Enforceable Consent Agreement Development for Hydrogen Fluoride; Solicitation of Interested Parties and Notice of Public Meeting

ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-42201B; FRL-5765-5]

Enforceable Consent Agreement Development for Hydrogen Fluoride;

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 hydrogen fluoride 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 hydrogen fluoride.

DATES: EPA must receive written notification requesting designation as

an interested party for hydrogen fluoride on or before January 30,

1998. Those persons who identify themselves as interested parties for

hydrogen fluoride 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 8:30 a.m. to 12:30 p.m. on

February 5, 1998.

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

42201B. 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 hydrogen fluoride from

the Chemical Manufacturers Association, Hydrogen Fluoride Panel (CMA HF

Panel) on November 27, 1996. Based on the PK proposal received for

hydrogen fluoride, the Agency developed a preliminary technical

analysis. A copy of this preliminary technical analysis was sent to the

CMA HF Panel on June 26, 1997. The CMA HF Panel reviewed EPA's analysis

and notified EPA on September 10, 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 hydrogen

fluoride and is providing public notice that the Agency is hereby

initiating the procedures for ECA

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negotiations for the HAP chemical, hydrogen fluoride. 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, hydrogen

fluoride, will focus on the use of PK studies and mechanistic data to

help meet testing requirements for hydrogen fluoride. In addition,

discussion will include the adequacy of the available data base to be

used for extrapolation to obtain the data needs identified for hydrogen

fluoride 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 hydrogen fluoride.

III. Identification of Interested Parties

EPA is soliciting interested parties to monitor or participate in

testing negotiations on an ECA for hydrogen fluoride. The CMA HF Panel,

the submitter of the PK proposal for hydrogen fluoride, and the member

companies of the CMA HF 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 hydrogen fluoride 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 hydrogen fluoride 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 Hydrogen

Fluoride

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 hydrogen fluoride under TSCA section 12(b)

upon the successful conclusion of an ECA for hydrogen fluoride.

VI. Public Record and Electronic Submissions

As described above, hydrogen fluoride 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-42201B (including comments and data

submitted electronically as described below). The

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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-

42201B. 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-42201B. 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, Hydrogen Fluoride (HF)

Panel, ``Proposal for a Physiologically-Based Pharmacokinetic (PBPK)

Model for Hydrogen Fluoride'' (June 26, 1997).

2. U.S. EPA, ``Preliminary EPA Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy for Hydrogen Fluoride'' and

cover letter (June 26, 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. 98-559 Filed 1-8-98; 8:45 am]

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