Document ID: EPA-HQ-OPP-2006-0848-0003
Agency: epa
Document Type: Rule
Title: Fenamidone; Pesticide Tolerance
Posted Date: 2007-10-24T04:00Z

[Federal Register: October 24, 2007 (Volume 72, Number 205)]
[Rules and Regulations]               
[Page 60266-60272]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc07-16]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0848; FRL-8152-9]

 
Fenamidone; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
fenamidone in or on carrot; sunflower; Brassica, head and stem, 
subgroup 5A; Brassica, leafy greens, subgroup 5B; vegetable, fruiting, 
group 8, except nonbell pepper; pepper, nonbell; vegetable, leafy, 
except Brassica, group 4; cotton, gin byproducts; cotton, undelinted 
seed; and combined residues of fenamidone and its metabolite RPA 717879 
in or on strawberry. 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-2006-0848. 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 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: Shaja R. Brothers, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: 
brothers.shaja@epa.gov@epa.govbrothers.shaja@epa.gov@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:

[[Page 60267]]

     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-2006-0848 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-2006-0848, 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 November 8, 2006 (71 FR 65506-65507) 
(FRL-8099-9), 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 by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 
08540, and Bayer Crop Science, 2 T.W. Alexander Drive, Research 
Triangle Park, NC 27709. The petitions 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 carrot at 0.15 parts per 
million (ppm) (PP 6E7109); sunflower at 0.08 ppm (PP 5E6924); brassica, 
head and stem, subgroup 5A at 4.0 ppm (PP 5E6925); brassica, 
leafy greens, subgroup 5B at 35 ppm (PP 5E6925); vegetables, fruiting, 
group 8, except nonbell peppers at 2.0 ppm (PP 5E6925); vegetable, 
leafy, except brassica, group 4 at 35 ppm (PP 5E6925); cotton, 
undelinted seed at 0.02 ppm (PP 5F6898); and cotton, gin byproducts at 
0.02 ppm (PP 5F6898), and residues of the fungicide fenamidone (4-H-
imidazol-4-one, 3,5-dihydro-5-methyl-2-(methlthio)-5-phenyl-3-
(phenylamino)-, (S)-) and its metabolite RPA 717879 (2,4-
imidazolidinedione, 5-methyl-5-phenyl), in or on strawberry at 0.02 ppm 
(PP 5F6898).
    This notice referenced a summary of the petition prepared by Bayer 
Crop Science, the registrant, which is available to the public in the 
docket, at http://www.regulations.gov. There were no comments received 

in response to the notice of filing.
    Based upon review of the data supporting the petitions, EPA has 
revised the tolerance levels for some of the proposed petitions. The 
reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the petitioned-for tolerance 
for residues of fenamidone on carrot at 0.15 ppm; sunflower at 0.02 
ppm; Brassica, head and stem, subgroup 5A at 5.0 ppm; Brassica, leafy 
greens, subgroup 5B at 55 ppm; vegetable, fruiting, group 8, except 
nonbell pepper at 1.0 ppm; pepper, nonbell at 3.5 ppm; vegetable, 
leafy, except Brassica, group 4 at 60 ppm; cotton, gin byproducts at 
0.02 ppm; cotton, undelinted seed at 0.02 ppm; and strawberry at 0.02 
ppm. EPA's assessment of exposures and risks associated with 
establishing the tolerances follows.

[[Page 60268]]

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 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 in Human Health 
Risk Assessment for Fenamidone on pages 31-34. The referenced document 
is available in the docket established by this action, which is 
described under ADDRESSES, and is identified as EPA-HQ-OPP-2006-0848. 
The docket is electronically available at http://www.regulations.gov.

