[Federal Register Volume 63, Number 24 (Thursday, February 5, 1998)]
[Proposed Rules]
[Pages 5915-5918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2877]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42187M; FRL-5769-3]

RIN 2070-AC76


Amended Proposed Test Rule for Hazardous Air Pollutants; 
Extension of Comment Period; Clarification

AGENCY: Environmental Protection Agency (EPA).

ACTION: Extension of comment period on amended proposed rule; extension 
of deadline for receipt of alternative testing proposals; 
clarification.

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SUMMARY: EPA is extending the public comment period from February 9, 
1998 to May 11, 1998, on the proposed rule published in the Federal 
Register of June 26, 1996 (61 FR 33178) (FRL-4869-1), amended December 
24, 1997 (62 FR 67466) (FRL-5742-2), requiring the testing of certain 
hazardous air pollutants (HAPs) for specific health effects. EPA is 
also extending the deadline for the receipt of proposals for 
enforceable consent agreements (ECAs) for HAPs test rule chemicals for 
which proposals for ECAs have not been received from February 9, 1998 
to March 11, 1998. In addition, EPA is clarifying Unit III.C. ``Persons 
Required to Test'' of the amended proposed HAPs preamble and the 
corresponding proposed regulatory text of the amendment to indicate 
those persons who would be required to initially comply with the HAPs 
rule.

DATES: Written comments on the proposed rule, as amended, must be 
received by EPA on or before May 11, 1998. ECA proposals to provide 
alternative testing to meet HAPs testing requirements must be received 
by EPA on or before March 11, 1998.

ADDRESSES: Submit three copies of written comments on the proposed HAPs 
test rule, as amended, identified by docket control number (OPPTS-
42187A; FRL-4869-1) to: U.S. Environmental Protection Agency, Office of 
Pollution Prevention and Toxics (OPPT), Document Control Office (7407), 
Rm. G-099, 401 M St., SW., Washington, DC 20460. The Document Control 
Office telephone number is (202) 260-7093.
    Submit three copies of ECA proposals to: U.S. Environmental 
Protection Agency, Office of Pollution Prevention and Toxics, Document 
Control Office (7407), Room G-099, 401 M St., SW., Washington, DC 
20460. The Document Control Office telephone number is

[[Page 5916]]

(202) 260-7093. ECA proposals should be labeled: ``ECA Proposal for 
(HAP chemical name) to Provide Alternative Testing to Meet HAPs Rule 
Testing Requirements,'' identified by Document Control Number (OPPTS-
42187B; FRL-5742-2).
    Comments and data may also be submitted electronically to 
[email protected]. Follow the instructions under Unit III. of 
this document. No confidential business information (CBI) should be 
submitted through electronic mail.

FOR FURTHER INFORMATION CONTACT: For additional 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-H[email protected]. For 
technical information contact: Richard W. Leukroth, Jr., Project 
Manager, Chemical Control Division (7405), Office of Pollution 
Prevention and Toxics, U.S. Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460; telephone: (202) 260-0321; fax: (202) 260-
1096; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Electronic Availability

Internet

    Electronic copies of this document and various support documents 
are available from the EPA Home Page at the Federal Register -- 
Environmental Documents entry for this document under ``Laws and 
Regulations'' (http://www.epa.gov/fedrgstr/EPA-TOX/ 1998/).

Fax-On-Demand

    Using a faxphone call 202-401-0527 and select item 4640 for an 
index of available material and corresponding item numbers related to 
this document.

