified may not be less than 90 days’; andCommentsClose CommentsPermalink
(D) by inserting ‘and entered into the public database established pursuant to section 8(d)’ after ‘conclusions of the agency and shall be published in the Federal Register’.CommentsClose CommentsPermalink
SEC. 10. MIXTURES.
(a) Mixture Definition and Determination- Section 3 of the Toxic Substances Control Act (
(1) by amending paragraph (8) to read as follows:CommentsClose CommentsPermalink
‘(8) The term ‘mixture’ means any composition of two or more chemical substances if the composition does not occur in nature, and is not, in whole or in part, the result of a chemical reaction.’; andCommentsClose CommentsPermalink
(2) by inserting after paragraph (b)(2) the following new paragraph:CommentsClose CommentsPermalink
‘(3) The Administrator may determine different mixtures comprised of the same chemical substances to be the same mixture for purposes of this Act, if the substance characteristics of the mixtures are identical. Mixtures which would be considered new mixtures but for grouping under this paragraph shall not be considered new mixtures for purposes of this Act.’.CommentsClose CommentsPermalink
(b) Quantification- Subsection (c) of section 8 of the Toxic Substances Control Act (
‘(3) MIXTURE SURVEY- Not later than 6 years after the date of enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall, based on declarations under this section and a survey of processors as necessary and appropriate, characterize the number of mixtures, including mixtures grouped pursuant to paragraph (b)(3) of section 3, introduced into commerce in the United States, and the number of such mixtures that have or may have substance characteristics that are different, in kind or degree, from the substance characteristics of the constituent chemical substances, and shall publish such characterization in the Federal Register and enter it in the public database established in subsection (d).’.CommentsClose CommentsPermalink
SEC. 11. INSPECTIONS AND SUBPOENAS.
Section 11 of the Toxic Substances Control Act (
(1) in subsection (a)--CommentsClose CommentsPermalink
(A) by inserting ‘commercial’ after ‘establishment, facility, or other’;CommentsClose CommentsPermalink
(B) by striking ‘premises in which chemical substances, mixtures’ and inserting ‘premises in which chemical substances or mixtures subject to this Act, articles containing such substances or mixtures’;CommentsClose CommentsPermalink
(C) by inserting ‘and any place where records relating to such chemical substances, mixtures, articles, or products or otherwise relating to compliance with this Act, are held’ after ‘or such articles in connection with distribution in commerce’; andCommentsClose CommentsPermalink
(D) by adding at the end the following:CommentsClose CommentsPermalink
‘The Administrator, and any duly designated representative of the Administrator, may also inspect and obtain samples of any such chemical substances, mixtures, or articles, and any containers or labeling of such chemical substances, mixtures, or articles.’; andCommentsClose CommentsPermalink
(2) in subsection (b)--CommentsClose CommentsPermalink
(A) in paragraph (1), by striking ‘chemical substances, mixtures, or products’ and inserting ‘chemical substances or mixtures subject to this Act, articles containing such substances or mixtures, or products’; andCommentsClose CommentsPermalink
(B) in paragraph (2)(E), by inserting ‘or order’ after ‘rule’.CommentsClose CommentsPermalink
SEC. 12. EXPORTS.
Section 12 of the Toxic Substances Control Act (
(1) by striking subsection (a) and redesignating subsections (b) and (c) as subsections (a) and (b), respectively;CommentsClose CommentsPermalink
(2) in subsection (a), as redesignated by paragraph (1) of this section--CommentsClose CommentsPermalink
(A) in paragraph (1)--CommentsClose CommentsPermalink
(i) by striking ‘or intends to export’;CommentsClose CommentsPermalink
(ii) by striking ‘or 5(b)’;CommentsClose CommentsPermalink
(iii) by striking ‘or intent to export’ and inserting ‘not later than 30 days after the date of exportation of the substance or mixture’; andCommentsClose CommentsPermalink
(iv) by inserting ‘promptly thereafter’ before ‘furnish’;CommentsClose CommentsPermalink
(B) in paragraph (2)--CommentsClose CommentsPermalink
(i) by striking ‘or intends to export’;CommentsClose CommentsPermalink
(ii) by striking ‘an order has been issued under section 5 or a rule has been proposed or promulgated under section 5 or 6, or with respect to which an action is pending, or relief has been granted under section 5 or 7’ and inserting ‘a condition has been imposed pursuant to section 6(c)(2) or an action has been taken pursuant to section 7’;CommentsClose CommentsPermalink
(iii) by striking ‘or intent to export’ and inserting ‘not later than 30 days after the date of exportation of the substance or mixture’;CommentsClose CommentsPermalink
(iv) by inserting ‘promptly thereafter’ before ‘furnish’; andCommentsClose CommentsPermalink
(v) by striking ‘such rule, order, action, or relief’ and inserting ‘such condition imposed pursuant to section 6(c)(2) or such action taken pursuant to section 7’; andCommentsClose CommentsPermalink
(C) by adding at the end the following new paragraph:CommentsClose CommentsPermalink
‘(3)(A) Any person that has previously notified the Administrator of the exportation of a chemical substance or mixture under this section shall notify the Administrator of any change in the information provided in the original notice not later than 30 days after such a change.CommentsClose CommentsPermalink
‘(B) The Administrator shall furnish, as promptly as feasible, an updated notice to the governments that have been notified pursuant to paragraphs (1) and (2) regarding the exportation of any chemical substance or mixture subject to this section if--CommentsClose CommentsPermalink
‘(i) new data for such substance or mixture have been received by the Administrator pursuant to section 4, section 5(b), section 8(e), or section 8(h);CommentsClose CommentsPermalink
‘(ii) the Administrator has received notice under subparagraph (A) of a change in the information provided in the original notice; orCommentsClose CommentsPermalink
‘(iii) a change has been made in any conditions imposed pursuant to section 6(c) or section 7 for such substance or mixture.’;CommentsClose CommentsPermalink
(3) in subsection (b), as redesignated by paragraph (1), by striking paragraph (2) and redesignating paragraphs (3), (4), (5), and (6) as paragraphs (2), (3), (4), and (5), respectively; andCommentsClose CommentsPermalink
(4) by adding at the end the following new subsections:CommentsClose CommentsPermalink
‘(c) Chemicals Listed Under the PIC Convention- If any person intends to export to a foreign country a chemical substance or mixture listed in Annex III of the PIC Convention as of the date of enactment of the Toxic Chemicals Safety Act of 2010, such person shall file the notice required under subsection (a) not later than 30 days prior to the date of exportation of such substance or mixture and shall include therein the information required for export under such Convention as of the date of enactment of the Toxic Chemicals Safety Act of 2010.CommentsClose CommentsPermalink
‘(d) Public Records- The Administrator shall maintain copies of all current notices provided to other governments under this section, and make such copies available to the public in electronic format.CommentsClose CommentsPermalink
‘(e) Definition- For purposes of this title, the term ‘PIC Convention’ means the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, adopted in Rotterdam on September 10, 1998, and any subsequent amendment or protocol.’.CommentsClose CommentsPermalink
SEC. 13. ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES.
Section 13 of the Toxic Substances Control Act (
(1) by redesignating subsections (a) and (b) as subsections (b) and (c), respectively;CommentsClose CommentsPermalink
(2) by inserting, before subsection (b), as redesignated by paragraph (1) of this section, the following new subsection:CommentsClose CommentsPermalink
‘(a) Duties of Importers- The importer of any chemical substance, mixture, or article containing a chemical substance or mixture for distribution in commerce shall satisfy all requirements under sections 4, 5, 6, and 8 of this Act, without regard to whether the chemical substance or mixture has been formed into or contained in an article prior to importation.’;CommentsClose CommentsPermalink
(3) in subsection (b), as redesignated by paragraph (1) of this section--CommentsClose CommentsPermalink
(A) by amending the subsection heading to read as follows:CommentsClose CommentsPermalink
‘(b) Entry- ’;CommentsClose CommentsPermalink
(B) by striking ‘Secretary of the Treasury’ each place it appears and inserting ‘Secretary of Homeland Security’; andCommentsClose CommentsPermalink
(C) in paragraph (1), by striking the em dash and subparagraphs (A) and (B) and inserting ‘the substance, mixture, or article fails to comply with or is offered for entry in violation of any rule or order in effect under this Act.’; andCommentsClose CommentsPermalink
(4) in subsection (c), as redesignated by paragraph (1) of this section--CommentsClose CommentsPermalink
(A) by striking ‘Secretary of the Treasury’ and inserting ‘Secretary of Homeland Security’; andCommentsClose CommentsPermalink
(B) by striking ‘subsection (a)’ and inserting ‘subsection (b)’.CommentsClose CommentsPermalink
SEC. 14. DISCLOSURE OF DATA.
