82_FR_22031 82 FR 21941 - Flonicamid; Pesticide Tolerances

82 FR 21941 - Flonicamid; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 90 (May 11, 2017)

Page Range21941-21946
FR Document2017-09592

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 In addition, this regulation revokes the established tolerance for vegetable, fruiting, group 8-10 that is superseded by this action.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).

Federal Register, Volume 82 Issue 90 (Thursday, May 11, 2017)
[Federal Register Volume 82, Number 90 (Thursday, May 11, 2017)]
[Rules and Regulations]
[Pages 21941-21946]
From the Federal Register Online  [www.thefederalregister.org]
[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superseded by this action.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: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-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: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established 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



                                                                 Federal Register / Vol. 82, No. 90 / Thursday, May 11, 2017 / Rules and Regulations                                          21941

                                             ENVIRONMENTAL PROTECTION                                producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                             AGENCY                                                  pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                                                                                     list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.
                                             40 CFR Part 180                                         Classification System (NAICS) codes is                NW., Washington, DC 20460–0001.
                                             [EPA–HQ–OPP–2016–0013; FRL–9959–91]                     not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                                                                                     provides a guide to help readers
                                                                                                                                                           arrangements for hand delivery or
                                             Flonicamid; Pesticide Tolerances                        determine whether this document
                                                                                                                                                           delivery of boxed information, please
                                                                                                     applies to them. Potentially affected
                                             AGENCY:  Environmental Protection                       entities may include:                                 follow the instructions at http://
                                             Agency (EPA).                                              • Crop production (NAICS code 111).                www.epa.gov/dockets/contacts.html.
                                             ACTION: Final rule.                                        • Animal production (NAICS code                      Additional instructions on
                                                                                                     112).                                                 commenting or visiting the docket,
                                             SUMMARY:   This regulation establishes                     • Food manufacturing (NAICS code                   along with more information about
                                             tolerances for residues of flonicamid in                311).                                                 dockets generally, is available at http://
                                             or on multiple commodities which are                       • Pesticide manufacturing (NAICS                   www.epa.gov/dockets.
                                             identified and discussed later in this                  code 32532).
                                             document. In addition, this regulation                                                                        II. Summary of Petitioned-For
                                                                                                     B. How can I get electronic access to
                                             revokes the established tolerance for                                                                         Tolerance
                                                                                                     other related information?
                                             vegetable, fruiting, group 8–10 that is
                                             superseded by this action. Interregional                   You may access a frequently updated                   In the Federal Register of May 19,
                                             Research Project Number 4 (IR–4) and                    electronic version of EPA’s tolerance                 2016 (81 FR 31581) (FRL–9946–02);
                                             ISK Biosciences Corporation requested                   regulations at 40 CFR part 180 through                August 12, 2016 (81 FR 53379) (FRL–
                                             these tolerances under the Federal Food,                the Government Printing Office’s e-CFR                9949–53) and December 9, 2016 (81 FR
                                             Drug, and Cosmetic Act (FFDCA).                         site at http://www.ecfr.gov/cgi-bin/text-             89036) (FRL–9953–69), EPA issued
                                             DATES: This regulation is effective May                 idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  documents pursuant to FFDCA section
                                             11, 2017. Objections and requests for                   40tab_02.tpl.                                         408(d)(3), 21 U.S.C. 346a(d)(3),
                                             hearings must be received on or before                  C. How can I file an objection or hearing             announcing the filing of pesticide
                                             July 10, 2017, and must be filed in                     request?                                              petitions (PPs) by IR–4 (PP 5E8428); and
                                             accordance with the instructions                                                                              ISK Biosciences (PP 5F8416 and
                                                                                                       Under FFDCA section 408(g), 21
                                             provided in 40 CFR part 178 (see also                                                                         6F8443), respectively. These petitions
                                                                                                     U.S.C. 346a, any person may file an
                                             Unit I.C. of the SUPPLEMENTARY                                                                                request that 40 CFR 180.613 be
                                                                                                     objection to any aspect of this regulation
                                             INFORMATION).                                                                                                 amended by establishing tolerances for
                                                                                                     and may also request a hearing on those
                                             ADDRESSES:    The docket for this action,               objections. You must file your objection              residues of the insecticide flonicamid,
                                             identified by docket identification (ID)                or request a hearing on this regulation               N-(cyanomethyl)-4-(trifluoromethyl)-3-
                                             number EPA–HQ–OPP–2016–0013, is                         in accordance with the instructions                   pyridinecarboxamide, and its
                                             available at http://www.regulations.gov                 provided in 40 CFR part 178. To ensure                metabolites, TFNA (4-
                                             or at the Office of Pesticide Programs                  proper receipt by EPA, you must                       trifluoromethylinicotinic acid), TFNA–
                                             Regulatory Public Docket (OPP Docket)                   identify docket ID number EPA–HQ–                     AM (4-trifluoromethylnicotinamide),
                                             in the Environmental Protection Agency                  OPP–2016–0013 in the subject line on                  and TFNG, N-(4-
                                             Docket Center (EPA/DC), West William                    the first page of your submission. All                trifluoromethylnicotinoyl)glycine,
                                             Jefferson Clinton Bldg., Rm. 3334, 1301                 objections and requests for a hearing                 calculated as the stoichiometric
                                             Constitution Ave. NW., Washington, DC                   must be in writing, and must be                       equivalent of flonicamid, in or on
                                             20460–0001. The Public Reading Room                     received by the Hearing Clerk on or                   several commodities as follows.
                                             is open from 8:30 a.m. to 4:30 p.m.,                    before July 10, 2017. Addresses for mail              Pesticide petition 5E8428 submitted by
                                             Monday through Friday, excluding legal                  and hand delivery of objections and                   IR–4 Project Headquarters, Rutgers, The
                                             holidays. The telephone number for the                  hearing requests are provided in 40 CFR               State University of New Jersey, 500
                                             Public Reading Room is (202) 566–1744,                  178.25(b).                                            College Road East, Suite 201 W.,
                                             and the telephone number for the OPP                      In addition to filing an objection or               Princeton, NJ 08540 requests to increase
                                             Docket is (703) 305–5805. Please review                 hearing request with the Hearing Clerk                the existing tolerance on Vegetables,
                                             the visitor instructions and additional                 as described in 40 CFR part 178, please               fruiting, group 8–10 from 0.4 ppm to
                                             information about the docket available                  submit a copy of the filing (excluding                1.50 ppm. Pesticide petitions 5F8416
                                             at http://www.epa.gov/dockets.                          any Confidential Business Information                 and 6F8443 submitted by ISK
                                             FOR FURTHER INFORMATION CONTACT:                        (CBI)) for inclusion in the public docket.
                                                                                                                                                           Biosciences Corporation, 7470 Auburn
                                             Michael L. Goodis, Director,                            Information not marked confidential
                                                                                                                                                           Rd., Suite A, Concord, OH 44077
                                             Registration Division (7505P), Office of                pursuant to 40 CFR part 2 may be
                                                                                                     disclosed publicly by EPA without prior               request tolerances on tea at 40 ppm and
                                             Pesticide Programs, Environmental
                                                                                                     notice. Submit the non-CBI copy of your               fruit, citrus group 10–10 at 1.5 ppm,
                                             Protection Agency, 1200 Pennsylvania
                                                                                                     objection or hearing request, identified              respectively. All supporting documents
                                             Ave. NW., Washington, DC 20460–0001;
                                                                                                     by docket ID number EPA–HQ–OPP–                       for this final rule, which bundles the
                                             main telephone number: (703) 305–
                                             7090; email address:                                    2016–0013, by one of the following                    three above-referenced petitions for
                                             RDFRNotices@epa.gov.                                    methods:                                              purposes of this final rule, are found in
pmangrum on DSK3GDR082PROD with RULES




