Document ID: EPA-HQ-OPP-2016-0013-0008
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances:Flonicamid
Posted Date: 2017-05-11T04:00Z

[Federal Register Volume 82, Number 90 (Thursday, May 11, 2017)]
[Rules and Regulations]
[Pages 21941-21946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09592]

[[Page 21941]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0013; FRL-9959-91]

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 multiple commodities which are identified and 
discussed later in this document. In addition, this regulation revokes 
the established tolerance for vegetable, fruiting, group 8-10 that is 
superseded by this action. Interregional Research Project Number 4 (IR-
4) and ISK Biosciences Corporation requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 11, 2017. Objections and 
requests for hearings must be received on or before July 10, 2017, 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-2016-0013, 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: Michael L. Goodis, Director, 
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: RDFRNotices@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://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-2016-0013 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 
July 10, 2017. 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-2016-0013, 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.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 19, 2016 (81 FR 31581) (FRL-9946-
02); August 12, 2016 (81 FR 53379) (FRL-9949-53) and December 9, 2016 
(81 FR 89036) (FRL-9953-69), EPA issued documents pursuant to FFDCA 
section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of 
pesticide petitions (PPs) by IR-4 (PP 5E8428); and ISK Biosciences (PP 
5F8416 and 6F8443), respectively. These petitions request that 40 CFR 
180.613 be amended by establishing tolerances for residues of the 
insecticide flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-
pyridinecarboxamide, and its metabolites, TFNA (4-
trifluoromethylinicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric 
equivalent of flonicamid, in or on several commodities as follows. 
Pesticide petition 5E8428 submitted by IR-4 Project Headquarters, 
Rutgers, The State University of New Jersey, 500 College Road East, 
Suite 201 W., Princeton, NJ 08540 requests to increase the existing 
tolerance on Vegetables, fruiting, group 8-10 from 0.4 ppm to 1.50 ppm. 
Pesticide petitions 5F8416 and 6F8443 submitted by ISK Biosciences 
Corporation, 7470 Auburn Rd., Suite A, Concord, OH 44077 request 
tolerances on tea at 40 ppm and fruit, citrus group 10-10 at 1.5 ppm, 
respectively. All supporting documents for this final rule, which 
bundles the three above-referenced petitions for purposes of this final 
rule, are found in docket ID EPA-HQ-OPP-2016-0013.
    Summaries of the petitions prepared by IR4 and the registrant, ISK 
Biosciences Corporation, are available in the following dockets at 
http://www.regulations.gov: PP 5E8428 in

[[Page 21942]]

Docket: EPA-HQ-OPP-2016-0013; PP 5F8416 in Docket: EPA-HQ-OPP-2011-
0985; and PP 6F8443 in EPA-HQ-OPP-2015-0561. Comments were received on 
the notices of filings. EPA's responses to the comments are discussed 
in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance level for certain crops and corrected commodity 
definitions to be consistent with current EPA policies. The reasons for 
these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 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 database 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.
    Flonicamid and its metabolites of concern, TFNA, TFNA-AM, TFNG, 
TFNG-AM, and TFNA-OH, demonstrated low toxicity in acute oral toxicity 
studies. Fonicamid showed no systemic toxicity in a 28-day dermal study 
at the limit dose.
    Feeding studies in rats and dogs show the kidney and liver are the 
target organs for flonicamid toxicity. In repeat-dose subchronic and 
chronic oral toxicity studies, the consistently observed adverse effect 
in rats and mice were kidney toxicity (i.e., hyaline deposition and 
nephritis); in dogs, vomiting and increased percentage of reticulocytes 
(an indicator for potential anemia).
    There is no evidence that flonicamid results in increased 
susceptibility (qualitative or quantitative) in utero in rats or 
rabbits in the prenatal developmental studies or in young rats in the 
2-generation reproduction study. In the rat prenatal developmental 
toxicity study, maternal toxicity consisted of kidney toxicity (i.e., 
nephritis) in the absence of developmental toxicity at the highest-dose 
tested (HDT); in the rabbit, maternal toxicity consisted of decreased 
food consumption in the absence of developmental toxicity at the HDT. 
In the rat reproduction and fertility effects study, parental toxicity 
(i.e., kidney hyaline deposition and luteinizing hormone level 
increases) occurred at doses much lower than doses causing offspring 
effects (i.e., decreased body weight and delayed sexual maturation).
    There are no concerns for flonicamid neurotoxicity. In the acute 
neurotoxicity study in rats, signs of toxicity such as decreased motor 
activity, tremors, impaired gait, and impaired respiration were 
observed at lethal dose levels (1000 mg/kg). In the subchronic 
neurotoxicity study, decreased body weight, food consumption, foot 
splay, and motor activity were observed in males at doses greater than 
67 mg/kg/day, and in females at 722 mg/kg/day. In the immunotoxicity 
study in mice, there were no indications of increased immunotoxic 
potential in the T-cell dependent antibody response (TDAR) assay at the 
limit dose.
    Mutagenicity studies were negative for flonicamid and its 
metabolites of concern. Treatment-related lung tumors were observed in 
CD-1 mice. This tumor type, however, is associated with species and 
strain sensitivity and is not directly correlated with cancer risks in 
humans. Nasal cavity tumors in male Wistar rats were linked to incisor 
inflammation. Nasolacrimal duct tumor findings for females were 
confounded by the lack of a dose-response, and the biological 
significance of these tumors is questionable. The determination of 
carcinogenicity potential for flonicamid was based on the weight of the 
evidence approach and resulted in the classification of ``suggestive 
evidence of carcinogenicity, but not sufficient to assess human 
carcinogenic potential.'' The Agency 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.
    Specific information on the studies received and the nature of the 
adverse effects caused by flonicamid 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 ``Subject: Flonicamid. Human Health 
Risk Assessment for New Uses on Legume Vegetables, Subgroups 6A, 6B, 
and 6C; Add Directions for use on Greenhouse Grown Peppers and Increase 
the Tolerance for Residues on Fruiting Vegetables, Group 8-10; New Use 
on Citrus Fruits, Group 10-10; and a Tolerance without U.S. 
Registration for residues in/on Dried Tea'' at page 28 in docket ID 
number EPA-HQ-OPP-2016-0013.

