[Federal Register Volume 80, Number 84 (Friday, May 1, 2015)]
[Rules and Regulations]
[Pages 24824-24830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10149]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0248; FRL-9926-24]
Azoxystrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
azoxystrobin in or on coffee, green bean; pear, Asian; and tea, dried.
Syngenta Crop Protection, LLC requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA) to cover residues of
azoxystrobin in coffee, Asian pear, and tea imported into the United
States; there are currently no U.S. registrations for pesticides
containing azoxystrobin that are used on coffee, Asian pear, or tea.
DATES: This regulation is effective May 1, 2015. Objections and
requests for hearings must be received on or before June 30, 2015, 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0248, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl
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-2014-0248 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
[[Page 24825]]
before June 30, 2015. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0248, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
II. Summary of Petitioned-For Tolerance
In the Federal Register of May 23, 2014 (79 FR 29729) (FRL-9910-
29), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
3E8228) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the fungicide azoxystrobin, in
or on coffee, bean, green at 0.03 parts per million (ppm); pear, Asian
at 0.07 ppm and tea at 10 ppm. That document referenced a summary of
the petition prepared by Syngenta Crop Protection, LLC, the petitioner,
which is available in the docket, http://www.regulations.gov. A comment
was received on the notice of filing. EPA's response to this comment is
discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
increased the tolerance on tea from what the petitioner requested. The
reason for this change 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. . .
.''
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 azoxystrobin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with azoxystrobin 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.
Azoxystrobin has low acute toxicity via the oral, dermal, and
inhalation routes of exposure. It is not an eye or skin irritant and is
not a skin sensitizer. Repeated oral dosing of azoxystrobin to rats
resulted in decreased body weights, decreased food intake and
utilization, increased diarrhea, and other clinical toxicity
observations (increased urinary incontinence, hunched postures, and
distended abdomens). In addition, liver effects characterized by
increased liver weights, increase in alkaline phosphatase and gamma
glutamyltransferase, decrease in albumin, and gross and histological
lesions in the liver and bile ducts, were seen in rats. In dogs,
effects on liver/biliary function were found after oral administration.
In the acute neurotoxicity study in rats, increased incidence of
diarrhea was observed at all dose levels tested. Decreases in body
weight and food utilization were noted in the rat subchronic
neurotoxicity study. There were no indications of treatment-related
neurotoxicity in either the acute or subchronic neurotoxicity studies.
In the rat developmental toxicity study, diarrhea, urinary
incontinence, and salivation were observed in maternal animals; in the
rabbit developmental toxicity study, maternal animals exhibited
decreased body weight gain. No adverse treatment-related developmental
effects were seen in either study. In the rat reproduction study,
offspring and parental effects (decreased body weights and increased
adjusted liver weights) were observed at the same dose.
There was no evidence of carcinogenicity in rats and mice. As a
result, EPA has classified azoxystrobin as ``not likely to be
carcinogenic to humans.'' Azoxystrobin induced a weak mutagenic
response in the mouse lymphoma assay, but the activity expressed in
vitro is not expected to be expressed in whole animals.
Specific information on the studies received and the nature of the
adverse effects caused by azoxystrobin 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 http://www.regulations.gov in document ``Human Health Aggregate Risk
Assessment for Permanent Tolerances on Imported Asian Pear, Imported
Tea, and Imported Coffee; Establishment of Permanent Tolerances on Ti
Palm and for Crop Group Conversions for Stone Fruits Group 12-12 and
Tree Nut Group 14-12 Crop Groups'' on page 5 in docket ID number EPA-
HQ-OPP-2014-0248.
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
[[Page 24826]]
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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for azoxystrobin used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Azoxystrobin for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (All Populations).. LOAEL = 200 mg/kg/ Acute RfD = 0.67mg/ Acute Neurotoxicity--Rat.
day. kg/day. LOAEL = 200 mg/kg/day based on
UFA = 10x........... aPAD = 0.67 mg/kg/ diarrhea at two-hours post dose
UFH = 10x........... day. at all dose levels tested.
FQPA SF = 3x........
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Chronic dietary (All populations) NOAEL = 18 mg/kg/day Chronic RfD = 0.18 Combined Chronic Toxicity/
UFA = 10x........... mg/kg/day. Carcinogenicity Feeding Study--
UFH = 10x........... cPAD = 0.18 mg/kg/ Rat.
