[Federal Register Volume 63, Number 76 (Tuesday, April 21, 1998)]
[Proposed Rules]
[Pages 19694-19699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10494]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-42187N; FRL-5780-6]
RIN 2070-AC76
Amended Proposed Test Rule for Hazardous Air Pollutants;
Extension of Comment Period
AGENCY: Environmental Protection Agency (EPA).
ACTION: Amended proposed rule; extension of comment period.
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SUMMARY: EPA is proposing additional amendments to the proposed test
rule (61 FR 33178, June 26, 1996, as amended at 62 FR 67466, December
24, 1997) that was issued under section 4(a) of the Toxic Substances
Control Act (TSCA) that would require manufacturers (including
importers) and processors to test the hazardous air pollutants (HAPs)
specified in the amended proposed test rule for certain health effects.
This second amended proposed test rule modifies the provisions
identifying the persons that would be required to test under the HAPs
rule, and provides additional guidance to persons in determining what
their responsibilities would be
[[Page 19695]]
under the rule. In addition, EPA is extending the public comment period
in order to provide interested persons with sufficient time to consider
the changes described in this proposed rule and to comment accordingly.
DATES: Written comments on this proposed rule must be received by EPA
on or before June 22, 1998. The public comment period on the June 26,
1996, proposed rule and the December 24, 1997, amended proposed rule is
being extended from May 11, 1998 to June 22, 1998.
ADDRESSES: Submit three copies of written comments on the second
amended proposed HAPs test rule, identified by document 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. See
Unit IV. of this preamble for further instructions. The Document
Control Office telephone number is (202) 260-7093.
Comments and data may also be submitted electronically to
oppt.ncic@epamail.epa.gov. Follow the instructions under Unit IV. 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, U.S. 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: 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:
leukroth.rich@epamail.epa.gov.
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 Document service 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 issued a proposed test rule
under TSCA section 4(a), 15 U.S.C. 2603(a), (the ``original HAPs
proposal'') to require health effects testing of the following
hazardous air pollutant chemicals: 1,1'-biphenyl (CAS No. 92-52-4),
carbonyl sulfide (CAS No. 463-58-1), chlorine (CAS No. 7782-50-5),
chlorobenzene (CAS No. 108-90-7), chloroprene (CAS No. 126-99-8),
ortho-cresol (CAS No. 95-48-7), meta-cresol (CAS No. 108-39-4), para-
cresol (CAS No. 106-44-5), diethanolamine (CAS No. 111-42-2),
ethylbenzene (CAS No. 100-41-4), ethylene dichloride (CAS No. 107-06-
2), ethylene glycol (CAS No. 107-21-1), hydrochloric acid (CAS No.
7647-01-0), hydrogen fluoride (CAS No. 7664-39-3), maleic anhydride
(CAS No. 108-31-6), methyl isobutyl ketone (CAS No. 108-10-1), methyl
methacrylate (CAS No. 80-62-6), naphthalene (CAS No. 91-20-3), phenol
(CAS No. 108-95-2), phthalic anhydride (CAS No. 85-44-9), 1,2,4-
trichlorobenzene (CAS No. 120-82-1), 1,1,2-trichloroethane (CAS No. 79-
00-5), and vinylidene chloride (CAS No. 75-35-4). The proposal also
invited the submission of proposals for enforceable consent agreements
(ECAs) for the HAPs chemicals which would include pharmacokinetics (PK)
studies (61 FR 33178, 33189).
The deadline for written comments on the proposed HAPs test rule
contained in the June 26, 1996 Federal Register proposal was December
23, 1996. EPA has successively extended the comment period on this
proposed rule as follows: on October 18, 1996 (61 FR 54383) (FRL-5571-
3), the comment period was extended from December 23, 1996 to January
31, 1997; on December 23, 1996 (61 FR 67516) (FRL-5580-6), it was
extended from January 31, 1997 to March 31, 1997; on February 28, 1997
(62 FR 9142) (FRL-5592-1), it was extended from March 31, 1997 to April
30, 1997; on March 28, 1997 (62 FR 14850) (FRL-5598-4), it was extended
from April 30, 1997 to June 30, 1997; on May 30, 1997 (62 FR 29318)
(FRL-5831-6), it was extended from June 30, 1997 to August 15, 1997; on
July 15, 1997 (62 FR 37833) (FRL-5732-2), it was extended from August
15, 1997 to September 30, 1997; on September 26, 1997 (62 FR 50546)
(FRL-5748-8), it was extended from September 30, 1997 to December 1,
1997; on November 28, 1997 (62 FR 63299) (FRL-5759-2), it was extended
from December 1, 1997 to January 9, 1998; and on February 5, 1998 (63
FR 5915)(FRL-5769-3), it was extended from January 9, 1998 to May 11,
1998. These extensions to the comment period were necessary to allow
the Agency more time to finalize eleven TSCA health effects test
guidelines to be cross-referenced in the amended HAPs test rule
proposal, and to respond to the ECA proposals for PK studies submitted
by industry.
