Document ID: EPA-HQ-OPP-2007-0234-0003
Agency: epa
Document Type: Rule
Title: Fluazinam; Pesticide Tolerance
Posted Date: 2007-10-24T04:00Z

[Federal Register: October 24, 2007 (Volume 72, Number 205)]
[Rules and Regulations]               
[Page 60255-60261]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc07-14]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0234; FRL-8152-4]

 
Fluazinam; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluazinam in or on aronia berry; buffalo currant; bushberry subgroup 
13B; Chilean guava; European barberry; ginseng; highbush cranberry; 
honeysuckle, edible; jostaberry; juneberry; lingonberry; native 
currant; pea and bean, dried shelled, except soybean, subgroup 6C, 
except pea; pea and bean, succulent shelled, subgroup 6B, except pea; 
salal; sea buckthorn; turnip, greens; vegetable, Brassica leafy, group 
5; and vegetable, legume, edible-podded, subgroup 6A, except pea. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 24, 2007. Objections and 
requests for hearings must be received on or before December 24, 2007, 
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-2007-0234. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow

[[Page 60256]]

the instructions on the regulations.gov website to view the docket 
index or access available documents. All documents in the docket are 
listed in the docket index available in 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: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: stanton.susan@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), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0234 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before December 24, 2007.
    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-2007-0234, 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'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 30, 2007 (72 FR 21261-21263) (FRL-
8124-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
6E7137 and 6E7139) by Interregional Research Project Number 4 (IR-4), 
500 College Road East, Suite 201W, Princeton, New Jersey, 08540. PP 
6E7137 requested that 40 CFR 180.574 be amended by establishing 
tolerances for residues of the fungicide fluazinam in or on Vegetable, 
legume, edible podded, subgroup 6A, except pea at 0.15 parts per 
million (ppm); Brassica, leafy greens, subgroup 5B at 0.02 ppm; 
Brassica, head and stem, subgroup 5A at 0.01 ppm; and turnip, tops at 
0.02 ppm; and residues of fluazinam and its metabolite AMGT in or on 
Bushberry subgroup 13B; berry, aronia; blueberry, lowbush; currant, 
buffalo; guava, chilean; barberry, European; cranberry, highbush; 
honeysuckle; jostaberry; Juneberry; lingonberry; currant, native; 
salal; and buckthorn, sea at 4.5 ppm. PP 6E7139 requested that 40 CFR 
180.574 be amended by establishing tolerances for residues of fluazinam 
in or on ginseng at 3.0 ppm; bean, dry at 0.01 ppm; and pea and bean, 
succulent shelled, subgroup 6B, except pea at 0.02 ppm. That notice 
referenced a summary of the petition prepared by ISK Biosciences 
Corporation, the registrant, which is available to the public 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 
modified commodity terms and/or tolerance levels for most commodities. 
EPA has also determined that the tolerances for berries should include 
parent fluazinam only. The reasons for these changes are explained in 
Unit V.

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

[[Page 60257]]

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. . . 
. '' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    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 the petitioned-for 
tolerances for residues of fluazinam on Aronia berry at 7.0 ppm; 
buffalo currant at 7.0 ppm; bushberry subgroup 13B at 7.0 ppm; Chilean 
guava at 7.0 ppm; European barberry at 7.0 ppm; ginseng at 4.5 ppm; 
highbush cranberry at 7.0 ppm; honeysuckle, edible at 7.0 ppm; 
jostaberry at 7.0 ppm; juneberry at 7.0 ppm; lingonberry at 7.0 ppm; 
native currant at 7.0 ppm; pea and bean, dried shelled, except soybean, 
subgroup 6C, except pea at 0.02 ppm; pea and bean, succulent shelled, 
subgroup 6B, except pea at 0.04 ppm; salal at 7.0 ppm; sea buckthorn at 
7.0 ppm; turnip, greens at 0.01 ppm; vegetable, Brassica leafy, group 5 
at 0.01 ppm; and vegetable, legume, edible-podded, subgroup 6A, except 
pea at 0.10 ppm. EPA's assessment of exposures and risks associated 
with establishing these tolerances 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. 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 ``Fluazinam: Human Health Risk 

