[Federal Register Volume 63, Number 13 (Wednesday, January 21, 1998)]
[Notices]
[Pages 3109-3111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1355]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-42203B; FRL-5766-7]
Enforceable Consent Agreement Development for Diethanolamine;
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 diethanolamine (CAS No. 111-
42-2) 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 diethanolamine.
DATES: EPA must receive written notification requesting designation as
an interested party for diethanolamine on or before February 11, 1998.
Those persons who identify themselves as interested parties for
diethanolamine 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 5:00 p.m. on
February 24, 1998.
ADDRESSES: Each comment must bear the docket control number OPPTS-
42203B. 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. 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
[[Page 3110]]
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 diethanolamine from the Chemical Manufacturers Association,
Alkanolamines Panel (CMA Alkanolamines Panel) on November 25, 1996.
Based on the PK proposal received for diethanolamine, the Agency
developed a preliminary technical analysis. A copy of this preliminary
technical analysis was sent to the CMA Alkanolamines Panel on November
21, 1997. The CMA Alkanolamines Panel reviewed EPA's analysis and
notified EPA on December 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 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
diethanolamine and is providing public notice that the Agency is hereby
initiating the procedures for ECA negotiations for the HAP chemical,
diethanolamine. The procedures for ECA negotiations are described at 40
CFR 790.22(b).
EPA does not intend to publish additional Federal Register
documents to solicit interested parties and announce public meetings to
initiate ECA proceedings for other HAPs chemicals for which PK
proposals were submitted in response to the June 26, 1996 EPA
invitation to submit PK proposals. In a letter dated December 4, 1997,
the Chlorobenzene Producers Association did not express a continued
interest to enter into ECA proceedings for the HAPs chemical 1,2,4-
trichlorobenzene. In the December 24, 1997 amendment to the HAPs
rulemaking (62 FR 67466) (FRL-5742-2), EPA invited the submission of
proposals for ECAs on all the HAPs chemicals for which ECA proposals
have not been received (62 FR 67474). If the Agency receives such
alternative testing proposals and decides to proceed with ECA
proceedings for these proposals, it will publish, as appropriate,
additional Federal Register documents soliciting persons to notify the
Agency in writing of their interest in participating in or monitoring
negotiations for the development of ECAs for the development of
alternative testing to meet HAPs rule testing requirements.
With the publication of this document EPA has published a total of
seven solicitations of interested parties and announcements of public
meetings for ECAs on HAPs chemicals. EPA does not intend to publish
additional Federal Register documents to solicit interested parties and
announce public meetings to initiate ECA proceedings for other HAPs
chemicals for which PK proposals were submitted in response to the EPA
invitation to submit PK proposals that was contained in the original
HAPs proposal, dated June 26, 1996 (61 FR 33178). In a letter to EPA
dated December 4, 1997, the Chlorobenzene Producers Association did not
express a continued interest in entering into ECA proceedings for the
HAPs chemical 1,2,4-trichlorobenzene.
In the December 24, 1997, amendment to the proposed HAPs rule (62
FR 67466), EPA invited the submission of proposals for ECAs on all the
HAPs chemicals for which ECA proposals have not been received. If the
Agency receives such alternative testing proposals and decides to
proceed with ECA proceedings for these proposals, it will publish, as
appropriate, additional Federal Register documents soliciting persons
to notify the Agency in writing of their interest in participating in
or monitoring negotiations for the development of ECAs for alternative
testing to meet HAPs rule testing requirements.
Negotiations on developing an ECA for the HAP chemical,
diethanolamine, will focus on the use of PK studies and mechanistic
data to help meet testing requirements for diethanolamine. In addition,
discussion will include the adequacy of the available data base to be
used for extrapolation to obtain the data needs identified for
diethanolamine 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 diethanolamine.
III. Identification of Interested Parties
EPA is soliciting interested parties to monitor or participate in
testing negotiations on an ECA for diethanolamine. The CMA
Alkanolamines Panel, the submitter of the PK proposal for
diethanolamine, and the member companies of the CMA Alkanolamines 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 open
to the public. The negotiation time schedule for diethanolamine 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 diethanolamine 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.
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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 Diethanolamine
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 diethanolamine under TSCA section 12(b) upon
the successful conclusion of an ECA for diethanolamine.
VI. Public Record and Electronic Submissions
As described above, diethanolamine 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-42203B (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-
42203B. 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-42203B. 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 67476, December 24, 1997).
B. PK proposal materials consisting of:
1. Chemical Manufacturers Association, Alkanolamine Panel,
`Proposal for Pharmacokinetics Studies of Diethanolamine`` (November
25, 1996).
2. U.S. EPA, ``Preliminary EPA Technical Analysis of Proposed
Industry Pharmacokinetics (PK) Strategy for Diethanolamine`` and cover
letter (November 21, 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. 98-1355 Filed 1-20-98; 8:45 am]
BILLING CODE 6065-50-F
