Document ID: EPA-HQ-OPP-2012-0009-0011
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fluazinam
Posted Date: 2012-11-07T05:00Z

[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Rules and Regulations]
[Pages 66723-66729]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27198]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0009; FRL-9366-6]

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 melon subgroup 9A and pepper/eggplant subgroup 8-
10B, associated with pesticide petition (PP) 1E7959; and soybean, seed 
and soybean, hulls, associated with PP 2F7977. Interregional Research 
Project Number 4 (IR-4) and ISK Biosciences Corporation requested the 
tolerances associated with PPs 1E7959 and 2F7977, respectively, under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 7, 2012. Objections and 
requests for hearings must be received on or before January 7, 2013, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0009, 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), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; email address: Nollen.Laura@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection

[[Page 66724]]

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-2012-0009 in the 
subject line on the first page of your submission. All objections and 
requests for a hearing must be in writing, and must be received by the 
Hearing Clerk on or before January 7, 2013. Addresses for mail and hand 
delivery of objections and hearing requests are provided in 40 CFR 
178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0009, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For-Tolerance

    In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-
9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1E7959) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.574 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), in or on fruiting vegetables group, 
pepper/eggplant subgroup 8-10B at 0.10 parts per million (ppm); and 
cucurbit vegetables, melon subgroup 9A at 0.08 ppm. That document 
referenced a summary of the petition prepared on behalf of IR-4 by ISK 
Biosciences Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov. Comments were received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
IV.C.
    Additionally, in the Federal Register of July 25, 2012 (77 FR 
43562) (FRL-9353-6), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a PP 2F7977 
by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 
44077. The petition requested that 40 CFR 180.574 be amended by 
establishing tolerances for residues of the fungicide fluazinam in or 
on soybean, seed at 0.01 ppm; and soybean, hulls at 0.02 ppm. That 
document referenced a summary of the petition prepared by ISK 
Biosciences Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon review of the data supporting the petitions, EPA has 
revised the tolerances for several commodities. The reason for these 
changes is 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 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.
    Following subchronic and chronic exposure to fluazinam, the liver 
appeared to be a primary target organ in rats, dogs, and mice. Signs of 
liver toxicity included changes in clinical chemistry (increased serum 
alkaline phosphatase and aspartate aminotransferase), increased 
absolute and/or relative liver weights, increased incidences of gross 
lesions (pale, enlarged, pitted, mottled, accentuated markings), and a 
variety of histopathological lesions. Treatment-related effects were 
also observed in other organs following subchronic and chronic exposure 
to fluazinam, but these effects were not consistently noted in all 
three species or in all studies in a given species. In a subchronic 
inhalation toxicity study in rats, pulmonary effects were observed at 
the mid and high doses. These effects included dose-related increases 
in lung/bronchial weights and increased incidences of alveolar 
macrophages and peribronchiolar proliferation in both sexes.
    In the developmental toxicity study in rabbits, treatment-related 
maternal effects (decreased food consumption and increased liver 
histopathology) were noted in the absence of fetal effects. In the 2-
generation rat reproduction study, decreased pup weight gain was seen 
at the highest dose tested, in the presence of decreased food 
consumption and liver histopathology in parental animals. In a 
developmental toxicity study in rats, fetal effects included decreases 
in body and placental weights, increased incidences of facial/palate 
clefts, diaphragmatic hernias, delayed ossification in several bone 
types, increases in late resorptions, as well as evidence of a greenish 
amniotic fluid and post-implantation loss. Maternal effects, including 
decreases in body weight gain/food consumption and increases in water

[[Page 66725]]

