38970 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * * * 

Sodium alkyl naphthalenesulfonates (CAS Reg. Nos. 68909–83–1, 68909–84–2, 

68909–82–0, 27213–90–7, 26264–58–4, 27178–87–6, 111163–74–7, 908356–16–1, 

25417–20–3, 25638–17–9, 145578–88–7, 1322–93–6, 1323–19–9, 7403–47–6, 

68442–09–1, 127646–44–0, 908356–18–3).

Limited to no more than 

30% by weight in pesticide end-use products.

Surfactants, related adjuvants of surfactants 

* * * * * * * 

■ 4. In § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * * * 

Sodium alkyl naphthalenesulfonates (CAS Reg. Nos. 68909–83–1, 68909–84–2, 

68909–82–0, 27213–90–7, 26264–58–4, 27178–87–6, 111163–74–7, 908356–16–1, 

25417–20–3, 25638–17–9, 145578–88–7, 1322–93–6, 1323–19–9, 7403–47–6, 

68442–09–1, 127646–44–0, 908356–18–3).

Limited to no more than 

30% by weight in pesticide end-use products.

Surfactants, related adjuvants of surfactants 

* * * * * * * 

[FR Doc. E9–18702 Filed 8–4–09; 8:45 am] 

BILLING CODE 6560–50–S 

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. 

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: 

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. 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 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. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

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 plantparasitic 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 


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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. 

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 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 LD50 of Pasteuria 

usgae is 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 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 108 spores/milliliter (mL). Thus, the 

acute dermal LD50 is greater than 2,000 

mg/kg for 108 spores/mL in male and 

female rats. There were no treatmentrelated 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 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. 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 108 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 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 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 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 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. Nonoccupational 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. Nonoccupational 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 nonoccupational 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 


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38974 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

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. 

■ 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. Section 180.1290 is added to 

subpart D to read as follows: 

§ 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 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 599 

[ Docket No. NHTSA–2009–0120] 

RIN 2127–AK54; Notice 1 

Requirements and Procedures for 

Consumer Assistance To Recycle and 

Save Program 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

regulation implementing the Consumer 

Assistance to Recycle and Save (CARS) 

Program, published on July 29, 2009 in 

the Federal Register, under the CARS 

Act (Pub. L. 111–32). The rule clarifies 

the insurance eligibility requirements 

for trade-in vehicles under the CARS 

program. The rule makes substantive 

changes and a conforming amendment 

related to the timing for disabling tradein vehicle engines. The rule also makes 

a technical amendment to the 

requirements and procedures for 

identifying salvage auctions and 

disposal facilities. Finally, we provide a 

clarification related to the insurance 

requirement under the CARS Act. 

DATES: This final rule is effective August 

5, 2009. Petitions: If you wish to petition 

for reconsideration of this rule, your 

petition must be received by September 

21, 2009. 

ADDRESSES: If you submit a petition for 

reconsideration of this rule, you should 

refer in your petition to the docket 

number of this document and submit 

your petition to: Administrator, 

National Highway Traffic Safety 

Administration, 1200 New Jersey 

Avenue, SE., West Building, 

Washington, DC 20590. 

The petition will be placed in the 

public docket. Anyone is able to search 

the electronic form of all documents 

received into any of our dockets by the 

name of the individual submitting the 

document (or signing the document, if 

submitted on behalf of an association, 

business, labor union, etc.). You may 

review the complete User Notice and 

Privacy Notice for Regulations.gov at 

http://www.regulations.gov/search/ 

footer/privacyanduse.jsp. 

FOR FURTHER INFORMATION CONTACT: For 

questions, you may call David Bonelli, 

NHTSA Office of Chief Counsel, 

telephone (202) 366–5834. 

SUPPLEMENTARY INFORMATION: This final 

rule amends the regulation 

implementing the Consumer Assistance 

to Recycle and Save (CARS) Program, 

published on July 29, 2009 (74 FR 

37878), under the CARS Act (Pub. L. 

111–32). The rule makes substantive 

changes and a conforming amendment 

related to the timing for disabling tradein vehicle engines. The rule also makes 

a technical amendment to the 

requirements and procedures for 

identifying salvage auctions and 

disposal facilities. Finally, the agency 

clarifies the application of the insurance 

requirement under the CARS Act. 

a. Engine Disablement 

The rule currently requires a dealer 

that receives an eligible trade-in vehicle 

under the CARS program to disable that 

vehicle’s engine prior to submitting an 

application for reimbursement and prior 

to transferring the vehicle to a disposal 

facility. That requirement is 


srobinson on DSKHWCL6B1PROD with RULES