    The existing toxicological database for fenamidone supports the 
establishment of permanent tolerances for residues of fenamidone in or 
on the commodities proposed in this action. Fenamidone has low acute 
toxicity via the oral, dermal, and inhalation routes with all studies 
being in toxicity category III or IV. It is a moderate eye irritant, 
but is not a dermal irritant or a dermal sensitizer. The acute oral 
assay tests indicated that female rats were more sensitive to the 
parent than male rats.
    The target organs in chronic studies in the mouse and dog were the 
liver, and in the rat were the liver and thyroid. In the chronic 
toxicity rat study, the systemic NOAEL was based on diffuse C-cell 
hyperplasia of the thyroid in both sexes as the most sensitive 
indicator of toxicity. At higher doses, follicular cells and the liver 
were affected. The similarity in the systemic NOAELs and the type of 
toxicity observed (primarily liver) for the 90-day rat studies with the 
parent and plant metabolites (RPA 412636, RPA 412708, and RPA 410193) 
demonstrated that, on a subchronic basis, the plant metabolites were 
not more toxic than the parent. The carcinogenic potential was negative 
for mice dosed up to the limit dose with liver effects seen as the 
systemic toxicity. In rats, fenamidone did produce a statistically 
significant increase (p<  0.01 for both trend and pair-wise comparison) 
in benign, endometrial stromal polyps at 5,000 ppm, the highest dose 
tested (HDT). Consultation with an EPA consulting pathologist resulted 
in these findings being characterized as benign proliferate lesions 
that do not progress to malignant carcinomas or sarcomas. Based on 
these findings, EPA classified fenamidone as ``not likely'' to be a 
human carcinogen. All mutagenicity studies were negative for both the 
parent and plant metabolites (RPA 412636, RPA 412708, and RPA 410193).
    Fenamidone did not demonstrate any qualitative or quantitative 
increased susceptibility in the rat and rabbit developmental toxicity 
studies or the 2-generation rat reproduction study. In rabbits, there 
were no developmental effects up to the HDT and in the presence of 
maternal toxicity. In rats, developmental findings and maternal 
findings both occurred at the limit dose. In the 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. There were no effects on fertility and other 
measured reproductive parameters. In the acute neurotoxicity study in 
rats, the most commonly observed clinical sign was staining/soiling of 
the anogenital region at 500 and 2,000 milligrams/kilogram (mg/kg). 
These findings were observed at low incidences and were consistent with 
those observed on day 1 of the functional observational battery (FOB). 
Other day-1 FOB findings included mucous in the feces of the 500 and 
2,000 mg/kg males and females; hunched posture when walking or sitting 
in the 2,000 mg/kg females; and unsteady gait in the 500 and 2,000 mg/
kg females. In the subchronic neurotoxicity study (Sprague Dawley rat), 
marginal decrease in brain weights was observed only in high dose 
males. Additionally, fenamidone displayed decreased brain weight in 
F1 female adults and F2 female offspring in the 
rat reproduction study. Other evidence of neurotoxicity (clinical signs 
such as lethargy, prostration, tremors, eye closure, unsteady gait) was 
observed in a mouse bone marrow micronucleus assay with plant 
metabolites (RPA 412636 and RPA 412708).
    Based on the evidence of neurotoxicity summarized above, EPA 
requested a developmental neurotoxicity (DNT) study conducted with 
Sprague Dawley rats. The petitioner submitted a DNT study conducted 
with Wistar rats. In this study, no maternal toxicity was observed at 
doses up to 4,700 ppm (429 mg/kg/day). The offspring systemic toxicity 
manifested as decreased body weight (9 to 11%) and body weight gain (8 
to 20%) during pre-weaning and decreased body weight (4 to 6%) during 
post-weaning. The offspring NOAEL was 1,000 ppm (92.3 mg/kg/day). The 
results of this DNT study suggest increased susceptibility of offspring 
to fenamidone; however, the concern for increased susceptibility is low 
since there is a well established NOAEL protecting the offspring and 
the NOAEL used for establishing the chronic reference dose (cRfD) is 
approximately 45X below the NOAEL observed for the offspring toxicity 
in the DNT study. EPA reviewed these data and determined that the 10X 
database uncertainty factor due to lack of DNT should be removed. 
However, since this study was conducted using Wistar rats rather than 
Sprague Dawley rat as requested, EPA requested a modified DNT in the 
Sprague Dawley rat with measurement of the following endpoint: brain 
weights (samples should be retained for possible morphometric 
measurements); this study is necessary to confirm the lack of brain 
weight changes in the Wistar rat DNT.

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

[[Page 60269]]

EPA uses in risk characterization and a complete description of the 
risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.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 entitled ``Fenamidone Human Health Risk Assessment'' on page 
12 in Docket ID EPA-HQ-OPP-2006-0848.

