Trifloxystrobin; Pesticide Tolerances, 33190-33195 [2010-13938]
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Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Rules and Regulations
EPA-APPROVED NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES IN THE NEW MEXICO SIP
Applicable geographic or nonattainment area
Name of SIP provision
*
Interstate transport for the
1997 ozone and PM 2.5
NAAQS.
*
State submittal/effective
date
*
New Mexico ...........................
*
09/17/07
[FR Doc. 2010–13686 Filed 6–10–10; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0278; FRL–8829–2]
Trifloxystrobin; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation increases
existing tolerances for residues of
trifloxystrobin in or on corn, field,
forage; corn, sweet, forage; and corn,
sweet, stover. Bayer CropScience
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA). Additionally, EPA is
removing several tolerances which have
expired.
DATES: This regulation is effective June
11, 2010. Objections and requests for
hearings must be received on or before
August 10, 2010, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2009–0278. All documents in the
docket are listed in the docket index
available at https://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
https://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.),
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ADDRESSES:
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EPA approval date
*
06/11/10 [insert FR page
number where the document begins].
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:
Tawanda Maignan, Registration
Division (7505P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (703) 308-8050; e-mail address:
maignan.tawanda@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 those engaged in the
following activities:
• 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 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 Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.gpoaccess.gov/ecfr.
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Explanation
*
*
06/11/10 Approval for revisions to prohibit significant
contribution to nonattainment in any other State.
To access the harmonized test
guidelines referenced in this document
electronically, please go https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’
C. How Can I File an Objection or
Hearing Request?
Under FFDCA section 408(g), 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. 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–2009–0278 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before August 10, 2010. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
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. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2009–0278, by one of
the following methods:
• Federal eRulemaking Portal: https://
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
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Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
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II. Summary of Petitioned-For
Tolerance
In the Federal Register of August 19,
2009 (74 FR 41898) (FRL–8426–7), 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 petition (PP 8F7487) by Bayer
CropScience, 2 T.W. Alexander Drive,
P.O. Box 12014, Research Triangle Park,
NC 27709. The petition requested that
40 CFR 180.555 be amended by
increasing existing tolerances for
residues of the fungicide trifloxystrobin,
benzeneacetic acid, (E,E)-a(methoxyimino)-2-[[[[1-[3(trifluoromethyl)
phenyl]ethylidene]amino]oxy]methyl]methyl ester), in or on corn, field, forage
at 6.0 parts per million (ppm); corn,
sweet, forage at 7.0 ppm; and corn,
sweet, stover at 4.0 ppm. That notice
referenced a summary of the petition
prepared by Bayer CropScience, the
registrant, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon the review of the data
supporting the petition, the Agency is
increasing the existing meat, fat and
meat byproduct of cattle, goats, horses,
and sheep tolerances to 0.1 ppm. The
reasons for these changes are explained
in Unit IV.C.
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
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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....’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, 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 trifloxystrobin
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with trifloxystrobin follows.
dose levels. However, trifloxystrobin is
negative in the remaining mutagenicity
studies.
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-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
‘‘Trifloxystrobin. Human Health Risk
Assessment for a Section 3 Petition
Proposing Increased Tolerances for
Residues in/on Field, Sweet and Pop
Corn’’ at pages 17 to 21 in docket ID
number EPA–HQ–OPP–2009–0278.
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.
Trifloxystrobin exhibits very low
toxicity following single oral, dermal
and inhalation exposures. It is a strong
dermal sensitizer. In repeated dose tests
in rats, the liver is the target organ for
trifloxystrobin; toxicity is induced
following oral and dermal exposure for
28 days. In the available toxicity studies
on trifloxystrobin, there was no
estrogen, androgen, and/or thyroid
mediated toxicity. The toxicological
database for trifloxystrobin does not
show any evidence of treatment-related
effects on the immune system. Further,
there was no evidence of neurotoxicity
at the limit dose in an unacceptable
acute neurotoxicity study or in the other
subchronic and chronic studies in the
database. There is no evidence of
increased susceptibility following prenatal exposure to rats and rabbits and
post-natal exposures to rats.
