[Federal Register Volume 74, Number 66 (Wednesday, April 8, 2009)]
[Rules and Regulations]
[Pages 15865-15869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7172]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0762; FRL-8408-7]


Bacillus subtilis MBI 600; 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 biofungicide, Bacillus subtilis MBI 
600, in or on all food commodities, including residues resulting from 
post-harvest uses, when applied/used in accordance with good 
agricultural practices. Becker Underwood, Inc. submitted a petition to 
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting 
an amendment to expand the existing exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of Bacillus subtilis MBI 600 in or on 
all food commodities.

DATES: This regulation is effective April 8, 2009. Objections and 
requests for hearings must be received on or before June 8, 2009, 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-2008-0762. All documents in the 
docket are listed in the docket index available at http://www.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: Denise Greenway, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8263; e-mail address: <a href="/cdn-cgi/l/email-protection#c3a4b1a6a6adb4a2baeda7a6adaab0a683a6b3a2eda4acb5"><span class="__cf_email__" data-cfemail="197e6b7c7c776e7860377d7c77706a7c597c6978377e766f">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide

[[Page 15866]]

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. 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 electronically available documents 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 e-CFR site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2008-0762 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 June 8, 2009.
    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-2008-0762, by one of the following methods.
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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 Facility'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 November 14, 2008 (73 FR 67512) (FRL-
8388-3), 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 8F7368) by Becker Underwood, Inc., 801 Dayton Ave., P. O. 
Box 667, Ames, IA 50010. The petition requested that 40 CFR 180.1128 be 
amended by expanding the existing exemption from the requirement of a 
tolerance for the biofungicide Bacillus subtilis MBI 600 to cover 
residues in or on all food commodities, including residues resulting 
from post-harvest uses. The notice included a summary of the petition 
prepared by the petitioner Becker Underwood, Inc.
    Previously, on June 8, 1994 (59 FR 29543) (FRL-4865-8), EPA issued 
a final rule granting an exemption from the requirement of a tolerance 
for residues of Bacillus subtilis MBI 600 in or on all raw agricultural 
commodities when applied as a seed treatment on seeds used for growing 
agricultural crops. In submitting this current petition (i.e., 8F7368), 
Becker Underwood, Inc. is relying on the data previously submitted by 
another company, Gustafson, Inc., in support of the existing tolerance 
exemption for Bacillus subtilis MBI 600. These data were previously 
summarized by EPA in the June 8, 1994, final rule. On July 18, 2002, 
EPA issued a Tolerance Reassessment Decision in which it found that the 
existing tolerance exemption for Bacillus subtilis MBI 600 continues to 
meet the FQPA safety standard. This determination in 2002 was based on 
EPA's review of the data on which Becker Underwood, Inc., is now 
relying in connection with this action.
    There was one comment received in response to the notice of filing. 
The commenter expressed dissatisfaction with the level of safety EPA 
provides to Americans. Pursuant to its authority under the FFDCA, EPA 
conducted a comprehensive assessment of Bacillus subtilis MBI 600, 
including a review of studies addressing acute oral, pulmonary and 
intravenous injection toxicity/pathogenicity; acute dermal toxicity; 
primary eye irritation: and skin sensitization. EPA review of these 
studies indicated that the active ingredient is not toxic to test 
animals when administered via the oral, pulmonary, intravenous or 
dermal routes of exposure. In addition, the active ingredient was not 
infective or pathogenic to test animals when administered via the oral, 
pulmonary or intravenous routes. Moreover, no reports of 
hypersensitivity have been recorded in personnel working with this 
organism. Based on these data, the Agency has concluded that there is a 
reasonable certainty that no harm will result from dietary exposure to 
residues of Bacillus subtilis MBI 600 in or on all food commodities, 
including residues resulting from post-harvest uses. Thus, under the 
standard in FFDCA section 408(c)(2), an exemption from the requirement 
of a tolerance is appropriate.
    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

[[Page 15867]]