Assessment for Proposed Use on Edible-Podded Beans, Shelled Succulent 
and Dried Beans, Brassica Leafy Vegetables, Bushberries, and Ginseng''. 
The referenced document is available in the docket established by this 
action, which is described under ADDRESSES, and is identified as EPA-
HQ-OPP-2007-0234-0003 in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable UFs. Short-, intermediate-, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. 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 can be found at http://www.regulations.gov in 

document ``Fluazinam: Human Health Risk Assessment for Proposed Use on 
Edible-Podded Beans, Shelled Succulent and Dried Beans, Brassica Leafy 
Vegetables, Bushberries, and Ginseng'' at pages 25-26 in docket ID 
number EPA-HQ-OPP-2007-0234.

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 also considered exposure to residues of the metabolite 
AMGT, which has been identified as a metabolite of toxicological 
concern in all crops except peanuts, root and tuber vegetables and bulb 
vegetables. EPA assessed dietary exposures from fluazinam and AMGT 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.
    In estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture (USDA) 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA assumed all foods for which 
there are tolerances were treated and contain tolerance-level residues 
of fluazinam. AMGT residues were calculated based on the mean ratio of 
metabolite to parent seen in field trials. For crops where this 
information was not available (Brassica and legume vegetables), a 
conservative, upper-bound ratio derived from metabolism studies was 
used to estimate AMGT residues.
    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 assumed all foods 
for which there are tolerances were treated and contain tolerance-level 
residues of fluazinam. AMGT residues were calculated as described for 
the acute dietary exposure assessment.
    iii. Cancer. In accordance with the 2005 Guidelines for Carcinogen 
Risk Assessment, for fluazinam there is ``Suggestive evidence of 
carcinogenic potential.'' 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

[[Page 60258]]

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. 
Additionally, it is noted that the point of departure (1.1 milligrams/
kilograms/day) (mg/kg/day)) selected for deriving the chronic reference 
dose will adequately account for all chronic effects determined to 
result from exposure to fluazinam in chronic animal studies, including 
the equivocal cancer effects.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for fluazinum. Tolerance level residues and 100 PCT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for fluazinam in drinking water. Because 
the Agency does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate characteristics of 
fluazinam. 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 Groundwater (SCI-GROW) models, the estimated 
environmental concentrations (EECs) of fluazinam for acute exposures 
are estimated to be 71.0 parts per billion (ppb) for surface water and 
0.187 ppb for ground water. The EECs for chronic exposures are 
estimated to be 17.7 ppb for surface water and 0.187 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 71.0 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 17.7 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 not 
registered for use on any sites 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to fluazinam and 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 not assumed that fluazinam has 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 of FFDCA provides that EPA shall apply an 
additional (``10X'') tenfold 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. In applying 
this provision, EPA either retains the default value of 10X when 
reliable data do not support the choice of a different factor, or, if 
reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology database for fluazinam includes rat and rabbit developmental 
toxicity studies, a developmental neurotoxicity study in rats and a 2-
generation reproduction toxicity study in rats.
    There was no evidence of increased qualitative or quantitative 
susceptibility of fetuses following in utero exposure to fluazinam in 
the rabbit developmental study and no evidence of increased 
susceptibility of offspring in the 2-generation reproduction study in 
rats. However, there was evidence of increased qualitative 
susceptibility of fetuses to fluazinam in the developmental toxicity 
study in rats. In this study, increased incidences of facial/palate 
clefts and other rare deformities in the fetuses were observed in the 
presence of minimal maternal toxicity. In a developmental neurotoxicity 
study, decreases in body weight and body weight gain and a delay in 
completion of balano-preputial separation were observed in pups. These 
effects were seen in the absence of maternal effects, suggesting 
increased quantitative susceptibility of the offspring.
    Although there is qualitative evidence of increased susceptibility 
in young in the developmental toxicity study in rats, there are no 
residual uncertainties with regard to prenatal and/or postnatal 
toxicity following in utero exposure of rats or rabbits. Considering 
the overall toxicity profile and the doses and endpoints selected for 
risk assessment for fluazinam, the degree of concern for the effects 
observed in the study is low. There is a clear NOAEL for the fetal 
effects seen, the effects occurred in the presence of maternal 
toxicity, and they were only seen at the highest dose tested. 
Additionally, the NOAEL of 50 mg/kg/day identified in this 
developmental toxicity study in rats is significantly higher than the 
NOAEL used (7 mg/kg/day) to establish the acute Reference Dose (aRfD) 
of 0.07 mg/kg/day (females 13-49); thus, the aRfD is