Trifloxystrobin was determined not to
be carcinogenic in mice or rats
following long-term dietary
administration. Trifloxystrobin is
positive for mutagenicity in Chinese
Hamster V79 cells, albeit at cytotoxic
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level – generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD) – and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for trifloxystrobin used for
human risk assessment is shown in the
following Table.
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B. Toxicological Points of Departure/
Levels of Concern
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TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TRIFLOXYSTROBIN FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/Scenario
Point of Departure and Uncertainty/
Safety Factors
RfD, PAD, LOC for Risk
Assessment
Study and Toxicological Effects
Acute dietary (Females
13–49 years of age)
NOAEL = 250 milligrams/kilograms/
day (mg/kg/day)
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 2.5 mg/kg/day
aPAD = 2.5 mg/kg/day
Developmental Toxicity-Rabbit. LOAEL =
500 mg/kg/day based on increased fetal
skeletal anomalies.
Chronic dietary (All populations)
NOAEL= 3.8 mg/kg/day
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.038 mg/
kg/day
cPAD = 0.038 mg/kg/day
Two-Generation
reproduction
study-Rat.
LOAEL = 55.3 mg/kg/day based on decreases in body weight, body weight
gains, reduced food consumption and
histopathological lesions in the liver, kidneys and spleen.
Incidental Oral Short- (1 to
30 days) and
Intermediate- (1-6
months) Term
Offspring NOAEL= 3.8 mg/kg/day
UFA = NA
UFH = NA
FQPA SF = NA
LOC for MOE = 100
Two-Generation
reproduction
study-Rat.
LOAEL = 55.3 mg/kg/day based on reduced pup body weights during lactation.
Dermal Short- (1 to 30
days) and Intermediate(1 to 6 months) Term
Dermal study NOAEL = 100 mg/kg/
day
UFA = NA
UFH = NA
FQPA SF = NA
LOC for MOE = 100
28-Day Dermal Toxicity Study-Rat. LOAEL =
1,000 mg/kg/day based on increases in
mean absolute and relative liver and kidney weights.
Inhalation Short- (1 to 30
days), and Intermediate(1 to 6 months) Term
Oral study NOAEL= 3.8 mg/kg/day
(inhalation absorption rate =
100%)
UFA = NA
UFH = NA
FQPA SF = NA
LOC for MOE = 100
Two-Generation
reproduction
study-Rat.
LOAEL = 55.3 mg/kg/day based on decreases in body weight, body weight
gains, reduced food consumption and
histopathological lesions in the liver, kidneys and spleen.
Cancer (oral, dermal, inhalation)
Trifloxystrobin is classified as ‘‘Not Likely Human Carcinogen’’ based on the lack of evidence of carcinogenicity in
mouse and rat cancer studies.
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UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population
(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference
dose. MOE = margin of exposure. LOC = level of concern.
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
for females 13 to 49 years old, EPA
conducted an analysis using the Dietary
Exposure Evaluation Model
(DEEMTM7.81), which 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). EPA used tolerance
level residues. EPA assumed all
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commodities with established or
proposed tolerances were treated with
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 to be included in DEEM. As to
residue levels in food, EPA used
tolerance level residues for all
commodities with the exception of
apples, oranges and grapes. For these
commodities EPA used anticipated
residues. EPA assumed all commodities
with established or proposed tolerances
were treated with trifloxystrobin.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that trifloxystrobin does not
pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. Section
408(b)(2)(E) of FFDCA authorizes EPA
to use available data and information on
the anticipated residue levels of
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pesticide residues in food and the actual
levels of pesticide residues that have
been measured in food. If EPA relies on
such information, EPA must require
pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the
tolerance is established, modified, or
left in effect, demonstrating that the
levels in food are not above the levels
anticipated. For the present action, EPA
will issue such data call-ins as are
required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section
408(f)(1). Data will be required to be
submitted no later than 5 years from the
date of issuance of these tolerances.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for trifloxystrobin in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
trifloxystrobin. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
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can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS), GENeric
Estimated Exposure Concentration
(GENEEC), and/or Screening
Concentration in Ground Water (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
trifloxystrobin for the proposed new
application are higher than those
previously assessed for corn; however,
the EDWCs for both corn rates are less
than those previously estimated, via
GENEEC, for turf use.
