[Federal Register Volume 68, Number 117 (Wednesday, June 18, 2003)]
[Rules and Regulations]
[Pages 36476-36480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15129]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0113; FRL-7301-1]
Bacillus Pumilus Strain QST2808; Temporary Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a temporary exemption from the
requirement of a tolerance for residues of the Bacillus pumilus strain
QST2808 in or on all agricultural commodities when applied/used in
accordance with label directions. AgraQuest, Inc. submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA), requesting
the temporary tolerance exemption. This regulation eliminates the need
to establish a maximum permissible level for residues of Bacillus
pumilus strain QST2808. The temporary tolerance exemption will expire
on June 30, 2006.
DATES: This regulation is effective June 18, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0113,
must be received by EPA on or before August 18, 2003.
ADDRESSES: Written objections and hearing requests may be submitted by
mail or through hand delivery/courier. Follow the detailed instructions
as provided in Unit VIII. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Susanne Cerrelli, Biopesticides and
Pollution Prevention Division (7511C), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8077 ; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
[sbull] Crop production/Agriculture (NAICS 111)
[sbull] Animal production (NAICS 112)
[sbull] Food manufacturing (NAICS 311)
[sbull] Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0113. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title --40/40cfr180 --00.html,
a beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of May 3, 2001 (66 FR 22225) (FRL-6773-9),
EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
a pesticide tolerance petition (PP 1G6240), submitted by AgraQuest,
Inc., 1530 Drew Avenue, Davis, CA 95616. This notice included a summary
of the petition prepared by the petitioner AgraQuest, Inc. There were
no comments received in response to the notice of filing.
The petition requested that 40 CFR part 180 be amended by
establishing a temporary exemption from the requirement of a tolerance
for residues of Bacillus pumilus strain QST2808. Section
408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from
the requirement for a tolerance (the legal limit for a pesticide
chemical residue in or on a food) only if EPA
[[Page 36477]]
determines that the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of
the FFDCA defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C) of the
FFDCA requires EPA to give special consideration to exposure of infants
and children to the pesticide chemical residue in establishing a
tolerance and to ``ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to the
pesticide chemical residue. . . .'' Additionally, section 408(b)(2)(D)
of the FFDCA requires that the Agency consider ``available information
concerning the cumulative effects of a particular pesticide's
residues'' and ``other substances that have a common mechanism of
toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
Bacillus pumilus is a ubiquitous and naturally occurring bacteria
found in soil. The results of the acute toxicology and pathogenicity
studies required of the petitioner under section 408(d)(2)(A) of the
FFDCA in support of its petition for a temporary exemption from the
requirement of a tolerance for Bacillus pumilus strain QST2808 indicate
negligible to no mammalian toxicity. In addition, no pathogenicity was
observed in any of the tests conducted with the Bacillus pumilus strain
QST2808 Technical product.
The toxicology and pathogenicity data generated by AgraQuest, Inc
in support of this temporary exemption from the requirement of a
tolerance are summarized below.
1. Acute oral toxicity and pathogenicity rats (OPPTS Harmonized
Guideline 885.3050; Master Record Identification Number (MRID) 451366-
04). Fifteen male and fifteen female rats each were administered 4.1 x
109 cfu of Bacillus pumilus strain QST2808 Technical and
observed for 14 days. Based on the data, Bacillus pumilus strain
QST2808 does not appear to be toxic, infective, and/or pathogenic in
rats, when dosed at 4.1 x 109 cfu/animal. Classification:
Acceptable; Toxicity Category IV. (C. Etsitty's Memorandum to John L.
Kough, dated 1/7/02 (hereinafter referred to as ``BPPD Review - 1/7/
02'')).
2. Acute dermal toxicity (OPPTS Harmonized Guideline 885.3100; MRID
451366-05). Five male and five female rabbits were dermally treated
with 2g/kg body weight Bacillus pumilus strain QST2808 Technical for 24
hours and observed for the following 14 days. The acute lethal dose
(LD50) is greater than 2,000 mg/kg. Classification:
Acceptable; Toxicity Category III. (BPPD Review - 1/7/02).
