§ 2603. Testing of chemical substances and mixtures

§ 2603. Testing of chemical substances and mixtures

(a) Testing requirements

(1) If the Administrator finds that—

the Administrator shall by rule, or, in the case of a chemical substance or mixture described in subparagraph (A)(i), by rule, order, or consent agreement, require that testing be conducted on such substance or mixture to develop information with respect to the health and environmental effects for which there is an insufficiency of information and experience and which is relevant to a determination that the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture, or that any combination of such activities, does or does not present an unreasonable risk of injury to health or the environment.

(A)

(i)

(I) the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or that any combination of such activities, may present an unreasonable risk of injury to health or the environment,

(II) there is insufficient information and experience upon which the effects of such manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted, and

(III) testing of such substance or mixture with respect to such effects is necessary to develop such information; or

(ii)

(I) a chemical substance or mixture is or will be produced in substantial quantities, and (aa) it enters or may reasonably be anticipated to enter the environment in substantial quantities or (bb) there is or may be significant or substantial human exposure to such substance or mixture,

(II) there is insufficient information and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted, and

(III) testing of such substance or mixture with respect to such effects is necessary to develop such information; and

(B) in the case of a mixture, the effects which the mixture’s manufacture, distribution in commerce, processing, use, or disposal or any combination of such activities may have on health or the environment may not be reasonably and more efficiently determined or predicted by testing the chemical substances which comprise the mixture;

(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 2604 of this title or to perform a risk evaluation under section 2605(b) of this title;

(ii) to implement a requirement imposed in a rule, order, or consent agreement under subsection (e) or (f) of section 2604 of this title or in a rule promulgated under section 2605(a) of this title;

(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 2611(a)(2) of this title; and

(B) 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—

(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.

(b) Testing requirement rule, order, or consent agreement

(1) A rule, order, or consent agreement under subsection (a) shall include—

In determining the protocols and methodologies and period to be included, pursuant to subparagraphs (B) and (C), in a rule, order, or consent agreement under subsection (a), the Administrator’s considerations shall include the relative costs of the various test protocols and methodologies which may be required under the rule, order, or consent agreement and the reasonably foreseeable availability of the facilities and personnel needed to perform the testing required under the rule, order, or consent agreement. Any such rule, order, or consent agreement may require the submission to the Administrator of preliminary information during the period prescribed under subparagraph (C).

(A) identification of the chemical substance or mixture for which testing is required under the rule, order, or consent agreement,

(B) protocols and methodologies for the development of information for such substance or mixture, and

(C) with respect to chemical substances which are not new chemical substances and to mixtures, 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 information developed in accordance with the protocols and methodologies referred to in subparagraph (B).

(2)

(A) The health and environmental effects for which protocols and methodologies for the development of information may be prescribed include carcinogenesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synergistic effects, and any other effect which may present an unreasonable risk of injury to health or the environment. 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. The characteristics of chemical substances and mixtures for which such protocols and methodologies 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 protocols and methodologies include epidemiologic studies, serial or tiered testing, 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 protocols and methodologies for development of information prescribed in rules, orders, and consent agreements under subsection (a) and shall, if necessary, institute proceedings to make appropriate revisions of such protocols and methodologies.

(3)

(A) A rule or order under subsection (a) respecting a chemical substance or mixture shall require the persons described in subparagraph (B) or (C), as applicable, to conduct tests and submit information 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 information on behalf of the persons making the designation.

(B) 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):

(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)(i)(II) or (a)(1)(A)(ii)(II) with respect to the manufacture of such substance or mixture.

(ii) Each person who processes or intends to process such substance or mixture if the Administrator makes a finding described in subsection (a)(1)(A)(i)(II) or (a)(1)(A)(ii)(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)(i)(II) or (a)(1)(A)(ii)(II) with respect to the distribution in commerce, use, or disposal of such substance or mixture.

(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.

(4) Any rule, order, or consent agreement under subsection (a) requiring the testing of and submission of information for a particular chemical substance or mixture shall expire at the end of the reimbursement period (as defined in subsection (c)(3)(B)) which is applicable to information for such substance or mixture unless the Administrator repeals the rule or order or modifies the consent agreement to terminate the requirement before such date; and a rule, order, or consent agreement under subsection (a) requiring the testing of and submission of information for a category of chemical substances or mixtures shall expire with respect to a chemical substance or mixture included in the category at the end of the reimbursement period (as so defined) which is applicable to information for such substance or mixture unless the Administrator before such date repeals or modifies the application of the rule, order, or consent agreement to such substance or mixture or repeals the rule or order or modifies the consent agreement to terminate the requirement.