[[Page 60259]]

protective of any potential developmental effects.
    Quantitative evidence of increased susceptibility was also observed 
in a developmental neurotoxicity study in rats. In pups, there were 
decreases in body weight and body weight gain during lactation, and 
delayed preputial separation observed at 10 mg/kg/day (NOAEL=2 mg/kg/
day). Although the NOAEL of 2 mg/kg/day is lower than that used for the 
acute RfD for females 13-49 (7 mg/kg/day), the effects noted in the 
developmental neurotoxicity study are attributable to multiple doses 
and are considered postnatal effects. Therefore, the study endpoint is 
not appropriate either for acute dietary exposures or for use with the 
population subgroup females 13-49 (with this subgroup the concern is 
for prenatal exposures). The chronic RfD of 0.011 mg/kg/day is based on 
a lower NOAEL of 1.1 mg/kg/day and is considered protective of 
potential developmental effects.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for fluazinam is complete in regard to 
pre-and postnatal toxicity and neurotoxicity.
    ii. A developmental neurotoxicity study (DNT) in rats was submitted 
to address the presence of neurotoxic lesions observed after fluazinam 
exposure in sub-chronic and chronic toxicity studies and to address the 
qualitative susceptibility seen in the rat developmental toxicity 
study. In the DNT study, there were no neurotoxic effects observed in 
either dams or pups. However, there was evidence of quantitative 
susceptibility for other effects in the DNT study, based on decreases 
in body weight and body weight gain, and delayed preputial separation 
in pups in the absence of maternal toxicity. There are no residual 
uncertainties for these effects, and toxicity endpoints and traditional 
UFs to be used in the risk assessment will be protective of these 
potential developmental effects.
    iii. Although there is qualitative evidence of increased 
susceptibility in the prenatal developmental study in rats, the risk 
assessment team did not identify any residual uncertainties after 
establishing toxicity endpoints and traditional UFs to be used in the 
risk assessment of fluazinam. The degree of concern for prenatal and/or 
postnatal toxicity is low.
    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. Conservative ground and 
surface water modeling estimates were used. These assessments will not 
underestimate the exposure and risks posed by fluazinam.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the MOE called for by the product of all applicable UFs is 
not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, EPA performed two different acute risk 
assessments - one focusing on females 13 to 49 years old and designed 
to protect against prenatal effects and the other focusing on acute 
effects relevant to all other population groups. The more sensitive 
acute endpoint was seen as to prenatal effects rather than other acute 
effects. For females 13 to 49 years old, the acute dietary exposure 
from food and water will occupy 8% of the aPAD addressing prenatal 
effects. As to acute effects other than prenatal effects, the acute 
dietary exposure from food and water to fluazinam will occupy 3% of the 
aPAD for infants less than 1-year 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 exposure to fluazinam 
from food and water will utilize 16% of the cPAD for infants less than 
1-year old, the population group with the greatest estimated exposure. 
There are no residential uses for fluazinam that result in chronic 
residential exposure to fluazinam.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Fluazinam is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Fluazinam is 
not registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. The Agency has 
determined that quantification of human cancer risk is not necessary 
for fluazinam and that the chronic risk assessment based on the 
established cPAD is protective of potential cancer effects. Based on 
the results of the chronic risk assessment discussed above in Unit 
III.E.2, EPA concludes that fluazinam is not expected to pose a 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

    Adequate enforcement methodology (gas chromatography with electron-
capture detection) is available to enforce the tolerance expression. 
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; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no established or proposed Codex MRLs for residues of 
fluazinam in plant or animal commodities.