consumption and urogenital staining, were observed at the same dose 
level. In the rat developmental neurotoxicity (DNT) study, effects in 
pups (including decreases in body weight/body weight gain and delayed 
preputial separation) were noted in the absence of maternal toxicity.
    In an acute neurotoxicity study in rats, effects included decreases 
in motor activity and soft stools; these effects were considered to be 
due to systemic toxicity and not a result of frank neurotoxicity. No 
signs of neurotoxicity were observed in two subchronic neurotoxicity 
studies in rat up to the highest dose tested. A neurotoxic lesion 
described as vacuolation of the white matter of the central nervous 
system was observed in subchronic and chronic studies in mice and dogs; 
however, this lesion was found to be reversible and is attributed to an 
impurity. Based on the level of this impurity in technical grade 
fluazinam, the risk assessment for the parent compound is considered 
protective of the effects noted. In an immunotoxicity study in mice, 
significant suppressions of anti-sheep red blood cell antibody-forming 
cell assay response were demonstrated at the highest dose tested.
    In a rat carcinogenicity study, there was some evidence that 
fluazinam induced an increase in thyroid gland follicular cell tumors 
in male rats. There were statistically significant positive trends for 
thyroid gland follicular cell adenocarcinomas and combined follicular 
cell adenomas/adenocarcinomas. The incidences of thyroid gland adenomas 
seen at 100 ppm (3.8 mg/kg/day) and adenocarcinomas at 1,000 ppm were 
slightly outside their respective ranges for the historical controls. 
However, this increased incidence of thyroid tumors at 100 ppm was not 
observed in male rats in another chronic study. Further in the rat 
carcinogenicity study where these effects were seen, the animals in the 
lower dose groups were only microscopically examined for thyroid 
lesions if abnormalities were observed in that organ at gross necropsy 
and therefore, the incidences of thyroid tumors in the lower dose 
groups may have been somewhat misleading (too high). In one mouse 
carcinogenicity study, clear evidence of a treatment-related increase 
of hepatocellular tumors was observed in male mice; in another mouse 
carcinogenicity study, there was equivocal evidence that fluazinam may 
have induced an increase in hepatocellular tumors in male mice. There 
was no evidence of statistically significant tumor increases in female 
mice or rats in any study and no evidence of mutagenic activity in the 
submitted mutagenicity studies for fluazinam. EPA has classified 
fluazinam as having suggestive evidence of carcinogenicity. Due to the 
equivocal and inconsistent nature of the cancer response in the rat and 
mouse studies, the Agency determined that quantification of risk using 
a non-linear approach (i.e., RfD) will adequately account for all 
chronic toxicity, including carcinogenicity, that 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 document, ``Fluazinam. Human Health Risk 
Assessment to Support New Uses on Soybeans, the Melon Subgroup (9-A), 
and the Pepper/Eggplant Subgroup (8-10B), and to Support Registration 
Review'' at pages 43-49 in docket ID number EPA-HQ-OPP-2012-0009.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fluazinam used for 
human risk assessment is shown in Table 1 of this unit. To assess 
short-term dermal exposure, the dermal toxicity and dermal absorption 
studies were used to determine a refined dermal equivalent dose (RDD). 
To calculate a RDD, in vitro results using rat skin are corrected for 
any differences between in vitro and in vivo absorption rates and 
species differences between rats and humans. This refinement in dermal 
absorption is important because absorption by human skin is usually 
lower than that by rat skin. Accordingly, the combined use of the data 
from three dermal absorption studies and two testing systems offers 
greater precision in estimating human dermal absorption, which 
strengthens the reliability of the dermal risk assessment.

   Table 1--Summary of Toxicological Doses and Endpoints for Fluazinam for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/Scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years of  NOAEL = 7 milligrams/    Acute RfD = 0.07 mg/kg/  Developmental Toxicity
 age).                                  kilogram/day (mg/kg/     day.                     Study--Rabbits
                                        day).                   aPAD = 0.07 mg/kg/day..  LOAEL = 12 mg/kg/day
                                       UFA = 10x..............                            based on increased
                                       UFH = 10x..............                            incidence of total
                                       FQPA SF = 1x...........                            litter resorptions and
                                                                                          possible increased
                                                                                          incidence of fetal
                                                                                          skeletal
                                                                                          abnormalities.
----------------------------------------------------------------------------------------------------------------

[[Page 66726]]

 
Acute dietary (General population      NOAEL = 50 mg/kg/day...  Acute RfD = 0.5 mg/kg/   Acute Neurotoxicity--
 including infants and children).      UFA = 10x..............   day.                     Rats
                                       UFH = 10x..............  aPAD = 0.5 mg/kg/day...  LOAEL = 1000 mg/kg/day
                                       FQPA SF = 1x...........                            based on decreased
                                                                                          motor activity and
                                                                                          soft stools on day of
                                                                                          dosing.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL = 1.1 mg/kg/day..  Chronic RfD = 0.011 mg/  Co-critical:
                                       UFA = 10x..............   kg/day.                 Carcinogenicity--Mice
                                       UFH = 10x..............  cPAD = 0.011 mg/kg/day.  LOAEL = 10.7 mg/kg/day
                                       FQPA SF = 1x...........                            based on liver
                                                                                          histopathology and
                                                                                          increased liver weight
                                                                                         Chronic Dog
                                                                                         LOAEL = 10 mg/kg/day
                                                                                          based on marginal
                                                                                          increases in the
                                                                                          incidence of nasal
                                                                                          dryness in females and
                                                                                          the incidence/severity
                                                                                          of gastric lymphoid
                                                                                          hyperplasia in both
                                                                                          sexes.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days).....  Dermal study NOAEL= 10   RDD*= 24.4 mg/kg/day...  21-Day Dermal Toxicity--
                                        mg/kg/day.              LOC for MOE = 100......   Rats
                                       Refined Dermal                                    LOAEL= 100 mg/kg/day
                                        absorption rate =                                 based on liver effects
                                        2.44%.                                            (increased AST and
                                       UFA = 10x..............                            cholesterol levels).
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....           Non-linear RfD approach was used to assess cancer risk.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). * A Refined Dermal Equivalent Dose (RDD) of 24.4 mg/kg/day was
  calculated using the dermal POD and dermal absorption data.

