Document ID: EPA-HQ-OPP-2015-0197-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fluazinam
Posted Date: 2016-04-08T04:00Z

[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Rules and Regulations]
[Pages 20545-20550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08138]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0197; FRL-9942-99]

Fluazinam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluazinam in or on cabbage, mayhaw, the cucurbit vegetable crop group 
9, and the tuberous and corm vegetable subgroup 1C and amends the 
existing tolerance for ``vegetable, Brassica leafy, group 5'' to read 
``vegetable, Brassica leafy, group 5, except cabbage.'' Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

[[Page 20546]]

DATES: This regulation is effective April 8, 2016. Objections and 
requests for hearings must be received on or before June 7, 2016, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0197, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2015-0197 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 
June 7, 2016. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0197, 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 20, 2015 (80 FR 28925) (FRL-9927-
39), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
5E8349) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 
08540. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide fluazinam (3-
chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-
(trifluoromethyl)-2-pyridinamine), including its metabolites and 
degradates in or on mayhaw at 2.0 parts per million (ppm); cabbage at 
3.0 ppm; the squash/cucumber subgroup 9B at 0.05 ppm; and vegetable, 
tuberous and corm, subgroup 1C at 0.02 ppm. The petition also requested 
to amend the tolerances in 40 CFR 180.574 in or on the vegetable, 
Brassica leafy, group 5 at 0.01 by changing it to read ``vegetable, 
Brassica leafy, group 5, except cabbage'' at 0.01 ppm and by removing 
the existing tolerance on potato at 0.02 ppm upon approval of the 
requested tolerance on the tuberous and corm subgroup 1C. That document 
referenced a summary of the petition prepared by ISK Biosciences, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    EPA is combining the existing tolerance for the melon subgroup 9A 
tolerance with the proposed squash/cucumber subgroup 9B tolerance and 
establishing a tolerance for the entire cucurbit vegetable crop group 
9, rather than just subgroup 9B. The reason for these changes is 
explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has

[[Page 20547]]

sufficient data to assess the hazards of and to make a determination on 
aggregate exposure for fluazinam including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with fluazinam follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The liver is a primary target organ for fluazinam and numerous 
liver effects were observed in rats, mice, and dogs after oral and 
dermal exposure. After inhalation exposure, portal of entry effects 
(increased lung/bronchial weights, alveolar macrophages and 
peribronchiolar proliferation) were seen.
    Clinical signs were observed in an acute oral neurotoxicity study 
in rats; decreases in motor activity and soft stools were seen on the 
day of dosing at the limit dose. These effects were attributed to 
systemic toxicity and were not considered to be evidence of frank 
neurotoxicity. In two subchronic neurotoxicity studies (evaluated 
together) in rats, no evidence of neurotoxicity was observed. A 
neurotoxic lesion was observed initially in long-term studies in mice 
and dogs; however, the lesion is reversible and was later attributed to 
the presence of an impurity (Impurity-5) in the technical material. A 
NOAEL for the impurity was determined (based on the maximum 
concentration of Impurity-5 in technical grade fluazinam), equivalent 
to a NOAEL for central nervous system (CNS) effects of 20 mg/kg/day for 
technical grade fluazinam. The current acute and chronic reference 
doses selected for risk assessment are lower than the determined NOAEL 
and thus, protective of any possible neurotoxic effects resulting from 
exposure to Impurity-5.
    In an immunotoxicity study in mice, significant suppressions of 
anti-SRBC AFC assay response were demonstrated at the highest dose 
tested indicating potential immunotoxicity. However, clear NOAELs and 
LOAELs were identified for the effects seen in the study and the points 
of departure (PODs) and endpoints selected for risk assessment are 
protective of immunotoxic effects.
    There was no evidence of increased quantitative or qualitative 
susceptibility in the rabbit developmental or rat reproduction studies. 
However, quantitative susceptibility was seen in rat developmental and 
developmental neurotoxicity (DNT) studies where fetal/offspring effects 
were observed in the absence of maternal toxicity. The concern is low 
for the increased susceptibility noted in the studies since clear 
NOAELs are established, and the most sensitive endpoints/PODs are used 
for risk assessment and are protective of the observed susceptibility. 
Therefore, the Food Quality Protection Act (FQPA) safety factor (SF) 
has been reduced to 1x.
    Fluazinam is classified as having ``Suggestive evidence of 
carcinogenicity, but not sufficient to assess human carcinogenic 
potential,'' based on increases in thyroid gland follicular cell tumors 
in male rats and increases in hepatocellular tumors in male mice. 
Although there is evidence of thyroid tumors in male rats and liver 
tumors in male mice, the NOAEL used (1.12 mg/kg/day) for establishing 
the chronic reference dose (cRfD) is approximately 3-fold lower than 
the lowest dose that induced tumors (3.8 mg/kg/day). The Agency has 
determined that quantification of cancer risk using a non-linear 
approach (cRfD) would adequately account for all chronic toxicity, 
including carcinogenicity, which could result from exposure to 
fluazinam.
    Specific information on the studies received and the nature of the 
adverse effects caused by fluazinam 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 the document titled ``Fluazinam. Human Health 
Risk Assessment to Support Section 3 Registration for New Uses on 
Tuberous and Corm, Subgroup 1C, Mayhaw, Squash/Cucumber Subgroup 9B; 
Amended Uses on Cabbage'' on page 44 in docket ID number EPA-HQ-OPP-
2015-0197.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for fluazinam used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of November 7, 2012 (77 FR 66723) 
(FRL-9366-6).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluazinam, EPA considered exposure under the petitioned-for 
tolerances as well as all existing fluazinam tolerances in 40 CFR 
180.574. EPA assessed dietary exposures from fluazinam in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Such effects were identified 
for fluazinam. In estimating acute dietary exposure, EPA used food 
consumption information from the 2003-2008 United States 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, the acute analysis is based on tolerance-level residues for all 
commodities and uses high-end residue estimates for the metabolite AMGT 
((3-[[4-amino-3-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]amino]-2-
nitro-6-(trifluoromethyl) phenyl]thio]-2-(beta-D-glucopyranosyloxy) 
propionic acid)). In addition, the acute assessment assumes 100 percent 
crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. As to residue levels in food, the chronic

