[Federal Register Volume 73, Number 224 (Wednesday, November 19, 2008)]
[Rules and Regulations]
[Pages 69559-69564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27485]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0417; FRL-8389-5]
Polyoxin D Zinc Salt; 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 polyoxin D zinc salt (zinc 5-[[2-
amino-5-o-(aminocarbonyl)-2-deoxy-L-xylonoyl]amino]-1-(5-carboxy-3,4-
dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,5-dideoxy-[beta]-D-
allofuranuronatein) on almonds, cucurbit vegetables, fruiting
vegetables, ginseng, grapes, pistachios, pome fruits, potatoes and
strawberries when applied/used as a biochemical pesticide to control
and suppress fungal diseases. Arysta LifeScience North America
Corporation 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 polyoxin D zinc salt (zinc 5-
[[2-amino-5-o-(aminocarbonyl)-2-deoxy-L-xylonoyl]amino]-1-(5-carboxy-
3,4-dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,5-dideoxy-[beta]-D-
allofuranuronatein).
DATES: This regulation is effective November 19, 2008. Objections and
requests for hearings must be received on or before January 20, 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--0417. 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: Chris Pfeifer, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0031; e-mail
address: [email protected].
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
[[Page 69560]]
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-2008-0417 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 January 20, 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-2008-0417, 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 July 31, 2008 (73 FR 44719) (FRL-8374-
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 7F7252) by Arysta LifeScience North America Corporation,
15401 Weston Parkway, Suite 150, Cary, NC 27513. The petition requested
that 40 CFR part 180 be amended by establishing an exemption from the
requirement of a tolerance for residues of polyoxin D zinc salt (zinc
5-[[2-amino-5-o-(aminocarbonyl)-2-deoxy-L-xylonoyl]amino]-1-(5-carboxy-
3,4-dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,5-dideoxy-[beta]-D-
allofuranuronatein). This notice included a summary of the petition
prepared by the petitioner Arysta LifeScience North America
Corporation. 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.
Polyoxin D zinc salt is a brown musty smelling powder derived
through the fermentation of the microbe Streptomyces cacaoi var.
asoensis, which was isolated from a soil sample collected in Japan. It
is registered with EPA's Biopesticides and Pollution Prevention
Division (BPPD) as a biochemical active ingredient, intended for
incorporation into sprayable fungicides for turf. As an active
ingredient, it has a non-toxic mode of action, which acts against
fungi; not by killing it, but by inhibiting chitin growth in the cell
walls, and thus precluding the development of fungal colonies. Its
effects are considered fungi-exclusive in that it has no mode of action
relative to mammals. Polyoxin D zinc salt does not persist in the
environment, biodegrading readily within 2 to 3 days. Finally, polyoxin
D zinc salt has a well understood low toxicity profile.
Polyoxin-D zinc salt was first assessed by EPA in 1997 with regard
to the
[[Page 69561]]
human health risks associated with its fungicidal use on turf. The risk
assessment concluded that the commercial turf uses of polyoxin D zinc
salt posed no health risks to either occupational users or to any non-
occupational populations that might be exposed. A battery of acute and
chronic toxicological studies, submitted in support of this non-food
use, showed that polyoxin D zinc salt induced ``minimal toxic affects
to humans through oral, dermal, ocular or inhalation routes of
exposure.'' These studies included all acute toxicity studies,
mutagenicity studies, developmental studies, and exposure and
oncogenicity studies. Additionally, EPA's risk assessment considered
the active ingredient in light of the requirements of the Food Quality
Protection Act (FQPA) and made a determination of ``reasonable
certainty of no harm to human health.'' Altogether, the Agency's 1997
risk assessment of polyoxin D zinc salt concluded that there are no
risks expected for acute, subchronic, chronic, immune, endocrine, or
non-dietary cumulative exposures due to the negligible toxicity
associated with the active ingredient.