Section 14 of the Toxic Substances Control Act (
(1) by redesignating subsections (a) and (b) as subsections (c) and (d), respectively;CommentsClose CommentsPermalink
(2) by redesignating subsections (c) through (e) as subsections (f) through (h), respectively;CommentsClose CommentsPermalink
(3) by inserting, before subsection (c), as redesignated by paragraph (1) of this section, the following new subsections:CommentsClose CommentsPermalink
‘(a) Administrator Responsibilities- The Administrator shall ensure that--CommentsClose CommentsPermalink
‘(1) information control designations under this section are not a determinant of public disclosure pursuant to
section 552 of title 5, United States Code (commonly referred to as the ‘Freedom of Information Act’); andCommentsClose CommentsPermalink‘(2) all information in the Administrator’s possession that is releasable pursuant to an appropriate request under
section 552 of title 5, United States Code (commonly referred to as the ‘Freedom of Information Act’), is made available to members of the public.CommentsClose CommentsPermalink‘(b) Rule of Construction- Nothing in this section shall be construed to prevent or discourage the Administrator from voluntarily releasing to the public any unclassified information that is not exempt from disclosure under
section 552 of title 5, United States Code (commonly referred to as the ‘Freedom of Information Act’).’;CommentsClose CommentsPermalink
(4) in subsection (c), as redesignated by paragraph (1) of this subsection--CommentsClose CommentsPermalink
(A) by striking ‘Except as provided by subsection (b)’ and all that follows through ‘subsection (b)(4) of such section,’ and inserting ‘Except as provided by subsection (d), information submitted to the Administrator pursuant to this Act may be designated for information protection by the submitter of such information based on the submitter’s reasonable belief that the information is eligible for protection under
(B) by inserting ‘unless the designation is determined to be inappropriate,’ after ‘Administrator or by any officer or employee of the United States,’;CommentsClose CommentsPermalink
(C) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively;CommentsClose CommentsPermalink
(D) by adding after paragraph (2) the following new paragraph:CommentsClose CommentsPermalink
‘(3) shall be disclosed upon request to a State, tribal, or municipal government, including identification of the location of the manufacture, processing, or storage of a chemical substance upon the request of the government for the purpose of administration or enforcement of a law, if one or more applicable agreements ensure that the recipient government will take appropriate steps to maintain the confidentiality of the information in accordance with this section and section 350.27 of title 40, Code of Federal Regulations, or any successor to such regulation;’; andCommentsClose CommentsPermalink
(E) in paragraph (4), as redesignated by subparagraph (C) of this paragraph, by striking ‘an unreasonable’ and inserting ‘a substantial’;CommentsClose CommentsPermalink
(5) in subsection (d), as redesignated by paragraph (1) of this section--CommentsClose CommentsPermalink
(A) in the subsection heading, by striking ‘Data From Health and Safety Studies’ and inserting ‘Information Not Eligible for Protection’;CommentsClose CommentsPermalink
(B) by amending paragraph (1) to read as follows:CommentsClose CommentsPermalink
‘(1) The following types of information shall not be eligible for protection under this section, and the Administrator shall not approve a request to protect information of the following types under this section:CommentsClose CommentsPermalink
‘(A) The identity of a chemical substance when included in a health and safety study, safety standard determination under section 6(b), or information indicating the presence of the chemical substance in a consumer article intended for use or reasonably expected to be used by children or indicating exposure to the chemical substance in children.CommentsClose CommentsPermalink
‘(B) The components of a mixture, when included in a health and safety study, safety standard determination under section 6(b), or information indicating the presence of the mixture in a consumer article intended for use or reasonably expected to be used by children or indicating exposure to the mixture in children.CommentsClose CommentsPermalink
‘(C) Any safety standard developed under section 6(b).CommentsClose CommentsPermalink
‘(D) Any health and safety study which is submitted under this Act with respect to--CommentsClose CommentsPermalink
‘(i) any chemical substance or mixture--CommentsClose CommentsPermalink
‘(I) which, on the date on which such study is to be disclosed has been offered for commercial distribution; orCommentsClose CommentsPermalink
‘(II) for which testing is required under section 4 or for which notification is required under section 5 of this title; andCommentsClose CommentsPermalink
‘(ii) 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).CommentsClose CommentsPermalink
‘(E) Any information indicating the presence of a chemical substance or mixture in a consumer article intended for use or reasonably expected to be used by children or indicating exposure to the chemical substance or mixture in children.CommentsClose CommentsPermalink
This paragraph does not authorize the release of any data which discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.’; andCommentsClose CommentsPermalink
(C) in paragraph (2)--CommentsClose CommentsPermalink
(i) by striking ‘the first sentence of paragraph (1)’ and inserting ‘paragraph (1)(D)’; andCommentsClose CommentsPermalink
(ii) by striking ‘in the second sentence of such paragraph’ and inserting ‘in the last sentence of paragraph (1)’;CommentsClose CommentsPermalink
(6) by inserting after subsection (d), as redesignated by paragraph (1) of this section, the following new subsection:CommentsClose CommentsPermalink
‘(e) Guidance- Not later than 1 year after the date of enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall by order develop and make publicly available guidance that specifies--CommentsClose CommentsPermalink
‘(1) the format for and manner for designating information for protection;CommentsClose CommentsPermalink
‘(2) the acceptable bases on which written requests to protect information under this section may be approved, which shall be no more restrictive of public disclosure than
section 552 of title 5, United States Code ; andCommentsClose CommentsPermalink‘(3) the documentation that must accompany such requests.’;CommentsClose CommentsPermalink
(7) by amending subsection (f), as redesignated by paragraph (2) of this section, to read as follows:CommentsClose CommentsPermalink
‘(f) Designation and Release of Confidential Information-CommentsClose CommentsPermalink
‘(1) DUTIES OF MANUFACTURERS AND PROCESSORS- In submitting information under this Act, a manufacturer, processor, or distributor in commerce may 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 paragraph shall be accompanied by the appropriate fee under subsection (i), shall be made in writing and in such manner as the Administrator may prescribe, and shall include--CommentsClose CommentsPermalink
‘(A) justification for each claim of confidentiality;CommentsClose CommentsPermalink
‘(B) a certification that the information is not otherwise publicly available; andCommentsClose CommentsPermalink
‘(C) separate copies of all submitted information, with 1 copy containing and 1 copy excluding the information to which the request applies.CommentsClose CommentsPermalink
Designations shall last for 5 years, at which time the information shall be made public unless the manufacturer or processor has submitted a request for renewal, accompanied by the appropriate fee under subsection (i), made in writing and in such manner as the Administrator may prescribe, including all of the elements required for the initial submission.CommentsClose CommentsPermalink
‘(2) DUTIES OF THE ADMINISTRATOR- The Administrator shall--CommentsClose CommentsPermalink
‘(A) evaluate a representative sample of all submitted designations and requests for renewal within 60 days of their submission to determine whether--CommentsClose CommentsPermalink
‘(i) each claim of confidentiality is justified under
section 552 of title 5, United States Code , and any applicable guidance published under subsection (e);CommentsClose CommentsPermalink‘(ii) the designation was accompanied by the appropriate fee, made in writing and in such manner as prescribed by the Administrator, and included the necessary components; andCommentsClose CommentsPermalink
‘(iii) the information is not publicly available;CommentsClose CommentsPermalink
‘(B) release all information previously designated for protection if one or more of the criteria in subparagraph (A) are not found;CommentsClose CommentsPermalink
‘(C) determine whether the criteria in subparagraph (A) were met at the time the designation was made; andCommentsClose CommentsPermalink
‘(D) make such determinations publicly available.CommentsClose CommentsPermalink
‘(3) NOTIFICATION- (A) Except as provided by subparagraph (B), if the Administrator proposes to release for inspection data which has been designated under paragraph (1) but not released under paragraph (2), the Administrator shall notify, in writing and by certified mail, the manufacturer, processor, or distributor in commerce who submitted such information 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, such notice shall be given immediately upon approval of such request by the Administrator. The Administrator shall release the information in accordance with the disclosure and procedural requirements of
section 552 of title 5, United States Code .CommentsClose CommentsPermalink‘(B)(i) Subparagraph (A) shall not apply to the release of information under paragraph (1), (2), (3), (4), or (5) of subsection (c) of this section, except that the Administrator may not release data under paragraph (4) of subsection (c) of this section 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 if the Administrator determines that the release of such data is necessary to protect against an imminent risk of injury to health or the environment.CommentsClose CommentsPermalink
‘(ii) Subparagraph (A) shall not apply to the release of information described in subsection (c)(1) of this section other than information described in the last sentence of such subsection.’;CommentsClose CommentsPermalink
(8) in subsection (g), as redesignated by paragraph (2) of this section--CommentsClose CommentsPermalink
(A) by amending the subsection heading to read as follows:CommentsClose CommentsPermalink
‘(g) Penalties for Wrongful Designation or Disclosure- ’;CommentsClose CommentsPermalink
(B) by redesignating paragraphs (1) and (2) as paragraphs (3) and (4), respectively;CommentsClose CommentsPermalink
(C) by inserting before paragraph (3), as redesignated by subparagraph (B) of this paragraph, the following new paragraphs:CommentsClose CommentsPermalink
‘(1) Any manufacturer or processor whose designation of information for protection under this section is found by the Administrator not to have met the criteria for protection under this section at the time the designation was made may be subject to administrative penalties under section 15.CommentsClose CommentsPermalink
‘(2) Any manufacturer or processor who, knowing that information does not meet the criteria for protection under this section, willfully designates such information for protection, shall be guilty of a misdemeanor and fined not more than $5,000 or imprisoned for not more than one year, or both.’; andCommentsClose CommentsPermalink
(D) in paragraph (4), as redesignated by subparagraph (B) of this paragraph--CommentsClose CommentsPermalink
(i) by striking ‘paragraph (1)’ and inserting ‘paragraph (3)’; andCommentsClose CommentsPermalink
(ii) by striking ‘subsection (a)(2)’ and inserting ‘subsection (c)(2)’; andCommentsClose CommentsPermalink
(9) by adding at the end the following new subsections:CommentsClose CommentsPermalink
‘(i) Fees- The Administrator may, by rule, require the payment of a reasonable fee from any person designating information for protection under this section or seeking to renew such a designation to defray the cost of administering this section. In setting a fee under this subsection, the Administrator shall take into account the ability to pay of the person designating or seeking renewal and the cost to the Administrator of reviewing such designations.CommentsClose CommentsPermalink
‘(j) Risk Information for Workers- The Administrator shall provide standards for and facilitate the provision of the chemical identity, safety standard determination, health and safety data, and any other information determined by the Administrator to be necessary to ensure worker safety, that pertains to chemical substances or mixtures, that workers may come into contact with or otherwise be exposed to during the course of their work, to such workers and representatives of each certified or recognized bargaining agent representing such workers.’.CommentsClose CommentsPermalink
SEC. 15. PROHIBITED ACTS.
Section 15 of the Toxic Substances Control Act (
(1) in paragraph (1), by striking ‘(A)’ and all that follows through ‘under title II’ and inserting ‘any rule, order, prohibition, restriction, or other requirement imposed by this Act or by the Administrator under this Act’;CommentsClose CommentsPermalink
(2) by amending paragraphs (2) and (3) to read as follows:CommentsClose CommentsPermalink
‘(2) manufacture, process, distribute in commerce, use for commercial purposes, or dispose of a chemical substance or mixture, or an article containing a chemical substance or mixture, which such person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of any rule, order, prohibition, restriction, or other requirement imposed by this Act or by the Administrator under this Act;CommentsClose CommentsPermalink
‘(3) fail or refuse to (A) establish or maintain accurate and complete records, (B) submit or make accurate and complete reports, notices, disclosures, declarations, certifications, or other information, or (C) permit access to or copying of records, as required by this Act or a rule thereunder;’;CommentsClose CommentsPermalink
(3) in paragraph (4), by striking the final period and inserting ‘; or’; andCommentsClose CommentsPermalink
(4) by adding at the end the following new paragraphs:CommentsClose CommentsPermalink
‘(5) make or submit a statement, declaration, disclosure, certification, data set, or any oral, written, or electronic representation that is materially false, in whole or in part, or to falsify or conceal any material fact, in taking any action or making any communication pursuant to this Act or pursuant to any rule or order promulgated or issued under this Act;CommentsClose CommentsPermalink
‘(6) introduce or deliver for introduction into commerce or knowingly distribute in commerce a chemical substance or mixture, or an article containing a chemical substance or mixture--CommentsClose CommentsPermalink
‘(A) that lacks or fails to comply in any material respect with any applicable labeling requirements imposed pursuant to section 6(c); orCommentsClose CommentsPermalink
‘(B) the label, labeling or advertising of which is misleading in any material respect, including by reason of representations, either explicit or implicit, that the chemical substance or mixture is available for a use other than an intended use; orCommentsClose CommentsPermalink
‘(7) forge, counterfeit, simulate, falsely represent, or use without proper authority any mark, stamp, tag, label, or other identification device authorized or required by this Act or by the Administrator under this Act.’.CommentsClose CommentsPermalink
SEC. 16. PENALTIES.
