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dichlorethene HAP consent testing
[Federal Register: December 19, 1997 (Volume 62, Number 244)]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
Enforceable Consent Agreement Development for Ethylene
Dichloride; Solicitation of Interested Parties and Notice of Public
AGENCY: Environmental Protection Agency (EPA).
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
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:
firstname.lastname@example.org. 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.
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: email@example.com.
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
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
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,
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
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
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
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