[[Page 20548]]

analysis is based on tolerance-level residues for all commodities 
except apples. For apples, the average field trial value was used. As 
with the acute assessment, it incorporates high-end estimates for AMGT, 
100 PCT assumptions, default processing factors for all relevant 
processed commodities without a separate tolerance.
    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 fluazinam. Cancer risk was assessed using the same 
exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fluazinam and its transformation products, including 
DCPA (6-(4-carboxy-3-chloro-2,6-dinitroanilino)-5-chloronicotinic 
acid), CAPA (3-chloro-6-(3-chloro-2,6-dinitro-4-trifluoromethyl 
anilino)nicotinic acid), DAPA (3-chloro-N\4\-(3-chloro-5-
trifluoromethyl-2-pyridyl)-[alpha],[alpha],[alpha]-trifluorotoluene-
3,5,5-triamine; 3-chloro-2(2,6-diamino-3-chloro-
[alpha],[alpha],[alpha]-trifluoro-p-toluidino)-5-(trifluoromethyl) 
pyridine), HYPA (5-[[3-chloro-5-(trifluoromethyl-2-pyridyl]amino]-
[alpha],[alpha],[alpha]-trifluoro-4,6-dinitro-o-cresol), and AMPA (2-
(6-amino-3-chloro-[alpha],[alpha],[alpha]-trifluoro-2-nitro-p-
toluidino)-3-chloro-5-(trifluoromethyl)pyridine).
    These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of fluazinam and its 
transformation products. Further information regarding EPA drinking 
water models used in pesticide exposure assessment can be found at 
http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) and the 
Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated 
drinking water concentrations (EDWCs) for total residues of fluazinam 
and its transformation products for acute exposures are estimated to be 
226 parts per billion (ppb) for surface water and 137 ppb for ground 
water and for chronic exposures are estimated to be 37.8 ppb for 
surface water and 119 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 226 ppb was used to assess 
the contribution to drinking water, and for the chronic dietary risk 
assessment, the water concentration of value 119 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).
    Fluazinam is currently registered for the following uses that could 
result in residential exposures: golf course turf. EPA assessed 
residential exposure using the following assumptions: Only short-term 
dermal exposure is expected for residential post-application scenarios 
for children, teens, and adults who could potentially be exposed when 
they play golf on treated turf. No other residential exposures are 
expected. 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 fluazinam to share a common mechanism of toxicity 
with any other substances, and fluazinam does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that fluazinam 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 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. There was no evidence of 
increased quantitative or qualitative susceptibility in the rabbit 
developmental or rat reproduction studies. However, quantitative 
susceptibility was seen in rat developmental and DNT studies where 
fetal/offspring effects were observed in the absence of maternal 
toxicity. The concern is low for the increased susceptibility noted in 
the studies since clear NOAELs are established, and the most sensitive 
endpoints/PODs are used for risk assessment and are protective of the 
observed susceptibility.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for fluazinam is complete.
    ii. Although indications of neurotoxicity and immunotoxicity were 
observed in the database for fluazinam, there were clear NOAELs for 
these effects, and the endpoints and doses for risk assessment are 
protective of the potential effects.
    iii. There is no evidence that fluazinam results in increased 
susceptibility in the rabbit developmental or rat reproduction studies. 
However, quantitative susceptibility was seen in rat developmental and 
DNT studies where fetal/offspring effects were observed in

