Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 8731 

need to determine and issue new 

interest assumptions promptly so that 

the assumptions can reflect current 

market conditions as accurately as 

possible. 

Because of the need to provide 

immediate guidance for the payment of 

benefits under plans with valuation 

dates during March 2012, PBGC finds 

that good cause exists for making the 

assumptions set forth in this 

amendment effective less than 30 days 

after publication. 

PBGC has determined that this action 

is not a ‘‘significant regulatory action’’ 

under the criteria set forth in Executive 

Order 12866. 

Because no general notice of proposed 

rulemaking is required for this 

amendment, the Regulatory Flexibility 

Act of 1980 does not apply. See 5 U.S.C. 

601(2). 

List of Subjects in 29 CFR Part 4022 

Employee benefit plans, Pension 

insurance, Pensions, Reporting and 

recordkeeping requirements. 

In consideration of the foregoing, 29 

CFR part 4022 is amended as follows: 

PART 4022—BENEFITS PAYABLE IN 

TERMINATED SINGLE-EMPLOYER 

PLANS 

■ 1. The authority citation for part 4022 

continues to read as follows: 

Authority: 29 U.S.C. 1302, 1322, 1322b, 

1341(c)(3)(D), and 1344. 

■ 2. In appendix B to part 4022, Rate Set 

221, as set forth below, is added to the 

table. 

Appendix B to Part 4022—Lump Sum 

Interest Rates for PBGC Payments 

Rate set 

For plans with a valuation 

date Immediate 

annuity rate 

(percent) 

Deferred annuities 

(percent) 

On or after Before i1 i2 i3 n1 n2

*******

221 .................................... 3–1–12 4–1–12 1.25 4.00 4.00 4.00 7 8 

■ 3. In appendix C to part 4022, Rate Set 

221, as set forth below, is added to the 

table. 

Appendix C to Part 4022—Lump Sum 

Interest Rates for Private-Sector 

Payments 

Rate set 

For plans with a valuation 

date Immediate 

annuity rate 

(percent) 

Deferred annuities 

(percent) 

On or after Before i1 i2 i3 n1 n2

*******

221 .................................... 3–1–12 4–1–12 1.25 4.00 4.00 4.00 7 8 

Issued in Washington, DC, on this 8th day 

of February 2012. 

Laricke Blanchard, 

Deputy Director for Policy, Pension Benefit 

Guaranty Corporation. 

[FR Doc. 2012–3540 Filed 2–14–12; 8:45 am] 

BILLING CODE 7709–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0099; FRL–9337–3] 

Aureobasidium pullulans Strains DSM 

14940 and DSM 14941; 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 

Aureobasidium pullulans strains DSM 

14940 and DSM 14941 in or on all food 

commodities when applied pre-harvest 

and used in accordance with good 

agricultural practices. Bio-ferm GmbH 

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 Aureobasidium pullulans 

strains DSM 14940 and DSM 14941. 

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–2010–0099. 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 the disclosure 

of which is restricted by statute. Certain 

other material, such as copyrighted 

material, is not made available via 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: 

Susanne Cerrelli, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8077; email address: 

cerrelli.susanne@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 


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8732 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 

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, 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–2010–0099 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–2010–0099, 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 March 10, 

2010 (75 FR 11171) (FRL–8810–8), 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 9F7623) 

by Bio-ferm GmbH, Konrad Lorenz Str. 

20, Tulln, 3430, Austria. The petition 

requested that 40 CFR part 180 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of Aureobasidium pullulans 

strains DSM 14940 and DSM 14941. 

This notice referenced a summary of the 

petition prepared by the petitioner Bioferm GmbH, which is available in the 

docket, http://www.regulations.gov. 

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 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. 

