37734 Federal Register / Vol. 75, No. 125 / Wednesday, June 30, 2010 / Rules and Regulations 

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. 

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 


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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 plantparasitic 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 hostspecific 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 


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37736 Federal Register / Vol. 75, No. 125 / Wednesday, June 30, 2010 / Rules and Regulations 

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 nonoccupational 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-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 


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Federal Register / Vol. 75, No. 125 / Wednesday, June 30, 2010 / Rules and Regulations 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. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In subpart D, revise §180.1290 to 

read as follows: 

§ 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 


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