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 National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). As to residue levels in food, EPA utilized 
tolerance-level residues, 100 percent crop treated (PCT) for all 
commodities, and used DEEM default processing factors, when 
appropriate.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA utilized tolerance-
level residues for all commodities except apple (for which the average 
field trial residue value was used), assumed 100 PCT for all 
commodities, and used DEEM default processing factors, when 
appropriate.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or non-linear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or non-linear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on the data summarized in Unit 
III.A., EPA has concluded that a nonlinear RfD approach is appropriate 
for assessing cancer risk to fluazinam. Cancer risk was assessed using 
the same exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue 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 residues of concern in

[[Page 66727]]

drinking water for risk assessment are parent fluazinam and its 
degradates, including DCPA, CAPA, DAPA, HYPA, and AMPA. The Agency used 
screening level water exposure models in the dietary exposure analysis 
and risk assessment for fluazinam and its degradates in drinking water. 
These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of fluazinam and its 
degradates. Further information regarding EPA drinking water models 
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of fluazinam and its 
degradates for surface water are estimated to be 226 parts per billion 
(ppb) for acute exposures and 37.8 ppb for chronic exposures. For 
ground water, the EDWCs are estimated to be 0.404 ppb for both acute 
and chronic exposures.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The water concentration values 
of 226 ppb and 37.8 ppb were used to assess the contribution to 
drinking water in the acute and chronic dietary risk assessments, 
respectively.
    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 following use that could result in residential 
exposures: On turf at golf courses only. EPA assessed potential 
residential short-term post-application dermal exposure from 
individuals, including adults, youth (11 to <16 years old), and 
children (6 to <11 years old), playing golf on treated turf. The short- 
and intermediate-term toxicological endpoints for fluazinam are the 
same for the dermal route of exposure. As a result, only the short-term 
dermal exposure was assessed. The resulting short-term risk estimates 
are considered to be protective of intermediate-term exposure and risk.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has not found 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://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology database for fluazinam includes rat and rabbit developmental 
toxicity studies, a 2-generation reproductive toxicity study in rats, 
and a DNT study in the rat. There was no evidence of increased 
quantitative or qualitative susceptibility in the rabbit developmental 
toxicity study or the rat 2-generation reproductive toxicity study; 
however, evidence of increased qualitative susceptibility of fetuses 
was observed in the rat developmental toxicity study and evidence of 
increased quantitative susceptibility of fetuses was observed in the 
rat DNT study.
    In the developmental toxicity study in rats, fetal effects 
(increased incidences of facial/palate clefts and other rare 
deformities in the fetuses) were observed in the presence of minimal 
maternal toxicity (decreased body weight gain and food consumption, and 
increased water consumption and urogenital staining). In the rat DNT 
study, decreases in body weight/body weight gain and a delay in 
completion of balano-preputial separation were observed in pups in the 
absence of maternal effects, suggesting increased quantitative 
susceptibility of the offspring.
    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. There is no evidence that fluazinam results in increased 
susceptibility in in utero rabbits in the prenatal developmental 
studies or in young rats in the 2-generation reproduction study; 
however, increased qualitative susceptibility was noted in the rat 
developmental toxicity study. The degree of concern for the observed 
effects is low because fetal effects were observed only at the highest 
dose tested in the presence of maternal toxicity, and there is a clear 
NOAEL for the fetal effects seen. Additionally, the NOAEL (50 mg/kg/
day) identified in the developmental toxicity study in rats is 
significantly higher than the NOAEL used (7 mg/kg/day) to establish the 
aRfD for females 13-49. Therefore, the aRfD is protective of any 
potential developmental effects and there are no residual uncertainties 
for prenatal and/or postnatal toxicity.
    Additionally, while a DNT study in rat did not show evidence of 
neurotoxicity, the study showed evidence of increased quantitative 
susceptibility of offspring. Although the NOAEL for this study (2 mg/
kg/day) is lower than that used for the aRfD for females 13-49 (7 mg/
kg/day), the effects noted in the DNT study are considered to be 
postnatal effects attributable to multiple doses; therefore, the study 
endpoint is not appropriate for acute dietary exposures. The cRfD 
(0.011 mg/kg/day) is based on a lower NOAEL (1.1 mg/kg/day), and is 
considered to be protective of potential developmental effects. 
Therefore, the degree of concern is low for the observed effects and 
there are no residual uncertainties with regard to prenatal and/or 
postnatal neurotoxicity.
    iii. There are no residual uncertainties identified in the exposure 
databases. The acute and chronic dietary food exposure assessments were 
performed based on 100 PCT for all commodities. Additionally, the acute 
assessment is based on tolerance-level residues for all commodities, 
and the chronic assessment is based on tolerance-level