                                                                                                       • Federal eRulemaking Portal: http://               docket ID EPA–HQ–OPP–2016–0013.
                                             SUPPLEMENTARY INFORMATION:
                                                                                                     www.regulations.gov. Follow the online                   Summaries of the petitions prepared
                                             I. General Information                                  instructions for submitting comments.                 by IR4 and the registrant, ISK
                                                                                                     Do not submit electronically any                      Biosciences Corporation, are available
                                             A. Does this action apply to me?                        information you consider to be CBI or                 in the following dockets at http://
                                               You may be potentially affected by                    other information whose disclosure is                 www.regulations.gov: PP 5E8428 in
                                             this action if you are an agricultural                  restricted by statute.


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                                             21942               Federal Register / Vol. 82, No. 90 / Thursday, May 11, 2017 / Rules and Regulations

                                             Docket: EPA–HQ–OPP–2016–0013; PP                        TFNG–AM, and TFNA–OH,                                 carcinogenicity potential for flonicamid
                                             5F8416 in Docket: EPA–HQ–OPP–2011–                      demonstrated low toxicity in acute oral               was based on the weight of the evidence
                                             0985; and PP 6F8443 in EPA–HQ–OPP–                      toxicity studies. Fonicamid showed no                 approach and resulted in the
                                             2015–0561. Comments were received on                    systemic toxicity in a 28-day dermal                  classification of ‘‘suggestive evidence of
                                             the notices of filings. EPA’s responses to              study at the limit dose.                              carcinogenicity, but not sufficient to
                                             the comments are discussed in Unit                         Feeding studies in rats and dogs show              assess human carcinogenic potential.’’
                                             IV.C.                                                   the kidney and liver are the target                   The Agency determined that
                                               Based upon review of the data                         organs for flonicamid toxicity. In repeat-            quantification of risk using a non-linear
                                             supporting the petition, EPA has revised                dose subchronic and chronic oral                      approach (i.e., using a chronic reference
                                             the tolerance level for certain crops and               toxicity studies, the consistently                    dose (cRfD)) adequately accounts for all
                                             corrected commodity definitions to be                   observed adverse effect in rats and mice              chronic toxicity, including
                                             consistent with current EPA policies.                   were kidney toxicity (i.e., hyaline                   carcinogenicity that could result from
                                             The reasons for these changes are                       deposition and nephritis); in dogs,                   exposure to flonicamid.
                                             explained in Unit IV.D.                                 vomiting and increased percentage of                     Specific information on the studies
                                                                                                     reticulocytes (an indicator for potential             received and the nature of the adverse
                                             III. Aggregate Risk Assessment and
                                                                                                     anemia).                                              effects caused by flonicamid as well as
                                             Determination of Safety                                    There is no evidence that flonicamid               the no-observed-adverse-effect-level
                                                Section 408(b)(2)(A)(i) of FFDCA                     results in increased susceptibility                   (NOAEL) and the lowest-observed-
                                             allows EPA to establish a tolerance (the                (qualitative or quantitative) in utero in             adverse-effect-level (LOAEL) from the
                                             legal limit for a pesticide chemical                    rats or rabbits in the prenatal                       toxicity studies can be found at http://
                                             residue in or on a food) only if EPA                    developmental studies or in young rats                www.regulations.gov in document
                                             determines that the tolerance is ‘‘safe.’’              in the 2-generation reproduction study.               ‘‘Subject: Flonicamid. Human Health
                                             Section 408(b)(2)(A)(ii) of FFDCA                       In the rat prenatal developmental                     Risk Assessment for New Uses on
                                             defines ‘‘safe’’ to mean that ‘‘there is a              toxicity study, maternal toxicity                     Legume Vegetables, Subgroups 6A, 6B,
                                             reasonable certainty that no harm will                  consisted of kidney toxicity (i.e.,                   and 6C; Add Directions for use on
                                             result from aggregate exposure to the                   nephritis) in the absence of                          Greenhouse Grown Peppers and
                                             pesticide chemical residue, including                   developmental toxicity at the highest-                Increase the Tolerance for Residues on
                                             all anticipated dietary exposures and all               dose tested (HDT); in the rabbit,                     Fruiting Vegetables, Group 8–10; New
                                             other exposures for which there is                      maternal toxicity consisted of decreased              Use on Citrus Fruits, Group 10–10; and
                                             reliable information.’’ This includes                   food consumption in the absence of                    a Tolerance without U.S. Registration
                                             exposure through drinking water and in                  developmental toxicity at the HDT. In                 for residues in/on Dried Tea’’ at page 28
