
[Federal Register: October 28, 2009 (Volume 74, Number 207)]
[Rules and Regulations]               
[Page 55454-55458]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc09-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0760; FRL-8436-6]

 
 Ulocladium oudemansii (U3 Strain); 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 microbial fungicide, Ulocladium 
oudemansii (U3 Strain), in or on all food commodities when applied or 
used pre-harvest only, and excluding applications made post-harvest or 
to processed commodities. Botry-Zen, Ltd. 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 Ulocladium oudemansii (U3 Strain).

DATES: This regulation is effective October 28, 2009. Objections and 
requests for hearings must be received on or before December 28, 2009, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0760. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8263; e-mail address: greenway.denise@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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR site at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2008-0760 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk on or before December 28, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked

[[Page 55455]]

confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0760, 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 November 14, 2008 (73 FR 67512) (FRL-
8388-3), 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 7F7269) by Botry-Zen, Ltd., 21 Willis St., P.O. Box 5664, 
Dunedin, New Zealand. The petition requested that 40 CFR part 180 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of Ulocladium oudemansii (U3 Strain). This 
notice stated that a summary of the petition prepared by the 
petitioner, Botry-Zen, Ltd., was included in the docket. In response to 
EPA's notice announcing the filing of this petition, one comment was 
received from an anonymous person. The commenter complained of 
perceived inadequacy regarding the Agency's assessment of the subject 
petition, expressed dissatisfaction with the Agency's overall history 
concerning pesticide petition approvals, EPA's ability to protect the 
health of the American public, and opined that human testing should be 
conducted on the subject active ingredient. The commenter did not 
provide, however, any information in support of his/her position or 
specify the desired human studies assessment parameter(s). Before 
issuing any tolerance exemption, the Agency examines the potential 
effects of the pesticide on humans and the environment. For this 
particular microbial pesticide, EPA conducted a comprehensive 
assessment of Ulocladium oudemansii (U3 Strain), including a review of 
the acceptable studies and other supporting information addressing the 
potential effects of this pesticide. EPA's review of these data and 
information indicated that the active ingredient is not toxic to test 
animals when administered via the oral, dermal, or intraperitoneal 
routes of exposure and is unlikely under the conditions of use to be a 
human health hazard by the pulmonary route because the large aggregated 
fungal spore material is not respirable. Also, there was no evidence 
that the active ingredient is a mutagen. In addition, the active 
ingredient was not infective or pathogenic to test animals when 
administered via the oral, dermal or intravenous routes. Moreover, 
growth temperature analysis has shown that Ulocladium oudemansii (U3 
strain) does not grow above 30 [deg]C, making infection of humans and 
other mammals having normal body temperatures above 37 [deg]C unlikely. 
No reports of hypersensitivity have been recorded in personnel working 
with this organism. Based on these data, the Agency has concluded that 
there is a reasonable certainty that no harm will result from dietary 
exposure to residues of Ulocladium oudemansii (U3 Strain), when applied 
or used pre-harvest only in or on all food commodities (excluding 
applications made post-harvest or to processed commodities). Thus, 
under the standard in FFDCA section 408(c)(2), an exemption from the 
requirement of a tolerance is appropriate.
    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.
    Ulocladium oudemansii is a naturally occurring soil saprophyte 
found worldwide. The subject of this tolerance exemption, Ulocladium 
oudemansii (U3 strain), was originally isolated from kiwifruit leaf 
litter debris in 1995 from a Massey University kiwifruit research plot 
in New Zealand. The active ingredient is the asexual spore of the soil 
saprophytic fungus Ulocladium oudemansii. Ulocladium oudemansii (U3 
Strain) is a fungicide intended for the control of the plant pathogens, 
Botrytis cinerea and Sclerotinia sclerotiorumn, when applied pre-
harvest to growing fruit and vegetable crops or ornamental plants. The 
organism controls the pathogens by occupying their ecological niche, in 
dead and senescent plant material, and out-competing them for space and 
nutrients. Ulocladium oudemansii (U3 strain) is non-invasive and does 
not damage living plant tissue.
    An acceptable acute oral toxicity/pathogenicity study performed in 
rats (MRID 472465-03) demonstrated the lack of mammalian toxicity at 
tested levels of exposure to Ulocladium oudemansii (U3 Strain). In this 
study, Ulocladium oudemansii (U3 Strain) was not toxic, infective nor 
pathogenic to rats given an oral dose of 1 x 108 colony 
forming units (CFU) per animal. The study resulted in a classification 
of

