[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15595]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Cyflufenamid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
cyflufenamid in or on multiple commodities which are identified and
discussed later in this document. Nippon Soda Co., Ltd., c/o Nisso
America, Inc. requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective June 27, 2012. Objections and
hearings must be received on or before August 27, 2012, 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-2009-0029; FRL-9352-5, is
available either electronically through http://www.regulations.gov or
in hard copy at the OPP Docket in the Environmental Protection Agency
Docket Center (EPA/DC), located in EPA West, 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: Samantha Hulkower, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 603-0683; email address:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
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 or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0029 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
August 27, 2012. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any 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 a copy of your non-CBI objection or
hearing request, identified by docket ID number EPA-HQ-OPP-2009-0029,
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), Mail Code: 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 April 8, 2009 (74 FR 15971) (FRL-8407-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8F7488) by Nippon Soda Co., Ltd., c/o Nisso America, Inc., 45 Broadway,
Suite 2120, New York, NY 10006. The petition requested that 40 CFR part
180 be amended by establishing tolerances for residues of the fungicide
cyflufenamid, in or on cucurbit vegetables (crop group 9) at 0.05 parts
per million (ppm); pome fruit (crop group 11), 0.05 ppm; apple, wet
pomace, at 0.10 ppm; small fruit vine climbing, except fuzzy kiwifruit
(subgroup 13-07F) at 0.15 ppm; grape, raisin, at 0.30 ppm, and low
growing berry (subgroup 13-07G), except cranberry, at 0.20 ppm. That
notice referenced a summary of the petition prepared by Nippon Soda
Co., Ltd., c/o Nisso America, Inc, the registrant, which is available
in the docket, at http://www.regulations.gov. There were no comments
received in response to the notice of filing
Based upon review of the data supporting the petition, EPA has
slightly increased the tolerances for pome fruit (Crop Group 11), 0.05
ppm to 0.06 ppm, and cucurbits (Crop Group 9), 0.05 to 0.07 ppm. The
reasons for these changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
Consistent with 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 cyflufenamid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with cyflufenamid 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. Cyflufenamid has low acute toxicity via the oral, dermal and
inhalation routes of exposure. Though slightly irritating to the eye,
cyflufenamid is not a skin irritant or sensitizer. In the mammalian
toxicology database, the liver was the primary target organ for
cyflufenamid toxicity. Across species, duration and gender, changes in
weight, clinical chemistry and pathology indicated treatment-related
perturbations in and adverse effects on liver function.
Thyroid effects due to treatment with cyflufenamid, seen only in
the rat, included increased follicular cell hypertrophy (as well as
increased organ weight) and neoplastic thyroid follicular adenomas.
Kidney effects related to treatment included increased kidney weight
accompanied by tubular vacuolation and slight decreases in sodium and
Treatment-related cardiotoxicity was noted in the rat and mouse
feeding studies. Observed myocardial vacuolation and lipidosis may be
attributed to decreased lipid metabolism; cyflufenamid caused an
approximately 50% inhibition of carnitine palmitoyltransferase in both
rat and mouse heart microsomal fractions in a non-guideline mechanistic
study. Carnitine palmitoyltransferase is involved in the transport of
long chain fatty acids into the mitochondrial matrix for oxidation.
Fatty acid oxidation is an important source of energy for ATP
production in the mitochondria.
Cyflufenamid-induced brain vacuolation was specific to the dog and
not associated with any apparent clinical sign of neurotoxicity.
Supplementary studies investigating this phenomenon determined that
vacuolation was due to myelin edema affecting the white matter of the
cerebrum and thalamus. Furthermore, this brain lesion was partially
reversed after a 13-week recovery period (following 90-day exposure)
and fully reversed after a 26-week recovery period. This effect was not
observed in any other species. A subchronic neurotoxicity study in rats
showed no evidence of neurotoxicity.
