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dichlorethene HAP consent testing

  [Federal Register: December 19, 1997 (Volume 62, Number 244)]
  [Page 66626-66628]
  >From the Federal Register Online via GPO Access [wais.access.gpo.gov]
   [OPPTS-42197B; FRL-5763-1]
   Enforceable Consent Agreement Development for Ethylene
  Dichloride; Solicitation of Interested Parties and Notice of Public
    AGENCY: Environmental Protection Agency (EPA).
    ACTION: Notice.
    SUMMARY: EPA is soliciting interested parties who want to monitor or
  participate in negotiations on an enforceable consent agreement (ECA)
  concerning the use of pharmacokinetics (PK) studies and mechanistic
  data to help meet testing requirements for ethylene dichloride (CAS No.
  107-06-02) in the proposed hazardous air pollutants (HAPs) test rule.
  In addition, EPA invites all interested parties to attend a public
  meeting to initiate negotiations on the ECA for ethylene dichloride.
    DATES: EPA must receive written notification requesting designation
  as an interested party for ethylene dichloride on or before January 9,
  1998. Those persons who identify themselves as interested parties for
  ethylene dichloride may submit written comments to EPA on the PK
  proposal for this chemical, on EPA's preliminary technical analysis,
  and on other materials in the docket for the proposed HAPs test rule,
  that relate to the ECA process for this chemical by January 9, 1998.
       The public meeting is scheduled from 10 a.m. to 2 p.m. on January
  12, 1998.
    ADDRESSES: Each comment must bear the docket control number, OPPTS-
  42197B. All comments should be sent in triplicate to: OPPT Document
  Control Officer (7407), Office of Pollution Prevention and Toxics,
  Environmental Protection Agency, 401 M St., SW., Rm. G-099, East Tower,
  Washington, DC 20460.
      EPA will address these comments at the public meeting.
       Comments and data may also be submitted electronically to:
  oppt.ncic@epamail.epa.gov. following the instructions under Unit VI. of
  this document. No Confidential Business Information (CBI) should be
  submitted through e-mail.
       All comments which contain information claimed as CBI must be
  clearly marked as such. Three sanitized copies of any comments
  containing information claimed as CBI must also be submitted and will
  be placed in the public record for this document.
  [[Page 66627]]
   Persons submitting information any portion of which they believe is
  entitled to treatment as CBI by EPA must assert a business
  confidentiality claim in accordance with 40 CFR 2.203(b) for each such
  portion. This claim must be made at the time that the information is
  submitted to EPA. If a submitter does not assert a confidentiality
  claim at the time of submission, EPA will make the information
  available to the public without further notice to the submitter.
       The public meeting will be held at EPA Headquarters, 401 M St.,
  SW., Washington, DC in the EPA Conference Center, North Conference Area
  in Room 1.
    FOR FURTHER INFORMATION CONTACT:  For additional information: 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 address: TSCA-
        For technical information: 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 address: leukroth.rich@epamail.epa.gov.
   I. Electronic Availability
        Internet: Electronic copies of this document and various support
  documents are available from the EPA Home Page at the  Federal Register
  --Environmental Documents entry for this document under ``Laws and
  Regulations'' (http://www.epa.gov/fedrgstr/EPA-TOX/1997/).
   II. Background
       EPA proposed health effects testing under section 4(a) of the
  Toxic Substances Control Act (TSCA) on June 26, 1996, for a number of
  HAPs chemicals (61 FR 33178) (FRL-4869-1). As indicated in the proposed
  HAPs test rule, EPA would use the data obtained from testing to
  implement several provisions of section 112 of the Clean Air Act (CAA),
  including the determination of residual risk, the estimation of the
  risks associated with accidental releases of chemicals, and
  determinations whether substances should be removed from the CAA
  section 112(b)(1) list of hazardous air pollutants (delisting). The
  data also would be used by other Federal agencies (e.g. Agency for
  Toxic Substances and Disease Registry (ATSDR), National Institute of
  Occupational Safety and Health (NIOSH), Occupational Safety and Health
  Administration (OSHA), and Consumer Product Safety Commission (CPSC))
  in assessing chemical risks and in taking appropriate actions within
  their programs.
       In the proposed HAPs test rule, EPA invited the submission of
  proposals for pharmacokinetics (PK) studies for the HAPs chemicals,
  which could provide the basis for negotiation of ECAs. These PK studies
  would be used to inform EPA about the use of 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 test rule. EPA received a PK proposal
  for ethylene dichloride from the HAP Task Force on November 25, 1996.
