[Federal Register Volume 74, Number 149 (Wednesday, August 5, 2009)]
[Rules and Regulations]
[Pages 38970-38974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18472]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0881; FRL-8429-1]


Pasteuria usgae; Temporary Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a temporary exemption from the 
requirement of a tolerance for residues of the microbial pesticide, 
Pasteuria usgae, on strawberries when applied/used as a nematicide in 
accordance with the terms of Experimental Use Permit (EUP) 85004-EUP-1. 
MacIntosh and Associates, Incorporated, 1203 Hartford Avenue, Saint 
Paul, MN 55116-1622 (on behalf of Pasteuria Bioscience, Incorporated, 
12085 Research Drive, Suite 185, Alachua, FL 32615) submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting the temporary tolerance exemption. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Pasteuria usgae in or on strawberries. The temporary 
tolerance exemption expires on December 31, 2010.

DATES: This regulation is effective August 5, 2009. Objections and 
requests for hearings must be received on or before October 5, 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-2008-0881. 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: Jeannine Kausch, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 347-8920; e-mail 
address: <a href="/cdn-cgi/l/email-protection#214a40545242490f4b44404f4f484f44614451400f464e57"><span class="__cf_email__" data-cfemail="2c474d595f4f440246494d42424542496c495c4d024b435a">[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 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.

[[Page 38971]]

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. To access the OPPTS Harmonized Guidelines referenced in this 
document, go direcrly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

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-2008-0881 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 October 5, 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-2008-0881, 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 January 8, 2009 (74 FR 808) (FRL-8394-
2), 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 8G7471) by MacIntosh and Associates, Incorporated, 1203 
Hartford Avenue, Saint Paul, MN 55116-1622 (on behalf of Pasteuria 
Bioscience, Incorporated, 12085 Research Drive, Suite 185, Alachua, FL 
32615). The petition requested that 40 CFR part 180 be amended by 
establishing a temporary exemption from the requirement of a tolerance 
for residues of Pasteuria usgae in or on strawberries. This notice 
included a summary of the petition prepared by the petitioner MacIntosh 
and Associates, Incorporated (on behalf of Pasteuria Bioscience, 
Incorporated). 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 
sections 408(b)(2)(C) and (D) 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.
    Pasteuria, a genus of bacteria, includes a number of species that 
have shown potential in controlling plant-parasitic nematodes. These 
bacteria are obligate endoparasites, organisms that grow internally in 
a limited range of hosts. Pasteuria usgae, a recently discovered 
species, is host-specific for the sting nematode (Belonolaimus 
longicaudatus). This species of Pasteuria is pending recognition by the 
Judicial Commission of the International Committee for Systematic 
Bacteriology. There is sufficient evidence from morphology, host 
specificity, and genomics to justify Pasteuria usgae as a distinct 
species. In developing a product for crop application, such as a use on 
strawberries, the difficulty of growing Pasteuria outside of a nematode 
host has always been an obstacle. This host specificity is at the core 
of EPA's conclusions that Pasteuria usgae may be granted a temporary 
exemption from the requirement of a tolerance. Additional information 
regarding Pasteuria usgae can be found in the biopesticides 
registration action document (BRAD) on the Biopesticides and Pollution 
Prevention Division (BPPD) website: http://www.epa.gov/pesticides/biopesticides.
    Studies submitted to the Agency were issued master record 
identification (MRID) numbers and reviewed by BPPD scientists. The 
following summaries of the toxicological profile of Pasteuria usgae are 
based on an Agency risk assessment memorandum and related data 
evaluation records dated April 9, 2009.
    1. Acute oral toxicity and pathogenicity - rat, (OPPTS Harmonized 
Guideline 885.3050; MRID No. 474267-09). Pasteuria usgae does not 
appear to be toxic and/or pathogenic

