8736 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 

Aureobasidium pullulans strains DSM 

14940 and DSM 14941. Therefore, an 

exemption from the requirement of a 

tolerance is established for residues of 

Aureobasidium pullulans strains DSM 

14940 and DSM 14941 in or on all food 

commodities when applied as a 

preharvest fungicide and used in 

accordance with good agricultural 

practices. 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

X. References 

1. Chi, Z., F. Wang, Z. Chi, L. Yue, G. Liu, 

T. Zhang. 2009. Bioproducts from 

ureobasidium pullulans, a 

biotechnologically important yeast. 

Appl. Microbiol. Biotechnol., 82: 793– 

804. 

2. Cooke, W.B. 1959. An ecological life 

history of Aureobasidium pullulans (De 

Bary) Arnaud. Mycopathologia, 12: 1–45. 

3. Slepecky, R.A. and W.T. Starmer. 2009. 

Phenotypic plasticity in fungi: a review 

with observations on Aureobasidium 

pullulans. Mycologia 101: 823–832. 

4. Fleet, G.H. 2002. The yeast ecology of wine 

grapes. Pp. 1–17 in Biodiversity and 

Biotechnol. Of Wine Yeasts (Ciani, M., 

ed.). Research Signpost, Kerala, India. 

5. Fleet, G.H. 2003. Yeast interactions and 

wine flavor. Int. J. Food Microbiol., 86: 

11–22. 

6. Granado, J., B. Thurig, E. Kieffer, L. Petrini, 

A. Fliessbach, L. Tamm, F.P. Weibel, 

G.S. Wyss. 2008. Culturable fungi of 

stored ‘Golden Delicious’ apple fruits: a 

one-season comparison study of organic 

and integrated production systems in 

Switzerland. Microb. Ecol., 56: 720–732. 

7. Gao, X.-X., H. Zhou, D.-Y. Xu, C.-H. Yu, 

Y.-Q. Chen, L.-H. Qu. 2005. High 

diversity of endophytic fungi from the 

pharmaceutical plant, Heterosmilax 

japonica Kunth revealed by cultivationindependent approach. FEMS Microbiol. 

Letters, 249: 255–266. 

8. Osono, T. 2008. Endophytic and epiphytic 

phyllosphere fungi of Camellia japonica: 

seasonal and leaf age-dependent 

variations. Mycologia, 100: 387–391. 

9. Slavikova, E., R. Vadkertiova, and D. 

Vranova. 2007. Yeasts colonizing the leaf 

surfaces. J. Basic Microbiol. 47: 344–350. 

10. Suryanarayanan, T.S., S.K. Wittlinger, 

and S.H. Faeth. 2005. Endophytic fungi 

associated with cacti in Arizona. Mycol. 

Res. 109: 635–639. 

11. Webb, T.A. and J.O. Mundt. 1978. Molds 

on vegetables at the time of harvest. 

Appl. Environ. Microbiol., 35: 655–658. 

12. Kockova-Kratochvilova, A., M. 

Cernakova, and E. Slavikova. 1980. 

Morphological changes during the life 

cycle of Aureobasidium pullulans (de 

Bary) Arnaud. Folia Microbiologica, 25. 

13. U.S. EPA. December 2011. DRAFT 

Biopesticides Registration Action 

Document of Aureobasidium pullulans 

strains DSM 14940 and 14941. 

14. Slavikova, E. and R. Vadkertiova. 1997. 

Seasonal occurrence of yeasts and yeast 

like organisms in the river Danube. 

Antonie van Leeuwenhoek 72: 77–80, 

1997. 

XI. 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: January 30, 2012. 

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. Section 180.1312 is added to 

subpart D to read as follows: 

§ 180.1312 Aureobasidium pullulans 

strains DSM 14940 and DSM 14941; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of the microbial pesticides, 

Aureobasidium pullulans strains DSM 

14940 and DSM 14941 in or on all food 

commodities when applied preharvest 

and used in accordance with good 

agricultural practices. 

