[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Rules and Regulations]
[Pages 66723-66729]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27198]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0009; FRL-9366-6]
Fluazinam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
fluazinam in or on melon subgroup 9A and pepper/eggplant subgroup 8-
10B, associated with pesticide petition (PP) 1E7959; and soybean, seed
and soybean, hulls, associated with PP 2F7977. Interregional Research
Project Number 4 (IR-4) and ISK Biosciences Corporation requested the
tolerances associated with PPs 1E7959 and 2F7977, respectively, under
the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective November 7, 2012. Objections and
requests for hearings must be received on or before January 7, 2013,
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-2012-0009, 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), EPA West 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: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; email address: Nollen.Laura@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.
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
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/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
[[Page 66724]]
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-2012-0009 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 January 7, 2013. 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-2012-0009, 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 Confidential Business
Information (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.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For-Tolerance
In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-
9), 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
1E7959) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The petition requested that 40 CFR 180.574 be amended by
establishing tolerances for residues of the fungicide fluazinam, (3-
chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-
(trifluoromethyl)-2-pyridinamine), in or on fruiting vegetables group,
pepper/eggplant subgroup 8-10B at 0.10 parts per million (ppm); and
cucurbit vegetables, melon subgroup 9A at 0.08 ppm. That document
referenced a summary of the petition prepared on behalf of IR-4 by ISK
Biosciences Corporation, the registrant, which is available in the
docket, http://www.regulations.gov. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit
IV.C.
Additionally, in the Federal Register of July 25, 2012 (77 FR
43562) (FRL-9353-6), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a PP 2F7977
by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH
44077. The petition requested that 40 CFR 180.574 be amended by
establishing tolerances for residues of the fungicide fluazinam in or
on soybean, seed at 0.01 ppm; and soybean, hulls at 0.02 ppm. That
document referenced a summary of the petition prepared by ISK
Biosciences Corporation, the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
Based upon review of the data supporting the petitions, EPA has
revised the tolerances for several commodities. The reason for these
changes is explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue * *
*.''
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 fluazinam including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fluazinam 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.
Following subchronic and chronic exposure to fluazinam, the liver
appeared to be a primary target organ in rats, dogs, and mice. Signs of
liver toxicity included changes in clinical chemistry (increased serum
alkaline phosphatase and aspartate aminotransferase), increased
absolute and/or relative liver weights, increased incidences of gross
lesions (pale, enlarged, pitted, mottled, accentuated markings), and a
variety of histopathological lesions. Treatment-related effects were
also observed in other organs following subchronic and chronic exposure
to fluazinam, but these effects were not consistently noted in all
three species or in all studies in a given species. In a subchronic
inhalation toxicity study in rats, pulmonary effects were observed at
the mid and high doses. These effects included dose-related increases
in lung/bronchial weights and increased incidences of alveolar
macrophages and peribronchiolar proliferation in both sexes.
In the developmental toxicity study in rabbits, treatment-related
maternal effects (decreased food consumption and increased liver
histopathology) were noted in the absence of fetal effects. In the 2-
generation rat reproduction study, decreased pup weight gain was seen
at the highest dose tested, in the presence of decreased food
consumption and liver histopathology in parental animals. In a
developmental toxicity study in rats, fetal effects included decreases
in body and placental weights, increased incidences of facial/palate
clefts, diaphragmatic hernias, delayed ossification in several bone
types, increases in late resorptions, as well as evidence of a greenish
amniotic fluid and post-implantation loss. Maternal effects, including
decreases in body weight gain/food consumption and increases in water
[[Page 66725]]
consumption and urogenital staining, were observed at the same dose
level. In the rat developmental neurotoxicity (DNT) study, effects in
pups (including decreases in body weight/body weight gain and delayed
preputial separation) were noted in the absence of maternal toxicity.
In an acute neurotoxicity study in rats, effects included decreases
in motor activity and soft stools; these effects were considered to be
due to systemic toxicity and not a result of frank neurotoxicity. No
signs of neurotoxicity were observed in two subchronic neurotoxicity
studies in rat up to the highest dose tested. A neurotoxic lesion
described as vacuolation of the white matter of the central nervous
system was observed in subchronic and chronic studies in mice and dogs;
however, this lesion was found to be reversible and is attributed to an
impurity. Based on the level of this impurity in technical grade
fluazinam, the risk assessment for the parent compound is considered
protective of the effects noted. In an immunotoxicity study in mice,
significant suppressions of anti-sheep red blood cell antibody-forming
cell assay response were demonstrated at the highest dose tested.
