Document ID: EPA-HQ-OPP-2008-0164-0006
Agency: epa
Document Type: Rule
Title: Candida oleophila
Posted Date: 2009-05-13T04:00Z

[Federal Register: May 13, 2009 (Volume 74, Number 91)]
[Rules and Regulations]               
[Page 22460-22464]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13my09-10]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0164; FRL-8412-9]

 
Candida oleophila Strain O; 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 microbial pesticide, Candida 
oleophila Strain O, on apples and pears when applied/used as a post-
harvest biofungicide. BioNext sprl (in care of SynTech Global, LLC) 
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 Candida oleophila Strain O.

DATES: This regulation is effective May 13, 2009. Objections and 
requests for hearings must be received on or before July 13, 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-2008-0164. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Jeannine Kausch, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 347-8920; e-mail address: kausch.jeannine@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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-2008-0164 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 July 13, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0164, by one of the following methods.

[[Page 22461]]

     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 28, 2008 (73 FR 16673) (FRL-8355-
6), 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 7F7310) by BioNext sprl, Passage des deportes, 2, B-5030 
Gembloux, Belgium (in care of SynTech Global, LLC, P.O. Box 640, 
Hockessin, DE 19707). The petition requested that 40 CFR part 180 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of Candida oleophila Strain O. This notice 
included a summary of the petition prepared by the petitioner, BioNext 
sprl (in care of SynTech Global, LLC). 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.
    Candida oleophila Strain O is a single-celled yeast in the phylum 
Ascomycota, the class Ascomycetes, and the family Saccharomycetaceae. 
Found naturally on plant tissues (fruits, flowers, and wood) and in 
water, it was originally isolated from Golden Delicious apples and is 
intended for use as an antagonist to control the fungal pathogens, grey 
mold (Botrytis cinerea) and blue mold (Penicillium expansum), that 
cause post-harvest decay on apples and pears. The mode of action for 
Candida oleophila Strain O is primarily through competition for 
nutrients and pre-colonization of plant wound sites. Submitted data 
also suggest that production of beta-1,3-glucanases (i.e., hydrolytic 
enzymes that can degrade fungal phytopathogen cell walls) may 
contribute to its antagonistic activity. According to reported testing, 
Candida oleophila Strain O does not grow above 33[deg]C, is sensitive 
to ultraviolet light, and is dependent on a carbon source for growth. 
Some species of Candida are reported as opportunistic pathogens to 
humans and/or animals. Candida oleophila, however, is an environmental 
microbe unable to grow at mammalian body temperatures and easily 
distinguished from the Candida species reported as clinical isolates. 
More importantly, no pathogenic effects or infections from Candida 
oleophila Strain O were seen in the submitted infectivity studies 
discussed below and there have been no clinical reports of Candida 
oleophila infection even though various strains of this species 
naturally occur on food commodities such as apples, olives, 
strawberries, fermenting grapes, and tomatoes. Additional information 
regarding Candida oleophila Strain O can be found in the Biopesticides 
Registration Action Document (BRAD) on the Biopesticides and Pollution 
Prevention Division (BPPD) website: http://www.epa.gov/pesticides/
biopesticides.
    Studies submitted to the Agency were issued Master Record 
Identification (MRID) Numbers and reviewed by BPPD scientists. These 
submissions were considered in light of the microbial pesticides data 
requirements, which became final on December 26, 2007 (72 FR 61002). 
The following summaries of the toxicological profile of Candida 
oleophila Strain O are based on an Agency risk assessment memorandum 
and related data evaluation records dated November 13, 2008.

A. Acute Oral Toxicity and Pathogenicity - Rat (Office of Prevention, 
Pesticides, and Toxic Substances [OPPTS] Guideline 885.3050; MRID No. 
473138-07)

    In an acute oral toxicity and pathogenicity study, groups of rats 
were given a single oral dose of Candida oleophila Strain O at a dose 
of 2.3-3.8 x 108 colony-forming units (CFU)/animal. The 
animals were observed for a period of up to 22 days with interim 
scheduled sacrifices on days 4, 8, and 15. There were no treatment-
related clinical signs, necropsy findings, or changes in body weight. 
No test organisms were recovered from the gastrointestinal contents, 
any organs, or blood of any animal or feces from treated animals 
sacrificed on day 22. Based on the results of this study, Candida 
oleophila Strain O does not appear to be toxic, infective, and/or 
pathogenic in rats. This study was rated ``ACCEPTABLE'' for risk 
assessment purposes.