                                             residential settings, but does not include              the rat reproduction and fertility effects            in docket ID number EPA–HQ–OPP–
                                             occupational exposure. Section                          study, parental toxicity (i.e., kidney                2016–0013.
                                             408(b)(2)(C) of FFDCA requires EPA to                   hyaline deposition and luteinizing
                                                                                                     hormone level increases) occurred at                  B. Toxicological Points of Departure/
                                             give special consideration to exposure
                                                                                                     doses much lower than doses causing                   Levels of Concern
                                             of infants and children to the pesticide
                                             chemical residue in establishing a                      offspring effects (i.e., decreased body                  Once a pesticide’s toxicological
                                             tolerance and to ‘‘ensure that there is a               weight and delayed sexual maturation).                profile is determined, EPA identifies
                                             reasonable certainty that no harm will                     There are no concerns for flonicamid               toxicological points of departure (POD)
                                             result to infants and children from                     neurotoxicity. In the acute neurotoxicity             and levels of concern to use in
                                             aggregate exposure to the pesticide                     study in rats, signs of toxicity such as              evaluating the risk posed by human
                                             chemical residue. . . .’’                               decreased motor activity, tremors,                    exposure to the pesticide. For hazards
                                                Consistent with FFDCA section                        impaired gait, and impaired respiration               that have a threshold below which there
                                             408(b)(2)(D), and the factors specified in              were observed at lethal dose levels                   is no appreciable risk, the toxicological
                                             FFDCA section 408(b)(2)(D), EPA has                     (1000 mg/kg). In the subchronic                       POD is used as the basis for derivation
                                             reviewed the available scientific data                  neurotoxicity study, decreased body                   of reference values for risk assessment.
                                             and other relevant information in                       weight, food consumption, foot splay,                 PODs are developed based on a careful
                                             support of this action. EPA has                         and motor activity were observed in                   analysis of the doses in each
                                             sufficient data to assess the hazards of                males at doses greater than 67 mg/kg/                 toxicological study to determine the
                                             and to make a determination on                          day, and in females at 722 mg/kg/day.                 dose at which no adverse effects are
                                             aggregate exposure for flonicamid,                      In the immunotoxicity study in mice,                  observed (the NOAEL) and the lowest
                                             including exposure resulting from the                   there were no indications of increased                dose at which adverse effects of concern
                                             tolerances established by this action.                  immunotoxic potential in the T-cell                   are identified (the LOAEL). Uncertainty/
                                             EPA’s assessment of exposures and risks                 dependent antibody response (TDAR)                    safety factors are used in conjunction
                                             associated with flonicamid follows.                     assay at the limit dose.                              with the POD to calculate a safe
                                                                                                        Mutagenicity studies were negative                 exposure level—generally referred to as
                                             A. Toxicological Profile                                for flonicamid and its metabolites of                 a population-adjusted dose (PAD) or a
                                               EPA has evaluated the available                       concern. Treatment-related lung tumors                reference dose (RfD)—and a safe margin
                                             toxicity database and considered its                    were observed in CD–1 mice. This                      of exposure (MOE). For non-threshold
                                             validity, completeness, and reliability as              tumor type, however, is associated with               risks, the Agency assumes that any
                                             well as the relationship of the results of              species and strain sensitivity and is not             amount of exposure will lead to some
                                             the studies to human risk. EPA has also                 directly correlated with cancer risks in              degree of risk. Thus, the Agency
pmangrum on DSK3GDR082PROD with RULES




                                             considered available information                        humans. Nasal cavity tumors in male                   estimates risk in terms of the probability
                                             concerning the variability of the                       Wistar rats were linked to incisor                    of an occurrence of the adverse effect
                                             sensitivities of major identifiable                     inflammation. Nasolacrimal duct tumor                 expected in a lifetime. For more
                                             subgroups of consumers, including                       findings for females were confounded                  information on the general principles
                                             infants and children.                                   by the lack of a dose-response, and the               EPA uses in risk characterization and a
                                               Flonicamid and its metabolites of                     biological significance of these tumors is            complete description of the risk
                                             concern, TFNA, TFNA–AM, TFNG,                           questionable. The determination of                    assessment process, see http://


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                                                                 Federal Register / Vol. 82, No. 90 / Thursday, May 11, 2017 / Rules and Regulations                                        21943

