[Federal Register Volume 73, Number 89 (Wednesday, May 7, 2008)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10121]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Bacillus firmus isolate 1582; Exemption from the Requirement of a
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the Bacillus firmus isolate 1582 or
Bacillus firmus I-1582 on all food/feed commodities when applied/used
as soil applications and seed treatments. AgroGreen 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 an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of Bacillus firmus I-1582.
DATES: This regulation is effective May 7, 2008. Objections and
requests for hearings must be received on or before July 7, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0159. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8097; e-mail address: firstname.lastname@example.org.
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:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 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 applicable 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 Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, as amended by 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. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0159 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before July 7, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0159, by one of the following methods.
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of March 21, 2007 (72 FR 13277) (FRL-8117-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 6F7111) by AgroGreen, Biological Division, Minrav
Infrastructures (1993) Ltd., 3 Habossem Str, P.O. Box 153, Ashdod
77101, Israel. The petition requested that 40 CFR part 180 be amended
by establishing an exemption from the requirement of a tolerance for
residues of Bacillus firmus isolate I-1582 when used as a soil
application or seed treatment. This notice included a summary of the
petition prepared by the petitioner RegWest Company, LLC, 30856 Rocky
Road, Greeley, CO 80631-9375, United States Department of Agriculture
(USDA) and submitted on behalf of AgroGreen. The current representative
for AgroGreen is SciReg, Inc. 12733 Director's Loop, Woodbridge, VA
22192, USA. There were no comments received in response to the notice
Section 408(c)(2)(A)(i) of 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 determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of 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. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require 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 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 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 firmus isolate 1582 (called B. firmus I-1582) (U.S. Patent
No. 6,406,690) is a Microbial Pesticide Control Agent (MPCA). It is
intended to be used as a biological nematode suppressant on fruits,
vegetables, field crops, and on such non-food crops as turf, and
ornamentals. Further information regarding this MPCA can be found in
the Biopesticide Registration Action Document (BRAD) on the
Biopesticides and Pollution and Prevention Division website http://
Studies submitted to the agency were issued Master Record
Identification numbers (MRIDs) and then reviewed by the Biopesticides
and Pollution Prevention Division (BPPD). The Agency also considered
these submissions in light of the new microbial pesticides data
requirements, which became final on December 26, 2007 (72 FR 61002).
The following summaries of the toxicological profile of Bacillus firmus
isolate I-1582 are based on Agency reviews or Data Evaluation Records
(DERs) dated March 05, 2008. These reviews include the following acute
toxicity/pathogenicity studies; oral, dermal, pulmonary and injection.
a. Acute oral toxicity/pathogenicity - rats (OPPTS 885.3050; MRID
#46933007; DER 03/05/2008). Nineteen male and 19 female Sprague-Dawley
rats were each treated by a single oral gavage dose of 0.1 mL per
animal (>108 colony forming unit (cfu) animal) of Bacillus
firmus I-1582 spores. The presented data showed no clinical signs and
no weight loss related to test substance in rats. Bacillus firmus I-
1582 was detected in brain, blood, cecum content, kidneys, lungs, lymph
nodes, and spleen of the treated animals with clearance from the blood
by day 7 and from all other organs by day 14. Necropsy was not
conducted. Based on the presented/submitted data, Bacillus firmus I-
1582 does not appear to be toxic, infective, and/or pathogenic in rats,
when dosed orally at >108 cfu/animal. This study was
classified as ``acceptable'' and the pesticide considered Toxicity
Category IV for acute oral effects.
b. Acute dermal toxicity/pathogenicity - rabbits (OPPTS 885.3100;
MRID #46933008; DER 03/05/2008). Five male and five female New Zealand
White rabbits were each treated with 5,050 milligrams/kilogram/
bodyweight (mg/kg/bwt) Bacillus firmus I-1582 spore suspension applied
to the clipped dorsal trunk in an area of approximately 10% of the body
surface in a dermal occlusion test according to standard laboratory
procedures. Animals were observed for dermal irritation 60 minutes
after patch removal. The test animals were observed for mortality and
clinical signs of toxicity at least three times on the day of treatment
and once daily thereafter for 14 days. The rabbits were euthanized on
day 14 and necropsies were performed. With the exception of one female
that lost weight during the first week, all animals had normal body
weight gain. All rabbits appeared normal during the study and all
survived the study. Very slight to well defined erythema was observed
on day 1 with clearance by day 4. No observable abnormalities were
noted at necropsy. The dermal LD50 for males, females, and
combined was greater than 5,050 mg/kg. Thus, Bacillus firmus I-1582 is
not toxic, infective, or pathogenic via the dermal route of exposure,
and the active ingredient is placed in Toxicity Category IV for acute
c. Acute pulmonary toxicity/pathogenicity - rats (OPPTS 885.3150;
MRID #46933009; DER 03/05/2008). Thirty male and 30 female Sprague-
Dawley rats received 0.1 mL per animal (>108 cfu/animal)
Bacillus firmus I-1582 by intratracheal instillation. The presented
data show no adverse abnormal clinical signs in rats. No test organisms
were detected in any sample from the control rats. All six animals
sacrificed on day 3 had significant cfus (686 to 30,731 cfu/g) in their
lungs. The test organism was detected in brain, blood, cecum content,
kidneys, lungs, lymph nodes, and spleen of the treated animals.