B. Acute Subcutaneous Injection Toxicity and Pathogenicity - Rat (OPPTS 
Guideline 885.3200; MRID No. 473138-08)

     In an acute subcutaneous injection toxicity and pathogenicity 
study, groups of rats were injected subcutaneously with Candida 
oleophila Strain O with a dose of 1.1-2.0 x 107 CFU/animal. 
The animals were observed for up to 22 days. There were no treatment-
related clinical signs, necropsy findings, or changes in body weight. 
No test

[[Page 22462]]

organisms were recovered from the gastrointestinal contents, organs, 
blood, or the injection site of any animal. Based on the results of 
this study, Candida oleophila Strain O does not appear to be toxic, 
infective, and/or pathogenic in rats, when dosed at 1.1-2.0 x 
107 CFU/animal. This study was rated ``ACCEPTABLE'' for risk 
assessment purposes.

C. Acute Pulmonary Toxicity and Pathogenicity - Rat (OPPTS Guideline 
885.3150; MRID No. 473138-09)

    In an acute pulmonary toxicity and pathogenicity study, groups of 
rats were exposed by the intratracheal route to Candida oleophila 
Strain O at a dose of 1.2-5.2 x 108 CFU/animal. The animals 
were observed for up to 22 days. There were no test substance-related 
clinical signs, necropsy findings, or changes in body weight. Test 
organisms were recovered in the lungs from the treated males and 
females sacrificed one hour post dosing with clearance by day 4. No 
test organisms were recovered from the gastrointestinal contents, 
organs, or blood of any animal or feces from treated animals sacrificed 
on day 22. Based on these results, Candida oleophila Strain O does not 
appear to be toxic, infective, and/or pathogenic to rats at 1.2-5.2 x 
108 CFU/animal. This study was rated ``ACCEPTABLE'' for risk 
assessment purposes.

D. Hypersensitivity Incidents (OPPTS Guideline 885.3400; MRID No. 
473138-12)

    During a pilot-plant production trial using fermentation vessels 
and involving large amounts of Candida oleophila Strain O, 3 of 6 
workers (all on the same work team) not wearing personal protective 
equipment (PPE) reported clinical symptoms of a respiratory reaction. 
No adverse dermal effects have been reported by workers. Respiratory 
and dermal sensitization to consumers is not anticipated, mainly due to 
the extremely high exposure to Candida oleophila Strain O encountered 
by workers during the fermentation process as opposed to the very low 
exposure anticipated on treated fruit intended for human consumption. 
Any future hypersensitivity reports must be reported per OPPTS 
Guideline 885.3400.

E. Bacterial Reverse Mutation Test (OPPTS Guideline 870.5100; MRID No. 
473138-13) and In Vitro Mammalian Cell Gene Mutation Test (OPPTS 
Guideline 870.5300; MRID No. 473138-14)

    Two mutagenicity tests were submitted, reviewed, and indicated that 
Candida oleophila Strain O did not have mutagenic potential. These 
studies were rated ``SUPPLEMENTAL'' for the purposes of risk assessment 
and they are not required studies for this active ingredient.

