[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Rules and Regulations]
[Pages 70890-70896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29618]



40 CFR Part 180

[EPA-HQ-OPP-2010-0866; FRL-9325-4]

Fenamidone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for inadvertent 
residues of fenamidone in or on the cereal grains crop group 15, except 
rice and the forage, fodder, and straw of cereal grains crop group 16, 
except rice. Bayer Crop Science requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 16, 2011. Objections and 
requests for hearings must be received on or before January 17, 2012, 
and must be filed in accordance with the instructions provided in 40 
CFR part

[[Page 70891]]

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-2010-0866. 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) 

FOR FURTHER INFORMATION CONTACT: Rosemary Kearns, Registration 
Division, Office of Pesticide Programs, Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 
telephone number: (703) 305-5611; email address: 
[email protected].


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 

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection 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-2010-0866 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
January 17, 2012. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0866, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of December 15, 2010 (75 FR 78240) (FRL-
8853-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0F7764) by Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle 
Park, NC 27709. The petition requested that 40 CFR 180.547 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 grain, cereal, group 15 (except rice) 
at 0.1 ppm; grain, forage, group 16 (except rice) at 0.3 ppm; and 
grain, stover, group 16 (except rice) at 0.5 ppm. That notice 
referenced a summary of the petition prepared by Bayer CropScience, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    EPA has modified the commodity definitions for which tolerances are 
being established. The reason for these changes is explained in Unit 

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 fenamidone

[[Page 70892]]

including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with 
fenamidone 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 
    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. An acceptable guideline immunotoxicity study 
in rats has been reviewed. While the study showed a potential 
immunosuppression at the highest dose tested, the existing risk 
assessment points of departure are lower and are therefore protective 
of this potential effect. Fenamidone is not likely to be a human 
carcinogen based on the negative carcinogenic potential of fenamidone 
in rats and mice and studies indicate that there is no concern for 
mutagenicity for fenamidone.
    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 Dawleyrat), 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 
    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, 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 docket ID EPA-HQ-OPP-2010-0866 on pages 25-28 of 
the document titled ``Fenamidone: Human Health Risk Assessment to 
Support the Label Amendment to Permit Rotation to All Cereal Grain, 
Except Rice and Establish Revised Tolerances for Inadvertent 

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fenamidone used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Fenamidone for Use in Human Health Risk Assessment
                                     Point of departure and
         Exposure/scenario              uncertainty/safety   RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                 effects
Acute dietary (All populations)....  NOAEL = 125 milligrams/ Acute RfD = 1.25 mg/kg/ Acute Neurotoxicity in
                                      kilograms/day (mg/kg/   day.                    Rats: LOAEL = 500 mg/kg/
                                      day).                  aPAD = 1.25 mg/kg/day.   day based on urination,
                                     UFA = 10x.............                           staining/soiling of the
                                     UFH = 10x.............                           anogenital region, mucous
                                     FQPA SF = 1x..........                           in the feces, and unsteady
                                                                                      gait in the females.
Chronic dietary (All populations)..  NOAEL= 2.83 mg/kg/day.  Chronic RfD = 0.0283    2 Year Chronic Toxicity/
                                     UFA = 10x.............   mg/kg/day.              Carcinogenicity in Rats:
                                     UFH = 10x.............  cPAD = 0.0283 mg/kg/     LOAEL = 7.07/9.24 mg/kg/
                                     FQPA SF = 1x..........   day.                    day (M/F) based on
                                                                                      increase in severity of
                                                                                      diffuse thyroid C-cell
                                                                                      hyperplasia in both sexes.
Cancer (Oral, dermal, inhalation)..     Based on the negative carcinogenic potential of fenamidone in rats and
                                          mice, EPA has classified fenamidone as ``not likely'' to be a human
                                                    carcinogen by all relevant routes of exposure.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose.

[[Page 70893]]

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 
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for fenamidone. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA conducted a conservative acute dietary risk 
assessment which used maximum field trial residue values and assumed 
100 percent crop treated for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA conducted a 
conservative acute dietary risk assessment which used maximum field 
trial residue values and assumed 100 percent crop treated for all 
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fenamidone does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA 
authorizes EPA to use available data and information on the anticipated 
residue levels of pesticide residues in food and the actual levels of 
pesticide residues that have been measured in food. If EPA relies on 
such information, EPA must require pursuant to FFDCA section 408(f)(1) 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. For the present action, EPA will 
issue such data call-ins as are required by FFDCA section 408(b)(2)(E) 
and authorized under FFDCA section 408(f)(1). Data will be required to 
be submitted no later than 5 years from the date of issuance of these 
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fenamidone in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
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 Screening Concentration in Ground Water (SCI-
GROW) models the estimated drinking water concentrations (EDWCs) of 
fenamidone for acute exposures are estimated to be 47.88 parts per 
billion (ppb) for surface water and 178 ppb for ground water. For 
chronic exposures for non-cancer assessments these levels are estimated 
to be 12.86 ppb for surface water and 178 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For both acute and chronic 
dietary risk assessments, the water concentration value of 178 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).
    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 Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
    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 dose 
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