Section 16 of the Toxic Substances Control Act (
(1) in subsection (a)--CommentsClose CommentsPermalink
(A) in paragraph (1)--CommentsClose CommentsPermalink
(i) by striking ‘provision of section 15 or 409’ and inserting ‘provision of this Act or a rule promulgated or order issued pursuant to this Act, as described in section 15’;CommentsClose CommentsPermalink
(ii) by striking ‘$25,000’ and inserting ‘$37,500’; andCommentsClose CommentsPermalink
(iii) by striking ‘violation of section 15 or 409’ and inserting ‘violation of this Act’;CommentsClose CommentsPermalink
(B) by redesignating paragraphs (2), (3), and (4) as paragraphs (3), (4), and (5), respectively;CommentsClose CommentsPermalink
(C) by inserting after paragraph (1) the following new paragraph:CommentsClose CommentsPermalink
‘(2) In the case of any violation described in paragraph (1), the Administrator may commence a civil action in the appropriate United States district court to assess penalties pursuant to paragraph (1) or commence administrative action to assess penalties pursuant to paragraph (3).’;CommentsClose CommentsPermalink
(D) in subparagraph (A) of paragraph (3), as redesignated by subparagraph (B) of this paragraph--CommentsClose CommentsPermalink
(i) by striking ‘A civil penalty for a violation of section 15 or 409’ and inserting ‘In any administrative action to assess penalties for a violation described in paragraph (1), a civil penalty for a violation’; andCommentsClose CommentsPermalink
(ii) by striking ‘within 15 days of’ and inserting ‘not later than 15 days after’;CommentsClose CommentsPermalink
(E) in paragraph (4), as redesignated by subparagraph (B) of this paragraph--CommentsClose CommentsPermalink
(i) by striking ‘paragraph (2)(A)’ and inserting ‘paragraph (3)(A)’; andCommentsClose CommentsPermalink
(ii) by striking ‘the United States Court of Appeals for the District of Columbia Circuit or for any other circuit’ and inserting ‘the appropriate district court of the United States for the district’; andCommentsClose CommentsPermalink
(F) in paragraph (5), as redesignated by subparagraph (B) of this paragraph, by striking ‘paragraph (3)’ each place it appears and inserting ‘paragraph (4)’; andCommentsClose CommentsPermalink
(2) in subsection (b)--CommentsClose CommentsPermalink
(A) by inserting ‘(1)’ before ‘Any person who’;CommentsClose CommentsPermalink
(B) by inserting ‘this Act, as described in’ before ‘section 15’;CommentsClose CommentsPermalink
(C) by striking ‘or 409’;CommentsClose CommentsPermalink
(D) by striking ‘$25,000’ and inserting ‘$50,000’;CommentsClose CommentsPermalink
(E) by striking ‘one year’ and inserting ‘5 years’; andCommentsClose CommentsPermalink
(F) by adding at the end the following new paragraph:CommentsClose CommentsPermalink
‘(2) Any person who knowingly or willfully violates any provision of this Act and who knows that such violation may result in imminent danger of death or serious bodily injury to any person shall, upon conviction, be subject to a fine of not more than $250,000 or imprisonment of not more than 15 years, or both. A person that is not an individual shall, upon conviction of violating this paragraph, be subject to a fine of not more than $1,000,000.’.CommentsClose CommentsPermalink
SEC. 17. SPECIFIC ENFORCEMENT AND SEIZURE.
Section 17 of the Toxic Substances Control Act (
(1) in subsection (a)--CommentsClose CommentsPermalink
(A) in paragraph (1)--CommentsClose CommentsPermalink
(i) in subparagraph (A), by striking ‘or 409’;CommentsClose CommentsPermalink
(ii) in subparagraph (B), by striking ‘section 5, 6, or title IV, or by a rule or order under section 5, 6, or title IV’ and inserting ‘this Act or a rule or order promulgated or issued under this Act’; andCommentsClose CommentsPermalink
(iii) in subparagraph (D)--CommentsClose CommentsPermalink
(I) by striking ‘chemical substance, mixture, or product’ and inserting ‘ chemical substance or mixture subject to this Act, article containing such substance or mixture, or product’;CommentsClose CommentsPermalink
(II) by striking ‘of section 5, 6, or title IV’ and inserting ‘of this Act’;CommentsClose CommentsPermalink
(III) by striking ‘under section 5, 6, or title IV’ and inserting ‘promulgated or issued under this Act, as described in section 15’;CommentsClose CommentsPermalink
(IV) by inserting ‘, article’ before ‘, or product and, to the extent’;CommentsClose CommentsPermalink
(V) by inserting ‘, article’ before ‘, or product or exposed to such substance’;CommentsClose CommentsPermalink
(VI) by inserting ‘, article’ before ‘, or product, (ii) to give’; andCommentsClose CommentsPermalink
(VII) by inserting ‘, article’ before ‘, or product, whichever the person to which the requirement’; andCommentsClose CommentsPermalink
(B) in paragraph (2)--CommentsClose CommentsPermalink
(i) by striking ‘A civil action described in paragraph (1)’ and inserting ‘The district courts of the United States shall have jurisdiction over a civil action described in paragraph (1). A civil action’; andCommentsClose CommentsPermalink
(ii) in subparagraph (A), by inserting ‘this Act, as described in’ before ‘section 15’; andCommentsClose CommentsPermalink
(2) in subsection (b), by striking ‘chemical substance, mixture, or product’ and inserting ‘chemical substance or mixture subject to this Act, or product’.CommentsClose CommentsPermalink
SEC. 18. PREEMPTION.
Section 18 of the Toxic Substances Control Act (
‘SEC. 18. PREEMPTION.
‘Nothing in this Act affects the right of a State or political subdivision of a State or a tribe to adopt or enforce any regulation, requirement, or standard of performance that is different from or in addition to a regulation, requirement, liability, or standard of performance established pursuant to this Act unless compliance with both this Act and the State or political subdivision of a State or tribe regulation, requirement, or standard of performance is impossible.’.CommentsClose CommentsPermalink
SEC. 19. JUDICIAL REVIEW.
Section 19 of the Toxic Substances Control Act (
(1) in subsection (a)--CommentsClose CommentsPermalink
(A) in paragraph (1)--CommentsClose CommentsPermalink
(i) by striking subparagraph (B);CommentsClose CommentsPermalink
(ii) by striking ‘(A)’;CommentsClose CommentsPermalink
(iii) by inserting ‘or issuance’ after ‘promulgation’;CommentsClose CommentsPermalink
(iv) by striking ‘section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 8, or under title II or IV’ and inserting ‘this Act’;CommentsClose CommentsPermalink
(v) by inserting ‘or order’ after ‘rule’ each place it appears;CommentsClose CommentsPermalink
(vi) by inserting ‘except that if such petition is based solely on grounds arising after such sixtieth day, then any petition for judicial review of such rule or order shall be filed within 60 days after such grounds arise’ after ‘such person’s principal place of business is located’;CommentsClose CommentsPermalink
(vii) by striking ‘(other than in an enforcement proceeding)’; andCommentsClose CommentsPermalink
(viii) by striking ‘subparagraph’ and inserting ‘paragraph’;CommentsClose CommentsPermalink
(B) in paragraph (2)--CommentsClose CommentsPermalink
(i) by striking ‘paragraph (1)(A)’ and inserting ‘paragraph (1)’;CommentsClose CommentsPermalink
(ii) by striking ‘rulemaking’; andCommentsClose CommentsPermalink
(iii) by inserting ‘or order’ after ‘rule’; andCommentsClose CommentsPermalink
(C) by striking paragraph (3);CommentsClose CommentsPermalink
(2) in subsection (b), by inserting ‘or order’ after ‘rule’ each place it appears; andCommentsClose CommentsPermalink
(3) in subsection (c)--CommentsClose CommentsPermalink
(A) by amending paragraph (1) to read as follows:CommentsClose CommentsPermalink
‘(1) Upon the filing of a petition under subsection (a)(1) for judicial review of a rule or order, the court shall have jurisdiction--CommentsClose CommentsPermalink
‘(A) to grant appropriate relief, including interim relief, as provided in chapter 7 of title 5, United States Code; andCommentsClose CommentsPermalink
‘(B) to review such rule or order in accordance with chapter 7 of title 5, United States Code.’; andCommentsClose CommentsPermalink
(B) in paragraph (2), by inserting ‘or order’ after ‘rule’.CommentsClose CommentsPermalink
SEC. 20. CITIZENS’ CIVIL ACTION.
Section 20 of the Toxic Substances Control Act (
(1) in subsection (a)--CommentsClose CommentsPermalink
(A) in paragraph (1)--CommentsClose CommentsPermalink
(i) by striking ‘under section 4, 5, or 6, or title II or IV,’; andCommentsClose CommentsPermalink
(ii) by striking ‘section 5 or title II or IV to restrain such violation’ and inserting ‘this Act’; andCommentsClose CommentsPermalink
(B) in the matter following paragraph (2), by inserting ‘, to enforce this Act or any rule promulgated or order issued under this Act, or to order the Administrator to perform an act or duty under this Act which is not discretionary, as the case may be’ after ‘citizenship of the parties’; andCommentsClose CommentsPermalink
(2) in subsection (b)(1), by striking ‘to restrain’ and inserting ‘respecting’.CommentsClose CommentsPermalink
SEC. 21. CITIZENS’ PETITIONS.
Section 21 of the Toxic Substances Control Act (
(1) in subsection (a), by striking ‘under section 4, 6, or 8 or an order under section 5(e) or (6)(b)(2)’ and inserting ‘, order, or any other action authorized under this Act’; andCommentsClose CommentsPermalink
(2) in subsection (b)--CommentsClose CommentsPermalink
(A) in paragraph (1), by striking ‘under section 4, 6, or 8 or an order under section 5(e), 6(b)(1)(A), or 6(b)(1)(B)’ and inserting ‘or order or to initiate other action authorized under this Act’;CommentsClose CommentsPermalink
(B) in paragraph (3), by striking ‘section 4, 5, 6, or 8’ and inserting ‘the applicable provisions of this Act’; andCommentsClose CommentsPermalink
(C) in paragraph (4)--CommentsClose CommentsPermalink
(i) in subparagraph (A), by striking ‘a rulemaking proceeding’ and inserting ‘a proceeding authorized under this Act’; andCommentsClose CommentsPermalink
(ii) in subparagraph (B)--CommentsClose CommentsPermalink
(I) by striking ‘a proceeding to issue a rule under section 4, 6, or 8 or an order under section 5(e) or 6(b)(2)’ and inserting ‘a proceeding authorized under this Act’;CommentsClose CommentsPermalink
(II) in clause (i)--CommentsClose CommentsPermalink
(aa) by inserting ‘or order’ after ‘issuance of a rule’;CommentsClose CommentsPermalink
(bb) by striking ‘or an order under section 5(e)’; andCommentsClose CommentsPermalink
(cc) by striking ‘an unreasonable’ and inserting ‘a substantial’; andCommentsClose CommentsPermalink
(III) in clause (ii)--CommentsClose CommentsPermalink
(aa) by inserting ‘except as provided in clause (i)’ before ‘in the case of’;CommentsClose CommentsPermalink
(bb) by striking ‘issuance of a rule under section 6 or 8 or an order under section 6(b)(2)’ and inserting ‘promulgation of a rule, issuance of an order, or imposition or issuance of a restriction or use condition under this Act’; andCommentsClose CommentsPermalink
(cc) by striking ‘an unreasonable’ and inserting ‘a substantial’.CommentsClose CommentsPermalink
SEC. 22. EMPLOYEE PROTECTION.