In a rat carcinogenicity study, there was some evidence that
fluazinam induced an increase in thyroid gland follicular cell tumors
in male rats. There were statistically significant positive trends for
thyroid gland follicular cell adenocarcinomas and combined follicular
cell adenomas/adenocarcinomas. The incidences of thyroid gland adenomas
seen at 100 ppm (3.8 mg/kg/day) and adenocarcinomas at 1,000 ppm were
slightly outside their respective ranges for the historical controls.
However, this increased incidence of thyroid tumors at 100 ppm was not
observed in male rats in another chronic study. Further in the rat
carcinogenicity study where these effects were seen, the animals in the
lower dose groups were only microscopically examined for thyroid
lesions if abnormalities were observed in that organ at gross necropsy
and therefore, the incidences of thyroid tumors in the lower dose
groups may have been somewhat misleading (too high). In one mouse
carcinogenicity study, clear evidence of a treatment-related increase
of hepatocellular tumors was observed in male mice; in another mouse
carcinogenicity study, there was equivocal evidence that fluazinam may
have induced an increase in hepatocellular tumors in male mice. There
was no evidence of statistically significant tumor increases in female
mice or rats in any study and no evidence of mutagenic activity in the
submitted mutagenicity studies for fluazinam. EPA has classified
fluazinam as having suggestive evidence of carcinogenicity. Due to the
equivocal and inconsistent nature of the cancer response in the rat and
mouse studies, the Agency determined that quantification of risk using
a non-linear approach (i.e., RfD) will adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to fluazinam.
Specific information on the studies received and the nature of the
adverse effects caused by fluazinam 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, ``Fluazinam. Human Health Risk
Assessment to Support New Uses on Soybeans, the Melon Subgroup (9-A),
and the Pepper/Eggplant Subgroup (8-10B), and to Support Registration
Review'' at pages 43-49 in docket ID number EPA-HQ-OPP-2012-0009.
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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for fluazinam used for
human risk assessment is shown in Table 1 of this unit. To assess
short-term dermal exposure, the dermal toxicity and dermal absorption
studies were used to determine a refined dermal equivalent dose (RDD).
To calculate a RDD, in vitro results using rat skin are corrected for
any differences between in vitro and in vivo absorption rates and
species differences between rats and humans. This refinement in dermal
absorption is important because absorption by human skin is usually
lower than that by rat skin. Accordingly, the combined use of the data
from three dermal absorption studies and two testing systems offers
greater precision in estimating human dermal absorption, which
strengthens the reliability of the dermal risk assessment.
Table 1--Summary of Toxicological Doses and Endpoints for Fluazinam for Use in Human Health Risk Assessment
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Point of departure and
Exposure/Scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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Acute dietary (Females 13-50 years of NOAEL = 7 milligrams/ Acute RfD = 0.07 mg/kg/ Developmental Toxicity
age). kilogram/day (mg/kg/ day. Study--Rabbits
day). aPAD = 0.07 mg/kg/day.. LOAEL = 12 mg/kg/day
UFA = 10x.............. based on increased
UFH = 10x.............. incidence of total
FQPA SF = 1x........... litter resorptions and
possible increased
incidence of fetal
skeletal
abnormalities.
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[[Page 66726]]
Acute dietary (General population NOAEL = 50 mg/kg/day... Acute RfD = 0.5 mg/kg/ Acute Neurotoxicity--
including infants and children). UFA = 10x.............. day. Rats
UFH = 10x.............. aPAD = 0.5 mg/kg/day... LOAEL = 1000 mg/kg/day
FQPA SF = 1x........... based on decreased
motor activity and
soft stools on day of
dosing.
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Chronic dietary (All populations).... NOAEL = 1.1 mg/kg/day.. Chronic RfD = 0.011 mg/ Co-critical:
UFA = 10x.............. kg/day. Carcinogenicity--Mice
UFH = 10x.............. cPAD = 0.011 mg/kg/day. LOAEL = 10.7 mg/kg/day
FQPA SF = 1x........... based on liver
histopathology and
increased liver weight
Chronic Dog
LOAEL = 10 mg/kg/day
based on marginal
increases in the
incidence of nasal
dryness in females and
the incidence/severity
of gastric lymphoid
hyperplasia in both
sexes.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)..... Dermal study NOAEL= 10 RDD*= 24.4 mg/kg/day... 21-Day Dermal Toxicity--
mg/kg/day. LOC for MOE = 100...... Rats
Refined Dermal LOAEL= 100 mg/kg/day
absorption rate = based on liver effects
2.44%. (increased AST and
UFA = 10x.............. cholesterol levels).
UFH = 10x..............
FQPA SF = 1x...........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).... Non-linear RfD approach was used to assess cancer risk.
