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Proposed Test Rule for Hazardous Air Pollutants; Extension of Comment Period

  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
  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.
  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-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.
  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
      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
  [[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:
      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
      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