[FR Doc. 2012–3585 Filed 2–14–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0807; FRL–9337–2] 

Pasteuria nishizawae—Pn1; 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 Pasteuria 

nishizawae—Pn1 in or on all food 

commodities when applied as a 

nematicide and used in accordance with 

good agricultural practices. Pasteuria 

Bioscience, Inc. 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 nishizawae—Pn1 under the 

FFDCA. 

DATES: This regulation is effective 

February 15, 2012. Objections and 

requests for hearings must be received 

on or before April 16, 2012, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 


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Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 8737 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0807. 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), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8920; email 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:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. To access the harmonized 

test guidelines referenced in this 

document electronically, please go to 

http://www.epa.gov/ocspp 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–2010–0807 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 April 16, 2012. 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–2010–0807, 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 February 4, 

2011 (76 FR 6465) (FRL–8858–7), 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 0F7749) 

by Pasteuria Bioscience, Inc., 12085 

Research Dr., 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 nishizawae—Pn1. This 

notice referenced a summary of the 

petition prepared by the petitioner, 

Pasteuria Bioscience, Inc., which is 

available in the docket via http:// 

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit VII.C. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. Pursuant to 

section 408(c)(2)(B) of FFDCA, in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which require 

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance exemption 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 EPA 

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 


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8738 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 

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. 

A. Overview of Pasteuria nishizawae— 

Pn1 

Pasteuria, a genus of bacteria, 

includes several species that have 

shown potential in controlling plantparasitic nematodes that attack and 

cause significant damage to many 

agricultural crops (see, e.g., the Federal 

Register of December 28, 1994 (59 FR 

66740) (FRL–4923–4) and June 30, 2010 

(75 FR 37734) (FRL–8831–9) for final 

rules that established tolerance 

exemptions for residues of the 

nematicides, Pasteuria penetrans (40 

CFR 180.1135) and Pasteuria usgae (40 

CFR 180.1290), respectively). These 

gram-positive, mycelial, endosporeforming bacteria are mostly obligate 

parasites (i.e., organisms that depend on 

particular hosts to complete their own 

life cycle) of plant-parasitic nematodes, 

although one Pasteuria species— 

Pasteuria ramosa—is known to 

parasitize Daphnia species, which are 

tiny crustaceans often called ‘‘water 

fleas’’ due to their flea-like size and 

appearance (Refs. 1 and 2). Pasteuria 

species are ubiquitous in most 

environments and are found in 

nematodes in at least 80 countries on 5 

continents, as well as on islands in the 

Atlantic, Pacific, and Indian Oceans 

(Ref. 2). Higher population densities 

often occur in areas where there is an 

ample supply of nematode hosts (e.g., 

where crops susceptible to nematodes 

are cultivated) (Refs. 3, 4, and 5). 

Pasteuria nishizawae—Pn1 was 

specifically isolated from an Illinois 

soybean field in the mid-2000s (Ref. 1). 

Although endospores of Pasteuria 

nishizawae have been observed to attach 

to the cuticle of 3 nematodes of the 

genus Heterodera and 1 nematode of the 

genus Globodera, it is known only to 

infect and complete its life cycle within 

the female soybean cyst nematode 

(Heterodera glycines) (Ref. 2). In the 

following manner, Pasteuria 

nishizawae—Pn1 exerts a pesticidal 

effect on the soybean cyst nematode 

through parasitism that ultimately 

results in the death of infected females: 

1. Endospores attach to the cuticle of 

a juvenile soybean cyst nematode 

female. 

2. Once a soybean cyst nematode 

female invades soybean roots, Pasteuria 

nishizawae—Pn1 produces a germ tube 

that penetrates the body of the 

nematode. 

3. Primary and secondary 

microcolonies of Pasteuria 

nishizawae—Pn1 develop and 

proliferate within the body of the 

nematode, causing its death (Ref. 2). 