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://

[[Page 21943]]

www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-
human-health-risk-pesticides.
    A summary of the toxicological endpoints for flonicamid used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of November 14, 2012 (77 FR 67771) 
(FRL-9368-7).

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 Dietary Exposure Evaluation Model--Food 
Commodity Intake Database (DEEM-FCIDTM), Version 3.16, which 
incorporates 2003-2008 food consumption information from the U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). 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-
FCID\TM\) default processing factors. The processing factor was set to 
1.0 for potato granules/flakes, tomato paste and tomato puree; for all 
other processed commodities DEEM default processing factors were used.
    iii. Cancer. 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 percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for flonicamid. Tolerance level residues and/or 100% 
CT 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    The drinking water assessment was conducted using both a parent 
only exposure, and a total toxic residue approach, which considers the 
parent compound and its major degradates of concern. Total toxic 
residues include 4-trifluoromethylnicotinic acid (TFNA), 4-
trifluoromethylnictinamide (TFNA-AM), 6-hydro-4-
trifluoromethylnicotinic acid (TFNA-OH), N-(4-
trifluoromethylnicotinoyl)glycine (TFNG), and N-(4-
trifluoromethylnicotinoyl)glycinamide (TFNG-AM).
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW), the 
estimated drinking water concentrations (EDWCs) of flonicamid for 
chronic exposures for non-cancer assessments are estimated to be 0.94 
parts per billion (ppb) for surface water and 9.92 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 value of 9.92 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 not 
registered for any specific use patterns that would result in 
residential exposure.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicity database for flonicamid includes prenatal developmental 
toxicity studies in rats and rabbits and a multigeneration reproduction 
toxicity study in rats. There is no evidence that flonicamid results in 
increased susceptibility (qualitative or quantitative) in utero in 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.

[[Page 21944]]

    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, except where assessing risks from 
inhalation exposure as discussed below. Those decisions are based on 
the following findings:
    i. The toxicity database for flonicamid is essentially complete, 
except for an outstanding subchronic 28-day inhalation study. In the 
absence of a subchronic inhalation study, EPA has retained a 10X FQPA 
SF to assess risks from inhalation exposure, although at present, 
residential inhalation exposure is not expected from existing or 
pending uses of flonicamid.
    ii. There is no evidence that flonicamid is a neurotoxic chemical. 
As discussed in Unit III.A., EPA has concluded that the clinical signs 
observed from available acute and subchronic neurotoxicity studies were 
not the result of a neurotoxic mechanism. Therefore, there is no need 
for a developmental neurotoxicity study or additional UFs to account 
for neurotoxicity.
    iii. There is no evidence that flonicamid results in increased 
susceptibility in utero in rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The chronic dietary food exposure assessment was based on 
100 PCT, tolerance-level residues and where applicable, default 
processing factors. EPA made conservative (protective) assumptions in 
the ground and surface water modeling used to assess exposure to 
flonicamid in drinking water. These assessments will not underestimate 
the exposure and risks posed by flonicamid.

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, 
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 59% of the cPAD for 
children 1-2 years old the population group receiving the greatest 
exposure. There are no residential uses for flonicamid.
    3. Short- and intermediate-term risks. 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). Flonicamid is not 
registered for any use patterns that would result in short- and 
intermediate-term residential exposures.
    4. Aggregate cancer risk for U.S. population. Based on the 
information referenced in Unit III.A., EPA has concluded that the cPAD 
is protective of possible cancer effects from flonicamid, and as 
evidenced in Unit III.E.2, aggregate exposure to flonicamid is below 
the cPAD.
    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 methodology (FMC Method No. P-3561M, a liquid 
chromatography with tandem mass spectrometry (LC/MS/MS) method) is 
available to enforce the tolerance expression for flonicamid and its 
metabolites in or on plant commodities.
    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 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 MRLs for flonicamid.