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. The Agency generated dietary exposure estimates for exposure 
to fenamidone and its residues of concern. The following paragraphs are 
summaries of these analyses. EPA assessed dietary exposures from 
fenamidone 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 one-day or single exposure.
    In estimating acute dietary exposure to fenamidone, EPA used food 
consumption information from the USDA 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA assumed maximum field trial residues for the 
residues of concern for risk assessment and 100% crop treated. The 
Dietary Exposure Evaluation Model (DEEMTM) (ver. 7.81) 
default processing factors were maintained for all commodities 
excluding grape juice, dried potato, tomato paste, and tomato puree; 
for these commodities; the DEEMTM (ver. 7.81) default 
processing factors were reduced to 1 based on processing data (grape), 
or empirical processing factors were applied to the RAC residue (tomato 
paste, tomato puree, and dried potato).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment for fenamidone, EPA used the food consumption data from the 
USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA 
assumed maximum field trial residues for the residues of concern for 
risk assessment and 100% crop treated. DEEMTM (ver. 7.81) 
default processing factors were maintained for all commodities 
excluding grape juice, dried potato, tomato paste, and tomato puree; 
for these commodities, the DEEMTM (ver. 7.81) default 
processing factors were reduced to 1 based on processing data (grape), 
or empirical processing factors were applied to the RAC residue (tomato 
paste, tomato puree, and dried potato).
    iii. Cancer. EPA has classified fenamidone as a ``not likely'' 
human carcinogen. Therefore, a cancer dietary exposure analysis was not 
performed.
    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 pursuant 
to FFDCA section 408(f)(1) require 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 this tolerance.
    2. Dietary exposure from drinking water. Biotransformation 
(metabolism) under aerobic conditions and direct photolysis in water 
are the major routes of transformation of fenamidone in the 
environment. Fenamidone half-lives were 5 to 8 days in aerobic soils, 
67 to 128 days in aerobic water-sediments, and 5 to 8 days in water 
exposed to summer sunlight (direct photolysis). Fenamidone is highly 
persistent in anaerobic water-sediment systems (half-life longer than 
1,000 days). Adsorption of fenamidone onto soils is moderate (mean 
Koc less than 388). Therefore, fenamidone is not persistent 
in soil or in shallow water under aerobic conditions. Under field 
conditions, the half-lives of fenamidone ranged from 9 to 82 days. 
Given that biotransformation is the major route of degradation and 
considering the widespread, potential use areas of different soils, 
microbial population and activity, water bodies, climates/meteorology, 
and agricultural practices, high variability in persistence in soil and 
water-sediment systems is to be expected. Likewise, variability in type 
and relative amount of products would also be expected. EPA reviewed 
the environmental fate data for fenamidone and concluded that the 
residues of concern in water are RPA 412636, RPA 412708, RPA 411639, 
RPA 413255, and RPA 409446, RPA 410995RPA-412636.
    The Agency lacks sufficient monitoring data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
fenamidone 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 fenamidone. 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 the Screening Concentration in Groundwater 
(SCI-GROW) models, the estimated environmental concentrations (EECs) of 
fenamidone for acute exposures are estimated to be 41.66 parts per 
billion (ppb) for surface water and 178 ppb for ground water. The EECs 
for chronic exposures are estimated to be 11.88 ppb for surface water 
and 178 ppb for ground water. Estimates were performed for combined 
residues of parent fenamidone and the residues of concern previously 
mentioned.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute and chronic 
dietary risk assessment, the water concentration value of 178 ppb 
(highest estimate; based on three applications at 0.267 pounds of 
active ingredient per acre) was used to access 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).
    Fenamidone 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 the 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 fenamidone and any other 
substances and fenamidone does not appear to produce a toxic metabolite 
produced by

[[Page 60270]]

other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that fenamidone 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. No quantitative or 
qualitative evidence of increased susceptibility of rat or rabbit 
fetuses to in utero exposure in the developmental toxicity studies was 
observed. There was no developmental toxicity in rabbit fetuses up to 
100 mg/kg/day (HDT), which resulted in an increased absolute liver 
weight in the does. 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 DNT study conducted with Wistar rats showed no maternal 
toxicity up to 429 mg/kg/day. The offspring systemic toxicity 
manifested as decreased body weight (9 to 11%) and body weight gain (8 
to 20%) during pre-weaning and decreased body weight (4 to 6%) during 
post-weaning with a NOAEL of 92.3 mg/kg/day. The results of this DNT 
study suggest increased susceptibility of offspring to fenamidone; 
however, the concern for increased susceptibility is low since there is 
a well established NOAEL protecting the offspring and the NOAEL used 
for establishing the chronic reference dose (cRfD; see below) is 
approximately 45x below the NOAEL observed for the offspring toxicity 
in the DNT study.
    There is confidence that the sensitivity of any developmental 
neurological effects have been identified. EPA required a DNT based on 
a marginal decrease in brain weight in high dose males in the 
subchronic neurotoxicity study in rats, decreased brain weight in 
female adults and female offspring in the 2-generation reproduction 
study, and clinical signs that may be indicative of neurotoxic effects 
at relatively high doses in several studies. A DNT was conducted and 
showed no neurotoxic effects. Because, however, the DNT was conducted 
in a different strain of rat (Wistar) than the studies that showed 
brain effects (Sprague-Dawley), EPA has required that an abbreviated 
DNT be conducted in the Sprague-Dawley rat that focuses on brain 
effects. Due to the clear NOAEL from the existing DNT as well as the 
clear NOAELs in the studies evidencing brain effects, EPA regards the 
abbreviated DNT as confirmatory in nature and unlikely to change the 
characterization or magnitude of the risk for fenamidone.
    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 toxicology database is complete other than the confirmatory 
DNT study.
    ii. No qualitative or quantitative increased susceptibility in the 
developmental toxicity studies (rat and rabbit).
    iii. No qualitative or quantitative increased susceptibility in the 
2-generation reproduction study (rat).
    iv. Low concern for residual uncertainties in the DNT study (rat) 
since there is a well established offspring NOAEL which is 45X greater 
than the NOAEL used to establish the chronic dietary endpoint.
    v. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% crop treated (CT) and tolerance-level residues or maximum 
levels from crop field trials. Conservative ground and surface water 
modeling estimates were used. These assessments will not underestimate 
the exposure and risks posed by fenamidone.

