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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42187F; FRL-5598-4]

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 April 30, 1997

to June 30, 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 February 28, 1997, EPA extended the

public comment period from March 31, 1997 to April 30, 1997 (62 FR

9142)(FRL-5592-1).

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

or before June 30, 1997.

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.

A public version of the official rulemaking record supporting this

action, excluding confidential business information (CBI), is available

for inspection at the TSCA Nonconfidential Information Center, Rm. NE-

B607, 401 M St., SW., Washington, DC 20460, from 12 noon to 4 p.m.,

Monday through Friday, except on legal holidays.

All comments that 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 rulemaking. Persons submitting

information that they believe is entitled to treatment as CBI must

assert a business confidentiality claim in accordance with 40 CFR part

2. 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 treat the information as non-

confidential and may make it available to the public without further

notice to the submitter.

Comments and data may also be submitted in electronic form by

sending electronic mail (e-mail) to: [email protected]. Such

comments and data must be submitted in 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 file format or ASCII

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

identified by (OPPTS-42187A)(FRL-4869-1). No information claimed as CBI

should be submitted through e-mail. Comments in electronic form may be

filed online at many federal depository libraries.

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

version, will be maintained in paper form. EPA will transfer all

comments received electronically into paper form and will place the

paper copies in the official record. The official record is the paper

record maintained at the address listed at the beginning of the

``ADDRESSES'' section of this document.

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: 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

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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) 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 on or before May 30, 1997.

In addition, there has been a delay in finalizing Agency reviews of

the PK proposals. EPA 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. These negotiations will be

conducted under the process described in subpart B of 40 CFR part 790.

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.

Comments on the proposed rule should be submitted as described in the

``ADDRESSES'' section of this document prior to the close of the

comment period.

Accordingly, EPA is extending the comment period on the proposed

rule to June 30, 1997.

List of Subjects in 40 CFR Part 799

Environmental protection, Chemicals, Hazardous substances,

Reporting and recordkeeping requirements.

Dated: March 24, 1997.

Charles M. Auer,

Director, Chemical Control Division, Office of Pollution Prevention and

Toxics.

[FR Doc. 97-7815 Filed 3-27-97; 8:45 am]

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