[[Page 38972]]

in rats when dosed at 1 x 10<SUP>8</SUP> spores/animal. There were no 
treatment-related clinical signs or necropsy findings in rats receiving 
a single oral dose of 1 x 10<SUP>8</SUP> Pasteuria usgae spores. Three 
males in the microbial pest control agent (MPCA)-treated group gained 
weight through day 14 but lost weight by day 21. All other animals 
gained weight prior to scheduled sacrifice. Microbial enumeration was 
not performed because the testing laboratory showed that the test 
material would not grow on agar media. Therefore, while no significant 
adverse effects were seen, the typical clearance of the microbe could 
not be confirmed. However, because the spores are highly specific to 
sting nematode, infectivity is unlikely to be a concern. This study was 
rated ``Acceptable'' and Pasteuria usgae was classified as Toxicity 
Category IV.
    2. Acute injection toxicity and pathogenicity - rat, (OPPTS 
Harmonized Guideline 885.3200; MRID No. 474267-11). There were no 
treatment-related significant adverse effects seen in the rats 
receiving a single intravenous dose of 10<SUP>8</SUP> Pasteuria usgae 
spores. One treated female lost weight by day 7 but gained weight prior 
to sacrifice on day 14. All other animals gained weight throughout the 
study. All animals survived and appeared normal during the study. No 
abnormalities were observed in any animal at necropsy or in harvested 
organs. No significant variations in organ weight were found between 
different groups or sexes. The acute intravenous LD<INF>50</INF> of 
Pasteuria usgae is greater than 1 x 10<SUP>8</SUP> spores/animal in 
male and female rats. Pasteuria usgae does not appear to be toxic and/
or pathogenic in rats when dosed at 10<SUP>8</SUP> spores/animal. MRID 
No. 474267-09 reported that the microbial enumeration was not done 
because the test material would not grow on agar media. Since microbial 
enumeration was not performed, the infectivity was uncertain. However, 
because the spores are highly specific to sting nematode, infectivity 
is unlikely to be a concern. Pasteuria usgae was not pathogenic as 
tested in this study. This study was rated ``Acceptable'' and Pasteuria 
usgae was classified as Toxicity Category IV.
    3. Acute dermal toxicity - rat, (OPPTS Harmonized Guideline 
885.3100; MRID No. 474267-12). Based on the results of this study, 
Pasteuria usgae does not appear to be toxic in rats when treated with 
2,000 milligrams/kilogram (mg/kg) at 10<SUP>8</SUP> spores/milliliter 
(mL). Thus, the acute dermal LD<INF>50</INF> is greater than 2,000 mg/
kg for 10<SUP>8</SUP> spores/mL in male and female rats. There were no 
treatment-related significant adverse effects seen in the dosed rats. 
Two males and one female had very slight erythema on day 1 with 
clearance by day 4. One male lost weight slightly during the second 
week and one male and two females lost weight during the first week, 
but all gained weight by the end of the study. All other animals gained 
weight throughout the study. This study was rated ``Acceptable'' and 
Pasteuria usgae was classified as Toxicity Category IV.
    4. Acute pulmonary toxicity and pathogenicity - rat, (OPPTS 
Harmonized Guideline 885.3150; MRID No. 474267-10). In an acute 
pulmonary toxicity and pathogenicity assessment, there were no test 
substance-related significant adverse effects seen in rats receiving a 
single dose of approximately 1-3 x 10<SUP>8</SUP> spores of Pasteuria 
usgae. One dosed female exhibited pale lungs. Additionally, one 
untreated control female lost weight by day 21 and another untreated 
control female lost weight by day 14 but gained weight by day 21. One 
MPCA-treated male did not gain weight by day 7 but gained weight 
thereafter. However, all other animals gained weight throughout the 
study. Based on these results, Pasteuria usgae does not appear to be 
toxic and/or pathogenic in rats when dosed at approximately 1-3 x 
10<SUP>8</SUP> spores/animal. Microbial enumeration was not performed 
because the testing laboratory showed that the test material would not 
grow on agar media. Therefore, while no significant adverse effects 
were seen, the typical clearance of the microbe could not be confirmed. 
However, because the spores are highly specific to sting nematode, 
infectivity is unlikely to be a concern. This study was rated 
``Acceptable'' and Pasteuria usgae was classified as Toxicity Category 
IV.
    5. Hypersensitivity Incidents, (OPPTS Harmonized Guideline 
885.3400; MRID No. 474350-02). No hypersensitivity incidents--involving 
Pasteuria usgae and occurring during fermentation, processing, 
formulation, or research--have been reported to the Agency. Any future 
hypersensitivity incidents must be reported per OPPTS Harmonized 
Guideline 885.3400.

