Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Notices 51107

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS–42107E; FRL–5744–3]

RIN 2070–AB94

Testing Consent Order for 1,6-

Hexamethylene Diisocyanate (HDI)

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of consent agreement.

SUMMARY: Pursuant to section 4 of the

Toxic Substances Control Act (TSCA),

EPA has issued a testing consent order

(Order) that incorporates an enforceable

consent agreement (ECA) with ARCO

Chemical Company, Bayer Corporation,

and Rhone-Poulenc Inc. (collectively,

the Companies). The Companies have

agreed to perform certain health effects

tests on 1,6-hexamethylene diisocyanate

(HDI) (CAS No. 822–06–0). This notice

announces the ECA and Order for HDI

and summarizes the terms of the ECA.

EFFECTIVE DATES: The effective date of

the ECA and Order is September 30,

1997.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Rm. ET–543B, U.S.

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460;

telephone: (202) 554–1404; TDD: (202)

554–0551; e-mail: TSCAHotline@epamail.epa.gov. For specific

information regarding this notice, or the

ECA and Order, contact Keith J. Cronin,

Project Manager, Chemical Control

Division (7405), Office of Pollution

Prevention and Toxics, U.S.

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460;

telephone: (202) 260–8157; fax: (202)

260–1096; e-mail:

cronin.keith@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

ELECTRONIC AVAILABILITY: 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/).

This notice announces the ECA and

Order for HDI and summarizes the terms

of the ECA.

I. Introduction

HDI is an aliphatic diisocyanate. HDI

is used in the manufacture of higher

molecular biuret polyisocyanate resins

and trimer polyisocyanate resins used in

polyurethane paint systems. The

production and use of HDI in

polyurethane paint systems result in

potential exposures to substantial

numbers of workers. The greatest

potential for occupational exposure to

HDI is coating application operations,

with an estimated 153,000 auto body

repair workers having a potential for

some exposure to paints containing HDI

biuret and trimer.

In the Federal Register of May 20,

1988 (53 FR 18196), the Interagency

Testing Committee (ITC) designated HDI

for health effects testing for chronic

toxicity, oncogenicity, and reproductive

and developmental effects. EPA

responded to the ITC’s designation of

HDI by issuing a proposed test rule in

the Federal Register of May 17, 1989 (54

FR 21240), requiring that HDI be tested

for oncogenicity, mutagenicity,

reproductive toxicity, developmental

toxicity, neurotoxicity,

pharmacokinetics, and hydrolysis under

section 4 of TSCA. The proposed rule

contains a chemical profile of HDI, a

discussion of EPA’s TSCA section 4(a)

findings, and the proposed test

standards and reporting requirements.

EPA based its proposal on section

4(a)(1)(B) of TSCA, finding that HDI is

produced in substantial quantities and

that there is or may be substantial

human exposure from its manufacture,

processing, and use.

EPA has reviewed significant new

scientific data developed since

publication of the proposed rule in

1989. The new data—which address

chronic toxicity, subchronic toxicity,

mutagenicity, and hydrolysis—

significantly affect the final scope of

testing needs for this chemical

substance. In view of the impact of these

developments on the scope of needed

HDI testing, EPA published a notice on

June 12, 1995 (60 FR 30874) (FRL–

4938–2) soliciting testing proposals for

HDI.

II. Enforceable Consent Agreement

Negotiations

In response to EPA’s offer to negotiate

an ECA, the Chemical Manufacturers

Association (CMA) HDI Panel submitted

a proposal for a testing program (Ref. 1).

EPA held a public meeting to

negotiate an ECA for HDI on September

25, 1996. This meeting was attended by

representatives of the Companies and

other interested parties. During the

public meeting, consensus was reached

on the ECA, and on the tests to be

included in the ECA. On August 26,

1997, EPA received the ECA signed by

the Companies. On September 23, 1997,

EPA signed the ECA and accompanying

Order.

III. Proposed Test Rule

EPA has decided not to finalize the

proposed test rule for HDI (54 FR 21240,

May 17, 1989). EPA has instead reached

agreement with the Companies that the

testing requirements for HDI in the

proposed rule will be met by

implementing the ECA and Order, and

that the issuance of the ECA and Order

constitutes final EPA action for

purposes of 5 U.S.C. 704. Should EPA

decide in the future that it requires

additional data on HDI, EPA will

initiate a separate action.

IV. Testing Program

The following table 1 describes the

required testing, test standards, and

reporting requirements under the ECA

for HDI. This testing program will allow

EPA to characterize further the potential

health hazards resulting from exposure

to HDI. The appendices referenced in

this table are specific to the enforceable

consent agreement and are not

appendices in 40 CFR part 798.

