Document ID: EPA-HQ-OPP-2007-0159-0003
Agency: epa
Document Type: Rule
Title: Bacillus firmus isolate 1582; Exemption from the Requirement of a Tolerance
Posted Date: 2008-05-07T04:00Z

[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Rules and Regulations]               
[Page 25524-25528]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my08-12]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0159; FRL-8362-7]

 
Bacillus firmus isolate 1582; Exemption from the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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: bacchus.shanaz@epa.gov.

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:
     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://
www.gpoaccess.gov/ecfr.

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

[[Page 25525]]

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 
of filing.
    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://
www.epa.gov/pesticides/biopesticides.
    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 
dermal effects.
    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

[[Page 25526]]

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 
inhalation.
    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 
acceptable.
    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 
or mammals.
    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 
pathogens searched.
    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.

[[Page 25527]]

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 
minimal.
    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 
immunotoxicity testing.

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 
firmus I-1582.

VIII. Conclusions

    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.

[[Page 25528]]

 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 
note).

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 
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: April 23, 2008.
Debra Edwards,
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), 346a and 371.

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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]

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