[Federal Register Volume 63, Number 6 (Friday, January 9, 1998)]
[Notices]
[Pages 1469-1471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-562]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-42200B; FRL-5765-3]


Enforceable Consent Agreement Development for Phthalic Anhydride; 
Solicitation of Interested Parties and Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

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 phthalic anhydride 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 phthalic anhydride.

DATES: EPA must receive written notification requesting designation as 
an interested party for phthalic anhydride on or before January 30, 
1998. Those persons who identify themselves as interested parties for 
phthalic 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 1 p.m. to 5 p.m. on February 
5, 1998.

ADDRESSES: Each comment must bear the docket control number, OPPTS-
42200B. 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

[[Page 1470]]

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 phthalic anhydride from 
the Chemical Manufacturers Association, Phthalic Anhydride Producers 
Task Group (CMA PA Task Group) on November 22, 1996. Based on the PK 
proposal received for phthalic anhydride, the Agency developed a 
preliminary technical analysis. A copy of this preliminary technical 
analysis was sent to the CMA PA Task Group on July 10, 1997. The CMA PA 
Task Group 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 phthalic anhydride and is providing public notice 
that the Agency is hereby initiating the procedures for ECA 
negotiations for the HAP chemical, phthalic 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.
    Negotiations on developing an ECA for the HAP chemical, phthalic 
anhydride, will focus on the use of PK studies and mechanistic data to 
help meet testing requirements for phthalic 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 phthalic 
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 phthalic anhydride.

III. Identification of Interested Parties

    EPA is soliciting interested parties to monitor or participate in 
testing negotiations on an ECA for phthalic anhydride. The CMA PA Task 
Group, the submitter of the PK proposal for phthalic anhydride, and the 
member companies of the CMA PA Task Group 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 phthalic 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 phthalic 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.

[[Page 1471]]

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

VI. Public Record and Electronic Submissions

    As described above, phthalic 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-42200B (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-
42200B. 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-42200B. 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, Phthalic Anhydride Producers 
Task Group, ``Testing Proposal of the Chemical Manufacturers 
Association Phthalic Anhydride Producers Task Group in Response to 
EPA's Proposed Rule for Phthalic Anhydride'' (November 22, 1996).
    2. U.S. EPA, ``Preliminary EPA Technical Analysis of Proposed 
Industry Pharmacokinetics (PK) Strategy for Phthalic 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. 98-562 Filed 1-8-98; 8:45 am]
 BILLING CODE 6560-50-F