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

    Dietary exposure to Pasteuria usgae may occur, mainly through food. 
However, the lack of acute oral toxicity/pathogenicity, based on the 
toxicology test on rats presented in Unit III, along with the inability 
of the microbe to grow outside of a nematode host, support the 
establishment of a temporary exemption from the requirement of a 
tolerance for Pasteuria usgae. Additionally, under 40 CFR 180.1135, a 
similar active ingredient, Pasteuria penetrans, was assessed previously 
and granted a permanent exemption from the requirement of a tolerance 
in or on all raw agricultural commodities, except roots and tubers, 
when used as a nematicide in the production of fruits and vegetables in 
greenhouses (59 FR 66740, December 28, 1994).
    1. Food. The program description for EUP 85004-EUP-1 details 
application timing and methods, which indicate strawberry exposure to 
Pasteuria usgae is unlikely to occur (e.g., Pasteuria usgae 
formulations are applied via overhead spray or broadcast at bed 
formation or prior to planting but only via drip irrigation during 
plant growth). Should exposure to Pasteuria usgae take place during the 
course of EUP 85004-EUP-1, standard practices of washing, cooking, or 
processing fruits will reduce residues of Pasteuria usgae and minimize 
dietary exposure. Any actual dietary exposure is expected to be several 
orders of magnitude lower than the dose used in the acute oral 
toxicity/pathogenicity test referenced in Unit III, during which no 
toxic or pathogenic effects were observed in rats. The Agency concludes 
that there is a reasonable certainty that no harm will result from the 
aggregate exposure to the residues of Pasteuria usgae in food.
    2. Drinking water exposure. Exposure of humans to residues of 
Pasteuria usgae in drinking water is unlikely. The proposed use 
patterns, use sites, and application methods associated with EUP 85004-
EUP-1 do not include direct application to aquatic environments. In the 
unlikely event that Pasteuria usgae is transferred to surface or ground 
water intended for eventual human consumption, the microbe would not 
survive the conditions water is subjected to in a drinking water 
treatment facility, including flocculation, chlorination, pH 
adjustments, and/or filtration. Even if oral exposure should occur 
through drinking water, the Agency concludes that there is a reasonable 
certainty that no harm will result from the exposure to the residues of 
Pasteuria usgae in all the anticipated drinking water

[[Page 38973]]

exposures because of the lack of acute oral toxicity/pathogenicity to 
mammals and the host-specific nature of the microbe, as previously 
described.

B. Other Non-Occupational Exposure

    Potential non-occupational dermal or inhalation exposure is 
considered unlikely for this distinctly agricultural use with specific 
application timing and methods.
    1. Dermal exposure. Non-occupational dermal exposure to Pasteuria 
usgae, when used as labeled and according to the terms of EUP 85004-
EUP-1, is expected to be negligible because the use is limited to 
agricultural settings. Additionally, the methods and timing of 
application explained in the program description for EUP 85004-EUP-1 
should make strawberry exposure to Pasteuria usgae unlikely. If non-
occupational dermal exposure were to occur through treated food 
commodities, the risk posed by this low toxicity microbe is likely to 
be minimal based on the dermal toxicity test described in Unit III.
    2. Inhalation exposure. Non-occupational inhalation exposure to 
Pasteuria usgae, when used as labeled and according to the terms of EUP 
85004-EUP-1, is expected to be negligible because the use is limited to 
agricultural settings. Additionally, the methods and timing of 
application allow for sufficient drying of any treated commodities 
(should exposure to Pasteuria usgae even occur) prior to distribution 
to consumers, which further reduces the possibility for non-
occupational inhalation exposure. If non-occupational inhalation 
exposure were to occur through treated food commodities, the risk posed 
by this low toxicity microbe is likely to be minimal based on the 
pulmonary toxicity and pathogenicity test described in Unit III.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to 
consider the cumulative effects of exposure to Pasteuria usgae 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. As demonstrated in Unit III, Pasteuria usgae 
is not toxic or pathogenic to mammals via any of the routes of exposure 
examined. Consequently, since this microbial pesticide has no 
demonstrated toxicity and is specific to the sting nematode, there is 
no reason to anticipate cumulative effects from the residues of this 
product with other related microbial pesticides.