[[Page 20549]]

the absence of maternal toxicity. The concern is low for the increased 
susceptibility noted in the studies since clear NOAELs are established, 
and the most sensitive endpoints/PODs are used for risk assessment.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues for all commodities except 
apples, where anticipated residues were used in the chronic assessment. 
EPA made conservative (protective) assumptions in the ground and 
surface water modeling used to assess exposure to fluazinam and its 
transformation products in drinking water. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children. These assessments will not underestimate the exposure and 
risks posed by fluazinam.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to fluazinam will occupy 32% of the aPAD for females 13-49 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fluazinam from food and water will utilize 92% of the cPAD for all 
infants, the population group receiving the greatest exposure. Based on 
the explanation in Unit III.C.3., regarding residential use patterns, 
chronic residential exposure to residues of fluazinam is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Fluazinam is 
currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to fluazinam.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 690 for children 
6 to <11 years old, 820 for youth 11 to <16 years old and 890 for 
adults. Because EPA's level of concern for fluazinam is a MOE of 100 or 
below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
fluazinam is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
fluazinam.
    5. Aggregate cancer risk for U.S. population. EPA assessed cancer 
risk using a non-linear approach (i.e., RfD) since it adequately 
accounts for all chronic toxicity, including carcinogenicity, that 
could result from exposure to fluazinam. As the chronic dietary 
endpoint and dose are protective of potential cancer effects, fluazinam 
is not expected to pose an aggregate cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to fluazinam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate Gas Chromatography with Electron Capture Detector (GC/
ECD) method is available for enforcing fluazinam tolerances on plant 
commodities.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

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

C. Revisions to Petitioned-For Tolerances

    Because the tolerance level for the existing melon subgroup 9A is 
the same as the squash/cucumber subgroup 9B tolerance the Agency is 
establishing, the Agency is combining the tolerances for the two 
subgroups and establishing a tolerance for the entire cucurbit 
vegetable crop group 9.

V. Conclusion

    Therefore, tolerances are established for residues of fluazinam (3-
chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-
(trifluoromethyl)-2-pyridinamine), including its metabolites and 
degradates in or on mayhaw at 2.0 ppm; cabbage at 3.0 ppm; cucurbit 
vegetables crop group 9 at 0.07 ppm; and vegetable, tuberous and corm, 
subgroup 1C at 0.02 ppm. In addition, the existing tolerance on the 
vegetable, Brassica leafy, group 5 at 0.01 is modified to read 
``vegetable, Brassica leafy, group 5, except cabbage'' at 0.01 ppm and 
the existing tolerance on potato at 0.02 ppm is removed as unnecessary 
since it is covered by the tolerance on the tuberous and corm subgroup 
1C, and the melon subgroup 9A tolerance is removed since it is now 
replaced by the cucurbit vegetables crop group 9 tolerance.

[[Page 20550]]

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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This 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 31, 2016.
G. Jeffrey Herndon,
Acting 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.  180.574, amend the table in paragraph (a)(1) as follows:
0
a. Alphabetically add the entries ``Cabbage'' and ``Mayhaw''.
0
b. Remove the entries ``Melon subgroup 9A'' and ``Potato''.
0
c. Remove the entry for ``Vegetable, Brassica leafy, group 5'' and 
alphabetically add entries for ``Vegetable, Brassica leafy, group 5, 
except cabbage'' and ``Vegetable, tuberous and corm, subgroup 1C``.
    The additions read as follows:

Sec.  180.574  Fluazinam; tolerances for residues.

    (a) * * * (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cabbage...................................................          3.0
 
                                * * * * *
Mayhaw....................................................          2.0
 
                                * * * * *
Vegetable, Brassica leafy, group 5, except cabbage........          0.01
Vegetable, cucurbit, group 9..............................          0.07
 
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C.................          0.02
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-08138 Filed 4-7-16; 8:45 am]
 BILLING CODE 6560-50-P