An amended proposed HAPs test rule was published on December 24,
1997 (62 FR 67466) (FRL-5742-2) (the ``first amended proposal'') that:
Used test guidelines codified at 40 CFR part 799, subpart H; removed
the testing requirements for phenol; specified export notification
requirements; reviewed the status of proposals for PK ECAs and invited
ECA proposals for all HAPs chemicals for which proposals had not yet
been received; discussed revisions to the economic assessment;
referenced additional support documents in the rulemaking record;
described modifications to the ``Persons Required To Test'' portion of
the proposed rule; and made other changes and clarifications to the
original proposal. The amended proposed HAPs test rule extended the
comment period from January 9, 1998 to February 9, 1998. On February 5,
1998 (63 FR 5915)(FRL-5769-3), the comment period was extended from
February 9, 1998 to May 11, 1998. This extension was granted by the
Agency in response to requests by the public for additional time in
which to fully consider the changes effected by the first amended
proposal and to adjust industry alliances. Also, in this document, the
Agency clarified the ``Persons Required To Test'' section of the
amended proposed HAPs preamble and the corresponding proposed
regulatory text.
In this second amended proposal, EPA is modifying the provision
regarding the persons that would be required to test under the HAPs
rule and is providing additional information to persons to assist them
in determining what their responsibilities would be under the rule. The
Agency is also extending the public comment period on the amended HAPs
proposed rule from May 11, 1998 to June 22, 1998. This extension is
needed to provide commenters with sufficient time to consider the
changes described in this proposed rule, and to comment accordingly.
For all aspects of the first amended HAPs test rule proposal that
are not addressed by this second amendment to the HAPs proposal, the
discussion in the preamble of the first amended HAPs test rule proposal
continues to apply.
[[Page 19696]]
III. Modifications and Clarifications
EPA is proposing to modify Unit III.C., the ``Persons Required To
Test'' portion of the preamble to the first amended proposed rule (62
FR 67466, 67469-72) and the corresponding section in the proposed
regulatory text at 40 CFR 799.5053(a)(2), ``Persons required to submit
study plans, conduct tests, and submit data'' (62 FR 67466, 67481). The
Agency is also proposing to modify the clarification contained in the
document published at 63 FR 5915, February 5, 1998, and is requesting
comment on the modification. In addition, EPA is making clarifications
concerning the physical states of the HAPs chemicals that are covered
under the proposal, as amended. The clarifications and modifications
are described in detail below.
A. Timeframe During Which Persons Would Be Subject to the Rule
The original HAPs proposal stated that persons who manufacture
(including import) or process, or who intend to manufacture (including
import) or process, any of the HAPs chemicals included in the rule,
other than as an impurity, would be subject to the rule (61 FR 33178,
33189). The original proposal did not distinguish among persons subject
to the rule based on low-volume production beyond the provisions of 40
CFR 790.42(a). The regulations at 40 CFR 790.42(a) provide that, while
legally subject to a test rule, processors, persons who manufacture
less than 500 kg (1,100 lbs) of the chemical annually, and persons who
manufacture small quantities of the chemical solely for research and
development, are not required to comply with the rule unless directed
to do so by EPA in a subsequent Federal Register document if no
manufacturer has submitted a notice of its intent to conduct testing.
Under the original HAPs proposal, all other manufacturers (including
importers) of HAPs chemicals would have been required to comply with
the rule when promulgated (``initially comply'') (61 FR 33178, 33189-
33190).