A. Overview of Aureobasidium 

Pullulans Strains DSM 14940 and DSM 

14941 

Aureobasidium pullulans is a ‘‘yeastlike’’ saprophytic fungus found in the 

phyllosphere of many plants, and it has 

been isolated from soil and aquatic 

environments (Refs. 1, 2, and 3). It is 

commonly isolated from healthy grape 

(Refs. 4 and 5) and apple (Ref. 6) plants, 

as well as other plants (Refs. 7, 8, 9, 10, 

and 11). Although associated with 

disease in some plants, the fungus 

generally is recognized as a saprobe, 

since it derives its nourishment from 

nonliving or decaying organic matter, 

and is only considered a weak pathogen 

or parasite of certain plants (Refs. 2 and 

12). It is a known antagonist of several 

plant disease-causing organisms, and is 

an important producer of enzymes for 

biotechnological and industrial 

applications (Ref. 1). 

Aureobasidium pullulans strains DSM 

14940 and DSM 14941 were isolated 

from apple leaves and classified by the 

German Strain Collection for 

Microorganisms (DSMZ). Neither is a 


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Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 8733 

mutant nor genetically modified strain 

and they are not closely related to 

toxigenic human pathogens. As 

discussed in Pesticide Petition (PP) 

9F7623, product analysis data 

demonstrate that Aureobasidium 

pullulans strain DSM 14941 is closely 

related to strain DSM 14940. The two 

strains share many similar genetic and 

morphological characteristics. Bioferm 

GmbH has proposed to register two 

manufacturing-use pesticide products 

(MPs): ‘‘Aureobasidium pullulans strain 

DSM 14941 Technical,’’ and 

‘‘Aureobasidium pullulans strain DSM 

14940 Technical.’’ The active ingredient 

is 80% w/w (minimum of × 109 colony 

forming units/grams (unit of measure for 

bacteria (cfu/g)) in each of the proposed 

technical products. 

Bio-ferm GmbH has proposed to 

register two end-use products (EPs) 

containing equal parts of 

Aureobasidium pullulans strains DSM 

14940 and DSM 14941: ‘‘Blossom 

Protect’’ will be applied to pome fruit 

only during the blossoming period to 

protect plants against bacterial fire 

blight, and ‘‘Botector’’ will be applied 

preharvest to grapes, pome fruit, stone 

fruit, and strawberries to protect these 

crops against fruit rot diseases caused 

by Botrytis sp., Monilia sp., Penicillium 

sp., Nectria sp., and Pezicula sp. 

B. Microbial Pesticide Toxicology Data 

Requirements 

The Agency has determined that, for 

preharvest uses, all mammalian 

toxicology data requirements submitted 

to support the petition to exempt 

residues of Aureobasidium pullulans 

strains DSM 14940 and DSM 14941 

from the requirement of a tolerance have 

been fulfilled (Ref. 13). 

The product analysis data 

demonstrated that Aureobasidium 

pullulans strain DSM 14941 is closely 

related to strain DSM 14940. Because 

the strains are closely related, the 

Agency has determined that the findings 

of the submitted acute toxicity/ 

pathogenicity studies conducted only 

with strain DSM 14941 supported both 

strains, and those studies show no 

evidence of toxicity, or pathogenicity at 

the doses tested. In addition, both 

strains were tested in an acute 

subcutaneous injection toxicity/ 

pathogenicity study in rats. The results 

of this study indicated that both strains 

were not toxic, infective, and/or 

pathogenic to the test animals. These 

findings were supported by the results 

of a study of the influence of 

temperature on the growth of the two 

Aureobasidium pullulans strains, which 

showed that growth of both strains does 

not occur at or above 35 °C. Since 

human body temperature is 37 °C, and 

based on the results from these studies 

as discussed in this unit the Agency 

concluded that neither strain would be 

toxic, infective and/or pathogenic in 

humans. 

1. Acute Oral Toxicity/Pathogenicity 

(Office of Chemical Safety and Pollution 

Prevention (OCSPP) Guideline 885.3050; 

Master Record Identification Number 

(MRID) No. 47899302. Twenty-four rats 

were administered a single dose of 

Aureobasidium pullulans strain DSM 

14941. Three animals of each sex were 

sacrificed on days 3, 7, and 14; the 

remaining animals were sacrificed at 

test end on day 21. Body tissues were 

examined for Aureobasidium pullulans. 

