Page:United States Statutes at Large Volume 90 Part 2.djvu/539

 PUBLIC LAW 94-469—OCT. 11, 1976 which the persons required to conduct the testing shall submit to the Administrator data developed in accordance with the standards referred to in subparagraph (B). In determining the standards and period to be included, pursuant to subparagraphs (B) and (C), in a rule under subsection (a), the Administrator's considerations shall include the relative costs of the various test protocols and methodologies which ma^ be required under the rule and the reasonably foreseeable availability of the facilities and personnel needed to perform the testing required under the rule. Any such rule may require the submission to the Administrator of preliminary data during the period prescribed under subparagraph (C). (2)(A) The health and environmental effects for which standards for the development of test data may be prescribed include carcinogenesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synei'i^istic effects, and any other effect which may present an unreasonable risk of injury to health or the environment. The characteristics of chemical substances and mixtures for which such standards may be prescribed include persistence, acute toxicity, subacute toxicity, chronic toxicity, and any other characteristic which may present such a risk. The methodologies that may be prescribed in such standards include epidemiologic studies, serial or hierarchical tests, in vitro tests, and whole animal tests, except that before prescribing epidemiologic studies of employees, the Administrator shall consult with the Director of the National Institute for Occupational Safety and Health. (B) From time to time, but not less than once each 12 months, the Administrator shall review the adequacy of the standards for development of data prescribed in rules under subsection (a) and shall, if necessary, institute proceedings to make appropriate revisions of such standards. (3)(A) A rule under subsection (a) respecting a chemical substance or mixture shall require the persons described in subparagraph (B) to conduct tests and submit data to the Administrator on such substance or mixture, except that the Administrator may permit two or more of such persons to designate one such person or a qualified third party to conduct such tests and submit such data on behalf of the persons making the designation. (B) The following persons shall be required to conduct tests and submit data on a chemical substance or mixture subject to a rule under subsection (a): (i) Each person who manufactures or intends to manufacture such substance or mixture if the Administrator makes a finding described in subsection (a)(1)(A) (ii) or (a)(1)(B) (ii) with respect to the manufacture of such substance or mixture. (ii) Each pereon who processes or intends to process such substance or mixture if the Administrator makes a finding described in subsection (a)(1)(A) (ii) or (a)(1)(B) (ii) with respect to the processing of such substance or mixture. (iii) Each person who manufactures or processes or intends to manufacture or process such substance or mixture if the Administrator makes a finding described in subsection (a)(1)(A) (ii) or (a)(1)(B) (ii) with respect to the distribution in commerce, use, or disposal of such substance or mixture. (4) Any rule under subsection (a) requiring the testing of and submission of data for a particular chemical substance or mixture shall expire at the end of the reimbursement period (as defined in subsection (c)(8)(B)) which is applicable to test data for such substance or mixture unless the Administrator repeals the rule before such date;

90 STAT. 2007

Consultations.

Review of standards.

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