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

    Dietary exposure to Candida oleophila Strain O is likely to occur, 
mainly through food. However, the lack of acute oral toxicity/
pathogenicity, based on the toxicology test on rats presented in Unit 
III., and the ubiquitous nature of the microbe on various food 
commodities support the establishment of an exemption from the 
requirement of a tolerance for Candida oleophila Strain O. 
Additionally, under 40 CFR 180.1144, a similar active ingredient, 
Candida oleophila isolate I-182, was assessed previously and granted an 
exemption from the requirement of a tolerance when used as a post-
harvest biological fungicide in or on all raw agricultural commodities.
    1. Food. Candida oleophila Strain O is naturally present on apples 
as it was originally isolated in 1991 from the surface of Golden 
Delicious apples. Based on information submitted to the Agency, 
population densities of white yeasts are estimated to reach 1.5 x 
103 CFU/square centimeter (cm2) on harvested 
apples, which includes the natural population of Candida oleophila. 
Background levels of Candida oleophila Strain O on apples are expected 
to be below 1.5 x 103 CFU/cm2. Post-harvest 
treatment with Candida oleophila Strain O will probably lead to a 
temporary increased level of this yeast on apples. The mode of action 
of Candida oleophila Strain O is primarily based on competition for 
nutrients; therefore, sufficient colonization of apple surfaces has to 
be reached to ensure efficacy of the active ingredient. The recommended 
application rate of Candida oleophila Strain O leads to an expected 
residual Candida oleophila Strain O population of approximately 4 x 
104 CFU/cm2 (105 CFU/apple). Standard 
practices of washing, peeling, cooking, or processing fruits further 
reduces residues of Candida oleophila Strain O and minimizes dietary 
exposure. Actual dietary exposure is expected to be several orders of 
magnitude lower than the dose used in the acute oral toxicity/
pathogenicity test referenced in Unit III., during which no toxic or 
pathogenic effects were observed in rats. The Agency concludes that 
there is a reasonable certainty that no harm will result from the 
aggregate exposure to the residues of Candida oleophila Strain O in 
food.
    2. Drinking water exposure. Exposure of humans to residues of 
Candida oleophila Strain O in drinking water is unlikely. The proposed 
use pattern, use sites, and application methods for Candida oleophila 
Strain O (i.e., dip or drench application to apples and pears after 
harvest and prior to storage) does not include direct application to 
aquatic environments. In the unlikely event that Candida oleophila 
Strain O was transferred to surface or ground water intended for 
eventual human consumption, the microbe would not survive the 
conditions water is subjected to in a drinking water treatment 
facility, including flocculation, chlorination, pH adjustments, and/or 
filtration. Even if oral exposure should occur through drinking water, 
the Agency concludes that there is a reasonable certainty that no harm 
will result from the exposure to the residues of Candida oleophila 
Strain O in all the anticipated drinking water exposures because of the 
lack of acute oral toxicity/pathogenicity to mammals and the ubiquitous 
nature of the microbe, as previously described.

B. Other Non-Occupational Exposure

    Potential non-occupational dermal or inhalation exposure is 
considered unlikely for this distinctly agricultural use (i.e., post-
harvest treatment of the harvested portions--pears and apples--of 
agricultural plants).
    1. Dermal exposure. Non-occupational dermal exposure to Candida 
oleophila Strain O, when used as labeled, is expected to be negligible 
because it is limited to post-harvest agricultural treatment of apples 
and pears. However, should non-occupational dermal exposure occur 
through treated food commodities, the risk posed by this low toxicity 
microbe is likely to be minimal based on the toxicity and pathogenicity 
tests described in Unit III. Furthermore, exposure would not be 
expected to exceed background as similar yeasts and those in the genus 
and species, Candida oleophila, are commonly associated with particular 
food commodities.

[[Page 22463]]

    2. Inhalation exposure. Non-occupational inhalation exposure to 
Candida oleophila Strain O, when used as labeled, is expected to be 
negligible because of the method of application (i.e., dipping and 
drenching of apples and pears), which then allows sufficient time for 
drying prior to distribution to consumers. Furthermore, most of the 
residual yeast on apples and pears is trapped in the cuticular wax and 
it is unlikely to be inhaled by consumers.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to 
consider the cumulative effects of exposure to Candida oleophila Strain 
O and to other substances that have a common mechanism of toxicity. 
These considerations include the possible cumulative effects of such 
residues on infants and children. As demonstrated in Unit III., Candida 
oleophila Strain O is not toxic or pathogenic to mammals via several 
routes of exposure. Additionally, there are no other Candida oleophila 
strains currently registered as pesticides with the Agency. 
Consequently, since this microbial pesticide has no demonstrated 
toxicity, there is no reason to anticipate cumulative effects from the 
residues of this product with other related microbial pesticides.