New toxicity data have since been submitted in support of the
request by the applicant to allow food uses (detailed in this rule) of
this registered non-food use active ingredient. These data have been
incorporated into a comprehensive risk assessment on polyoxin D zinc
salt and provide sufficient grounds for this exemption from the
requirement of a tolerance. The new data include a new mutagenicity
study, a 90-day subchronic oral toxicity study, a 2-generation
developmental toxicity study, an immunotoxicty study, and calculations
for terrestrial residues. All new data confirm a lack of human health
hazard associated with dietary exposures. These new toxicity data,
coupled with the data to support the original non-food uses, allow for
a comprehensive dietary risk analysis, and fully demonstrate polyoxin D
zinc salt's lack of acute, subchronic, and/or chronic toxicity with
regard to dietary exposure. All data substantiate the lack of dietary
risk associated with the food use of polyoxin D zinc salt.
All data supporting the use of polyoxin D zinc salt on the food
crops mentioned in this rule confirm that the dietary risks to humans
are negligible for the following reasons:
i. The fungistatic mode of action of this active ingredient is
specific to fungi and poses no risk to mammals.
ii. Polyoxin D zinc salt is not digestible by mammals and passes
through the digestive system.
iii. Theoretical (potential) residues are substantially less than
the doses that were actually used in polyoxin D zinc salts' toxicity
studies, which showed virtual non-toxicity.
iv. A complete battery of toxicological studies show no
toxicological endpoints and confirm the active ingredient's very low
toxicity. For the reasons listed in this unit, any potential residues
of polyoxin D zinc salt are considered to be safe with regard to
dietary risk. Summaries of the supporting toxicological information are
found in this unit.
1. Acute toxicity. Acute toxicity studies were submitted to support
the initial registration of polyoxin D zinc salt. These studies show a
lack of significant acute toxicological endpoints, and support the
finding that polyoxin D zinc salt poses no significant human health
risk with regard to food uses listed in the summary section of this
document. A pr[eacute]cis of the acute toxicity studies follows:
i. The acute oral LD50 is greater than 10,000
milligrams/kilograms (mg/kg) in rats, a result that confirms acute non-
toxicity through the oral route, and undergirds the risk assessment
finding that any amount of residues of polyoxin D zinc salt, if
consumed, is not a health concern.
ii. The acute dermal LD50 in rats is greater than 2,000
mg/kg in rats, and demonstrates very low toxicity through dermal
exposure. While no significant dermal exposure is expected as a result
of pesticidal applications associated with these new food uses, these
data substantiate polyoxin D zinc salt's relative non-toxicity to both
occupational users and the general public.
iii. The acute inhalation LC50 is greater than 2.17 mg/L
in rats, and shows no significant inhalation toxicity. Again, no
significant new inhalation exposure is expected; and relatedly, no
risks are expected for occupational users or the general public as a
result of these new food uses.
iv. Primary dermal irritation in rabbits was considered slight,
which finding bolsters the information presented in the acute dermal
toxicity study.
v. A hypersensitivity study on guinea pigs further demonstrated
that the active ingredient was not a dermal sensitizer. The acute
toxicity studies demonstrate that even if there were residues present
in food, there would be negligible toxic effects associated with
polyoxin D zinc salt.
2. Mutagenicity. Data demonstrate that polyoxin D zinc salt is non-
mutagenic. Accordingly, residues associated with the new pesticidal
food uses of polyoxin D zinc salt are not expected to pose any risk to
humans with regard to mutagenicity. Studies submitted in support of the
original 1997 registration of polyoxin D zinc salt first showed the
active ingredient to be without mutagenic effect. While an Ames Assay
(Master Record Identification Number (MRID 433230-01)) showed polyoxin
D to be weakly mutagenic, a battery of three complementary mutagenicity
tests supported negative conclusions for mutagenicity. In further
support of that finding of non-mutagenicity, no maternal toxicity or
developmental toxicity were observed in a developmental toxicity study
submitted at that time (MRID 432618-36). More recently, two additional
studies were submitted in support of non-mutagenicity with regard to a
food use. A Tier II Mammalian Erythrocyte Micronucleus Study (OPPTS
870.5395; MRID 47145102) showed no mutagenic effect. The test material
was not toxic to male mice at any dose tested, and there were no
reported sex differences in response to the test. In a second study,
polyoxin D zinc salt was tested to the limit dose of 2,000 mg/kg on
mice. The mice showed no clinical signs or mortality, and there was no
significant increase in the frequency of micronucleated PCEs, further
indicating no mutagenic effect. The mutagenicity studies are sufficient
to confirm that there are no expected dietary, occupational, or non-
occupational risks of mutagenicity with regard to new food uses.