In the first amended HAPs proposal, EPA specified the timeframe
during which manufacturing and processing volume calculations would be
made to determine who would be subject to the rule (both those who
would have to initially comply and others). EPA stated in the preamble
and in the proposed regulatory text (40 CFR 799.5053 (a)(2)(ii),
(a)(2)(iv), and (a)(2)(v)) that this timeframe consisted of the last
complete corporate fiscal year prior to the publication of the final
rule (62 FR 67466, 67470, 67481). EPA now proposes that the timeframe
be changed to the last complete calendar year prior to the publication
of the final rule or any successive complete calendar year prior to the
end of the reimbursement period, as defined in 40 CFR 791.3(h). The
Agency would base its determination concerning which persons would be
subject to the rule on the amount of manufacturing (including
importing) or processing of a HAP chemical at a facility during the
last complete calendar year prior to the publication of the final rule
or during any complete calendar year until the expiration of the rule
at the end of the reimbursement period. In the past, EPA has covered
persons under test rules where they manufactured (including imported)
or processed a test rule chemical between the effective date of the
rule and the end of the reimbursement period. See, e.g., 40 CFR
799.1053(b)(1); 40 CFR 799.1560(b); 40 CFR 799.1575(b); 40 CFR
799.1645(b); 40 CFR 799.1700(b); 40 CFR 799.2155(b). The Agency
believes that determining which persons would be subject to the test
rule based on the period during which the rule is in effect is more
appropriate for purposes of obtaining the needed testing and
reimbursement than restricting the timeframe to one year alone, as
would have been the result under the first amended proposal.
EPA is proposing to use the calendar year as the time period within
which to measure chemical manufacturing (including importing) and
processing rather than the corporate fiscal year as a more convenient
time period for potentially regulated persons to determine whether they
are subject to the rule. This approach would be consistent with
reporting requirements in other regulations, such as the Toxic Release
Inventory reporting regulations (40 CFR 372.30(a)), under the Emergency
Planning and Community Right-To-Know Act (EPCRA), 42 U.S.C. 11023. EPA
invites comment on this modification to the ``Persons Required To
Test'' provisions of the first amended proposed rule.
B. Threshold and De Minimis Provisions
As EPA discussed in its clarification of February 5, 1998 (63 FR
5915, 5917), the language in both the preamble and proposed regulatory
text of Sec. 799.5053 of the first amended proposal that indicates what
persons would be subject to the HAPs test rule and when they would have
to comply is ambiguous.
Those persons who would be required to initially comply with the
HAPs rule are: Any person who, during the last complete calendar year
prior to the publication of the final rule in the Federal Register, and
any person who, in any successive complete calendar year prior to the
end of the reimbursement period, manufactures (including imports) at a
particular facility any of the HAPs chemicals included in the first
amended proposed rule in an amount of 25,000 lbs or more (regardless of
the form of the HAP chemical, e.g., 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). ``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. In determining whether the 25,000 lbs threshold has
been met for a particular HAP chemical, persons are not to take into
account 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 1 percent by weight of the chemical
substance or mixture.
For example, if a person manufactures 9,000,000 lbs of a petroleum
refinery stream during a given calendar year at a particular facility,
30,000 lbs of which is a HAP chemical that is a component of the
stream, that person would not take into account this amount of HAP
chemical when determining whether the 25,000 lbs threshold has been met
for the year at that facility because the HAP chemical component
consists of less than 1 percent by weight of the total stream.
Similarly, if a person manufactures 500,000 lbs of a complex mixture
during a given calendar year at a facility, 10,000 lbs of which is a
HAP chemical byproduct that is a component of the complex mixture, that
person would not be required to initially comply with the rule on the
basis of its manufacture of the HAP chemical in the complex mixture
alone. This result is due to the fact that, although the HAP chemical
component consists of at least 1 percent by weight of the total complex
mixture, the total amount of HAP chemical manufactured at that facility
is less than 25,000 lbs. (Note that his answer assumes that the person
is not manufacturing the same HAP in other forms at the same facility.)
In this second amended proposal, EPA is proposing regulatory language
(40 CFR 799.5053 (a)(2)(ii) and (a)(2)(iv)) that would replace the
language that was proposed in the first amended proposed
[[Page 19697]]
rule at 40 CFR 799.5053 (a)(2)(ii), (a)(2)(iv) and (a)(2)(v) (62 FR
67466, 67481).
C. Physical State of Chemical
EPA is clarifying that the persons that would be subject to the
proposed HAPs test rule, as amended, are those who manufacture
(including import) or process a chemical included in the proposed rule,
as amended, in any physical state (i.e., solid, liquid, or gas).
Persons should refer to the Chemical Abstracts Service Registry Numbers
in the proposed rule, as amended, to determine which chemicals would be
covered under the rule.