All samples of feces, blood, brain, lung, 

liver, kidney, spleen, stomach, and 

intestine were negative. The lymph 

nodes of one animal sacrificed on day 

7 tested positive for the presence of 

Aureobasidium pullulans DSM 14941. 

These findings show a pattern of 

clearance with no Aureobasidium 

pullulans DSM 14941 detected by day 

14. The results of this acceptable study 

demonstrated that Aureobasidium 

pullulans DSM 14941 was not toxic, 

infective, and/or pathogenic in rats, 

when dosed at 4 × 108 cfu/animal. 

2. Acute Pulmonary Toxicity/ 

Pathogenicity (OCSPP Guideline 

885.3150; MRID No. 47899303). Male 

and female animals were exposed 

intratracheally with Aureobasidium 

pullulans strain DSM 14941 Technical 

(4 × 108 cfu/g). Interim sacrifices were 

made 3 hours post-dose and on study 

days 3, 7, and 14; the remaining animals 

were sacrificed at study end on day 21. 

There was no mortality, and, except on 

the day of dosing when the entire test 

material group showed reduced motor 

activity and dyspnea, all animals 

appeared normal throughout the study. 

Tissue samples were evaluated for 

Aureobasidium pullulans after sacrifice. 

The following tissues were negative for 

Aureobasidium pullulans at all time 

points: Feces, brain, kidney, and 

intestine. Blood samples were negative 

except for one male on day 0; lung 

samples were negative except for two 

males and two females on day 0; liver 

samples were negative except for three 

males on day 0; spleen samples were 

negative except for two males on day 0; 

lymph node samples were negative 

except for one animal on day 7, and 

stomach samples were negative except 

for two males on day 0. These findings 

show a pattern of clearance with no 

Aureobasidium pullulans DSM 14941 

detected by day 14. The results of this 

acceptable study demonstrated that 

Aureobasidium pullulans DSM 14941 

was not toxic, infective, and/or 

pathogenic in rat, when dosed at 0.8 × 

108 cfu/animal. 

3. Acute Injection Toxicity/ 

Pathogenicity (OCSPP Guideline 

885.3200; MRID No. 47871807 and 

47871808). In an acute subcutaneous 

toxicity/pathogenicity study (MRID 

47871807), male and female rats were 

injected with Aureobasidium pullulans 

strain DSM 14940 (2.36 × 1010 cfu/g) 

and DSM 14941 (1.5 × 1010 cfu/g). 

Interim sacrifices were made on days 3, 

7, and 14; the remaining animals were 

sacrificed at test end on day 21. There 

were no deaths, and all animals 

appeared normal throughout the study 

except for edema or slight erythema at 

the injection site. Samples of the 

following tissues were negative for 

Aureobasidium pullulans at all time 

points: Feces, blood, brain, lung, liver, 

kidney, spleen, stomach, and intestine. 

Lymph node samples were negative 

except for one animal sacrificed on day 

7. The study author suggested this was 

likely a post-mortem transmission. A 

pattern of clearance was observed in 

this study, with no Aureobasidium 

pullulans DSM 14941 or 14940 detected 

by day 14. The results of this acceptable 

study demonstrated that Aureobasidium 

pullulans strains DSMZ 14940 and 

DSMZ 14941 were not toxic, infective, 

and/or pathogenic in rats, when dosed 

at 1.95 × 107 or 1.12 × 107cfu/animal, 

respectively. 

In a second acute subcutaneous 

toxicity/pathogenicity study (MRID 

47871808), male and female rats were 

injected with Aureobasidium pullulans 

strain DSM 14941 (1.1 × 109 cfu/g). 

