66628 Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Notices

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 dichloride 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 Dichloride

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 dichloride under TSCA

section 12(b) upon the successful

conclusion of an ECA for ethylene

dichloride.

VI. Public Record and Electronic

Submissions

As described above, ethylene

dichloride is listed as a chemical that

would be subject to testing requirements

under the proposed HAPs test rule. This

ECA negotiation process and the

proposed rule, are separate and parallel

activities. The official record for this

ECA action, including the public

version, has been established under

docket control number OPPTS–42197B

(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; FRL–4869–1,

the record for the proposed HAPs test

rule, and all materials and submissions

filed under docket control number

OPPTS–42187B; FRL–4869–1, 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–42197B. 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–

42197B. 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).

B. PK proposal materials consisting

of:

1. HAP Task Force, ‘‘Proposal for

Pharmacokinetics Study of Ethylene

Dicholoride’’ (November 22, 1996) and

cover letter (November 25, 1996).

2. U.S. EPA, ‘‘Preliminary EPA

Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy

for Ethylene Dichloride’’ and cover

letter (June 26, 1997).

List of Subjects

Environmental protection, Chemicals,

Hazardous substances, Reporting and

recordkeeping requirements.

Dated: December 17, 1997.

Charles M. Auer,

Director, Chemical Control Division, Office

of Pollution Prevention and Toxics.

[FR Doc. 97–33328 Filed 12–18–97; 8:45 am]

BILLING CODE 6065–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS–42198B; FRL–5763–2]

Enforceable Consent Agreement

Development for 1,1,2-Trichloroethane;

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 1,1,2-

trichloroethane (CAS No. 79–00–5) 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 1,1,2-trichloroethane.
Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Notices 66629

DATES: EPA must receive written

notification requesting designation as an

interested party for 1,1,2-trichloroethane

on or before January 9, 1998. Those

persons who identify themselves as

interested parties for 1,1,2-

trichloroethane 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 9,

1998.

The public meeting is scheduled from

8 a.m. to 10 a.m. on January 12, 1998.

ADDRESSES: Each comment must bear

the docket control number, OPPTS–

42198B. 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.

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 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/1997/).

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 1,1,2-trichloroethane from

the HAP Task Force on November 25,

1996. Based on the PK proposal

received for 1,1,2-trichloroethane, the

Agency developed a preliminary

technical analysis. A copy of this

preliminary technical analysis was sent

to the HAP Task Force on June 26, 1997.

The HAP Task Force reviewed EPA’s

analysis and notified EPA on July 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 materials

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 1,1,2-

trichloroethane and is providing public

notice that the Agency is hereby

initiating the procedures for ECA

negotiations for the HAP chemical,

1,1,2-trichloroethane. 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, 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. 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. 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 must be submitted under

docket control number, OPPTS–42187A,

as described in the proposed HAPs test

rule published on June 26, 1996, 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

preamble.

Negotiations on developing an ECA

for the HAP chemical, 1,1,2-

trichloroethane, will focus on the use of

PK studies and mechanistic data to help

meet testing requirements for 1,1,2-

trichloroethane. In addition, discussion

will include the adequacy of the

available data base to be used for

extrapolation to obtain the data needs

identified for 1,1,2-trichloroethane in
66630 Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Notices

the proposed HAPs test rule. 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 1,1,2-trichloroethane.

III. Identification of Interested Parties

EPA is soliciting interested parties to

monitor or participate in testing

negotiations on an ECA for 1,1,2-

trichloroethane. The HAP Task Force,

the submitter of the PK proposal for

1,1,2-trichloroethane, and the member

companies of the HAP Task Force 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 9, 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 1,1,2-

trichloroethane 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 1,1,2-trichloroethane 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 1,1,2-trichloroethane

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 1,1,2-trichloroethane under

TSCA section 12(b) upon the successful

conclusion of an ECA for 1,1,2-

trichloroethane.

VI. Public Record and Electronic

Submissions

As described above, 1,1,2-

trichloroethane is listed as a chemical

that would be subject to testing

requirements under the proposed HAPs

test rule. This ECA negotiation process

and the proposed rule, are separate and

parallel activities. The official record for

this ECA action, including the public

version, has been established under

docket control number OPPTS–42198B

(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; FRL–4869–1,

the record for the proposed HAPs test

rule, and all materials and submissions

filed under docket control number

OPPTS–42187B; FRL–4869–1, 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–42198B. 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–

42198B. 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).

B. PK proposal materials consisting

of:

1. HAP Task Force, ‘‘Proposal for

Pharmacokinetics Study of 1,1,2-

Trichloroethane’’ (November 22, 1996)

and cover letter (November 25, 1996).

2. U.S. EPA, ‘‘Preliminary EPA

Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy

for 1,1,2-Trichloroethane’’ and cover

letter (June 26, 1997).
Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Notices 66631

List of Subjects

Environmental protection, Chemicals,

Hazardous substances, Reporting and

recordkeeping requirements.

Dated: December 17, 1997.

Charles M. Auer,

Director, Chemical Control Division, Office

of Pollution Prevention and Toxics.