V. Conclusion

    Based upon review of the data supporting the petition, EPA has 
modified the proposed tolerances as follows:
     The tolerances for Bushberry subgroup 13B and related 
berries were increased from 4.5 ppm to 7.0 ppm based on analyses 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. Although IR-4 proposed tolerances for 
combined residues of fluazinam and AMGT on these commodities, EPA 
determined, based on the low levels of AMGT seen in the field trials, 
that only parent fluazinam should be included in the tolerance 
expression.
     The commodity terms for dry beans and succulent shelled 
legumes were

[[Page 60260]]

revised to read ``Pea and bean, dried shelled, except soybean, subgroup 
6C, except pea'' and ``Pea and bean, succulent shelled, subgroup 6B, 
except pea'' to agree with recommended commodity terms in the Office of 
Pesticide Program's Food and Feed Commodity Vocabulary. Tolerances for 
these commodities were increased from 0.01 ppm to 0.02 ppm (dried) and 
from 0.02 ppm to 0.04 ppm (succulent) to account for the 50% 
dissipation of residues observed in the storage stability study.
     The commodity term for edible-podded legume vegetables was 
revised to read ``Vegetable, legume, edible-podded, subgroup 6A, except 
pea'' to agree with the Food and Feed Commodity Vocabulary. The 
tolerance level was decreased from 0.15 ppm to 0.10 ppm based on 
maximum residues seen in the field trials, since 80% of the residues 
were non-detectable and, therefore, not appropriate for analysis using 
the Tolerance Spreadsheet.
     IR-4 proposed separate tolerances of 0.02 ppm and 0.01 ppm 
for ``Leafy Brassica greens subgroup'' and ``Head and stem Brassica 
subgroup'', respectively. EPA determined that a single tolerance of 
0.01 ppm covering the entire crop group ``Vegetable, Brassica leafy, 
group 5'' would be appropriate, based on the results of field trials 
showing no residues above the method limit of quantitation (LOQ) in any 
of the representative commodities (broccoli, cabbage and mustard 
greens). The tolerance for turnip greens was revised from 0.02 to 0.01 
ppm on the same basis.
     The tolerance for ginseng was increased from 3.00 ppm to 
4.5 ppm to account for dissipation of residues observed in the storage 
stability study.
    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 Aronia berry at 7.0 ppm; 
buffalo currant at 7.0 ppm; bushberry subgroup 13B at 7.0 ppm; Chilean 
guava at 7.0 ppm; European barberry at 7.0 ppm; ginseng at 4.5 ppm; 
highbush cranberry at 7.0 ppm; honeysuckle, edible at 7.0 ppm; 
jostaberry at 7.0 ppm; juneberry at 7.0 ppm; lingonberry at 7.0 ppm; 
native currant at 7.0 ppm; pea and bean, dried shelled, except soybean, 
subgroup 6C, except pea at 0.02 ppm; pea and bean, succulent shelled, 
subgroup 6B, except pea at 0.04 ppm; salal at 7.0 ppm; sea buckthorn at 
7.0 ppm; turnip, greens at 0.01 ppm; vegetable, Brassica leafy, group 5 
at 0.01 ppm; and vegetable, legume, edible-podded, subgroup 6A, except 
pea at 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, 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 6, 2000) do not apply to this rule. In addition, This 
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: October 11, 2007.
Donald R. Stubbs,
Acting 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 by removing the heading General from 
paragraph (a)(1) and adding General to paragraph (a) and by 
alphabetically adding 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
------------------------------------------------------------------------
Aronia berry...............................................          7.0
Buffalo currant............................................          7.0
Bushberry subgroup 13B.....................................          7.0
Chilean guava..............................................          7.0
European barberry..........................................          7.0
Ginseng....................................................          4.5
Highbush cranberry.........................................          7.0

[[Page 60261]]

Honeysuckle, edible........................................          7.0
Jostaberry.................................................          7.0
Juneberry..................................................          7.0
Lingonberry................................................          7.0
Native currant.............................................          7.0
Pea and bean, dried shelled, except soybean, subgroup 6C,           0.02
 except pea................................................
Pea and bean, succulent shelled, subgroup 6B, except pea...         0.04

                                * * * * *
Salal......................................................          7.0
Sea buckthorn..............................................          7.0
Turnip, greens.............................................         0.01
Vegetable, Brassica leafy, group 5.........................         0.01
Vegetable, legume, edible-podded, subgroup 6A, except pea..         0.10
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-20581 Filed 10-23-07; 8:45 am]

BILLING CODE 6560-50-S