3. Primary eye irritation (OPPTS Harmonized Guideline 870.2400;
MRID 452679-01). Three male rabbits each were administered 0.1 mL of
QST2808 Technical in the everted lower lid of one eye and then observed
for 72 hours. Based on the data, QST2808 Technical showed minimal
effects to the eye. Classification: Acceptable; Toxicity Category IV.
(BPPD Review - 1/7/02).
4. Acute injection toxicity/pathogenicity (OPPTS Harmonized
Guideline 885.3200; MRID 451366-07). Eighteen male and eighteen female
rats each were dosed at 1.6 x 108 cfu Bacillus pumilus
strain QST2808 Technical intravenously and monitored over a period of
28 days. A gross necropsy was performed on all rats. Based on the data,
the test organism was not toxic, infective, or pathogenic to rats.
Classification: Acceptable. (BPPD Review - 1/7/02).
5. Acute pulmonary toxicity/pathogenicity (OPPTS Harmonized
Guideline 885.3150; MRID 451366-06). Eighteen male and eighteen female
rats each were administered 1.6 x 108 cfu Bacillus pumilus
strain QST2808 Technical by a single intratracheal dosage and monitored
over a period of 35 days for clinical signs of toxicity. Necropsy
studies showed no significant signs of abnormalities due to the test
organism. Based on the data, Bacillus pumilus strain QST2808 was not
toxic, infective, and/or pathogenic to rats when dosed at 1.6 x
108 cfu/animal. Classification: Acceptable. (BPPD Review -
1/7/02).
6. Acute Inhalation toxicity (OPPTS Harmonized Guideline 870.1300).
Results of the acute pulmonary toxicity/pathogenicity (MRID 451366-06)
performed with Bacillus pumilus strain QST2808 Technical indicate that
it is not toxic, infective, and/or pathogenic to rats when dosed at 1.6
x 108 cfu/animal. For the purposes of this specific action,
the Agency has determined that the acute pulmonary toxicity/
pathogenicity data are adequate to support and/or fulfill this
particular data requirement.
7. Primary dermal irritation (OPPTS Harmonized Guideline 870.2500;
MRID 452679-02). Each of three male adult rabbits were treated dermally
with 0.5 mL QST2808 Technical for 4 hours and observed for the
following 72 hours. Based on the data, no abnormal clinical signs were
noted. Approximately 60 minutes after patch removal, very slight
erythema was noted on one of the three rabbits with resolution by 24
hours. When dosed with QST2808 Technical at 0.5 mL/animal, QST2808
Technical was essentially non-irritating. Classification: Acceptable;
Toxicity Category IV. (BPPD Review - 1/7/02).
8. Hypersensitivity incidents (OPPTS Harmonized Guideline
885.3400). The registrant reported (November 1, 2000) no incidents to
date.
9. Immune response. There is no information to suggest that
Bacillus pumilus strain QST2808 has an effect on the immune system. The
submitted toxicity/pathogenicity studies in rodents indicated that
following several routes of exposure, the immune system is still intact
and able to process and clear the active ingredient (MRID 451366-04;
451366-06, and 451366-07).
Based on the data generated in accordance with the Tier I data
requirements set forth in 40 CFR Sec. 158.740(c), the Tier II and Tier
III data requirements were not triggered and, therefore, not required
in connection with this action. In addition, because the Tier II and
Tier III data requirements were not required, the residue data
requirements set forth in 40 CFR Sec. 158.740(b) also were not
required.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of the FFDCA directs
EPA to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or
[[Page 36478]]
buildings (residential and other indoor uses).
A. Dietary Exposure
Humans and animals are commonly exposed to Bacillus pumilus, a
ubiquitous microorganism that inhabits soil. No toxicological endpoints
were identified for Bacillus pumilus strain QST2808. The low toxicity
and non-pathogenicity/infectivity of Bacillus pumilus strain QST2808 is
demonstrated by the data summarized in Unit III of this action.
1. Food. While the proposed use pattern may result in dietary
exposure with possible residues in or on agricultural commodities,
negligible to no risk is expected for the general population, including
infants and children, or animals because Bacillus pumilus strain
QST2808 technical demonstrated no pathogenicity or oral toxicity at the
maximum doses tested, as noted above in (Unit III).
