Sec. 4. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES
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## SEC. 4 TESTING OF CHEMICAL SUBSTANCES AND MIXTURES Section 4 of the Toxic Substances Control Act (15 U.S.C. 2603) is amended— ####
(1)by striking “standards” each place it appears and inserting “protocols and methodologies”; ####
(2)in subsection (a)— #####
(A)by striking “If the Administrator finds” and inserting “(1) If the Administrator finds”; #####
(B)in paragraph (1), as so designated— ######
(i)by striking “(1)(A)(i)” and inserting “(A)(i)(I)”; ######
(ii)by striking “(ii)” each place it appears and inserting “(II)”; ######
(iii)by striking “are insufficient data” and inserting “is insufficient information” each place it appears; ######
(iv)by striking “(iii)” each place it appears and inserting “(III)”; ######
(v)by striking “such data” and inserting “such information” each place it appears; ######
(vi)by striking “(B)(i)” and inserting “(ii)(I)”; ######
(vii)by striking “(I)” and inserting “(aa)”; ######
(viii)by striking “(II)” and inserting “(bb)”; ######
(ix)by striking “(2)” and inserting “(B)”; and ######
(x)in the matter following subparagraph (B), as so redesignated— ######
(I)by inserting “, or, in the case of a chemical substance or mixture described in subparagraph (A)(i), by rule, order, or consent agreement,” after “rule”; ######
(II)by striking “data” each place it appears and inserting “information”; and ######
(III)by striking “and which are relevant” and inserting “and which is relevant”; and #####
(C)by adding at the end the following: > > #### “(2) Additional testing authority > > In addition to the authority provided under paragraph (1), the Administrator may, by rule, order, or consent agreement— > > > ##### “(A) > > require the development of new information relating to a chemical substance or mixture if the Administrator determines that the information is necessary— > > > ###### “(i) > > to review a notice under section 5 or to perform a risk evaluation under section 6(b); > > > ###### “(ii) > > to implement a requirement imposed in a rule, order, or consent agreement under subsection
(e)or
(f)of section 5 or in a rule promulgated under section 6(a); > > > ###### “(iii) > > at the request of a Federal implementing authority under another Federal law, to meet the regulatory testing needs of that authority with regard to toxicity and exposure; or > > > ###### “(iv) > > pursuant to section 12(a)(2); and > > > ##### “(B) > > require the development of new information for the purposes of prioritizing a chemical substance under section 6(b) only if the Administrator determines that such information is necessary to establish the priority of the substance, subject to the limitations that— > > > ###### “(i) > > not later than 90 days after the date of receipt of information regarding a chemical substance complying with a rule, order, or consent agreement under this subparagraph, the Administrator shall designate the chemical substance as a high-priority substance or a low-priority substance; and > > > ###### “(ii) > > information required by the Administrator under this subparagraph shall not be required for the purposes of establishing or implementing a minimum information requirement of broader applicability. > > > #### “(3) Statement of need > > When requiring the development of new information relating to a chemical substance or mixture under paragraph (2), the Administrator shall identify the need for the new information, describe how information reasonably available to the Administrator was used to inform the decision to require new information, explain the basis for any decision that requires the use of vertebrate animals, and, as applicable, explain why issuance of an order is warranted instead of promulgating a rule or entering into a consent agreement. > > > #### “(4) Tiered testing > > When requiring the development of new information under this subsection, the Administrator shall employ a tiered screening and testing process, under which the results of screening-level tests or assessments of available information inform the decision as to whether 1 or more additional tests are necessary, unless information available to the Administrator justifies more advanced testing of potential health or environmental effects or potential exposure without first conducting screening-level testing.” > ; ####
(3)in subsection (b)— #####
(A)in paragraph (1)— ######
(i)in subparagraph (B), by striking “test data” and inserting “information”; ######
(ii)in subparagraph (C), by striking “data” and inserting “information”; and ######
(iii)in the matter following subparagraph (C), by striking “data” and inserting “information”; #####
(B)in paragraph (2)— ######
(i)in subparagraph (A)— ######
(I)by striking “test data” and inserting “information”; ######