[FR Doc. 97–33329 Filed 12–18–97; 8:45 am]

BILLING CODE 6065–50–F

FEDERAL MARITIME COMMISSION

Ocean Freight Forwarder License

Applicants

Notice is hereby given that the

following applicants have filed with the

Federal Maritime Commission

applications for licenses as ocean freight

forwarders pursuant to section 19 of the

Shipping Act of 1984 (46 U.S.C. app.

1718 and 46 CFR 510).

Persons knowing of any reason why

any of the following applicants should

not receive a license are requested to

contact the Office of Freight Forwarders,

Federal Maritime Commission,

Washington, D.C. 20573.

Prem International, Inc., 7225 N.W. 25th

Street, Suite 203, Miami, FL 33122,

Officers: Hugo Pedro Kelly, President,

Sergio Barci, Vice President

UT Freight Forwarders Ltd., 161–15

Rockaway Blvd., Jamaica, NY 11434,

Officers: John Hwang, President, Lisa

Cho, Secretary

Triton Forwarding, Inc., 3080 Bristol

Street, Suite 610, Costa Mesa, CA

92626, Officers: Anthony G. Khamis,

Director, Leonard Yanovsky, Director

Interamericas Consulting Import Export

Inc., 22716 SW 65 Way, Boca Raton,

FL 33428, Officer: Iracema V.S.

Heidal, President.

Dated: December 15, 1997.

Ronald D. Murphy,

Assistant Secretary.

[FR Doc. 97–33121 Filed 12–18–97; 8:45 am]

BILLING CODE 6730–01–M

FEDERAL RESERVE SYSTEM

Formations of, Acquisitions by, and

Mergers of Bank Holding Companies

The companies listed in this notice

have applied to the Board for approval,

pursuant to the Bank Holding Company

Act of 1956 (12 U.S.C. 1841 et seq.)

(BHC Act), Regulation Y (12 CFR Part

225), and all other applicable statutes

and regulations to become a bank

holding company and/or to acquire the

assets or the ownership of, control of, or

the power to vote shares of a bank or

bank holding company and all of the

banks and nonbanking companies

owned by the bank holding company,

including the companies listed below.

The applications listed below, as well

as other related filings required by the

Board, are available for immediate

inspection at the Federal Reserve Bank

indicated. The application also will be

available for inspection at the offices of

the Board of Governors. Interested

persons may express their views in

writing on the standards enumerated in

the BHC Act (12 U.S.C. 1842(c)). If the

proposal also involves the acquisition of

a nonbanking company, the review also

includes whether the acquisition of the

nonbanking company complies with the

standards in section 4 of the BHC Act.

Unless otherwise noted, nonbanking

activities will be conducted throughout

the United States.

Unless otherwise noted, comments

regarding each of these applications

must be received at the Reserve Bank

indicated or the offices of the Board of

Governors not later than January 15,

1998.

A. Federal Reserve Bank of Dallas

(Genie D. Short, Vice President) 2200

North Pearl Street, Dallas, Texas 75201-

2272:

1. Industry Bancshares, Inc., Industry,

Texas; to acquire 100 percent of the

voting shares of Citizens State Bank,

Buffalo, Texas.

B. Federal Reserve Bank of San

Francisco (Pat Marshall, Manager of

Analytical Support, Consumer

Regulation Group) 101 Market Street,

San Francisco, California 94105-1579:

1. New Century Financial

Corporation, Spokane, Washington; to

become a bank holding company by

acquiring 100 percent of the voting

shares of New Century Bank (in

organization), Spokane, Washington.

Board of Governors of the Federal Reserve

System, December 16, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–33201 Filed 12–18–97; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee Information Line

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has changed its

procedure for accessing the Advisory

Committee Information Line (the

information line) concerning those

advisory committees under the purview

of the Center for Biologics Evaluation

and Research (CBER). CBER has

assigned a separate 5-digit code to each

of its advisory committees.

FOR FURTHER INFORMATION CONTACT:

Donna M. Combs, Committee

Management Office (HFA–306), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4820.

SUPPLEMENTARY INFORMATION: The

information line provides the public

with access to the most current

information available on upcoming FDA

advisory committee meetings, guidance

for making an oral presentation during

the open public hearing portion of an

advisory committee meeting, and

procedures for obtaining copies of

transcripts of advisory committee

meetings. The information line can be

accessed by dialing 1–800–741–8138 or

301–443–0572. Each advisory

committee has been assigned a 5-digit

code on the information line that

enables the public to obtain information

about a particular advisory committee

by using that code. This 5-digit code

appears in each individual notice of a

meeting. Information provided is

preliminary and may change before a

meeting is held. The information line

will be updated when such changes are

made. The following is a list of CBER’s

advisory committees and the 5-digit

code assigned to each advisory

committee:

Committee name Code

Allergenic Products Advisory Committee ........................................................................................................ 12388

Biological Response Modifiers Advisory Committee ....................................................................................... 12389

Blood Products Advisory Committee ............................................................................................................... 19516