Section 23 of the Toxic Substances Control Act (
(1) In subsection (a)--CommentsClose CommentsPermalink
(A) by striking ‘employer may discharge’ and inserting ‘manufacturer, processor, or distributor may discharge’;CommentsClose CommentsPermalink
(B) by redesignating paragraphs (1), (2), and (3) as paragraphs (2), (3), and (4), respectively;CommentsClose CommentsPermalink
(C) by inserting before paragraph (2), as redesignated by subparagraph (B) of this paragraph, the following new paragraph:CommentsClose CommentsPermalink
‘(1) provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, the appropriate official of the tribe, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of any provision of this Act;’;CommentsClose CommentsPermalink
(D) in paragraph (3), as redesignated by subparagraph (B) of this paragraph--CommentsClose CommentsPermalink
(i) by inserting ‘concerning any such violation or’ after ‘testified or is about to testify’; andCommentsClose CommentsPermalink
(ii) by striking ‘or’ after ‘Act;’;CommentsClose CommentsPermalink
(E) in paragraph (4), as redesignated by subparagraph (B) of this paragraph, by inserting ‘or’ after ‘Act;’; andCommentsClose CommentsPermalink
(F) by adding at the end the following new paragraph:CommentsClose CommentsPermalink
‘(5) objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee (or other such person) reasonably believed to be in violation of any provision of this Act.’.CommentsClose CommentsPermalink
(2) By striking subsection (e) and amending subsections (b), (c), and (d) to read as follows:CommentsClose CommentsPermalink
‘(b) Remedy- (1) Any employee who believes that the employee has been discharged or otherwise discriminated against by any person in violation of subsection (a) of this section may, not later than 180 days after the date on which such alleged violation occurs, file (or have any person file on the employee’s behalf) a complaint with the Secretary of Labor (hereinafter in this section referred to as the ‘Secretary’) alleging such discharge or discrimination and identifying the person responsible for such act. Upon receipt of such a complaint, the Secretary shall notify, in writing, the person named in the complaint of the filing of the complaint, of the allegations contained in the complaint, of the substance of evidence supporting the complaint, and of the opportunities that will be afforded to such person under paragraph (2).CommentsClose CommentsPermalink
‘(2)(A) Not later than 60 days after the date of receipt of a complaint filed under paragraph (1) and after affording the complainant and the person named in the complaint an opportunity to submit to the Secretary a written response to the complaint and an opportunity to meet with a representative of the Secretary to present statements from witnesses, the Secretary shall initiate an investigation and determine whether there is reasonable cause to believe that the complaint has merit and notify, in writing, the complainant and the person alleged to have committed a violation of subsection (a) of the Secretary’s findings. If the Secretary concludes that there is reasonable cause to believe that a violation of subsection (a) of this section has occurred, the Secretary shall accompany the Secretary’s findings with a preliminary order providing the relief prescribed by paragraph (3)(B). Not later than 30 days after the date of notification of findings under this paragraph, either the person alleged to have committed the violation or the complainant may file objections to the findings or preliminary order, or both, and request a hearing on the record. The filing of such objections shall not operate to stay any reinstatement remedy contained in the preliminary order. Any such hearing shall be conducted expeditiously. If a hearing is not requested in such 30-day period, the preliminary order shall be deemed a final order that is not subject to judicial review.CommentsClose CommentsPermalink
‘(B)(i) The Secretary shall dismiss a complaint filed under this subsection and shall not conduct an investigation otherwise required under subparagraph (A) unless the complainant makes a prima facie showing that any behavior described in paragraphs (1) through (5) of subsection (a) was a contributing factor in the unfavorable personnel action alleged in the complaint.CommentsClose CommentsPermalink
‘(ii) Notwithstanding a finding by the Secretary that the complainant has made the prima facie showing required under clause (i), no investigation otherwise required under subparagraph (A) shall be conducted if the employer demonstrates, by clear and convincing evidence, that the employer would have taken the same unfavorable personnel action in the absence of that behavior.CommentsClose CommentsPermalink
‘(iii) The Secretary may determine that a violation of subsection (a) has occurred only if the complainant demonstrates that any behavior described in paragraphs (1) through (5) of subsection (a) was a contributing factor in the unfavorable personnel action alleged in the complaint.CommentsClose CommentsPermalink
‘(iv) Relief may not be ordered under subparagraph (A) if the employer demonstrates by clear and convincing evidence that the employer would have taken the same unfavorable personnel action in the absence of that behavior.CommentsClose CommentsPermalink
‘(3)(A) Not later than 120 days after the date of conclusion of any hearing under paragraph (2), the Secretary shall issue a final order providing the relief prescribed by this paragraph or denying the complaint. At any time before issuance of a final order, a proceeding under this subsection may be terminated on the basis of a settlement agreement entered into by the Secretary, the complainant, and the person alleged to have committed the violation.CommentsClose CommentsPermalink
‘(B) If, in response to a complaint filed under paragraph (1), the Secretary determines that a violation of subsection (a) has occurred, the Secretary shall order the person who committed such violation--CommentsClose CommentsPermalink
‘(i) to take affirmative action to abate the violation;CommentsClose CommentsPermalink
‘(ii) to reinstate the complainant to the complainant’s former position together with the compensation (including back pay), terms, conditions, and privileges of the complainant’s employment;CommentsClose CommentsPermalink
‘(iii) to provide compensatory damages; andCommentsClose CommentsPermalink
‘(iv) where appropriate, exemplary damages.CommentsClose CommentsPermalink
If such an order is issued, the Secretary, at the request of the complainant, shall assess against the person against whom the order is issued a sum equal to the aggregate amount of all costs and expenses (including attorney’s and expert witness fees) reasonably incurred, as determined by the Secretary, by the complainant for, or in connection with, the bringing of the complaint upon which the order was issued.CommentsClose CommentsPermalink
‘(C) If the Secretary finds that a complaint under paragraph (1) is frivolous or has been brought in bad faith, the Secretary may award to the prevailing employer a reasonable attorney’s fee, not exceeding $1,000, to be paid by the complainant.CommentsClose CommentsPermalink
‘(4) If the Secretary has not issued a final decision within 210 days after the filing of the complaint, the complainant may bring an action at law or equity for de novo review in the appropriate district court of the United States with jurisdiction, which shall have jurisdiction over such an action without regard to the amount in controversy, and which action shall, at the request of either party to such action, be tried by the court with a jury. The proceedings shall be governed by the same legal burdens of proof specified in paragraph (2)(B). The court shall have jurisdiction to grant all relief necessary to make the employee whole, including injunctive relief and compensatory damages, including--CommentsClose CommentsPermalink
‘(A) reinstatement with the same seniority status that the employee would have had, but for the discharge or discrimination;CommentsClose CommentsPermalink
‘(B) the amount of back pay, with interest; andCommentsClose CommentsPermalink
‘(C) compensation for any special damages sustained as a result of the discharge or discrimination, including litigation costs, expert witness fees, and reasonable attorney’s fees.CommentsClose CommentsPermalink
‘(5)(A) Unless the complainant brings an action under paragraph (4), any employee or employer adversely affected or aggrieved by a final order issued under paragraph (3) may obtain review of the order in the United States Court of Appeals for the circuit in which the violation, with respect to which the order was issued, allegedly occurred or the circuit in which the complainant resided on the date of such violation. The petition for review must be filed within 60 days from the issuance of the final order of the Secretary. Such review shall conform to chapter 7 of title 5, United States Code. The commencement of proceedings under this subparagraph shall not, unless ordered by the court, operate as a stay of the order.CommentsClose CommentsPermalink
‘(B) An order of the Secretary, with respect to which review could have been obtained under subparagraph (A) shall not be subject to judicial review in any criminal or other civil proceeding.CommentsClose CommentsPermalink
‘(6) Whenever a person has failed to comply with an order issued under paragraph (3), the Secretary shall file a civil action in the United States district court for the district in which the violation was found to occur, or in the United States district court for the District of Columbia, to enforce such order. In actions brought under this paragraph, the district courts shall have jurisdiction to grant all appropriate relief, including injunctive relief and compensatory damages.CommentsClose CommentsPermalink
‘(7)(A) A person on whose behalf an order was issued under paragraph (3) may commence a civil action against the person to whom such order was issued to require compliance with such order. The appropriate United States district court shall have jurisdiction, without regard to the amount in controversy or the citizenship of the parties, to enforce such order.CommentsClose CommentsPermalink
‘(B) The court, in issuing any final order under this paragraph, may award costs of litigation (including reasonable attorney’s and expert witness fees) to any party whenever the court determines such award is appropriate.CommentsClose CommentsPermalink
‘(c) Nondiscretionary Duty- Any nondiscretionary duty imposed by this section shall be enforceable in a mandamus proceeding brought under
section 1361 of title 28, United States Code .CommentsClose CommentsPermalink‘(d) Deliberate Violation- Subsection (a) shall not apply with respect to an employee of a manufacturer, processor, or distributor who, acting without direction from such manufacturer, processor, or distributor (or such person’s agent), deliberately causes a violation or alleged violation of any rule, order, regulation, or safety standard under this Act or any other law enforced by the Administrator.’.CommentsClose CommentsPermalink
SEC. 23. EMPLOYMENT EFFECTS.
Section 24 of the Toxic Substances Control Act (
(1) in subsection (a)--CommentsClose CommentsPermalink
(A) by striking ‘continuing’ and inserting ‘periodic’; andCommentsClose CommentsPermalink
(B) by striking the em dash and paragraphs (1) and (2) and inserting ‘the implementation of this Act.’; andCommentsClose CommentsPermalink
(2) in subsection (b)--CommentsClose CommentsPermalink
(A) in paragraph (1), by striking ‘section 4, 5, or 6 or a requirement of section 5 or 6’ and inserting ‘this Act’;CommentsClose CommentsPermalink
(B) in paragraph (2)--CommentsClose CommentsPermalink
(i) in subparagraph (A), by striking ‘by order issued’ and inserting ‘in writing,’; andCommentsClose CommentsPermalink
(ii) in subparagraph (B)--CommentsClose CommentsPermalink
(I) in clause (i), by inserting ‘and’ after the ‘such request,’; andCommentsClose CommentsPermalink
(II) by striking clause (ii) and redesignating clause (iii) as clause (ii); andCommentsClose CommentsPermalink
(C) by amending paragraph (4) to read as follows:CommentsClose CommentsPermalink
‘(4) This section shall not be construed--CommentsClose CommentsPermalink
‘(A) to require the Administrator to amend or repeal any rule or order under this Act; orCommentsClose CommentsPermalink
‘(B) to impose a condition on the Administrator’s authority to issue orders or promulgate rules under this Act.’.CommentsClose CommentsPermalink
SEC. 24. ADMINISTRATION OF THE ACT.
Section 26 of the Toxic Substances Control Act (
(1) by amending subsection (b) to read as follows:CommentsClose CommentsPermalink
‘(b) Fees- The Administrator shall, by rule, require the payment of a reasonable fee from any person required to submit data under this Act to defray the cost of administering this Act. In setting a fee under this subsection, 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 data production are shared under this Act.’; andCommentsClose CommentsPermalink
(2) by redesignating subsections (d) through (g) as subsections (f) through (i), respectively;CommentsClose CommentsPermalink
(3) by inserting after subsection (c) the following new subsections:CommentsClose CommentsPermalink
‘(d) Action With Respect to Specific Chemical Substances- Any action authorized under this Act to be taken by the Administrator through rule or order shall be made through order if the action applies to a single chemical substance or single category of chemical substances.CommentsClose CommentsPermalink
‘(e) Action With Respect to Articles Containing a Chemical Substance or Mixture- No action taken under this title with respect to articles containing a chemical substance or mixture shall apply to articles already introduced or delivered for introduction into commerce, unless the action is taken pursuant to section 7 to address an imminent hazard and the Administrator has determined that action against articles introduced or delivered for introduction into commerce is necessary to protect health or the environment.’; andCommentsClose CommentsPermalink
(4) by adding at the end the following new subsection:CommentsClose CommentsPermalink
‘(j) Rulemaking- In carrying out this Act, the Administrator is authorized to prescribe such regulations as are necessary to carry out this Act.’.CommentsClose CommentsPermalink
SEC. 25. STATE PROGRAMS.