                                             www2.epa.gov/pesticide-science-and-                     and/or 100% CT were assumed for all                   ‘‘available information’’ concerning the
                                             assessing-pesticide-risks/assessing-                    food commodities.                                     cumulative effects of a particular
                                             human-health-risk-pesticides.                              2. Dietary exposure from drinking                  pesticide’s residues and ‘‘other
                                               A summary of the toxicological                        water.                                                substances that have a common
                                             endpoints for flonicamid used for                          The Agency used screening level                    mechanism of toxicity.’’
                                             human risk assessment is discussed in                   water exposure models in the dietary                     EPA has not found flonicamid to
                                             Unit III.B. of the final rule published in              exposure analysis and risk assessment                 share a common mechanism of toxicity
                                             the Federal Register of November 14,                    for flonicamid in drinking water. These               with any other substances, and
                                             2012 (77 FR 67771) (FRL–9368–7).                        simulation models take into account                   flonicamid does not appear to produce
                                                                                                     data on the physical, chemical, and fate/             a toxic metabolite produced by other
                                             C. Exposure Assessment                                  transport characteristics of flonicamid.              substances. For the purposes of this
                                                1. Dietary exposure from food and                    Further information regarding EPA                     tolerance action, therefore, EPA has
                                             feed uses. In evaluating dietary                        drinking water models used in pesticide               assumed that flonicamid does not have
                                             exposure to flonicamid, EPA considered                  exposure assessment can be found at                   a common mechanism of toxicity with
                                             exposure under the petitioned-for                       http://www2.epa.gov/pesticide-science-                other substances. For information
                                             tolerances as well as all existing                      and-assessing-pesticide-risks/about-                  regarding EPA’s efforts to determine
                                             flonicamid tolerances in 40 CFR                         water-exposure-models-used-pesticide.                 which chemicals have a common
                                             180.613. EPA assessed dietary                              The drinking water assessment was                  mechanism of toxicity and to evaluate
                                             exposures from flonicamid in food as                    conducted using both a parent only                    the cumulative effects of such
                                             follows:                                                exposure, and a total toxic residue                   chemicals, see EPA’s Web site at http://
                                                i. Acute exposure. Quantitative acute                approach, which considers the parent                  www2.epa.gov/pesticide-science-and-
                                             dietary exposure and risk assessments                   compound and its major degradates of                  assessing-pesticide-risks/cumulative-
                                             are performed for a food-use pesticide,                 concern. Total toxic residues include 4-              assessment-risk-pesticides.
                                             if a toxicological study has indicated the              trifluoromethylnicotinic acid (TFNA), 4-
                                             possibility of an effect of concern                     trifluoromethylnictinamide (TFNA-                     D. Safety Factor for Infants and
                                             occurring as a result of a 1-day or single              AM), 6-hydro-4-trifluoromethylnicotinic               Children
                                             exposure. No such effects were                          acid (TFNA-OH), N-(4-                                    1. In general. Section 408(b)(2)(C) of
                                             identified in the toxicological studies                 trifluoromethylnicotinoyl)glycine                     FFDCA provides that EPA shall apply
                                             for flonicamid; therefore, a quantitative               (TFNG), and N-(4-                                     an additional tenfold (10X) margin of
                                             acute dietary exposure assessment is                    trifluoromethylnicotinoyl)glycinamide                 safety for infants and children in the
                                             unnecessary.                                            (TFNG-AM).                                            case of threshold effects to account for
                                                ii. Chronic exposure. In conducting                     Based on the Pesticide Root Zone                   prenatal and postnatal toxicity and the
                                             the chronic dietary exposure assessment                 Model Ground Water (PRZM GW), the                     completeness of the database on toxicity
                                             EPA used the Dietary Exposure                           estimated drinking water concentrations               and exposure unless EPA determines
                                             Evaluation Model—Food Commodity                         (EDWCs) of flonicamid for chronic                     based on reliable data that a different
                                             Intake Database (DEEM–FCIDTM),                          exposures for non-cancer assessments                  margin of safety will be safe for infants
                                             Version 3.16, which incorporates 2003–                  are estimated to be 0.94 parts per billion            and children. This additional margin of
                                             2008 food consumption information                       (ppb) for surface water and 9.92 ppb for              safety is commonly referred to as the
                                             from the U.S. Department of                             ground water.                                         FQPA Safety Factor (SF). In applying
                                             Agriculture’s (USDA’s) National Health                     Modeled estimates of drinking water                this provision, EPA either retains the
                                             and Nutrition Examination Survey,                       concentrations were directly entered                  default value of 10X, or uses a different
                                             What We Eat in America, (NHANES/                        into the dietary exposure model. For                  additional safety factor when reliable
                                             WWEIA). As to residue levels in food,                   chronic dietary risk assessment, the                  data available to EPA support the choice
                                             EPA used an unrefined chronic dietary                   water concentration value of 9.92 ppb                 of a different factor.
                                             assessment conducted assuming 100                       was used to assess the contribution to                   2. Prenatal and postnatal sensitivity.
                                             percent crop treated (PCT) estimates,                   drinking water.                                       The prenatal and postnatal toxicity
                                             tolerance-level residues for all                           3. From non-dietary exposure. The                  database for flonicamid includes
                                             commodities, and empirical or Dietary                   term ‘‘residential exposure’’ is used in              prenatal developmental toxicity studies
                                             Exposure Evaluation Model—Food                          this document to refer to non-                        in rats and rabbits and a multigeneration
                                             Commodity Intake Database (DEEM–                        occupational, non-dietary exposure                    reproduction toxicity study in rats.
                                             FCIDTM) default processing factors. The                 (e.g., for lawn and garden pest control,              There is no evidence that flonicamid
                                             processing factor was set to 1.0 for                    indoor pest control, termiticides, and                results in increased susceptibility
                                             potato granules/flakes, tomato paste and                flea and tick control on pets).                       (qualitative or quantitative) in utero in
                                             tomato puree; for all other processed                   Flonicamid is not registered for any                  rats or rabbits in the prenatal
                                             commodities DEEM default processing                     specific use patterns that would result               developmental studies or in young rats
                                             factors were used.                                      in residential exposure.                              in the multi-generation reproduction
                                                iii. Cancer. Based on the data                          Further information regarding EPA                  study. No developmental effects were
                                             summarized in Unit III.A., EPA has                      standard assumptions and generic                      seen in rabbits. In the multi-generation
                                             concluded that a nonlinear RfD                          inputs for residential exposures may be               reproduction study, developmental
                                             approach is appropriate for assessing                   found at http://www2.epa.gov/pesticide-               delays in the offspring (decreased body
                                             cancer risk to flonicamid. Cancer risk                  science-and-assessing-pesticide-risks/                weights, delayed sexual maturation)
                                             was assessed using the same exposure                    standard-operating-procedures-                        were seen only in the presence of
pmangrum on DSK3GDR082PROD with RULES




                                             estimates as discussed in Unit III.C.1.ii.,             residential-pesticide.                                parental toxicity (kidney and blood
                                             chronic exposure.                                          4. Cumulative effects from substances              effects). Also, there are clear NOAELs
                                                iv. Anticipated residue and percent                  with a common mechanism of toxicity.                  and LOAELs for all effects. The degree
                                             crop treated (PCT) information. EPA did                 Section 408(b)(2)(D)(v) of FFDCA                      of concern for prenatal and/or post-natal
                                             not use anticipated residue and/or PCT                  requires that, when considering whether               susceptibility is, therefore, low due to
                                             information in the dietary assessment                   to establish, modify, or revoke a                     the lack of evidence of qualitative and
                                             for flonicamid. Tolerance level residues                tolerance, the Agency consider                        quantitative susceptibility.


