[Federal Register Volume 62, Number 135 (Tuesday, July 15, 1997)] [Proposed Rules] [Pages 37833-37834] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-18563] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 799 [OPPTS-42187I; FRL-5732-2] RIN 2070-AC76 Proposed Test Rule for Hazardous Air Pollutants; Extension of Comment Period AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule; extension of comment period. ----------------------------------------------------------------------- SUMMARY: EPA is extending the public comment period from August 15, 1997, to September 30, 1997, on the proposed rule published in the Federal Register of June 26, 1996 (61 FR 33178)(FRL-4869-1) requiring the testing of 21 hazardous air pollutants (HAPs) for certain health effects. This extension is needed to allow the Agency more time to respond to the proposals for pharmacokinetics (PK) studies and to finalize the test guidelines to be referenced in the proposed HAPs test rule. DATES: Written comments on the proposed rule must be received by EPA on or before September 30, 1997. ADDRESSES: Submit three copies of written comments on the proposed HAPs test rule, identified by docket control number (OPPTS-42187A; FRL-4869- 1) to: Environmental Protection Agency, Office of Pollution Prevention and Toxics (OPPT), Document Control Office (7407), Rm. G-099, 401 M St., SW., Washington, DC 20460. Comments and data may also be submitted electronically by following the instructions under Unit II. of this document. No Confidential Business Information (CBI) should be submitted through e-mail. FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, Environmental Assistance Division (7408), Rm. ET-543B, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; telephone (202) 554-1404; TDD: (202) 554-0551; e-mail: TSCA-H[email protected]. For technical information contact: Richard W. Leukroth, Jr., Project Manager, Chemical Control Division (7405), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; telephone: (202) 260-0321; fax: (202) 260-8850; e-mail: [email protected]. SUPPLEMENTARY INFORMATION: I. Background and General Information On June 26, 1996 (61 FR 33178), EPA proposed health effects testing, under section 4(a) of the Toxic Substances Control Act (TSCA), of the following hazardous air pollutants (HAPs): 1,1'-biphenyl, carbonyl sulfide, chlorine, chlorobenzene, chloroprene, cresols [3 isomers: ortho-, meta-, para-], diethanolamine, ethylbenzene, ethylene dichloride, ethylene glycol, hydrochloric acid, hydrogen fluoride, maleic anhydride, methyl isobutyl ketone, methyl methacrylate, naphthalene, phenol, phthalic anhydride, 1,2,4-trichlorobenzene, 1,1,2- trichloroethane, and vinylidene chloride. EPA would use the data generated under the rule to implement several provisions of section 112 of the Clean Air Act and to meet other EPA data needs and those of other Federal agencies. In the HAPs proposal, EPA invited the submission of proposals for pharmacokinetics (PK) studies for the HAPs chemicals, which could provide the basis for negotiation of enforceable consent agreements (ECAs). These PK studies would be used to conduct route-to-route extrapolation of toxicity data from routes other than inhalation to predict the effects of inhalation exposure, as an alternative to testing proposed under the HAPs rule. On October 18, 1996, EPA extended the public comment period on the proposed rule from December 23, 1996, to January 31, 1997 (61 FR 54383) (FRL-5571-3). This extension was for the purpose of allowing more time for the submission of PK proposals and adequate time for comments on the proposed rule to be submitted after the Agency had responded to the proposals. EPA has received eight PK proposals (for diethanolamine, ethylene dichloride, ethylene glycol, hydrogen fluoride, maleic anhydride, phthalic anhydride, 1,2,4-trichlorobenzene, and 1,1,2- trichloroethane). In addition, the Agency has received a proposal to develop a non-PK-related ECA for methyl isobutyl ketone. EPA has agreed to review the contents of this proposal and to provide comments on its technical merit and relevance to the proposed HAPs testing requirements. Due to the complexity of the issues raised by the PK proposals and other issues related to test guidelines, EPA successively extended the public comment period (61 FR 67516, December 23, 1996 (FRL-5580-6); 62 FR 9142, February 28, 1997 (FRL-5592-1); 62 FR 14850, March 28, 1997 (FRL-5598-4); 62 FR 29318, May 30, 1997 (FRL-5722-1)) to allow the Agency [[Page 37834]] more time to respond to the PK proposals and to finalize the test guidelines to be referenced in the proposed HAPs test rule. The proposed HAPs rule published on June 26, 1996 (61 FR 33178) provides that testing would be conducted using the harmonized guidelines developed by the Office of Prevention, Pesticides and Toxic Substances (OPPTS) that were published as public drafts on June 20, 1996 (61 FR 31522)(FRL-5367-7). The process of developing these harmonized guidelines is proceeding at the same time as the development of the HAPs test rule. For the purposes of the proposed HAPs test rule and testing under TSCA section 4(a), the Office of Pollution Prevention and Toxics (OPPT) intends to publish final TSCA test guidelines developed from the OPPTS harmonized guidelines. The Agency will solicit public comment on the applicability of the test guidelines as they are cross-referenced in the HAPs rule and will follow this practice with respect to all future TSCA section 4(a) test rules. These guidelines will be published in the Federal Register as soon as possible but in any event no later than August 29, 1997. EPA has developed preliminary technical analyses of three PK proposals (hydrogen fluoride, 1,1,2-trichlorethane, and ethylene dichloride). Copies of these preliminary technical analyses have been sent to the submitters and placed in the public record for this action (OPPTS-42187B, FRL-4869-1). The Agency intends to provide comments to the submitters of the other PK proposals as soon as possible but in any event prior to the close of the comment period. EPA also recognizes that submitters may need to revise their proposals based on EPA comments. EPA finds that the public should have adequate opportunity to comment on the development of ECAs based on the PK proposals. If the Agency decides to proceed with the ECA process, EPA will announce, in the Federal Register, one or more public meetings to discuss the proposals and to negotiate ECAs based on the proposals. In that document, the Agency will solicit persons interested in participating in or monitoring negotiations for the development of ECAs based on the revised PK testing proposals. The procedures for ECA negotiations are described at 40 CFR 790.22(b). The Agency emphasizes that the submission of proposals to develop ECAs to conduct alternative testing using PK is no guarantee that EPA and the submitters will, in fact, conclude such agreements. Therefore, EPA urges all submitters of PK proposals to comment on the HAPs proposed rule as an activity separate from the PK proposal/ECA process. II. Public Record The official record for this rulemaking, as well as the public version, has been established for this rulemaking under docket control number [OPPTS-42187A; FRL-4869-1] (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 12 noon to 4 p.m., Monday through Friday, excluding legal holidays. The official rulemaking record is located at the address in ``ADDRESSES'' at the beginning of this document. Electronic comments can be sent directly to EPA at: [email protected] Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on disks in WordPerfect in 5.1 file format or ASCII file format. All comments and data in electronic form must be identified by the docket control number [OPPTS-42187A; FRL-4869-1]. Electronic comments on the proposed rule may be filed online at many Federal Depository Libraries. List of Subjects in 40 CFR Part 799 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: July 9, 1997. Charles M. Auer, Director, Chemical Control Division, Office of Pollution Prevention and Toxics. Accordingly, EPA is extending the comment period on the proposed rule to September 30, 1997. [FR Doc.97-18563 Filed: 7-14-97; 8:45 am] BILLING CODE 6560-50-F