[Federal Register Volume 62, Number 125 (Monday, June 30, 1997)] [Rules and Regulations] [Pages 35103-35105] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-17175] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 766 and 799 [OPPTS-40030; FRL-5728-5] Technical Amendments to Test Rules and Enforceable Testing Consent Agreements/Testing Consent Orders AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: EPA has approved by letter certain modifications to test standards and schedules for chemical testing programs under section 4 of the Toxic Substances Control Act (TSCA). These modifications, requested by test sponsors, will be incorporated in the respective test rules or enforceable testing consent agreements/testing consent orders. Because these modifications do not significantly alter the scope of a test or significantly change the schedule for its completion, EPA approved these requests without seeking public notice and comment. EPA annually publishes a rule describing all of the modifications granted by letter for the previous year. DATES: This rule is effective June 30, 1997. FOR FURTHER INFORMATION CONTACT:Susan B. Hazen, Director, Environmental Assistance Office (7408), Office of Pollution Prevention and Toxics, Environmental Protection Agency, Rm. E-543B, 401 M St., SW., Washington, DC 20460. Telephone: (202) 554-1404, TDD: (202) 554-0551, Internet address: TSCA-H[email protected]. SUPPLEMENTARY INFORMATION: EPA published a rule in the Federal Register of September 1, 1989 (54 FR 36311) amending procedures in 40 CFR part 790 for modifying test standards and schedules for test rules and enforceable testing consent agreements/testing consent orders under section 4 of TSCA. The amended procedures allow EPA to approve requested modifications which do not alter the scope of a test or significantly change the schedule for its completion. These modifications are approved by letter without public notice and comment. The rule also requires immediate placement of these letters in the public record and publication of these modifications in the Federal Register. This rule includes modifications approved from January 1, 1996, through December 31, 1996. For a detailed description of the rationale for these modifications and for the correspondence relating to specific chemical test modifications, refer to the public record for the appropriate chemical substance or to the public record for this rulemaking (OPPTS-40030). I. Discussion of Modifications Each chemical substance discussed in this rule is identified by a specific CAS number and docket control number. The following table lists all chemical-specific modifications approved from January 1, 1996, through December 31, 1996. [[Page 35104]] Modifications to Test Standards and Enforceable Testing Consent Agreements/Testing Consent Orders (January 1, 1996, Through December 31, 1996) ---------------------------------------------------------------------------------------------------------------- Chemical name/CAS No. CFR Cite Test Modifications Docket control No. ---------------------------------------------------------------------------------------------------------------- Final rules: Drinking Water Contaminants: 1,1,2,2-Tetrachloroethane/CAS 799.5075 14-day oral subacute 5................... 40030/42111C No. 79-34-5 testing. Polyhalogenated Dibenzo-para- Dioxins/Dibenzofurans (Dioxins/Furans): Chloranil (2,3,5,6- Part 766 Analytical testing.. 5................... 40030/40028/83002M tetrachloro-2,5- cyclohexadiene-1,4-dione/CAS No. 118-75-2 Enforceable Testing Agreements/ Orders: Alkyl Glycidyl Ethers (AGEs): Alkyl Glycidyl Ether (AGE C12- 799.5000 90-day subchronic 5................... 40030/42185 C13)/CAS No.120547-52-6 dermal toxicity study. Neurotoxicity: Dermal subchronic 5 functional observational battery. Dermal subchronic 5 motor activity. Dermal subchronic 5 neuropathology. Dermal subchronic 5 electrophysiology. Developmental 5 toxicity study. Genetic toxicity studies: Micronucleus assay 5 Gene mutation in 5 stomatic cells in culture. Reveise mutation 5 assay. Change in required 2 purity of test substance. Cyclohexane/CAS No. 110-82-7 799.5000 90-day subchronic 5................... 40030/42094C inhalation toxicity 9 test in rats. 5 Developmental toxicity test standard in rats. Developmental toxicity studies in rats and rabbits. Tertiary Amyl Methyl Ether 799.5000 Pharmacokinetics 5................... 40030/42180 (TAME), CAS No. 994-05-8 study. 5 90-day subchronic 5 study. 5,11 Neurotoxicity screen 5 Reproductive inhalation study. Developmental toxicity study. ---------------------------------------------------------------------------------------------------------------- Modifications: 1. Modify sampling schedule. 2. Change test substance (form/purity). 3. Change non-critical test procedure or condition. 4. Add satellite group for further testing. 5. Extend test or protocol deadline, delete test initiation date. 6. Clarify and/or add specific guideline requirement. 7. Alter specific guideline requirement approved for certain test(s). 8. Correct CAS No. 9. Amend test standard. 