[Federal Register: January 2, 2008 (Volume 73, Number 1)]
[Rules and Regulations]
[Page 52-57]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ja08-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0732; FRL-8342-6]
Trifloxystrobin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for the combined
residues of trifloxystrobin, and its free form acid metabolite in or on
asparagus; papaya; sapote, black; canistel; sapote, mamey; mango;
sapodilla; star apple; vegetable, root, except sugar beet, subgroup 1B;
radish, tops; fruit, citrus, group 10; citrus, oil; citrus, dried pulp;
and strawberry. Interregional Research Project Number 4 (IR-4), and
Bayer Crop Science requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective January 2, 2008. Objections and
requests for hearings must be received on or before March 3, 2008, 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-2006-0732. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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: Shaja R. Brothers, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
[[Page 53]]
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 those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide 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 an electronic copy of this Federal
Register document through the electronic docket 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 EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0732 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 as required by 40 CFR part 178 on or
before March 3, 2008.
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 this copy, identified by docket ID number
EPA-HQ-OPP-2006-0732, 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'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. Petition for Tolerance
In the Federal Registers of September 13, 2006 (71 FR 54058) (FRL-
8091-2), and August 22, 2007 (72 FR 47010) (FRL-8142-5), EPA issued
notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3),
announcing the filing of pesticide petitions (PPs) 6E7088, 6F7123,
7F7171 by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540; and Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive,
Research Triangle Park, NC 27709. These petitions requested that 40 CFR
180.555 be amended by establishing tolerances for combined residues of
the fungicide trifloxystrobin, (Benzeneacetic acid, ( E,E )-[alpha]-
(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)
phenyl]ethylidene]amino]oxy]methyl]-, methyl ester) and the free form
of its acid metabolite CGA-321113 (( E,E )-methoxyimino-[2-[1-(3-
trifluoromethyl-phenyl)-ethylideneaminooxymethyl]-phenyl]acetic acid,
in or on asparagus at 0.07 parts per million (ppm); papaya at 0.7 ppm;
sapote, black at 0.7ppm; canistel at 0.7 ppm; sapote, mamey at 0.7 ppm;
mango at 0.7 ppm; sapodilla at 0.7 ppm; star apple at 0.7 ppm;
vegetable, root, except sugar beet, subgroup 1B at 0.1 ppm; and radish,
tops at 10 ppm (6E7088); fruit, citrus, group 10 at 0.4 ppm; citrus,
oil at 36 ppm; citrus, dried pulp at 1.0 ppm (6F7123); and strawberry
at 1.1 ppm (6F7171). These notices referenced a summary of the
petitions prepared by Bayer CropScience, the registrant, which is
available to the public in the docket, http://www.regulations.gov. One
comment was received from a private citizen on the notice of filing
concerning the tolerances for strawberry and citrus. EPA's response to
these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
increased the tolerances on fruit, citrus, group 10 from 0.4 to 0.6
ppm, and citrus, oil from 36 to 38 ppm. The reason for these changes is
explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(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.
Section 408(b)(2)(C) of FFDCA requires 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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerance
for combined residues of trifloxystrobin on asparagus at 0.07
[[Page 54]]
ppm; papaya at 0.7 ppm; sapote, black at 0.7 ppm; canistel at 0.7 ppm;
sapote, mamey at 0.7 ppm; mango at 0.7 ppm; sapodilla at 0.7 ppm; star
apple at 0.7 ppm; vegetable, root, except sugar beet, subgroup 1B at
0.1 ppm; and radish, tops at 10 ppm; fruit, citrus, group 10 at 0.6
ppm; citrus, oil at 38 ppm; citrus, dried pulp at 1.0 ppm; and
strawberry at 1.1 ppm. EPA's assessment of exposures and risks
associated with establishing these tolerances follow.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific information on the studies received and the nature
of the adverse effects caused by trifloxystrobin as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found in the
Trifloxystrobin: Human Health Risk Assessment for Section 3
Registration for the Proposed Uses on Grasses Grown for Seed on pages
41 and 42 at http://www.regulations.gov. The referenced document is
available in docket EPA-HQ-OPP-2007-0539.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-term, intermediate-term, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
A summary of the toxicological endpoints for trifloxystrobin used
for human risk assessment can be found at http://www.regulations.gov in
the Trifloxystrobin: Human Health Risk Assessment for Section 3 Uses on
Asparagus; Vegetable, Root Except Sugar Beet, Subgroup 1B; Radish
(Tops); and Papaya, Black Sapote, Canistel, Mamey Sapote, Mango,
Sapodilla, and Star Apple, Citrus Fruits, Crop Group 10; Citrus, Oil;
and Citrus, Dried Pulp, and Strawberry on pages 16 and 17 for docket ID
number EPA-HQ-OPP-2006-0732.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to trifloxystrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing trifloxystrobin
tolerances in 40 CFR 180.555. EPA assessed dietary exposures from
trifloxystrobin in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. In estimating acute dietary
exposure, EPA used food consumption information from the U.S.