Effects on reproductive organs and/or parameters were noted in
several subchronic studies at doses greater than the respective Lowest
Observed Adverse Effect Level (LOAELs). Decreased uterus and cervix
weights, adrenal cortical hypertrophy and reduced quality and quantity
of spermatozoa were observed in dogs. Leydig cell hypertrophy was
observed in rats and mice. It is unclear what toxicological
significance should be ascribed to these findings since they may be
secondary to systemic toxicity or hepatic enzyme induction. Mating
performance and fertility in the P/F0 generation were both
unaffected by treatment with cyflufenamid in the 2-generation
reproductive toxicity study in rats. Sex ratio, sexual maturation,
estrous cyclicity, sperm quantity and quality, mating performance and
fertility, gestation and viability indices in the F1
generation were all unaffected by treatment.
Cyflufenamid is classified as ``likely to be carcinogenic to
humans.'' This was based on the presence of two tumor types in two
species: Thyroid follicular cell tumors in male rats and liver tumors
in male mice. There is no concern for mutagenicity or clastogenicity.
The unit risk, Q1*, of cyflufenamid based upon male mouse
liver combined adenoma and carcinoma tumor rates is 6.61 x
10-3 (mg/kg/day)-1 in human equivalents.
Specific information on the studies received and the nature of the
adverse effects caused by cyflufenamid 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 Risk Assessment,''
docket ID number EPA-HQ-OPP-2009-0029.
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 cyflufenamid used for
human risk assessment is shown in Table 1 below. No hazards were
identified for acute dietary across all populations. For dermal short
and intermediate term exposures no adverse effects were observed in the
dermal toxicity study and there are no concerns for developmental or
neurological toxicities, therefore no hazards are expected for these
Table 1--Summary of Toxicological Doses and Endpoints for Cyflufenamid for Use in Human Health Risk Assessment
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
Chronic dietary (All populations) NOAEL= 4.4 mg/kg/day cRfD = 0.044 mg/kg/ Combined Chronic Toxicity/
UFA = 10x........... day. Carcinogenicity Study in Rats
UFH = 10x........... cPAD = 0.044 mg/kg/ LOAEL = 22 mg/kg/day based on
FQPA SF = 1x........ day.. decreased body weight gain;
weight, increased liver weight
and centrilobular hepatocytic
Incidental oral short-term (1 to NOAEL= 5 mg/kg/day.. LOC for MOE = 100.. Prenatal Developmental Study in
30 days) and intermediate-term UFA = 10x........... Rabbits Maternal
(1 to 6 months). UFH = 10x........... LOAEL = 10 mg/kg/day based on
FQPA SF = 1x........ decreased body weight, body
weight gain and food consumption.
Inhalation short-term (1 to 30 NOAEL= 5 mg/kg/day.. LOC for MOE = 100.. Prenatal Developmental Study in
days) and intermediate-term (1 UFA = 10x........... Rabbits Maternal
to 6 months). UFH = 10x........... LOAEL = 10 mg/kg/day based on
FQPA SF = 1x........ decreased body weight, body
weight gain and food consumption.
Cancer (Oral, dermal, inhalation) Likely to be carcinogenic to humans. Quantification of cancer risk was
recommended. The Q1* value is 6.61 x 10-3 (mg/kg/day)-1.
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 (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).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyflufenamid, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from cyflufenamid 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. No such effects were
identified in the toxicological studies for cyflufenamid; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey
of Food Intake by Individuals (CSFII). As to residue levels in food,
this dietary assessment was based on average field trial residues for
all proposed crops and 100% crop treated (CT). Empirical processing
factors were used for apple juice and grape juice. A separate tolerance
was set for grape, raisin; therefore, the processing factor for this
commodity was set at 1. For all other processed commodities, Dietary
Exposure Evaluation Model (DEEM) version 7.81 default processing
factors were assumed.
