43820 Federal Register / Vol. 62, No. 158 / Friday, August 15, 1997 / Rules and Regulations ENVIRONMENTAL PROTECTION standard can modify these guidelines as Agency experts and, in some instances, AGENCY needed for an individual test substance. presented at domestic and international The Agency uses a system where colloquia to solicit the views of 40 CFR Part 799 standardized guidelines are organized recognized experts and the regulated by testing endpoint and codified in a community. The draft harmonized [OPPTS±42193; FRL±5719±5] subpart of this part. When a test rule is guidelines are made available as public RIN 2070±AB76 promulgated, the test standard specified drafts. A notice is published in the in the test rule cross-references the Federal Register announcing their Toxic Substances Control Act Test guideline for the bulk of the testing availability and soliciting public Guidelines requirements. In this context, the public comment. is given notice of, and an opportunity to Seven of the 11 health effects test AGENCY: Environmental Protection comment on, the guidelines as they are guidelines that are being codified in Agency (EPA). applied in chemical-specific test rules. subpart H of 40 CFR part 799 have their ACTION: Final rule. This approach eliminates the need to origin in this harmonization process. A repeat the same test specifications for notice was published in the Federal SUMMARY: This rule establishes 11 Toxic each substance-specific test rule since Register of June 20, 1996, (61 FR 31522 Substances Control Act (TSCA) health most of the specifications for testing do (FRL±5367±7)) announcing the effects test guidelines in the Code of not change across substances. The test availability of the proposed test Federal Regulations (CFR). specifications in a guideline can be guidelines for Series 870ÐHealth Establishment of these guidelines is varied, when necessary, to the specific Effects Test Guidelines and soliciting necessary to ensure enforceable test requirements of a test rule by language public comment. Comments were standards in test rules promulgated in the test rule itself. received, and a meeting of the Agency's under section 4 of TSCA. Codification of In 1985, the Agency established a set Federal Insecticide, Fungicide, and this series of TSCA test guidelines does of TSCA test guidelines in 40 CFR parts Rodenticide Act (FIFRA) Scientific not by itself impose obligations upon 795 through 798 (50 FR 39252, Advisory Panel (SAP) was held on any person. Obligations are only September 27, 1985). These guidelines October 29 and 30, 1996. The SAP, an imposed when these guidelines are were established as standardized advisory committee consisting of cross-referenced in a test rule protocols for laboratory testing of an scientific experts both inside and promulgated under section 4 of TSCA. effect or characteristic deemed outside the U.S. Government, reviewed DATES: This rule is effective on August important for the evaluation of health or the guidelines and made comments. The 15, 1997. environmental hazards of a chemical. Agency reviewed these comments in developing the harmonized health FOR FURTHER INFORMATION CONTACT: Standardized guidelines are necessary effects guidelines. Susan Hazen, Director, Environmental for the establishment of enforceable test Four of the 11 guidelines Assistance Division (7408), Office of standards in test rules promulgated (§ § 799.9510, 799.9530, 799.9538, and Pollution Prevention and Toxics, under section 4 of TSCA. 799.9539) were initially developed by Environmental Protection Agency, Rm. The Agency has over time amended the OECD. E-543B, 401 M St., SW., Washington, DC and improved these guidelines (52 FR 20460; telephone: (202) 554±1404; TDD: 19072, May 20, 1987). In order to reduce III. TSCA Test Guidelines (202) 554±0551; e-mail: TSCA- the text of the CFR, the Agency deleted those guidelines which had not been Harmonization has resulted in [email protected]. For specific significantly improved guidelines. information regarding this action or cited in any test rules (60 FR 31917, June 19, 1995 (FRL±4955±2)). However, creating a single set of related activities, please contact Roger guidelines which can be used by both Nelson, Chemical Control Division, II. OPPTS Harmonized Test Guidelines OPP, in its administration of the FIFRA OPPT; telephone: (202) 260±8163; e- EPA is undertaking a comprehensive and the Federal Food, Drug and mail: [email protected]. modification, or harmonization, of its Cosmetic Act (FFDCA), and the Office of SUPPLEMENTARY INFORMATION: This final pesticides and toxics guidelines for Pollution Prevention and Toxics rule establishes a new series of TSCA testing of health effects, environmental (OPPT), which administers TSCA test guidelines in the