FQPA SF = 1x........ day. LOAEL = 82.4/117 mg/kg/day (M/F)
based on reduced body weights in
both sexes and bile duct lesions
in males.
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Incidental oral short-term....... NOAEL = 35 mg/kg/day LOC for MOE = 100.. 2-Generation Reproduction Study--
(1 to 30 days) & intermediate- UFA = 10x........... Rat.
term. UFH = 10x........... LOAEL = 165 mg/kg/day based on
(1 to 6 months).................. FQPA SF = 1x........ decreased pup weights in both
males and females ([darr]8-21%).
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Dermal........................... No hazard was identified for this 21-Day Repeated Dose Dermal Study--
(All durations).................. exposure scenario. Rat. No dermal or systemic
toxicity was seen at the limit
dose (1,000 mg/kg/day).
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Inhalation \1\................... NOAEL = 35 mg/kg/day LOC for MOE = 100.. 2-Generation Reproduction Study--
short-term....................... \2\. Rat.
(1 to 30 days) & intermediate- UFA = 10x........... LOAEL = 165 mg/kg/day based on
term. UFH = 10x........... decreased pup weights in both
(1 to 6 months).................. FQPA SF = 1x........ males and females ([darr]8-21%).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Azoxystrobin is classified as ``Not Likely'' to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure.
NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD =
reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH =
potential variation in sensitivity among members of the human population (intraspecies).
\1\ To protect for the body weight decreases seen in the pups, a 69 kg body weight was used for estimating short-
and intermediate-term inhalation doses because the pup body weight decrease also influenced by the maternal
health.
\2\ Toxicity via the inhalation route is assumed to be equivalent to the oral route.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to azoxystrobin, EPA considered exposure under the petitioned-
for tolerances as well as all existing azoxystrobin tolerances in 40
CFR 180.507. EPA assessed dietary exposures from azoxystrobin 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.
Such effects were identified for azoxystrobin. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) Nationwide Health and Nutrition
Examination Survey, What We Eat In America (NHANES/WWEIA) conducted
from 2003-2008. As to residue levels in food, the acute dietary
assessment incorporated tolerance-level residues for all commodities
except for citrus fruits (which used the highest residues from residue
trials); 100 percent crop treated (PCT); and Dietary Exposure
Evaluation Model (DEEM) (ver. 3.16) default processing factors, except
for where tolerances were established for processed commodities or when
processing studies showed no concentration. Field trial data were
translated from the representative commodities to the non-
representative commodities according to HED SOP 2000.1``Guidance for
Translation of Field Trial Data from Representative Commodities in the
Crop Group Regulation to other Commodities in Each Crop Group/
Subgroup.''
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's (NHANES/
WWEIA) conducted from 2003-2008. As to residue levels in food, the
chronic dietary analysis incorporated tolerance-level residues for all
commodities, average PCT estimates when available and DEEM (ver. 3.16)
default processing factors, except for where tolerances
[[Page 24827]]
were established for processed commodities or when processing studies
showed no concentration.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that azoxystrobin should be classified as ``not likely'' to
be carcinogenic to humans. Therefore a cancer risk assessment 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.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency estimated the PCT for the chronic dietary exposure
assessment for existing uses as follows: Almonds, 20%; apricots, 10%;
artichokes, 20%; asparagus, <2.5%; barley, <2.5%; green beans, 15%;
blueberries, 15%; broccoli, 10%; cabbage, 10%; cane berries, 5%;
cantaloupes, 20%; carrots, 10%; cauliflower, <2.5%; celery, 10%; corn,
<2.5%; cotton, <2.5%; cotton (seed treatment), 25%; cucumbers, 20%; dry
beans/peas, <2.5%; eggplant, 30%; garlic, 70%; grapefruit, 20%; grapes,
5%; hazelnuts, 5%; lemons, <2.5%; lettuce, <2.5%; nectarines, <2.5%;
onions, 5%; oranges, 5%; peaches, 5%; peanuts, 20%; peanuts (seed
treatment), 30%; green peas, <2.5%; pecans, 5%; peppers, 20%;
pistachios, 5%; plums/prunes, <2.5%; potatoes, 40%; potatoes (seed
treatment), <1%; pumpkins, 20%; rice, 40%; soybeans, 5%; soybeans (seed
treatment), <1%; spinach, 10%; squash, 20%; strawberries, 25%; sugar
beets, 10%; sugar beets (seed treatment), <2.5%; sweet corn, 15%;
tangelos, 25%; tangerines, 10%; tobacco, 15%; tomatoes, 25%; walnuts,
>2.5%; watermelons, 15%; wheat, 5%; wheat seed (seed treatment), <1%.