Section 28 of the Toxic Substances Control Act (
(1) in subsection (a)--CommentsClose CommentsPermalink
(A) by amending the subsection heading to read as follows:CommentsClose CommentsPermalink
‘(a) State Grants- ’;CommentsClose CommentsPermalink
(B) before ‘For the purpose of complementing’, by inserting the following:CommentsClose CommentsPermalink
‘(1) IN GENERAL- ’;CommentsClose CommentsPermalink
(C) by inserting ‘and tribes’ after ‘may make grants to States’;CommentsClose CommentsPermalink
(D) by striking ‘unreasonable risks within the States’ and inserting ‘risks within the States and tribes’;CommentsClose CommentsPermalink
(E) by striking ‘is unable or is not likely to take’ and inserting ‘has not taken’; andCommentsClose CommentsPermalink
(F) by inserting ‘or tribe’ after ‘no grant for any State’;CommentsClose CommentsPermalink
(2) by redesignating subsections (b), (c), and (d) as paragraphs (2), (3), and (4), respectively;CommentsClose CommentsPermalink
(3) in paragraph (2), as redesignated by paragraph (2) of this section--CommentsClose CommentsPermalink
(A) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively;CommentsClose CommentsPermalink
(B) in subparagraph (A), as redesignated by subparagraph (A) of this paragraph--CommentsClose CommentsPermalink
(i) by redesignating subparagraphs (A) through (F) as clauses (i) through (vi), respectively;CommentsClose CommentsPermalink
(ii) in clause (ii), as redesignated by clause (i), by inserting ‘or tribe’; andCommentsClose CommentsPermalink
(iii) by striking ‘subsection (a)’ each place it appears and inserting ‘paragraph (1)’;CommentsClose CommentsPermalink
(C) in subparagraph (B), as redesignated by subparagraph (B) of this paragraph--CommentsClose CommentsPermalink
(i) by striking ‘paragraph (1)’ and inserting ‘subparagraph (A)’;CommentsClose CommentsPermalink
(ii) by inserting ‘or tribe’ after ‘State’ each place it appears; andCommentsClose CommentsPermalink
(iii) by striking ‘including cancer, birth defects, and gene mutations,’;CommentsClose CommentsPermalink
(4) in paragraph (3), as redesignated by paragraph (2) of this section, by striking ‘subsection (a)’ and inserting ‘this subsection’;CommentsClose CommentsPermalink
(5) in paragraph (4), as redesignated by paragraph (2) of this section, by striking ‘subsection (a)’ and inserting ‘this subsection’; andCommentsClose CommentsPermalink
(6) by inserting at the end the following new subsection:CommentsClose CommentsPermalink
‘(b) State Coordination- Not later than 18 months after enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall establish a process to coordinate with State and tribal governments, on an on-going basis, to share data and priorities relating to the management of chemical substances and mixtures under this title and under programs operated by States and tribes, in keeping with requirements of section 14. The areas for coordination shall include the following:CommentsClose CommentsPermalink
‘(1) Grant funding under subsection (a).CommentsClose CommentsPermalink
‘(2) Design and development of the public database established pursuant to section 8(d).CommentsClose CommentsPermalink
‘(3) Development of a process by which confidential business information may be shared with the States under section 14.CommentsClose CommentsPermalink
‘(4) Development of action plans under section 38(d).’.CommentsClose CommentsPermalink
SEC. 26. AUTHORIZATION FOR APPROPRIATIONS.
(a) Authorization- Section 29 of the Toxic Substances Control Act (
‘SEC. 29. AUTHORIZATION FOR APPROPRIATIONS.
‘There are authorized to be appropriated to the Administrator to carry out this Act such sums as necessary for each of fiscal years 2011 through 2018.’.CommentsClose CommentsPermalink
SEC. 27. ADDITIONAL REQUIREMENTS.
(a) Additional Requirements- The Toxic Substances Control Act (
‘SEC. 32. CHEMICAL SUBSTANCES AND MIXTURES THAT ARE PERSISTENT, BIOACCUMULATIVE, AND TOXIC.
‘(a) Identification- Not later than 1 year after the date of enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall by rule establish criteria to identify chemical substances and mixtures that are persistent, bioaccumulative, and toxic, or are degraded or metabolized into chemical substances that are persistent, bioaccumulative, and toxic, and for which there is documented evidence of exposure to humans or the environment.CommentsClose CommentsPermalink
‘(b) Publication- Not later than 6 months after the promulgation of the rule under subsection (a), and every 3 years thereafter, the Administrator shall publish a list of all chemical substances and mixtures that meet those criteria, based on available scientific information.CommentsClose CommentsPermalink
‘(c) Risk Management-CommentsClose CommentsPermalink
‘(1) EXPEDITED EXPOSURE REDUCTION- As promptly as feasible and not later than 18 months after the listing of a chemical substance or mixture under subsection (b), the Administrator shall impose conditions authorized under section 6(c) on the manufacture, processing, use, distribution in commerce, and disposal of such chemical substance or mixture necessary to achieve the greatest practicable reductions in exposure to the chemical substance or mixture.CommentsClose CommentsPermalink
‘(2) RESIDUAL RISK ASSESSMENT- Within one year after the effective date of such conditions, the Administrator shall determine whether the chemical substance or mixture meets the safety standard with the conditions imposed, taking into account the residual risk posed by continued exposure to the chemical substance or mixture, and shall impose any further conditions authorized under section 6(c) necessary to ensure that the chemical substance or mixture meets the safety standard.CommentsClose CommentsPermalink
‘(d) Manufacturer Duties-CommentsClose CommentsPermalink
‘(1) NO MINIMUM DATA SET- Notwithstanding the requirements of section 4(a) of this title, manufacturers and processors of chemical substances or mixtures listed pursuant to subsection (b) shall not be required to submit a minimum data set for such chemical substances or mixtures, unless requested to do so by the Administrator.CommentsClose CommentsPermalink
‘(2) DECLARATION- Not later than 6 months after a chemical substance or mixture is listed under subsection (b), manufacturers and processors of such chemical substance or mixture shall submit the declaration required by section 8(a)(2).CommentsClose CommentsPermalink
‘(e) New Chemical Substances and New Uses-CommentsClose CommentsPermalink
‘(1) For each new chemical substance subject to section 5(a)(1), the Administrator shall determine whether the chemical substance or mixture, or a degradation product or metabolite of the chemical substance or mixture, meets the criteria established under subsection (a) of this section.CommentsClose CommentsPermalink
‘(2) For each chemical substance or mixture identified in paragraph (1), and for any proposed new use of a chemical substance subject to section 5(a)(1) that is identified in subsection (b), the Administrator shall allow manufacture, processing, and distribution in commerce of the substance only for a use which the Administrator determines meets the requirements of section 6(e).CommentsClose CommentsPermalink
‘SEC. 33. CHILDREN’S ENVIRONMENTAL HEALTH.
‘(a) Children’s Environmental Health Research-CommentsClose CommentsPermalink
‘(1) IN GENERAL- Subject to amounts made available in advance in appropriations Acts, the Administrator shall enter into contracts and make grants to further understanding of the vulnerability of children to chemical substances.CommentsClose CommentsPermalink
‘(2) CONSULTATION- Contracts and grants under this section shall be made in consultation with Science Advisory Board on Children’s Health and Toxic Substances established under subsection (b) and the Children’s Health Protection Advisory Committee established in response to Executive Order 13045.CommentsClose CommentsPermalink
‘(b) Science Advisory Board on Children’s Health and Toxic Substances-CommentsClose CommentsPermalink
‘(1) ESTABLISHMENT- Not later than 90 days after the date of enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall consult with the head of any other appropriate Federal agency to establish an advisory board to be known as the ‘Science Advisory Board on Children’s Health and Toxic Substances’. The Board, and any subcommittee thereof, shall be subject to the Federal Advisory Committee Act (5 U.S.C. App.).CommentsClose CommentsPermalink
‘(2) PURPOSES- The purposes of the Science Advisory Board on Children’s Health and Toxic Substances shall be to provide independent advice, expert consultation, and peer review upon the request of the Administrator on the scientific and technical aspects of issues relating to the implementation of this title with respect to protecting children’s health under this Act.CommentsClose CommentsPermalink
‘(3) COMPOSITION- The Administrator shall--CommentsClose CommentsPermalink
‘(A) appoint the members of the Board, including, at a minimum, one employee of--CommentsClose CommentsPermalink
‘(i) the National Institute of Environmental Health Sciences;CommentsClose CommentsPermalink
‘(ii) the Centers for Disease Control and Prevention;CommentsClose CommentsPermalink
‘(iii) the National Toxicology Program;CommentsClose CommentsPermalink
‘(iv) the National Cancer Institute;CommentsClose CommentsPermalink
‘(v) the National Tribal Science Council; andCommentsClose CommentsPermalink
‘(vi) not fewer than 3 centers of children’s health at leading universities;CommentsClose CommentsPermalink
‘(B) ensure that at least 1/3 of the members of the Board have specific scientific expertise in the relationship of chemical exposures to prenatal, infant, and children’s health; andCommentsClose CommentsPermalink
‘(C) ensure that all appointments shall be made without regard to political affiliation or political activity, unless required by Federal statute.CommentsClose CommentsPermalink
‘(4) DISCLOSURE-CommentsClose CommentsPermalink
‘(A) The Administrator shall make publicly available in accordance with subparagraph (B) the following information:CommentsClose CommentsPermalink
‘(i) A description of the process used to establish and appoint the members of the advisory committee, including the following:CommentsClose CommentsPermalink
‘(I) The process for identifying prospective members.CommentsClose CommentsPermalink
‘(II) The process of selecting members for balance of viewpoints or expertise.CommentsClose CommentsPermalink
‘(ii) A list of all current members, including, for each member, the following:CommentsClose CommentsPermalink
‘(I) The name of any person or entity that nominated the member.CommentsClose CommentsPermalink
‘(II) The reason the member was appointed to the committee.CommentsClose CommentsPermalink
‘(III) Whether the member is designated as a special government employee or a representative.CommentsClose CommentsPermalink
‘(IV) In the case of a representative, the individuals or entity whose viewpoint the member represents.CommentsClose CommentsPermalink
‘(iii) A list of all members designated as special government employees for whom written certifications were made under
section 208(b) of title 18, United States Code , a summary description of the conflict necessitating the certification, and the reason for granting the certification.CommentsClose CommentsPermalink‘(iv) Transcripts or audio or video recordings of all meetings of the committee.CommentsClose CommentsPermalink
‘(v) Any additional information considered relevant by the head of the agency to which the advisory committee reports.CommentsClose CommentsPermalink
‘(B)(i) Except as provided in clause (ii), the Administrator shall make the information required to be disclosed under subparagraph (A) available electronically on the official public internet site of the agency at least 15 calendar days before each meeting of an advisory committee. If the Administrator determines that such timing is not practicable for any required information, the information shall be made available as soon as practicable but no later than 48 hours before the next meeting of the committee. The Administrator may withhold from disclosure any information that would be exempt from disclosure under
section 552 of title 5, United States Code .CommentsClose CommentsPermalink‘(ii) The Administrator shall make available electronically, on the official public internet site of the agency, a transcript or audio or video recording of each advisory committee meeting not later than 30 calendar days after the meeting.CommentsClose CommentsPermalink
‘(c) Biomonitoring-CommentsClose CommentsPermalink
‘(1) STUDY-CommentsClose CommentsPermalink
‘(A) If, through studies performed pursuant to grants and contracts under subsection (a), testing or biomonitoring under section 4, or other available research, the Administrator identifies a chemical substance (or a metabolite or degradation product of such substance) that is likely to be present in human biological media at a level above that normally found in such media that is likely to have adverse effects on early childhood development, the Administrator shall, except as provided in subparagraph (B), coordinate with the Secretary of Health and Human Services to conduct, not later than 2 years after the date on which the Administrator makes such identification, a biomonitoring study to determine the presence of the chemical substance in human biological media in, at a minimum, pregnant women and infants.CommentsClose CommentsPermalink
‘(B) A biomonitoring study under subparagraph (A) shall not be required if--CommentsClose CommentsPermalink
‘(i) the Administrator determines that the chemical substance is already subject to equivalent testing;CommentsClose CommentsPermalink
‘(ii) the Administrator has determined that the chemical substance meets the safety standard; orCommentsClose CommentsPermalink
‘(iii) a safety standard determination is pending, and the Administrator determines that such a study is not required to complete the determination.CommentsClose CommentsPermalink
‘(2) PUBLICATION- Upon completion of any biomonitoring study conducted pursuant to paragraph (1), the Administrator shall publish the results of the study on the public database established pursuant to section 8(d).CommentsClose CommentsPermalink
‘(3) POSITIVE RESULTS-CommentsClose CommentsPermalink
‘(A) DISCLOSURE- Whenever a chemical substance or mixture (or a metabolite or degradation product of such substance or mixture) is determined to be present in human biological media in a biomonitoring study conducted pursuant to paragraph (1), the manufacturers and processors of such chemical substance or mixture shall, not later than 180 days after the date of publication of such study, disclose to the Administrator, commercial customers of the manufacturers and processors, consumers, and the public--CommentsClose CommentsPermalink
‘(i) all known uses of the chemical substance or mixture; andCommentsClose CommentsPermalink
‘(ii) all articles in which the chemical substance or mixture is or is expected to be present.CommentsClose CommentsPermalink
‘(B) COST AND FORM OF DISCLOSURE- Information under clauses (i) and (ii) of subparagraph (A) shall be--CommentsClose CommentsPermalink
‘(i) added to the public database established pursuant to section 8(d); andCommentsClose CommentsPermalink
‘(ii) made readily accessible and free of charge by each applicable manufacturer and processor in electronic format to the commercial customers of such manufacturer or processor, consumers, and the public.CommentsClose CommentsPermalink
‘SEC. 34. REDUCTION OF ANIMAL-BASED TESTING.
