Document ID: EPA-HQ-OPP-2013-0161-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fenamidone
Posted Date: 2014-03-12T04:00Z

[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Rules and Regulations]
[Pages 13877-13882]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05399]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0161; FRL-9906-99]

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 ginseng; bean, succulent, except cowpea; onion, 
blub, subgroup 3-07A; and onion, green, subgroup 3-07B. This regulation 
additionally removes several individual tolerances that are superseded 
by inclusion in crop subgroup tolerances. Interregional

[[Page 13878]]

Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 12, 2014. Objections and 
requests for hearings must be received on or before May 12, 2014, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2013-0161, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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://www.ecfr.gov/cgi-bin/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-2013-0161 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 
May 12, 2014. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0161, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 5, 2013 (78 FR 33785) (FRL-9386-2), 
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 3E8150) 
by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ 08540. The 
petition 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 ginseng at 0.80 parts per million (ppm); bean, succulent at 0.80 
ppm; onion, bulb, subgroup 03-07A at 0.20 ppm; and onion, green, 
subgroup 03-07B at 1.5 ppm. The petition additionally requested to 
remove the established tolerances in or on garlic at 0.20 ppm; garlic, 
great headed at 0.20 ppm; leek at 1.5 ppm; onion, bulb at 0.20 ppm; 
onion, green at 1.5 ppm; onion, welsh at 1.5 ppm; shallot, bulb at 0.20 
ppm; and shallot, fresh leaves at 1.5 ppm, as they will be superseded 
by the tolerances described in this unit. That document referenced a 
summary of the petition prepared on behalf of IR-4 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.
    Based upon review of the data supporting the petition, EPA has 
determined that cowpea should not be included in the tolerance in or on 
bean, succulent. The reason for this change 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. . . 
.''
    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

[[Page 13879]]

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 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 
children.
    The target organs in subchronic toxicity studies for fenamidone 
were generally the liver; rarely, the thyroid or spleen were also 
affected. Target organs for chronic toxicity studies were the liver in 
the mouse and dog, and the liver and thyroid in the rat. In the chronic 
toxicity rat study, diffuse C-cell hyperplasia of the thyroid in both 
sexes was the most sensitive indicator of toxicity, and at higher doses 
follicular cells and the liver were also affected. The similarity in 
the systemic no-observed-adverse-effect-levels (NOAELs) and the type of 
toxicity observed (primarily liver) for the subchronic rat studies with 
the parent and plant metabolites (RPA 412636, RPA 412708, and RPA 
410193) demonstrated that, on a subchronic basis, plant metabolites 
were not more toxic than the parent.
    In the acute neurotoxicity study in rats, clinical signs included 
staining of the anogenital region, mucous in the feces, hunched 
posture, and unsteady gait. In the subchronic neurotoxicity study in 
rats, marginal decreases in brain weights were observed only in high 
dose males. Additionally, decreased brain weight occurred in the rat 
reproduction study. 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.
    In prenatal developmental toxicity studies in rabbits and rats, 
there were no developmental effects up to the highest dose tested 
(HDT). Maternal toxicity in these studies was observed as increased 
liver weights in maternal rabbits and decreased body weight gains and 
food consumption in maternal rats. In the reproduction study in rats, 
decreased absolute brain weight in F2 female pups occurred at the same 
dose levels as decreased absolute brain weight in F1 parental females. 
There were no effects on fertility or other measured reproductive 
parameters conducted with fenamidone.
    An immunotoxicity study in rats showed a potential 
immunosuppression at the HDT; however, the existing risk assessment 
points of departure are lower and are therefore protective of this 
potential effect. No carcinogenic potential was observed in chronic 
studies in rat, mice, and dog; therefore, EPA has determined that 
fenamidone is not likely to be a human carcinogen by all relevant 
routes of exposure. All mutagenicity studies were negative for both the 
parent and plant metabolites, except the parent induced mutant colonies 
at the tk locus and increased chromosomal aberrations in human 
peripheral blood.
    Specific information on the studies received and the nature of the 
adverse effects caused by fenamidone as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in document: ``Fenamidone: 
Human Health Risk Assessment to Support the Section (3) Registration 
and the Establishment of Tolerances for Uses on Ginseng, Succulent 
Beans (Except Cowpea), Bulb Onion (Subgroup 3-07A), and Green Onion 
(Subgroup 3-07B).'' at pp. 30-34 in docket ID number EPA-HQ-OPP-2013-
0161.

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 the NOAEL and the LOAEL of concern are 
identified. 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 discussed in Unit III.B., Table 1 of the final 
rule published in the Federal Register of November 16, 2011 (76 FR 
70890) (FRL-9325-4).

