[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Rules and Regulations]
[Pages 71947-71952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29462]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0179; FRL-9933-61]
Flutriafol; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerances for residues of
flutriafol in or on hop, dried cones. Cheminova A/S, c/o Cheminova,
Inc. requested this tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA). Additionally, tolerances are being removed that
were inadvertently returned from an earlier Final rule.
DATES: This regulation is effective November 18, 2015. Objections and
requests for hearings must be received on or before January 19, 2016,
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-2015-0179, 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
Printing 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-2015-0179 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 19, 2016. 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-2015-0179, 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.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
[[Page 71948]]
II. Summary of Petitioned-for Tolerance and This Action
In the Federal Register of April 22, 2015 (80 FR 22466) (FRL-9925-
79), 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
4F8294) by Cheminova Inc., c/o Cheminova A/S, 1600 Wilson Blvd., Suite
700, Arlington, VA 22209-2510. The petition requested that 40 CFR
180.629 be amended by establishing tolerances for residues of the
fungicide flutriafol, (()-[alpha]-(2-fluorophenyl)-[alpha]-
(4-fluorophenyl)-1H-1,2,4-triazole-1-ethanol), in or on hops, dried
cones at 20 parts per million (ppm). That document referenced a summary
of the petition prepared by Cheminova Inc., c/o Cheminova A/S, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing. For purposes of accuracy, the Agency notes that a
harmless error was made in the notice of filing publication and is
correcting that misstatement here: The petition was actually filed by
Cheminova A/S, c/o Cheminova, Inc.
Additionally, in the Federal Register of February 4, 2015 (80 FR
5946) (FRL-9922-06) EPA established tolerances for residues of
flutriafol, in or on several commodities, including cotton, gin
byproducts at 6.0 ppm and cotton, undelinted seed at 0.50 ppm. When
establishing the general tolerances in paragraph (a) for cotton, gin
byproducts at 6.0 ppm and cotton, undelinted seed at 0.50 ppm, EPA
inadvertently forgot to remove the existing tolerances for cotton, gin
byproducts at 0.02 ppm and cotton, undelinted seed at 0.01 ppm from the
table in paragraph (d) for Indirect or inadvertent residues. These
indirect tolerances were made redundant by the establishment of the
tolerances in the General section at a higher level for the same
commodities. Therefore, EPA is removing the cotton, gin byproducts and
cotton, undelinted seed tolerances established in Sec. 180.629(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 flutriafol including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with flutriafol 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. Consistent with the mammalian toxicity profiles of the other
triazole fungicides, the prevalent adverse effects following oral
exposure to flutriafol were in the liver. Effects consisted of
increases in liver enzyme release (alkaline phosphatase), liver
weights, and histopathology findings (hepatocyte vacuolization to
centrilobular hypertrophy and slight increases in hemosiderin-laden
Kupffer cells, minimal to severe fatty changes, and bile duct
proliferation/cholangiolar fibrosis). Progression of toxicity occurred
with time as some effects were only observed at chronic durations.
Slight indications of effects in the hematopoietic system were
sporadically seen in all species consisting of slight anemia, increased
platelets, white blood cells, neutrophils, and lymphocytes. The effects
in the neurotoxicity screening batteries were observed only at higher
doses and were considered secondary effects (decreased motor activity
and hindlimb grip strength, ptosis, lost righting reflex, hunched
posture, and ataxia). Flutriafol showed no evidence of dermal toxicity,
or immunotoxicity. Flutriafol showed no evidence of carcinogenicity in
rodents or in vitro.
There is evidence of increased quantitative and qualitative pre-
and postnatal susceptibility for flutriafol in rats and rabbits. In the
first of two rat developmental toxicity studies, developmental effects
(delayed ossification or non-ossification of the skeleton in the
fetuses) were observed at a lower dose than that where maternal effects
were observed. In the second rat developmental study, developmental
effects (external, visceral, and skeletal malformations; embryo
lethality; skeletal variations; a generalized delay in fetal
development; and fewer live fetuses) were more severe than the
decreased food consumption and body-weight gains observed in the dams
at the same dose. For rabbits, intrauterine deaths occurred at a dose
level that also caused adverse effects in maternal animals. In the 2-
generation reproduction studies, effects in the offspring decreased
litter size and percentage of live births (increased pup mortality) and
liver toxicity can be attributed to the systemic toxicity of the
parental animals (decreased body weight and food consumption and liver
toxicity) observed at the same dose.
Flutriafol is categorized as having high oral acute toxicity in the
mouse. It is categorized as having low acute toxicity via the oral,
dermal and inhalation routes in rats. Flutriafol is minimally
irritating to the eyes and is not a dermal irritant. Flutriafol was not
shown to be a skin sensitizer when tested in guinea pigs.
