[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]
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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.
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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