In most cases, EPA uses available data from USDA/National
Agricultural Statistics Service (NASS), proprietary market surveys, and
the National Pesticide Use Database for the chemical/crop combination
for the most recent 6-7 years. EPA uses an average PCT for chronic
dietary risk analysis. The average PCT figure for each existing use is
derived by combining available public and private market survey data
for that use, averaging across all observations, and rounding to the
nearest 5%, except for those situations in which the average PCT is
less than 1%. In those cases, 1% is used as the average PCT and 2.5% is
used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk
analysis. The maximum PCT figure is the highest observed maximum value
reported within the recent 6 years of available public and private
market survey data for the existing use and rounded up to the nearest
multiple of 5%.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which azoxystrobin may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for azoxystrobin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of azoxystrobin. 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.
Based on the Screening Concentration in Ground Water (SCI-GROW)
model and Pesticide Root Zone Model Ground Water (PRZM GW), for surface
water, the estimated drinking water concentrations (EDWCs) of
azoxystrobin for acute exposures are estimated to be 70.2 parts per
billion (ppb) and for chronic exposures are estimated to be 48.5 ppb.
For ground water, the estimated drinking water concentration for both
acute and chronic exposure scenarios is 3.1 ppb.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 70.2 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 48.5 ppb was used to
assess 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). Azoxystrobin is
currently registered for the following uses that could result in
residential exposures: Outdoor residential (lawns, ornamentals, flower
gardens, vegetables, fruit and nut trees, berries and vines) and
recreational (golf courses, parks and athletic fields) sites.
Additionally, it is registered for use on indoor carpets/other surfaces
by non-commercial applicators, and in treated paints (preservative
incorporation).
The proposed uses do not impact the aggregate risk assessment;
however, the scenarios that do impact the aggregate assessment have
been re-evaluated in this assessment to reflect the revised incidental
oral and inhalation PODs. Using those new PODs, EPA assessed
residential exposure using the 2012 updated residential standard
operating procedures (SOPs) that are now used in all human health
assessments.
[[Page 24828]]
For the adult aggregate assessment, the Agency used inhalation
exposure from adult handlers applying treated paint via airless
sprayers; for the aggregate assessment for children, the Agency used
post-application inhalation exposure from space-trays and hand-to-mouth
exposures from indoor applications to treated carpets for children 1 to
<2 years old.
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 azoxystrobin to share a common mechanism of
toxicity with any other substances, and azoxystrobin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
azoxystrobin 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 Web site at http://
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 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. The prenatal and postnatal
toxicity database for azoxystrobin includes prenatal developmental
toxicity studies in rats and rabbits and a 2-generation reproduction
study in young rats. In these studies, there is no evidence that
azoxystrobin results in increased quantitative sensitivity to
developing fetuses. Also in the reproduction study, the offspring and
the parental effects occurred at the same dose level.
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 for all exposure scenarios except acute
exposure. For assessing acute dietary risk, EPA is retaining an FQPA
factor of 3X to account for the use of a LOAEL from the acute
neurotoxicity study to derive an acute reference dose. The Agency
believes that a 3X FQPA SF (as opposed to a 10X) will be adequate to
extrapolate a NOAEL in assessing acute risk based on the following
considerations:
The LOAEL is based on a transient effect (diarrhea in
rats) expected to be relatively insignificant in nature. This effect is
also seen in other chemicals of the same class.
The diarrhea was only seen in studies using gavage dosing
in the rat, but not in studies using repeat dosing through dietary
administration in rats or mice, and not through gavage dosing in
rabbits.
The very high dose level needed to reach the acute oral
lethal dose (LD)50 (>5000 mg/kg), and the overall low
toxicity of azoxystrobin.
The decision to reduce the FQPA safety factor to 1X for the
assessment of the remaining exposure scenarios is based on the
following findings:
i. The toxicity database for azoxystrobin is complete.
ii. There is no indication that azoxystrobin is a neurotoxic
chemical. Although clinical signs were observed in the acute and
subchronic neurotoxicity studies which included transient diarrhea,
decreased body weight, body weight gain, and food utilization, no other
effects were seen in those studies that would be considered indicative
of neurotoxicity. Therefore, there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that azoxystrobin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. In the reproduction study, the offspring and the parental
effects occurred at the same dose level.
iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary (food) exposure assessments utilized
conservative upper-bound inputs including assuming 100% CT and
tolerance-level residues for all commodities except citrus fruits where
the highest field trial residue was used as a refinement. The chronic
dietary exposure assessment was partially refined, and used tolerance-
level residues for all commodities and PCT information for selected
crops. EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to azoxystrobin in
drinking water. EPA used similarly conservative assumptions to assess
post-application exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by azoxystrobin.