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, the acute dietary exposure from food and water 
to fenamidone will occupy 5% of the aPAD for the population group 
children 1 to 2 years old, the highest estimated acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fenamidone from food and water will utilize 82% of the cPAD for the 
population group children 1 to 2 years old, the highest estimated 
chronic risk. There are no residential uses for fenamidone that result 
in chronic residential exposure to fenamidone.
    3. Aggregate cancer risk for U.S. population. EPA has classified 
fenamidone as a ``not likely'' human carcinogen. EPA does not expect 
fenamidone to pose a cancer risk.
    4. 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.

[[Page 60271]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a liquid chromatograph/mass 
spectrometer/mass spectrometer (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 currently no established Codex maximum residue limits for 
the proposed tolerances.

C. Explanation of Tolerance Revisions

    1. Sunflower. The geographical representation of the sunflower 
field trial data fulfill the data requirements suggested in OPPTS 
860.1500 for sunflower. Based on the sunflower seed field trial data, 
EPA concludes that a sunflower seed tolerance for residues of 
fenamidone per se of 0.02 ppm is appropriate.
    2. Brassica, head and stem, subgroup 5-A. The geographical 
representation of the broccoli, cabbage, and mustard green field trial 
data fulfill the data requirements suggested in OPPTS 860.1500 for a 
Brassica (cole) leafy vegetables crop group registration or crop 
subgroup 5a and 5b tolerances. EPA notes that these field trials 
employed 1.0x the proposed single application rate but 1.4x the 
proposed seasonal rate. Based on the residue decline data which 
indicated that combined residues of fenamidone, RPA 717879, RPA 408056, 
and RPA 405862 reduced 52% (broccoli), 43% (cabbage), and 87% (mustard 
green) as the pre-harvest (PHI) increased from 0 to 7 days, EPA 
concludes that the final application, which was conducted at 1x the 
proposed rate, will drive the magnitude of the residue in or on the 
Brassica (cole) leafy vegetables. Based on the broccoli, cabbage, and 
mustard green field trial data and the tolerance spreadsheet 
calculator, tolerances for residues of fenamidone per se of 5.0 ppm, 
1.3 ppm, and 55 ppm were recommended. Since the maximum residues and 
recommended tolerances are not within 5x, EPA concludes that a crop 
group tolerance is not appropriate but that crop subgroup tolerances 
are appropriate. EPA concludes that a head and stem Brassica crop 
subgroup 5a tolerance of 5.0 ppm and a leafy Brassica greens crop 
subgroup 5b tolerance of 55 ppm for residues of fenamidone per se are 
appropriate.
    3. Vegetable, fruiting, group 8. The geographical representation of 
the tomato and pepper field trial data fulfill the data requirements 
suggested in OPPTS 860.1500 for a fruiting vegetable crop group 
registration. EPA notes that these field trials employed 1.0x the 
proposed single application rate but 1.4x the proposed seasonal rate. 
Based on the residue decline data which indicated that combined 
residues of fenamidone, RPA 717879, RPA 408056, and RPA 405862 reduced 
65% (bell pepper) and 34 to 73% (tomato) as the PHI increased from 0 to 
21 (bell pepper) and 7 to 35 days (tomato; nonbell pepper decline data 
were not submitted), EPA concludes that the final application, which 
were conducted at 0.7 to 1.0x the proposed rate, will drive the 
magnitude of the residue in or on fruiting vegetables.
    4. Pepper, nonbell. Based on the tomato, bell pepper, and nonbell 
pepper field trial data and the tolerance spreadsheet calculator, 
tolerances for the residues of fenamidone per se of 1.0 ppm, 0.40 ppm, 
and 3.5 ppm were recommended. Since the pepper and nonbell pepper 
maximum residues and recommended tolerances are not within 5X, EPA 
concludes that a fruiting vegetable crop group tolerance is not 
appropriate. Based on the residue data and since tomato is the major 
food commodity in the fruiting vegetable crop group, EPA concludes that 
it is appropriate to set nonbell pepper and fruiting vegetable (except 
nonbell pepper) tolerances. Therefore, EPA concludes that the following 
tolerances for residues of fenamidone per se are appropriate: fruiting 
vegetable (except nonbell pepper) - 1.0 ppm and nonbell peppers - 3.5 
ppm (the currently established tomato tolerance should be deleted).
    5. Vegetable, leafy, except Brassica, group 4. The geographical 
representation of the lettuce (head and leaf), celery, and spinach 
field trial data fulfill the data requirements suggested in OPPTS 
860.1500 for leafy vegetables (except Brassica) crop group 
registration. EPA notes that these field trials employed 1.0x the 
proposed single application rate but 1.3 to 1.4x the proposed seasonal 
rate. Based on the residue decline data which indicated that combined 
residues of fenamidone, RPA 717879, RPA 408056, and RPA 405862 reduced 
36% (celery), 70% (spinach), and 99% (leaf lettuce) as the PHI 
increased from 0 to 7 days, EPA concludes that the final application, 
which was conducted at 1x the proposed rate, will drive the magnitude 
of the residue in or on leafy vegetables (except Brassica). Based on 
the head lettuce, leaf lettuce, celery, and spinach field trial data 
and the tolerance spreadsheet calculator, tolerances for the residues 
of fenamidone per se of 18 ppm, 45 ppm, 45 ppm, and 60 ppm were 
recommended. EPA concludes that a leafy vegetables (except Brassica) 
crop group tolerance of 60 ppm for residues of fenamidone per se is 
appropriate (the currently established lettuce, leaf and lettuce, head 
tolerances should be deleted).

