[Federal Register Volume 63, Number 6 (Friday, January 9, 1998)]
[Notices]
[Pages 1464-1467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-558]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-42199B; FRL-5765-1]


Enforceable Consent Agreement Development for Maleic Anhydride; 
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 maleic anhydride in the 
proposed hazardous air pollutants (HAPs) test

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rule. In addition, EPA invites all interested parties to attend a 
public meeting to initiate negotiations on the ECA for maleic 
anhydride.

DATES: EPA must receive written notification requesting designation as 
an interested party for maleic anhydride on or before January 30, 1998. 
Those persons who identify themselves as interested parties for maleic 
anhydride 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 30, 1998.
    The public meeting is scheduled from 9 a.m. to 1 p.m. on February 
6, 1998.

ADDRESSES: Each comment must bear the docket control number, OPPTS-
42199B. 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.
    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. E-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 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 maleic anhydride from 
the Chemical Manufacturers Association, Maleic Anhydride Panel (CMA MA 
Panel) on November 8, 1996. Based on the PK proposal received for 
maleic anhydride, the Agency developed a preliminary technical 
analysis. A copy of this preliminary technical analysis was sent to the 
CMA MA Panel on July 10, 1997. The CMA MA Panel reviewed EPA's analysis 
and notified EPA on September 3, 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 maleic 
anhydride and is providing public notice that the Agency is hereby 
initiating the procedures for ECA negotiations for the HAP chemical, 
maleic anhydride. 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.

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    Negotiations on developing an ECA for the HAP chemical, maleic 
anhydride, will focus on the use of PK studies and mechanistic data to 
help meet testing requirements for maleic anhydride. In addition, 
discussion will include the adequacy of the available data base to be 
used for extrapolation to obtain the data needs identified for maleic 
anhydride 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 maleic anhydride.

III. Identification of Interested Parties

    EPA is soliciting interested parties to monitor or participate in 
testing negotiations on an ECA for maleic anhydride. The CMA MA Panel, 
the submitter of the PK proposal for maleic anhydride, and the member 
companies of the CMA MA 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 January 30, 1998 will be 
given the status of interested parties. Interested parties must respond 
in writing to the address specified in ``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 maleic anhydride 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 maleic anhydride 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 Maleic 
Anhydride

    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 maleic anhydride under TSCA section 12(b) 
upon the successful conclusion of an ECA for maleic anhydride.

VI. Public Record and Electronic Submissions

    As described above, maleic anhydride 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-42199B (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-
42199B. 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-42199B. 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).

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    B. PK proposal materials consisting of:
    1. Chemical Manufacturers Association, Maleic Anhydride Panel, 
``Developing an Inhalation Testing Program for Maleic Anhydride'' 
(November 8, 1996).
    2. U.S. EPA, ``Preliminary EPA Technical Analysis of Proposed 
Industry Pharmacokinetics (PK) Strategy for Maleic Anhydride'' and 
cover letter (July 10, 1997).

List of Subjects

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: January 5, 1998.
Charles M. Auer,

Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

[FR Doc. 98-558 Filed 1-8-98; 8:45 am]
BILLING CODE 6560-50-F