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xtnsn of comment, testing of 21 HAPs for certain health effects

  >[Federal Register: November 28, 1997 (Volume 62, Number 229)]
  >[Proposed Rules]
  >[Page 63299-63301]
  >>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
  >40 CFR Part 799
  >[OPPTS-42187K; FRL-5759-2]
  >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 December 1,
  >1997 to January 9, 1998, 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
  >amend the HAPs test rule proposal.
  >DATES: Written comments on the proposed rule must be received by EPA on
  >or before January 9, 1998.
  >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 to
  >oppt.ncic@epamail.epa.gov. Follow the instructions under Unit II. of
  >this document. No Confidential Business Information (CBI) should be
  >submitted through e-mail.
  >FOR FURTHER INFORMATION CONTACT: For general information, Susan B.
  >Hazen, Director, Environmental Assistance Division (7408), Rm. ET-543B,
  >Office of Pollution Prevention and Toxics,
  >[[Page 63300]]
  >Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
  >telephone (202) 554-1404; TDD: (202) 554-0551; e-mail: TSCA-
  >Hotline@epamail.epa.gov. 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: leukroth.rich@epamail.epa.gov.
  >    Electronic Availability: Electronic copies of this document, all
  >Federal Register support documents, and the eleven TSCA test guidelines
  >are available from the EPA Home Page at the Federal Register --
  >Environmental Documents entry under ``Laws and Regulations'' (http://
  >I. Background and General Information
  >    On June 26, 1996 (61 FR 33178), EPA proposed health effects
  >testing, under section 4(a) of 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. Due to the complexity of the issues raised by the eight PK
  >proposals that the Agency received in response to the HAPs proposal 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); 62 FR 37833, July
  >15, 1997 (FRL-5732-2)); to allow the Agency more time to respond to the
  >PK proposals and to finalize the test guidelines to be referenced in
  >the proposed HAPs test rule. EPA extended the comment period again (62
  >FR 50546, September 26, 1997 (FRL-5748-8)), to allow the Agency time to
  >complete work on amending the proposed HAPs test rule to incorporate
  >the new TSCA 799 test guidelines, revise the economic analysis in
  >consideration of the new test guidelines, and to complete preliminary
  >technical analyses for each PK proposal. This extension of the comment
  >period is needed to allow the Agency more time to complete work on
  >amending the proposed HAPs test rule.
  >    EPA has completed preliminary technical analyses for each PK
  >proposal submitted in response to the Agency's June 26, 1996
  >solicitation. These include the HAPs chemicals: hydrogen fluoride,
  >1,1,2-trichlorethane, ethylene dichloride, maleic anhydride, phthalic
  >anhydride, 1,2,4-trichlorobenzene, diethanolamine, and ethylene glycol.
  >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 recognizes that submitters may need to
  >revise their proposals based on EPA comments. 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. In that document, the Agency will solicit persons
  >interested in participating in or monitoring negotiations to develop
  >ECAs based on: the PK testing proposals or revisions thereof, EPA's
  >preliminary technical analyses, and additional comments on EPA's
  >preliminary technical analyses provided by the submitters. 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.
  >    On August 15, 1997, EPA promulgated eleven new TSCA test guidelines
  >(62 FR 43820)(FRL-5719-5), codified at 40 CFR part 799, subpart H.
  >These TSCA part 799 test guidelines were developed based on the Office
  >of Pollution Prevention and Toxic Substances (OPPTS) harmonized
  >guidelines that were developed from the OPPTS guideline harmonization
  >process. In the original HAPs proposal and subsequent notices extending
  >the comment period on the rule, EPA indicated that, for the purposes of
  >this rulemaking and testing under TSCA section 4(a), the Office of
  >Pollution Prevention and Toxics (OPPT) intends to reference final TSCA
  >test guidelines developed from the OPPTS harmonized guidelines. The
  >eleven TSCA test guidelines are included in the record for this
  >rulemaking. EPA is amending the proposed HAPs test rule to reference
  >the eleven new TSCA part 799 test guidelines and to seek comment on the
  >guidelines as referenced in enforceable test standards in the
  >forthcoming amended HAPs proposal. In addition, the amendment will
  >provide a revised economic assessment and describe other changes and
  >clarifications to the proposed test rule. This amendment to the
  >proposed HAPs test rule will be published in the Federal Register as
  >soon as possible but in any event no later than January 9, 1998.
  >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 in the TSCA
  >Nonconfidential Information Center, Rm NE-B607, 401 M St., SW.,
  >Washington, DC.
  >    Electronic comments can be sent directly to EPA at
  >    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).
  >[[Page 63301]]
  >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: November 20, 1997.
  >Charles M. Auer,
  >Chemical Control Division, Office of Pollution Prevention and Toxics.
  >    Accordingly, EPA is extending the comment period on the proposed
  >rule to January 9, 1997.
  >[FR Doc. 97-31128 Filed 11-26-97; 8:45 am]
  >BILLING CODE 6560-50-F
  >End of EPA-AIR Digest 1078