Interim sacrifices were made on days 1 

and 7; the remaining animals were 

sacrificed at test end on day 21. There 

were no deaths, and all animals 

appeared normal throughout the study 

except for severe edema or slight 

erythema at the injection site. Samples 

of the following tissues were negative 

for Aureobasidium pullulans at all time 

points: Brain, lung, spleen, kidney, 

lymph nodes, blood and urine. The skin 

was positive for Aureobasidium 

pullulans in three males and three 

females from the test material group on 

day 1 and in two females of the same 

group on day 7. The liver of one male 

from the test material group was 

positive on day 1. The cecum contents 

were positive in one male and one 

female from the test material group on 

day 1 and in two females from the same 

group on day 7. These findings show a 

pattern of clearance with no 

Aureobasidium pullulans DSM 14941 

detected by day 21. The results of this 

acceptable study demonstrated that 

Aureobasidium pullulans DSM 14941 

was not toxic, infective, and/or 


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8734 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 

pathogenic in rats, when dosed at 1.6 × 

107 cfu/animal. 

4. Acute Dermal Toxicity (OCSPP 

Guideline 870.1200; MRID 47869615). In 

an acute dermal toxicity study, the 

shaved skin of 10 rats was dosed with 

2,000 milligram/kilogram (mg/kg) 

Blossom Protect (7 × 109 cfu/g each of 

strains DSM 14940 and DSM 14941) for 

24 hours. One male exhibited 

chromodacryorrhea from day 7 to day 

14 and one female exhibited 

chromodacryorrhea from day 1 to day 2 

of the study, but this was not considered 

to be toxicologically significant because 

this is a normal but rare response and 

it did not result in mortality. All 

animals appeared healthy at necropsy. 

The lethal dose (LD50) was >2,000 mg/ 

kg. This study was rated acceptable, and 

the end use product (EP) is classified as 

toxicity category IV. 

5. Primary Dermal Irritation (OCSPP 

Guideline 870.2500; MRID 47869619). In 

a dermal irritation study, the shaved 

skin of 3 rabbits was dosed with 0.5 g 

Blossom Protect (7 × 109 cfu/g 

Aureobasidium pullulans strain DSM 

14940 and 7 × 109 cfu/g Aureobasidium 

pullulans strain DSM 14941) moistened 

with 1.0 milliliter (mL) deionized water 

for 4 hours. All animals appeared 

normal throughout the study; thus, 

Blossom Protect was considered to be 

non-irritating. This study was rated 

acceptable, and the EP is classified as 

toxicity category IV. 

6. Acute Oral Toxicity (OCSPP 

Guideline 870.1100; MRID No. 

47869614. In an acute oral toxicity 

study, six animals received a single 

2,000 mg/kg body weight (bw) dose of 

Blossom Protect 22% (2 × 1010 cfu/g) 

Aureobasidium pullulans strain DSM 

14940, 22% (2 × 1010 cfu/g) 

Aureobasidium pullulans strain DSM 

14941, 25% sucrose, 6% water. There 

was no mortality, and all animals 

appeared normal throughout the study. 

The LD50 was >2,000 mg/kg. This study 

was rated acceptable, and the EP is 

classified as toxicity category III. 

7. Acute Inhalation Toxicity (OCSPP 

Guideline 870.1300; MRID 47869617). In 

an acute inhalation toxicity study, 10 

animals were exposed nose-only to a 

10% suspension of Blossom Protect (7 × 

10 9 cfu/g A. pullulans strain DSM 

14940 and 7 × 109 cfu/g A. pullulans 

strain DSM 14941) at 5.17 milligrams 

per liter (mg/L). The Mass Medium 

Aerodynamic Diameter (MMAD) was 

4.2 mm. There were no deaths and all 

animals appeared healthy throughout 

the study. Necropsy was unremarkable. 

The lethal concentration (LC50) was 

>5.17 mg/L. This study was rated 

acceptable, and the EP is classified as 

toxicity category IV. 

8. Acute Eye Irritation (OCSPP 

Guideline 870.2400; MRID 47869618). In 

an eye irritation study, three rabbits 

were dosed with 0.1 mL (60–62 grams 

(g) of Blossom Protect (7 × 109 cfu/g A. 

pullulans strain DSM 14940 and 7 × 109

cfu/g A. pullulans strain DSM 14941). 

One animal had a score of 1 for 

conjunctival redness 1 hour after 

application. There were no other 

clinical signs, and all animals appeared 

normal at 24 hours. Blossom protect was 

considered to be virtually non-irritating. 

