[Federal Register Volume 63, Number 13 (Wednesday, January 21, 1998)]
[Notices]
[Pages 3111-3113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1357]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-42202B; FRL-5766-6]
Enforceable Consent Agreement Development for Ethylene Glycol;
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 glycol (CAS No.
107-21-1) 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 glycol.
DATES: EPA must receive written notification requesting designation as
an interested party for ethylene glycol on or before February 11, 1998.
Those persons who identify themselves as interested parties for
ethylene glycol 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 February 11, 1998.
The public meeting is scheduled from 9:00 a.m. to 1:00 p.m. on
February 23, 1998.
ADDRESSES: Each comment must bear the docket control number, OPPTS-
42202B. 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.
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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 on 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-
Hotline@epamail.epa.gov.
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.
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/1998/).
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 glycol from the Chemical Manufacturers Association,
Ethylene Glycol Panel (CMA EG Panel) on November 5, 1996. Based on the
PK proposal received for ethylene glycol, the Agency developed a
preliminary technical analysis. A copy of this preliminary technical
analysis was sent to the CMA EG Panel on August 26, 1997. The CMA EG
Panel reviewed EPA's analysis and notified EPA on October 6, 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
references, and correspondence 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 glycol and is providing public notice that the
Agency is hereby initiating the procedures for ECA negotiations for the
HAP chemical, ethylene glycol. 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, as amended on December 24, 1997 (62
FR 67466) (FRL-5742-2), 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, as amended. 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, as amended. 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, as amended, must be submitted under docket control
number, OPPTS-42187A, as described in the proposed HAPs test rule
published on June 26, 1996, as amended on December 24, 1997, 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 document.
Negotiations on developing an ECA for the HAP chemical, ethylene
glycol, will focus on the use of PK studies and mechanistic data to
help meet testing requirements for ethylene glycol. 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
glycol in the proposed HAPs test rule, as amended. 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 glycol.
III. Identification of Interested Parties
EPA is soliciting interested parties to monitor or participate in
testing negotiations on an ECA for ethylene glycol. The CMA EG Panel,
the submitter of the PK proposal for ethylene glycol, and the member
companies of the CMA EG Panel 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 February 11, 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
[[Page 3113]]
open to the public. The negotiation time schedule for ethylene glycol
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 glycol 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 glycol
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 glycol under TSCA section 12(b)
upon the successful conclusion of an ECA for ethylene glycol.
VI. Public Record and Electronic Submissions
As described above, ethylene glycol is listed as a chemical that
would be subject to testing requirements under the proposed HAPs test
rule, as amended. This ECA negotiation process and the proposed rule,
as amended, are separate and parallel activities. The official record
for this ECA action, including the public version, has been established
under docket control number OPPTS-42202B (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, the record for the proposed HAPs
test rule, as amended, and all materials and submissions filed under
docket control number OPPTS-42187B, 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-
42202B. 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:
oppt.ncic@epamail.epa.gov.
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-42202B. 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).
2. ``Amended Proposed Test Rule for Hazardous Air Pollutants;
Extension of Comment Period`` (62 FR 67466; December 24, 1997).
B. PK proposal materials consisting of:
1. Chemical Manufacturers Association, Ethylene Glycol Panel,
``Proposal for Pharmacokinetic Studies of Ethylene Glycol`` (November
5, 1996).
2. U.S. EPA, ``Preliminary EPA Technical Analysis of Proposed
Industry Pharmacokinetics (PK) Strategy for Ethylene Glycol`` and cover
letter (August 26, 1997).
List of Subjects
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: January 13, 1998.
Wardner G. Penberthy,
Acting Director, Chemical Control Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 98-1357 Filed 1-20-98; 8:45 am]
BILLING CODE 6065-50-F