In light of the demonstrated 

nematicidal capabilities and host 

specificity of Pasteuria nishizawae— 

Pn1, Pasteuria Bioscience, Inc. has 

proposed to register pesticide products 

that could be applied to soybean or its 

seed to control the soybean cyst 

nematode. 

B. Microbial Pesticide Toxicology Data 

Requirements 

All applicable mammalian toxicology 

data requirements supporting the 

request for an exemption from the 

requirement of a tolerance for residues 

of Pasteuria nishizawae—Pn1 in or on 

all food commodities have been fulfilled 

with data submitted by the petitioner. 

The results of the acute dermal toxicity 

and primary dermal irritation tests 

revealed no toxicity or irritation 

attributed to Pasteuria nishizawae— 

Pn1, and these studies received a 

Toxicity Category IV classification (see 

40 CFR 156.62). Moreover, acute oral, 

pulmonary, and injection toxicity/ 

pathogenicity tests indicated that 

Pasteuria nishizawae—Pn1 was not 

toxic and/or pathogenic via the tested 

routes of exposure. Although infectivity 

and clearance were not evaluated in any 

of the acute toxicity/pathogenicity tests, 

EPA believes that these endpoints are 

not a concern given the host specificity 

of Pasteuria nishizawae for the soybean 

cyst nematode (Refs. 1 and 2). Finally, 

the petitioner has reported that no 

hypersensitivity incidents occurred 

during development and testing of this 

bacterium. The overall conclusions from 

all toxicological information submitted 

by the petitioner are briefly described in 

this unit, while more in-depth synopses 

of some study results can be found in 

the associated Biopesticides Registration 

Action Document provided as a 

reference in Unit IX. (Ref. 6). 

1. Acute oral toxicity/pathogenicity— 

rat (Harmonized Guideline 885.3050; 

Master Record Identification Number 

(MRID No.) 481517–09). A supplemental 

acute oral toxicity/pathogenicity study 

demonstrated that Pasteuria 

nishizawae—Pn1 was not toxic and/or 

pathogenic to laboratory rats when 

administered by oral gavage in a single 

dose of 1.6 × 109 spores per animal. 

Although clearance and infectivity were 

not measured, EPA believes these 

endpoints are not a concern given 

Pasteuria nishizawae—Pn1’s wellestablished host specificity for the 

soybean cyst nematode (Refs. 1 and 2). 

2. Acute pulmonary toxicity/ 

pathogenicity—rat (Harmonized 

Guideline 885.3150; MRID No. 481517– 

10). A supplemental acute pulmonary 

toxicity/pathogenicity study 

demonstrated that Pasteuria 

nishizawae—Pn1 was not toxic and/or 

pathogenic to laboratory rats when 

administered by intratracheal 

instillation in a single dose of 1.6 × 108

spores per animal. Although clearance 

and infectivity were not measured, EPA 

believes these endpoints are not a 

concern given Pasteuria nishizawae— 

Pn1’s well-established host specificity 

for the soybean cyst nematode (Refs. 1 

and 2). 

3. Acute injection toxicity/ 

pathogenicity (intravenous)—rat 

(Harmonized Guideline 885.3200; MRID 

No. 481517–11). A supplemental acute 

injection toxicity/pathogenicity study 

demonstrated that Pasteuria 

nishizawae—Pn1 was not toxic and/or 

pathogenic to laboratory rats when 

administered intravenously in a single 

dose of 1.0 × 109 spores per animal. 

Although clearance and infectivity were 

not measured, EPA believes these 

endpoints are not a concern given 

Pasteuria nishizawae—Pn1’s wellestablished host specificity for the 

soybean cyst nematode (Refs. 1 and 2). 

4. Hypersensitivity incidents 

(Harmonized Guideline 885.3400; MRID 

No. 481517–12). The petitioner reported 

that no hypersensitivity incidents, 

including immediate-type or delayedtype reactions of humans and domestic 

animals, occurred during research, 

development, or testing of Pasteuria 

nishizawae—Pn1. 