[[Page 70894]]

performance up to 438.3 mg/kg/day (highest dose tested; 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 preweaning 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. There were no neurobehavioral or neuropathological changes in 
the offspring at any dose;
    ii. A clear NOAEL for the adverse effects in the study was 
    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 NOAEL of 2.83 mg/kg/day used for the long-term risk 
assessment is 33x 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 
    i. The toxicology database for fenamidone is complete for purposes 
of the characterization of potential pre-natal and/or post-natal risks 
to infants and children.
    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. No qualitative or quantitative increased susceptibility of rat 
or rabbit fetuses to in utero exposure in the developmental toxicity 
studies was observed. There was no qualitative or quantitative 
increased susceptibility in the two generation reproduction study 
(rat). There is low concern for residual uncertainties in the DNT study 
in the rat since there is a well established offspring NOAEL for the 
reasons noted in Unit III.D.2.
    iv. Residue values used in the dietary risk assessments are 
unlikely to underestimate risk. Dietary exposure assessments were 
conducted using maximum field trial residue values and assumed 100% 
crop treated. Therefore, the acute and chronic dietary, food only, 
exposure is considered an upper bound conservative estimate. The 
contribution from drinking water is minimal. EPA concludes that the 
acute and chronic exposure estimates in this analysis are unlikely to 
underestimate actual exposure. The drinking water component of the 
dietary assessment utilizes water concentration values generated by 
modeling parameters which are designed to provide conservative, health 
protective, high-end estimates of water concentrations which will not 
likely be exceeded.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to fenamidone will occupy 5% of the aPAD for children 1-2 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fenamidone from food and water will utilize 90% of the cPAD for 
children 1-2 years old the population group receiving the greatest 
exposure. There are no residential uses for fenamidone.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, fenamidone 
is not registered for any use patterns that would result in short- and/
or intermediate-term residential exposure. Short- and/or intermediate-
term risk is assessed based on short- and/or intermediate-term 
residential exposure plus chronic dietary exposure. Because there is no 
short- or intermediate-term residential exposure and chronic dietary 
exposure has already been assessed under the appropriately protective 
cPAD (which is at least as protective as the POD used to assess short-
term risk), no further assessment of short- or intermediate-term risk 
is necessary, and EPA relies on the chronic dietary risk assessment for 
evaluating short- and intermediate-term risk for fenamidone.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fenamidone is not expected to pose a cancer risk to humans.
    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; 
email address: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 

[[Page 70895]]

is a party. EPA may establish a tolerance that is different from a 
Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are no Codex MRLs for fenamidone in cereal crops (crop group 
15 and 16, except rice).

C. Revisions to Petitioned-For Tolerances

    EPA has modified the commodity definitions that were proposed in 
the Notice of Filing to (1) be consistent with Agency policy and 
nomenclature and (2) to have all of crop group 16 under a single 
tolerance instead of separated into separate ones as proposed.
    EPA is removing the tolerances for corn, field forage; corn, field, 
grain; corn, field, stover; corn, sweet, forage, corn, sweet, plus cob 
with husks removed; corn, sweet, stover; wheat, grain; wheat, hay; 
wheat, forage; and wheat, straw from paragraph (d) that are covered by 
the newly created crop group tolerances.
    Also, EPA has revised the tolerance expression to clarify (1) that, 
as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of fenamidone not specifically mentioned; 
and (2) that compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for indirect or inadvertent 
residues of fenamidone (4-H-imidazol-4-one, 3,5-dihydro-5-methyl-2-
(methylthio)-5-phenyl-3-(phenylamino, (S)-) and its metabolite RPA 
717879 (2,4-imidazolidinedione, 5-methyl-5-phenyl) in or on grain, 
cereal, group 15, except rice at 0.1 ppm; and grain, cereal, forage, 
fodder and straw, group 16, except rice at 0.5 ppm.

VI. Statutory and Executive Order Reviews

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

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 27, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

2. In Sec.  180.579, revise paragraphs (a)(1) introductory text, (a)(2) 
introductory text, (c) introductory text, and paragraph (d) to read as 

Sec.  180.579  Fenamidone; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide, fenamidone, including its metabolites and degradates, in or 
on the following commodities. Compliance with the tolerance levels is 
to be determined by measuring only fenamidone (4H-Imidazol-4-one, 3,5-
dihydro-5-methyl- 2-(methylthio)-5-phenyl-3 (phenylamino)-,(S)-), in or 
on the commodities:
* * * * *
    (2) Tolerances are established for residues of the fungicide 
fenamidone, including its metabolites and degradates, in or on the 
following commodities. Compliance with the tolerance levels is to be 
determined by measuring fenamidone (4H-Imidazol-4-one, 3,5-dihydro-5-
methyl-2-(methylthio)-5-phenyl-3 (phenylamino)-,(S)-), and its 
metabolite RPA 717879 (2,4-imidazolidinedione, 5-methyl-5-phenyl), in 
or on the commodities:
* * * * *
    (c) Tolerances with regional registrations. A tolerance with 
regional registration as defined in Sec.  180.1(l) is established for 
residues of the fungicide fenamidone, including its metabolites and 
degradates, in or on the following commodities. Compliance with the

[[Page 70896]]

tolerance levels is to be determined by measuring only fenamidone (4H-
Imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3 
(phenylam- ino)-,(S)-), in or on the commodity:
* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for residues of the fungicide fenamidone, including its metabolites and 
degradates, in or on the following commodities. Compliance with the 
tolerance levels is to be determined by measuring fenamidone (4H-
Imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3 
(phenylamino)-,(S)-), and its metabolite RPA 717879 (2,4-
imidazolidinedione, 5-methyl-5-phenyl), in or on the following 
commodities when present therein as a result of application of 
fenamidone to the crops in paragraph (a)(1).

                                                              Parts per
                         Commodity                             million
Grain, cereal, group 15, except rice......................          0.1
Grain, cereal, forage, fodder and straw, group 16, except           0.5
Soybean, forage...........................................          0.15
Soybean, hay..............................................          0.25
Soybean, seed.............................................          0.02
Strawberry................................................          0.15

[FR Doc. 2011-29618 Filed 11-15-11; 8:45 am]