CFR. effects, and chemical fate. The rationale presented certain challenges. Under FIFRA, test guidelines are used I. Introduction for this harmonization is to incorporate state of the art science, and to minimize in an interactive process between the Section 4(b)(1)(B) of TSCA requires variations among the protocols Agency and registrants seeking that test rules promulgated under the contained in: registration of pesticides or food residue authority of TSCA section 4 include 1. Test guidelines developed by the tolerances. Flexibility to tailor required ``standards for the development of test EPA Office of Pesticide Programs (OPP), testing to individual circumstances is data for such substance or mixture * * which appeared in publications of the critical, and the Agency has *.'' Test rules promulgated under TSCA National Technical Information Service. considerable discretion to determine section 4 must specify the standards for 2. The series of TSCA test guidelines whether submitted test results are the development of data. Standards established in 1985, which are adequate to support the requested established in test rules for the contained in 40 CFR parts 795, 796, 797, action. Under this scheme, registrants development of data must specify how and 798. have an intrinsic motivation to conduct the study is to be conducted, what data 3. Guidelines published by the well-grounded testing. Thus, pesticide will be collected, and how the data will Organization for Economic Cooperation testing protocols tend to have few be analyzed. The Agency has found that and Development (OECD). absolute requirements specifying the these specifications to a large degree can Harmonization operates as follows: details of the conduct of the testing. be standardized into a common set of EPA scientists develop guidelines (or By contrast the Agency is required protocols, or, as the Agency terms them, modify existing guidelines) for specific under section 4 of TSCA to impose ``guidelines.'' These guidelines are endpoints. The new or rewritten prescriptive test requirements by notice organized by testing endpoint. Each test guidelines are reviewed by other and comment rulemaking. Rules Federal Register / Vol. 62, No. 158 / Friday, August 15, 1997 / Rules and Regulations 43821 promulgated under section 4 of TSCA older, 1985 non-harmonized guidelines essentially those resulting from the specify classes of affected parties, in 40 CFR parts 795 through 798. The harmonization process with minor usually manufacturers and processors of only significant difference between the changes to promote enforceability. EPA the chemical being specified for testing, TSCA test guidelines and the OPPTS has elected to codify these new rather than interacting with companies harmonized test guidelines is that guidelines in part 799 so as to on an individual basis. These certain recommended procedures in the distinguish them from the pre- rulemakings typically take years to OPPTS harmonized test guidelines are harmonization guidelines in 40 CFR complete. Without initiating another made mandatory (i.e., the guideline parts 795 through 798. rulemaking process, the Agency has the states that they ``shall'' be carried out). These guidelines will be placed in a ability to require further testing only if IV. Codification in 40 CFR Part 799 new subpart H of part 799. In addition, the tests were not conducted in EPA plans to reserve additional subparts The Agency had originally planned accordance with the procedures of part 799 for test guidelines, so that not to publish the guidelines in the CFR, specified in the test rule. In addition, the structure of part 799 would be as but to instead make the guidelines the Agency has an alternative process of follows: negotiating TSCA testing requirements available via other means (such as the via enforceable consent agreements Internet) and reference the guidelines in Subpart AÐGeneral Provisions (ECAs), but these agreements require the specific test rules using the Subpart BÐSpecific Chemical Test consent of all the parties involved. incorporation by reference procedures Rules provided by 5 U.S.C. 552(a)(1)(E) and 1 Under TSCA section 4 enforceable Subpart CÐTesting Consent Orders test standards, much in the conduct of CFR part 51. In the Federal Register these test protocols is left to the document proposing the TSCA section 4 Subpart DÐMultichemical Test Rules judgment of those professionals test rule for 21 hazardous air pollutant Subpart EÐG [Reserved] conducting the testing. EPA believes substances (HAPs) (61 FR 33178, 33187, Subpart HÐHealth Effects Test that certain provisions must be June 26, 1996 (FRL±4869±1)), the Guidelines mandatory whenever the guidelines are Agency stated that it was considering cross-referenced