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.
    Toxicological data on the active ingredient were previously 
submitted to support the existing exemption from the requirement of a 
tolerance for residues of Bacillus subtilis MBI 600 resulting from its 
use in the treatment of seeds used for growing agricultural crops, and 
to support various pesticide product registrations held by the 
petitioner. The previously submitted studies on the active ingredient 
include the following:
    An acceptable acute oral toxicity/pathogenicity study performed in 
rats (MRID 419074-02) demonstrated the lack of mammalian toxicity at 
high levels of exposure to Bacillus subtilis MBI 600. In this study, 
Bacillus subtilis MBI 600 was not toxic, infective nor pathogenic to 
rats given an oral dose of 2 x 10<SUP>8</SUP> colony forming units 
(CFU) per animal. The study resulted in a classification of Toxicity 
Category IV for this strain of Bacillus subtilis.
    An acceptable acute pulmonary toxicity/pathogenicity study in rats 
(MRID 419074-04) demonstrated that Bacillus subtilis MBI 600 was 
neither toxic, pathogenic nor infective to rats dosed intratracheally 
with 3.4 x 10<SUP>8</SUP> CFU of the test material. The study resulted 
in a classification of Toxicity Category IV for this strain of Bacillus 
subtilis.
    An acceptable acute intravenous injection toxicity/pathogenicity 
study in rats (MRID 419074-05) demonstrated that Bacillus subtilis MBI 
600 was neither toxic, pathogenic nor infective to rats dosed 
intravenously with approximately 4 x 10<SUP>7</SUP> CFU of the test 
material. Although the microbe was detected in every organ tested, the 
test material displayed a distinct pattern of clearance. The study 
resulted in a classification of Toxicity Category IV for this strain of 
Bacillus subtilis.
    An acceptable acute dermal toxicity study in rabbits (MRID 419074-
03) demonstrated that Bacillus subtilis MBI 600 was not toxic to 
rabbits when a single 5 x 10<SUP>10</SUP> dose was administered 
dermally. The study resulted in a classification of Toxicity Category 
IV for this strain of Bacillus subtilis.
    An acceptable primary eye irritation study in rabbits (MRID 419074-
06) demonstrated that Bacillus subtilis MBI 600 produced a slight 
ocular irritation when a single 0.1 gram ocular dose was administered. 
Ocular irritation dissipated by day 4. The study resulted in a 
classification of Toxicity Category IV for this strain of Bacillus 
subtilis.
    A supplemental skin sensitization test resulted in an overall 
moderate reaction in guinea pigs 24 to 78 hours post-treatment. 
However, an acceptable dermal sensitization study, conducted with an 
end use formulation, demonstrated no irritation 2 weeks after 
sensitization and treatment using 400 milligrams of test material. As a 
result, the product was determined to not be a dermal sensitizer. 
Furthermore, in the nearly 15 years since its initial registration as 
an active ingredient, there have been no hypersensitivity reports 
associated with Bacillus subtilis MBI 600 pesticide products.

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

    Bacillus subtilis MBI 600 is ubiquitous in the environment, 
especially in soils and agricultural environments (indeed, strain MBI 
600 of Bacillus subtilis is a naturally-occurring isolate of the genus 
Bacillus, originally isolated from faba beans grown at Nottingham 
University School of Agriculture in the United Kingdom). As a result, 
dietary exposure to background levels of the naturally occurring 
microbe likely is already occurring and likely will continue to occur. 
Because of its ubiquitous presence in the environment, the Agency 
expects there to be no increase in exposure to Bacillus subtilis MBI 
600 resulting from the existing and proposed pesticidal uses when 
compared to existing exposure to background levels of Bacillus subtilis 
MBI 600.
    1. Food. As discussed above, dietary exposure to the naturally 
occurring microbe likely is already occurring and likely will continue 
to occur. Notably, similar Bacillus subtilis strains are used 
internationally in the production of food grade products and in 
fermented foods in Japan and Thailand. Reports in the literature 
implicating Bacillus subtilis (as distinguished from the specific 
strain, Bacillus subtilis MBI 600, at issue in this action) in food-
borne illness do not describe any pathogen or toxin production, but 
rather simple spoilage from Bacillus subtilis growth in dough. Such 
low-quality dough would not be suitable for bread production by 
commercial bakeries and so the Agency considers this particular food 
exposure scenario to be unlikely and the risk to be negligible. The 
risk posed to adults, infants and children from food-related exposures 
to Bacillus subtilis MBI 600 is minimal due to the demonstrated lack of 
acute oral toxicity/pathogenicity associated with the microbial 
pesticide. Based on the evaluation of the submitted data, there are no 
dietary risks that exceed the Agency's level of concern.
    2. Drinking water exposure. Because Bacillus subtilis MBI 600 is 
ubiquitous in the environment, exposure to the microbe through drinking 
water may already be occurring and likely will continue to occur. While 
the proposed and existing use sites do not include direct application 
to aquatic environments, the intended use of Bacillus subtilis MBI 600 
is treatment of growing crops or seed for the control of plant disease. 
If such uses were to result in pesticide spray drift or runoff that 
were to reach surface or ground waters, there is the potential for 
human exposure to Bacillus subtilis MBI 600 residues, albeit greatly 
diluted, in drinking water. Municipal drinking water treatment 
processes and deep water wells, however, would both further reduce any 
such residues. More importantly, even if oral exposure to this 
ubiquitous microbe should occur through drinking water, due to its 
demonstrated lack of acute oral toxicity/pathogenicity, the Agency 
concludes that there is a reasonable certainty that no harm will result 
from such exposure.