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 PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to azoxystrobin will occupy 40% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
azoxystrobin from food and water will utilize 15% of the cPAD for
children 1-2 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
azoxystrobin 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).
Azoxystrobin 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 azoxystrobin.
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 2,400 for adults
and 280 for children 1-2 years old. Because EPA's
[[Page 24829]]
level of concern for azoxystrobin 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).
Because no intermediate-term adverse effect was identified,
azoxystrobin is not expected to pose an intermediate-term risk.
Therefore, the intermediate-term aggregate risk would be equivalent to
the chronic dietary exposure estimate.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, azoxystrobin 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 azoxystrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography with a
nitrogen-phosphorus detector (GC/NPD) method, RAM 243/04) is available
to enforce the tolerance expression for residues of azoxystrobin and
its Z-isomer in crop commodities. This method (designated RAM 243,
dated 5/15/98) has been submitted to FDA for inclusion in the Pesticide
Analytical Manual (PAM), Volume II.
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:
[email protected].
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 United Nations
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 azoxystrobin in or on coffee,
bean at 0.03 ppm. The US tolerance for coffee is harmonized with the
Codex MRL. The Codex has not established a MRL for Asian pear or tea.
C. Response to Comments
One comment was received in response to the notice of filing of
Syngenta Crop Protection's petition. The commenter objected to the
increase of chemical residues generally and expressed additional
concerns about the carcinogenic effects of chemicals in general on
humans. The Agency understands the commenter's concerns regarding toxic
chemicals and their potential effects on humans. Pursuant to its
authority under the FFDCA, and as discussed further in this preamble,
EPA conducted a comprehensive assessment of azoxystrobin, which
included an assessment on the carcinogenic potential of azoxystrobin.
Based on its assessment of the available data, the Agency has concluded
that azoxystrobin is not likely to be a carcinogen and that there is a
reasonable certainty that no harm will result from aggregate exposure
to residues of azoxystrobin.
D. Revisions to Petitioned-For Tolerances
The tolerance on tea has been revised from what was proposed in the
initial petition. EPA is increasing the proposed tolerance for tea from
10 ppm to 20.0 ppm. The proposed tolerance of 10 ppm for tea is
insufficient, as the trials were conducted at 50% of the label maximum
rate. Correction by proportionality to the maximum label rate provides
a tolerance recommendation of 20.0 ppm. Also, because magnitude of
residue data used to determine the appropriate tolerance level were
provided for dried tea only, EPA is only establishing a tolerance for
dried tea at this time.
In addition, EPA is altering the commodity name for ``coffee, green
bean'' from the petitioned-for name (``coffee, bean, green'') to be
consistent with the general food and feed commodity vocabulary EPA uses
for tolerances and exemptions.
V. Conclusion
Therefore, tolerances are established for residues of azoxystrobin,
in or on coffee, green bean at 0.03 ppm; pear, Asian at 0.07 ppm; and
tea, dried at 20.0 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) 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 action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action 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 FFDCA section 408(d), 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as
[[Page 24830]]
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1501 et seq.).
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 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: April 23, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
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. 180.507:
0
a. Add alphabetically the entries for ``Coffee, green bean''; \1\
``Pear, Asian'',\1\ ``Tea, dried'' \1\ to the table in paragraph
(a)(1).
0
b. Revise footnote \1\ at the end of the table in paragraph (a)(1).
The additions and revision read as follows:
Sec. 180.507 Azoxystrobin; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Coffee, green bean \1\..................................... 0.03
* * * * *
Pear, Asian \1\............................................ 0.07
* * * * *
Tea, dried \1\............................................. 20.0
* * * * *
------------------------------------------------------------------------
\1\ There are no United States registrations for use of azoxystrobin on
coffee, green bean; ginseng; pear, Asian and tea, dried.
* * * * *
[FR Doc. 2015-10149 Filed 4-30-15; 8:45 am]
BILLING CODE 6560-50-P