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40 CFR Part 791 — Data Reimbursement

Office of the Federal Register (NARA) · Code of Federal Regulations (eCFR, Office of the Federal Register)
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PART 791—DATA REIMBURSEMENT Authority: 15 U.S.C. 2603 and 2607. Source: 48 FR 31791, July 11, 1983, unless otherwise noted. Subpart A—General Provisions § 791.1 Scope and authority. (a) This part establishes procedures and criteria to be used in determining fair amounts of reimbursement for testing costs incurred under section 4(a) of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2603(a)). (b) Section 4(c) of TSCA requires EPA to develop rules for the determination of fair and equitable reimbursement (15 U.S.C. 2603 (c)). § 791.2 Applicability. (a) This rule is potentially applicable to all manufacturers, importers and processors who may be required by a specific test rule promulgated under section 4(a) of TSCA to conduct tests and submit data, and who seek the assistance of the Administrator in determining the amount or method of reimbursement. Persons subject to a test rule have an obligation from the date the test rule becomes effective until the end of the reimbursement period, either to test or to obtain an exemption and pay reimbursement. (b) The provisions of this rule will take effect only when private efforts to resolve a dispute have failed and a manufacturer or processor requests EPA's assistance. § 791.3 Definitions. Terms defined in the Act, and not explicitly defined herein, are used with the meanings given in the Act. (a) The Act et seq. (b) The Agency EPA (c) Byproduct (d) Dispute (e) Exemption holder (f) Impurity (g) A party (1) Seeks reimbursement from another person under these rules, or (2) From whom reimbursement is sought under these rules. (h) Reimbursement period (i) Small business (j) Test rule Subpart B—Hearing Procedures § 791.20 Initiation of reimbursement proceeding. (a) When persons subject to a test rule are unable to reach an agreement on the amount or method of reimbursement for test data development as described in TSCA section 4(c)(3)(A), any of them may initiate a proceeding by filing two signed copies of a request for a hearing with a regional office of the American Arbitration Association and mailing a copy of the request to EPA, and to each person from whom they seek reimbursement, or who seeks reimbursement from them. (b) The request for hearing must contain the following: (1) The names and addresses of the filing party and its counsel, if any. (2) Identification of the test rule under which the dispute arose. (3) A list of the parties from whom reimbursement is sought or who are seeking reimbursement, a brief description of the attempts to reach agreement and a concise explanation of the issues on which the parties are unable to agree. (c) The request for a hearing shall be accompanied by the appropriate administrative fee, as provided in a current Fee Schedule of the American Arbitration Association. § 791.22 Consolidation of hearings. (a) Promptly upon receipt of the request for a hearing, the Administrator will publish a notice in the Federal Register, (b) Any other person wishing to participate in the hearing shall so notify EPA within 45 days of the Federal Register § 791.27 Pre-hearing preparation. (a) Responses to requests for hearings. (b) Pre-hearing conference. (c) Fixing of locale. (d) Time and place. § 791.29 Appointment of hearing officer. (a) Qualifications of hearing officer. (b) Appointment from panel. (c) Nationality of hearing officer in international dispute. (d) Number of hearing officers. (e) Notice of appointment. (f) Disclosure and challenge procedure. (g) Vacancies. § 791.30 Hearing procedures. (a) Representation by counsel. (b) Stenographic record. (c) Attendance at hearings. (d) Oaths. (e) Order of proceedings. (2) The hearing officer may, at the beginning of the hearing, ask for statements clarifying the issues involved. (3) The party or parties seeking reimbursement shall then present a claim and proofs and witnesses, who shall submit to questions or other examination. The party or parties from whom reimbursement is sought shall then present a defense and proofs and witnesses, who shall submit to questions or other examination. The hearing officer has discretion to vary this procedure but shall afford full and equal opportunity to all parties for the presentation of any material or relevant proofs. (4) Exhibits, when offered by any party, shall be received in evidence by the hearing officer. The names and addresses of all witnesses and exhibits in order received shall be made a part of the record. (f) Hearing in the absence of a party. (g) Evidence. (2) All documents not filed with the hearing officer at the hearing, but arranged for by agreement of the parties, shall be filed with the American Arbitration Association for transmission to the hearing officer, according to the agreed-upon schedule. All parties shall be afforded opportunity to examine such documents. (h) Evidence by affidavit and filing of documents. (i) Closing of hearings. (j) Reopening of hearings. (k) Waiver of oral hearings. (l) Waiver of rules. (m) Extensions of time. (n) Communication with hearing officer. § 791.31 Expedited procedures. Unless the American Arbitration Association in its discretion determines otherwise, the Expedited Procedures described in this section shall be applied in any case where the total claim of any party does not exceed $5,000, exclusive of interest and hearing costs, and may be applied in other cases if the parties agree. (a) Application of rules. (b) Notice by telephone. (c) Appointment and qualifications of hearing officers. (d) Time and place of hearing. (e) The hearing. (f) Time of award. § 791.34 Serving of notice. (a) Each party shall be deemed to have consented that any papers, notices or process necessary or proper for the initiation or continuation of a hearing under these rules and for any appeal to EPA or any court action in connection therewith may be served upon such party by mail addressed to such party or its attorney at its last known address or by personal service, within or without the state wherein the arbitration is to be held (whether such party be within or without the United States of America), provided that reasonable opportunity to be heard with regard thereto has been granted such party. (b) The American Arbitration Association shall, upon the written request of a party, furnish to such party, at its expense, certified facsimiles of any papers in the American Arbitration Association's possession that may be