Table 1.—Required Testing, Test Standards and Reporting Requirements for HDI

Description of test Test standard Deadline for final

report1 (months)

Interim reports2

required (number)

Genotoxicity:

1. Mammalian cells in culture 798.5300

(40 CFR)

12 1

2. Salmonella Typhimurium 798.5265

(40 CFR)

12 1
51108 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Notices

Table 1.—Required Testing, Test Standards and Reporting Requirements for HDI—Continued

Description of test Test standard Deadline for final

report1 (months)

Interim reports2

required (number)

3. In vivo Cytogenetics 798.5385

(40 CFR)

(Appendix I)

12 1

Developmental Toxicity: One species (rat), inhalation 798.4900

(40 CFR)

(Appendix II)

21 3

Reproductive developmental screen with functional

observational battery; One species (rat), via inhalation OECD 422

(Appendix III)

21 3

2-generation reproductive study3 798.4700

as proposed for revision (59

FR 42272, August 17, 1994)

(Appendix IV)

244 3

1 Number of months after the effective date of the testing consent order. 2 Interim reports are required every 6 months from the effective date until the final report is submitted. This column shows the

number of interim reports required for each test. 3 This study must be conducted if the Agency determines that the results of the reproductive/developmental screening test

show statistically or biologically significant adverse reproductive or developmental effects. If the results of the reproductive/developmental screening test are equivocal, the 2-generation reproductive/developmental study will not be required unless the Agency

concludes that the use of HDI may present an unreasonsable risk to human health or the environment in light of (1) a weight-ofthe-evidence evaluation of HDI’s reproductive/developmental effects, and (2) worker exposure practices and/or manufacturer

product stewardship activities. The Agency shall, in any event, provide the Panel with an opportunity to meet and discuss the

screening test results with the Agency before making a determination under this paragraph. 4 Figure indicates the reporting deadline, in months, calculated from the date of notification to the test sponsor by certified letter of FEDERAL REGISTER notice that the Agency has determined this required testing must be performed.

V. Export Notification

At a later date EPA will propose to

amend 40 CFR 799.5000 by adding HDI

to the list of chemicals subject to testing

consent orders, thereby subjecting all

persons who export or who intend to

export HDI, of any purity, to the export

notification requirements of section

12(b) of TSCA.

VI. Public Record

EPA has established an official record

for this ECA and Order under docket

number OPPTS–42107E, which is

available for inspection from 12 noon to

4 p.m., Monday through Friday,

excluding legal holidays. The official

record is located in the TSCA

Nonconfidential Information Center in

Rm. NE–B607, 401 M St., SW.,

Washington, DC 20460. Information

claimed as Confidential Business

Information (CBI), while part of the

record, is not available for public

review. This record contains the basic

information considered in developing

this ECA and Order and includes the

following information.

A. Supporting Documentation

(1) Testing Consent Order for HDI,

with incorporated Enforceable Consent

Agreement and associated testing

protocols attached as appendices.

(2) Federal Register notices pertaining

to this notice, the Testing Consent Order

and the Enforceable Consent Agreement,

consisting of:

(a) Notice of Proposed Rulemaking for

HDI (54 FR 21240, May 17, 1989).

(b) Notice of Solicitation of Testing

Proposals for 1,6-Hexamethylene

Diisocyanate for Negotiation of a TSCA

Section 4 Enforceable Consent

Agreement (60 FR 30874, June 12,

1995).

(3) Communications consisting of:

(a) Written letters.

(b) Meeting summaries.

(4) Reports—published and

unpublished factual materials.

B. References

1. The Hexamethylene Diisocyanate

Panel of the Chemical Manufacturers

Association. Letter from Langley A.

Spurlock to EPA. Enforceable Testing

Agreement Proposal for 1,6-

Hexamethylene Diisocyanate.

Washington, DC (August 11, 1995).

List of Subjects

Environmental protection.

Dated: September 23, 1997.

Lynn R. Goldman,

Assistant Administrator for Prevention,

Pesticides, and Toxic Substances.

[FR Doc. 97–25893 Filed 9-29-97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

Sunshine Act Meeting; Additional Item

To Be Considered at Open Meeting

Thursday, September 25, 1997

The Federal Communications

Commission will consider an additional

item on the subject listed below at the

Open Meeting scheduled for 9:30 a.m.,

Thursday, September 25, 1997, at 1919

M Street, N.W., Washington, D.C.

Item No., Bureau; and Subject

3—Wireless Telecommunications—

Title: Amendment of the

Commission’s Rules Regarding

Installment Payment Financing for C

Block Personal Communications

Service (PCS) Licenses. (WT Docket

No. 97–82). Summary: The

Commission will consider action

concerning resumption of installment

payments for PCS C and F Block

licensees and other repayment

options for C Block licensees.

The prompt and orderly conduct of

the Commission business requires that

less than 7-days notice be given

consideration of this additional item.

Action by the Commission September

25, 1997, Chairman Hundt and

Commissioners Quello, Ness and Chong

voting to consider this item.