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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). * A Refined Dermal Equivalent Dose (RDD) of 24.4 mg/kg/day was
calculated using the dermal POD and dermal absorption data.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluazinam, EPA considered exposure under the petitioned-
for-tolerances as well as all existing fluazinam tolerances in 40 CFR
180.574. EPA assessed dietary exposures from fluazinam 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 fluazinam. In estimating acute
dietary exposure, EPA used food consumption information from the 2003-
2008 National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, EPA utilized
tolerance-level residues, 100 percent crop treated (PCT) for all
commodities, and used DEEM default processing factors, when
appropriate.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA utilized tolerance-
level residues for all commodities except apple (for which the average
field trial residue value was used), assumed 100 PCT for all
commodities, and used DEEM default processing factors, when
appropriate.
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or non-linear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or non-linear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has concluded that a nonlinear RfD approach is appropriate
for assessing cancer risk to fluazinam. Cancer risk was assessed using
the same exposure estimates as discussed in Unit III.C.1.ii.
iv. Anticipated residue 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 residues of concern in
[[Page 66727]]
drinking water for risk assessment are parent fluazinam and its
degradates, including DCPA, CAPA, DAPA, HYPA, and AMPA. The Agency used
screening level water exposure models in the dietary exposure analysis
and risk assessment for fluazinam and its degradates in drinking water.
These simulation models take into account data on the physical,
chemical, and fate/transport characteristics of fluazinam and its
degradates. 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 First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of fluazinam and its
degradates for surface water are estimated to be 226 parts per billion
(ppb) for acute exposures and 37.8 ppb for chronic exposures. For
ground water, the EDWCs are estimated to be 0.404 ppb for both acute
and chronic exposures.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. The water concentration values
of 226 ppb and 37.8 ppb were used to assess the contribution to
drinking water in the acute and chronic dietary risk assessments,
respectively.
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). Fluazinam is
currently registered for following use that could result in residential
exposures: On turf at golf courses only. EPA assessed potential
residential short-term post-application dermal exposure from
individuals, including adults, youth (11 to <16 years old), and
children (6 to <11 years old), playing golf on treated turf. The short-
and intermediate-term toxicological endpoints for fluazinam are the
same for the dermal route of exposure. As a result, only the short-term
dermal exposure was assessed. The resulting short-term risk estimates
are considered to be protective of intermediate-term exposure and risk.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://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 fluazinam
to share a common mechanism of toxicity with any other substances, and
fluazinam does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that fluazinam 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 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. The prenatal and postnatal
toxicology database for fluazinam includes rat and rabbit developmental
toxicity studies, a 2-generation reproductive toxicity study in rats,
and a DNT study in the rat. There was no evidence of increased
quantitative or qualitative susceptibility in the rabbit developmental
toxicity study or the rat 2-generation reproductive toxicity study;
however, evidence of increased qualitative susceptibility of fetuses
was observed in the rat developmental toxicity study and evidence of
increased quantitative susceptibility of fetuses was observed in the
rat DNT study.
In the developmental toxicity study in rats, fetal effects
(increased incidences of facial/palate clefts and other rare
deformities in the fetuses) were observed in the presence of minimal
maternal toxicity (decreased body weight gain and food consumption, and
increased water consumption and urogenital staining). In the rat DNT
study, decreases in body weight/body weight gain and a delay in
completion of balano-preputial separation were observed in pups in the
absence of maternal effects, suggesting increased quantitative
susceptibility of the offspring.
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 fluazinam is complete.
ii. There is no evidence that fluazinam results in increased
susceptibility in in utero rabbits in the prenatal developmental
studies or in young rats in the 2-generation reproduction study;
however, increased qualitative susceptibility was noted in the rat
developmental toxicity study. The degree of concern for the observed
effects is low because fetal effects were observed only at the highest
dose tested in the presence of maternal toxicity, and there is a clear
NOAEL for the fetal effects seen. Additionally, the NOAEL (50 mg/kg/
day) identified in the developmental toxicity study in rats is
significantly higher than the NOAEL used (7 mg/kg/day) to establish the
aRfD for females 13-49. Therefore, the aRfD is protective of any
potential developmental effects and there are no residual uncertainties
for prenatal and/or postnatal toxicity.
Additionally, while a DNT study in rat did not show evidence of
neurotoxicity, the study showed evidence of increased quantitative
susceptibility of offspring. Although the NOAEL for this study (2 mg/
kg/day) is lower than that used for the aRfD for females 13-49 (7 mg/
kg/day), the effects noted in the DNT study are considered to be
postnatal effects attributable to multiple doses; therefore, the study
endpoint is not appropriate for acute dietary exposures. The cRfD
(0.011 mg/kg/day) is based on a lower NOAEL (1.1 mg/kg/day), and is
considered to be protective of potential developmental effects.