V. Conclusion

    Therefore, the tolerances are established for residues of 
fenamidone, (4H-Imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-
phenyl-3-(phenylamino)-(S)-), in or on carrot at 0.15 ppm; sunflower at 
0.02 ppm; Brassica, head and stem, subgroup 5A at 5.0 ppm; Brassica, 
leafy greens, subgroup 5B at 55 ppm; vegetable, fruiting, group 8, 
except nonbell pepper at 1.0 ppm; pepper, nonbell at 3.5 ppm; 
vegetable, leafy, except Brassica, group 4 at 60 ppm; cotton, gin 
byproducts at 0.02 ppm; and cotton, undelinted seed at 0.02 ppm.
    The tolerance is also established for combined residues of 
fenamidone, (4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methlthio)-5-
phenyl-3-(phenylamino, (S)-) and its metabolite RPA 717879 (2,4-
imidazolidinedione, 5-methyl-5-phenyl) in or on strawberry at 0.02 ppm.
    Tolerances should be deleted for lettuce, leaf; lettuce; head; and 
tomato as these commodities are included in the newly established 
``vegetable, fruiting, group 8, except nonbell peppers,'' group, and 
vegetable, leafy, except Brassica, group 4.

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

[[Page 60272]]

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 5, 2007.
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 180.579 is amended by alphabetically adding the 
commoditiesBrassica, head and stem, subgroup 5A; Brassica, leafy 
greens, subgroup 5B;carrot; cotton, gin byproducts; cotton, undelinted 
seed, pepper, nonbell; sunflower; vegetable, fruiting, group 8, except 
nonbell pepper; vegetable, leafy, except Brassica, group 4; and by 
removing lettuce, head; lettuce, leaf; and tomato from the table in 
paragraph (a)(1) and by alphabetically adding strawberry to the table 
in paragraph (d) to read as follows:

Sec.  180.579  Fenamidone; tolerances for residues.

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

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A.......................          5.0
Brassica, leafy greens, subgroup 5B........................           55
Carrot.....................................................         0.15
Cotton, gin byproducts.....................................         0.02
Cotton, undelinted seed....................................         0.02
                                * * * * *
Pepper, nonbell............................................          3.5
                                * * * * *
Sunflower..................................................         0.02
                                * * * * *
Vegetable, fruiting, group 8, except nonbell pepper........          1.0
Vegetable, leafy, except Brassica, group 4.................           60
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (d) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Strawberry.................................................         0.15
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E7-20670 Filed 10-23-07; 8:45 am]

BILLING CODE 6560-50-S