Sec. 4. Testing of chemical substances and mixtures
2,000 words·~9 min read·
/bill/114/hr/2576/eah/section-4A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— by striking standards each place it appears and inserting protocols and methodologies ; in subsection (a)— by striking If the Administrator finds and inserting
(1)If the Administrator finds ; in paragraph (1), as so designated— by striking (1)(A)(i) and inserting (A)(i)(I) ; by striking
(ii)each place it appears and inserting
(II); by striking are insufficient data and inserting is insufficient information each place it appears; by striking
(iii)each place it appears and inserting
(III); by striking such data and inserting such information each place it appears; by striking (B)(i) and inserting (ii)(I) ; by striking
(I)and inserting
(aa); by striking
(II)and inserting
(bb); by striking
(2)and inserting
(B); and in the matter following subparagraph (B), as so redesignated— 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 ; by striking data each place it appears and inserting information ; and by striking and which are relevant and inserting and which is relevant ; and by adding at the end the following: In addition to the authority provided under paragraph (1), the Administrator may, by rule, order, or consent agreement— require the development of new information relating to a chemical substance or mixture if the Administrator determines that the information is necessary— to review a notice under section 5 or to perform a risk evaluation under section 6(b); 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); 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 pursuant to section 12(a)(2); and 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— 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 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. 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. 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. ; in subsection (b)— in paragraph (1)— in subparagraph (B), by striking test data and inserting information ; in subparagraph (C), by striking data and inserting information ; and in the matter following subparagraph (C), by striking data and inserting information ; in paragraph (2)— in subparagraph (A)— by striking test data and inserting information ; 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 by striking hierarchical tests and inserting tiered testing ; and in subparagraph (B), by striking data and inserting information ; in paragraph (3)— by striking data each place it appears and inserting information ; in subparagraph (A), by inserting or (C), as applicable, after subparagraph
(B); 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) ; in subparagraph (B), in the matter before clause (i), by striking subsection
(a)and inserting subsection (a)(1) ; and by adding at the end the following: 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. ; in paragraph (4)— by striking of data each place it appears and inserting of information ; and by striking test data each place it appears and inserting information ; and by striking paragraph (5); in subsection (c)— in paragraph (1), by striking data and inserting information ; in paragraph (2), by striking data each place it appears and inserting information ; in paragraph (3)— by striking test data each place it appears and inserting information ; and by striking such data each place it appears and inserting such information ; and in paragraph
(4)by striking test data each place it appears and inserting information ; in subsection (d)— by striking test data each place it appears and inserting information ; by striking such data each place it appears and inserting such information ; and by striking for which data have and inserting for which information has ; in subsection (e)— in paragraph (1)— in subparagraph (A)— by striking promulgation of a rule and inserting development of information ; and by striking data each place it appears and inserting information ; and 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 in paragraph (2)(A)— by striking eight members and inserting ten members ; and by adding at the end the following: One member appointed by the Chairman of the Consumer Product Safety Commission from Commissioners or employees of the Commission. One member appointed by the Commissioner of Food and Drugs from employees of the Food and Drug Administration. ; in subsection (f)— in paragraph (1), by striking test data and inserting information ; and in the matter following paragraph (2)— by striking or will present ; by striking from cancer, gene mutations, or birth defects ; by striking data or ; by striking appropriate and inserting applicable ; and by inserting , made without consideration of costs or other nonrisk factors, after publish in the Federal Register a finding ; in subsection (g)— by amending the subsection heading to read as follows: ; Petition for protocols and methodologies for the development of information by striking test data each place it appears and inserting information ; and by striking submit data and inserting submit information ; and by adding at the end the following: 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— 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— toxicity information; computational toxicology and bioinformatics; and high-throughput screening methods and the prediction models of those methods; and encouraging and facilitating— 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; 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 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. 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— 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— computational toxicology and bioinformatics; high-throughput screening methods; testing of categories of chemical substances; tiered testing methods; in vitro studies; systems biology; 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 industry consortia that develop information submitted under this title; as practicable, ensure that the strategic plan developed under subparagraph
(A)is reflected in the development of requirements for testing under this section; 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; 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); 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 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. 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. Nothing in this paragraph shall, under any circumstance, limit or restrict the submission of any existing information to the Administrator. A violation of this paragraph shall not be a prohibited act under section 15. This paragraph authorizes, but does not require, the Administrator to review the means by which a person conducted testing described in subparagraph (A). .
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Sec. 4
Testing of chemical substances and mixtures
Cites 1Cited by 0 across 0 sources