Document ID: EPA-HQ-OPP-2008-0458-0003
Agency: epa
Document Type: Rule
Title: Fenamidone; Pesticide Tolerances
Posted Date: 2009-07-15T04:00Z

[Federal Register: July 15, 2009 (Volume 74, Number 134)]
[Rules and Regulations]               
[Page 34252-34257]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jy09-21]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0458; FRL-8423-8]

 
Fenamidone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fenamidone in or on cilantro, leaves; grape; okra; turnip, greens; and 
vegetable, root, except sugar beet, subgroup 1B, except radish; and 
combined residues of fenamidone and its metabolite RPA 717879 in or on 
corn, field, forage; corn, field, grain; corn, field, stover; corn, 
sweet, forage; corn, sweet, kernel plus cob with husks removed; corn, 
sweet, stover; soybean, forage; soybean, hay; and soybean, seed. It 
also removes existing permanent and time-limited tolerances on carrot 
that are superseded by the new tolerance on vegetable, root, except 
sugar beet, subgroup 1B, except radish. The new tolerance on grape will 
be a tolerance with regional registration (East of the Rocky Mountains) 
and will replace the current tolerance which is restricted to imported 
grapes. Interregional Research Project Number 4 (IR-4) and Bayer 
CropScience requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 15, 2009. Objections and 
requests for hearings must be received on or before September 14, 2009, 
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-2008-0458. 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: 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).
     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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents 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 e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

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 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-2008-0458 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 September 14, 2009.
    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

[[Page 34253]]

without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0458, 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 Registers of June 13, 2008 (73 FR 33814) (FRL-8367-
3) and December 3, 2008 (73 FR 73644) (FRL 8386-9), EPA issued notices 
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of a pesticide petition (PP 8E7350) by 
Interregional Research Project Number 4 (IR-4), 500 College Road East, 
Suite 201W, Princeton, NJ 08540; and a pesticide petition (PP 8F7410) 
by Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle Park, NC 
27709. PP 8E7350 requested that 40 CFR 180.579 be amended by 
establishing tolerances for residues of the fungicide fenamidone, 4H-
Imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-
(phenylamino)-, (S)-, in or on vegetables, root, except sugar beet, 
subgroup 1B, except radish at 0.2 parts per million (ppm); turnip, 
leaves at 55 ppm; coriander, leaves at 60 ppm; okra at 3.5 ppm; and a 
tolerance with regional registration for residues of fenamidone on 
grape at 1.0 ppm. The grape tolerance would replace an existing grape 
tolerance that was established only to address the importation of 
grapes containing fenamidone residues. PP 8F7410 requested that 40 CFR 
180.579 be amended by establishing tolerances for indirect or 
inadvertent residues of fenamidone and its metabolite RPA 717879, 2,4-
imidazolidinedione, 5-methyl-5-phenyl, in or on corn, field, forage at 
0.50 ppm; corn, field grain at 0.02 ppm; corn, stover at 0.35 ppm; 
corn, sweet, forage at 0.15 ppm; corn, sweet, kernel plus cob with 
husks removed at 0.02 ppm; soybean, forage at 0.20 ppm; soybean, hay at 
0.20 ppm; and soybean, seed at 0.02 ppm (all in PP 8F7410). The notices 
referenced summaries of the petitions prepared by Bayer CropScience, 
the registrant, which are available to the public in docket ID numbers 
EPA-HQ-OPP-2008-0458 (PP 8E7350) and EPA-HQ-OPP-2006-0848 (PP 8F7410) 
at http://www.regulations.gov. There were no comments received in 
response to the notices of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the commodity terms, and/or tolerance levels for several 
commodities. EPA also determined that separate tolerances should be 
established on stover from field and sweet corn. 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 the petitioned-for 
tolerances for residues of fenamidone on cilantro, leaves at 60 ppm; 
okra at 3.5 ppm; turnip, greens at 55 ppm; and vegetable, root, except 
sugar beet, subgroup 1B, except radish at 0.15 ppm; a tolerance with 
regional registration in or on grape at 1.0 ppm; and tolerances for 
combined residues of fenamidone and its metabolite RPA 717879 in or on 
corn, field, forage at 0.25 ppm; corn, field, grain at 0.02 ppm; corn, 
field, stover at 0.40 ppm; corn, sweet, forage at 0.15 ppm; corn, 
sweet, kernel plus cob with husks removed at 0.02 ppm; corn, sweet, 
stover at 0.20 ppm; soybean, forage at 0.15 ppm; soybean, hay at 0.25 
ppm; and soybean, seed at 0.02 ppm. EPA's assessment of exposures and 
risks associated with establishing 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.
    Fenamidone has low acute toxicity via the oral, dermal and 
inhalation routes of exposure. It is a moderate eye irritant, but is 
not a dermal irritant or a dermal sensitizer. The liver is the target 
organ in chronic studies in the rat, mouse and dog. The thyroid is also 
a target organ in the rat. There is no evidence of immunotoxicity in 
the available toxicity studies with fenamidone and no indication of 
carcinogenicity in the carcinogenicity studies conducted in rats and 
mice. EPA has classified fenamidone as ``not likely to be a human 
carcinogen'' by all relevant routes of exposure.
    Fenamidone did not demonstrate any qualitative or quantitative 
increased susceptibility of fetuses or offspring in the rat and rabbit 
developmental toxicity studies or the 2-generation rat reproduction 
study. In the rat reproduction study (Sprague Dawley rat), decreased 
absolute brain weight and pup body weight occurred at the same dose 
levels as decreased absolute brain weight and parental body weight, 
food consumption and increased liver and spleen weight. Developmental 
toxicity (decreased fetal weights and incomplete ossification) was 
observed in the rat only at the limit dose. Fenamidone did not produce 
developmental toxicity in the rabbit or reproductive toxicity in the 
rat.
    No treatment-related effects were observed on motor activity or in 
the functional observation battery (FOB) parameters measured in the 
subchronic neurotoxicity study in rats. In this subchronic 
neurotoxicity study, marginal decreases in brain weights were observed 
only in high dose males. In the acute neurotoxicity study in rats, the 
most commonly observed clinical sign was staining/soiling of the 
anogenital region. Other day-1 FOB findings included mucous in the 
feces,