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

    FFDCA section 408(b)(2)(C) 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 408(b)(2)(C) 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. Margins of exposure (safety), which are often referred to 
as uncertainty factors, are incorporated into EPA risk assessments 
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.
    Based on the acute toxicity and pathogenicity data discussed in 
Unit III, EPA concludes that there is a reasonable certainty that no 
harm will result from aggregate exposure to the U.S. population, 
including infants and children, to the residues of Pasteuria usgae. 
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 Pasteuria usgae do not 
demonstrate toxic, pathogenic, or infective potential to mammals. Thus, 
there are no threshold effects of concern and, as a result, the 
provision requiring an additional margin of safety does not apply. 
Further, the considerations of consumption patterns, special 
susceptibility, and cumulative effects do not apply to pesticides 
without a demonstrated significant adverse effect.

VII. Other Considerations

A. Endocrine Disruptors

    Section 408(p) of the FFDCA requires EPA 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 such other endocrine effect as the Administrator may 
designate.'' Following the recommendations of its Endocrine Disruptor 
Screening and Testing Advisory Committee (EDSTAC), EPA determined that 
there were scientific bases for including, as part of its program, 
androgen and thyroid hormone systems, in addition to the estrogen 
hormone system. EPA also adopted EDSTAC's recommendation that the 
Program include evaluations of potential effects on wildlife.
    The Agency has no knowledge of Pasteuria usgae being an endocrine 
disruptor, nor is this microbe related to any class of known endocrine 
disruptors. Following several routes of exposure in rodents, the Tier I 
toxicology data indicated that the immune system was still intact. 
However, due to the difficulties in recovering Pasteuria usgae, 
clearance could not be determined; nevertheless, there is no reason to 
believe that additional data, specifically on the endocrine effects of 
this microbial pesticide, are required at this time. Consequently, 
endocrine-related concerns did not impact the Agency's safety finding 
for Pasteuria usgae. When the appropriate screening and/or testing 
protocols being considered under the Agency's Endocrine Disruptor 
Screening Program (EDSP) have been developed and vetted, Pasteuria 
usgae may be subjected to additional screening and/or testing to better 
characterize effects related to endocrine disruption.

B. Analytical Method(s)

    The Agency is establishing a temporary exemption from the 
requirement of a tolerance without any numerical limitation; therefore, 
the Agency has concluded that an analytical method is not required for 
enforcement purposes for Pasteuria usgae.

C. Codex Maximum Residue Level

    No Codex maximum residue level exists for Pasteuria usgae.

VIII. Statutory and Executive Order Reviews

    This final rule establishes a temporary exemption from the 
requirement of 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

[[Page 38974]]

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 temporary 
exemption from the requirement of a 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).

IX. 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: July 22, 2009.
Debra Edwards,
Director, 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 180.1290 is added to subpart D to read as follows:


Sec.  180.1290  Pasteuria usgae; temporary exemption from the 
requirement of a tolerance.

    Pasteuria usgae is temporarily exempt from the requirement of a 
tolerance when applied/used as a nematicide on strawberries in 
accordance with the terms of EUP 85004-EUP-1. This temporary exemption 
from the requirement of a tolerance expires and is revoked on December 
31, 2010.
[FR Doc. E9-18472 Filed 8-4-09; 8:45 am]
BILLING CODE 6560-50-S?>


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