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                                             21944               Federal Register / Vol. 82, No. 90 / Thursday, May 11, 2017 / Rules and Regulations

                                                3. Conclusion. EPA has determined                    a single oral exposure was identified                 United Nations Food and Agriculture
                                             that reliable data show the safety of                   and no acute dietary endpoint was                     Organization/World Health
                                             infants and children would be                           selected. Therefore, flonicamid is not                Organization food standards program,
                                             adequately protected if the FQPA SF                     expected to pose an acute risk.                       and it is recognized as an international
                                             were reduced to 1X, except where                           2. Chronic risk. Using the exposure                food safety standards-setting
                                             assessing risks from inhalation exposure                assumptions described in this unit for                organization in trade agreements to
                                             as discussed below. Those decisions are                 chronic exposure, EPA has concluded                   which the United States is a party. EPA
                                             based on the following findings:                        that chronic exposure to flonicamid                   may establish a tolerance that is
                                                i. The toxicity database for flonicamid              from food and water will utilize 59% of               different from a Codex MRL; however,
                                             is essentially complete, except for an                  the cPAD for children 1–2 years old the               FFDCA section 408(b)(4) requires that
                                             outstanding subchronic 28-day                           population group receiving the greatest               EPA explain the reasons for departing
                                             inhalation study. In the absence of a                   exposure. There are no residential uses               from the Codex level.
                                             subchronic inhalation study, EPA has                    for flonicamid.                                          The Codex has not established MRLs
                                             retained a 10X FQPA SF to assess risks                     3. Short- and intermediate-term risks.             for flonicamid.
                                             from inhalation exposure, although at                   Short- and intermediate-term aggregate                C. Response to Comments
                                             present, residential inhalation exposure                exposures take into account short- and
                                             is not expected from existing or pending                intermediate-term residential exposures                  1. Anonymous comments: One
                                             uses of flonicamid.                                     plus chronic exposure to food and water               comment each on petitions, 5E8428 and
                                                ii. There is no evidence that                        (considered to be a background                        5F8416, was received. Both comments
                                             flonicamid is a neurotoxic chemical. As                 exposure level). Flonicamid is not                    claim that flonicamid is a ‘‘toxic
                                             discussed in Unit III.A., EPA has                       registered for any use patterns that                  pesticide’’ and residues at any level in
                                             concluded that the clinical signs                       would result in short- and intermediate-              food commodities including tea (leaves)
                                             observed from available acute and                       term residential exposures.                           should not be allowed and requested
                                             subchronic neurotoxicity studies were                      4. Aggregate cancer risk for U.S.                  that EPA deny setting tolerances for the
                                             not the result of a neurotoxic                          population. Based on the information                  petition-for new uses of flonicamid. One
                                             mechanism. Therefore, there is no need                  referenced in Unit III.A., EPA has                    comment stated that the proposed
                                             for a developmental neurotoxicity study                 concluded that the cPAD is protective of              flonicamid use would add to about
                                             or additional UFs to account for                                                                              25,000 toxic chemicals currently in the
                                                                                                     possible cancer effects from flonicamid,
                                             neurotoxicity.                                                                                                environment and combine to create
                                                                                                     and as evidenced in Unit III.E.2,
                                                iii. There is no evidence that                                                                             even more toxic chemical residues in
                                                                                                     aggregate exposure to flonicamid is
                                             flonicamid results in increased                                                                               food and drinking water further
                                                                                                     below the cPAD.
                                             susceptibility in utero in rats or rabbits                                                                    increasing harmful effects to humans
                                                                                                        5. Determination of safety. Based on
                                             in the prenatal developmental studies or                                                                      and environment.
                                                                                                     these risk assessments, EPA concludes                    Agency response: The Agency
                                             in young rats in the 2-generation                       that there is a reasonable certainty that
                                             reproduction study.                                                                                           understands the commenters’ concerns
                                                                                                     no harm will result to the general                    and recognizes that some individuals
                                                iv. There are no residual uncertainties              population, or to infants and children
                                             identified in the exposure databases.                                                                         believe that pesticides should be banned
                                                                                                     from aggregate exposure to flonicamid                 completely. However, under the existing
                                             The chronic dietary food exposure                       residues.
                                             assessment was based on 100 PCT,                                                                              legal framework provided by FFDCA
                                             tolerance-level residues and where                      IV. Other Considerations                              section 408, EPA is authorized to
                                             applicable, default processing factors.                                                                       establish pesticide tolerances or
                                                                                                     A. Analytical Enforcement Methodology                 exemptions where persons seeking such
                                             EPA made conservative (protective)
                                             assumptions in the ground and surface                      Adequate enforcement methodology                   tolerances or exemptions have
                                             water modeling used to assess exposure                  (FMC Method No. P–3561M, a liquid                     demonstrated that the pesticide meets
                                             to flonicamid in drinking water. These                  chromatography with tandem mass                       the safety standard imposed by that
                                             assessments will not underestimate the                  spectrometry (LC/MS/MS) method) is                    statute.
                                             exposure and risks posed by flonicamid.                 available to enforce the tolerance                       When new or amended tolerances are
                                                                                                     expression for flonicamid and its                     requested for the presence of the
                                             E. Aggregate Risks and Determination of                 metabolites in or on plant commodities.               residues of a pesticide and its
                                             Safety                                                     The method may be requested from:                  toxicologically significant metabolite(s)
                                                EPA determines whether acute and                     Chief, Analytical Chemistry Branch,                   in food or feed, the Agency, as is
                                             chronic dietary pesticide exposures are                 Environmental Science Center, 701                     required by FFDCA section 408,
                                             safe by comparing aggregate exposure                    Mapes Rd., Ft. Meade, MD 20755–5350;                  estimates the risk of the potential
                                             estimates to the acute PAD (aPAD) and                   telephone number: (410) 305–2905;                     exposure to these residues by
                                             chronic PAD (cPAD). For linear cancer                   email address: residuemethods@                        performing an aggregate risk assessment.
                                             risks, EPA calculates the lifetime                      epa.gov.                                              Such a risk assessment integrates the
                                             probability of acquiring cancer given the                                                                     individual assessments that are
                                                                                                     B. International Residue Limits                       conducted for food, drinking water, and
                                             estimated aggregate exposure. Short-,
                                             intermediate-, and chronic-term risks                     In making its tolerance decisions, EPA              residential exposures. Additionally, the
                                             are evaluated by comparing the                          seeks to harmonize U.S. tolerances with               Agency, as is further required by FFDCA
                                             estimated aggregate food, water, and                    international standards whenever                      Section 408, considers available
                                             residential exposure to the appropriate                 possible, consistent with U.S. food                   information concerning what are termed
pmangrum on DSK3GDR082PROD with RULES