5. Acute dermal toxicity—rabbit 

(Harmonized Guideline 870.1200; MRID 

No. 481517–14). An acceptable acute 

dermal toxicity study demonstrated that 

a test substance containing Pasteuria 

nishizawae—Pn1 was not toxic to 

rabbits when dosed at 2,000 milligrams 

per kilogram (mg/kg) for 24 hours. The 

dermal median lethal dose, which is a 

statistically derived single dose that can 

be expected to cause death in 50% of 

test animals, was greater than 2,000 mg/ 

kg for male and female rats combined 

(Toxicity Category IV). 

6. Primary dermal irritation—rabbit 

(Harmonized Guideline 870.2500; MRID 

No. 481517–16). An acceptable primary 

dermal irritation study demonstrated 


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Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 8739 

that a test substance containing 

Pasteuria nishizawae—Pn1 was 

essentially non-irritating to the skin of 

rabbits (Toxicity Category IV). 

IV. Aggregate Exposure 

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 

1. Food exposure. Dietary exposure to 

Pasteuria nishizawae—Pn1, a naturally 

occurring soil bacterium (Refs. 7, 8, and 

9), is anticipated to be negligible. For 

optimal control of the target pest 

(soybean cyst nematode), Pasteuria 

nishizawae—Pn1 is applied in a manner 

that facilitates spore movement into or 

spore placement near the root zone of 

potentially affected plants. This requires 

that end users take certain actions, 

depending on the treatment type, that 

would inevitably minimize the amount 

of Pasteuria nishizawae—Pn1 residues 

on above-ground commodities. That is, 

although Pasteuria nishizawae—Pn1 

can be applied to soil, plants, or seeds, 

some seeds are incorporated into the 

soil immediately after treatment (atplanting, hopper box, planter box, or 

slurry box seed treatments), and 

pesticide applications made to plants or 

the soil are always followed by 

irrigation to incorporate Pasteuria 

nishizawae—Pn1 into the soil. In 

instances where food commodities 

develop underground or where treated 

seed is diverted for food or feed 

purposes or to process into oil, exposure 

to Pasteuria nishizawae—Pn1 is a more 

likely scenario. Regardless of the 

situation, should Pasteuria 

nishizawae—Pn1 be present on food, its 

specificity for the soybean cyst 

nematode and available data indicate no 

toxicity, pathogenicity, and/or 

infectivity is likely to occur with any 

dietary exposure that results from 

pesticide applications made in 

accordance with good agricultural 

practices (see additional discussion in 

Unit III.). 

2. Drinking water exposure. Exposure 

to residues of Pasteuria nishizawae— 

Pn1 in consumed drinking water is 

possible but not likely. The proposed 

use patterns for Pasteuria nishizawae— 

Pn1 are soil directed, soil incorporated, 

and/or seed directed, thereby limiting 

contact with surface water by drift and 

runoff. Furthermore, ground water is not 

expected to have significant exposure to 

Pasteuria nishizawae—Pn1 since, like 

other microorganisms, this microbial 

pesticide would likely be filtered out by 

the particulate nature of many soil types 

(Refs. 10, 11, and 12). If Pasteuria 

nishizawae—Pn1 were to be transferred 

to surface or ground waters (e.g., 

through spray drift or runoff) that are 

intended for eventual human 

consumption and directed to 

wastewater treatment systems or 

drinking water facilities, it may not 

survive some of the conditions water is 

subjected to in such systems or 

facilities, including chlorination, pH 

adjustments, and filtration (Refs. 13 and 

14). In the remote likelihood that 

Pasteuria nishizawae—Pn1 is present in 

drinking water (e.g., water not subject to 

certain conditions in treatment systems 

and facilities), its specificity for the 

soybean cyst nematode and available 

data indicate no toxicity, pathogenicity, 

and/or infectivity is likely to occur with 

any drinking water exposure that results 

from pesticide applications made in 

accordance with good agricultural 

practices (see additional discussion in 

Unit III.). 

