Proposed Test Rule for Hazardous Air Pollutants; Extension of Comment Period

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42187I; FRL-5732-2]

RIN 2070-AC76

Proposed Test Rule for Hazardous Air Pollutants; Extension of

Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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SUMMARY: EPA is extending the public comment period from August 15,

1997, to September 30, 1997, on the proposed rule published in the

Federal Register of June 26, 1996 (61 FR 33178)(FRL-4869-1) requiring

the testing of 21 hazardous air pollutants (HAPs) for certain health

effects. This extension is needed to allow the Agency more time to

respond to the proposals for pharmacokinetics (PK) studies and to

finalize the test guidelines to be referenced in the proposed HAPs test

rule.

DATES: Written comments on the proposed rule must be received by EPA on

or before September 30, 1997.

ADDRESSES: Submit three copies of written comments on the proposed HAPs

test rule, identified by docket control number (OPPTS-42187A; FRL-4869-

1) to: Environmental Protection Agency, Office of Pollution Prevention

and Toxics (OPPT), Document Control Office (7407), Rm. G-099, 401 M

St., SW., Washington, DC 20460.

Comments and data may also be submitted electronically by following

the instructions under Unit II. of this document. No Confidential

Business Information (CBI) should be submitted through e-mail.

FOR FURTHER INFORMATION CONTACT: 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: TSCA-H[email protected].

For technical information contact: 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: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background and General Information

On June 26, 1996 (61 FR 33178), EPA proposed health effects

testing, under section 4(a) of the Toxic Substances Control Act (TSCA),

of the following hazardous air pollutants (HAPs): 1,1'-biphenyl,

carbonyl sulfide, chlorine, chlorobenzene, chloroprene, cresols [3

isomers: ortho-, meta-, para-], diethanolamine, ethylbenzene, ethylene

dichloride, ethylene glycol, hydrochloric acid, hydrogen fluoride,

maleic anhydride, methyl isobutyl ketone, methyl methacrylate,

naphthalene, phenol, phthalic anhydride, 1,2,4-trichlorobenzene, 1,1,2-

trichloroethane, and vinylidene chloride. EPA would use the data

generated under the rule to implement several provisions of section 112

of the Clean Air Act and to meet other EPA data needs and those of

other Federal agencies. In the HAPs proposal, EPA invited the

submission of proposals for pharmacokinetics (PK) studies for the HAPs

chemicals, which could provide the basis for negotiation of enforceable

consent agreements (ECAs). These PK studies would be used to conduct

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 rule.

On October 18, 1996, EPA extended the public comment period on the

proposed rule from December 23, 1996, to January 31, 1997 (61 FR 54383)

(FRL-5571-3). This extension was for the purpose of allowing more time

for the submission of PK proposals and adequate time for comments on

the proposed rule to be submitted after the Agency had responded to the

proposals. EPA has received eight PK proposals (for diethanolamine,

ethylene dichloride, ethylene glycol, hydrogen fluoride, maleic

anhydride, phthalic anhydride, 1,2,4-trichlorobenzene, and 1,1,2-

trichloroethane). In addition, the Agency has received a proposal to

develop a non-PK-related ECA for methyl isobutyl ketone. EPA has agreed

to review the contents of this proposal and to provide comments on its

technical merit and relevance to the proposed HAPs testing

requirements.

Due to the complexity of the issues raised by the PK proposals and

other issues related to test guidelines, EPA successively extended the

public comment period (61 FR 67516, December 23, 1996 (FRL-5580-6); 62

FR 9142, February 28, 1997 (FRL-5592-1); 62 FR 14850, March 28, 1997

(FRL-5598-4); 62 FR 29318, May 30, 1997 (FRL-5722-1)) to allow the

Agency

[[Page 37834]]

more time to respond to the PK proposals and to finalize the test

guidelines to be referenced in the proposed HAPs test rule.

The proposed HAPs rule published on June 26, 1996 (61 FR 33178)

provides that testing would be conducted using the harmonized

guidelines developed by the Office of Prevention, Pesticides and Toxic

Substances (OPPTS) that were published as public drafts on June 20,

1996 (61 FR 31522)(FRL-5367-7). The process of developing these

harmonized guidelines is proceeding at the same time as the development

of the HAPs test rule. For the purposes of the proposed HAPs test rule

and testing under TSCA section 4(a), the Office of Pollution Prevention

and Toxics (OPPT) intends to publish final TSCA test guidelines

developed from the OPPTS harmonized guidelines. The Agency will solicit

public comment on the applicability of the test guidelines as they are

cross-referenced in the HAPs rule and will follow this practice with

respect to all future TSCA section 4(a) test rules. These guidelines

will be published in the Federal Register as soon as possible but in

any event no later than August 29, 1997.

EPA has developed preliminary technical analyses of three PK

proposals (hydrogen fluoride, 1,1,2-trichlorethane, and ethylene

dichloride). Copies of these preliminary technical analyses have been

sent to the submitters and placed in the public record for this action

(OPPTS-42187B, FRL-4869-1). The Agency intends to provide comments to

the submitters of the other PK proposals as soon as possible but in any

event prior to the close of the comment period. EPA also recognizes

that submitters may need to revise their proposals based on EPA

comments. EPA finds that the public should have adequate opportunity to

comment on the development of ECAs based on the PK proposals. If the

Agency decides to proceed with the ECA process, EPA will announce, in

the Federal Register, one or more public meetings to discuss the

proposals and to negotiate ECAs based on the proposals. In that

document, the Agency will solicit persons interested in participating

in or monitoring negotiations for the development of ECAs based on the

revised PK testing proposals. The procedures for ECA negotiations are

described at 40 CFR 790.22(b).

The Agency emphasizes that the submission of proposals to develop

ECAs to conduct alternative testing using PK is no guarantee that EPA

and the submitters will, in fact, conclude such agreements. Therefore,

EPA urges all submitters of PK proposals to comment on the HAPs

proposed rule as an activity separate from the PK proposal/ECA process.

II. Public Record

The official record for this rulemaking, as well as the public

version, has been established for this rulemaking under docket control

number [OPPTS-42187A; FRL-4869-1] (including comments and data

submitted electronically as described below). A public version of this

record, including printed, paper versions of electronic comments, which

does not include any information claimed as CBI, is available for

inspection from 12 noon to 4 p.m., Monday through Friday, excluding

legal holidays. The official rulemaking record is located at the

address in ``ADDRESSES'' at the beginning of this document.

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 in 5.1 file format or

ASCII file format. All comments and data in electronic form must be

identified by the docket control number [OPPTS-42187A; FRL-4869-1].

Electronic comments on the proposed rule may be filed online at many

Federal Depository Libraries.

List of Subjects in 40 CFR Part 799

Environmental protection, Chemicals, Hazardous substances,

Reporting and recordkeeping requirements.

Dated: July 9, 1997.

Charles M. Auer,

Director, Chemical Control Division, Office of Pollution Prevention and

Toxics.

Accordingly, EPA is extending the comment period on the proposed

rule to September 30, 1997.

[FR Doc.97-18563 Filed: 7-14-97; 8:45 am]

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