                                             PODs to ensure that an adequate MOE                     safety standards and agricultural                     the cumulative toxicological effects of
                                             exists.                                                 practices. EPA considers the                          the residues of that pesticide and of
                                                1. Acute risk. An acute aggregate risk               international maximum residue limits                  other substances having a common
                                             assessment takes into account acute                     (MRLs) established by the Codex                       mechanism of toxicity with it. The
                                             exposure estimates from dietary                         Alimentarius Commission (Codex), as                   Agency has concluded after this
                                             consumption of food and drinking                        required by FFDCA section 408(b)(4).                  assessment that there is a reasonable
                                             water. No adverse effect resulting from                 The Codex Alimentarius is a joint                     certainty that no harm will result from


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                                                                 Federal Register / Vol. 82, No. 90 / Thursday, May 11, 2017 / Rules and Regulations                                                 21945

                                             exposure to the residues of interest.                   Vegetable, fruiting, group 8–10 because               to this action. In addition, this action
                                             Therefore, the proposed tolerance(s) are                it is superseded by the new tolerances                does not impose any enforceable duty or
                                             found to be acceptable.                                 for subgroups 8–10A and 8–10B.                        contain any unfunded mandate as
                                                2. Comment: A comment on petition                                                                          described under Title II of the Unfunded
                                             6F8443 stressed the importance of the                   VI. Statutory and Executive Order
                                                                                                                                                           Mandates Reform Act (UMRA) (2 U.S.C.
                                             Agency’s use of concise and reliable                    Reviews
                                                                                                                                                           1501 et seq.).
                                             analytical methods to identify and                         This action establishes tolerances                   This action does not involve any
                                             quantify chemical residues of                           under FFDCA section 408(d) in                         technical standards that would require
                                             flonicamid and various fungicides in                    response to a petition submitted to the               Agency consideration of voluntary
                                             order to draw accurate and definitive                   Agency. The Office of Management and                  consensus standards pursuant to section
                                             scientific conclusions regarding their                  Budget (OMB) has exempted these types                 12(d) of the National Technology
                                             effects on the environment.                             of actions from review under Executive                Transfer and Advancement Act
                                                Agency response: An available,                       Order 12866, entitled ‘‘Regulatory                    (NTTAA) (15 U.S.C. 272 note).
                                             accurate and concise EPA approved                       Planning and Review’’ (58 FR 51735,
                                             analytical method is a prerequisite for                 October 4, 1993). Because this action                 VII. Congressional Review Act
                                             EPA pesticide registration and critical to              has been exempted from review under                     Pursuant to the Congressional Review
                                             the Agency’s ability to identify, monitor               Executive Order 12866, this action is                 Act (5 U.S.C. 801 et seq.), EPA will
                                             and enforce pesticides residues,                        not subject to Executive Order 13211,                 submit a report containing this rule and
                                             including metabolites and degradates of                 entitled ‘‘Actions Concerning                         other required information to the U.S.
                                             concern, that may exist in trace amounts                Regulations That Significantly Affect                 Senate, the U.S. House of
                                             in plants, animals and the environment.                 Energy Supply, Distribution, or Use’’ (66             Representatives, and the Comptroller
                                             Unit IV.A. of this document identifies                  FR 28355, May 22, 2001) or Executive                  General of the United States prior to
                                             the specific analytical method used by                  Order 13045, entitled ‘‘Protection of                 publication of the rule in the Federal
                                             the Agency in enforcing appropriate                     Children from Environmental Health                    Register. This action is not a ‘‘major
                                             flonicamid use as well as how                           Risks and Safety Risks’’ (62 FR 19885,                rule’’ as defined by 5 U.S.C. 804(2).
                                             additional information can be obtained                  April 23, 1997). This action does not
                                             on the method.                                          contain any information collections                   List of Subjects in 40 CFR Part 180
                                                                                                     subject to OMB approval under the                       Environmental protection,
                                             D. Revisions to Petitioned-For
                                                                                                     Paperwork Reduction Act (PRA) (44                     Administrative practice and procedure,
                                             Tolerances
                                                                                                     U.S.C. 3501 et seq.), nor does it require             Agricultural commodities, Pesticides
                                                Although the petitioner requested that               any special considerations under                      and pests, Reporting and recordkeeping
                                             the vegetable, fruiting group 8–10                      Executive Order 12898, entitled                       requirements.
                                             tolerances be increased from 0.4 ppm to                 ‘‘Federal Actions to Address
                                             1.5 ppm, data submitted did not support                 Environmental Justice in Minority                       Dated: March 21, 2017.
                                             an increase in tolerances for the entire                Populations and Low-Income                            Michael Goodis,
                                             subgroup. The submitted data (which                     Populations’’ (59 FR 7629, February 16,               Director, Registration Division, Office of
                                             examined residues on greenhouse                         1994).                                                Pesticide Programs.
                                             peppers only) only support an increase                     Since tolerances and exemptions that                 Therefore, 40 CFR chapter I is
                                             for the commodities in subgroup 8–10B.                  are established on the basis of a petition            amended as follows:
                                             Therefore, EPA is maintaining the                       under FFDCA section 408(d), such as
                                             existing tolerance level for crops in                   the tolerance in this final rule, do not              PART 180—[AMENDED]
                                             subgroup 8–10A and revising the                         require the issuance of a proposed rule,
                                             tolerance level for crops in subgroup 8–                the requirements of the Regulatory                    ■ 1. The authority citation for part 180
                                             10B. Using the Organization for                         Flexibility Act (RFA) (5 U.S.C. 601 et                continues to read as follows:
                                             Economic Cooperation and                                seq.), do not apply.                                      Authority: 21 U.S.C. 321(q), 346a and 371.
                                             Development (OECD) tolerance                               This action directly regulates growers,
                                             calculation procedures and available                    food processors, food handlers, and food              ■  2. In § 180.613:
                                             field trial data (average) residues, EPA is             retailers, not States or tribes, nor does             ■  i. Remove ‘‘Vegetable, fruiting, group
                                             establishing a tolerance for Pepper/                    this action alter the relationships or                8–10’’ from the table in paragraph (a).
                                             Eggplant subgroup 8–10B at 3.0 ppm,                     distribution of power and                             ■ ii. Add alphabetically the following
                                             instead of at 1.5 ppm as requested.                     responsibilities established by Congress              commodities to the table in paragraph
                                                                                                     in the preemption provisions of FFDCA                 (a): ‘‘Fruit, citrus, group 10–10’’;
                                             V. Conclusion                                           section 408(n)(4). As such, the Agency                ‘‘Pepper/Eggplant, subgroup 8–10B’’;
                                                Therefore, tolerances are established                has determined that this action will not              and ‘‘Tomato subgroup 8–10A’’.
                                             for residues of flonicamid, N-                          have a substantial direct effect on States            ■ iii. Add ‘‘Tea’’ to the table in
                                             (cyanomethyl)-4-(trifluoromethyl)-3-                    or tribal governments, on the                         paragraph (a) and add footnote 1.
                                             pyridinecarboxamide, and its                            relationship between the national                        The additions to the table in
                                             metabolites, TFNA (4-                                   government and the States or tribal                   paragraph (a) read as follows:
                                             trifluoromethylinicotinic acid), TFNA-                  governments, or on the distribution of
                                             AM (4-trifluoromethylnicotinamide),                     power and responsibilities among the                  § 180.613 Flonicamid; tolerances for
                                             and TFNG, N-(4-                                         various levels of government or between               residues.
                                             trifluoromethylnicotinoyl)glycine,                      the Federal Government and Indian                         (a) * * *
pmangrum on DSK3GDR082PROD with RULES