[[Page 34254]]

hunched posture and unsteady gait. In a developmental neurotoxicity 
study in Wistar rats, no neurobehavioral effects and no 
neuropathological changes were observed at any dose in the offspring, 
but decreased body weight was observed during pre- and post-weaning.
     Specific information on the studies received and the nature of the 
adverse effects caused by fenamidone 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 Fenamidone. Human Health Risk 
Assessment to Support Section 3 Proposals to Add New Uses on the Root 
Vegetable Subgroup 1B (except radish), Okra, Turnip Greens, Cilantro 
Leaves, Grapes Grown East of the Rock Mountains and Rotational Crop 
Uses for Field Corn, Sweet Corn and Soybeans, page 30 in docket ID 
number EPA-HQ-OPP-2008-0458.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD 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 
dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    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 
greater than that 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 fenamidone used for 
human risk assessment can be found at http://www.regulations.gov in the 
document Fenamidone. Human Health Risk Assessment to Support Section 3 
Proposals to Add New Uses on the Root Vegetable Subgroup 1B (except 
radish), Okra, Turnip Greens, Cilantro Leaves, Grapes Grown East of the 
Rock Mountains and Rotational Crop Uses for Field Corn, Sweet Corn and 
Soybeans, page 12 in docket ID number EPA-HQ-OPP-2008-0458.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenamidone, EPA considered exposure under the petitioned-
for tolerances as well as all existing fenamidone tolerances in 40 CFR 
180.579. EPA assessed dietary exposures from fenamidone 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 United States Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intakes by 
Individuals (CSFII). As to residue levels in food, EPA assumed that 
100% of all crops with existing or proposed registrations are treated 
with fenamidone and that residues are present at maximum field trial 
levels.
    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 that 100% of 
all crops with existing or proposed registrations are treated with 
fenamidone and that residues are present at maximum field trial levels.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, EPA classified fenamidone as ``not likely to be 
carcinogenic to humans;'' therefore, an exposure assessment for 
evaluating cancer risk is not needed for this chemical.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    EPA did not use PCT information in assessing dietary exposure to 
fenamidone.
    2. Dietary exposure from drinking water. The fenamidone residues of 
toxicological concern in drinking water include parent fenamidone and 
its degradation products, RPA 412636, RPA 412108, RPA 411639, RPA 
413255, RPA 409446, and RPA 410995. The Agency used screening level 
water exposure models in the dietary exposure analysis and risk 
assessment for fenamidone and its degradates in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of fenamidone 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
fenamidone and its degradates for acute exposures are estimated to be 
47.88 parts per billion (ppb) for surface water and 176 ppb for ground 
water. The EDWCs of fenamidone and its degradates for chronic exposures 
for non-cancer assessments are estimated to be 12.86 ppb for surface 
water and 176 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute and chronic dietary 
risk assessment, the water concentration value of 176 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in

[[Page 34255]]