‘(a) Duties of the Administrator- The Administrator shall take action to minimize the use of animals in testing of chemical substances or mixtures, including--CommentsClose CommentsPermalink
‘(1) encouraging and facilitating, where practicable--CommentsClose CommentsPermalink
‘(A) use of existing data of sufficient scientific quality;CommentsClose CommentsPermalink
‘(B) use of test methods that eliminate or reduce the use of animals but provide data of high scientific quality;CommentsClose CommentsPermalink
‘(C) grouping of 2 or more chemical substances into scientifically appropriate categories where testing of one chemical substance will provide reliable and useful data on others in the category;CommentsClose CommentsPermalink
‘(D) formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests; andCommentsClose CommentsPermalink
‘(E) parallel submission of data from animal-based studies and from emerging methods and models;CommentsClose CommentsPermalink
‘(2) funding research and validation studies to reduce, refine, and replace the use of animal tests in accordance with this subsection;CommentsClose CommentsPermalink
‘(3) in consultation with the Interagency Coordinating Committee on the Validation of Alternative Methods, and after providing an opportunity for public comment, developing a strategic plan to promote the development and implementation of alternative test methods and testing strategies to generate information used for safety standard determinations under section 6(b) that do not use animals, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening; andCommentsClose CommentsPermalink
‘(4) biennially reporting to Congress on progress made in implementing this section.CommentsClose CommentsPermalink
‘(b) List of Methods- Not later than 1 year after the date of enactment of the Toxic Chemicals Safety Act of 2010, and triennially thereafter, the Administrator, in consultation with the Interagency Coordinating Committee on the Validation of Alternative Methods, shall publish a list of demonstrated testing methods that reduce the use of animals in testing.CommentsClose CommentsPermalink
‘(c) Criteria for Adapting or Waiving Animal Testing Requirements- Upon request from a manufacturer or processor that is required to conduct animal-based testing of a chemical substance or mixture under this title, the Administrator may adapt or waive such requirement in part or in whole if the Administrator determines that--CommentsClose CommentsPermalink
‘(1) there is sufficient weight-of-evidence that a chemical substance or mixture has, or does not have, a particular property for which such testing would be required;CommentsClose CommentsPermalink
‘(2) testing for a specific adverse effect is technically not practicable to conduct as a consequence of the substance characteristics; orCommentsClose CommentsPermalink
‘(3) a chemical substance or mixture cannot be tested in animals at concentrations that do not result in significant pain or distress as a consequence of the substance characteristics, such as potential to cause severe corrosion or severe irritation to tissues.CommentsClose CommentsPermalink
A waiver under this subsection does not waive the duty of the manufacturer or processor to demonstrate that the chemical substance or mixture meets the safety standard under section 5(a) or section 6(b).CommentsClose CommentsPermalink
‘SEC. 35. SAFER ALTERNATIVES AND GREEN CHEMISTRY AND ENGINEERING.
‘(a) Safer Alternatives-CommentsClose CommentsPermalink
‘(1) INCENTIVES- Not later than 1 year after the date of enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall, after notice and opportunity for comment, establish a program to create incentives for the development of safer alternatives to existing chemical substances and mixtures that reduce or avoid the use and generation of hazardous chemical substances or mixtures. The program under this paragraph shall include--CommentsClose CommentsPermalink
‘(A) recognition for a chemical substance or mixture, an article containing such substance or mixture, or a non-chemical alternative, determined by the Administrator under paragraph (2) to be a safer alternative for all intended uses or for a particular use of an existing chemical substance or mixture by means of a special designation intended for use in marketing the safer alternative, and periodic public awards; andCommentsClose CommentsPermalink
‘(B) such other financial or non-financial incentives as the Administrator considers to be appropriate to encourage the development, marketing, and use of chemical substances or mixtures, articles containing such substances or mixtures, or non-chemical alternatives, determined by the Administrator to be safer alternatives for all uses or for particular uses of existing chemical substances or mixtures.CommentsClose CommentsPermalink
‘(2) SAFER ALTERNATIVE ASSESSMENT- Any person seeking approval for a safer alternative under this section shall submit to the Administrator an application, including the safer alternative data set described in subparagraph (A) and shall bear the burden of demonstrating that the safer alternative standard is met, pursuant to subparagraph (B).CommentsClose CommentsPermalink
‘(A) SAFER ALTERNATIVE DATA SET- Not later than one year after the date of enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall establish, by rule, the data that constitute the safer alternative data set. The rule shall identify the information that the Administrator determines will be useful for the safer alternative standard determination under subparagraph (B) and shall include--CommentsClose CommentsPermalink
‘(i) chemical identity for the applicant alternative chemical substance or mixture, article containing such substance or mixture, or non-chemical alternative and the chemical substance or mixture targeted for substitution;CommentsClose CommentsPermalink
‘(ii) the proposed use, if applicable, or all intended uses of the applicant alternative;CommentsClose CommentsPermalink
‘(iii) substance characteristics, toxicological properties, and biological and environmental fate and transport data for the applicant alternative;CommentsClose CommentsPermalink
‘(iv) known and potential exposures for the applicant alternative;CommentsClose CommentsPermalink
‘(v) a comparative analysis of the applicant alternative and the chemical substance or mixture targeted for substitution based on the best publicly-available science on the targeted substance demonstrating that the applicant alternative will involve lower hazard, lower exposure, or both; andCommentsClose CommentsPermalink
‘(vi) a demonstration that the applicant alternative is effective for the proposed use or for all intended uses, as applicable.CommentsClose CommentsPermalink
The rule shall require any person applying for approval of a safer alternative to submit the safer alternative data set, and may provide a form for such application.CommentsClose CommentsPermalink
‘(B) SAFER ALTERNATIVE STANDARD DETERMINATION- The Administrator shall, following the submission of a safer alternative data set pursuant to subparagraph (A), approve the applicant alternative chemical substance or mixture, article containing such substance or mixture, or non-chemical alternative for the proposed use or uses if the Administrator determines that the proposed alternative is effective for the proposed use or uses and--CommentsClose CommentsPermalink
‘(i) provides a reasonable certainty of no harm from the aggregate exposure to the alternative substance from intended uses, including to vulnerable populations, and protects the public welfare, considering the lifecycle of the alternative substance and cumulative exposures and other relevant considerations, and, when compared to the chemical substance or mixture targeted for substitution--CommentsClose CommentsPermalink
‘(I) reduces the potential for harm to human health or the environment;CommentsClose CommentsPermalink
‘(II) has been shown not to be persistent or bioaccumulative, while the chemical substance or mixture targeted for substitution has not; orCommentsClose CommentsPermalink
‘(III) does not require the use of hazardous, persistent, or bioaccumulative substances during its manufacture or processing, while the chemical substance or mixture targeted for substitution does; orCommentsClose CommentsPermalink
‘(ii) in the case that the applicant alternative cannot provide a reasonable certainty of no harm from the aggregate exposure to the alternative substance from intended uses, including to vulnerable populations, and protect the public welfare, considering the lifecycle of the alternative substance and cumulative exposures and other relevant considerations, the chemical substance or mixture targeted for substitution had been granted or would qualify for a critical use exemption under section 6(e) and the applicant alternative chemical substance or mixture, article containing such substance or mixture, or non-chemical alternative, when compared to the chemical substance or mixture targeted for substitution--CommentsClose CommentsPermalink
‘(I) reduces the potential for harm to human health or the environment;CommentsClose CommentsPermalink
‘(II) has been shown not to be persistent or bioaccumulative, while the chemical substance or mixture targeted for substitution has not; orCommentsClose CommentsPermalink
‘(III) does not require the use of hazardous, persistent, or bioaccumulative substances during its manufacture or processing, while the chemical substance or mixture targeted for substitution does.CommentsClose CommentsPermalink
Any applicant alternative approved under this section shall be exempt from the requirements of sections 4, 5, and 6 for the uses considered and approved in the approval under this section, except that any approval under this section shall expire after 15 years, at which time a renewal will be required pursuant to section 6(b).CommentsClose CommentsPermalink
‘(C) CONSIDERATION IN DETERMINATION- Any safer alternative standard determination made under this subsection shall be considered by the Administrator in making a safety standard determination under section 6(b) or in granting an exemption under section 6(e) for the chemical substance or mixture targeted for substitution by the application under this subsection.CommentsClose CommentsPermalink
‘(b) Green Chemistry-CommentsClose CommentsPermalink
‘(1) GREEN CHEMISTRY RESEARCH NETWORK- Not later than 2 years after the date of enactment of the Toxic Chemicals Safety Act of 2010, and subject to amounts made available in advance in appropriations Acts, the Administrator shall establish an interdisciplinary network of regional centers, to support the research, development, and adoption of safer alternatives to existing chemical substances and mixtures, particularly chemical substances and mixtures listed on the priority list under section 6(a).CommentsClose CommentsPermalink
‘(2) GREEN CHEMISTRY AND ENGINEERING RESEARCH- Subject to amounts made available in advance in appropriations Acts, the Administrator shall make grants and enter into contracts to promote and support the research, development, and adoption of safer alternatives to existing chemical substances and mixtures.CommentsClose CommentsPermalink
‘(3) GREEN CHEMISTRY WORKFORCE EDUCATION AND TRAINING PROGRAM-CommentsClose CommentsPermalink
‘(A) ESTABLISHMENT OF PROGRAM- The Administrator shall establish a program to facilitate the development of a workforce, including industrial and scientific workers, that produces safer alternatives to existing chemical substances and mixtures.CommentsClose CommentsPermalink
‘(B) GOALS- The goals of the program established under subparagraph (A) are to provide workforce training on skills that will--CommentsClose CommentsPermalink
‘(i) facilitate the expansion of green chemistry in the United States to create new and safer jobs;CommentsClose CommentsPermalink
‘(ii) develop a scientifically and technically trained green chemistry workforce in the United States;CommentsClose CommentsPermalink
‘(iii) inform and engage communities about green chemistry; andCommentsClose CommentsPermalink
‘(iv) promote innovation and strong public health and environmental protections.CommentsClose CommentsPermalink
‘(C) IMPLEMENTATION- The Administrator shall, subject to amounts made available in advance in appropriations Acts, implement the program established under subparagraph (A) to achieve the goals under subparagraph (B), including by--CommentsClose CommentsPermalink
‘(i) promoting the development of a broad range of skills relevant to the production and use of safer alternatives to existing chemical substances and mixtures, including their design, manufacturing, and use and disposal;CommentsClose CommentsPermalink
‘(ii) developing partnerships with educational institutions, training organizations, private sector companies, community organizations, labor unions, and other non-profit organizations; andCommentsClose CommentsPermalink
‘(iii) in coordination with the Secretary of Labor and the Secretary of Energy, providing grants to State and local governments and to the partnerships established pursuant to clause (ii) to promote and support activities consistent with achieving the goals under subparagraph (B).CommentsClose CommentsPermalink
‘SEC. 36. INTERNATIONAL COOPERATION AND AGREEMENTS.
