[Federal Register Volume 62, Number 135 (Tuesday, July 15, 1997)]
[Proposed Rules]
[Pages 37833-37834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18563]


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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]
BILLING CODE 6560-50-F