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). Fenamidone 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 fenamidone to share a common mechanism of 
toxicity with any other substances, and fenamidone does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fenamidone 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 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 pre- and postnatal 
toxicity database for fenamidone includes rat and rabbit developmental 
toxicity studies, a rat developmental neurotoxicity study (DNT) and a 
2-generation reproduction toxicity study in rats. No evidence of 
increased quantitative or qualitative susceptibility of rat or rabbit 
fetuses to in utero exposure was observed in the developmental toxicity 
studies. There was no developmental toxicity in rabbit fetuses up to 
100 milligrams/kilogram/day (mg/kg/day), the highest dose tested (HDT); 
whereas an increase in absolute liver weight was observed in the does 
at 30 and 100 mg/kg/day. Since the liver was identified as one of the 
principal target organs in rodents and dogs, the occurrence of this 
finding in rabbits at 30 and 100 mg/kg/day was considered strong 
evidence of maternal toxicity. In the rat developmental study, 
developmental toxicity manifested as decreased fetal body weight and 
incomplete fetal ossification in the presence of maternal toxicity in 
the form of decreased body weight and food consumption at the limit 
dose (1,000 mg/kg/day). The effects at the limit dose were comparable 
between fetuses and dams. No quantitative or qualitative evidence of 
increased susceptibility was observed in the 2-generation reproduction 
study in rats. In that study, both the parental and offspring LOAELs 
were based on decreased absolute brain weight in female F1 
adults and female F2 offspring at 89.2 mg/kg/day. At 438.3 
mg/kg/day, parental effects consisted of decreased body weight and food 
consumption, and increased liver and spleen weight. Decreased pup body 
weight was also observed at the same dose level of 438.3 mg/kg/day. 
There were no effects on reproductive performance up to 438.3 mg/kg/day 
(HDT).
    The results of the DNT study indicated an increased susceptibility 
of offspring. There was no maternal toxicity at the HDT (429 mg/kg/
day). Effects in the offspring included decreased body weight (9-11%) 
and body weight gain (8-20%) during pre-weaning and decreased body 
weight (4-6%) during post-weaning at 429 mg/kg/day (LOAEL). There were 
no neurobehavioral effects and no neuropathological changes at any dose 
in the offspring. The concern for the increased susceptibility observed 
in the DNT is low because:
    i. Of the lack of neurobehavioral or neuropathological changes in 
the offspring at any dose;
    ii. A clear NOAEL for the adverse effects in the study was 
identified;
    iii. The endpoints used for the various risk assessment scenarios 
are much more sensitive than that of the decreased bodyweight of the 
offspring occurring at almost half the limit-dose (429 mg/kg/day); and
    iv. The NOAELs of 10.4, 5.4 and 2.83 mg/kg/day used for short-term, 
intermediate-term and long-term risk assessments, respectively, are 
considerably (9-45 fold) lower than the offspring NOAEL of 92.3 mg/kg/
day in the DNT.
    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 fenamidone is adequate to assess the 
pre- and postnatal toxicity of fenamidone. In accordance with the 
revised 40 CFR part 158 Data Requirements for Pesticides, an 
immunotoxicity study (870.7800) is required for fenamidone. In the 
absence of specific immunotoxicity studies, EPA has evaluated the 
available fenamidone toxicity data to determine whether an additional 
database uncertainty factor is needed to account for potential 
immunotoxicity. There was no evidence of adverse effects on the organs 
of the immune system in any study with fenamidone, and fenamidone does 
not belong to a class of chemicals (e.g., the organotins, heavy metals, 
or halogenated aromatic hydrocarbons) that would be expected to be 
immunotoxic. Based on these considerations, EPA does not believe that 
conducting immunotoxicity testing will result in a point of departure 
lower than those already selected for fenamidone; therefore, an 
additional database uncertainty factor is not needed to account for 
potential immunotoxicity.
    ii. There was no evidence of neurotoxicity in the subchronic 
neurotoxicity study submitted for fenamidone. There was evidence of 
neurotoxicity (urination, staining/soiling of the anogenital region, 
mucous in the feces and unsteady gait in females) in the acute 
neurotoxicity study, and EPA used the NOAEL from this study to assess 
acute dietary exposure. There was also evidence of neurotoxicity 
(decreased absolute brain weights) in the 2-generation rat reproduction 
study; however, there was no indication of increased susceptibility of 
offspring with regard to these effects. Finally, there was no evidence 
of neurotoxicity at any dose in the submitted DNT study. Based on the 
results of these studies, EPA concluded that there is no need for 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that fenamidone results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in offspring in the 2-generation reproduction 
study. Although there is evidence of increased quantitative 
susceptibility in the DNT study, the degree of concern is low and the 
Agency did not identify any residual uncertainties after establishing 
toxicity

[[Page 34256]]

endpoints and traditional UFs to be used in the risk assessment of 
fenamidone.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on reliable data from residue field trials and assuming 100 PCT. EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to fenamidone in drinking water. 
Residential exposure is not expected from the existing and new uses of 
fenamidone. These assessments will not underestimate the exposure and 
risks posed by fenamidone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
fenamidone will occupy 5% of the aPAD for children, 1 to 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 
fenamidone from food and water will utilize 88% of the cPAD for 
children, 1 to 2 years old, the population group receiving the greatest 
exposure. There are no residential uses for fenamidone.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure take into account short-term or 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Fenamidone is 
not registered for any use patterns that would result in residential 
exposure. Therefore, the short-term or intermediate-term aggregate risk 
is the sum of the risk from exposure to fenamidone through food and 
water and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Fenamidone is 
classified as ``not likely to be carcinogenic to humans'' and is, 
therefore, not expected to pose a cancer risk.
    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 fenamidone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatographic method 
coupled with tandem mass spectrum detection (LC/MS/MS)) 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 Codex, Canadian or Mexican MRLs (maximum residue 
levels) for residues of fenamidone in or on any of the commodities 
requested in these petitions.

