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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42187J; FRL-5748-8]

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 September 30,

1997 to December 1, 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

amend the HAPs test rule proposal to reference eleven new Toxic

Substances Control Act (TSCA) test guidelines and make other changes

and clarifications to the proposed rule.

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

or before December 1, 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 to

[email protected]. Follow 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:

Electronic Availability: Electronic copies of this document, all

Federal Register support documents, and the eleven TSCA test guidelines

are available from the EPA Home Page at the Federal Register -

Environmental Documents entry under ``Laws and Regulations'' (http://

www.epa.gov/fedrgstr).

I. Background and General Information

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

testing, under section 4(a) of 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

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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

1,1,2trichloroethane). In addition, the Agency has received another

proposal to develop an ECA for an alternative testing program 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); 62 FR 37833, July

15, 1997 (FRL-5732-2)) to allow the Agency more time to respond to the

PK proposals and to finalize the test guidelines to be referenced in

the proposed HAPs test rule. This extension of the comment period is

needed to allow the Agency more time to complete work on amending the

proposed HAPs test rule.

EPA has completed seven preliminary technical analyses for the PK

proposals that were submitted in response to the Agency's solicitation

on June 26, 1996. These include HAPs chemicals: hydrogen fluoride,

1,1,2-trichlorethane, ethylene dichloride, maleic anhydride, phthalic

anhydride, 1,2,4- trichlorobenzene, and ethylene glycol. 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 submitter of the

other PK proposal 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. 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. In that document, the Agency will solicit

persons interested in participating in or monitoring negotiations to

develop ECAs based on: the PK testing proposals or revisions thereof,

EPA's preliminary technical analyses, and additional comments on EPA's

preliminary technical analyses provided by the submitters. 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.

On August 15, 1997, EPA promulgated eleven new TSCA test guidelines

(62 FR 43820)(FRL-5719-5), codified at 40 CFR part 799, subpart H.

These TSCA part 799 test guidelines were developed based on the OPPTS

harmonized guidelines that were developed from the OPPTS guideline

harmonization process. In the original HAPs proposal and subsequent

notices extending the comment period on the rule, EPA indicated that,

for the purposes of this rulemaking and testing under TSCA section

4(a), the Office of Pollution Prevention and Toxics (OPPT) intends to

reference final TSCA test guidelines developed from the OPPTS

harmonized guidelines. The eleven TSCA test guidelines are included in

the record for this rulemaking.

EPA is amending the proposed HAPs test rule to reference the eleven

new TSCA part 799 test guidelines and to seek comment on the guidelines

as referenced in enforceable test standards in the forthcoming amended

HAPs proposal. In addition, the amendment will provide a revised

economic assessment and describe other changes and clarifications to

the proposed test rule. This amendment to the proposed HAPs test rule

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

any event no later than December 1, 1997.

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 in the TSCA

Nonconfidential Information Center, Rm NE-B607, 401 M St., SW.,

Washington, DC.

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: September 22, 1997.

Charles M. Auer,

Chemical Control Division, Office of Pollution Prevention and Toxics.

Accordingly, EPA is extending the comment period on the proposed

rule to December 1, 1997.

[FR Doc. 97-25657 Filed 9-25-97; 8:45 am]

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