Clearance was observed from the blood, kidneys, and liver by day 7 and
from all other organs by day 14. Necropsy studies were not conducted.
Based on the presented/submitted data, the test organisms were not
toxic, infective and/or pathogenic to rats and the active ingredient
was placed in Toxicity Category IV for acute pulmonary effects.
d. Acute inhalation toxicity (OPPTS 870.1300; MRID # 46933009; DER
03/05/2008). An acute inhalation study was not required for this non-
volatile active ingredient. The Agency also considered the acute
pulmonary study in Unit III.c., the nature of the inert ingredients,
the label requirements for Personal Protective Equipment for workers,
and the potential low exposure associated
with the proposed application methods. Based on its non-volatile
nature, if the pesticide is used as labeled, it will pose minimal to
non-existent risk to non-occupationally-exposed populations via
e. Acute injection toxicity/pathogenicity - rats (OPPTS 885.3200;
MRID # 46933010; DER 03/05/2008). Twenty six male and 26 female
Sprague-Dawley rats each received a dose of 0.1 mL per animal
(>107 cfu/animal), by injection into the tail vein. The
presented data showed no observable clinical signs in treated rats. No
test organisms were recovered in any samples from the control rats. The
test organism was detected in the blood, kidneys, liver, lungs, lymph
nodes, and spleen of the treated rats. Clearance from the brain, blood,
kidneys, lymph nodes, and spleen was established by day 21 after
dosing. Clearance from the cecum and liver was established by day 14
after dosing. Necropsy studies showed no abnormal findings. Bacillus
firmus spores did not appear to be toxic, infective, and/or pathogenic
in rats, when dosed at >107 cfu/animal. The submission is classified as
f. Cell culture (OPPTS 885.3500). This data requirement is only
required for active ingredients that are viruses and not for this type
of bacterial pesticide.
g. Waiver request: Hypersensitivity incidents technical-grade
active ingredient (TGAI) (OPPTS 885.3400; DER 03/05/2008). In addition
to the rationales in Unit III.h., the applicant requested that
hypersensitivity incidents be waived based on there being no adverse
effects of Bacillus firmus or its metabolites to humans or mammals in
literature searches. The request to waive this requirement is not
granted. As required for all pesticides, the Agency requires that
hypersensitivity incidents, should adverse effects occur, must be
reported to comply with section 6(a)(2) 40CFR159.152.
h. Waiver requests for Tiers II and Tier III (OPPTS 885.3550); MRID
#s 46933011; 47024806; DER 03/05/2008). The registrant requested that
the Agency waive the requirement for submission of data to support Tier
II and Tier III requirements for the TGAI.
The following rationales were provided to support requests to waive
submission of the studies
1. The active ingredient, Bacillus firmus strain I-1582, is a
naturally occurring microorganism.
2. No reports of adverse effects of Bacillus firmus or its
metabolites to humans or mammals were found in literature searches.
3. The proposed uses of the proposed End-use Product (EP) are not
expected to result in increased exposure or adverse effects to humans
4. The bacteria count falls to sub-effective levels in the
environment within 90 days of treatment.
5. The submitted studies, MRIDs 46933007, 46933008, 46933009, and
46933010, did not show pathogenicity to animals treated by oral gavage,
dermal application, pulmonary instillation, or intravenous injection.
