[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
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(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