2. Drinking water exposure. Most importantly, there is no evidence
of adverse effects from oral, dermal, or inhalation exposure to this
microbial agent. (See ``Unit III. Toxicological Profile'' above.) In
addition, the potential for transfer of Bacillus pumilus strain QST2808
to surface or ground water during run-off associated with intended use
applications is considered minimal to non-existent, due in part to its
percolation through and resulting capture in soil. Accordingly, the use
of this microbial pest control agent on terrestrial plants is not
anticipated to negatively impact the quality of drinking water.
B. Other Non-Occupational Exposure
Based on the proposed use patterns, the potential of non-dietary
exposures to Bacillus pumilus strain QST2808 pesticide residues for the
general population, including infants and children, is unlikely.
Accordingly, the Agency believes that the potential aggregate non-
occupational exposure, derived from dermal and inhalation exposure
through the application of Bacillus pumilus strain QST2808, should fall
well below the currently tested microbial safety levels.
1. Dermal exposure. The potential for dermal exposure to Bacillus
pumilus strain QST2808 pesticide residues for the general population,
including infants and children, is unlikely because potential use sites
are agricultural and horticultural. However, since Bacillus pumilus
strain QST2808 is a naturally occurring bacteria in soil, there is a
great likelihood of prior exposure for most, if not all individuals.
Accordingly, the increase in exposure due to this proposed product
would be negligible. Furthermore, and as demonstrated in Unit III of
this action, the organism is of low dermal toxicity, the acute lethal
dose (LD50) is greater than 2,000 mg/kg, and the QST2808
Technical was essentially non-irritating (Toxicity Category IV).
Accordingly, the risks anticipated for this route of exposure are
considered minimal.
2. Inhalation exposure. The potential for inhalation exposure to
Bacillus pumilus strain QST2808 pesticide residues for the general
population, including infants and children is unlikely because
potential use sites are agricultural and horticultural. However, since
Bacillus pumilus is a natural occurring bacteria in soil, there is a
great likelihood of prior exposure for most, if not all individuals.
Accordingly, the increase in exposure due to this proposed product
would be negligible. Furthermore, and as demonstrated in Unit III of
this action, the acute pulmonary toxicity/pathogenicity testing
performed on the technical formulation did not demonstrate
pathogenicity or toxicity of Bacillus pumilus strain QST2808. (See Unit
III above.) Accordingly, the risks anticipated for this route of
exposure are considered minimal.
V. Cumulative Effects
The Agency has considered the potential for cumulative effects of
Bacillus pumilus strain QST2808 and other substances in relation to a
common mechanism of toxicity. These considerations include the possible
cumulative effects of such residues on infants and children. Bacillus
pumilus strain QST2808 is practically non-toxic to mammals. Because no
mechanism of pathogenicity or toxicity in mammals has been identified
for this organism (see Unit III above), no cumulative effects from the
residues of this product with other related microbial pesticides is
anticipated.
VI. Determination of Safety for U.S. Population, Infants and Children
There is a reasonable certainty that no harm to the U.S.
population, including infants and children, will result from aggregate
exposure to residues of Bacillus pumilus strain QST2808 due to its use
as a microbial pest control agent. This includes all anticipated
dietary exposures and all other exposures for which there is reliable
information. As discussed previously, Bacillus pumilus strain QST2808
is not pathogenic or infective and is practically non-toxic to mammals.
(See Unit III above.) Accordingly, exempting Bacillus pumilus strain
QST 2808 from the requirement of a tolerance should be considered safe
and pose no significant risk.
FFDCA section 408(b)(2)(C) provides that EPA shall apply an
additional tenfold margin of exposure (safety) for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and
exposure, unless EPA determines that a different margin of exposure
(safety) will be safe for infants and children. Margins of exposure
(safety) are incorporated into EPA risk assessments either directly
through the use of a margin of exposure analysis or by using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. Due to the ubiquitous nature of Bacillus
pumilus, residues of this microbial pesticide in or on agricultural
commodities are not expected to significantly increase exposure to the
U.S. population, including infants and children. Here, EPA concludes
that the toxicity and exposure data are sufficiently complete to
adequately address the potential for additional sensitivity of infants
and children to residues of Bacillus pumilus strain QST2808 and that
there is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to Bacillus pumilus strain QST2808
residues.