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed tolerance level residues and 100 percent
crop treated (PCT) was performed for trifloxystrobin.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 1994-1996,
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance
level residues and 100 PCT was performed for trifloxystrobin. PCT and/
or anticipated residues were not used.
iii. Cancer. Trifloxystrobin is classified as a ``not likely
carcinogen''; therefore, quantification of human cancer risk is not
required and a cancer dietary exposure assessment was not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for trifloxystrobin in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the environmental
fate characteristics of trifloxystrobin. Further information regarding
EPA drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Trifloxystrobin is immobile in soil. It degrades and transforms
rapidly in soil and aquatic environments. The primary degradate is CGA-
321113. Estimated drinking water concentrations (EDWCs) were calculated
for total trifloxystrobin residues (parent trifloxystrobin plus the
major degradate CGA-321113) using the Agency's First Index Reservior
Screening Tool (FIRST) model for surface water and the Screening
Concentration in Ground Water (SCI-GROW) model for ground water. The
interim method for drinking water estimates for pesticides used in rice
paddies was also used to generate EDWCs. The use site with the highest
application rate is turf, with a maximum label rate of 1.078 pounds
active ingredient/acre/year (lb ai/A/yr) (three applications at 0.359
lb ai/A/yr). Drinking water estimates were also provided for rice
paddies that may be treated with trifloxystrobin.
The Agency determined that the highest EDWC for both acute and
chronic analysis should use 140 parts per billion (ppb) based on the
model for the use on rice. Because this model does not account for
degradation of the chemical or dilution with uncontaminated water
outside of the rice paddy, the calculated EDWCs (140 ppb) are expected
to exceed concentrations likely to be found in drinking water derived
from surface water sources.
Based on the FIRST, and SCI-GROW models, the estimated
environmental concentrations (EECs) of trifloxystrobin for acute and
chronic exposures for surface water are estimated at 140 ppb. Acute and
chronic exposure for ground water is estimated at 3.4 ppb.
Modeled estimates of drinking water concentrations were directly
entered
[[Page 55]]
into the dietary exposure model. For the acute and chronic dietary risk
assessments, the water concentration values of 140 ppb (acute and
chronic) were used to access the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Trifloxystrobin is currently registered for the following
residential non-dietary sites: CompassTM is registered for
residential use on turf grass and ornamentals disease control. However,
this product may only be applied by a Certified Pest Control Operator
(PCO). Therefore, an assessment for residential handlers was not
performed.
There is potential for dermal (adults and children) and oral
exposure (children only) during post-application activities. EPA
assessed residential post-application exposure using the following
assumptions:
i. Dermal exposure from pesticide residues on lawns;
ii. Incidental non-dietary ingestion of pesticide residues on lawns
from hand-to-mouth transfer;
iii. Incidental non-dietary ingestion of residues from object-to-
mouth activities (pesticide-treated turf grass); and
iv. Incidental non-dietary ingestion of soil from pesticide-treated
residential areas.
Post-application exposures from various activities following lawn
treatment are considered to be the most common and significant in
residential settings. Exposure via incidental non-dietary ingestion
involving other plant material may occur but is expected to result in
much less exposure than the four exposure scenarios listed above.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to trifloxystrobin and any
other substances and trifloxystrobin does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that trifloxystrobin
has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative
.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') 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 on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the FQPA safety factor. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is no indication of
increased susceptibility of rat or rabbits to trifloxystrobin. In the
developmental and reproduction toxicity studies, effects in the
fetuses/offspring were observed only at or above treatment levels which
resulted in evidence of parental toxicity.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for trifloxystrobin is complete except for
an acute neurotoxicity study which is classified as unacceptable. The
toxicity database contains developmental toxicity studies in two
species (rats and rabbits) and a 2-generation reproduction study in
rats which are adequate to assess prenatal and/or postnatal
susceptibility to infants and children. Although the available,
submitted acute neurotoxicity study was found to be unacceptable, based
on a weight-of-the evidence review of the available data, the lack of
this study does not impact the Agency's ability to make an FQPA safety
factor decision. Since there was no evidence of neurotoxicity in this
study at the limit dose nor in the other subchronic and chronic studies
in the database, there is no uncertainty concerning neurotoxic effects
and EPA has reliable data to show that removal of the FQPA safety
factor is safe for children. Additionally, these data demonstrate that
a developmental neurotoxicity study is not required for this pesticide.
ii. There is no residual concern for prenatal or postnatal toxicity
or increased sensitivity in infants and children. In both the rat
developmental study and the 2-generation reproduction studies there
were no effects in fetal animals or offspring at the highest dose
tested. Although developmental effects were seen in the rabbit
developmental study, there was a clear NOAEL identified for these
effects and that NOAEL was used in setting the aPAD. Moreover, adverse
effects were seen in the adult animals in this study at a lower level.
iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. Conservative ground water and
surface water modeling estimates were used. Similarly, conservative
assumptions were used to assess post-application exposure to children
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by trifloxystrobin.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the MOE called for by the product of all
applicable UFs is not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to trifloxystrobin will occupy < 1% of the aPAD for females 13 to 49
years old.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
trifloxystrobin from food and water will utilize 52% of the cPAD for
all infants less than 1 year old. Based on the use pattern, chronic
residential exposure to residues of trifloxystrobin is not expected to
underestimate risk to adults or children.