[[Page 55456]]

Toxicity Category IV for this strain of Ulocladium oudemansii.
    An acceptable acute intraperitoneal injection toxicity/
pathogenicity study in rats (MRID 472465-02) demonstrated that 
Ulocladium oudemansii (U3 Strain) was neither toxic, pathogenic nor 
infective to rats dosed intraperitoneally with greater than 
107 CFU of the test material.
    An acceptable acute dermal toxicity/pathogenicity study in rats 
(MRID 472465-04) demonstrated that Ulocladium oudemansii (U3 Strain) 
was not toxic, infective nor pathogenic to rats when treated dermally 
at 1 x 108 CFU/animal. There were no treatment-related 
clinical signs, dermal irritation, necropsy findings or changes in body 
weight. No test organism was recovered from blood, brain, kidney, 
liver, cervical lymph nodes or spleen of any animal. The study resulted 
in a classification of Toxicity Category III for this strain of 
Ulocladium oudemansii.
    An acceptable acute eye irritation study in rabbits (MRID 472465-
06) demonstrated that Ulocladium oudemansii (U3 Strain) administered at 
a purity of not less than 2 x 108 CFU/gram (g) and a minimum 
spore viability of 90% at 0.1 milliliter (ml)/animal is non-irritating. 
The study resulted in a classification of Toxicity Category IV for this 
strain of Ulocladium oudemansii.
    An acceptable primary dermal irritation study in rabbits (MRID 
472465-07) demonstrated that Ulocladium oudemansii (U3 Strain) 
administered at a purity of not less than 2 x 108 CFU/g and 
a minimum spore viability of 90% at 0.5 ml/animal is non-irritating. 
The study resulted in a classification of Toxicity Category IV for this 
strain of Ulocladium oudemansii.
    An acceptable skin sensitization test in guinea pigs (MRID 472465-
08) demonstrated that Ulocladium oudemansii (U3 Strain) administered at 
a purity of not less than 2 x 108 CFU/g and a minimum spore 
viability of 90% is not a dermal sensitizer. Furthermore, there have 
been no reports of hypersensitivity associated with Ulocladium 
oudemansii (U3 Strain).
    Although not triggered by results of the Tier I toxicology studies, 
nor otherwise required, an acceptable bacterial reverse mutation study 
was submitted which showed the active ingredient to be non-mutagenic 
under test conditions in the tested species.
    In addition to the acceptable toxicology studies summarized above, 
the Agency considered this other toxicology data and information in 
assessing the petitioner's tolerance exemption request.
    Pulmonary Toxicity/Pathogenicity. A submitted acute pulmonary 
toxicity/pathogenicity study in rats (MRID 472465-05) did not satisfy 
the guideline requirement because the large aggregated fungal spore 
test material could not be manipulated into a particle size suitable 
for respiration in an inhalation study. The Agency notes that large 
particles such as these are unlikely to be inhaled and deposited in the 
pulmonary region, while any deposited in the naso-pharnygeal region are 
removed by coughing, sneezing or physical wiping from the nasal area. 
Particles deposited in the tracheobronchial region are removed by the 
mucocillary escalator system. Particles could be swallowed, but would 
represent no human health concern based on the lack of mammalian 
toxicity observed in the acceptable Ulocladium oudemansii (U3 Strain) 
acute oral toxicity/pathogenicity study cited above. The Agency 
concludes that, under conditions of use, Ulocladium oudemansii (U3 
Strain) is unlikely to present a significant inhalation hazard to 
humans because the large aggregated fungal spore material is not 
respirable. In justifying its waiver request for this guideline study, 
Botry-Zen, Ltd. included in its rationale a discussion of the inability 
to dose test animals due both to the large size of the test particles 
and their rapid sedimentation in solution, and argued that any 
respirable dust or fines would not be expected to be toxic or 
irritating, based upon results from the acute oral and other submitted 
toxicology/pathogenicity studies summarized in this Unit. The presented 
rationale supports the Agency's decision to waive this data 
requirement.