Based on the PRZM/EXAMS,
GENEEC, and/or SCI-GROW models, the
EDWCs of trifloxystrobin plus its major
degradation product, CGA-321113 for
acute exposures are estimated to be
47.99 parts per billion (ppb) and 47.31
ppb for chronic exposures. Modeled
estimates of drinking water
concentrations were directly entered
into the dietary exposure model.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, 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 uses that could result
in residential exposures: ornamentals
and turfgrass. EPA assessed residential
exposure using the following
assumptions: adult post application
dermal exposure; child’s post
application dermal and/or hand to
mouth. Further information regarding
EPA standard assumptions and generic
inputs for residential exposures may be
found at https://www.epa.gov/pesticides/
trac/science/trac6a05.pdf.
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.’’
EPA has not found trifloxystrobin to
share a common mechanism of toxicity
with 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
assumed that trifloxystrobin does not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
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mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) 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 (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There is no indication of increased
susceptibility of rat or rabbits to
trifloxystrobin. In the prenatal
developmental study in rats, there was
no developmental toxicity at the limit
dose. In the prenatal developmental
study in rabbits, developmental toxicity
was seen at a dose that was higher than
the dose that caused maternal toxicity.
In the two generation reproduction
study, there was no offspring toxicity at
the highest dose tested.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1x. That decision is
based on the following findings:
i. The toxicity database for
trifloxystrobin is complete except for
neurotoxicity and immunotoxicity
testing. Recent changes to 40 CFR part
158 make neurotoxicity and
immunotoxicity testing required for
pesticide registration; however, the
existing data are sufficient for endpoint
selection for exposure/risk assessment
scenarios, and for evaluation of the
requirements under the FQPA.
Although acute and subchronic
neurotoxicity and immunotoxicity
studies are needed to complete the
database, there are no concerns for
immunotoxicity or neurotoxicity based
on the results of the existing studies.
The toxicological database for
trifloxystrobin does not show any
evidence of treatment-related effects on
the immune system. There was a
decrease in the incidence of
hemosiderosis in the spleen of F0 and
F1 parental males and females in the 2generation reproduction study. The
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33193
effect was not seen in any other toxicity
studies, and it was not a primary effect
on the spleen. This decrease may
indicate a decrease of red blood cell
turnover; but it is not an effect on the
immune system. Further, there was no
evidence of neurotoxicity at the limit
dose in an unacceptable acute
neurotoxicity study or in the other
subchronic and chronic studies in the
database. The EPA does not believe that
conducting neurotoxicity or
immunotoxicity studies will result in a
dose less than the PODs already used in
this risk assessment and an additional
database uncertainty factor for potential
neurotoxicity and/or immunotoxicity
does not need to be applied.
ii. There is no indication that
trifloxystrobin is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional uncertainty factors (UFs) to
account for neurotoxicity.
iii. There is no evidence that
trifloxystrobin results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the two-generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The acute and chronic dietary food
exposure assessments utilize existing
and proposed tolerance level residues
and 100% crop treated information for
all commodities, except for apples,
oranges, and grapes which utilized
anticipated residue levels for the
chronic dietary. By using these
screening-level assessments with minor
refinement, actual exposures/risks from
residues in food will not be
underestimated. EPA made conservative
(protective) assumptions in the ground
and surface water modeling used to
assess exposure to trifloxystrobin in
drinking water. EPA used similarly
conservative assumptions to assess
postapplication exposure of 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
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
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PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, 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-term risk. Using the
exposure assumptions described in this
unit for chronic exposure, EPA has
concluded that chronic exposure to
trifloxystrobin from food and water will
utilize 15% of the cPAD for the general
U.S. population and 43% of the cPAD
for children 1 to 2 years old, the
population group receiving the greatest
exposure. Based on the explanation in
Unit III.C.3., regarding residential use
patterns, chronic residential exposure to
residues of trifloxystrobin is not
expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term 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 exposure through food
and water with short-term residential
exposures to trifloxystrobin.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in aggregate
MOEs of 1,200 for adults (dermal
residential + dietary food and drinking
water exposures); 680 for children 1 to
2 years old (dermal residential + dietary
food and drinking water exposures); and
170 for children 1 to 2 years old
(incidental oral + dietary food and
drinking water exposures). Because
EPA’s level of concern for
trifloxystrobin is a MOE of 100 or
below, these MOEs are not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Trifloxystrobin is not expected to pose
an intermediate-term risk based on a
short soil half-life (approximately 2
days).
