[Federal Register Volume 77, Number 220 (Wednesday, November 14, 2012)]
[Rules and Regulations]
[Pages 67771-67777]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27702]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0985; FRL-9368-7]
Flonicamid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
flonicamid in or on Berry, low growing, subgroup 13-07G; Rapeseed
subgroup 20A, and cucumber. Interregional Research Project Number 4
(IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective November 14, 2012. Objections and
requests for hearings must be received on or before January 14, 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-2011-0985, is available at http://www.regulations.gov or at the Office of Pesticide Programs
[[Page 67772]]
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: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7610; email address: jackson.sidney@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 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-2011-0985 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 14, 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-2011-0985, 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 Wednesday, 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 1E7842) by IR-4, IR-4 Project Headquarters, 500 College
Road East, Suite 201 W, Princeton, NJ 08540. The petition requested
that 40 CFR 180.613 be amended by establishing tolerances for combined
residues of the insecticide, flonicamid, N-(cyanomethyl)-4-
(trifluoromethyl)-3-pyridinecarboxamide and its metabolites TFNA, 4-
trifluoromethylnicotinic acid, TFNA-AM, 4-trifluoromethylnicotinamide,
TFNG, N-(4-trifluoromethylnicotinoyl)glycine, in or on cucumber at 1.3
parts per million (ppm), Berry, low growing subgroup 13-07G at 1.4 and
Rapeseed subgroup 20A at 1.5 ppm. That document referenced a summary of
the petition prepared by ISK Biosciences, 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 petition and/or
current Agency policies, EPA has revised/modified the petitioned-for
flonicamid residue tolerance level in certain commodities and revised
the tolerance expression for flonicamid residues. EPA is also revising
the existing crop group tolerance on ``Vegetable, cucurbit, group 9''
to exclude cucumbers. 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 flonicamid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with flonicamid follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also
[[Page 67773]]
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
Flonicamid has low acute toxicity via the oral, inhalation and
dermal routes of exposure. Flonicamid is nonirritating to the eye and
skin and is not a dermal sensitizer. Its metabolites, TFNA, TFNA-AM,
TFNG, TFNG-AM, and TFNA-OH, also demonstrated low toxicity in acute
oral toxicity studies. In the 28-day dermal study with flonicamid
technical no dermal or systemic toxicity was seen at the limit dose. In
oral studies using rats and dogs, the kidney and liver are the target
organs for flonicamid toxicity. Increased kidney weight and hyaline
droplet deposition were observed as well as liver centrilobular
hypertrophy in the rat 28-day oral range-finding, 90-day oral,
developmental, and reproductive studies. The 90-day dog study showed
kidney tubular vacuolation as well as increased adrenal weights,
increased reticulocytes and decreased thymus weights. Increased
reticulocyte count was noted in both the subchronic and chronic dog
studies.
In rats, developmental effects including increased incidence of
cervical ribs were observed at maternally toxic (liver and kidney gross
and histopathological effects) dose levels. In rabbits, developmental
effects were not observed at any dose level including maternally toxic
doses. Offspring effects (decreased body weight and delayed sexual
maturation) in the multi-generation study were seen only in the
presence of parental toxicity (kidney effects in males, blood effects
in females). Thus, there is no evidence that flonicamid results in
increased susceptibility (qualitative or quantitative) in in utero rats
or rabbits in the prenatal developmental studies or in young rats in
the 2-generation reproduction study.
There are no concerns for flonicamid neurotoxicity. Although
clinical signs suggesting potential neurotoxic effects (e.g., decreased
motor activity, tremors) were seen in the acute and subchronic
neurotoxicity studies; other effects in these studies (e.g., increased
mortality, and significant decreases in food consumption and body
weight) indicated that the clinical signs were a result of the animals
being in an extreme condition or otherwise compromised and in a state
of general malaise. Also, these types of effects were not observed in
the other subchronic or chronic studies in mice, rats or dogs. Thus,
there is not clear evidence of neurotoxicity. Lastly, clear no-
observed-adverse-effect-levels (NOAELs) and lowest-observed-adverse-
effect-levels (LOAELs) were defined for the clinical signs, which are
above the levels currently used for risk assessment purposes.
Preliminary results of a 28-day oral (dietary) immunotoxicity study of
technical flonicamid in female CD-1 mice suggest that flonicamid is not
an immuno-suppressant, either structurally or functionally up to and
including dose levels exceeding the Limit Dose.
Although there is some limited evidence suggesting that flonicamid
has a potential for carcinogenic effects, EPA determined that
quantification of risk using a non-linear approach (i.e., using a
chronic reference dose (cRfD)) adequately accounts for all chronic
toxicity, including carcinogenicity that could result from exposure to
flonicamid. The following considerations support that determination.
First, mutagenicity studies were negative for the parent chemical,
flonicamid, and its metabolites, TFNA, TFNA-AM, TFNG, TFNG-AM, and
TFNA-OH. Second, although flonicamid is carcinogenic in CD-1 mice,
based on increased incidences of lung tumors associated with Clara cell
activation, this tumor type is associated with species and strain
sensitivity and is not directly correlated with cancer risks in humans.