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

    Ulocladium oudemansii, a common soil fungus, is ubiquitous in the 
environment and exists worldwide as a naturally-occurring saprophyte, 
i.e., an organism that lives and feeds on dead and decaying plant 
matter. The subject of this tolerance exemption, Ulocladium oudemansii 
(U3 strain), was originally isolated from kiwifruit leaf litter. Spores 
of Ulocladium oudemansii (U3 strain), when deposited under the suitable 
environmental conditions on dead or decaying plant debris, will 
germinate and colonize the necrotic plant tissue. But if such decayed 
vegetative matter is not available, or becomes exhausted, the fungus 
cannot survive. Therefore, despite its presence in soils, dietary 
exposure from the proposed use of Ulocladium oudemansii (U3 strain) 
will be minimal on food due to its limited viability in the absence of 
a decayed plant material nutrient source. Also, there are no known 
mycotoxins associated with Ulocladium species, and the submitted 
toxicological studies indicate no risk to human health from dietary 
exposure to Ulocladium oudemansii (U3 strain). Furthermore, the fungus 
produces no recognized toxins, enzymes or virulence factors normally 
associated with mammalian invasiveness or toxicity. Additionally, 
growth temperature analysis has shown that Ulocladium oudemansii (U3 
strain) does not grow above 30 [deg]C, making infection of humans and 
other mammals having normal body temperatures at or above 37 [deg]C 
unlikely.
    1. Food. As discussed above, Ulocladium oudemansii (U3 Strain) 
applied to food crops to control plant pathogens will not survive 
except on dead or decaying plant tissues. Food crops exhibiting such 
tissues are of poor quality, are not commonly consumed, and are not 
commercially marketed. Good quality food free of such decayed material 
will not support the fungus and so Ulocladium oudemansii (U3 Strain) 
residues would not be expected. Due to the limited survivability of 
Ulocladium oudemansii (U3 Strain) once its decayed plant material 
nutrient source is exhausted, dietary exposure to the naturally-
occurring microbe from the proposed pre-harvest applications to food 
crops is unlikely. Even if oral exposure from ingestion of poor-quality 
treated crops should occur, the hazard posed to adults, infants and 
children from food-related exposures to Ulocladium oudemansii (U3 
Strain) will be minimal due to the demonstrated lack of acute oral 
toxicity/pathogenicity associated with the microbial pesticide. Based 
on the evaluation of the submitted data, there are no dietary risks 
that exceed the Agency's level of concern.
    2. Drinking water exposure. Exposure of humans to residues of 
Ulocladium oudemansii (U3 Strain) in consumed drinking water would be 
unlikely. Ulocladium oudemansii (U3 Strain) is not known to grow or 
thrive in aquatic environments. Potential exposure via surface water 
would be negligible and exposure via drinking water would be

[[Page 55457]]

impossible to measure. Ulocladium oudemansii (U3 Strain) is intended 
for use on agricultural and horticultural plants, and has limited 
survival potential once its carrier nutrient source is depleted. The 
risk of the microorganism passing through soil to groundwater is 
minimal to unlikely. Additionally, the fungus would not tolerate 
municipal drinking water treatment processes, such as chlorination, pH 
adjustment, high temperature and/or anaerobic conditions. More 
importantly, even if oral exposure to this ubiquitous microbe should 
occur through drinking water, due to its demonstrated lack of acute 
oral toxicity/pathogenicity, the Agency concludes that there is a 
reasonable certainty that no harm will result from such exposure.

