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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42187H; FRL-5722-1]

RIN 2070-AC76

Proposed Test Rule for Hazardous Air Pollutants; Extension of

Comment Period on Proposed Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Extension of comment period on proposed test rule.

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SUMMARY: EPA is extending the public comment period from June 30, 1997,

to August 15, 1997, on the proposed rule to require the testing of 21

hazardous air pollutants (HAPs) for certain health effects. This

proposed rule was published in the Federal Register on June 26, 1996

(61 FR 33178)(FRL-4869-1). On March 28, 1997, EPA extended the public

comment period from March 30, 1997, to June 30, 1997 (62 FR 14850)(FRL-

5598-4).

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

or before August 15, 1997.

[[Page 29319]]

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

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

4869-1) to: U.S. 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, U.S. 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, U.S. 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

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], 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 enforcable 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 received several PK proposals. Due to the complexity of

the issues raised by these proposals, 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)) 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.

The HAPs proposed 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 proposed on June 20, 1996 (61 FR

31522)(FRL-5367-7). The process of developing these 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 promulgate final TSCA test guidelines. The Agency will

solicit public comment on the applicability of the test guidelines to

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

July 15, 1997.

EPA analysis of the PK proposals continue. The Agency intends to

provide comments to all submitters of PK proposals as soon as possible

but, at 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. In addition, the Agency believes that the public should

have adequate opportunity to comment on the development of ECAs based

on the PK proposals. If the Agency finds the original or revised PK

proposals acceptable, EPA will therefore announce, in the Federal

Register, one or more public meetings to discuss the proposals and to

negotiate ECAs based on the proposals. In that notice, 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 document

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 document control number [OPPTS-42187A; FRL-4869-1].

Electronic comments on this 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: May 27, 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 August 15, 1997.

[FR Doc. 97-14199 Filed 5-29-97; 8:45 am]

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