Flutriafol is considered to be ``Not likely to be Carcinogenic to
Humans'' based on the results of the carcinogenicity studies in rats
and mice. The results of the rat chronic toxicity/carcinogenicity study
and the mouse carcinogenicity study are negative for carcinogenicity.
All genotoxicity studies on flutriafol showed no evidence of
clastogenicity or mutagenicity.
Specific information on the studies received and the nature of the
adverse effects caused by flutriafol as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of June 6, 2014 (79 FR 32666) (FRL-
9910-38).
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
[[Page 71949]]
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 the NOAEL and the
LOAEL are identified. 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for flutriafol used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of June 6, 2014.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flutriafol, EPA considered exposure under the petitioned-
for tolerances as well as all existing flutriafol tolerances in 40 CFR
180.629. EPA assessed dietary exposures from flutriafol 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 flutriafol. 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, EPA made the following
assumptions for the acute exposure assessment: Tolerance-level residues
or tolerance-level residues adjusted to account for the residues of
concern for risk assessment and 100 percent crop treated (PCT). Since
adequate processing studies have been submitted which indicate that
tolerances for residues in/on apple juice, grape juice, dried prunes,
and tomato puree are unnecessary and since tolerances for residues in/
on raisin and tomato paste tolerances are established, the DEEM (ver.
7.81) default processing factors for these commodities were reduced to
1. The DEEM (ver. 7.81) default processing factors were retained for
the remaining relevant commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA conducted from 2003-2008. As to residue levels in food, EPA made
the following assumptions for the chronic exposure assessment:
Tolerance-level residues or tolerance-level residues adjusted to
account for the residues of concern for risk assessment and 100 PCT.
Since adequate processing studies have been submitted which indicate
that tolerances for residues in/on apple juice, grape juice, dried
prunes, and tomato puree are unnecessary and since tolerances for
residues in/on raisin and tomato paste tolerances are established, the
DEEM (ver. 7.81) default processing factors for these commodities were
reduced to 1. The DEEM (ver. 7.81) default processing factors were
retained for the remaining relevant commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that flutriafol 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.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for flutriafol. Tolerance-level residues and/or 100
PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flutriafol in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of flutriafol. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the First Index Reservoir Screening Tool (FIRST), and
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of flutriafol for acute exposures
are estimated to be 15.9 parts per billion (ppb) for surface water and
193 ppb for ground water.
For chronic exposures assessments the EDWC's are estimated to be
5.39 ppb for surface water and 165 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 193 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 165 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). Flutriafol is not
registered for any specific use patterns that would result in
residential exposure.
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.''
Flutriafol is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events. In conazoles, however, a variable pattern of
toxicological responses is found; some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects
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from substances found to have a common mechanism of toxicity, see EPA's
Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
Triazole-derived pesticides can form the metabolite 1,2,4-triazole
(T) and two triazole conjugates triazolylalanine (TA) and
triazolylacetic acid (TAA). To support existing tolerances and to
establish new tolerances for triazole-derivative pesticides, EPA
conducted an initial human-health risk assessment for exposure to T,
TA, and TAA resulting from the use of all current and pending uses of
any triazole-derived fungicide as of September 1, 2005. The risk
assessment was a highly conservative, screening-level evaluation in
terms of hazards associated with common metabolites (e.g., use of a
maximum combination of uncertainty factors) and potential dietary and
non-dietary exposures (i.e., high-end estimates of both dietary and
non-dietary exposures). In addition, the Agency retained the additional
10X Food Quality Protection Act (FQPA) safety factor (SF) for the
protection of infants and children. The assessment included evaluations
of risk for various subgroups, including those comprised of infants and
children. The Agency's complete risk assessment can be found in the
propiconazole reregistration docket at http://www.regulations.gov.
Docket ID Number EPA-HQ-OPP-2005-0497.
The most recent update to that aggregate human health risk
assessment for free traizoles and its conjugates was conducted on April
9, 2015. This assessment considered all proposed/registered triazole
derived pesticides uses with the resulting risk less than the Agency's
level of concern. An update to the aggregate human health risk
assessment for free triazoles and its conjugates may be found in this
current docket, docket ID number EPA-HQ-OPP-2015-0179-0014 entitled,
``Common Triazole Metabolites: Updated Aggregate Human Health Risk
Assessment to Address The New Section 3 Registrations for Use of
Propiconazole on Tea, Dill, Mustard Greens, Radish, and Watercress; Use
of Difenoconazole on Globe Artichoke, Ginseng and Greenhouse Grown
Cucumbers and Conversation of the Established Foliar Uses/Tolerances
for Stone Fruit and Tree Nut Crop Groups to Fruit, Stone, Group 12-12
and the Nut, Tree, Group 14-12.; and Use of Flutriafol on Hops.''