                                             calculated as the stoichiometric                        tribes. Thus, the Agency has determined
                                             equivalent of flonicamid, in or on Fruit,               that Executive Order 13132, entitled                                                           Parts per
                                                                                                                                                                       Commodity                     million
                                             citrus, group 10–10 at 1.5 ppm; Pepper/                 ‘‘Federalism’’ (64 FR 43255, August 10,
                                             Eggplant, subgroup 8–10B at 3.0 ppm;                    1999) and Executive Order 13175,
                                             Tea at 40 ppm; and Tomato subgroup 8–                   entitled ‘‘Consultation and Coordination                 *           *        *            *        *
                                             10A at 0.4 ppm. In addition, EPA is                     with Indian Tribal Governments’’ (65 FR               Fruit, citrus, group 10–10 ...........            1.5
                                             revoking the existing tolerance for                     67249, November 9, 2000) do not apply


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                                             21946                      Federal Register / Vol. 82, No. 90 / Thursday, May 11, 2017 / Rules and Regulations

                                                                                                  Parts per      (7505P), Office of Pesticide Programs,                   disclosed publicly by EPA without prior
                                                             Commodity                             million       Environmental Protection Agency, 1200                    notice. Submit the non-CBI copy of your
                                                                                                                 Pennsylvania Ave. NW., Washington,                       objection or hearing request, identified
                                                *            *              *               *              *     DC 20460–0001; main telephone                            by docket ID number EPA–HQ–OPP–
                                             Pepper/Eggplant, subgroup 8–                                        number: (703) 305–7090; email address:                   2016–0160, by one of the following
                                               10B ..........................................                3.0
                                                                                                                 RDFRNotices@epa.gov.                                     methods:
                                                *              *              *               *            *     SUPPLEMENTARY INFORMATION:                                 • Federal eRulemaking Portal: http://
                                              Tea1 ............................................                40                                                         www.regulations.gov. Follow the online
                                                                                                                     I. General Information                               instructions for submitting comments.
                                               *        *        *            *                            *         A. Does this action apply to me?                     Do not submit electronically any
                                             Tomato subgroup 8–10A ............                                0.4                                                        information you consider to be CBI or
                                                                                                                        You may be potentially affected by                other information whose disclosure is
                                                  *             *              *             *             *         this action if you are an agricultural               restricted by statute.
                                               1 There are no U.S. registrations for tea as
                                                                                                                     producer, food manufacturer, or                        • Mail: OPP Docket, Environmental
                                                                                                                     pesticide manufacturer. The following                Protection Agency Docket Center (EPA/
                                             of May 11, 2017.
                                                                                                                     list of North American Industrial                    DC), (28221T), 1200 Pennsylvania Ave.
                                             *        *         *        *         *                                 Classification System (NAICS) codes is               NW., Washington, DC 20460–0001.
                                             [FR Doc. 2017–09592 Filed 5–10–17; 8:45 am]                             not intended to be exhaustive, but rather              • Hand Delivery: To make special
                                             BILLING CODE 6560–50–P                                                  provides a guide to help readers                     arrangements for hand delivery or
                                                                                                                     determine whether this document                      delivery of boxed information, please
                                                                                                                     applies to them. Potentially affected                follow the instructions at http://
                                             ENVIRONMENTAL PROTECTION                                                entities may include:                                www.epa.gov/dockets/contacts.html.
                                             AGENCY                                                                     • Crop production (NAICS code 111).                 Additional instructions on
                                                                                                                        • Animal production (NAICS code                   commenting or visiting the docket,
                                             40 CFR Part 180
                                                                                                                     112).                                                along with more information about
                                             [EPA–HQ–OPP–2016–0160; FRL–9960–50]                                        • Food manufacturing (NAICS code                  dockets generally, is available at http://
                                                                                                                     311).                                                www.epa.gov/dockets.
                                             Fluazinam; Pesticide Tolerances                                            • Pesticide manufacturing (NAICS
                                                                                                                     code 32532).                                         II. Summary of Petitioned-For
                                             AGENCY:  Environmental Protection                                                                                            Tolerance
                                             Agency (EPA).                                                           B. How can I get electronic access to
                                             ACTION: Final rule.
                                                                                                                                                                             In the Federal Register of May 19,
                                                                                                                     other related information?