10. Neurotoxicity endpoint rule. 11. Revise protocol. Note: Only modifications under numbers 2, 5, 9, and 11 in the above table were approved in 1996. II. Public Record EPA has established a public record for this rulemaking under docket control number OPPTS-40030. The record is available for inspection from 12 noon to 4 p.m., Monday through Friday, excluding legal holidays, in the TSCA Nonconfidential Information Center, Environmental Protection Agency, Rm. NE B-607, 401 M St., SW., Washington, DC 20460. Requests for documents should be sent in writing to: Fax: (202) 260-5069 or e-mail: [email protected]. III. Regulatory Assessment Requirements A. Waiver of Notice of Proposed Rulemaking and Delay of Effective Date Because the test rule schedule modifications codified in this rule have no substantive effect on any person, EPA finds that public notice and comment are unnecessary. Thus, this rule may be promulgated without prior opportunity for public notice and comment pursuant to the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)), and may be made effective upon publication in the Federal Register, without a 30-day delay, pursuant to 5 U.S.C. 553(d)(3). B. Executive Order 12866 Under Executive Order 12866 (58 FR 51735, October 4, 1993), it has been determined that this action is not ``significant'' pursuant to the terms of this Executive Order because the modifications to the subject testing actions do not impose any additional requirements on the public. This action is therefore not subject to review by the Office of Management and Budget (OMB). C. Regulatory Flexibility Act Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), I hereby certify that this action will not have a significant economic impact on a substantial number of small entities because the modifications referenced in this rule do not alter the scope of any test required under a test rule or significantly change the reporting schedule for any test rule. D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 104-4, establishes requirements for Federal agencies to assess the effects of certain regulatory actions on State, local, and tribal governments and the private sector, and to seek input from State, local, and tribal governments on certain regulatory actions. EPA has determined that this action does not contain a Federal mandate that may [[Page 35105]] result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. No costs are imposed by this rulemaking since these test rule modifications only make non-significant changes to the reporting schedules for test rules. Therefore, this action is not subject to the requirements of section 202 and 205 of UMRA. The requirements of sections 203 and 204 of UMRA which relate to regulatory requirements that might significantly or uniquely affect small governments and to regulatory proposals that contain a significant Federal intergovernmental mandate, respectively, also do not apply to this rule because the rule affects only the private sector, i.e., those companies that test chemicals. E. Paperwork Reduction Act The information collection requirements associated with this rule have been approved by OMB under the provisions of the Paperwork Reduction Act, 44 U.S.C. 350l et seq., and have been assigned OMB control number 2070-0033 (EPA ICR No. 1139). EPA has determined that this rule does not change existing recordkeeping or reporting requirements nor does it impose any additional recordkeeping or reporting requirements on the public. F. Submission to Congress and the General Accounting Office Under 5 U.S.C. 801 (a)(1)(A), as added by the Small Business Regulatory Enforcement Fairness Act of 1996, EPA has submitted a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the General Accounting Office prior to publication of the rule in this Federal Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Parts 766 and 799 Environmental protection, Chemicals, Exports, Hazardous substances, Reporting and recordkeeping requirements. Dated: June 25, 1997. Susan H. Wayland, Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances. Therefore, 40 CFR chapter I is amended as follows: PART 766--[AMENDED] 1. In part 766: a. The authority citation for part 766 continues to read as follows: Authority: 15 U.S.C. 2603 and 2607. b. In Sec. 766.35, by adding an entry in numerical order by ``CAS No.'' to the table in paragraph (b)(4)(i) to read as follows: Sec. 766.35 Reporting requirements. * * * * * (b) * * * (4) * * * (i) * * * ---------------------------------------------------------------------------------------------------------------- CAS No. Submitter Chemical name Due date Effective Date ---------------------------------------------------------------------------------------------------------------- * * * * * * * 118-75-2....................... Rhone-Poulenc Inc. 2,3,5,6-tetrachloro- July 5, 1996..... June 30, 1997 2,5-cyclohexadiene- 1,4-dione. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * PART 799--[AMENDED] 2. In part 799: a. The authority citation for part 799 continues to read as follows: Authority: 15 U.S.C. 2603, 2611, 2625. b. In Sec. 799.5075, by revising paragraphs (c)(1)(ii)(A) and (d) to read as follows: * * * * * Sec. 799.5075 Drinking water contaminants subject to testing. * * * * * (c) * * * (1) * * * (ii) * * * (A) Each subacute test shall be completed and the final report submitted to EPA within 12 months of the date specified in paragraph (d)(1) of this section, except for 1,1,2,2-tetrachloroethane. The subacute testing for 1,1,2,2-tetrachloroethane shall be completed and the final report submitted to EPA by February 15, 1996. * * * * * (d) Effective date. (1) This section is effective on December 27, 1993, except for paragraphs (a)(1), (a)(2), (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(ii)(B), (c)(2)(i)(A), and (c)(2)(ii)(A). The effective date for paragraphs (a)(2), (c)(1)(ii)(B), and (c)(2)(ii)(A) is September 29, 1995. The effective date for paragraphs (a)(1), (c)(1)(i)(A), and (c)(2)(i)(A) is February 27, 1996. The effective date for paragraph (c)(1)(ii)(A) is June 30, 1997. (2) The guidelines and other test methods cited in this section are referenced as they exist on the effective date of the final rule. [FR Doc. 97-17175 Filed 6-27-97; 8:45 am] BILLING CODE 6560-50-F