3. Subchronic toxicity. Polyoxin D zinc salt has very low
subchronic oral toxicity, and demonstrates a lack of dietary risk at
the subchronic level. In a 90-Day Oral Toxicity study on rats (OPPTS
870.3100; MRID 47145101), polyoxin D zinc salt technical was
administered to ten rats. There were no toxicologically significant
treatment-related effects on mortality. Neurological assessments,
urinalysis, ophthalmology, hematology, clinical chemistry, and gross
and histologic pathology found no clinical signs of toxicologically
significant treatment-related effects. The no-observed-adverse-effect
level (NOAEL) in this study is 20,000 parts per million (ppm) (1,333
mg/kg/day) in females and 2,000 ppm (119 mg/kg/day) in males. The
lowest-observed-adverse-effect level (LOAEL) in males is 20,000 ppm
(1,166 mg/kg/day) based on decreased body
[[Page 69562]]
weight (bw) gain, food consumption and food efficiency; a LOAEL was not
observed in females. Based on the lack of meaningful subchronic
toxicological endpoints for the technical grade active ingredient
(TGAI), the fungi-exclusive mode of action as a chitin synthetase
inhibitor, and the related lack of toxic oral effect in mammals, there
are no subchronic oral toxicity concerns with polyoxin D zinc salt. It
is further noted that the proposed use patterns for this active
ingredient are not expected to result in any repeated and/or long-term
exposure by either the dermal or inhalation routes; and as a result, no
dermal or inhalation subchronic studies are required to establish this
food use.
4. Developmental toxicity. Data demonstrate that polyoxin D zinc
salt is not a developmental or reproductive toxicant. These findings
further confirm polyoxin D zinc salt's lack of mammalian toxicity, and
demonstrate a lack of dietary effect consistent with its fungi-
exclusive mode of action. A Tier III Two Generation Reproduction
Toxicity Study (OPPTS 870.3800; MRID 47120904) on rats showed no
parental systemic toxicity or differences in bw gain of either
generation. No abnormal clinical signs were observed during the study
period in any generation. No significant differences were found between
treated and control groups with regard to the average number of live
births per litter, average bw of live pups, ossification failure of the
chest ossification center, or bone variation. No differences were found
in the number of stillbirths and weaning rate. No specific
abnormalities in postnatal growth or general behavior was found between
treated and control groups. No differences were detected in mating,
pregnancy, delivery, or nursing rate by generation between the treated
and control groups. No chemical effects were found in males or females.
The reproductive NOAEL for polyoxin D zinc salt is 1%; a LOAEL was not
identified. Again, the data indicate the fungistatic nature of active
ingredient and the capacity of polyoxin D zinc salt to pass through
mammalian digestive systems. In sum, the study demonstrated a clear
lack of reproductive toxicity regarding dietary exposure and supports
the Agency's conclusion that there is no risk of developmental toxicity
associated with the new food uses.
5. Immunotoxicity. Polyoxin D zinc salt is not immunotoxic on a
dietary basis. No meaningful immunotoxicity endpoints (i.e., dietarily
possible) for polyoxin D zinc salt were identified. In an
immunotoxicity study based on dietary exposure (OPPTS 870.7800; MRID
47120901), polyoxin D zinc salt technical was administered to mice in
their diet for 28 days at various concentrations. There were no
compound-related deaths or effects on clinical observations, bw or food
consumption. There were no compound-related macroscopic findings noted,
and organ weights were unaffected. There were no compound-related
effects on the humoral immune response to the T-dependent antigen,
sRBC. This study shows the lack of dietary risk posed by the
immunotoxicity of polyoxin D zinc salt residues, and supports the
exemption from the requirement of a tolerance by further demonstrating
a lack of toxic endpoints.
6. Chronic exposure/oncogenicity. Based on the data, polyoxin D
zinc salt is not a chronic toxicant or oncogen. Results of chronic
toxicity/oncogenicity studies (MRIDs 432618-38 and -39) indicated that
there were no significant toxicity or oncogenic responses in mice dosed
with polyoxin D zinc salt over 2 years. The NOAEL was determined to be
2,058.7 mg TGAI/kg bw/day in males and 2,469.8 mg TGAI/kg bw/day in
females. The data show the lack of chronic toxicity/oncogenicity posed
by dietary exposure to polyoxin D zinc salt, and further demonstrate
the fungistatic nature of the active ingredient - i.e. polyoxin D zinc
salt can pass through the mammalian digestive system regularly without
toxic effect.
