Document ID: EPA-HQ-OPP-2010-0099-0010
Agency: epa
Document Type: Rule
Title: Exemptions from Requirement of a Tolerance: Aureobasidium pullulans strains DSM 14940 and DSM 14941
Posted Date: 2012-02-15T05:00Z

[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Rules and Regulations]
[Pages 8731-8736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3585]

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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.

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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

[[Page 8732]]

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/text-idx?&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 Bio-ferm 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 ``yeast-like'' 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

[[Page 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 x 10\9\ 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 [deg]C. Since human body 
temperature is 37 [deg]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 x 10\8\ 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 x 10\8\ 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 x 10\8\ 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 x 10\10\ 
cfu/g) and DSM 14941 (1.5 x 10\10\ 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 x 10\7\ or 1.12 x 10\7\cfu/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 x 10\9\ 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

[[Page 8734]]

pathogenic in rats, when dosed at 1.6 x 10\7\ 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 x 10\9\ 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 x 10\9\ cfu/g Aureobasidium 
pullulans strain DSM 14940 and 7 x 10\9\ 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 x 
10\10\ cfu/g) Aureobasidium pullulans strain DSM 14940, 22% (2 x 10\10\ 
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 x 10 \9\ 
cfu/g A. pullulans strain DSM 14940 and 7 x 10\9\ cfu/g A. pullulans 
strain DSM 14941) at 5.17 milligrams per liter (mg/L). The Mass Medium 
Aerodynamic Diameter (MMAD) was 4.2 [micro]m. 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 x 10\9\ cfu/g A. pullulans strain DSM 
14940 and 7 x 10\9\ 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 [deg]C. All three strains 
grew well at 30 [deg]C. At 33 [deg]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 [deg]C or 37 [deg]C, while strain CBS 
625.85 replicated (approximately) twice at 35 [deg]C and once at 37 
[deg]C. Based on the lack of growth of the DSM strains at 35 [deg]C and 
above, and given human body temperature is 37 [deg]C, Aureobasidium 
pullulan strains DSM 14940 and DSM 14941 are expected to be non-
pathogenic 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 non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).

A. Dietary Exposure

    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

[[Page 8735]]

high levels (up to 2.7 x 10\4\ cfu/centimeter\2\ (cm\2\) 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 [deg]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 non-occupational 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

[[Page 8736]]

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 cultivation-
independent 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]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.1312 is added to subpart D to read as follows:

Sec.  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