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xtnsn of comment, testing of 21 HAPs for certain health effects
>[Federal Register: November 28, 1997 (Volume 62, Number 229)]
>>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
>ENVIRONMENTAL PROTECTION AGENCY
>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 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@example.com. 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,
>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; e-mail: firstname.lastname@example.org.
> 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://
>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.,
> 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).
>comments on the proposed rule may be filed online at many Federal
>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
>End of EPA-AIR Digest 1078