B. Other Non-Occupational Exposure

    The proposed pesticide uses of Ulocladium oudemansii (U3 Strain) 
being established by this rule are limited to commercial agricultural 
and horticultural settings. There are no residential uses.
    The only other exposure is what people would normally encounter as 
part of the natural environment, not as a result of pesticide use. 
There have not been reports of disease or other effects from human 
exposure to Ulocladium oudemansii (U3 Strain) naturally present in 
soils.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires the Agency, when 
considering whether to establish, modify, or revoke a tolerance, to 
consider ``available information'' concerning the cumulative effects of 
pesticide residues and ``other substances that have a common mechanism 
of toxicity.'' These considerations include the cumulative effects of 
such residues on infants and children. Because, there is no indication 
of mammalian toxicity from Ulocladium oudemansii (U3 Strain), the 
Agency concludes that Ulocladium oudemansii (U3 Strain) does not share 
a common mechanism of toxicity with other substances. Therefore, 
section 408(b)(2)(D)(v) does not apply.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C), as amended by the Food Quality 
Protection Act (FQPA) of 1996, 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) also provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database unless EPA determines 
that a different margin of safety will be safe for infants and 
children.
    Based on the toxicity information discussed in Unit III., 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 Ulocladium oudemansii (U3 Strain). This 
includes all anticipated dietary exposures and all other exposures for 
which there is reliable information. The Agency has arrived at this 
conclusion because the data available on Ulocladium oudemansii (U3 
Strain) demonstrate a lack of toxicity/pathogenicity potential. 
Ulocladium oudemansii (U3 Strain) is not known to produce any 
recognized toxins, virulence factors or enzymes normally associated 
with mammalian invasiveness or toxicity. Thus, there are no threshold 
effects of concern and, as a result, the Agency has concluded that the 
additional tenfold margin of safety for infants and children is 
unnecessary in this instance.

VII. Other Considerations

A. Endocrine Disruptors

    Ulocladium oudemansii is a ubiquitous organism in the environment. 
The subject of this tolerance exemption, Ulocladium oudemansii (U3 
Strain), is non-toxic to mammals. To date, there is no evidence to 
suggest that Ulocladium oudemansii (U3 Strain) affects the immune 
system, functions in a manner similar to any known hormone, or that it 
acts as an endocrine disruptor. Indeed, the submitted toxicity/
pathogenicity studies in rodents indicate that, following several 
routes of exposure, the immune system is intact and able to process and 
clear the active ingredient. Therefore, it is unlikely that this 
organism will have estrogenic or endocrine effects.

B. Analytical Method(s)

    The Agency is establishing an exemption from the requirement of a 
tolerance for residues of Ulocladium oudemansii (U3 Strain), applied 
pre-harvest only, in or on all food commodities (excluding applications 
made post-harvest or to processed commodities), for the reasons stated 
above. Because the organism thrives on dead/decaying plant matter and 
does not damage living plant tissues, residues of Ulocladium oudemansii 
(U3 Strain) are not expected on food crops. Even if food crops carried 
such residues, the hazard posed from food-related exposures to 
Ulocladium oudemansii (U3 Strain) will be minimal due to the 
demonstrated lack of acute oral toxicity/pathogenicity associated with 
the microbial pesticide. Therefore, the Agency has concluded that an 
analytical method is not required for enforcement purposes for 
detecting Ulocladium oudemansii (U3 Strain) residues resulting from its 
pre-harvest use as a pesticide.

C. Codex Maximum Residue Level

    No Codex maximum residue level exists for the microbial fungicide, 
Ulocladium oudemansii (U3 Strain).

VIII. Conclusions

    There is a reasonable certainty that no harm will result from 
aggregate exposure to the U.S. population, including infants and 
children, to residues of the Ulocladium oudemansii (U3 Strain) in or on 
all food and feed commodities when Ulocladium oudemansii (U3 Strain) is 
used as a pre-harvest-only microbial fungicide (thereby excluding 
applications made post-harvest or to processed commodities), in 
accordance with good agricultural practices. This includes all 
anticipated dietary exposures and all other exposures for which there 
is reliable information. The Agency has arrived at this conclusion 
because, as discussed above, no toxic effects to mammals have been 
observed.

 IX. Statutory and Executive Order Reviews

    This final rule establishes an exemption from 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

[[Page 55458]]

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 exemption in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: October 18, 2009.
Debra Edwards,
Director, Office of Pesticide Programs.

0
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 180.1292 is added to subpart D to read as follows:


Sec.  180.1292  Ulocladium oudemansii (U3 Strain); exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established in/
on all food commodities for residues of Ulocladium oudemansii (U3 
Strain), when applied or used pre-harvest-only, excluding applications 
made post-harvest or to processed commodities, as a microbial fungicide 
in accordance with good agricultural practices.

[FR Doc. E9-25969 Filed 10-27-09; 8:45 am]

BILLING CODE 6560-50-S