II. Background

    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 (the Agency for Toxic 
Substances and Disease Registry (ATSDR), the National Institute for 
Occupational Safety and Health (NIOSH), the Occupational Safety and 
Health Administration (OSHA), and the Consumer Product Safety 
Commission (CPSC)).
    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 proposals for pharmacokinetics (PK) studies 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 proposals for PK studies that the Agency 
received in response to the HAPs proposal, 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) and 62 FR 63299, November 28, 
1997 (FRL-5759-2)) to allow the Agency more time to complete work on 
amending the proposed HAPs test rule.
    On December 24, 1997 (62 FR 67466) (FRL-5742-2) EPA amended the 
proposed test rule to cross-reference new TSCA test guidelines 
(codified at 40 CFR part 799, subpart H), remove the testing 
requirements for phenol, specify export notification requirements, 
revise the economic assessment, include additional support documents in 
the rulemaking record, and describe other changes and clarifications to 
the proposed test rule. In addition, the amendment invited ECA 
proposals for all of the HAPs chemicals for which ECA proposals had not 
been received to provide for alternative testing to meet the 
requirements contained in the amended HAPs proposal.
    In the proposed HAPs rule, 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. The Agency received PK proposals 
for eight HAPs chemicals: diethanolamine (CAS No. 111-42-2), ethylene 
dichloride (CAS No. 107-06-2), ethylene glycol (CAS No. 107-21-1), 
hydrogen fluoride (CAS No. 7664-39-3), maleic anhydride (CAS No. 108-
31-6), phthalic anhydride (CAS No. 85-44-9), 1,2,4-trichlorobenzene 
(CAS No. 120-82-1), and 1,1,2-trichloroethane (CAS No. 79-00-5). By 
notice in the Federal Register, EPA announced the date for a meeting to 
conduct ECA negotiations on seven of these chemicals (diethanolamine 
(63 FR 3109, January 21, 1998) (FRL-5766-7); ethylene glycol (63 FR 
3111, January 21, 1998) (FRL-5766-6); phthalic anhydride (63 FR 1469, 
January 9, 1998) (FRL-5765-3) ; hydrogen fluoride (63 FR 1467, January 
9, 1998) (FRL-5765-5); maleic anhydride (63 FR 1464, January 9, 1998) 
(FRL-5765-1); 1,1,2-trichloroethane (62 FR 66628, December 19, 1997) 
(FRL-5763-2); and ethylene dichloride (62 FR 66626, December 19, 1997) 
(FRL-5763-1)). Negotiating meetings on 1,1,2-trichloroethane and 
ethylene dichloride were held on January 12, 1998. The PK ECA 
negotiations will proceed on a separate but parallel track from the 
HAPs rulemaking process. EPA urges all persons participating in ECA 
negotiations to comment on the amended proposed HAPs rule as an 
activity separate from the PK proposal/ECA process.
    EPA has received requests for additional time to respond to the 
amended HAPs proposal (see documents referenced in Unit III. of this 
document). These requestors state that they would be unable to give 
full consideration of, or respond appropriately to, Unit III. C., `` 
Persons Required to Test`` (62 FR 67466, 67469-67472) of the amended 
HAPs proposal before the current close of the comment period. These 
persons assert that the Agency's proposed changes, that modify criteria 
for determining persons who would be subject to the HAPs test rule and 
when they would have to comply with the rule, form a new policy that 
results in the need to adjust the composition of groups or alliances 
previously formed to address testing under the HAPs proposal. 
Furthermore, these persons indicate that changes in the composition of 
testing alliances may result in the need to assess whether

[[Page 5917]]

comments and positions developed previously in this rulemaking process 
should be revised.
    The Agency maintains that the proposed changes made in the 
``Persons Required to Test'' section of the amended HAPs proposal would 
provide an equitable means to determine which entities would be 
responsible for testing HAPs chemicals. The amended proposal 
distinguished those persons who, although subject to the rule, would 
not be required to comply with the rule unless directed to do so by EPA 
in a subsequent notice if no manufacturer has submitted a notice of its 
intent to conduct testing from those persons who would be required to 
comply with the requirements of the rule when promulgated (``initially 
comply'').
    It has been brought to the attention of the Agency that the 
language (in both the preamble and the regulatory text) used to 
determine what persons would be subject to the HAPs test rule and when 
they would have to comply with the rule is ambiguous. The Agency is 
therefore clarifying who would be required to initially comply with the 
HAPs rule with regard to a particular HAP chemical, namely, any person 
who has, during the last complete corporate fiscal year prior to the 
publication of the final rule in the Federal Register, manufactured 
(including imported) the HAP chemical at any facility in an amount 
equal to or in excess of 25,000 lb (regardless of the form of the HAP 
chemical, i.e., as a Class 1 substance, as a component of a mixture, as 
a byproduct, as an impurity, as a component of a Class 2 substance, or 
as an isolated intermediate). The amount of a HAP chemical that is 
manufactured (including imported) as a component of a chemical 
substance or mixture at a concentration of less than one percent by 
weight is not to be taken into account in determining whether the 
25,000 lb threshold has been met. (``Naturally occurring substances,'' 
as described at 40 CFR 710.4(b), and non-isolated intermediates, as 
defined at 40 CFR 704.3, are not to be considered in determining 
whether a person is responsible for HAP chemical testing.)
     EPA requests that comments on the amended proposal be submitted 
with this clarification in mind. Regulatory text which would be more 
clear than that in the amended proposal might, rather than including 
both paragraphs (iv) and (v) in Sec. 799.5053(a)(2) as published in the 
amended proposal, include a single paragraph, Sec. 799.5053(a)(2)(iv), 
that might read as follows:

    (iv) Manufacturers (including importers) of a chemical substance 
specified in Table 1 who, during the last complete corporate fiscal 
year prior to the effective date specified in Table 1, at no 
facility manufactured such substance in an amount equal to or in 
excess of 25,000 lb must comply with the requirements of the rule 
with regard to such substance only if directed to do so by EPA in a 
subsequent notice because no manufacturer has submitted a notice of 
its intent to conduct testing. A chemical substance specified in 
Table 1 that is manufactured (including imported) as a component of 
another chemical substance or mixture in which the proportion of the 
substance specified in Table 1 is less than one percent by weight is 
not to be taken into account in determining whether the 25,000 lb 
threshold specified in this paragraph has been met.