6. Bacillus firmus was not found on any of eleven lists of
Based on these acceptable rationales and there being no
toxicological, infectivity or pathogenicity concerns in the Tier I
mammalian toxicity data submitted, the Agency granted the request to
waive studies required for Tier II and Tier III testing.
i. Waiver requests: EP and hypersensitivity incidents (OPPTS
885.3400; DER 03/05/2008). The applicant has submitted rationales to
waive data for acute oral toxicity/pathogenicity, acute pulmonary
toxicity/pathogenicity, acute dermal, primary eye, hypersensitivity
study, acute inhalation, and primary dermal, primary eye studies. These
rationales were based on the results of tests for the TGAI discussed in
the toxicological profile in Unit III of this document. In addition to
the rationales in Unit III.h., the applicant reiterated that there were
no reports of adverse effects of Bacillus firmus or its metabolites to
humans or mammals in literature searches.
The request to waive toxicity testing for the EP was based on
acceptable data reviews of the TGAI and the nature of the inert
ingredients which are exempt from the requirement of a tolerance. The
Agency decided to grant the request to waive the test for primary eye
irritation based on the acceptable low acute dermal toxicity category
IV classification of the pesticide. Any potential primary eye
irritation to this low toxcity pesticide can be mitigated by goggles or
personal protective eye equipment. In addition the application rate and
types of soil application and seed treatments indicate minimal to non-
existent risk via eye exposure. The request to waive the requirement
for hypersensitivity incidents for the EP is not granted. As required
for all pesticides, the Agency requires that hypersensitivity
incidents, should adverse effects occur, must be reported to comply
with section 6(a)(2) (40 CFR 159.152).
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of 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 buildings
(residential and other indoor uses).
A. Dietary Exposure
1. Food. Dietary exposure to the microbial pesticide is likely to
occur to this ubiquitous microbe. The lack of acute oral toxicity/
pathogenicity, based on the toxicology test in rats, supports the
exemption from the requirement of a tolerance for this active
ingredient. The pesticide is intended to be applied to the soil or to
be used as seed treatments, mainly for control of nematodes. It is not
systemic. Thus, dietary exposure by direct contact with food is not
expected. The acute oral study described in Unit III indicates that the
active ingredient is not toxic, infective or pathogenic when
administered to mammals (rats) via the oral route. In addition to this
acute oral study, other toxicology studies indicated that the microbe
cleared all organs within the time allotted for the studies.
There is no direct post-harvest treatment of food commodities with
Bacillus firmus I-1582. Thus, detectable residues of Bacillus firmus I-
1582 are not expected on agricultural crops or food commodities as a
result of the proposed use of this active ingredient. All inerts in the
proposed EP are exempt from the requirement of a tolerance. Based on
these observations, the Agency concluded that dietary exposure to
Bacillus firmus I-1582 is not expected to cause harm to human adults,
infants and children.
2. Drinking water exposure. Drinking water is not being screened
for Bacillus firmus I-1582 as a potential indicator of microbial
contamination. The pesticide is not intended for application to aquatic
agricultural crops. In the unlikely event that Bacillus firmus I-1582
was transferred to ground water, the microbe would not survive the
conditions of drinking water treatment, such as chlorination, pH
adjustments, and other water processing conditions. However, because of
the lack of mammalian toxicity, even if negligible oral exposure should
occur through drinking water, the Agency concludes that such exposure
would present no risk.
B. Other Non-Occupational Exposure
The Agency expects non-occupational dermal and inhalation exposure
to pose no harm if the pesticide is used as labeled. The proposed
product is anEP that is intended to be used commercially for seed and
soil treatments of agricultural crops. Other homeowner and residential
uses are also for soil applications outdoors at very low rates. No
indoor residential, school, or daycare uses are currently permitted for
this active ingredient. Even if there is non-occupational residential,
school or day care exposure from the proposed uses of Bacillus firmus
I-1582, the risk posed by this low toxicity microbe is likely to be
1. Dermal exposure. As discussed in Unit III. Bacillus firmus I-
1582 is not toxic, infective, or pathogenic via the dermal route of
exposure, and the active ingredient is placed in Toxicity Category IV
for acute dermal effects. The pesticide is proposed for use as soil and
seed treatments to agricultural crops. For these exposure scenarios,
non-occupational dermal exposure is not expected. The potential for
non-occupational exposure exists for residential and home and garden
use. However, low application rates, soil applications and the low
toxicity potential of the active ingredient indicate that non-
occupational exposure through these uses is not likely to cause harm to
the exposed population if the pesticide is used as labeled.