C. Response to Comments

    1. Anonymous comments: One comment each on petitions, 5E8428 and 
5F8416, was received. Both comments claim that flonicamid is a ``toxic 
pesticide'' and residues at any level in food commodities including tea 
(leaves) should not be allowed and requested that EPA deny setting 
tolerances for the petition-for new uses of flonicamid. One comment 
stated that the proposed flonicamid use would add to about 25,000 toxic 
chemicals currently in the environment and combine to create even more 
toxic chemical residues in food and drinking water further increasing 
harmful effects to humans and environment.
    Agency response: The Agency understands the commenters' concerns 
and recognizes that some individuals believe that pesticides should be 
banned completely. However, under the existing legal framework provided 
by FFDCA section 408, EPA is authorized to establish pesticide 
tolerances or exemptions where persons seeking such tolerances or 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by that statute.
    When new or amended tolerances are requested for the presence of 
the residues of a pesticide and its toxicologically significant 
metabolite(s) in food or feed, the Agency, as is required by FFDCA 
section 408, estimates the risk of the potential exposure to these 
residues by performing an aggregate risk assessment. Such a risk 
assessment integrates the individual assessments that are conducted for 
food, drinking water, and residential exposures. Additionally, the 
Agency, as is further required by FFDCA Section 408, considers 
available information concerning what are termed the cumulative 
toxicological effects of the residues of that pesticide and of other 
substances having a common mechanism of toxicity with it. The Agency 
has concluded after this assessment that there is a reasonable 
certainty that no harm will result from

[[Page 21945]]

exposure to the residues of interest. Therefore, the proposed 
tolerance(s) are found to be acceptable.
    2. Comment: A comment on petition 6F8443 stressed the importance of 
the Agency's use of concise and reliable analytical methods to identify 
and quantify chemical residues of flonicamid and various fungicides in 
order to draw accurate and definitive scientific conclusions regarding 
their effects on the environment.
    Agency response: An available, accurate and concise EPA approved 
analytical method is a prerequisite for EPA pesticide registration and 
critical to the Agency's ability to identify, monitor and enforce 
pesticides residues, including metabolites and degradates of concern, 
that may exist in trace amounts in plants, animals and the environment. 
Unit IV.A. of this document identifies the specific analytical method 
used by the Agency in enforcing appropriate flonicamid use as well as 
how additional information can be obtained on the method.

D. Revisions to Petitioned-For Tolerances

    Although the petitioner requested that the vegetable, fruiting 
group 8-10 tolerances be increased from 0.4 ppm to 1.5 ppm, data 
submitted did not support an increase in tolerances for the entire 
subgroup. The submitted data (which examined residues on greenhouse 
peppers only) only support an increase for the commodities in subgroup 
8-10B. Therefore, EPA is maintaining the existing tolerance level for 
crops in subgroup 8-10A and revising the tolerance level for crops in 
subgroup 8-10B. Using the Organization for Economic Cooperation and 
Development (OECD) tolerance calculation procedures and available field 
trial data (average) residues, EPA is establishing a tolerance for 
Pepper/Eggplant subgroup 8-10B at 3.0 ppm, instead of at 1.5 ppm as 
requested.

V. Conclusion

    Therefore, tolerances are established for residues of flonicamid, 
N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, and its 
metabolites, TFNA (4-trifluoromethylinicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric 
equivalent of flonicamid, in or on Fruit, citrus, group 10-10 at 1.5 
ppm; Pepper/Eggplant, subgroup 8-10B at 3.0 ppm; Tea at 40 ppm; and 
Tomato subgroup 8-10A at 0.4 ppm. In addition, EPA is revoking the 
existing tolerance for Vegetable, fruiting, group 8-10 because it is 
superseded by the new tolerances for subgroups 8-10A and 8-10B.

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 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: March 21, 2017.
Michael Goodis,
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.  180.613:
0
i. Remove ``Vegetable, fruiting, group 8-10'' from the table in 
paragraph (a).
0
ii. Add alphabetically the following commodities to the table in 
paragraph (a): ``Fruit, citrus, group 10-10''; ``Pepper/Eggplant, 
subgroup 8-10B''; and ``Tomato subgroup 8-10A''.
0
iii. Add ``Tea'' to the table in paragraph (a) and add footnote 1.
    The additions to the table in paragraph (a) read as follows:

Sec.  180.613   Flonicamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fruit, citrus, group 10-10..................................         1.5
 

[[Page 21946]]

 
                                * * * * *
Pepper/Eggplant, subgroup 8-10B.............................         3.0
 
                                * * * * *
 Tea\1\.....................................................          40
 
                                * * * * *
Tomato subgroup 8-10A.......................................         0.4
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for tea as of May 11, 2017.

* * * * *
[FR Doc. 2017-09592 Filed 5-10-17; 8:45 am]
 BILLING CODE 6560-50-P