required in appeal to EPA or judicial proceedings relating to the hearing. § 791.37 The award. (a) Time of award. (b) Form of award. (c) Delivery of award to parties. § 791.39 Fees and expenses. (a) Administrative fees. (2) The administrative fees shall be advanced by the initiating party or parties, subject to final apportionment by the hearing officer in the award. The administrative fee is increased by 10 percent of the original for each additional party. (b) Expenses. (c) Hearing officer's fee. [48 FR 31791, July 11, 1983, as amended at 83 FR 52724, Oct. 17, 2018] Subpart C—Basis for Proposed Order § 791.40 Basis for the proposed order. (a) The hearing officer shall propose a fair and equitable amount of reimbursement. The formula in paragraph (b) of this section shall be presumed to be fair and equitable as applied to all persons subject to a test rule. However, the hearing officer has the discretion to modify the formula, or to use some other basis for allocation if necessary. Additional factors that may be taken into account include, but are not limited to, relative amounts of exposure attributable to each person and the effect of the reimbursement share on competitive position. (b) In general, each person's share of the test cost shall be in proportion to its share of the total production volume of the test chemical: Where: R = the reimbursement share owed by company X. C = the total cost of the testing required by the test rule. V x V t (c) The burden of proposing modifications to the formula shall lie with the party requesting the modification. § 791.45 Processors. (a) Generally, processors will be deemed to have fulfilled their testing and reimbursement responsibilities indirectly, through higher prices passed on by those directly responsible, the manufacturers. There are three circumstances in which processors will have a responsibility to provide reimbursement directly to those paying for the testing: (1) When a test rule or subsequent Federal Register (2) When one or more manufacturers demonstrate to the hearing officer that it is necessary to include processors in order to provide fair and equitable reimbursement in a specific case. (3) When one or more processors voluntarily agree to reimburse manufacturers for a portion of test costs. Only those processors who volunteer will incur the obligation. (b) A hearing including processors shall be initiated in the same way as those including only manufacturers. Voluntary negotiations must be attempted in good faith first, and the request for a hearing must contain the names of the parties and a description of the unsuccessful negotiations. (c) When processors as well as manufacturers are required to provide reimbursement, the hearing officer will decide for each case how the reimbursement should be allocated among the participating parties. When a test rule is applicable solely to processors, the hearing officer will apply the formula to the amount of the test chemical purchased or processed. § 791.48 Production volume. (a) Production volume will be measured over a period that begins one calendar year before publication of the final test rule in the Federal Register (b) For the purpose of determining fair reimbursement shares, production volume shall include amounts of the test chemical imported in bulk form and mixtures, and the total domestic production of the chemical including that produced as a byproduct. Impurities will not be included unless the test rule specifically includes them. (c) Amounts of the test chemical manufactured for export will not be included unless covered by a finding under TSCA section 12(a)(2). (d) Chemicals excluded from the jurisdiction of TSCA by section 3(2)(B) need not be included in the computation of production volume. (Chemicals used as intermediates to produce pesticides are covered by TSCA.) (e) The burden of establishing the fact that particular amounts of the test chemical are produced for exempt purposes lies with the party seeking to exclude those amounts from the calculation of his production volume. § 791.50 Costs. (a) All costs reasonable and necessary to comply with the test rule, taking into account the practices of other laboratories in conducting similar tests, are eligible for reimbursement. Necessary costs include: (1) Direct and indirect costs of planning, conducting, analyzing and submitting the test results to EPA. (2) A reasonable profit, and a reasonable rate of interest and depreciation on the tester's initial capital investment. (3) The cost of repeating or repairing tests where failure was demonstrably due to some cause other than negligence of the tester. (b) Costs attributable to tests beyond those specified by EPA shall not be eligible for reimbursement under this rule. § 791.52 Multiple tests. When more than one of a particular kind of test required by the test rule is performed, the additional costs will be shared among all those holding exemptions. The costs of all the tests will be added together and each exemption holder shall be responsible for a share of the total which is equal to its share of the total production of the test chemical. The exemption holders shall divide their shares between test sponsors in proportion to the costs of their respective tests. Those sponsoring a particular test do not have to obtain exemptions for that test and therefore do not have reimbursement responsibilities for the same tests done by others. Subpart D—Review § 791.60 Review. (a) The hearing officer's proposed order shall become the final Agency order 30 days after issuance unless within the 30-day period one of the parties requests Agency review or the Administrator of his own initiative decides to review the proposed order. (b) The proposed order may be reviewed upon the record of the hearing and the petitions for review. If necessary, the Administrator may order the transcription of the stenographic record of the hearing, written briefs, oral arguments or any other reasonable aids to making an equitable decision. (c) The final Agency order may be reviewed in federal court as provided by 26 U.S.C. 2603(c). Subpart E—Final Order § 791.85 Availability of final Agency order. The final Agency order shall be available to the public for inspection and copying pursuant to 5 U.S.C. 552(a)(2), subject to necessary confidentiality restrictions. Subpart F—Prohibited Acts § 791.105 Prohibited acts. Failure to provide information required by the Agency or to pay the amounts awarded under this rule within time alloted in the final order shall constitute a violation of 15 U.S.C. 2614(1) or 2614(3).

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