7. Effects on immune and endocrine systems. There is no available
evidence demonstrating that polyoxin D zinc salt acts is an endocrine
disruptor in humans. Based on negative responses obtained from
developmental toxicity studies, chronic exposure studies, and
oncogenicity studies (MRIDs 432618-36, -38 and -39), no adverse effects
to the endocrine or immune systems are known or expected. The lack of
evidence of endocrine disruption is consistent with polyoxin D zinc
salt's non-toxic profile, and supports this exemption from the
requirement of a tolerance.
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 risks to humans are considered negligible based on the lack
of dietary toxicological endpoints for polyoxin D zinc salt, and its
non-toxic mode of action as a fungi-specific chitin synthetase
inhibitor that passes through mammalian digestive systems. No acute,
subchronic, mutagenic, immunotoxic, reproductive, or chronic dietary
toxicity hazards were identified in any of the studies used to support
this exemption from the requirement of a tolerance. Based on polyoxin D
zinc salt's virtual dietary non-toxicity for mammals, no aggregate
dietary exposure concerns are expected.
1. Food. A Terrestrial Exposure Model (T-Rex, v. 1.2.3; EPA, 2005)
used to calculate terrestrial residue data confirms that it is highly
unlikely that there will be adverse effects resulting from the use of
polyoxin D zinc salt via the oral route of exposure. EPA's T-Rex
calculations delimit aggregate consumption of residues to no more than
40 ppm polyoxin D zinc salt, a level that is far below the highest
doses used in any of the toxicity testing. T-Rex residue modeling,
findings of negligible toxicity, and information confirming polyoxin D
zinc salt's fungi-specific mode of action demonstrate a lack of
aggregate dietary risk sufficient to support this exemption from the
requirement of a tolerance.
2. Drinking water exposure. There is a small potential for trace
amounts of polyoxin D zinc salt to enter ground water or other drinking
water sources after a significant rainfall and surface water runoff,
and from incidental spray drift. While the active ingredient does
degrade in water over days, it still has the remote potential to reach
drinking water sources. Nonetheless, any residues resulting from the
scenarios in this unit are expected to be so diluted as to be
negligible. As a result, even if there is drinking water exposure, a
health risk to humans is considered negligible. Again, based on the
lack of toxicological endpoints for polyoxin D zinc salt, and its non-
toxic fungi-specific mode of action as a chitin synthetase inhibitor,
no dietary risks are expected with regard to drinking water exposure.
B. Other Non-Occupational Exposure
No new non-occupational exposure is expected to result from the new
agricultural uses of polyoxin D zinc salt. However, the Agency notes
that no health risks are expected from any exposure to this active
ingredient in any event. A 1997 risk assessment of polyoxin D zinc salt
makes clear that
[[Page 69563]]
even the expected non-agricultural non-occupational exposures that are
associated with this active ingredient pose negligible risks. Polyoxin
D zinc salt is characterized by its negligible toxicity; it has a non-
toxic, fungistatic, fungi-specific mode of action, and it demonstrates
no mammalian dietary effects.
1. Dermal exposure. No new non-occupational dermal exposures are
expected to result from the new agricultural uses of polyoxin D zinc
salt. Any new dermal exposure associated with this new agricultural use
pattern is expected to be occupational in nature.
2. Inhalation exposure. No new non-occupational inhalation
exposures are expected to result from the new agricultural uses of
polyoxin D zinc salt. Any new inhalation exposure associated with this
new agricultural use pattern is expected to be occupational in nature.
V. Cumulative Effects
Pursuant to section 408(b)(2)(D)(v) of FFDCA, EPA has considered
available information concerning the cumulative effects of polyoxin D
zinc salt residues and other substances that have a common mechanism of
toxicity. These considerations include the cumulative effects on
infants and children of polyoxin D zinc salt residues and other
substances with a common mechanism of toxicity. Because there is no
indication of mammalian toxicity, the Agency concludes that there are
no cumulative effects arising from polyoxin D zinc salt residues in or
on almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes,
pistachios, pome fruits, potatoes and strawberries.