                                                                                                                                                                          2016 (81 FR 31583) (FRL–9946–02),
                                             SUMMARY:   This regulation establishes a                                   You may access a frequently updated               EPA issued a document pursuant to
                                             tolerance for residues of fluazinam in or                               electronic version of EPA’s tolerance                FFDCA section 408(d)(3), 21 U.S.C.
                                             on tea, dried. ISK Biosciences                                          regulations at 40 CFR part 180 through               346a(d)(3), announcing the filing of a
                                             Corporation requested this tolerance                                    the Government Printing Office’s e-CFR               pesticide petition (PP 6E8449) by ISK
                                             under the Federal Food, Drug, and                                       site at http://www.ecfr.gov/cgi-bin/text-            Biosciences Corporation, 7470 Auburn
                                             Cosmetic Act (FFDCA).                                                   idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                 RD, Suite A, Concord, OH 44077. The
                                             DATES: This regulation is effective May                                 40tab_02.tpl.                                        petition requested that 40 CFR 180.574
                                             11, 2017. Objections and requests for                                   C. How can I file an objection or hearing            be amended by establishing tolerances
                                             hearings must be received on or before                                  request?                                             for residues of the fungicide fluazinam,
                                             July 10, 2017, and must be filed in                                                                                          in or on dried tea at 5.0 parts per
                                                                                                                       Under FFDCA section 408(g), 21                     million (ppm). That document
                                             accordance with the instructions
                                                                                                                     U.S.C. 346a, any person may file an                  referenced a summary of the petition
                                             provided in 40 CFR part 178 (see also
                                                                                                                     objection to any aspect of this regulation           prepared by ISK Biosciences
                                             Unit I.C. of the SUPPLEMENTARY
                                                                                                                     and may also request a hearing on those              Corporation, the registrant, which is
                                             INFORMATION).
                                                                                                                     objections. You must file your objection             available in the docket, http://
                                             ADDRESSES: The docket for this action,                                  or request a hearing on this regulation              www.regulations.gov. One comment was
                                             identified by docket identification (ID)                                in accordance with the instructions                  received on the notice of filing. EPA’s
                                             number EPA–HQ–OPP–2016–0160, is                                         provided in 40 CFR part 178. To ensure               response to these comments is
                                             available at http://www.regulations.gov                                 proper receipt by EPA, you must                      discussed in Unit IV.C.
                                             or at the Office of Pesticide Programs                                  identify docket ID number EPA–HQ–                       Based upon review of the data
                                             Regulatory Public Docket (OPP Docket)                                   OPP–2016–0160 in the subject line on                 supporting the petition, EPA has revised
                                             in the Environmental Protection Agency                                  the first page of your submission. All               the proposed tolerance from 5.0 ppm to
                                             Docket Center (EPA/DC), West William                                    objections and requests for a hearing                6.0 ppm. The reason for these changes
                                             Jefferson Clinton Bldg., Rm. 3334, 1301                                 must be in writing, and must be                      are explained in Unit IV.D.
                                             Constitution Ave. NW., Washington, DC                                   received by the Hearing Clerk on or
                                             20460–0001. The Public Reading Room                                     before July 10, 2017. Addresses for mail             III. Aggregate Risk Assessment and
                                             is open from 8:30 a.m. to 4:30 p.m.,                                    and hand delivery of objections and                  Determination of Safety
                                             Monday through Friday, excluding legal                                  hearing requests are provided in 40 CFR                 Section 408(b)(2)(A)(i) of FFDCA
                                             holidays. The telephone number for the                                  178.25(b).                                           allows EPA to establish a tolerance (the
                                             Public Reading Room is (202) 566–1744,                                    In addition to filing an objection or              legal limit for a pesticide chemical
pmangrum on DSK3GDR082PROD with RULES




                                             and the telephone number for the OPP                                    hearing request with the Hearing Clerk               residue in or on a food) only if EPA
                                             Docket is (703) 305–5805. Please review                                 as described in 40 CFR part 178, please              determines that the tolerance is ‘‘safe.’’
                                             the visitor instructions and additional                                 submit a copy of the filing (excluding               Section 408(b)(2)(A)(ii) of FFDCA
                                             information about the docket available                                  any Confidential Business Information                defines ‘‘safe’’ to mean that ‘‘there is a
                                             at http://www.epa.gov/dockets.                                          (CBI)) for inclusion in the public docket.           reasonable certainty that no harm will
                                             FOR FURTHER INFORMATION CONTACT:                                        Information not marked confidential                  result from aggregate exposure to the
                                             Michael Goodis, Registration Divison                                    pursuant to 40 CFR part 2 may be                     pesticide chemical residue, including


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Document Created: 2017-05-11 00:15:19
Document Modified: 2017-05-11 00:15:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactMichael 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
FR Citation82 FR 21941 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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