Document ID: EPA-HQ-OPP-2009-0179-0005
Agency: epa
Document Type: Rule
Title: Exemption from Requirement of Tolerance: Pasteuria Usgae
Posted Date: 2010-06-30T04:00Z

[Federal Register: June 30, 2010 (Volume 75, Number 125)]
[Rules and Regulations]               
[Page 37734-37737]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn10-13]                         

[[Page 37734]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0179; FRL-8831-9]

 
Pasteuria usgae; 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 microbial pesticide, Pasteuria 
usgae, in or on all food commodities when applied preharvest and used 
as a nematicide in accordance with good agricultural practices. 
MacIntosh and Associates Incorporated (on behalf of Pasteuria 
Bioscience Incorporated) submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of Pasteuria usgae.

DATES: This regulation is effective June 30, 2010. Objections and 
requests for hearings must be received on or before August 30, 2010, 
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-2009-0179. 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 Office of Pesticide Programs (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), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 347-8920; e-mail address: kausch.jeannine@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. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

    You may 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 harmonized test guidelines 
referenced in this document electronically, please go to http://
www.epa.gov/oppts and select ``Test Methods and Guidelines.''

C. How Can I File an Objection or Hearing Request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. 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-2009-0179 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
August 30, 2010. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0179, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: 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 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 April 8, 2009 (74 FR 15969) (FRL-8407-
6), 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 9F7539) 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 an exemption from the requirement of a tolerance for 
residues of Pasteuria usgae. This notice referenced a summary of the 
petition prepared by the petitioner, MacIntosh and Associates 
Incorporated (on behalf of Pasteuria Bioscience Incorporated), which is 
available in the docket, http://www.regulations.gov. There were no 
substantive 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

[[Page 37735]]

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.
     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 strain 
isolated from soil samples collected in Florida, is host-specific for 
the sting nematode [Belonolaimus longicaudatus]. This strain 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 strain. In developing products 
for crop applications, such as uses on strawberries and a wide variety 
of vegetables, 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 
permanent exemption from the requirement of a tolerance for all food 
commodities. 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.
    a. Acute Oral Toxicity and Pathogenicity - Rat: Harmonized Test 
Guideline 885.3050; MRID No. 474267-09. Pasteuria usgae does not appear 
to be toxic and/or pathogenic in rats when dosed at 1 x 108 
spores/animal. There were no treatment-related clinical signs or 
necropsy findings in rats receiving a single oral dose of 1 x 
108 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.
    b. Acute Injection Toxicity and Pathogenicity - Rat: Harmonized 
Test 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 108 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 median lethal dose 
(LD50) of Pasteuria usgae was greater than 1 x 
108 spores/animal in male and female rats. Pasteuria usgae 
does not appear to be toxic and/or pathogenic in rats when dosed at 
108 spores/animal. MRID No. 474267-09 reported that 
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 as ``Acceptable.''
    c. Acute Dermal Toxicity - Rat: Harmonized Test 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 108 spores/milliliter (mL). Thus, the 
acute dermal LD50 was greater than 2,000 mg/kg for 
108 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.
    d. Acute Pulmonary Toxicity and Pathogenicity - Rat: Harmonized 
Test 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 108 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. 
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 108 spores/animal. 
Microbial enumeration was not performed because the testing laboratory 
showed that the

[[Page 37736]]

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.
    e. Hypersensitivity Incidents: Harmonized Test 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 Harmonized Test 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 bacterium to grow outside of a specific nematode host, 
support the establishment of a permanent exemption from the requirement 
of a tolerance for Pasteuria usgae. There is presently a temporary 
exemption from the requirement of a tolerance established for residues 
of Pasteuria usgae under 40 CFR 180.1290, which will expire and be 
revoked on December 31, 2010. Pasteuria usgae is exempt from the 
requirement of a tolerance when applied/used as a nematicide on 
strawberries in accordance with the terms of Experimental Use Permit 
85004-EUP-1 August 5, 2009, (74 FR 38970) (FRL-8429-1). 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 December 28, 1994, 
(59 FR 66740) (FRL[dash]4924-4).
    1. Food. Dietary exposure to the naturally occurring soil 
bacterium, Pasteuria usgae, although a possibility, is anticipated to 
be negligible. For optimal control of sting nematode, Pasteuria usgae 
is applied in a manner that facilitates movement of spores into the 
root zone of the affected crop. This requires that end users take two 
particular actions that would inevitably minimize the amount of 
Pasteuria usgae residues on aboveground food commodities-soil-directed 
applications and irrigation with a specified amount of water following 
any such applications. For food commodities that develop underground, 
exposure to Pasteuria usgae residues is a more likely scenario, 
although standard post-harvest practices of washing, cooking, or 
processing would reduce such residues. In general, 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. Moreover, Pasteuria usgae is an obligate endoparasitic bacterium 
specific to the sting nematode. 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 consumed drinking water is unlikely. The currently 
approved and proposed use patterns, use sites, and application methods 
for Pasteuria usgae do not include direct application to aquatic 
environments. Furthermore, given that Pasteuria usgae spores attach 
specifically to the sting nematode, which is a plant-parasitic nematode 
that thrives only in sandy soil environments and is dependent upon 
plant roots to sustain life, future proposals to add aquatic use sites 
to pesticide products containing this bacterium are not expected. Even 
if oral exposure should occur through consumed 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 exposures because of the lack of acute oral 
toxicity/pathogenicity to mammals and the host-specific nature of the 
bacterium, as stated previously.

B. Other Non-Occupational Exposure

    Non-occupational exposure is considered unlikely for Pasteuria 
usgae as all currently approved or proposed uses occur in distinctly 
agricultural or commercial settings, and there are no currently 
approved or proposed uses for residential areas.
    The only other non-occupational exposure is that which would 
normally be encountered as part of the natural environment (i.e., not 
as a result of pesticide use). As expected since Pasteuria usgae is an 
obligate endoparasite of the sting nematode, there have been no reports 
of adverse effects from human exposure to this bacterium that naturally 
occurs in sandy soils, particularly those of the southeastern and 
midwestern United States.

V. Cumulative Effects from Substances with a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, 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 has not found Pasteuria usgae to share a common mechanism of 
toxicity with any other substances, and Pasteuria usgae does not appear 
to produce a toxic metabolite as its mode of action against the target 
pest. For the purposes of this tolerance action, therefore, EPA has 
assumed that Pasteuria usgae does not have a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's website at 
http://www.epa.gov/pesticides/cumulative.

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 (MOE) (safety), which are often 
referred to as uncertainty factors (UFs), are incorporated into EPA 
risk assessments

[[Page 37737]]

either directly or through the use of a MOE analysis, or by using UF 
(safety) 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 to the United States population, including infants and 
children, from aggregate exposure 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.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for Pasteuria usgae.

VIII. Conclusions

     Therefore, an exemption is established for residues of Pasteuria 
usgae in or on all food commodities when applied preharvest and used as 
a nematicide in accordance with good agricultural practices.

 IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption 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 the tolerance 
exemption in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply.
    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: June 11, 2010.
Steven Bradbury,
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. In subpart D, revise Sec. 180.1290 to read as follows:

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

    An exemption from the requirement of a tolerance is established for 
residues of Pasteuria usgae in or on all food commodities when applied 
preharvest and used as a nematicide in accordance with good 
agricultural practices.
[FR Doc. 2010-15465 Filed 6-29-10; 8:45 am]
BILLING CODE 6560-50-S