iii. Cancer. Cancer risk was assessed using the same exposure
estimates as discussed in Unit III.C.1.ii., chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use PCT information in the dietary assessment for
cyflufenamid. One-hundred PCT were assumed for all food commodities.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for cyflufenamid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of cyflufenamid. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
cyflufenamid for acute exposures are estimated to be 1.14 parts per
billion (ppb) for surface water and 4.68 ppb for ground water. Chronic
exposures for non-cancer assessments are estimated to be 0.03 ppb for
surface water and 4.68 ppb for ground water. Chronic exposures for
cancer assessments are estimated to be 0.01 ppb for surface water and
4.68 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
For acute dietary risk assessment, no toxic effects attributable to
a single exposure to cyflufenamid have been identified; therefore, an
acute reference dose (aRfD) has not been established and an acute
dietary exposure assessment was not conducted.
For chronic and cancer dietary risk assessments, the ground water
concentration value of 4.68 ppb was used to assess the contribution to
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).
Cyflufenamid is proposed to be registered for the following uses
that could result in residential exposures: Mixing, loading, and
applying a soluble concentrate formulation of cyflufenamid for
treatment of ornamental plantings and trees. EPA assessed residential
exposure using the following assumptions: Based on the use patterns,
residential handlers could be exposed to cyflufenamid on a short-term
basis. A short-term dermal endpoint was not identified; therefore, only
short-term non-cancer inhalation risks and cancer risks for residential
handlers were assessed.
When determining the potential for residential post-application
exposure, the Agency considers foliar residues, leaf to skin/hand
residue transfer, children's hand-to-mouth residue transfer, and
exposure time. In the case of cyflufenamid, potential exposure to
adults and children would be negligible for the following reasons:
Activities such as pruning/thinning ornamentals or playing
in and around ornamentals when residues may be present on the day of
the application are unlikely to co-occur;
If present, leaf to skin residue transfer would be
negligible because of the minimal frequency and duration of contact;
Children young enough to exhibit hand-to-mouth behavior
would not typically play in ornamental beds or trees.
Based on the frequency of application and unlikely potential for post-
application exposure, residential post-application risks were not
quantitatively assessed; thus, there are no postapplication residential
risk concerns for this use pattern.
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
cyflufenamid to share a common mechanism of toxicity with any other
substances, and cyflufenamid does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that cyflufenamid 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
2. Prenatal and postnatal sensitivity. There is no evidence of
susceptibility following in utero and/or postnatal exposure in the
developmental toxicity studies in rats or rabbits, and in the 2-
generation rat reproduction study. There are no residual uncertainties
concerning pre- and postnatal toxicity and no neurotoxicity concerns.
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
i. The toxicity database for cyflufenamid is complete, with the
exception of an acute neurotoxicity study (ACN, OPPTS 870.6200a). The
absence of this study does not raise any uncertainties with regard to
the safety of infants and children for the following reasons. First, no
acute affects have been attributed to cyflufenamid. In an acute oral
toxicity study, adverse effects were noted on the day of administration
(limit dose) but not thereafter; clinical signs of piloerection,
hunched posture, unsteady gait, pallid extremities, increased
salivation, ungroomed appearance and abnormal respiration were observed
in the majority of animals receiving 5,000 mg/kg and generally resolved
by Day 2 of the study. Second, an acceptable, guideline subchronic
neurotoxicity study is available and in it repeat exposure to doses up
to approximately 500 mg/kg/day did not elicit any neurotoxic effects as
assessed in the functional observational battery, motor activity,
neurohistopathology or brain morphometrics. Third, cyflufenamid is not
an apparently neurotoxic chemical based on clinical toxicity
assessments incorporated within the developmental and chronic rat
studies. In several short-term studies in rats (subacute and subchronic
feeding, plaque-forming cell assay, one-generation pilot, developmental
toxicity), no neurobehavioral signs were observed at the highest doses
tested. While the relevant and reversible effect of brain vacuolation
was observed in the subchronic dog study at approximately 70 mg/kg/day,
it is observed in the absence of overt neurotoxicity and nowhere else
in the toxicology database. Finally, based on this information, an
acute neurotoxicity screening test is very unlikely to yield a point of
departure less than the chronic NOAEL of 4.4 mg/kg/day if any adverse
effects are observed at all. Even if the chronic point of departure was
used in assessing acute risk, there would be no risk concern based on
acute dietary exposure.
