[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: 
<a href="/cdn-cgi/l/email-protection#284758585c06464b414b684d584945494144064d5849064f475e"><span class="__cf_email__" data-cfemail="6e011e1e1a40000d070d2e0b1e0f030f0702400b1e0f40090118">[email protected]</span></a>. 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-
H<a href="/cdn-cgi/l/email-protection#a6c9d2cacfc8c3e6c3d6c7cbc7cfca88c3d6c788c1c9d0"><span class="__cf_email__" data-cfemail="2e415a4247404b6e4b5e4f434f4742004b5e4f00494158">[email protected]</span></a>.
     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: <a href="/cdn-cgi/l/email-protection#563a33233d2439223e78243f353e163326373b373f3a7833263778313920"><span class="__cf_email__" data-cfemail="c3afa6b6a8b1acb7abedb1aaa0ab83a6b3a2aea2aaafeda6b3a2eda4acb5">[email protected]</span></a>.

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.

[[Page 3111]]

     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:
     <a href="/cdn-cgi/l/email-protection#4a253a3a3e64242923290a2f3a2b272b2326642f3a2b642d253c"><span class="__cf_email__" data-cfemail="06697676722868656f65466376676b676f6a2863766728616970">[email protected]</span></a>.

     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


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