VII. Other Considerations
A. Endocrine Disruptors
EPA is required under section 408(p) of the FFDCA, as amended by
FQPA, to develop a screening program to determine whether certain
substances (including all pesticide active and other ingredients) ``may
have an effect in humans that is similar to an effect produced by a
naturally-occurring estrogen, or other such endocrine effects as the
Administrator may designate.'' Following the recommendations of its
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC),
EPA determined that there is no scientific basis for including, as part
of the screening program, the androgen and thyroid hormone systems in
addition to the estrogen hormone system. EPA also adopted EDSTAC's
recommendation that the program include evaluations of potential
effects in wildlife. For pesticide chemicals, EPA will use FIFRA and,
to the extent that effects in wildlife may help determine whether a
substance may have an effect in humans, FFDCA authority to require
wildlife evaluations. As the science develops and resources allow,
screening of additional hormone
[[Page 36479]]
systems may be added to the Endocrine Disruptor Screening Program
(EDSP). When the appropriate screening and/or testing protocols being
considered under the Agency's EDSP have been developed, Bacillus
pumilus strain QST2808 may be subjected to additional screening and/or
testing to better characterize effects related to endocrine disruption.
To date, the Agency has no information to suggest that Bacillus
pumilus strain QST2808 has an effect on the endocrine systems.
Moreover, as is expected from a non-pathogenic microorganism that is
practically non-toxic to mammals, the submitted toxicity/pathogenicity
studies in rodents indicated that following several routes of exposure,
the immune system is still intact and able to process and clear the
active ingredient. (BPPD Review - 1/7/02).
B. Analytical Method
The Agency proposes to establish an exemption from the requirement
of a tolerance without any numerical limitation for the reasons stated
above, including Bacillus pumilus strain QST2808's lack of mammalian
toxicity. For the same reasons, the Agency has concluded that an
analytical method is not required for enforcement purpose for Bacillus
pumilus strain QST2808.
C. Codex Maximum Residue Level
There is no Codex Alimentarius Commission Maximum Residue Level for
Bacillus pumilus strain QST2808.
VIII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d),
as was provided in the old sections 408 and 409 of the FFDCA. However,
the period for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2003-0113 in the subject line on the
first page of your submission. All objections and requests for hearings
must be in writing, and must be mailed or delivered to the Hearing
Clerk on or before August 18, 2003.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at [email protected],
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VIII.A.,
you should also send a copy of your request to the PIRIB for its
inclusion in the official record that is described in Unit I.B.1. Mail
your copies, identified by docket ID number OPP-2003-0113, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: [email protected]. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
[[Page 36480]]
IX. Statutory and Executive Order Reviews
This final rule establishes a temporary exemption from the
tolerance requirement for Bacillus pumilus strain QST2808 under section
408(d) of the FFDCA in response to a petition submitted to the Agency.
The Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Because this rule
has been exempted from review under Executive Order 12866 due to its
lack of significance, this rule is not subject to Executive Order
13211, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under section 408(d) of the
FFDCA, such as the exemption in this final rule, do not require the
issuance of a proposed rule, the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition,
the Agency has determined that this action will not have a substantial
direct effect on States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule '' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 3, 2003.
James Jones,
Director, Office of Pesticide Programs.
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Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
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2. Section 180.1226 is added to subpart D to read as follows:
Sec. 180.1226 Bacillus pumilus strain QST2808; temporary exemption
from the requirement of a tolerance.
A temporary exemption from the requirement of a tolerance is
established for residues of the microbial pesticide Bacillus pumilus
strain QST2808 when used in or on all agricultural commodities when
applied/used in accordance with label directions.
[FR Doc. 03-15129 Filed 6-17 -03; 8:45 am]
BILLING CODE 6560-50-S