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 potential impact of in
utero and perinatal flutriafol exposure was investigated in three
developmental toxicity studies (two in rats, one in rabbits) and 2
multi-generation reproduction toxicity studies in rats. In the first of
two rat developmental toxicity studies, increased quantitative
susceptibility was observed with developmental effects (delayed
ossification or non-ossification of the skeleton in the fetuses) seen
at a lower dose than maternal effects. In the second rat developmental
study, a qualitative susceptibility was noted. Although developmental
toxicity occurred at the same dose level that elicited maternal
toxicity, the developmental effects (external, visceral, and skeletal
malformations; embryo lethality; skeletal variations; a generalized
delay in fetal development; and fewer live fetuses) were more severe
than the decreased food consumption and body-weight gains observed in
the dams. For rabbits, there was in increased qualitative fetal
susceptibly. Intrauterine deaths occurred at a dose level that also
caused adverse effects in maternal animals. In the 2-generation
reproduction studies, a qualitative susceptibility was also seen.
Effects in the offspring decreased litter size and percentage of live
births (increased pup mortality) and liver toxicity can be attributed
to the systemic toxicity of the parental animals (decreased body weight
and food consumption and liver toxicity).
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 flutriafol is complete.
ii. There is no indication that flutriafol is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity. Signs of neurotoxicity
were reported in the acute and subchronic neurotoxicity studies at the
highest dose only; however, these effects were primarily seen in
animals that were agonal (at the point of death) and, thus, are not
indicative of neurotoxicity. In addition, there was no evidence of
neurotoxicity in any additional short-term or long-term toxicity
studies in rats, mice, and dogs.
iii. There are no concerns or residual uncertainties for prenatal
and/or postnatal toxicity. Although there is evidence for increased
quantitative and qualitative susceptibility in the prenatal study in
rats and rabbits and the 2-generation reproduction study rats, there
are no concerns for the offspring toxicity observed in the
developmental and reproductive toxicity studies for the following
reasons: (1) clear NOAELs and LOAELs were established in the fetuses/
offspring for each of these studies; (2) the dose-response for these
effects are well-defined and characterized; (3) developmental endpoints
are used for assessing acute dietary risks to the most sensitive
population (females 13-49 years old) as well as all other short and
intermediate-term exposure scenarios; (4) the acute reference dose for
females 13-49 is 1,000 fold lower than the dose at which quantitative
susceptibility in the first developmental rat study was observed; and
(5) the chronic reference dose is greater than 300-fold lower than the
dose at which the offspring effects were observed in the 2-generation
reproduction studies.
iv. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to flutriafol in
drinking water. These assessments will not underestimate the exposure
and risks posed by flutriafol.
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.
[[Page 71951]]
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to flutriafol will occupy 39% of the aPAD for females 13-49 years, the
population group receiving the greatest % aPAD.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flutriafol from food and water will utilize 96% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for flutriafol.
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). Because there
is no short-term residential exposure, and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short-term risk), no
further assessment of short-term risk is necessary, and EPA relies on
the chronic dietary risk assessment for evaluating short-term risk for
flutriafol.
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 there is no intermediate-term residential exposure, and
chronic dietary exposure has already been assessed under the
appropriately protective cPAD (which is at least as protective as the
POD used to assess short-term risk), no further assessment of
intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
flutriafol.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, flutriafol 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 flutriafol residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology gas chromotography/nitrogen-
phosphorus detector (GC/NPD) for the proposed tolerances is available
to enforce the tolerances recommended herein 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:
[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 not established a MRL for flutriafol.
V. Conclusion
Therefore, tolerances are established for residues of flutriafol,
(()-[alpha]-(2-fluorophenyl)-[alpha]-(4-fluorophenyl)-1H-
1,2,4-triazole-1-ethanol), in or on hop, dried cones at 20 ppm.
Additionally, the tolerances for cotton, gin byproducts, and cotton,
undelinted seed established in 180.629(d) are being removed.
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 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
[[Page 71952]]
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: November 10, 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. 180.629:
0
a. Add alphabetically the commodity ``Hop, dried cones'' to the table
in paragraph (a).
0
b. Remove the commodities ``Cotton, gin byproducts,'' and ``Cotton,
undelinted seed'' from the table in paragraph (d).
The addition reads as follows:
Sec. 180.629 Flutriafol; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Hop, dried cones....................................... 20
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2015-29462 Filed 11-17-15; 8:45 am]
BILLING CODE 6560-50-P