B. Other Non-Occupational Exposure 

Given Pasteuria nishizawae’s natural 

presence in soil (Refs. 7, 8, and 9), nonoccupational exposure to the bacterium 

is likely already occurring. Additional 

exposure to Pasteuria nishizawae—Pn1 

due to pesticidal applications is not 

expected because all proposed pesticide 

end-use products are labeled for use in 

distinct agricultural settings. Even if 

non-occupational exposures were to 

occur (e.g., eventual expansion of use 

sites), such exposures would not exceed 

EPA’s level of concern in light of 

Pasteuria nishizawae—Pn1’s specificity 

for the soybean cyst nematode and test 

results that indicated Pasteuria 

nishizawae—Pn1 is not toxic (acute 

dermal toxicity and acute pulmonary 

toxicity/pathogenicity), is essentially 

non-irritating (primary dermal 

irritation), and is not pathogenic (acute 

pulmonary toxicity/pathogenicity) (see 

additional discussion in Unit III.). 

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 exemption, EPA consider 

‘‘available information concerning the 

cumulative effects of [a particular 

pesticide’s] * * * residues and other 

substances that have a common 

mechanism of toxicity.’’ 

No mechanism of toxicity in 

mammals has been identified for 

Pasteuria nishizawae—Pn1, and 

Pasteuria nishizawae—Pn1 does not 

appear to produce a toxic metabolite 

against the target pest. For the purposes 

of this tolerance action, EPA has 

assumed that Pasteuria nishizawae— 

Pn1 does not have a common 

mechanism of toxicity with other 

substances. Therefore, section 

408(b)(2)(D)(v) of FFDCA does not 

apply. 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 Web site 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, in considering the establishment of 

a tolerance or tolerance exemption for a 

pesticide chemical residue, 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 (10X) 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 on toxicity 

and exposure unless EPA determines 

that a different margin of safety will be 

safe for infants and children. This 

additional margin of safety is commonly 

referred to as the Food Quality 

Protection Act Safety Factor. In 

applying this provision, EPA either 

retains the default value of 10X or uses 

a different additional safety factor when 

reliable data available to EPA support 

the choice of a different factor. 

Based on the acute toxicity and 

pathogenicity data discussed in Unit 

III.B., as well as Pasteuria nishizawae— 

Pn1’s host specificity for the soybean 

cyst nematode, EPA concludes that 

there are no threshold effects of concern 

to infants, children, or adults when 

Pasteuria nishizawae—Pn1 is used as 

labeled in accordance with good 

agricultural practices. As a result, EPA 

concludes that no additional margin of 

exposure (safety) is necessary to protect 

infants and children and that not adding 

any additional margin of exposure 

(safety) will be safe for infants and 

children. 


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Moreover, based on the same data and 

EPA analysis as presented in this unit, 

the Agency is able to conclude that 

there is a reasonable certainty that no 

harm will result to the U.S. population, 

including infants and children, from 

aggregate exposure to the residues of 

Pasteuria nishizawae—Pn1 when it is 

used as labeled and in accordance with 

good agricultural practices as a 

nematicide. Such exposure includes all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information. EPA has arrived at 

this conclusion because, considered 

collectively, the data and information 

available on Pasteuria nishizawae—Pn1 

do not demonstrate toxic, pathogenic, 

and/or infective potential to mammals, 

including infants and children. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes for the 

reasons stated in this document and 

because EPA 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. In this context, 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 nishizawae—Pn1. 

C. Response to Comments 

Two comments were submitted. An 

anonymous commenter (EPA–HQ–OPP– 

2010–0012–0019) generally expressed 

opposition to EPA granting tolerance 

exemptions to several petitioners, 

including Pasteuria Bioscience, Inc. 