‘(a) Cooperation- In coordination with the Secretary of State and the head of any other Federal agency, as appropriate, the Administrator shall cooperate with any international effort which the Administrator determines has broad international support and a reasonable expectation of success--CommentsClose CommentsPermalink
‘(1) to develop a common protocol or electronic database relating to chemical substances and mixtures; orCommentsClose CommentsPermalink
‘(2) to develop safer alternatives for chemical substances and mixtures.CommentsClose CommentsPermalink
‘(b) Prohibition-CommentsClose CommentsPermalink
‘(1) PROHIBITION- Except as provided in paragraph (2), notwithstanding any other provision of law, effective 3 years after the date of enactment of the Toxic Chemicals Safety Act of 2010, no person shall manufacture, process, distribute in commerce, use for commercial purposes, or dispose of the following chemical substances, except in a manner determined by the Administrator to be protective of health and the environment:CommentsClose CommentsPermalink
‘(A) Hexabromobiphenyl.CommentsClose CommentsPermalink
‘(B) Hexachlorobenzene.CommentsClose CommentsPermalink
‘(C) Hexabromodiphenyl ether and Heptabromodiphenyl ether and congeners in the commercial OctaBDE mixture.CommentsClose CommentsPermalink
‘(D) Pentachlorobenzene.CommentsClose CommentsPermalink
‘(E) Tetrabromodiphenyl ether and pentabromodiphenyl ether and congeners in the commercial PentaBDE mixture.CommentsClose CommentsPermalink
‘(2) EXCEPTION- If the United States deposits its instrument of ratification for the Stockholm Convention, the PIC Convention, or the LRTAP POPs Protocol before the prohibition under paragraph (1) has taken effect, the effective date of the prohibition shall be determined in keeping with the requirements of the applicable agreement.CommentsClose CommentsPermalink
‘(c) Notice of Restrictions Under International Agreements- Not later than 60 days after the enactment of the Toxic Chemicals Safety Act of 2010, the Administrator, in consultation with the Secretary of State, shall publish in the Federal Register a notice of the chemical substances or mixtures that are subject to the Stockholm Convention, the PIC Convention, and the LRTAP POPs Protocol, including conditions or restrictions relating to such chemical substances or mixtures imposed by such agreements or by foreign governments pursuant to such agreements.CommentsClose CommentsPermalink
‘(d) Implementing Agreements- In consultation with the Secretary of State and the head of any other appropriate Federal agency (as determined by the Administrator), the Administrator shall implement the provisions of international agreements (and any subsequent amendment to such agreements) related to chemical substances and mixtures to which the United States becomes a party. Such implementation shall provide notice at each step in the listing and delisting process as required in such agreements and include requirements that:CommentsClose CommentsPermalink
‘(1) Not later than 30 days after the United States deposits its instrument of ratification for the Stockholm Convention, the PIC Convention, the LRTAP POPs Protocol, or any other international agreement related to chemical substances and mixtures, or not later than 30 days after the listing of any chemical substance or mixture subsequently added under such an instrument has entered into force for the United States, (whichever occurs earlier), the Administrator shall provide public notice of the chemical substances or mixtures that are subject to that agreement, and shall provide similar public notice of any chemical substance or mixture subsequently added under such agreement. In providing such notice, the Administrator may specify the applicable requirements for individual chemical substances or mixtures.CommentsClose CommentsPermalink
‘(2) Whenever a chemical substance or mixture is proposed for listing under an international agreement to which the United States is a party, the Administrator shall publish in the Federal Register a notice that--CommentsClose CommentsPermalink
‘(A) includes any relevant toxicity, exposure, and risk information related to the chemical substance or mixture known to the Administrator, as well as any domestic activities involving the chemical substance or mixture known to the Administrator;CommentsClose CommentsPermalink
‘(B) includes a summary of the process, under the international agreement, for the listing or delisting step that was taken, including criteria applied in that process and records generated by the international body during that process;CommentsClose CommentsPermalink
‘(C) requires any person that manufactures, processes, distributes in commerce, uses, or disposes of the chemical substance or mixture to provide to the Administrator any information that the Administrator determines to be necessary to assist the United States in its consideration of the proposal; andCommentsClose CommentsPermalink
‘(D) provides an opportunity for public comment on the proposed listing of the chemical substance or mixture.CommentsClose CommentsPermalink
The comments and information received under this paragraph shall be placed in a public docket and shall be considered in the Administrator’s review of the proposal.CommentsClose CommentsPermalink
‘(3) Any chemical substance or mixture listed under an international agreement to which the United States is a party that is not already subject to conditions under section 6(c) or already listed on the priority list under section 6(a) shall be promptly added to the priority list under section 6(a).CommentsClose CommentsPermalink
‘(4) If there are applicable obligations for a chemical substance or mixture under more than one international agreement to which the United States is a party, the most stringent of such obligations shall apply to ensure compliance with each of those agreements.CommentsClose CommentsPermalink
‘(e) Rules- The Administrator may promulgate such rules as the Administrator determines necessary to cooperate with international efforts pursuant to subsection (a) and to implement international agreements related to chemical substances and mixtures pursuant to subsection (d).CommentsClose CommentsPermalink
‘(f) Effect on Other Provisions of Law- Nothing in this section shall affect the authority of the Administrator to regulate a chemical substance or mixture under any other provision of law, provided that such regulation--CommentsClose CommentsPermalink
‘(1) is not less stringent than actions prescribed by this section; andCommentsClose CommentsPermalink
‘(2) does not impair the ability of the United States to comply with obligations under international agreements (and any subsequent amendment to such agreements) related to chemical substances and mixtures to which the United States becomes a party.CommentsClose CommentsPermalink
‘(g) Definitions- In this section:CommentsClose CommentsPermalink
‘(1) LRTAP CONVENTION- The term ‘LRTAP Convention’ means the Convention on Long-Range Transboundary Air Pollution, adopted in Geneva on November 13, 1979, and any subsequent amendment or protocol.CommentsClose CommentsPermalink
‘(2) LRTAP POPS PROTOCOL- The term ‘LRTAP POPs Protocol’ means the Protocol on Persistent Organic Pollutants to the LRTAP Convention, adopted in Aarhus on June 24, 1998, and any subsequent amendment.CommentsClose CommentsPermalink
‘(3) STOCKHOLM CONVENTION- The term ‘Stockholm Convention’ means the Stockholm Convention on Persistent Organic Pollutants adopted in Stockholm on May 22, 2001, and any subsequent amendment or protocol.CommentsClose CommentsPermalink
‘SEC. 37. DATA QUALITY.
‘Not later than 18 months after the date of enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall, by order, after notice and opportunity for comment, establish and implement procedures to ensure data quality under this Act including, at a minimum, requirements that--CommentsClose CommentsPermalink
‘(1) not less than annually, the Administrator randomly inspect commercial and private laboratories that develop the data required under this title;CommentsClose CommentsPermalink
‘(2) annually, the Administrator perform a comprehensive data audit on a subset, as selected by the Administrator, of the data submissions under this title;CommentsClose CommentsPermalink
‘(3) the Administrator have access to all records of privately sponsored health and safety studies initiated in response to requirements under this title; andCommentsClose CommentsPermalink
‘(4) the submitter of any study conducted by a third party in response to requirements under this title disclose to the Administrator and the public, at the time of submission, the sources of any funding used for the conduct or publication of the study received by the researchers who conducted the study.CommentsClose CommentsPermalink
‘SEC. 38. HOT SPOTS.