This study was rated acceptable, and the 

EP is classified as toxicity category IV. 

9. In vivo Micronucleus Assay (MRID 

47899304). Twenty mice (two groups of 

five male and two groups of five female 

mice) received single 2,000 mg/kg 

Aureobasidium pullulans strain DSM 

14941 dissolved in water by oral gavage. 

There were no clinical signs observed in 

any of the test animals, which were 

sacrificed 24 or 48 hours after receiving 

the test material. The femoral bone 

marrow was immediately harvested, and 

the ratio of polychromatic erythrocytes 

to total erythrocytes (mature and 

immature) was determined, and 2,000 

immature erythrocytes/animal were 

scored for the presence of 

micronucleated immature erythrocytes, 

a sign of potential toxicity or damage to 

genetic material in the cells. 

Aureobasidium pullulans strain DSM 

14941 did not produce a statistically 

significant increase in micronucleated 

immature erythrocytes compared to the 

untreated control animals. The response 

of the positive control animals (treated 

with a known toxic substance, 

cyclophosphamide, by intraperitoneal 

injection, at 10 mg/kg) was appropriate 

for comparison and did produce a 

statistically significant increase in 

micronucleated immature erythrocytes 

compared to the untreated control 

animals. This study was rated 

acceptable. 

10. Influence of Temperature on 

Reproduction (MRID 47871833). 

Aureobasidium pullulans strain CBS 

626.85 was isolated from the peritoneal 

dialysis fluid of a human in Australia. 

The effects of temperature on the 

reproduction or growth of 

Aureobasidium pullulans strains DSM 

14940 and, DSM 14941, in liquid 

culture or on agar plates were examined 

and compared against this positive 

control, Aureobasidium pullulans strain 

CBS 626.85, to observe the ability of 

these strains to reproduce at human 

body temperature of 37 °C. All three 

strains grew well at 30 °C. At 33 °C, the 

number of replications (per 48 hours) of 

the Aureobasidium pullulans strains 

DSM 14940 and, DSM 14941 was less 

than one, while the number of 

duplications for strain CBS 626.85 was 

approximately five. Neither strain DSM 

14940 or strain DSM 14941 was able to 

grow at 35 °C or 37 °C, while strain CBS 

625.85 replicated (approximately) twice 

at 35 °C and once at 37 °C. Based on the 

lack of growth of the DSM strains at 35 

°C and above, and given human body 

temperature is 37 °C, Aureobasidium 

pullulan strains DSM 14940 and DSM 

14941 are expected to be nonpathogenic in humans. This study was 

rated acceptable. 

11. Hypersensitivity Incidents (OCSPP 

Guideline 885.3400; MRID No. 

47945023). No hypersensitivity 

incidents, including immediate-type or 

delayed-type reactions of humans and 

domestic animals during research, 

development, or testing of 

Aureobasidium pullulans strains DSM 

14940 and DSM 14941 were reported by 

the applicant. Any future 

hypersensitivity incidents must be 

reported per OCSPP 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 

Should this microbial pesticide be 

present on food, the acute toxicity, 

infectivity, and pathogenicity data, as 

well as the data demonstrating the lack 

of growth at human body temperature 

submitted for Aureobasidium pullulans 

strains DSM 14940 and DSM 14941 

demonstrated that no toxicity, 

infectivity, and/or pathogenicity is 

likely to occur with any exposure level 

resulting from application of these two 

proposed pesticide active ingredients in 

accordance with good agricultural 

practices (see Unit III.B.). 

1. Food. Naturally occurring 

Aureobasidium pullulans is likely to be 

present on fresh produce. According to 

Webb and Mundt (1978) (Ref. 11) 

Aureobasidium pullulans is ‘‘a major 

resident on most green plants.’’ In a 

study with several species of crop 

plants, they determined Aureobasidium 

pullulans to be among the most 

abundant (71%–85%) of all fungi 

present on the plant surfaces. 