Specifically, this commenter mentioned 

concern with the prevalence of many 

toxic chemicals in the environment and 

lack of information regarding how such 

chemicals combine. Another commenter 

(EPA–HQ–OPP–2010–0905–0003) also 

expressed opposition to granting 

tolerances and tolerance exemptions for 

several chemicals, including Pasteuria 

nishizawae—Pn1, that were described 

in the Federal Register of February 4, 

2011. This commenter stated that the 

food supply must be rigorously tested, 

that studies submitted by the chemical 

industry must be subjected to 

independent peer review, and that only 

long-term studies can provide data on 

the health impact of exposure to the 

chemicals in the February 4, 2011 notice 

of filing. 

Data provided by the petitioner 

demonstrated that Pasteuria 

nishizawae—Pn1 is not toxic and/or 

pathogenic at the doses administered 

orally, intratracheally, intravenously, 

and dermally to rats or rabbits (see Unit 

III.B.). Although infectivity and 

clearance were not evaluated in any of 

these studies, EPA believes that these 

endpoints are not a concern given 

Pasteuria nishizawae—Pn1’s wellestablished host specificity for the 

soybean cyst nematode (Refs. 1 and 2). 

Moreover, since no mechanism of 

toxicity in mammals has been identified 

for Pasteuria nishizawae—Pn1, and 

Pasteuria nishizawae—Pn1 does not 

appear to produce a toxic metabolite 

against the target pest, EPA has assumed 

that Pasteuria nishizawae—Pn1 does 

not have a common mechanism of 

toxicity with other substances. After 

conducting a comprehensive assessment 

of the data and information submitted 

by the petitioner, EPA has concluded 

there is a reasonable certainty that no 

harm will result to the U.S. population, 

including infants and children, from 

aggregate exposure to residues of 

Pasteuria nishizawae—Pn1. Thus, 

under the standard in FFDCA section 

408(c)(2), a tolerance exemption is 

appropriate. 

D. Revisions to Requested Tolerance 

Exemption 

Two modifications have been made to 

the requested tolerance exemption. 

First, since Pasteuria Bioscience, Inc. 

already created a unique isolate 

identifier (i.e., Pn1) for Pasteuria 

nishizawae, inclusion of the American 

Type Culture Collection accession 

number (i.e., SD–5833) within this 

microbial pesticide’s taxonomic name 

was unnecessary. Use of just Pasteuria 

nishizawae—Pn1 throughout this 

document, particularly in the tolerance 

exemption expression, is now consistent 

with the representation of this active 

ingredient in other associated regulatory 

documents and should assist in 

preventing confusion regarding its 

nomenclature in the future. Second, 

EPA is changing ‘‘in or on all raw 

agricultural crops’’ to ‘‘in or on all food 

commodities’’ to align with the 

terminology the Agency currently uses 

when establishing tolerance exemptions 

for residues of other like active 

ingredients. 

VIII. Conclusions 

EPA concludes that there is a 

reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of Pasteuria 

nishizawae—Pn1. Therefore, an 

exemption from the requirement of a 

tolerance is established for residues of 

Pasteuria nishizawae—Pn1. 

IX. References 

1. U.S. EPA. 2011a. Pasteuria nishizawae 

strain PN1. Memorandum from J.V. 

Gagliardi, Ph.D. and J.L. Kough, Ph.D. to 

J. Kausch dated August 16, 2011. 

2. U.S. EPA. 2011b. Environmental Risk 

Assessment of Pasteuria nishizawae Pn1 

(PC 016455) for a Section 3 Registration 

of the Technical Product (EPA File 

Symbol 85004–A) and Two End Use 

Products (EPA File Symbols 85004–T 

and 85004–O) for Control of the Soybean 

Cyst Nematode in Soybeans. 

Memorandum from S. Borges and G. 

Tomimatsu, Ph.D. to J. Kausch dated 

September 15, 2011 (available as 

‘‘Supporting & Related Material’’ within 

docket ID number EPA–HQ–OPP–2010– 

0806). 