‘(a) Criteria- Not later than 1 year after the date of enactment of the Toxic Chemicals Safety Act of 2010, the Administrator shall promulgate a rule to--CommentsClose CommentsPermalink
‘(1) establish criteria for the determination of disproportionate exposure, which shall include criteria for identification of average exposure levels in the United States and criteria for identification of exceedences that are significant based on their potential impact on health or the environment;CommentsClose CommentsPermalink
‘(2) establish criteria to identify any locality that is disproportionately exposed; andCommentsClose CommentsPermalink
‘(3) develop a method for data collection on and categorization of patterns of disproportionate exposure and associated adverse effects.CommentsClose CommentsPermalink
‘(b) Identification-CommentsClose CommentsPermalink
‘(1) IN GENERAL- Not later than 18 months after promulgation of the rule under subsection (a), the Administrator shall identify localities within the United States subject to disproportionate exposure.CommentsClose CommentsPermalink
‘(2) USE OF DATA- In identifying localities under paragraph (1), the Administrator--CommentsClose CommentsPermalink
‘(A) shall use data contained in the National Air Toxic Assessment Database; andCommentsClose CommentsPermalink
‘(B) may use other data available to the Administrator, including data developed pursuant to--CommentsClose CommentsPermalink
‘(i) the Safe Drinking Water Act (
42 U.S.C. 300f et seq.);CommentsClose CommentsPermalink‘(ii) the Solid Waste Disposal Act (
42 U.S.C. 6901 et seq.);CommentsClose CommentsPermalink‘(iii) the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (
42 U.S.C. 9601 et seq.);CommentsClose CommentsPermalink‘(iv) the Emergency Planning and Community Right-to-Know Act of 1986 (
42 U.S.C. 11001 et seq.); andCommentsClose CommentsPermalink‘(v) the National Environmental Public Health Tracking program at the Centers for Disease Control and Prevention.CommentsClose CommentsPermalink
‘(3) PUBLIC PARTICIPATION- The Administrator shall provide an opportunity for State, local, and tribal governments and members of the public to nominate localities for which there may be disproportionate exposure for inclusion in the identification of localities under paragraph (1).CommentsClose CommentsPermalink
‘(c) Hot Spot List-CommentsClose CommentsPermalink
‘(1) IN GENERAL- Not later than 180 days after completing the identification of localities under subsection (b)(1), the Administrator shall, after notice and consultation with all applicable State, local, and tribal health and environmental officials, legislators and other elected officials, and members of the public, publish a list of the localities subject to disproportionate exposure identified pursuant to such subsection in the Federal Register and make such list available electronically. The initial list shall include at least 20 localities.CommentsClose CommentsPermalink
‘(2) UPDATING- Not later than 5 years after the date of publication of the list under paragraph (1), and at least once every 5 years thereafter, the Administrator shall update and republish such list. The Administrator may update and republish such list to add new localities that meet the criteria under subsection (a), or to remove localities when the Administrator determines that the percentage exposure reduction goal for such a locality established pursuant to subsection (d) has been achieved and no further action is needed. The Administrator shall notify all applicable State, local, and tribal health and environmental officials, legislators and other elected officials, and members of the public of such an updated listing.CommentsClose CommentsPermalink
‘(d) Action Plans- Not later than 1 year after publishing or updating the list under subsection (c), the Administrator shall coordinate with State, local, and tribal governments and members of the public to develop, for each locality identified on the list, an action plan to reduce disproportionate exposure within such locality. Each such action plan shall include--CommentsClose CommentsPermalink
‘(1) identification of the chemical substances and mixtures that contribute to the disproportionate exposure (including exposure levels, sources, and pathways);CommentsClose CommentsPermalink
‘(2) a description of actions to be undertaken by the Administrator or State, local, or tribal governments, to reduce disproportionate exposure within the locality;CommentsClose CommentsPermalink
‘(3) a percentage exposure reduction goal for each chemical substance and mixture identified under paragraph (1); andCommentsClose CommentsPermalink
‘(4) a timeline to achieve the percentage exposure reduction goal under paragraph (3).CommentsClose CommentsPermalink
‘(e) Report to Congress- Beginning on the date that is one year after the development of the first action plan under subsection (d), and annually thereafter, the Administrator shall--CommentsClose CommentsPermalink
‘(1) prepare and submit to Congress an annual report identifying--CommentsClose CommentsPermalink
‘(A) each locality added to the list in the prior year under subsection (c);CommentsClose CommentsPermalink
‘(B) each action plan developed in the prior year under subsection (d);CommentsClose CommentsPermalink
‘(C) the progress on each action plan to date; andCommentsClose CommentsPermalink
‘(D) the reasons why any timelines for percentage exposure reductions were not met and the revised timeline for meeting those reductions; andCommentsClose CommentsPermalink
‘(2) make the report available to the public in the public database established under section 8(d).CommentsClose CommentsPermalink
‘(f) Locality- In this section, the term ‘locality’ means any geographical area in which the Administrator identifies disproportionate exposure and may include a county, city, town, neighborhood, census tract, zip code, or other commonly understood political or geographical subdivision.CommentsClose CommentsPermalink
‘SEC. 39. EXEMPTION FOR CHEMICAL SUBSTANCES OR MIXTURES BASED ON INTRINSIC PROPERTIES.
‘(a) Authority to Exempt Certain Chemical Substances and Mixtures Based on Intrinsic Properties- If the Administrator determines that scientific consensus exists that the intrinsic properties of a chemical substance or mixture are such that it does not and would not pose any risk of injury to health or the environment under any current, proposed, or anticipated levels of production, patterns of use, or exposures arising at any stage across the lifecycle of the substance or mixture, the Administrator may, by order, exempt the substance or mixture, or particular uses of the substance or mixture, from one or more of the requirements of sections 4, 5, 6 and 8 of this Act. A determination under this section shall be based on consideration of the intrinsic properties of the substance or mixture, and shall not be based on findings or assumptions of low human or environmental exposure to the substance or mixture.CommentsClose CommentsPermalink
‘(b) Notice of Determination and Exemption- Within 30 days of determining and exempting, pursuant to subsection (a), a chemical substance or mixture, or a particular use of a chemical substance or mixture, the Administrator shall publish in the Federal Register, and shall add to the public database established pursuant to section 8(d), a notice that provides the specific identity of the chemical substance or mixture, and, for a particular use determined and exempted under subsection (a), the particular use of the substance or mixture, that the Administrator has determined and exempted under subsection (a) and that explains and documents the basis for the Administrator’s determination and exemption.CommentsClose CommentsPermalink
‘(c) Reconsideration of Determination and Exemption-CommentsClose CommentsPermalink
‘(1) IN GENERAL- The Administrator may reconsider and revoke or modify any determination or exemption under subsection (a) at any time if the Administrator determines that the conditions of subsection (a) are no longer met, or that such action is necessary to protect human health or the environment or is otherwise in the public interest. In the event of such revocation or modification, the Administrator shall provide public notice of the grounds for that determination and publish such notice on the public database established pursuant to section 8(d).CommentsClose CommentsPermalink
‘(2) EFFECTIVE DATE- Any revocation or modification undertaken pursuant to this subsection shall not take effect prior to the date that is one year after public notice of the determination, unless an earlier effective date is necessary to protect human health or the environment.CommentsClose CommentsPermalink
‘(d) Prior Regulatory Exemptions- Not later than one year after the date of enactment of the Toxic Chemicals Safety Act of 2010, exemptions granted by the Administrator pursuant to section 5(h)(4) of this Act prior to the date of enactment of the Toxic Chemicals Safety Act of 2010, as such section was in effect before such date of enactment, shall be reviewed by the Administrator and continued in effect under the authority granted by this section, as appropriate. Such an exemption shall continue to be in effect until such date as the Administrator determines, by order, that--CommentsClose CommentsPermalink
‘(1) the exemption is not authorized or not appropriate under this section, at which time the exemption shall cease to be in effect; orCommentsClose CommentsPermalink
‘(2) the exemption is authorized and appropriate under this section, at which time the Administrator may issue an order to modify or continue in effect the exemption pursuant to subsection (a).CommentsClose CommentsPermalink
‘(e) No Limitation on Authority- Nothing in this section shall be construed to limit or otherwise affect the Administrator’s authority under any other provision of this Act.CommentsClose CommentsPermalink
‘SEC. 40. APPLICATION OF THIS ACT TO FEDERAL AGENCIES.
‘(a) In General- Except as provided in subsection (e), each Federal agency, and any officer, agent, or employee thereof, shall be subject to, and comply with, all applicable requirements of this Act, both substantive and procedural, in the same manner, and to the same extent, as any person subject to such requirements. The substantive and procedural requirements referred to in this subsection include--CommentsClose CommentsPermalink
‘(1) any rule or order;CommentsClose CommentsPermalink
‘(2) any civil or administrative penalty or fine, regardless of whether such penalty or fine is punitive or coercive in nature or is imposed for isolated, intermittent, or continuing violations;CommentsClose CommentsPermalink
‘(3) any requirement for reporting;CommentsClose CommentsPermalink
‘(4) any provision for injunctive relief and such sanctions as may be imposed by a court to enforce such relief; andCommentsClose CommentsPermalink
‘(5) payment of user fees under section 26(b).CommentsClose CommentsPermalink
‘(b) Waiver of Immunity- The United States hereby expressly waives any immunity otherwise applicable to the United States with respect to any substantive or procedural requirement referred to under subsection (a).CommentsClose CommentsPermalink
‘(c) Civil Penalties- No agent, employee, or officer of the United States shall be personally liable for any civil penalty under this Act with respect to any act or omission within the scope of the official duties of the agent, employee, or officer.CommentsClose CommentsPermalink
‘(d) Criminal Sanctions- An agent, employee, or officer of the United States shall be subject to any criminal sanction (including any fine or imprisonment) under this Act, but no Federal agency shall be subject to any such sanction.CommentsClose CommentsPermalink
‘(e) Exemption-CommentsClose CommentsPermalink
‘(1) IN GENERAL- If the President determines it is in the paramount interest of the United States, the President may grant an exemption for any Federal agency from compliance with any requirement of this Act.CommentsClose CommentsPermalink
‘(2) LACK OF APPROPRIATION- No exemption shall be granted under paragraph (1) due to lack of appropriation unless the President has specifically requested such appropriation as a part of the budgetary process and the Congress has failed to make available such requested appropriation.CommentsClose CommentsPermalink
‘(3) PERIOD OF EXEMPTION- Any exemption granted under paragraph (1) shall be for a period of not more than 1 year, but additional exemptions may be granted for periods not to exceed 1 year upon the President’s making a new determination that such exemption is in the paramount interest of the United States.CommentsClose CommentsPermalink
‘(4) REPORT- Annually after the date of enactment of the Toxic Chemicals Safety Act of 2010, the President shall report to the Congress all exemptions under this subsection granted during the preceding calendar year, together with the reason for granting each such exemption.CommentsClose CommentsPermalink
‘(f) Administrative Enforcement Actions-CommentsClose CommentsPermalink
‘(1) IN GENERAL- The Administrator may commence an administrative enforcement action against any Federal agency pursuant to the enforcement authorities contained in this Act. The Administrator shall initiate an administrative enforcement action against such agency in the same manner and under the same circumstances as an action would be initiated against another person. Any voluntary resolution or settlement of an administrative enforcement action shall be set forth in a consent order.CommentsClose CommentsPermalink
‘(2) FINAL- No administrative order issued to a Federal agency shall become final until such agency has had the opportunity to confer with the Administrator.’.CommentsClose CommentsPermalink
(b) Conforming Amendment- The table of contents for the Toxic Substances Control Act is amended by adding after the item relating to section 31, the following new items:CommentsClose CommentsPermalink
‘Sec. 32. Chemical substances and mixtures that are persistent, bioaccumulative, and toxic.CommentsClose CommentsPermalink
‘Sec. 33. Children’s environmental health.CommentsClose CommentsPermalink
‘Sec. 34. Reduction of animal-based testing.CommentsClose CommentsPermalink
‘Sec. 35. Safer alternatives and green chemistry and engineering.CommentsClose CommentsPermalink
‘Sec. 36. International cooperation and agreements.CommentsClose CommentsPermalink
‘Sec. 37. Data quality.CommentsClose CommentsPermalink
‘Sec. 38. Hot spots.CommentsClose CommentsPermalink
‘Sec. 39. Exemption for chemical substances or mixtures based on intrinsic properties.CommentsClose CommentsPermalink
‘Sec. 40. Application of this Act to Federal agencies.’.CommentsClose CommentsPermalink
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U.S. Congress - Text of H.R.5820 as Introduced in House Toxic Chemicals Safety Act of 2010