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. Such effects were identified 
for fenamidone. In estimating acute dietary exposure, EPA used Dietary 
Exposure Evaluation Model software with the Food Commodity Intake 
Database (DEEM-FCID) Version 3.16, which uses food consumption data 
from the U.S. Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, ``What We Eat in America'' (NHANES/WWEIA) 
from 2003 through 2008. As to residue levels in food, EPA used maximum 
field trial residues for plant commodities and residues at the limit of 
quantitation for livestock commodities, assumed 100 percent crop 
treated (PCT) estimates for all commodities, and incorporated 
DEEMTM default processing factors, when applicable.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the same dietary risk assessment assumptions as 
for the acute dietary risk assessment.
    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 and PCT information. EPA did not use PCT 
information in the dietary assessment for fenamidone; 100 PCT were 
assumed for all food commodities. However, anticipated residues were 
used as maximum field trial residues for plant

[[Page 13880]]

commodities and residues at the limit of quantitation for livestock 
commodities. 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.
    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 PRZM Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of fenamidone for surface water 
are expected to be 41.7 parts per billion (ppb) for acute exposures and 
11.9 ppb for chronic exposures for non-cancer assessments. For 
groundwater, the EDWC of 207 ppb is estimated for all acute and chronic 
exposures.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute and chronic dietary 
risk assessments, the water concentration value of 207 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 Food Quality 
Protection Act Safety Factor (FQPA 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/kilograms/day (mg/kg/day), the HDT; maternal toxicity 
was exhibited as an increase in absolute liver weight, observed at 30 
and 100 mg/kg/day. In the rat developmental study, decreased fetal body 
weight and incomplete fetal ossification were observed, but were 
considered secondary to maternal toxicity observed as decreased body 
weight and food consumption at the limit dose (1,000 mg/kg/day). 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. Parental effects consisting of decreased body weight and food 
consumption and increased liver and spleen weights were noted at the 
same level as decreased pup body weight. There were no reproductive 
effects up to the 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.
    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 complete.
    ii. The concern for the increased susceptibility observed in the 
DNT is low because:
    a. There were no neurobehavioral or neuropathological changes in 
the offspring at any dose;
    b. A clear NOAEL for the adverse effects in the study was 
identified; and
    c. The endpoints used for the various risk assessment scenarios are 
much more sensitive than that of the decreased bodyweight of the 
offspring.
    Therefore, based on the information above, the available data and 
the selection of risk assessment endpoints, EPA has determined that all 
endpoints used in the risk assessment for fenamidone are protective of 
neurotoxic effects. Accordingly, additional uncertainty factors (UFs) 
to account for neurotoxicity are not necessary.
    iii. There is no evidence that fenamidone results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT, maximum field trial residues for plant commodities, and 
residues at the limit of quantitation for livestock commodities. EPA 
made conservative

[[Page 13881]]

(protective) assumptions in the ground and surface water modeling used 
to assess exposure to fenamidone in drinking water. These assessments 
will not underestimate the exposures and risks posed by fenamidone.

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 4.8% 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 89% 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 exposures take 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- or 
intermediate-term residential exposures. Short- and intermediate-term 
risk is assessed based on short- or intermediate-term residential 
exposure plus chronic dietary exposure. Because there are no short- or 
intermediate-term residential exposures and chronic dietary exposure 
has already been assessed under the appropriately protective cPAD 
(which is at least as protective as the POD used to assess short-term 
risk), no further assessment of short- or intermediate-term risks are 
necessary, and EPA relies on the chronic dietary risk assessment for 
evaluating short- and intermediate-term risks 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, a liquid chromatography with 
tandem mass spectrometry 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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance 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.
    The Codex has not established a MRL for fenamidone.

C. Revisions to Petitioned-For Tolerances

    Based on the data supporting the petition, EPA has determined that 
cowpea should not be included in the bean, succulent tolerance at 0.80 
ppm, as was proposed. The bean, succulent definition includes cowpea, 
and cowpea has forage and hay associated uses that are considered 
significant livestock feedstuffs. Because of the significant livestock 
feedstuffs for cowpea, the Agency requires a feeding study in order to 
determine the dietary burden associated with cowpea. Because an 
appropriate feeding study has not been submitted for fenamidone, cowpea 
has been excluded from the tolerance in or on bean, succulent.

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)-, in or on bean, succulent, except cowpea at 0.80 
ppm; ginseng at 0.80 ppm; onion, bulb, subgroup 3-07A at 0.20 ppm; and 
onion, green, subgroup 3-07B at 1.5 ppm. This regulation additionally 
removes established tolerances at 0.20 ppm in or on garlic; garlic, 
great headed; onion, bulb; and shallot, bulb. Finally, this regulation 
removes established tolerances at 1.5 ppm in or on leek; onion, green; 
onion, welsh; and shallot, fresh leaves.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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 FFDCA section 408(d), 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,

[[Page 13882]]

nor does this action alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of FFDCA section 408(n)(4). 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) (2 U.S.C. 
1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: February 28, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.579:
0
a. Remove the commodities ``Garlic''; ``Garlic, great headed''; 
``Leek''; ``Onion, bulb''; ``Onion, green''; ``Onion, welsh''; 
``Shallot, bulb''; and ``Shallot, fresh leaves'' from the table in 
paragraph (a)(1).
0
b. Add alphabetically the following commodities to the table in 
paragraph (a)(1). The amendments read as follows:

Sec.  180.579  Fenamidone; tolerances for residues.

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

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Bean, succulent, except cowpea............................          0.80
 
                                * * * * *
Ginseng...................................................          0.80
 
                                * * * * *
Onion, bulb, subgroup 3-07A...............................          0.20
Onion, green, subgroup 3-07B..............................          1.5
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-05399 Filed 3-11-14; 8:45 am]
BILLING CODE 6560-50-P