Therefore, the degree of concern is low for the observed effects and
there are no residual uncertainties with regard to prenatal and/or
postnatal neurotoxicity.
iii. There are no residual uncertainties identified in the exposure
databases. The acute and chronic dietary food exposure assessments were
performed based on 100 PCT for all commodities. Additionally, the acute
assessment is based on tolerance-level residues for all commodities,
and the chronic assessment is based on tolerance-level
[[Page 66728]]
residues for all commodities except apple (for which the average field
trial value was used). These assumptions result in high-end estimates
of dietary exposure. EPA made conservative (protective) assumptions in
the ground water and surface water modeling used to assess exposure to
fluazinam in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children. Incidental
oral exposure of toddlers is not expected from any use pattern for
fluazinam. These assessments will not underestimate the exposure and
risks posed by fluazinam.
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 fluazinam will occupy 28% of the aPAD for females 13-49 years old;
and 21% of the aPAD for children 1-2 years old, the population group
receiving the greatest exposure for the general population, including
infants and children.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluazinam from food and water will utilize 51% 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 fluazinam 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). Fluazinam 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 fluazinam.
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 730 for children
6-<11 years old, 880 for youth 11-<16 years old, and 970 for adults.
Because EPA's level of concern for fluazinam 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). Based on the discussion in Unit III.C.3., short-term risk
estimates are considered to be protective of intermediate-term exposure
and risk.
5. Aggregate cancer risk for U.S. population. Based on the
discussion in Unit III.A., EPA has concluded that the cPAD is
protective of possible cancer effects.
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 fluazinam residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate gas chromatography with electron capture detection (GC/
ECD) method (6148-94-0170-MD-001) is available to enforce fluazinam
tolerances on plant commodities. An adequate enforcement method for the
determination of AMGT is also available. The method is a high
performance liquid chromatography with ultraviolet detection (HPLC/UV)
enforcement method entitled ``Method Evaluation for the Analysis of
AMGT in Grapes.''
The methods 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 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 not established a MRL for fluazinam on the
commodities associated with this action.
C. Response to Comments
EPA received several comments to the docket, EPA-HQ-OPP-2012-0009;
however, only one of these public submissions was in response to the
Notice of Filing for PP 1E7959, while the remaining comments pertained
to unrelated petitions in the Federal Register notice. For PP 1E7959,
the commenter stated that no residue should be allowed for fluazinam
and that they do not support manufacture or use of this product. The
Agency understands the commenter's concerns and recognizes that some
individuals believe that pesticides should be banned on agricultural
crops. However, the existing legal framework provided by section 408 of
the Federal Food, Drug, and Cosmetic Act (FFDCA) states that tolerances
may be set when persons seeking such tolerances or exemptions have
demonstrated that the pesticide meets the safety standard imposed by
that statute. This citizen's comment appears to be directed at the
underlying statute and not EPA's implementation of it; the citizen has
made no contention that EPA has acted in violation of the statutory
framework. In addition, the commenter included several adverse effects
they believed were seen in animal toxicology studies for fluazinam. EPA
has found that there is a reasonable certainty of no harm to humans
after considering the toxicological studies and the exposure levels of
humans to fluazinam.
D. Revisions to Petitioned-For-Tolerances
Based on the data supporting the petitions, EPA revised the
proposed tolerances on melon subgroup 9A from 0.08 ppm to 0.07 ppm;
pepper/eggplant subgroup 8-10B from 0.10 ppm to 0.09 ppm; and soybean,
hulls from 0.02 ppm to 0.05 ppm. The Agency revised these tolerance
levels based on analysis of the residue field trial data using the
Organization for Economic Cooperation and Development (OECD) tolerance
calculation procedures.
[[Page 66729]]
V. Conclusion
Therefore, tolerances are established for residues of fluazinam,
(3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-
(trifluoromethyl)-2-pyridinamine), in or on melon subgroup 9A at 0.07
ppm; pepper/eggplant subgroup 8-10B at 0.09 ppm; soybean, seed at 0.01
ppm; and soybean, hulls at 0.05 ppm.
VI. Statutory and Executive Order Reviews
This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations that Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
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 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 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 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) (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 of 1995 (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: October 26, 2012.
Daniel J. Rosenblatt,
Acting 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. 180.574, alphabetically add the following commodities to
the table in paragraph (a)(1) to read as follows:
Sec. 180.574 Fluazinam; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * *
Melon subgroup 9A.......................................... 0.07
------------------------------------------------------------------------
* * * * *
Pepper/eggplant subgroup 8-10B............................. 0.09
------------------------------------------------------------------------
* * * * *
Soybean, seed.............................................. 0.01
------------------------------------------------------------------------
Soybean, hulls............................................. 0.05
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-27198 Filed 11-6-12; 8:45 am]
BILLING CODE 6560-50-P