[Federal Register Volume 62, Number 187 (Friday, September 26, 1997)]
[Proposed Rules]
[Pages 50546-50547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25657]


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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

[[Page 50547]]

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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