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

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the 
available information about consumption patterns among infants and 
children, special susceptibility of infants and children to pesticide 
chemical residues, and the cumulative effects on infants and children 
of the residues and other substances with a common mechanism of 
toxicity. In addition, FFDCA section 408(b)(2)(C) 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. Margins of exposure (safety), which are often referred to 
as uncertainty factors, are incorporated into EPA risk assessment 
either directly or through the use of a margin of exposure analysis, or 
by using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk.
    Based on the acute toxicity and pathogenicity data discussed in 
Unit III., EPA concludes that there is a reasonable certainty that no 
harm will result from aggregate exposure to the United States 
population, including infants and children, to the residues of Candida 
oleophila Strain O. 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 Candida 
oleophila Strain O do not demonstrate toxic, pathogenic, or infective 
potential to mammals. Thus, there are no threshold effects of concern 
and, as a result, the provision requiring an additional margin of 
safety does not apply. Further, the considerations of consumption 
patterns, special susceptibility, and cumulative effects do not apply 
to pesticides without a demonstrated significant adverse effect.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required, under Section 408(p) of the FFDCA, to develop a 
screening program to determine whether certain substances (including 
all pesticide active and other ingredients) ``may have an effect in 
humans that is similar to an effect produced by naturally-occurring 
estrogen, or other such endocrine effects as the Administrator may 
designate.'' Following the recommendations of its Endocrine Disruptor 
Screening and Testing Advisory Committee (EDSTAC), EPA determined that 
there was a scientific basis for including, as part of its program, 
androgen and thyroid hormone systems, in addition to the estrogen 
hormone system. EPA also adopted EDSTAC's recommendation that the 
program include evaluations of potential effects on wildlife.
    The Agency has no knowledge of Candida oleophila Strain O being an 
endocrine disruptor, nor is this microbe related to any class of known 
endocrine disruptors. Following several routes of exposure in rodents, 
the Tier I toxicology data indicated that the immune system was still 
intact and able to process and clear Candida oleophila Strain O from a 
variety of organs or tissues. Additional data, specifically on the 
endocrine effects of this microbial pesticide, are not required at this 
time. Consequently, endocrine-related concerns did not impact the 
Agency's safety finding for Candida oleophila Strain O. When the 
appropriate screening and/or testing protocols being considered under 
the Agency's Endocrine Disruptor Screening Program (EDSP) have been 
developed and implemented, Candida oleophila Strain O may be subject to 
additional screening and/or testing to better characterize effects 
related to endocrine disruption.

B. Analytical Method(s)

    The Agency proposes to establish an exemption from the requirement 
of a tolerance without any numerical limitation; therefore, the Agency 
has concluded that an analytical method is not required for enforcement 
purposes for Candida oleophila Strain O.

 C. Codex Maximum Residue Level

    No Codex maximum residue level exists for ECandida oleophila Strain 
O.

VIII. Conclusions

    The results of the studies discussed in Unit III meet the safety 
requirements of the Food Quality Protection Act (FQPA) of 1996. They 
support an exemption from the requirement of a tolerance for the 
residues of the microbial pesticide, Candida oleophila Strain O, on 
apples and pears. In addition, the Agency is of the opinion that, if 
the microbial active ingredient is used as allowed, aggregate exposure 
and cumulative effects are not likely to harm the United States 
population, including infants and children. Therefore, in response to 
pesticide tolerance petition 7F7310, an exemption from the requirement 
of a tolerance is established for the residues of the microbial 
pesticide, Candida oleophila Strain O, on apples and pears when 
applied/used as a post-harvest biofungicide.

 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).

[[Page 22464]]

    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.
    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:May 1, 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 180.1289 is added to subpart D to read as follows:

Sec.  180.1289  Candida oleophila Strain O; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
the residues of the microbial pesticide, Candida oleophila Strain O, on 
apples and pears when applied/used as a post-harvest biofungicide.

[FR Doc. E9-10962 Filed 5-12-09; 8:45 am]

BILLING CODE 6560-50-S