[Federal Register Volume 62, Number 229 (Friday, November 28, 1997)]
[Proposed Rules]
[Pages 63299-63301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31128]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42187K; FRL-5759-2]
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 December 1, 
1997 to January 9, 1998, 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.

DATES: Written comments on the proposed rule must be received by EPA on 
or before January 9, 1998.

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: For general information, Susan B. 
Hazen, Director, Environmental Assistance Division (7408), Rm. ET-543B, 
Office of Pollution Prevention and Toxics,

[[Page 63300]]

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 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. Due to the complexity of the issues raised by the eight PK 
proposals that the Agency received in response to the HAPs proposal 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. EPA extended the comment period again (62 
FR 50546, September 26, 1997 (FRL-5748-8)), to allow the Agency time to 
complete work on amending the proposed HAPs test rule to incorporate 
the new TSCA 799 test guidelines, revise the economic analysis in 
consideration of the new test guidelines, and to complete preliminary 
technical analyses for each PK proposal. 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 preliminary technical analyses for each PK 
proposal submitted in response to the Agency's June 26, 1996 
solicitation. These include the HAPs chemicals: hydrogen fluoride, 
1,1,2-trichlorethane, ethylene dichloride, maleic anhydride, phthalic 
anhydride, 1,2,4-trichlorobenzene, diethanolamine, 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 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 Office 
of Pollution Prevention and Toxic Substances (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 January 9, 1998.

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

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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: November 20, 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 January 9, 1997.

[FR Doc. 97-31128 Filed 11-26-97; 8:45 am]
BILLING CODE 6560-50-F