3. Cetintas R, Dickson DW. 2004. Persistence 

and suppressiveness of Pasteuria 

penetrans to Meloidogyne arenaria Race 

1. Journal of Nematology 36:540–549. 

4. Tain B, Yang J, Zhang K–Q. 2007. Bacteria 

used in the biological control of plantparasitic nematodes: Populations, 

mechanisms of action, and future 

prospects. FEMS Microbiology Ecology 

61:197–213. 

5. Noel GR. 2008. IPM of soybean cyst 

nematode in the USA. In: Integrated 

Management and Biocontrol of Vegetable 

and Grain Crops Nematodes. Eds. A. 

Cianio and K.G. Mukerji. Springer. Pages 

119–126. 

6. U.S. EPA. 2011c. Draft Pasteuria 

nishizawae—Pn1 Biopesticides 

Registration Action Document dated 

December 21, 2011 (available as 

‘‘Supporting & Related Material’’ within 

docket ID number EPA–HQ–OPP–2010– 

0806). 

7. Atibalentja N, Jakstys BP, Noel GR. 2004. 

Life cycle, ultrastructure, and host 

specificity of the North American isolate 

of Pasteuria that parasitizes the soybean 

cyst nematode, Heterodera glycines. 

Journal of Nematology 36:171–180. 

8. Noel GR, Atibalentja N, Domier LL. 2005. 

Emended description of Pasteuria 

nishizawae. International Journal of 

Systematic and Evolutionary 

Microbiology 55:1681–1685. 

9. Sayre RM, Wergin WP, Schmidt JM, Starr 

MP. 1991. Pasteuria nishizawae sp. nov., 


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a mycelial and endospore-forming 

bacterium parasitic on cyst nematode of 

genera Heterodera and Globodera. 

Research in Microbiology 14:551–564. 

10. Pang L, McLeod M, Aislabie J, Sˇimu ̊nek 

J, Close M, Hector R. 2008. Modeling 

transport of microbes in ten undisturbed 

soils under effluent irrigation. Vadose 

Zone Journal 7:97–111. 

11. Aislabie J, Smith JJ, Fraser R, McLeod M. 

2001. Leaching of bacterial indicators of 

faecal contamination through four New 

Zealand soils. Australian Journal of Soil 

Research 39:1397–1406. 

12. DeFelice K, Wollenhaupt N, Buchholz D. 

1993. Aquifers and Soil Filter Effect. 

Available from http:// 

extension.missouri.edu/p/WQ24. 

13. Centers for Disease Control and 

Prevention. 2009. Drinking Water— 

Water Treatment. Available from http:// 

www.cdc.gov/healthywater/drinking/ 

public/water_treatment.html. 

14. U.S. EPA. 2004. Primer for Municipal 

Wastewater Treatment Systems. EPA 

832–R–04–001. Available from http:// 

www.epa.gov/npdes/pubs/primer.pdf. 

X. 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 EPA. 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. 

As a result, this action does not 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, 

EPA 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, EPA 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) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

EPA 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). 

XI. 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: February 1, 2012. 

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. Section 180.1311 is added to 

subpart D to read as follows: 

§ 180.1311 Pasteuria nishizawae—Pn1; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Pasteuria nishizawae—Pn1 in or on 

all food commodities when applied as a 

nematicide and used in accordance with 

good agricultural practices. 

[FR Doc. 2012–3586 Filed 2–14–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0783; FRL–9332–9] 

Spirotetramat; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

spirotetramat in or on onion, dry bulb 

under section 408(l)(6) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

21 U.S.C. 346a(l)(6). This action is in 

response to EPA’s granting of an 

emergency exemption under section 18 

of the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) 

authorizing use of the pesticide on dry 

bulb onions. This regulation establishes 

a maximum permissible level for 

residues of spirotetramat in or on these 

commodities. The time-limited 

tolerances expire on December 31, 2014. 

DATES: This regulation is effective 

February 15, 2012. Objections and 

requests for hearings must be received 

on or before April 16, 2012, 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–2011–0783. All documents in the 

docket are listed in the docket index 

available in 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 


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