ii. There is no indication that cyflufenamid is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that cyflufenamid results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary assessment assumed 100% crop treated for
all commodities and utilized average field trial residues for all
proposed crops, default and empirical processing factors. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to cyflufenamid in drinking water. EPA
used similarly conservative assumptions to assess postapplication
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
cyflufenamid is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyflufenamid from food and water will utilize 1% of the cPAD for all
infants (<1 year old) the population group receiving the greatest
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 no
short-term adverse effect was identified, cyflufenamid is not expected
to pose a short-term risk.
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,
cyflufenamid is not expected to pose a intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Aggregate cancer
exposure takes into account residential handler exposure, plus chronic
exposure to food and water (considered to be a background exposure
level). The aggregate cancer risk (food, water, and residential) is 9.7
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 cyflufenamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate multiresidue methods test data for cyflufenamid were
submitted. Acceptable recoveries of cyflufenamid from a non-fatty
matrix (grape) were achieved under Protocol E. Acceptable recoveries
from a fatty matrix (milk) were also achieved under Protocol F. EPA
recommends that Food and Drug Administration (FDA) multiresidue methods
be used as the primary enforcement method. The submitted data will be
forwarded to the FDA for further evaluation.
Adequate enforcement methodologies are available to enforce the
tolerance expression. The LC/MS/MS method (Method 070276) was submitted
for the determination of cyflufenamid residues in/on pome fruit,
cucurbit vegetables, grapes, and strawberries. The proposed enforcement
method (Method 070276) which monitors only one transition ion, in
combination with the FDA multiresidue method meets the OPPTS Residue
Chemistry Test Guidelines for acceptable tolerance enforcement methods
(SOP Number ACB-019). An enforcement method for livestock commodities
is not needed because tolerances for cyflufenamid residues of concern
in meat, milk, poultry, and eggs are not required to support the
proposed uses based on the results of the goat metabolism study and the
calculated dietary burden.
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:
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 cyflufenamid. Cyflufenamid is not registered in
C. Revisions to Petitioned-For Tolerances
The EPA increased the proposed tolerance for pome fruit crop group
11 from 0.05 ppm to 0.06 ppm and for cucurbit crop group 9 from 0.05
ppm to 0.07 ppm. These changes were made by EPA based on North American
Free Trade Agreement (NAFTA) tolerance calculation procedures according
to the Standard Operating Procedure (SOP) Guidance for Setting
Pesticide Tolerances Based on Field Trial Data.
Therefore, tolerances are established for residues of cyflufenamid,
in or on Apple, wet pomace, 0.10 ppm; Berry, low growing, subgroup 13-
07G, except cranberry, 0.20 ppm; Fruit, pome, group 11, 0.06 ppm;
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F,
0.15 ppm; Grape, raisin, 0.30 ppm; Vegetable, cucurbit, group 9, 0.07
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
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) (Pub. L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: June 15, 2012.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.667 is added to subpart C to read as follows:
Sec. 180.667 Cyflufenamid, tolerance for residues.
(a) General. Tolerances are established for residues of the
fungicide cyflufenamid, including its metabolites and degradates, in or
on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only
cyflufenamid, [N(Z)]-N-[[(cyclopropylmethoxy)amino][2,3- difluoro-6-
Apple, wet pomace........................................... 0.10
Berry, low growing, subgroup 13-07G, except cranberry....... 0.20
Fruit, pome, group 11....................................... 0.06
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 0.15
Grape, raisin............................................... 0.30
Vegetable, cucurbit, group 9................................ 0.07
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2012-15595 Filed 6-26-12; 8:45 am]
BILLING CODE 6560-50-P