IV. 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 second amended
proposed rule 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:
oppt.ncic@epamail.epa.gov
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 second amended proposal may be filed online
at many Federal Depository Libraries.
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.
V. Regulatory Assessment Requirements
EPA's analysis in the first amended proposed rule of the regulatory
assessment requirements for the HAPs rulemaking (62 FR 67466, 67477-81)
is not altered by the amendments proposed in this second amended
proposed rule. The discussion provided in the first amended proposed
rule regarding the applicable regulatory assessment requirements is
still applicable. This second amended proposed rule includes new
sections to address the requirements of Executive Order 12875 and the
National Technology Transfer Advancement Act.
A. Economic Assessment
In conjunction with the issuance of the first amended HAPs
proposal, EPA prepared a revised economic assessment entitled
``Economic Assessment for the Amended Proposed TSCA Section 4(a) Test
Rule for 21 Hazardous Air Pollutants,'' OPPT/EETD/EPAB, November 14,
1997. (See document referenced in Unit V.H.1 of the preamble to the
first amended HAPs proposal (62 FR 67466, 67476), located in the docket
for this rulemaking). This report evaluates the potential for
significant economic impacts as a result of the testing on the HAPs
chemicals required under the first amended HAPs proposal, which is
identical to the testing required under this second amended HAPs
proposal. Although the number of manufacturers (including importers)
and processors subject to the HAPs test rule under the second amended
proposal may be greater than under the first amended proposal, the
conclusions of the economic assessment are not affected. The economic
assessment analyzes the economic effect of testing on a chemical-by-
chemical basis by comparing unit test costs to the chemical sales
price. (The analysis for carbonyl sulfide is similar, but uses the
sales price of a related chemical. See U.S. EPA, ``Economic Assessment
for the Amended Proposed TSCA Section 4(a) Test Rule for 21 Hazardous
Air Pollutants.'') This measure of economic impact depends on total
annualized test costs, total supply of the chemical, and the sales
price of the chemical (none of which is affected by the second amended
HAPs proposal). This measure is unrelated to the number of persons
subject to the rule. Therefore, the Agency continues to believe that
the HAPs test rule, if finalized according to this second amended
proposal, will not impose any significant economic impact.
B. Executive Order 12866 and Executive Order 12898; Unfunded Mandates
Reform Act; Executive Order 12875
Because the overall costs associated with testing under this second
amended HAPs proposal are expected to be the same as those associated
with testing under the first amended proposal, the second amended
proposal does not contain any provisions that would require additional
consideration by the Office of Management and Budget (OMB) under
Executive Order 12866, entitled ``Regulatory Planning and Review'' (58
FR 51735, October 4, 1993) or Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994). Similarly,
the second amended proposal does not require any actions under Title II
of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). The
Agency's activities related to these regulatory assessment requirements
are discussed in the original proposed rule (61 FR 33178, 33195-96). In
addition, the obligations imposed by Executive Order 12875, entitled
``Enhancing the Intergovernmental Partnership'' (58 FR 58093, October
28, 1993) are addressed in the discussion of UMRA in the original
proposed rule (61 FR 33178, 33196).
C. Regulatory Flexibility Act
For the original proposed HAPs test rule, EPA determined under
section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et
seq., that the HAPs test rule, if finalized as proposed, would not
result in a significant impact on small businesses. See Unit XI.B. of
the preamble to the original HAPs proposal (61 FR 33178, 33196). An
additional document was prepared under the first amended proposal to
provide information on small entity impacts. (See document referenced
at
[[Page 19698]]
Unit V.H.3 of the preamble to the first amended HAPs proposal (62 FR
67466, 67476-77)). The analysis contained in that document, which is in
the record for this proposed rule, also applies to this second amended
proposed rule. This analysis used the most recent single year of data
available at the time of the analysis to provide further information on
the potential economic impact of the proposed test rule on small
entities. EPA believes that these data are representative of the
universe of manufacturers and importers of the HAPs chemicals that
would be subject to the second amended proposed rule.