  Based on the PK proposal received for ethylene dichloride, the Agency
  developed a preliminary technical analysis. A copy of this preliminary
  technical analysis was sent to the HAP Task Force on June 26, 1997. The
  HAP Task Force reviewed EPA's analysis and notified EPA on July 31,
  1997, that it has a continued interest in pursuing the ECA process. A
  copy of the PK proposal, the EPA preliminary technical analysis and
  related materials is contained in the public record for this ECA
  process. These materials will be used during discussions at the
  negotiating meeting. EPA has decided to proceed with the ECA process
  for ethylene dichloride and is providing public notice that the Agency
  is hereby initiating the procedures for ECA negotiations for the HAP
  chemical, ethylene dichloride. The procedures for ECA negotiations are
  described at 40 CFR 790.22(b). EPA intends to publish, as appropriate,
  additional  Federal Register documents to solicit interested parties
  and announce public meetings for other HAPs chemicals for which PK
  proposals were submitted.
       The proposed HAPs test rule, and the ECA negotiations on chemicals
  included in the proposed rule are separate and parallel activities.
  While the Agency's objective of obtaining data could be accomplished by
  either activity, EPA recognizes that the final testing program
  performed by industry may differ depending on whether it is
  accomplished under the final HAPs test rule or via the ECA process.
  During the course of ECA negotiations, additional information may be
  brought forward that could cause the Agency to re-evaluate the nature
  of the testing requirements as stated in the proposed HAPs test rule.
  This could result in the development of an ECA that would fulfill the
  Agency's data needs in ways not stated in the proposed HAPs test rule.
  It is therefore essential for all interested parties to recognize these
  differences at the outset and respond accordingly within the framework
  of these two separate and parallel activities. Comments on the proposed
  HAPs test rule must be submitted under docket control number, OPPTS-
  42187A, as described in the proposed HAPs test rule published on June
  26, 1996, and will be addressed by EPA via the rulemaking process,
  which is separate and distinct from the ECA process. Participation in
  the ECA process is described in Units II. through IV. of this preamble.
       Negotiations on developing an ECA for the HAP chemical, ethylene
  dichloride, will focus on the use of PK studies and mechanistic data to
  help meet testing requirements for ethylene dichloride. In addition,
  discussion will include the adequacy of the available data base to be
  used for extrapolation to obtain the data needs identified for ethylene
  dichloride in the proposed HAPs test rule. The objective of the ECA
  process is to conclude an ECA that will set in place an industry-
  sponsored testing program that will adequately address EPA's data needs
  for ethylene dichloride.
   III. Identification of Interested Parties
       EPA is soliciting interested parties to monitor or participate in
  testing negotiations on an ECA for ethylene dichloride. The HAP Task
  Force, the submitter of the PK proposal for ethylene dichloride, and
  the member companies of the HAP Task Force are already considered
  interested parties and do not need to respond to this document.
  Additionally, any persons who respond to this document on or before
  January 9, 1998 will be given the status of interested parties.
  Interested parties must respond in writing to the address specified in
  the ``ADDRESSES'' at the beginning of this document. These interested
  parties will not incur any obligations by being so designated.
  Negotiations will be conducted in one or more meetings open to the
  public. The negotiation time schedule for ethylene dichloride will be
  established at the first negotiation meeting and will not exceed a
  period of 4 months from the initial meeting. If an ECA is not
  established in principle within this timeframe and EPA does not choose
  to extend the negotiation time period, negotiations will be terminated
  and testing will be required under the final HAPs test rule. If the
  testing from the ECA does not meet the Agency's needs,
  [[Page 66628]]
  EPA reserves the right to enter into rulemaking.
   IV. Public Participation in Negotiations
       Under EPA regulations, the Agency is required to provide the
  public with an opportunity to comment on and participate in the
  development of ECAs. The procedural rule for ECAs (40 CFR part 790)
  contains provisions to ensure that the views of interested parties are
  taken into account during the ECA process.