(II)by inserting “Protocols and methodologies for the development of information may also be prescribed for the assessment of exposure or exposure potential to humans or the environment.” after the first sentence; and ######
(III)by striking “hierarchical tests” and inserting “tiered testing”; and ######
(ii)in subparagraph (B), by striking “data” and inserting “information”; #####
(C)in paragraph (3)— ######
(i)by striking “data” each place it appears and inserting “information”; ######
(ii)in subparagraph (A), by inserting “or (C), as applicable,” after “subparagraph (B)”; ######
(iii)by striking “(a)(1)(A)(ii) or (a)(1)(B)(ii)” each place it appears in subparagraph
(B)and inserting “(a)(1)(A)(i)(II) or (a)(1)(A)(ii)(II)”; ######
(iv)in subparagraph (B), in the matter before clause (i), by striking “subsection (a)” and inserting “subsection (a)(1)”; and ######
(v)by adding at the end the following: > > ###### “(C) > > A rule or order under paragraph
(1)or
(2)of subsection
(a)may require the development of information by any person who manufactures or processes, or intends to manufacture or process, a chemical substance or mixture subject to the rule or order.” > ; #####
(D)in paragraph (4)— ######
(i)by striking “of data” each place it appears and inserting “of information”; and ######
(ii)by striking “test data” each place it appears and inserting “information”; and #####
(E)by striking paragraph (5); ####
(4)in subsection (c)— #####
(A)in paragraph (1), by striking “data” and inserting “information”; #####
(B)in paragraph (2), by striking “data” each place it appears and inserting “information”; #####
(C)in paragraph (3)— ######
(i)by striking “test data” each place it appears and inserting “information”; and ######
(ii)by striking “such data” each place it appears and inserting “such information”; and #####
(D)in paragraph
(4)by striking “test data” each place it appears and inserting “information”; ####
(5)in subsection (d)— #####
(A)by striking “test data” each place it appears and inserting “information”; #####
(B)by striking “such data” each place it appears and inserting “such information”; and #####
(C)by striking “for which data have” and inserting “for which information has”; ####
(6)in subsection (e)— #####
(A)in paragraph (1)— ######
(i)in subparagraph (A)— ######
(I)by striking “promulgation of a rule” and inserting “development of information”; and ######
(II)by striking “data” each place it appears and inserting “information”; and ######
(ii)in subparagraph (B), by striking “either initiate a rulemaking proceeding under subsection
(a)or if such a proceeding is not initiated within such period, publish in the Federal Register the Administrator’s reason for not initiating such a proceeding” and insert “issue an order, enter into a consent agreement, or initiate a rulemaking proceeding under subsection (a), or, if such an order or consent agreement is not issued or such a proceeding is not initiated within such period, publish in the Federal Register the Administrator’s reason for not issuing such an order, entering into such a consent agreement, or initiating such a proceeding”; and #####
(B)in paragraph (2)(A)— ######
(i)by striking “eight members” and inserting “ten members”; and ######
(ii)by adding at the end the following: > > ###### “(ix) > > One member appointed by the Chairman of the Consumer Product Safety Commission from Commissioners or employees of the Commission. > > > ###### “(x) > > One member appointed by the Commissioner of Food and Drugs from employees of the Food and Drug Administration.” > ; ####
(7)in subsection (f)— #####
(A)in paragraph (1), by striking “test data” and inserting “information”; and #####
(B)in the matter following paragraph (2)— ######
(i)by striking “or will present”; ######
(ii)by striking “from cancer, gene mutations, or birth defects”; ######
(iii)by striking “data or”; ######
(iv)by striking “appropriate” and inserting “applicable”; and ######
(v)by inserting “, made without consideration of costs or other nonrisk factors,” after “publish in the Federal Register a finding”; ####
(8)in subsection (g)— #####
(A)by amending the subsection heading to read as follows: “Petition for Protocols and Methodologies for the Development of Information”; #####
(B)by striking “test data” each place it appears and inserting “information”; and #####
(C)by striking “submit data” and inserting “submit information”; and ####