Aureobasidium pullulans made up an 

average of 77.1% of the mold species 

isolated on green beans, and occurred at 


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Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 8735 

high levels (up to 2.7 × 104 cfu/ 

centimeter2 (cm2) on certain fruits 

(cucumbers and squash). Dietary 

exposure to Aureobasidium pullulans 

strains DSM 14940 and DSM 14941, 

therefore, is possible from strawberries, 

grapes, pome and stone fruits harvested 

naturally and from plants treated with 

these fungicidal active ingredients. The 

submitted acute oral toxicity/ 

pathogenicity studies indicated that if 

Aureobasidium pullulans strains DSM 

14940 and DSM 14941 are ingested, no 

toxic or pathogenic effects will result. In 

addition, Aureobasidium pullulans 

strains DSM 14940 and DSM 14941 do 

not reproduce at the normal human 

body temperature of 37 °C. Therefore, in 

the event oral exposure should occur by 

ingesting treated fruits, the Agency 

concludes that there is a reasonable 

certainty that no harm will result from 

exposure to such residues. 

2. Drinking water exposure. Naturally 

occurring Aureobasidium pullulans is 

ubiquitous and has been isolated from 

all types of water (Ref. 14). Exposure of 

humans to residues of pesticides 

containing Aureobasidium pullulans 

strains DSM 14940 and DSM 14941 in 

consumed drinking water is possible but 

potential exposure through drinking 

water is reduced, given the proposed 

use patterns, use sites, and application 

methods for Aureobasidium pullulans 

strains DSM 14940 and DSM 14941, 

which do not include direct application 

to aquatic environments. In the event 

that Aureobasidium pullulans strains 

DSM 14940 and DSM 14941 are 

transferred to surface water or ground 

water intended for human consumption, 

the fungi would not survive the high 

temperatures, chlorination, pH 

adjustments, and/or filtration water is 

subjected to in a drinking water 

treatment facility. Even if oral exposure 

should occur through consumed 

drinking water, there is a reasonable 

certainty that no harm will result from 

exposure to such residues, based upon 

the lack of toxicity, infectivity, and/or 

pathogenicity, as well as the inability of 

these fungal strains to grow at human 

body temperature, demonstrated in the 

previously described toxicological 

studies (see Unit III.B.). 

B. Other Non-Occupational Exposure 

The use sites for these products 

include residential garden sites and 

agricultural sites. Aureobasidium 

pullulans is naturally present in many 

habitats, and based on the data and 

other information submitted to satisfy 

data requirements for registration of the 

MPs and EPs containing the active 

ingredients Aureobasidium pullulans 

strains DSM 14940 and DSM 14941, no 

toxicity, infectivity, pathogenicity or 

other adverse effects from nonoccupational exposure are expected (see 

Unit III.B.). 

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.’’ 

The likelihood of adverse cumulative 

effects occurring via a common 

mechanism of toxicity is minimal, based 

on the lack of toxicity/pathogenicity/ 

infectivity potential of the active 

ingredients when Aureobasidium 

pullulans strains DSM 14940 and DSM 

14941 are used in or on food 

commodities and/or labeled for 

residential uses (see Unit III.B.). In 

addition, Aureobasidium pullulans 

strains DSM 14940 and DSM 14941 do 

not appear to produce a toxic metabolite 

produced by 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 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 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 

FQPA 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 summarized in Unit 

III.B., 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 the residues of 

Aureobasidium pullulans strains DSM 

14940 and DSM 14941. This includes all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information. EPA has arrived at 

this conclusion because the data and 

information available on Aureobasidium 

pullulans strains DSM 14940 and DSM 

14941 do not demonstrate toxic, 

pathogenic, and/or infective potential to 

mammals. Thus, there are no threshold 

effects of concern and, as a result, the 

Agency has concluded that an 

additional margin of safety for infants 

and children is unnecessary in this 

instance. Further, the need to consider 

consumption patterns, special 

susceptibility, and cumulative effects 

does not arise when dealing with 

pesticides with no demonstrated 

significant adverse effects. 

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 Aureobasidium pullulans strains 

DSM 14940 or DSM 14941. 

VIII. Conclusions 

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 residues of 


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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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