       Individuals and groups who respond to this document will have the
  status of interested parties. All negotiating meetings for the
  development of this ECA for ethylene dichloride will be open to the
  public and minutes of each meeting will be prepared by EPA and placed
  in the public docket for this ECA process. The Agency will advise
  interested parties of meeting dates and make available meeting minutes,
  testing proposals, background documents, and other materials exchanged
  at or prepared for negotiating meetings. Where tentative agreement is
  reached on an acceptable testing program, a draft ECA will be made
  available for comment by interested parties and, if necessary, EPA will
  hold a public meeting to discuss any comments that have been received
  and determine whether revisions to the ECA are appropriate. EPA will
  not reimburse costs incurred by non-EPA participants in this ECA
  negotiation process.
       ECAs will only be concluded where an agreement can be obtained
  which is satisfactory to the Agency, manufacturers or processors who
  are potential test sponsors, and other interested parties, concerning
  the need for and scope of testing. In the absence of an ECA, EPA
  reserves the right to proceed with rulemaking.
       A. The Agency will not enter into an ECA if either:
       1. EPA and affected manufacturers or processors cannot reach an
  agreement on the provisions of the ECA; or
       2. The draft ECA is considered inadequate by other interested
  parties who have submitted timely written objections to the draft ECA.
       B. EPA may reject these objections if the Agency concludes either
       1. They are not made in good faith;
       2. They are untimely;
       3. They are not related to the adequacy of the proposed testing
  program or other features of the agreement that may affect EPA's
  ability to fulfill the goals and purposes of TSCA; or
       4. They are not accompanied by a specific explanation of the
  grounds on which the draft agreement is considered objectionable.
       EPA will prepare an explanation of the basis for each ECA. The
  explanatory document will summarize the agreement (including the
  required testing), explain the objectives of the testing, and outline
  the chemical's use and exposure characteristics. The document, which
  will also announce the availability of the ECA, will be published in
  the  Federal Register.
   V. Proposal of Export Notification Requirements for Ethylene
       EPA intends to publish a proposed rule in an upcoming  Federal
  Register document to require export notification by all persons who
  export or intend to export ethylene dichloride under TSCA section 12(b)
  upon the successful conclusion of an ECA for ethylene dichloride.
   VI. Public Record and Electronic Submissions
       As described above, ethylene dichloride is listed as a chemical
  that would be subject to testing requirements under the proposed HAPs
  test rule. This ECA negotiation process and the proposed rule, are
  separate and parallel activities. The official record for this ECA
  action, including the public version, has been established under docket
  control number OPPTS-42197B (including comments and data submitted
  electronically as described below). The official record for this
  document also includes all material and submissions filed under docket
  control number OPPTS-42187A; FRL-4869-1, the record for the proposed
  HAPs test rule, and all materials and submissions filed under docket
  control number OPPTS-42187B; FRL-4869-1, the record for the receipt of
  alternative testing proposals for developing ECAs for HAPs chemicals.
       The official record for this document, including the public
  version, which does not include any information claimed as CBI, has
  been established for this document under docket control number OPPTS-
  42197B. The public version of this record is available for inspection
  from 12 noon to 4 p.m., Monday through Friday, excluding legal
  holidays. The public record is located in the TSCA Nonconfidential
  Information Center, Rm. NE B-607, 401 M St., SW., Washington, DC 20460.
       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 5.1/6.1 or ASCII
  file format. All comments and data in electronic form must be
  identified by the docket control number, OPPTS-42197B. Electronic
  comments on this document may be filed online at many Federal
  Depository Libraries.
       The record contains the following information:
       A.  Federal Register notices/EPA documents pertaining to this
  notice consisting of:
       1. ``Proposed Test Rule for Hazardous Air Pollutants; Proposed
  Rule'' (61 FR 33178, June 26, 1996).
       B. PK proposal materials consisting of:
       1. HAP Task Force, ``Proposal for Pharmacokinetics Study of
  Ethylene Dicholoride'' (November 22, 1996) and cover letter (November
  25, 1996).
       2. U.S. EPA, ``Preliminary EPA Technical Analysis of Proposed
  Industry Pharmacokinetics (PK) Strategy for Ethylene Dichloride'' and
  cover letter (June 26, 1997).
   List of Subjects
       Environmental protection, Chemicals, Hazardous substances,
  Reporting and recordkeeping requirements.
      Dated: December 17, 1997.
  Charles M. Auer,
   Director, Chemical Control Division, Office of Pollution Prevention and Toxics
   [FR Doc. 97-33328 Filed 12-18-97; 8:45 am]
   BILLING CODE 6065-50-F