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Proposed Test Rule for Hazardous Air Pollutants; Extension of Comment Period
40 CFR Part 799
Proposed Test Rule for Hazardous Air Pollutants; Extension of
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule; extension of comment period.
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
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-Hotline@epamail.epa.gov.
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;
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
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
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:
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
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]
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