Third, nasal cavity tumors seen in male Wistar rats were linked to
incisor inflammation and not considered to be treatment related. These
tumor findings were confounded by the lack of a dose-response and the
biological significance is questionable.
Specific information on the studies received and the nature of the
adverse effects caused by flonicamid as well as the NOAEL and the LOAEL
from the toxicity studies can be found at http://www.regulations.gov in
document, ``Flonicamid: Human Health Risk Assessment for the Proposed
Use on Low Growing Berry, Rapeseed, and Greenhouse Grown Cucumbers'' at
page 29 in docket ID number EPA-HQ-OPP-2011-0985.
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 flonicamid used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Flonicamid for Use in Human Health Risk Assessment
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POD and uncertainty/ RfD, PAD, LOC for
Exposure/scenario safety factors risk assessment Study and toxicological effects
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Acute dietary (General population None/NA............. None/NA............ No toxicological effects seen in a
including infants and children). single dose study.
Chronic dietary (All populations) NOAEL= 3.7 mg/kg/day cRfD = 0.04 mg/kg/ 2-Generation reproduction rat
UFA = 10x........... day. study.
UFH = 10x........... cPAD = 0.04 mg/kg/ Parental LOAEL = 22 mg/kg/day
FQPA SF = 1x........ day. based on increased kidney
weights, kidney hyaline
deposition, increased blood serum
LH (F1 females).
[[Page 67774]]
Cancer........................... A nonlinear 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. POD = Point of Departure. 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).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flonicamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing flonicamid tolerances in 40 CFR
180.613. EPA assessed dietary exposures from flonicamid 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 flonicamid; 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 U.S. Department
of Agriculture (USDA) 1994-1996 and 1998 Continuing Service of Food
Intake by Individuals (CSFII). As to residue levels in food, EPA used
an unrefined chronic dietary assessment conducted assuming 100 percent
crop treated (PCT) estimates, tolerance-level residues for all
commodities, and empirical or Dietary Exposure Evaluation Model-Food
Commodity Intake Database (DEEM-FCIDTM) default processing
factors.
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 nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear 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
determine 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 flonicamid. Cancer risk was assessed using
the same exposure estimates as discussed in Unit III.C.1.ii., chronic
exposure.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for flonicamid. Tolerance-level residues and 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 flonicamid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of flonicamid. 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.
The drinking water assessment was conducted using a parent only and
total toxic residues of flonicamid (flonicamid TTR) approach. Total
toxic residues include TFNA, TFNA-AM, TFNA-OH, TFNG, and TFNG-AM.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) Screening Concentration in Ground Water (SCI-GROW)
models, the estimated drinking water concentrations (EDWCs) of total
toxic residues of flonicamid for chronic exposures for non-cancer
assessments are estimated to be 1.9 parts per billion (ppb) for surface
water and 0.00132 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 1.9 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). Flonicamid is
currently registered for the following uses that could result in non-
occupational exposures: Commercial ornamentals, interiorscapes, and
nurseries. However, these product labels do not allow use in home
gardens and greenhouses or in any residential settings. Therefore,
residential handler scenarios are not expected and need not be
assessed. Additionally, because no dermal toxicity endpoint was
identified for flonicamid, a post-application residential exposure/risk
assessment is not necessary. Post-application inhalation exposures are
expected to be negligible. Therefore, no residential exposure is
expected.
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 flonicamid to share a common mechanism of
toxicity with any other substances, and flonicamid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flonicamid 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
[[Page 67775]]
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
toxicity database for flonicamid includes prenatal developmental
toxicity studies in rats and rabbits and a multi-generation
reproduction toxicity study in rats. There is no evidence that
flonicamid results in increased susceptibility (qualitative or
quantitative) in in utero rats or rabbits in the prenatal developmental
studies or in young rats in the multi-generation reproduction study. No
developmental effects were seen in rabbits. In the multi-generation
reproduction study, developmental delays in the offspring (decreased
body weights, delayed sexual maturation) were seen only in the presence
of parental toxicity (kidney and blood effects). Also, there are clear
NOAELs and LOAELs for all effects. The degree of concern for prenatal
and/or post-natal susceptibility is, therefore, low due to the lack of
evidence of qualitative and quantitative susceptibility.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for chronic dietary and other exposures,
except as noted below. That decision is based on the following
findings:
i. The toxicity database for flonicamid is complete except for an
immunotoxicity study and a subchronic inhalation study. Existing data
are sufficient for endpoint selection for exposure/risk assessment
scenarios, and for evaluation of the requirements under the FQPA.
Except for decreased thymus weights in the subchronic dog study, there
are no other indications in the available studies that organs
associated with immune function are affected by flonicamid, and
preliminary results of the above-mentioned immunotoxicity study
suggested that flonicamid is not an immunosuppressant. EPA does not
believe that the final results of the immunotoxicity study will result
in a dose less than the point of departure already used in this risk
assessment and an additional database uncertainty factor for potential
immunotoxicity does not need to be applied.