C. Revisions to Petitioned-for Tolerances

    EPA has revised the commodity terms and/or tolerance levels for 
several commodities. EPA revised the commodity terms proposed by IR-4 
as ``vegetables, root, except sugar beet, subgroup 1B, except radish''; 
``coriander, leaves''; and ``turnip, leaves'' to read ``vegetable, 
root, except sugar beet, subgroup 1B, except radish''; ``cilantro, 
leaves''; and ``turnip, greens''; and determined that separate 
tolerances were needed for stover from field and sweet corn (i.e., 
``corn, field, stover'' and ``corn, sweet, stover'') to agree with the 
Food and Feed Vocabulary. EPA revised the tolerance level for 
``vegetable, root, except sugar beet, subgroup 1B, except radish'' from 
0.2 ppm to 0.15 ppm to agree with the existing tolerance on carrot, the 
representative commodity on which the proposed tolerance was based. EPA 
revised the tolerances for ``corn, field, forage'' from 0.50 ppm to 
0.25 ppm''; ``corn, field, stover'' from 0.35 ppm to 0.40 ppm; ``corn, 
sweet, stover'' from 0.35 ppm to 0.20 ppm; ``soybean, forage'' from 
0.20 ppm to 0.15 ppm; and ``soybean, hay'' from 0.20 ppm to 0.25 based 
on analyses of 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.

V. Conclusion

    Therefore, tolerances are established for residues of fenamidone, 
4H-Imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-
(phenylamino)-, (S)-, on cilantro, leaves at 60 ppm; okra at 3.5 ppm; 
turnip, greens at 55 ppm; and vegetable, root, except sugar beet, 
subgroup 1B, except radish at 0.15 ppm; a tolerance with regional 
registration is established for residues of fenamidone in or on grape 
at 1.0 ppm; and tolerances are established for combined residues of 
fenamidone and its metabolite RPA 717879 in or on corn, field, forage 
at 0.25 ppm; corn, field, grain at 0.02 ppm; corn, field, stover at 
0.40 ppm; corn, sweet, forage at 0.15 ppm; corn, sweet, kernel plus cob 
with husks removed at 0.02 ppm; corn, sweet, stover at 0.20 ppm; 
soybean, forage at 0.15 ppm; soybean, hay at 0.25 ppm; and soybean, 
seed at 0.02 ppm. The existing permanent and time-limited tolerances on 
carrot are removed, since residues on carrots will be covered by the 
new tolerance on vegetable, root, except sugar beet, subgroup 1B, 
except radish.

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).

[[Page 34257]]

    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: July 1, 2009.
G. Jeffery Herndon,
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 180.579 paragraph (a)(1) table is amended by removing the 
commodities ``carrot'' and ``grape (imported)'' and adding the 
following commodities; by removing and reserving paragraph (b); by 
revising paragraph (c); and by adding the following commodities to the 
table in paragraph (d) to read as follows:

Sec.  180.579  Fenamidone; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Cilantro, leaves.....................................                 60
                                * * * * *
Okra.................................................                3.5
                                * * * * *
Turnip, greens.......................................                 55
                                * * * * *
Vegetable, root, except sugar beet, subgroup 1B,                    0.15
 except radish.......................................
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. A tolerance with 
regional registration as defined in Sec. 180.1(m) is established for 
residues of fenamidone, 4H-Imidazol-4-one, 3,5-dihydro-5-methyl-2-
(methylthio)-5-phenyl-3-(phenylamino)-, (S)-, in or on the following 
commodity:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Grape\1\.............................................                1.0
------------------------------------------------------------------------
\1\ Applicable to grapes grown East of the Rocky Mountains.

    (d) Indirect or inadvertent residues. * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Corn, field, forage..................................               0.25
Corn, field, grain...................................               0.02
Corn, field, stover..................................               0.40
Corn, sweet, forage..................................               0.15
Corn, sweet, kernel plus cob with husks removed......               0.02
Corn, sweet, stover..................................               0.20
Soybean, forage......................................               0.15
Soybean, hay.........................................               0.25
Soybean, seed........................................               0.02
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E9-16817 Filed 7-14-09; 8:45 am]

BILLING CODE 6560-50-S