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5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
trifloxystrobin is not expected to pose a
cancer risk to humans.
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
Adequate enforcement methodology
(gas chromatography with nitrogen
phosphorus detection (GC/NPD)),
Method AG-659A is available to enforce
the tolerance expression. 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; email address: residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint U.N.
Food and Agriculture Organization/
World Health Organization food
standards program, and it is recognized
as an international food safety
standards-setting organization in trade
agreements to which the United States
is a party. EPA may establish a tolerance
that is different from a Codex MRL;
however, FFDCA section 408(b)(4)
requires that EPA explain the reasons
for departing from the Codex level.
The Codex has established a MRL for
trifloxystrobin in or on maize fodder
(dry) at 10 ppm. Canada has a proposed
(not yet established) MRL of 0.02 for
corn grain, sweet corn, popcorn grain
for parent and metabolite. Since the
Codex MRL is for a commodity that is
not recognized domestically and would
normally not be transported across
international borders, there is no
concern for international
harmonization. Also, since the Canadian
MRL has not been established, there is
no concern for international
harmonization.
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C. Revisions to Petitioned-For
Tolerances
Trifloxystrobin tolerances for crop
commodities listed in 40 CFR
180.555(a)(1) are expressed in terms of
the residues of the fungicide
trifloxystrobin, benzeneacetic acid,
(E,E)-a-(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. EPA has revised the
trifloxystrobin tolerance expression to
clarify the chemical moieties that are
covered by the tolerances and specify
how compliance with the tolerances is
to be measured.
EPA’s analysis of the adequacy of the
existing tolerances for meat, fat and
meat byproduct of cattle, goats, horses,
and sheep tolerances based on the
proposed tolerances as well as existing
tolerances indicates they need to be
increased to 0.1 ppm from 0.05 ppm.
Also, EPA is removing from paragraph
(b), tolerances for soybean, forage;
soybean, hay; and soybean, seed which
expired and were revoked on December
31, 2009.
V. Conclusion
Therefore, existing tolerances in 40
CFR 180.555(a) are increased for
residues of trifloxystrobin,
benzeneacetic acid, (E,E)-a(methoxyimino)-2-[[[[1-[3(trifluoromethyl)
phenyl]ethylidene]amino]oxy]methyl]methyl ester, in or on corn, field, forage
at 6.0 ppm; corn, sweet, forage at 7.0
ppm; and corn, sweet, stover at 4.0 ppm.
EPA is also removing paragraph (b)
tolerances for soybean, forage; soybean,
hay; and soybean, seed which expired
December 31, 2009.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
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
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Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Rules and Regulations
WReier-Aviles on DSKGBLS3C1PROD with RULES
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 tolerances 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).
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
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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 27, 2010.
Daniel J. Rosenblatt,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
Parts per
million
Commodity
*
*
*
*
Cattle, fat ..................................
Cattle, meat ..............................
Cattle, meat byproducts ...........
*
*
*
*
*
Corn, field, forage .....................
*
*
*
*
*
Corn, sweet, forage ..................
*
*
*
*
*
Corn, sweet, stover ..................
*
*
*
*
*
Goat, fat ....................................
Goat, meat ................................
Goat, meat byproducts .............
*
*
*
*
*
Horse, fat ..................................
Horse, meat ..............................
Horse, meat byproducts ...........
*
*
*
*
*
Sheep, fat .................................
Sheep, meat .............................
Sheep, meat byproducts ..........
*
0.1
0.1
0.1
6.0
7.0
4.0
0.1
0.1
0.1
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Amend § 180.555 as follows:
a. Revise the introductory text of
paragraph (a).
■
■
b. Revise the following entries in the
table in paragraph (a): cattle, fat; cattle,
meat; cattle, meat byproducts; corn,
field, forage; corn, sweet, forage; corn,
sweet, stover; goat, fat; goat, meat; goat,
meat byproducts; horse, fat; horse, meat;
horse, meat byproducts; and sheep, fat;
sheep, meat; and sheep, meat
byproducts.
