[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: 
[email protected]. following the instructions under Unit VI. of 
this document. No Confidential Business Information (CBI) should be 
submitted through e-mail.

[[Page 3112]]

    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-
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/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:
     [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-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