A subchronic 28-day inhalation study is required and is outstanding
at this time. In the absence of a route specific inhalation study, EPA
has retained a 10X FQPA SF to assess risks for inhalation exposure
scenarios. However, residential inhalation exposures are not expected.
ii. The available data base includes acute and subchronic
neurotoxicity studies. As discussed in Unit III.A., EPA has concluded
that the clinical signs observed in those studies were not the result
of a neurotoxic mechanism and that therefore a developmental
neurotoxicity study is not required.
iii. There was no evidence for quantitative or qualitative
susceptibility following oral exposures to rats in utero or oral
exposure to rabbits in utero.
iv. There are no residual uncertainties identified in the exposure
databases. An unrefined conservative chronic dietary exposure
assessment for food and drinking water was conducted, assuming
tolerance level residues for all existing and proposed commodities and
100 PCT of registered and proposed crops treated. The drinking water
assessment utilized water concentration values generated by models and
associated modeling parameters which are designed to produce
conservative, health protective, high-end estimates of water
concentrations which are not likely to be exceeded. The dietary (food
and drinking water) exposure assessment does not underestimate the
potential exposure for infants, children, or women of child bearing
age.
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. An endpoint attributable to a single oral dose was not
identified in the toxicity database; therefore, flonicamid 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
flonicamid from food and water will utilize 11% of the cPAD for the
general U.S. population and 28% of the cPAD for children 1 to 2 years
old, the population group receiving the greatest exposure. There are no
expected long-term residential exposures. Because drinking water
estimates have been combined with dietary exposures, the dietary
assessment discussed in Unit III.C.3., serves as the aggregate exposure
and risk assessment for flonicamid.
3. Short-term and Intermediate-term risk. Short- and intermediate-
term aggregate exposures take into account short- and intermediate-term
residential exposures plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term aggregate risk assessments were not conducted because
residential exposure is not expected from the use pattern proposed in
this registration request, or from any registered uses.
4. 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.
5. 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 flonicamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methods are available to enforce the
tolerances for flonicamid and the major metabolites in plants and
livestock. The proposed method for plants uses Liquid Chromatography
with Tandem Mass Spectrometry (LC/MS/MS) (FMC No. P-3561M) to determine
the residues of flonicamid and its major metabolites, TFNA-AM, TFNA,
and TFNG.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever
[[Page 67776]]
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.
There are no Codex MRLs established on the proposed crops.
C. Revisions to Petitioned-For Tolerances
Based on results from the Organization for Economic Cooperation and
Development (OECD) spreadsheet tolerance calculation procedures, EPA
modified certain IR-4 proposed tolerances for flonicamid residues. EPA
increased the proposed tolerance from 1.4 to 1.5 ppm for Berry, low
growing, subgroup 13-07G and from 1.3 to 1.5 ppm for cucumber. Because
there is an existing crop group tolerance for ``Vegetable, cucurbit,
group 9'' that applies to cucumbers, EPA, for the sake of clarity, is
revising that existing crop group tolerance to exclude cucumbers.
Finally, EPA has revised the tolerance expression to clarify (1)
that, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of flonicamid not specifically mentioned;
and (2) that compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.
V. Conclusion
Therefore, tolerances are established for the residues of
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide,
and its metabolites TFNA (4- trifluoromethylnicotinic acid, TFNA-AM (4-
trifluoromethylnicotinamide) and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, in or on cucumber at 1.5 ppm; Berry,
low growing, subgroup 13-07G at 1.5 ppm; and Rapeseed subgroup 20A at
1.5 ppm. Additionally, the tolerance entry for Vegetable, cucurbit
group 9, is revised to exclude cucumber.
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 tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of 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: November 1, 2012.
Lois Rossi,
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. Amend Sec. 180.613 as follows:
0
i. Revise the introductory text of paragraph (a)(1).
0
ii. Remove the entry ``Vegetable, cucurbit, group 9'' from the table in
paragraph (a)(1), and add alphabetically four new entries.
0
iii. Revise the introductory text of paragraph (a)(2).
The added and revised text read as follows:
Sec. 180.613 Flonicamid; tolerances for residues.
(a) * * * (1) Tolerances are established for the residues of the
insecticide flonicamid, including its metabolites and degradates, in or
on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only the sum of
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide,
and its metabolites, TFNA (4-trifluoromethylnicotinic acid), TFNA-AM
(4-trifluoromethylnicotinamide),
[[Page 67777]]
and TFNG, N-(4-trifluoromethylnicotinoyl)glycine, calculated as the
stoichiometric equivalent of flonicamid, in or on the following
commodities.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Berry, low growing, subgroup 13-07G..................... 1.5
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Cucumber................................................ 1.5
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Rapeseed subgroup 20A................................... 1.5
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Vegetable, cucurbit, group 9, except cucumber........... 0.4
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
(2) Tolerances are established for the residues of the insecticide
flonicamid, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide,
and its metabolites, TFNA (4-trifluoromethylnicotinic acid), and TFNA-
AM (4-trifluoromethylnicotinamide), calculated as the Stoichiometric
equivalent of flonicamid, in or on the following commodities.
* * * * *
[FR Doc. 2012-27702 Filed 11-13-12; 8:45 am]
BILLING CODE 6560-50-P