[Federal Register Volume 62, Number 244 (Friday, December 19, 1997)]
[Notices]
[Pages 66626-66628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33328]


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ENVIRONMENTAL PROTECTION AGENCY

 [OPPTS-42197B; FRL-5763-1]


 Enforceable Consent Agreement Development for Ethylene 
Dichloride; Solicitation of Interested Parties and Notice of Public 
Meeting

  AGENCY: Environmental Protection Agency (EPA).

  ACTION: Notice.

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  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: 
[email protected]. 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-
H[email protected].
      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: [email protected].

  SUPPLEMENTARY INFORMATION:

 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 
that:
     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 
Dichloride

     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:
    [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 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