■
■
c. Revise paragraph (b).
The revisions read as follows:
§ 180.555 Trifloxystrobin; tolerances for
residues.
(a) General. Tolerances are
established for residues of
trifloxystrobin, including its metabolites
and degradates, in or on the
commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only the sum of
trifloxystrobin, benzeneacetic acid,
(E,E)-a-(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, calculated as the
stoichiometric equivalent of
trifloxystrobin, in or on the commodity.
PO 00000
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*
*
*
*
0.1
0.1
0.1
0.1
0.1
0.1
*
(b) Section 18 emergency exemptions.
[Reserved]
*
*
*
*
*
[FR Doc. 2010–13938 Filed 6–10–10; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations
System
48 CFR Part 252
Defense Federal Acquisition
Regulation Supplement; New
Designated Country—Taiwan—DFARS
Case 2009–D010)
AGENCY: Defense Acquisition
Regulations System; Department of
Defense (DoD).
ACTION: Final rule.
SUMMARY: DoD is adopting, as final, an
interim rule amending the Defense
Federal Acquisition Regulation
Supplement (DFARS) to add Taiwan as
a designated country, due to the
accession of Taiwan to membership in
the World Trade Organization
Government Procurement Agreement.
DATES: Effective date: June 11, 2010.
FOR FURTHER INFORMATION CONTACT: Ms.
Amy Williams, Defense Acquisition
E:\FR\FM\11JNR1.SGM
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Agencies
[Federal Register Volume 75, Number 112 (Friday, June 11, 2010)]
[Rules and Regulations]
[Pages 33190-33195]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13938]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0278; FRL-8829-2]
Trifloxystrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation increases existing tolerances for residues of
trifloxystrobin in or on corn, field, forage; corn, sweet, forage; and
corn, sweet, stover. Bayer CropScience requested these tolerances under
the Federal Food, Drug, and Cosmetic Act (FFDCA). Additionally, EPA is
removing several tolerances which have expired.
DATES: This regulation is effective June 11, 2010. Objections and
requests for hearings must be received on or before August 10, 2010,
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-2009-0278. All documents in the
docket are listed in the docket index available at https://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 https://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: Tawanda Maignan, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8050; e-mail address: maignan.tawanda@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 those
engaged in the following activities:
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 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 Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.gpoaccess.gov/ecfr. To
access the harmonized test guidelines referenced in this document
electronically, please go https://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.''
C. How Can I File an Objection or Hearing Request?
Under FFDCA section 408(g), 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. 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-2009-0278 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
August 10, 2010. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0278, by one of the following methods:
Federal eRulemaking Portal: https://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
[[Page 33191]]
Friday, excluding legal holidays). Special arrangements should be made
for deliveries of boxed information. The Docket Facility telephone
number is (703) 305-5805.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 19, 2009 (74 FR 41898) (FRL-8426-
7), 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 petition (PP
8F7487) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
180.555 be amended by increasing existing tolerances for residues of
the fungicide trifloxystrobin, benzeneacetic acid, (E,E)-[alpha]-
(methoxyimino)-2-[[[[1-[3- (trifluoromethyl)
phenyl]ethylidene]amino]oxy]methyl]-methyl ester), in or on corn,
field, forage at 6.0 parts per million (ppm); corn, sweet, forage at
7.0 ppm; and corn, sweet, stover at 4.0 ppm. That notice referenced a
summary of the petition prepared by Bayer CropScience, the registrant,
which is available in the docket, https://www.regulations.gov. There
were no comments received in response to the notice of filing.
Based upon the review of the data supporting the petition, the
Agency is increasing the existing meat, fat and meat byproduct of
cattle, goats, horses, and sheep tolerances to 0.1 ppm. The reasons for
these changes are explained in Unit IV.C.
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....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 trifloxystrobin
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
trifloxystrobin follows.
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.