VI. Determination of Safety for U.S. Population, Infants and Children
Health risks to humans, including infants and children are
considered negligible. There is a lack of meaningful toxicological
endpoints for polyoxin D zinc salt. Moreover, polyoxin D zinc salt is
defined by its fungistatic non-toxic mode of action, and demonstrates
no mammalian effect. Accordingly, it is considered to have negligible
toxicity, and there are no acute or chronic dietary risk concerns for
sensitive subpopulations.
1. U.S. population. The Agency has determined that there is
reasonable certainty that no harm will result to the U.S. population
from aggregated exposure to residues of polyoxin D zinc salt. This
includes all dietary exposures and other exposures for which there is
reliable information. The Agency has arrived at this conclusion based
on polyoxin D zinc salt's non-toxic fungi-specific mode of action, and
its observed non-toxic effect on mammals. The Agency finds that the
combination of registered turf use and the proposed crop uses of
polyoxin D zinc salt has a reasonable certainty of no harm to the U.S.
population.
2. Infants and children. Section 408 of FFDCA provides that EPA
shall apply an additional tenfold margin of exposure (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 the EPA determines that a different margin of exposure (safety)
will be safe for infants and children. Based on all the reliable
available information the Agency reviewed on polyoxin D zinc salt, the
Agency concludes that there are no residual uncertainties for prenatal/
postnatal toxicity resulting from polyoxin D zinc salt, and that
polyoxin D zinc salt has relatively low toxicity to mammals from a
dietary standpoint, including infants and children. Accordingly, there
are no threshold effects of concern and an additional margin of safety
is not necessary to protect infants and children. Indeed, the available
data indicate that polyoxin D zinc salt has very low toxicity,
including to infants and children, and no increased sensitivity of
infants or children was indicated in any of the laboratory studies. In
sum, there is a reasonable certainty of no harm to infants and children
with regard to the proposed food uses of polyoxin D zinc salt.
VII. Other Considerations
A. Endocrine Disruptors
Based on available data, no endocrine system-related effects have
been identified with the consumption of polyoxin D zinc salt. No
evidence of endocrine system effects was observed in the
immunotoxicity, subchronic, chronic, teratology or reproduction
studies.
B. Analytical Method
Through this action, the Agency proposes an exemption from the
requirement of a tolerance of polyoxin D zinc salt when used on
almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes,
pistachios, pome fruits, potatoes and/or strawberries, without any
numerical limitations for residues. EPA has determined that residues
resulting from the pesticidal uses of polyoxin D zinc salt would as a
matter of viable application be low, and that there are no significant
toxicity concerns regarding this active ingredient. As a result, the
Agency has concluded that an analytical method is not required for
enforcement purposes for this proposed use of polyoxin D zinc salt.
C. Codex Maximum Residue Level
Through this action, the Agency proposes an exemption from the
requirement of a tolerance of polyoxin D zinc salt when used on
almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes,
pistachios, pome fruits, potatoes and/or strawberries, without any
numerical limitations for residues. EPA has determined that residues
resulting from the pesticidal uses of polyoxin D zinc salt would as a
matter of viable application be low, and that there are no significant
toxicity concerns regarding this active ingredient. As a result, the
Agency has concluded that an analytical method is not required for
enforcement purposes for this proposed use of polyoxin D zinc salt.
VIII. Conclusions
Based on the information submitted, and other information available
to the Agency, EPA is establishing an exemption from the tolerance
requirements pursuant to section 408(c) of FFDCA for residues of
polyoxin D zinc salt in or on almonds, cucurbit vegetables, fruiting
vegetables, ginseng, grapes, pistachios, pome fruits, potatoes and
strawberries.
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 69564]]
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: November 11, 2008.
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 180.1285 is added to subpart D to read as follows:
Sec. 180.1285 Polyoxin D zinc salt; exemption from the requirement of
a tolerance.
An exemption from the requirement of a tolerance is established for
the residues of the biochemical pesticide polyoxin D zinc when used as
a fungicide on almonds, cucurbit vegetables, fruiting vegetables,
ginseng, grapes, pistachios, pome fruits, potatoes and strawberries.
[FR Doc. E8-27485 Filed 11-18-08; 8:45 am]
BILLING CODE 6560-50-S