    EPA acknowledges that some additional time may be required for 
members of the public to give full consideration to the changes in the 
amended HAPs proposal and the clarification contained in this document, 
to adjust existing testing alliances, and to seek additional members of 
groups or alliances to conduct testing. However, the Agency does not 
believe that changes to existing testing alliances would likely result 
in the need to make new comments regarding the testing requirements in 
the amended proposal because these requirements have not changed 
substantially from those originally proposed. The Agency emphasizes 
that the data called for under the amended HAPs proposal are needed to 
meet requirements under section 112 of the Clean Air Act, and that 
these data are also needed for other government organizations (ATSDR, 
NIOSH, OSHA, CPSC) to meet the needs of their programs. With this 
general understanding, EPA has weighed these requests to extend the 
comment period with the need to move forward with testing of these HAPs 
chemicals and agrees to extend the comment period until May 11, 1998.
    In the December 24, 1997 amended HAPs proposal, EPA invited the 
submission of proposals for ECAs on all the HAPs chemicals for which 
ECA proposals have not been received. The Agency indicated that such 
proposals must clearly describe the rationale for proposing an 
alternative testing program, detail the full extent of the testing to 
be performed under the proposal, and describe how the proposed testing 
would meet the testing requirements contained in the amended HAPs 
proposal. EPA will review proposal submissions and may select 
candidates for ECA negotiations based on the ability of the proposal to 
fulfill the data requirements that are set forth in the amended HAPs 
proposal. If the Agency decides to proceed with the ECA process, it 
will publish a notice in the Federal Register soliciting persons 
interested in participating in or monitoring negotiations for the 
development of ECAs to notify the Agency in writing. EPA will seek to 
complete the development of any ECAs expeditiously, and, whenever 
possible, will work to complete such agreements within 12 months from 
the date of the Agency's acceptance of the proposal. The deadline for 
the receipt of alternative testing ECA proposals is being extended from 
February 9, 1998 to March 11, 1998.

III. Public Record and Electronic Submissions

    The official record for this rulemaking, including the public 
version, which does not include any information claimed as CBI, has 
been established for this rulemaking under document control number 
(OPPTS-42187A; FRL-4869-1). This docket also includes all material and 
submissions filed under docket number OPPTS-42193 (FRL-5719-5), the 
record for the rulemaking for the TSCA test guidelines, and all 
material and submissions filed under docket number OPPTS-42187B (FRL-
4869-1), the record for the receipt of proposals for developing ECAs 
for alternative testing of HAPs chemicals. This record contains the 
basic information considered by EPA in developing this proposed rule, 
as amended, and appropriate Federal Register documents. The public 
version of this record, including printed, paper versions of electronic 
comments, is available for inspection from 12 noon to 4 p.m., Monday 
through Friday, excluding legal holidays. The public record is located 
in the TSCA Nonconfidential Information Center, Rm. NE-B607, 401 M St., 
SW., Washington, DC 20460.
    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 5.1/6.1 file format or 
ASCII file format. All comments and data in electronic form must be 
identified by document control number (OPPTS-42187A; FRL-4869-1). 
Electronic comments on this proposed rule, as amended, may be filed 
online at many Federal Depository Libraries.

[[Page 5918]]

    All comments which contain information claimed as CBI must be 
clearly marked as such. Three sanitized copies of any comments 
containing information claimed as CBI must also be submitted and will 
be placed in the public record for this rulemaking. Persons submitting 
information any portion of which they believe is entitled to treatment 
as CBI by EPA must assert a business confidentiality claim in 
accordance with 40 CFR 2.203(b) for each such portion. This claim must 
be made at the time that the information is submitted to EPA. If a 
submitter does not assert a confidentiality claim at the time of 
submission, EPA will make the information available to the public 
without further notice to the submitter. No CBI should be submitted 
electronically.
    In addition to the documents listed in Unit X. of the original HAPs 
proposal and Unit V. of the amended HAPs proposal, the record includes 
the following additional referenced documents:
    1. Letter from M. L. Mullins, Chemical Manufacturers Association to 
Charles M. Auer, EPA, January 5, 1998.
    2. Letter from John F. Murray, Biphenyl Work Group to Charles M. 
Auer, EPA, January 8, 1998.
    3. Contact report from Richard W. Leukroth and Frank Kover, EPA, of 
phone conversation with W. McLeod, American Petroleum Institute, 
January 14, 1998.
    4. Letter from A. Crane, North American Insulation Manufacturers 
Association to C. Auer, EPA, January 9, 1998.
    5. Letter from J. Rucker, American Petroleum Institute to C. Auer, 
EPA, January 15, 1998.

List of Subjects in 40 CFR Part 799

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and record keeping requirements.

Dated: January 30, 1998.

Ward Penberthy,
Acting Director, Chemical Control Division, Office of Pollution 
Prevention and Toxics.

    Accordingly, EPA is extending the comment period on the proposed 
rule to May 11, 1998. EPA is also extending the period for the receipt 
of ECA proposals to provide alternative testing to meet HAPs testing 
requirements to March 11, 1998.
[FR Doc. 98-2877 Filed 2-4-98; 8:45 am]
BILLING CODE 6560-50-F