Trifloxystrobin exhibits very low toxicity following single oral,
dermal and inhalation exposures. It is a strong dermal sensitizer. In
repeated dose tests in rats, the liver is the target organ for
trifloxystrobin; toxicity is induced following oral and dermal exposure
for 28 days. In the available toxicity studies on trifloxystrobin,
there was no estrogen, androgen, and/or thyroid mediated toxicity. The
toxicological database for trifloxystrobin does not show any evidence
of treatment-related effects on the immune system. Further, there was
no evidence of neurotoxicity at the limit dose in an unacceptable acute
neurotoxicity study or in the other subchronic and chronic studies in
the database. There is no evidence of increased susceptibility
following pre-natal exposure to rats and rabbits and post-natal
exposures to rats. Trifloxystrobin was determined not to be
carcinogenic in mice or rats following long-term dietary
administration. Trifloxystrobin is positive for mutagenicity in Chinese
Hamster V79 cells, albeit at cytotoxic dose levels. However,
trifloxystrobin is negative in the remaining mutagenicity studies.
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 at https://www.regulations.gov in document ``Trifloxystrobin. Human Health Risk
Assessment for a Section 3 Petition Proposing Increased Tolerances for
Residues in/on Field, Sweet and Pop Corn'' at pages 17 to 21 in docket
ID number EPA-HQ-OPP-2009-0278.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level - generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for trifloxystrobin used
for human risk assessment is shown in the following Table.
[[Page 33192]]
Table--Summary of Toxicological Doses and Endpoints for trifloxystrobin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of Departure and
Exposure/Scenario Uncertainty/Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years of NOAEL = 250 milligrams/ Acute RfD = 2.5 mg/kg/ Developmental Toxicity-
age) kilograms/day (mg/kg/ day Rabbit. LOAEL = 500 mg/
day) aPAD = 2.5 mg/kg/day... kg/day based on
UFA = 10x.............. increased fetal
UFH = 10x.............. skeletal anomalies.
FQPA SF = 1x...........
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL= 3.8 mg/kg/day Chronic RfD = 0.038 mg/ Two-Generation
UFA = 10x.............. kg/day reproduction study-
UFH = 10x.............. cPAD = 0.038 mg/kg/day. Rat. LOAEL = 55.3 mg/
FQPA SF = 1x........... kg/day based on
decreases in body
weight, body weight
gains, reduced food
consumption and
histopathological
lesions in the liver,
kidneys and spleen.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short- (1 to 30 days) Offspring NOAEL= 3.8 mg/ LOC for MOE = 100 Two-Generation
and Intermediate- (1-6 months) Term kg/day reproduction study-
UFA = NA............... Rat. LOAEL = 55.3 mg/
UFH = NA............... kg/day based on
FQPA SF = NA........... reduced pup body
weights during
lactation.
----------------------------------------------------------------------------------------------------------------
Dermal Short- (1 to 30 days) and Dermal study NOAEL = LOC for MOE = 100 28-Day Dermal Toxicity
Intermediate- (1 to 6 months) Term 100 mg/kg/day Study-Rat. LOAEL =
UFA = NA............... 1,000 mg/kg/day based
UFH = NA............... on increases in mean
FQPA SF = NA........... absolute and relative
liver and kidney
weights.
----------------------------------------------------------------------------------------------------------------
Inhalation Short- (1 to 30 days), and Oral study NOAEL= 3.8 LOC for MOE = 100 Two-Generation
Intermediate- (1 to 6 months) Term mg/kg/day (inhalation reproduction study-
absorption rate = Rat. LOAEL = 55.3 mg/
100%) kg/day based on
UFA = NA............... decreases in body
UFH = NA............... weight, body weight
FQPA SF = NA........... gains, reduced food
consumption and
histopathological
lesions in the liver,
kidneys and spleen.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Trifloxystrobin is classified as ``Not Likely Human Carcinogen'' based
on the lack of evidence of carcinogenicity in mouse and rat cancer
studies.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
concern.
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 for females 13 to 49 years
old, EPA conducted an analysis using the Dietary Exposure Evaluation
Model (DEEMTM7.81), which 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).
