Document ID: EPA-HQ-OPP-2009-0032-0008
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fluazinam
Posted Date: 2010-05-12T04:00Z

[Federal Register: May 12, 2010 (Volume 75, Number 91)]
[Rules and Regulations]               
[Page 26662-26668]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my10-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0032; FRL-8824-5]

 
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 bushberry subgroup 13-07B; onion, bulb, subgroup 3-
07A; lettuce, head; and lettuce, leaf. This regulation additionally 
removes several established individual commodities and bushberry 
subgroup 13B, as they will be superseded by inclusion in bushberry 
subgroup 13-07B. Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective May 12, 2010. Objections and 
requests for hearings must be received on or before July 12, 2010, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0032. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

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; e-mail 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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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 cite at http://www.gpoaccess.gov/ecfr. To 
access the harmonized test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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

[[Page 26663]]

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-2009-0032 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 
12, 2010. 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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2009-0032, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
8E7506) by IR-4, 500 College Road East, Suite 201 W, 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 lettuce, head at 0.02 parts 
per million (ppm); lettuce, leaf at 2.0 ppm; onion, bulb, subgroup 3-
07A at 0.15 ppm; and bushberry subgroup 13-07B at 4.5 ppm. The petition 
additionally requested to remove the established tolerances in or on 
aronia berry, buffalo currant, Chilean guava, European barberry, 
highbush cranberry, edible honeysuckle, jostaberry, Juneberry, 
lingonberry, native currant, salal, sea buckthorn, and bushberry 
subgroup 13B at 7.0 ppm. The published notice of the petition 
referenced a summary of the petition prepared on behalf of IR-4 by ISK 
Biosciences, the registrant, which is available in the docket, http://
www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerances for bushberry subgroup 13-07B and 
onion, bulb, subgroup 3-07A. EPA has also revised the tolerance 
expression for all established commodities to be consistent with 
current Agency policy. The reasons for these changes are explained in 
Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 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 postimplantation loss. Maternal 
effects, including decreases in body weight gain/food consumption and 
increases in water 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 (HDT). 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 (impurity 5). Based on the level of this impurity in technical 
grade fluazinam, the risk assessment for the

[[Page 26664]]

parent compound is considered protective of the effects noted.
    In a rat carcinogenicity study, there was some evidence that 
fluazinam induced an increase in thyroid gland follicular cell tumors 
in male rats. 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.
    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 for the Proposed Uses on Apples, Carrots, Lettuce, and the 
Bulb Onion Subgroup (3-07A), and a Request for a Reduced Tolerance on 
the Bushberry Subgroup (13-07B),'' pp. 60-65 in docket ID number EPA-
HQ-OPP-2009-0032.

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 the table of this unit.

       Table--Summary of Toxicological Doses and Endpoints for fluazinam for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 7milligrams/     Acute RfD = 0.07 mg/kg/  Developmental Toxicity
(Females 13-49 years of 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.
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 50 mg/kg/day     Acute RfD = 0.5 mg/kg/   Acute Neurotoxicity-
(General population including infants  UFA = 10x..............   day                      Rats
 and children).                        UFH = 10x..............  aPAD = 0.5 mg/kg/day...  LOAEL = 1,000 mg/kg/day
                                       FQPA SF =1x............                            based on decreased
                                                                                          motor activity and
                                                                                          soft stools on day of
                                                                                          dosing.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL = 1.1 mg/kg/day    Chronic RfD = 0.011 mg/  Carcinogenicity-Mice
(All populations)....................  UFA = 10x..............   kg/day                   LOAEL = 10.7 mg/kg/day
                                       UFH = 10x..............  cPAD = 0.011 mg/kg/day.   based on liver
                                       FQPA SF = 1x...........                            histopathology and
                                                                                          increased liver
                                                                                          weight.
----------------------------------------------------------------------------------------------------------------
Cancer                                    Classification: Suggestive Evidence of Carcinogenicity. The cRfD is
(Oral, dermal, inhalation)...........                         protective of cancer effects.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

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 United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels in food, EPA 
utilized tolerance-level residues and assumed 100 percent crop treated 
(PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. 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) and assumed 100 PCT for all 
commodities.