As indicated in the first amended proposal (62 FR 67466, 67479),
EPA does not believe that the impacts described in the analysis
constitute a significant economic impact on a substantial number of
small entities. The analysis states that the worst-case estimate shows
that, on a HAP chemical by HAP chemical basis, a total of 8
manufacturers/importers (out of 365 manufacturers/importers initially
burdened) may be affected by the rule. No manufacturers/importers for
whom revenue data were available would be impacted by test costs that
exceed 1 percent of their sales. For 8 manufacturers/importers whose
revenues could not be determined, the size of the testing burden could
not be determined and, therefore, the potential for impacts at greater
than 1 percent of sales could not be ruled out. Nevertheless, in this
context the rule would not likely have a significant economic impact on
a substantial number of small entities because any impacts of 1 percent
or greater would affect fewer than 100 small entities. While some small
entities not identified in EPA's analysis may become subject in
subsequent years as a result of the changes made in the second amended
HAPs proposal, EPA believes that it is unlikely that sufficient numbers
of small entities would begin manufacturing or importing the HAPs
chemicals in sufficient amounts to alter the conclusions of this
analysis.
Therefore, the Agency continues to certify that the HAPs test rule,
if finalized according to this second amended proposal, will not have a
significant economic impact on a substantial number of small entities.
Any comments regarding the impacts that this proposed rule may
impose on small entities should be transmitted to the Agency in the
manner specified under ``ADDRESSES'' at the beginning of this document.
D. Paperwork Reduction Act
The information collection requirements associated with test rules
under TSCA section 4(a) in general have been approved by OMB pursuant
to the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (PRA), under OMB
control number 2070-0033 (EPA Information Collection Request (ICR) No.
1139). The information collection requirements contained in this second
amended proposed rule, however, are not effective until the final rule
is published, at which point the total estimated burden hours will be
added to the total burden approved by OMB under control number 2070-
0033. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information subject to OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations, after initial display in the preamble of the final rules,
are listed in 40 CFR part 9.
The list of public reporting burdens for the collection of
information for chemical substances under the first amended proposed
HAPs test rule, as well as the figures for the total public reporting
burden and the overall average per chemical (see Unit VI.D. of the
preamble, ``Paperwork Reduction Act,'' 62 FR 67466, 67479-80), were
different from the figures used in the original HAPs proposal (see Unit
XI.C. of the preamble, ``Paperwork Reduction Act,'' 61 FR 33178,
33196). However, the public reporting burdens under the first amended
proposed HAPs test rule and the second amended proposed HAPs test rule
are anticipated by EPA to be the same. The burdens calculated for the
first amended proposal were based on the tests required for each
chemical. The testing requirements are not changed by the second
amended proposed rule.
Comments are requested on the Agency's need for the information set
out in the first amended HAPs proposal, the accuracy of the provided
burden estimates, and any suggested methods for minimizing respondent
burden, including through the use of automated collection techniques.
Send comments to EPA as part of your overall comments on this proposed
rule in the manner specified under ``ADDRESSES'' at the beginning of
this document, or to the Director, OPPE Regulatory Information
Division, U.S. Environmental Protection Agency (Mail Code 2137), 401 M
Street, SW., Washington, DC 20460, with a copy to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
725 17th St., N.W., Washington, DC 20503, marked ``Attention: Desk
Officer for EPA.'' Please remember to include the OMB control number in
any correspondence. In developing the final rule, the Agency will
address any comments received regarding the information collection
requirements contained in this proposal, as amended.
E. Executive Order 13045
As stated in the first amended HAPs proposal (62 FR 67466, 67480-
81), the proposed HAPs test rule does not require special consideration
by OMB pursuant to the terms of Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997).
F. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Pub. L. No. 104-113, section 12(d) (15 U.S.C. 272
note), directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA requires EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
EPA is required under section 4 of TSCA to impose prescriptive test
requirements in test rules developed under section 4 and to review
their adequacy periodically. The testing that would be required under
this rulemaking would be conducted according to enforceable test
standards based on the health effects test guidelines (40 CFR part 799,
subpart H) that are cross-referenced in the first amended HAPs proposal
(62 FR 67466, 67467-67469, December 24, 1997). These guidelines are
based on harmonized guidelines that were developed through a process
that included informal opportunity for public input, and that are, in
some cases, internationally accepted. The guidelines were issued on
August 15, 1997 (62 FR 43820). Both the August 15, 1997 and the
December 24, 1997 Federal Register documents discuss the background to
the guidelines.
The acute testing guideline is modified in the proposed regulatory
text at Sec. 799.5053(b)(2) (62 FR 67466, 67484-
[[Page 19699]]
67485) to require the appraisal of pulmonary irritation during exposure
to a HAP chemical through the use of the mouse respiratory sensory
irritation assay method developed by the American Society for Testing
and Materials (ASTM), a voluntary consensus standard body (ASTM.