EPA used tolerance level residues. EPA assumed all commodities with
established or proposed tolerances were treated with 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 to be included in DEEM. As to residue levels in food,
EPA used tolerance level residues for all commodities with the
exception of apples, oranges and grapes. For these commodities EPA used
anticipated residues. EPA assumed all commodities with established or
proposed tolerances were treated with trifloxystrobin.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that trifloxystrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for trifloxystrobin in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of trifloxystrobin. Further information
regarding EPA drinking water models used in pesticide exposure
assessment
[[Page 33193]]
can be found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS), GENeric Estimated Exposure Concentration (GENEEC),
and/or Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of trifloxystrobin for
the proposed new application are higher than those previously assessed
for corn; however, the EDWCs for both corn rates are less than those
previously estimated, via GENEEC, for turf use.
Based on the PRZM/EXAMS, GENEEC, and/or SCI-GROW models, the EDWCs
of trifloxystrobin plus its major degradation product, CGA-321113 for
acute exposures are estimated to be 47.99 parts per billion (ppb) and
47.31 ppb for chronic exposures. Modeled estimates of drinking water
concentrations were directly entered into the dietary exposure model.
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 uses that
could result in residential exposures: ornamentals and turfgrass. EPA
assessed residential exposure using the following assumptions: adult
post application dermal exposure; child's post application dermal and/
or hand to mouth. Further information regarding EPA standard
assumptions and generic inputs for residential exposures may be found
at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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.''
EPA has not found trifloxystrobin to share a common mechanism of
toxicity with 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 assumed that
trifloxystrobin does not have 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 https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There is no indication of
increased susceptibility of rat or rabbits to trifloxystrobin. In the
prenatal developmental study in rats, there was no developmental
toxicity at the limit dose. In the prenatal developmental study in
rabbits, developmental toxicity was seen at a dose that was higher than
the dose that caused maternal toxicity. In the two generation
reproduction study, there was no offspring toxicity at the highest dose
tested.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
i. The toxicity database for trifloxystrobin is complete except for
neurotoxicity and immunotoxicity testing. Recent changes to 40 CFR part
158 make neurotoxicity and immunotoxicity testing required for
pesticide registration; however, the existing data are sufficient for
endpoint selection for exposure/risk assessment scenarios, and for
evaluation of the requirements under the FQPA. Although acute and
subchronic neurotoxicity and immunotoxicity studies are needed to
complete the database, there are no concerns for immunotoxicity or
neurotoxicity based on the results of the existing studies. The
toxicological database for trifloxystrobin does not show any evidence
of treatment-related effects on the immune system. There was a decrease
in the incidence of hemosiderosis in the spleen of F0 and F1 parental
males and females in the 2-generation reproduction study. The effect
was not seen in any other toxicity studies, and it was not a primary
effect on the spleen. This decrease may indicate a decrease of red
blood cell turnover; but it is not an effect on the immune system.
Further, there was no evidence of neurotoxicity at the limit dose in an
unacceptable acute neurotoxicity study or in the other subchronic and
chronic studies in the database. The EPA does not believe that
conducting neurotoxicity or immunotoxicity studies will result in a
dose less than the PODs already used in this risk assessment and an
additional database uncertainty factor for potential neurotoxicity and/
or immunotoxicity does not need to be applied.
ii. There is no indication that trifloxystrobin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors (UFs) to account for neurotoxicity.
iii. There is no evidence that trifloxystrobin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the two-generation
reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases. The acute and chronic dietary food exposure assessments
utilize existing and proposed tolerance level residues and 100% crop
treated information for all commodities, except for apples, oranges,
and grapes which utilized anticipated residue levels for the chronic
dietary. By using these screening-level assessments with minor
refinement, actual exposures/risks from residues in food will not be
underestimated. EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to
trifloxystrobin in drinking water. EPA used similarly conservative
assumptions to assess postapplication exposure of 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
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate
[[Page 33194]]
PODs to ensure that an adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
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-term risk. Using the exposure assumptions described in
this unit for chronic exposure, EPA has concluded that chronic exposure
to trifloxystrobin from food and water will utilize 15% of the cPAD for
the general U.S. population and 43% of the cPAD for children 1 to 2
years old, the population group receiving the greatest exposure. Based
on the explanation in Unit III.C.3., regarding residential use
patterns, chronic residential exposure to residues of trifloxystrobin
is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term 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 exposure through food and water
with short-term residential exposures to trifloxystrobin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 1,200 for adults
(dermal residential + dietary food and drinking water exposures); 680
for children 1 to 2 years old (dermal residential + dietary food and
drinking water exposures); and 170 for children 1 to 2 years old
(incidental oral + dietary food and drinking water exposures). Because
EPA's level of concern for trifloxystrobin is a MOE of 100 or below,
these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Trifloxystrobin is not expected to pose an intermediate-term
risk based on a short soil half-life (approximately 2 days).
