Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices 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:

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

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS–42202B; FRL–5766–6]

Enforceable Consent Agreement

Development for Ethylene Glycol;

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

ethylene glycol (CAS No. 107–21–1) 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 ethylene glycol.

DATES: EPA must receive written

notification requesting designation as an

interested party for ethylene glycol on

or before February 11, 1998. Those

persons who identify themselves as

interested parties for ethylene glycol

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 1:00 p.m. on February 23,

1998.

ADDRESSES: Each comment must bear

the docket control number, OPPTS–

42202B. 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.
3112 Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices

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: TSCAHotline@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

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 ethylene glycol from the

Chemical Manufacturers Association,

Ethylene Glycol Panel (CMA EG Panel)

on November 5, 1996. Based on the PK

proposal received for ethylene glycol,

the Agency developed a preliminary

technical analysis. A copy of this

preliminary technical analysis was sent

to the CMA EG Panel on August 26,

1997. The CMA EG Panel reviewed

EPA’s analysis and notified EPA on

October 6, 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

ethylene glycol and is providing public

notice that the Agency is hereby

initiating the procedures for ECA

negotiations for the HAP chemical,

ethylene glycol. 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 reevaluate 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, ethylene glycol,

will focus on the use of PK studies and

mechanistic data to help meet testing

requirements for ethylene glycol. In

addition, discussion will include the

adequacy of the available data base to be

used for extrapolation to obtain the data

needs identified for ethylene glycol 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 ethylene

glycol.

III. Identification of Interested Parties

EPA is soliciting interested parties to

monitor or participate in testing

negotiations on an ECA for ethylene

glycol. The CMA EG Panel, the

submitter of the PK proposal for

ethylene glycol, and the member

companies of the CMA EG 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
Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices 3113

open to the public. The negotiation time

schedule for ethylene glycol 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 ethylene glycol 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 Ethylene glycol

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 ethylene glycol under TSCA

section 12(b) upon the successful

conclusion of an ECA for ethylene

glycol.

VI. Public Record and Electronic

Submissions

As described above, ethylene glycol 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–42202B (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–42202B. 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–

42202B. 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, Ethylene Glycol Panel,

‘‘Proposal for Pharmacokinetic Studies

of Ethylene Glycol‘‘ (November 5, 1996).

2. U.S. EPA, ‘‘Preliminary EPA

Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy

for Ethylene Glycol‘‘ and cover letter

(August 26, 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. 98–1357 Filed 1–20–98; 8:45 am]

BILLING CODE 6065–50–F

FEDERAL COMMUNICATIONS

COMMISSION

Notice of Public Information

Collection(s) Submitted to OMB for

Review and Approval

January 13, 1998.

SUMMARY: The Federal Communications

Commission, as part of its continuing

effort to reduce paperwork burden