Testing of chemical substances and mixtures

If the Administrator finds that— 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— require the development of new information for the purposes of prioritizing a chemical substance under section 2605(b) of this title only if the Administrator determines that such information is necessary to establish the priority of the substance, subject to the limitations that— A rule, order, or consent agreement under subsection (a) shall include— The following persons shall be required to conduct tests and submit information on a chemical substance or mixture subject to a rule under subsection (a)(1): If, upon receipt of an application under paragraph (1), the Administrator determines that— If the exemption under paragraph (2) of any person from the requirement to conduct tests and submit information on a chemical substance or mixture is granted on the basis of the existence of previously submitted information and if such exemption is granted during the reimbursement period for such information (as prescribed by subparagraph (B)), then (unless such person and the persons referred to in clauses (i) and (ii) agree on the amount and method of reimbursement) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the Administrator)— For purposes of subparagraph (A), the reimbursement period for any information for a chemical substance or mixture is a period— ending— If the exemption under paragraph (2) of any person from the requirement to conduct tests and submit information on a chemical substance or mixture is granted on the basis of the fact that information is being developed by one or more persons pursuant to a rule, order, or consent agreement under subsection (a), then (unless such person and the persons referred to in clauses (i) and (ii) agree on the amount and method of reimbursement) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined under rules of the Administrator)— Upon the receipt of any information pursuant to a rule, order, or consent agreement under subsection (a), the Administrator shall publish a notice of the receipt of such information in the Federal Register within 15 days of its receipt. Subject to section 2613 of this title, each such notice shall (1) identify the chemical substance or mixture for which information has been received; (2) list the uses or intended uses of such substance or mixture and the information required by the applicable protocols and methodologies for the development of information; and (3) describe the nature of the information developed. Except as otherwise provided in section 2613 of this title, such information shall be made available by the Administrator for examination by any person. There is established a committee to make recommendations to the Administrator respecting the chemical substances and mixtures to which the Administrator should give priority consideration for the development of information under subsection (a). In making such a recommendation with respect to any chemical substance or mixture, the committee shall consider all relevant factors, including— The committee established by paragraph (1)(A) shall consist of ten members as follows: Upon the receipt of— A person intending to manufacture or process a chemical substance for which notice is required under section 2604(a) of this title and who is not required under a rule, order, or consent agreement under subsection (a) to conduct tests and submit information on such substance may petition the Administrator to prescribe protocols and methodologies for the development of information for such substance. The Administrator shall by order either grant or deny any such petition within 60 days of its receipt. If the petition is granted, the Administrator shall prescribe such protocols and methodologies for such substance within 75 days of the date the petition is granted. If the petition is denied, the Administrator shall publish, subject to section 2613 of this title, in the Federal Register the reasons for such denial. The Administrator shall reduce and replace, to the extent practicable, scientifically justified, and consistent with the policies of this subchapter, the use of vertebrate animals in the testing of chemical substances or mixtures under this subchapter 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— encouraging and facilitating— 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 June 22, 2016, 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— Any person developing information for submission under this subchapter 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 2614 of this title. This paragraph authorizes, but does not require, the Administrator to review the means by which a person conducted testing described in subparagraph (A).