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, trifloxystrobin is not expected to pose a cancer risk to
humans.
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
Adequate enforcement methodology (gas chromatography with nitrogen
phosphorus detection (GC/NPD)), Method AG-659A is available to enforce
the tolerance expression. 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
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has established a MRL for trifloxystrobin in or on maize
fodder (dry) at 10 ppm. Canada has a proposed (not yet established) MRL
of 0.02 for corn grain, sweet corn, popcorn grain for parent and
metabolite. Since the Codex MRL is for a commodity that is not
recognized domestically and would normally not be transported across
international borders, there is no concern for international
harmonization. Also, since the Canadian MRL has not been established,
there is no concern for international harmonization.
C. Revisions to Petitioned-For Tolerances
Trifloxystrobin tolerances for crop commodities listed in 40 CFR
180.555(a)(1) are expressed in terms of the 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. EPA has revised the
trifloxystrobin tolerance expression to clarify the chemical moieties
that are covered by the tolerances and specify how compliance with the
tolerances is to be measured.
EPA's analysis of the adequacy of the existing tolerances for meat,
fat and meat byproduct of cattle, goats, horses, and sheep tolerances
based on the proposed tolerances as well as existing tolerances
indicates they need to be increased to 0.1 ppm from 0.05 ppm. Also, EPA
is removing from paragraph (b), tolerances for soybean, forage;
soybean, hay; and soybean, seed which expired and were revoked on
December 31, 2009.
V. Conclusion
Therefore, existing tolerances in 40 CFR 180.555(a) are increased
for residues of trifloxystrobin, benzeneacetic acid, (E,E)-[alpha]-
(methoxyimino)-2-[[[[1-[3- (trifluoromethyl)
phenyl]ethylidene]amino]oxy]methyl]-methyl ester, in or on corn, field,
forage at 6.0 ppm; corn, sweet, forage at 7.0 ppm; and corn, sweet,
stover at 4.0 ppm. EPA is also removing paragraph (b) tolerances for
soybean, forage; soybean, hay; and soybean, seed which expired December
31, 2009.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances 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
[[Page 33195]]
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 tolerances 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).
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: May 27, 2010.
Daniel J. Rosenblatt,
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. Amend Sec. 180.555 as follows:
0
a. Revise the introductory text of paragraph (a).
0
b. Revise the following entries in the table in paragraph (a): cattle,
fat; cattle, meat; cattle, meat byproducts; corn, field, forage; corn,
sweet, forage; corn, sweet, stover; goat, fat; goat, meat; goat, meat
byproducts; horse, fat; horse, meat; horse, meat byproducts; and sheep,
fat; sheep, meat; and sheep, meat byproducts.
0
c. Revise paragraph (b).
The revisions read as follows:
Sec. 180.555 Trifloxystrobin; tolerances for residues.
(a) General. Tolerances are established for residues of
trifloxystrobin, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum 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, calculated as the
stoichiometric equivalent of trifloxystrobin, in or on the commodity.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cattle, fat................................................ 0.1
Cattle, meat............................................... 0.1
Cattle, meat byproducts.................................... 0.1
* * * * *
Corn, field, forage........................................ 6.0
* * * * *
Corn, sweet, forage........................................ 7.0
* * * * *
Corn, sweet, stover........................................ 4.0
* * * * *
Goat, fat.................................................. 0.1
Goat, meat................................................. 0.1
Goat, meat byproducts...................................... 0.1
* * * * *
Horse, fat................................................. 0.1
Horse, meat................................................ 0.1
Horse, meat byproducts..................................... 0.1
* * * * *
Sheep, fat................................................. 0.1
Sheep, meat................................................ 0.1
Sheep, meat byproducts..................................... 0.1
* * * * *
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2010-13938 Filed 6-10-10; 8:45 am]
BILLING CODE 6560-50-S