[[Page 26665]]

    iii. Cancer. Fluazinam has been classified as having suggestive 
evidence of carcinogenicity. This determination is based on weight of 
evidence considerations where a concern for potential carcinogenic 
effects in humans is raised, but the animal data are judged not 
sufficient for a stronger conclusion.
    Carcinogenicity studies were conducted in rats and mice. In rats, 
increased incidences of thyroid gland follicular cell tumors were seen 
in males but not in females. In mice, there were conflicting results 
with regard to hepatocarcinogenicity. In one study, benign and 
malignant liver tumors were seen in males; no liver tumors were seen in 
females. In the second study, carcinogenic response was equivocal and 
tumors did not occur in a dose-related manner. In males, the dose that 
induced liver tumors in the first study failed to induce liver tumors 
in the same strain of mice in the second study. In the second study, in 
females, liver tumors were seen only at an excessive toxic dose. There 
was no evidence of mutagenicity either in in vivo or in vitro assays. 
No chemicals structurally related to fluazinam were identified as 
carcinogens.
    Since the evidence for carcinogenicity is not sufficient to 
indicate anything greater than a suggestion of a carcinogenic 
potential, EPA concludes that quantification of cancer risk would not 
be scientifically appropriate, as it attaches greater significance to 
the positive cancer findings than the entire dataset warrants. Further, 
due to the equivocal and inconsistent nature of the cancer response in 
the rat and mouse studies (in rats, effects seen only in males; in 
mice, one study showed effects only in males but even these effects 
were not reproducible), EPA finds that when judged qualitatively the 
data indicate no greater than a negligible risk of cancer. The Agency 
has determined that the POD (1.1 mg/kg/day) selected for deriving the 
cRfD is protective of all chronic effects, including the equivocal 
cancer effects; therefore, the chronic dietary exposure assessment was 
relied upon for assessing cancer risk.
    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 section 408(f)(1) of 
FFDCA 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 section 408(b)(2)(E) of 
FFDCA and authorized under section 408(f)(1) of FFDCA. 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 
drinking water for risk assessment are parent fluazinam and its 
degradates, including DCPA, CAPA, DAPA, and HYPA. 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 117 parts per billion 
(ppb) for acute exposures and 19.8 ppb for chronic exposures. For 
ground water, the EDWCs are estimated to be 0.216 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 117 ppb and 19.8 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 not 
registered for any specific use patterns that would result in 
residential exposure.
    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 website 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 Food Quality 
Protection Act (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 prenatal 
developmental toxicity studies, a 2-generation reproductive toxicity 
study in rats, and a DNT study in rats. 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.

[[Page 26666]]

    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, except for 
immunotoxicity testing. Recent changes to 40 CFR part 158 make 
immunotoxicity testing (Harmonized Guideline 870.7800) required for 
pesticide registration; however, the existing data are sufficient for 
endpoint selection for exposure/risk assessment scenarios, and for 
evaluation of the requirements under the FQPA. The available data for 
fluazinam show no evidence of treatment-related effects on the immune 
system, and the Agency does not believe that conducting an 
immunotoxicity study will result in a lower POD than that currently 
selected for overall risk assessment. Therefore, an additional database 
uncertainty factor to account for potential immunotoxicity does not 
need to be applied.
    ii. A DNT study in rat is available and shows 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. Although there is qualitative evidence of increased 
susceptibility following in utero exposure to fluazinam in the rat 
developmental toxicity study, the degree of concern for the observed 
effects is low. Fetal effects were observed only at the HDT and 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.
    iv. 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 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 
and surface water modeling used to assess exposure to fluazinam in 
drinking water. Fluazinam is not registered for any specific use 
patterns that would result in residential exposure. 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 20% of the aPAD for females 13-49 years old 
and 20% of the aPAD for children 1-2 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 40% of the cPAD for all 
infants less than 1 year old, the population group receiving the 
greatest exposure. There are no residential uses for fluazinam.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposures takes into account short- and intermediate-term 
residential exposures plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, fluazinam 
is not registered for any use patterns that would result in short- or 
intermediate-term residential exposures. Short- and intermediate-term 
risk is assessed based on short- and intermediate-term residential 
exposures plus chronic dietary exposure. Because there are no short- or 
intermediate-term residential exposures 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 short-term 
risk), no further assessment of short- or intermediate-term risk is 
necessary, and EPA relies on the chronic dietary risk assessment for 
evaluating short- and intermediate-term risk for fluazinam.
    4. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit III.A., EPA has concluded that the cPAD is 
protective of possible cancer effects. Because chronic exposure is 20% 
of the cPAD for the most highly exposed population subgroups, cancer 
risk resulting from exposure to fluazinam is not of concern.
    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 fluazinam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology, gas chromatography with 
electron capture detection (GC/ECD), is available to enforce the 
tolerance expression for crop matrices. A high performance liquid 
chromatography with ultraviolet detection (HPLC/UV) enforcement method 
is also available to enforce the tolerance expression for wine grapes, 
which includes residues of the metabolite AMGT. These 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; e-mail 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 U.N. 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