[[Page 66728]]

residues for all commodities except apple (for which the average field 
trial value was used). These assumptions result in high-end estimates 
of dietary exposure. EPA made conservative (protective) assumptions in 
the ground water and surface water modeling used to assess exposure to 
fluazinam in drinking water. EPA used similarly conservative 
assumptions to assess post-application exposure of children. Incidental 
oral exposure of toddlers is not expected from any use pattern for 
fluazinam. 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 28% of the aPAD for females 13-49 years old; 
and 21% of the aPAD for children 1-2 years old, the population group 
receiving the greatest exposure for the general population, including 
infants and children.
    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 51% of the cPAD for children 
1-2 years old, 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 730 for children 
6-<11 years old, 880 for youth 11-<16 years old, and 970 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). Based on the discussion in Unit III.C.3., short-term risk 
estimates are considered to be protective of intermediate-term exposure 
and risk.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit III.A., EPA has concluded that the cPAD is 
protective of possible cancer effects.
    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 detection (GC/
ECD) method (6148-94-0170-MD-001) is available to enforce fluazinam 
tolerances on plant commodities. An adequate enforcement method for the 
determination of AMGT is also available. The method is a high 
performance liquid chromatography with ultraviolet detection (HPLC/UV) 
enforcement method entitled ``Method Evaluation for the Analysis of 
AMGT in Grapes.''
    The methods 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 a MRL for fluazinam on the 
commodities associated with this action.

C. Response to Comments

    EPA received several comments to the docket, EPA-HQ-OPP-2012-0009; 
however, only one of these public submissions was in response to the 
Notice of Filing for PP 1E7959, while the remaining comments pertained 
to unrelated petitions in the Federal Register notice. For PP 1E7959, 
the commenter stated that no residue should be allowed for fluazinam 
and that they do not support manufacture or use of this product. The 
Agency understands the commenter's concerns and recognizes that some 
individuals believe that pesticides should be banned on agricultural 
crops. However, the existing legal framework provided by section 408 of 
the Federal Food, Drug, and Cosmetic Act (FFDCA) states that tolerances 
may be set when persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute. This citizen's comment appears to be directed at the 
underlying statute and not EPA's implementation of it; the citizen has 
made no contention that EPA has acted in violation of the statutory 
framework. In addition, the commenter included several adverse effects 
they believed were seen in animal toxicology studies for fluazinam. EPA 
has found that there is a reasonable certainty of no harm to humans 
after considering the toxicological studies and the exposure levels of 
humans to fluazinam.

D. Revisions to Petitioned-For-Tolerances

    Based on the data supporting the petitions, EPA revised the 
proposed tolerances on melon subgroup 9A from 0.08 ppm to 0.07 ppm; 
pepper/eggplant subgroup 8-10B from 0.10 ppm to 0.09 ppm; and soybean, 
hulls from 0.02 ppm to 0.05 ppm. The Agency revised these tolerance 
levels based on analysis of the residue field trial data using the 
Organization for Economic Cooperation and Development (OECD) tolerance 
calculation procedures.

[[Page 66729]]

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), in or on melon subgroup 9A at 0.07 
ppm; pepper/eggplant subgroup 8-10B at 0.09 ppm; soybean, seed at 0.01 
ppm; and soybean, hulls at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations that Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: October 26, 2012.
Daniel J. Rosenblatt,
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, alphabetically add the following commodities to 
the table in paragraph (a)(1) to read as follows:

Sec.  180.574  Fluazinam; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
------------------------------------------------------------------------
                                * * * * *
Melon subgroup 9A..........................................         0.07
------------------------------------------------------------------------
 
                                * * * * *
Pepper/eggplant subgroup 8-10B.............................         0.09
------------------------------------------------------------------------
 
                                * * * * *
Soybean, seed..............................................         0.01
------------------------------------------------------------------------
Soybean, hulls.............................................         0.05
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-27198 Filed 11-6-12; 8:45 am]
BILLING CODE 6560-50-P