B. Other Non-Occupational Exposure

    The pesticide uses of Bacillus subtilis MBI 600, both those 
currently allowed and the additional ones being established by this 
rule, are limited to commercial agricultural and horticultural 
settings. There are no residential uses. Nonetheless, because Bacillus 
subtilis MBI 600 is naturally occurring and ubiquitous in the 
environment, the potential for non-dietary, non-occupational exposure 
to

[[Page 15868]]

its residues for the general population, including infants and 
children, is likely since populations have probably been previously 
exposed (and likely will continue to be exposed) to background levels 
of the microbe. However, neither such common human exposures to 
Bacillus subtilis MBI 600 naturally present in soils, waters and 
plants, nor exposures associated with similar Bacillus subtilis strains 
used internationally in producing food-grade products and fermented 
foods, have resulted in reports of disease or other effects. Finally, 
while the literature includes accounts of Bacillus subtilis infections 
in humans (which consistently are reported only in otherwise-
compromised individuals), those reports are most notable for their rare 
and exceptional nature.
    EPA's evaluation of the required high-dose Tier I acute toxicity 
and pathogenicity tests resulted in the assignment of Toxicity Category 
IV (least toxic), and determinations of not infective and not 
pathogenic, for all exposure routes. No toxicological end points of 
concern were identified. There are no dietary endpoints that exceed the 
Agency's Level of Concern (LOC). Therefore, the Agency has determined 
that any additional exposure to the microbe resulting from residues 
attributable to Bacillus subtilis MBI 600 pesticide use will not result 
in additional aggregate non-occupational risk from dermal and 
inhalation exposures. This conclusion, based solely on non-occupational 
exposures, is consistent with EPA's determination that no occupational 
risks exceed the Agency's LOC, meaning that even regular occupational 
exposures associated with this active ingredient pose negligible risk.

V. Cumulative Effects

    No mechanism of toxicity in mammals has been identified for 
Bacillus subtilis MBI 600. Therefore, no cumulative effect with other 
related organisms is anticipated. Because the available data 
demonstrate a lack of toxicity/pathogenicity potential for the active 
ingredient, adverse dietary effects are unlikely.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C), as amended by the Food Quality 
Protection Act (FQPA) of 1996, provides that EPA shall assess the 
available information about consumption patterns among infants and 
children, special susceptibility of infants and children to pesticide 
chemical residues, and the cumulative effects on infants and children 
of the residues and other substances with a common mechanism of 
toxicity. In addition, FFDCA section (b)(2)(C) also provides that EPA 
shall apply an additional tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database, unless EPA 
determines that a different margin of safety will be safe for infants 
and children.
    Based on the acute toxicity information discussed in Unit III., EPA 
concludes that there is a reasonable certainty that no harm will result 
to the United States population, including infants and children, from 
aggregate exposure to residues of Bacillus subtilis MBI 600. This 
includes all anticipated dietary exposures and all other exposures for 
which there is reliable information. The Agency has arrived at this 
conclusion because the data available on Bacillus subtilis MBI 600 
demonstrate a lack of toxicity/pathogenicity potential. Thus, there are 
no threshold effects of concern and, as a result, the Agency has 
concluded that the additional tenfold margin of safety for infants and 
children is unnecessary in this instance. Further, the need to consider 
consumption patterns, special susceptibility, and cumulative effects 
does not arise when dealing with pesticides with no demonstrated 
significant adverse effects.

VII. Other Considerations

A. Endocrine Disruptors

    Bacillus subtilis MBI 600 is a ubiquitous organism in the 
environment that is non-toxic to mammals. To date, there is no evidence 
to suggest that Bacillus subtilis MBI 600 affects the immune system, 
functions in a manner similar to any known hormone, or that it acts as 
an endocrine disruptor. Indeed, the submitted toxicity/pathogenicity 
studies in rodents indicate that, following several routes of exposure, 
the immune system is intact and able to process and clear the active 
ingredient. Therefore, it is unlikely that this organism will have 
estrogenic or endocrine effects.

B. Analytical Method

    The Agency is establishing an exemption from the requirement of a 
tolerance for residues of Bacillus subtilis MBI 600 in or on all food 
commodities, including residues resulting from post-harvest uses, for 
the reasons stated above. Therefore, the Agency has concluded that an 
analytical method is not required for enforcement purposes for 
detecting Bacillus subtilis MBI 600 residues resulting from its use as 
a pesticide.

C. Codex Maximum Residue Level

    No Codex maximum residue level (MRL) exists for Bacillus subtilis 
MBI 600.

VIII. Conclusions

    Based on the toxicity information for Bacillus subtilis MBI 600 
that was previously submitted and reviewed, EPA concludes that there is 
a reasonable certainty that no harm will result to the U.S. population, 
including infants and children, from aggregate exposure to Bacillus 
subtilis MBI 600 under reasonably foreseeable circumstances when used 
as a microbial pesticide in accordance with its label and good 
agricultural practices. This includes all anticipated dietary exposures 
and all other exposures for which there is reliable information. As a 
result, pursuant to FFDCA sections 408(c) and (d) EPA is establishing 
an exemption from the requirement of a tolerance for residues of the 
biofungicide Bacillus subtilis MBI 600 in or on all food commodities, 
including residues resulting from post-harvest uses, when applied or 
used in accordance with good agricultural practices.

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, entitled 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

[[Page 15869]]

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: March 20, 2009.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.1128 is revised to read as follows:


Sec.  180.1128  Bacillus subtilis MBI 600; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biofungicide Bacillus subtilis MBI 600 in or on all 
food commodities, including residues resulting from post-harvest uses, 
when applied or used in accordance with good agricultural practices.

[FR Doc. E9-7172 Filed 4-7-09; 8:45 am]
BILLING CODE 6560-50-S


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