(9)by adding at the end the following: > > ### “(h) Reduction of Testing on Vertebrates > > > #### “(1) In General > > The Administrator shall reduce and replace, to the extent practicable, scientifically justified, and consistent with the policies of this title, the use of vertebrate animals in the testing of chemical substances or mixtures under this title by— > > > ##### “(A) > > prior to making a request or adopting a requirement for testing using vertebrate animals, and in accordance with subsection (a)(3), taking into consideration, as appropriate and to the extent practicable and scientifically justified, reasonably available existing information, including— > > > ###### “(i) > > toxicity information; > > > ###### “(ii) > > computational toxicology and bioinformatics; and > > > ###### “(iii) > > high-throughput screening methods and the prediction models of those methods; and > > > ##### “(B) > > encouraging and facilitating— > > > ###### “(i) > > the use of scientifically valid test methods and strategies that reduce or replace the use of vertebrate animals while providing information of equivalent or better scientific quality and relevance that will support regulatory decisions under this title; > > > ###### “(ii) > > the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide scientifically valid and useful information on other chemical substances in the category; and > > > ###### “(iii) > > the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests, provided that such consortia make all information from such testing available to the Administrator. > > > #### “(2) Implementation of alternative testing methods > > To promote the development and timely incorporation of new scientifically valid test methods and strategies that are not based on vertebrate animals, the Administrator shall— > > > ##### “(A) > > not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures through, for example— > > > ###### “(i) > > computational toxicology and bioinformatics; > > > ###### “(ii) > > high-throughput screening methods; > > > ###### “(iii) > > testing of categories of chemical substances; > > > ###### “(iv) > > tiered testing methods; > > > ###### “(v) > > in vitro studies; > > > ###### “(vi) > > systems biology; > > > ###### “(vii) > > new or revised methods identified by validation bodies such as the Interagency Coordinating Committee on the Validation of Alternative Methods or the Organization for Economic Co-operation and Development; or > > > ###### “(viii) > > industry consortia that develop information submitted under this title; > > > ##### “(B) > > as practicable, ensure that the strategic plan developed under subparagraph
(A)is reflected in the development of requirements for testing under this section; > > > ##### “(C) > > include in the strategic plan developed under subparagraph
(A)a list, which the Administrator shall update on a regular basis, of particular alternative test methods or strategies the Administrator has identified that do not require new vertebrate animal testing and are scientifically reliable, relevant, and capable of providing information of equivalent or better scientific reliability and quality to that which would be obtained from vertebrate animal testing; > > > ##### “(D) > > provide an opportunity for public notice and comment on the contents of the plan developed under subparagraph (A), including the criteria for considering scientific reliability and relevance of the test methods and strategies that may be identified pursuant to subparagraph (C); > > > ##### “(E) > > beginning on the date that is 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and every 5 years thereafter, submit to Congress a report that describes the progress made in implementing the plan developed under subparagraph
(A)and goals for future alternative test methods and strategies implementation; and > > > ##### “(F) > > prioritize and, to the extent consistent with available resources and the Administrator’s other responsibilities under this title, carry out performance assessment, validation, and translational studies to accelerate the development of scientifically valid test methods and strategies that reduce, refine, or replace the use of vertebrate animals, including minimizing duplication, in any testing under this title. > > > #### “(3) Voluntary testing > > > ##### “(A) In general > > Any person developing information for submission under this title on a voluntary basis and not pursuant to any request or requirement by the Administrator shall first attempt to develop the information by means of an alternative test method or strategy identified by the Administrator pursuant to paragraph (2)(C), if the Administrator has identified such a test method or strategy for the development of such information, before conducting new vertebrate animal testing. > > > ##### “(B) Effect of paragraph > > Nothing in this paragraph shall, under any circumstance, limit or restrict the submission of any existing information to the Administrator. > > > ##### “(C) Relationship to other law > > A violation of this paragraph shall not be a prohibited act under section 15. > > > ##### “(D) Review of means > > This paragraph authorizes, but does not require, the Administrator to review the means by which a person conducted testing described in subparagraph (A).” > .
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Sec. 4
TESTING OF CHEMICAL SUBSTANCES AND MIXTURES
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