[[Page 56]]
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Trifloxystrobin is currently registered for uses that could result
in short-term residential exposure and the Agency has determined that
it is appropriate to aggregate chronic food and water and short-term
exposures for trifloxystrobin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential
exposures aggregated result in aggregate dermal MOEs of 1,200 and 670
for the U.S. population and all infants < 1 year old, respectively, and
an oral MOE of 150 for all infants < 1 year old.
4. Intermediate-term risk. Intermediate-term exposure (1 to 6
months) to the parent trifloxystrobin is not expected to occur in
residential settings due to its short half-life (about 2 days based on
soil and aquatic metabolism studies). Therefore, an intermediate-term
aggregate risk assessment was not performed.
5. Aggregate cancer risk for U.S. population. EPA has classified
trifloxystrobin as a ``not likely human carcinogen,'' and EPA considers
trifloxystrobin to pose no greater than a negligible cancer risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to trifloxystrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate gas chromatography with nitrogen phosphorus detector
(GC/NPD) method (Method AG-659A) is available for enforcing tolerances
for the combined residues of trifloxystrobin and CGA-321113 in plant
commodities.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are currently no Canadian maximum residue levels (MRLs) for
trifloxystrobin. Codex and Mexican MRLs have been established for
trifloxystrobin in or on various commodities; however, there are no
Mexican MRLs for the commodities associated with the proposed uses.
Codex MRLs have been established on carrots (0.1 ppm) and strawberry
(0.2 ppm), which differs from the MRL calculated by the MRL spreadsheet
for strawberry (1.1 ppm). Also, the residue definition for both Codex
and Mexican MRLs includes only parent compound in plant commodities,
but the definition for Codex MRLs in livestock commodities includes
parent and the acid metabolite, CGA321113. Harmonization in plant
commodities is not possible at this time as the current U.S. tolerance
definition includes the combined residues of trifloxystrobin and its
free acid metabolite.
C. Response to Comments
One comment was received from a private citizen who opposed the
authorization to sell any pesticide that leaves a residue on food. The
Agency has received this same comment from this commenter on numerous
previous occasions and rejects it for the reasons previously stated in
the Federal Register of 70 FR 1349, 1354 (January 7, 2005).
D. Explanation of Tolerance Revisions
Bayer CropScience requested a reduction in the pre-harvest interval
from 30 to 7 days for citrus and a corresponding modification of the
tolerance. The submitted field trial data and processing studies are
adequate to support this request. As a result, tolerance expressions
have been revised from 0.4 to 0.6 ppm for fruit, citrus, group 10; and
36 to 38 ppm for citrus, oil.
V. Conclusion
Therefore, the tolerances are established for combined residues of
trifloxystrobin, Benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-, methyl
ester, and the free form of its acid metabolite CGA-321113 (E,E)-
methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-
ethylideneaminooxymethyl]-phenyl]acetic acid, in or on asparagus at
0.07 ppm; papaya at 0.7 ppm; sapote, black at 0.7 ppm; canistel at 0.7
ppm; sapote, mamey at 0.7 ppm; mango at 0.7 ppm; sapodilla at 0.7 ppm;
star apple at 0.7 ppm; vegetable, root, except sugar beet, subgroup 1B
at 0.1 ppm; and radish, tops at 10 ppm; fruit, citrus, group 10 at 0.6
ppm; citrus, oil at 38 ppm; citrus, dried pulp at 1.0 ppm; and
strawberry at 1.1 ppm.
VI. 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
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 6, 2000) do not apply to this rule. In addition, This
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
[[Page 57]]
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).
VII. 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: December 20, 2007.
Lois Rossi,
Director, Registration Division, 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. In Sec. 180.555, the table to paragraph (a) is amended by revising
the entries for ``Citrus, dried pulp'' ``Citrus, oil'' and ``Fruit,
citrus, group 10,'' and by alphabetically adding new commodities to
read as follows:
Sec. 180.555 Trifloxystrobin.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Asparagus............................................ 0.07
* * * * *
Canistel............................................. 0.7
* * * * *
Citrus, dried pulp................................... 1.0
Citrus, oil.......................................... 38
* * * * *
Fruit, citrus, group 10.............................. 0.6
* * * * *
Mango................................................ 0.7
* * * * *
Papaya............................................... 0.7
* * * * *
Radish, tops......................................... 10
* * * * *
Sapodilla............................................ 0.7
Sapote, black........................................ 0.7
Sapote, mamey........................................ 0.7
* * * * *
Star apple........................................... 0.7
Strawberry........................................... 1.1
* * * * *
Vegetable, root, except sugar beet, subgroup 1B...... 0.1
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-25396 Filed 12-31-07; 8:45 am]
BILLING CODE 6560-50-S