(c) Exemption

(1) Any person required by a rule or order under subsection (a) to conduct tests and submit information on a chemical substance or mixture may apply to the Administrator (in such form and manner as the Administrator shall prescribe) for an exemption from such requirement.

(2) If, upon receipt of an application under paragraph (1), the Administrator determines that—

the Administrator shall exempt, in accordance with paragraph (3) or (4), the applicant from conducting tests and submitting information on such substance or mixture under the rule or order with respect to which such application was submitted.

(A) the chemical substance or mixture with respect to which such application was submitted is equivalent to a chemical substance or mixture for which information has been submitted to the Administrator in accordance with a rule, order, or consent agreement under subsection (a) or for which information is being developed pursuant to such a rule, order, or consent agreement, and

(B) submission of information by the applicant on such substance or mixture would be duplicative of information which has been submitted to the Administrator in accordance with such rule, order, or consent agreement or which is being developed pursuant to such rule, order, or consent agreement,

(3)

(A) 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)—

In promulgating rules for the determination of fair and equitable reimbursement to the persons described in clauses (i) and (ii) for costs incurred with respect to a chemical substance or mixture, the Administrator shall, after consultation with the Attorney General and the Federal Trade Commission, consider all relevant factors, including the effect on the competitive position of the person required to provide reimbursement in relation to the person to be reimbursed and the share of the market for such substance or mixture of the person required to provide reimbursement in relation to the share of such market of the persons to be reimbursed. An order under this subparagraph shall, for purposes of judicial review, be considered final agency action.

(i) to the person who previously submitted such information, for a portion of the costs incurred by such person in complying with the requirement to submit such information, and

(ii) to any other person who has been required under this subparagraph to contribute with respect to such costs, for a portion of the amount such person was required to contribute.

(B) For purposes of subparagraph (A), the reimbursement period for any information for a chemical substance or mixture is a period—

(i) beginning on the date such information is submitted in accordance with a rule, order, or consent agreement under subsection (a), and

(ii) ending—

whichever is later.

(I) five years after the date referred to in clause (i), or

(II) at the expiration of a period which begins on the date referred to in clause (i) and which is equal to the period which the Administrator determines was necessary to develop such information,

(4)

(A) 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)—

In promulgating rules for the determination of fair and equitable reimbursement to the persons described in clauses (i) and (ii) for costs incurred with respect to a chemical substance or mixture, the Administrator shall, after consultation with the Attorney General and the Federal Trade Commission, consider the factors described in the second sentence of paragraph (3)(A). An order under this subparagraph shall, for purposes of judicial review, be considered final agency action.

(i) to each such person who is developing such information, for a portion of the costs incurred by each such person in complying with such rule, order, or consent agreement, and

(ii) to any other person who has been required under this subparagraph to contribute with respect to the costs of complying with such rule, order, or consent agreement, for a portion of the amount such person was required to contribute.

(B) If any exemption is granted under paragraph (2) on the basis of the fact that one or more persons are developing information pursuant to a rule, order, or consent agreement under subsection (a) and if after such exemption is granted the Administrator determines that no such person has complied with such rule, order, or consent agreement, the Administrator shall (i) after providing written notice to the person who holds such exemption and an opportunity for a hearing, by order terminate such exemption, and (ii) notify in writing such person of the requirements of the rule or order with respect to which such exemption was granted.

(d) Notice 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.

(e) Priority list

(1)

(A) 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 recommendations of the committee shall be in the form of a list of chemical substances and mixtures which shall be set forth, either by individual substance or mixture or by groups of substances or mixtures, in the order in which the committee determines the Administrator should take action under subsection (a) with respect to the substances and mixtures. In establishing such list, the committee shall give priority attention to those chemical substances and mixtures which are known to cause or contribute to or which are suspected of causing or contributing to cancer, gene mutations, or birth defects. The committee shall designate chemical substances and mixtures on the list with respect to which the committee determines the Administrator should, within 12 months of the date on which such substances and mixtures are first designated, initiate a proceeding under subsection (a). 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.

(i) the quantities in which the substance or mixture is or will be manufactured,

(ii) the quantities in which the substance or mixture enters or will enter the environment,