``Standard Test Method for Estimating Sensory Irritancy of Airborne
Chemicals'' In: 1984 Annual Book of ASTM Standards. Water and
Environmental Technology. Section 11. Volume 11.04 Designation E-981-
84, pp. 572-584 (1984)). This method assesses the breathing patterns of
test animals.
The testing of bronchoalveolar lavage fluid under the subchronic
testing guideline is modified as described in the proposed regulatory
text at Sec. 799.5053(b)(3)(ii) (62 FR 67466, 67485) to include a
phagocytosis assay using the procedure of Burleson (Burleson, G.R. et
al. ``Poly (I): poly (C)-enhanced alveolar peritoneal macrophage
phagocytosis: Quantification by a new method utilizing fluorescent
beads.'' Proceedings of the Society for Experimental Biology and
Medicine. 184:468-476 (1987)) or Gilmour and Selgrade (Gilmour, G.I.,
and Selgrade, M.K. ``A Comparison of the Pulmonary Defenses against
Streptococcal Infection in Rats and Mice Following O3 Exposure:
Differences in Disease Susceptibility and Neutrophil Recruitment.''
Toxicology and Applied Pharmacology. 123:211-218 (1993)) to determine
macrophage activity.
EPA is not aware of any other potentially applicable voluntary
consensus standards which needed to be considered in lieu of the
guidelines at 40 CFR part 799, subpart H, that are cross-referenced in
this rulemaking. The Agency invites comment on the potential use of
voluntary consensus standards in this rulemaking, including the
identification of and information about other standards which the
Agency could consider.
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals, Hazardous substances,
Incorporation by reference, Reporting and recordkeeping requirements.
Dated: April 13, 1998.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Accordingly, EPA is extending the comment period on the proposed
rule and the first amended proposed rule from May 11, 1998 to June 22,
1998.
Therefore, it is proposed that 40 CFR chapter I, subchapter R, be
amended as follows:
PART 799--[AMENDED]
1. The authority citation for part 799 would continue to read as
follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
2. Section 799.5053, as proposed to be added at 62 FR 67481-67485,
December 24, 1997, is amended by revising paragraphs (a)(2)(ii) and
(a)(2)(iv) and removing paragraph (a)(2)(v) as follows:
(Note: The regulatory text changes proposed in this second
amended proposal supersede the corresponding changes proposed in the
first amended proposal. All other regulatory text changes proposed
in the first amended proposal that are not changed by this second
amended proposal continue to apply to this rulemaking.)
Sec. 799.5053 Chemical testing requirements for hazardous air
pollutants.
(a) General testing provisions. * * *
* * * * *
(2) Persons required to submit study plans, conduct tests, and
submit data. * * *
* * * * *
(ii) All persons who, during the last complete calendar year prior
to the effective date specified in Table 1 in paragraph (a)(6) of this
section or in any successive complete calendar year prior to the end of
the reimbursement period, as defined at 40 CFR 791.3(h), manufacture
(including import, manufacture as a byproduct as defined in 40 CFR
791.3(c), and manufacture, including import, as an impurity as defined
in 40 CFR 790.3) or process or intend to manufacture or process any
chemical substance specified in Table 1 in the form of a Class 1
substance (as described in 40 CFR 720.45(a)(1)(i)), or a component of a
Class 2 substance (as described in 40 CFR 720.45(a)(1)(i)) or mixture
(as defined in TSCA section 3(8)), but not as a component of a
naturally-occurring substance (as defined in 40 CFR 710.4(b)) or a non-
isolated intermediate (as defined in 40 CFR 704.3), at a facility
shall, with respect to such substance: submit letters of intent to
conduct testing, submit study plans, conduct testing under TSCA Good
Laboratory Practice Standards, and submit data, as specified in this
section and part 792 of this chapter, or submit exemption applications,
as specified in part 790 of this chapter.
* * * * *
(iv) Manufacturers (including importers) of a chemical substance
specified in Table 1 who, during the last complete calendar year prior
to the effective date specified in Table 1 or in any successive
complete calendar year prior to the end of the reimbursement period, at
no facility manufactured (including imported) such substance in an
amount equal to or in excess of 25,000 lbs 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 if 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 lbs threshold specified in this paragraph has been
met.
* * * * *
[FR Doc. 98-10494 Filed 4-20-98; 8:45 am]
BILLING CODE 6560-50-F