2. Inhalation exposure. A similar rationale supports the Agency's
conclusion that non-occupational inhalation exposure is not likely to
cause harm to the exposed population if the pesticide is used as
labeled. The active ingredient is placed in Toxicity Category IV on the
basis of the acute pulmonary study (see Unit III.) and is non-volatile.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to
consider the cumulative effect of exposure to Bacillus firmus I-1582
and to other substances that have a common mechanism of toxicity. These
considerations include the possible cumulative effects of such residues
on infants and children. Bacillus firmus I-1582 is not toxic or
pathogenic to mammals via several routes of exposure (Unit III.) There
are no other Bacillus firmus strains registered. Consequently, no
cumulative effects from the residues of this product with other related
microbial pesticides are anticipated.
VI. Determination of Safety for U.S. Population, Infants and Children
See Unit III. for acute toxicological evaluations of Bacillus
firmus I-1582. Further, 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 database on
toxicity and exposure, unless EPA determines that a different margin of
exposure (MOE) (safety) will be safe for infants and children. Margins
of exposure (safety), which often are referred to as uncertainty
factors, are incorporated into EPA risk assessment either directly or
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. Actual exposures to adults and children through diet
are expected to be several orders of magnitude less than the doses used
in the toxicity and pathogenicity tests referenced in Unit III. Thus,
the Agency has determined that an additional margin of safety for
infants and children is unnecessary.
VII. Other Considerations
A. Endocrine Immunotoxicity
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 was a scientific basis for including, as part
of the program, androgen and thyroid hormone systems, in addition to
the estrogen hormone system. EPA also adopted EDSTAC's recommendation
that it include evaluations of potential effects in wildlife.
The Agency has no knowledge of Bacillus firmus I-1582 being an
endocrine disruptor, nor if this microbe is related to any class of
known endocrine disruptors. Consequently, endocrine-related concerns
did not impact the Agency's safety finding for these Bacillus firmus I-
1582 strains. Additional data specifically on the endocrine effects of
this microbial pesticide are not required at this time. When the
appropriate screening and/or testing protocols being considered under
the Agency's Endocrine Disrupter Screening Program (EDSP) have been
developed and implemented, Bacillus firmus I-1582 may be subject to
additional screening and/or testing to better characterize effects
related to endocrine disruption.
As discussed in this document in Unit III. Tier I toxicology data
evaluated for this active ingredient showed clearance in a variety of
tissues and did not trigger Tier III data requirements for
B. Analytical Methods
The acute oral studies discussed in Unit III. demonstrate that the
active ingredient does not pose a dietary risk. In addition, the active
ingredient is not likely to come into contact with the treated food
commodities. Furthermore, the low application rate and non-persistence
on food during applications suggests very low exposure potential via
the dietary route. Since residues are not expected on treated
commodities, the Agency has concluded that an analytical method to
detect residues of this pesticide on treated food commodities for
enforcement purposes is not needed.
Nevertheless, the Agency has concluded that for analysis of the
pesticide itself, microbiological and biochemical methods exist and are
acceptable for enforcement purposes for product identity of Bacillus
firmus I-1582. Other appropriate methods are required for quality
control to assure that product characterization, the control of human
pathogens and other unintentional metabolites or ingredients are within
regulatory limits, and to ascertain storage stability and viability of
the pesticidal active ingredient.
C. Codex Maximum Residue Level
There is no Codex maximum residue level for residues of Bacillus
The results of the studies discussed in Unit III. meet the safety
standards of the 1996 FQPA. They support an exemption from the
requirement of a tolerance for residues of Bacillus firmus I-1582, on
treated food or feed commodities. In addition, the Agency is of the
opinion that, if the microbial active ingredient is used as allowed,
aggregate and cumulative exposures are not likely to harm the adult
human U.S. population, children and infants. Therefore, an exemption
from tolerance is granted for residues of Bacillus firmus I-1582 when
used as soil and seed treatments in/on all food/feed commodities in
response to pesticide petition 6F7111.
IX. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
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 final rule has been
exempted from review under Executive Order 12866, this final 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) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). 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., 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).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance 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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not 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).
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
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: April 23, 2008.
Director, Office of Pesticide Programs
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1282 is added to read as follows:
Sec. 180.1282 Bacillus firmus I-1582; exemption from the requirement
of a tolerance.
An exemption from the requirement of a tolerance is established in/
on all food/feed commodities, for residues of Bacillus firmus I-1582
when used as a soil application or seed treatment.
[FR Doc. E8-10121 Filed 5-6-08; 8:45 am]
BILLING CODE 6560-50-S