[[Page 26667]]

that is different from a Codex MRL; however, FFDCA section 408(b)(4) 
requires that EPA explain the reasons for departing from the Codex 
level.
    There are currently no Codex or Mexican MRLs established for 
residues of fluazinam in or on the commodities associated with this 
petition. However, Canada has an approved MRL for the use of fluazinam 
on bushberry subgroup 13B at 7.0 ppm, which is based on an earlier 
joint review effort between the Canadian Pesticide Management 
Regulatory Agency (PMRA) and EPA.

C. Revisions to Petitioned-For Tolerances

    Based on analysis of the data supporting the petition, EPA has 
revised the proposed tolerance for onion, bulb, subgroup 3-07A from 
0.15 ppm to 0.20 ppm. EPA revised this tolerance level based on 
analysis of the residue field trial data using the Agency's Tolerance 
Spreadsheet in accordance with the Agency's Guidance for Setting 
Pesticide Tolerances Based on Field Trial Data. EPA has also revised 
the tolerance expression to clarify:
    1. That, as provided in section 408(a)(3) of FFDCA, the tolerance 
covers metabolites and degradates of fluazinam not specifically 
mentioned; and
    2. That compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.
    Additionally, the Agency has revised the proposed tolerance for 
bushberry subgroup 13-07B from 4.5 ppm to 7.0 ppm. Permanent tolerances 
exist for residues of fluazinam in or on bushberry subgroup 13B and 
several individual bushberry commodities (aronia berry, buffalo 
currant, Chilean guava, European barberry, highbush cranberry, edible 
honeysuckle, jostaberry, juneberry, lingonberry, native currant, salal, 
and sea buckthorn) at 7.0 ppm. IR-4 petitioned the Agency to establish 
a tolerance for the revised bushberry subgroup 13-07B at 4.5 ppm, which 
would supersede the tolerances for both bushberry subgroup 13B and the 
individual bushberry tolerances. After reevaluating the existing data 
in support of the bushberry subgroup 13-07B tolerance in accordance 
with the Agency's Guidance for Setting Pesticide Tolerances Based on 
Field Trial Data, EPA has determined that the probability plot for the 
residue data are lognormally distributed and that the bushberry 
subgroup 13-07B tolerance should be established at 7.0 ppm. The revised 
tolerance for bushberry subgroup 13-07B at 7.0 ppm is equivalent to the 
existing tolerances for the individual bushberry commodities and 
bushberry subgroup 13B. Further, the 7.0 ppm tolerance on bushberry 
harmonizes with a MRL established in Canada, as discussed in Unit IV.B.

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 bushberry subgroup 13-07B 
at 7.0 ppm; lettuce, head at 0.02 ppm; lettuce, leaf at 2.0 ppm; and 
onion, bulb, subgroup 3-07A at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: May 4, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.574 is amended as follows:
0
i. Revise the introductory text of paragraph (a)(1);

[[Page 26668]]

0
ii. Remove the entries for ``Aronia berry''; ``Buffalo currant''; 
``Bushberry subgroup 13B''; ``Chilean guava''; ``European barberry''; 
``Highbush cranberry''; ``Honeysuckle, edible''; ``Jostaberry''; 
``Juneberry''; ``Lingonberry''; ``Native currant''; ``Salal''; and 
``Sea buckthorn'' from the table in paragraph (a)(1);
0
iii. Alphabetically add commodities to the table in paragraph (a)(1); 
and
0
iv. Revise the introductory text of paragraph (a)(2).
    The amendments read as follows:

Sec.  180.574  Fluazinam; tolerances for residues.

    (a) * * * (1) 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 the commodities in the table below. Compliance 
with the tolerance levels specified below is to be determined by 
measuring only fluazinam.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Bushberry subgroup 13-07B............................                7.0
                                * * * * *
Lettuce, head........................................               0.02
Lettuce, leaf........................................                2.0
Onion, bulb, subgroup 3-07A..........................               0.20
                                * * * * *
------------------------------------------------------------------------

    (2) Tolerances are established for residues of fluazinam, including 
its metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified below is to be 
determined by measuring only fluazinam and its 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).
* * * * *

[FR Doc. 2010-11302 Filed 5-11-10; 8:45 am]
BILLING CODE 6560-50-S