[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Rules and Regulations]
[Pages 70890-70896]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29618]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0866; FRL-9325-4]
Fenamidone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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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)
305-5805.
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:
kearns.rosemary@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I 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
IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue * *
*.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for 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
children.
Fenamidone has low acute toxicity via the oral, dermal and
inhalation routes of exposure. It is a moderate eye irritant, but is
not a dermal irritant or a dermal sensitizer. The liver is the target
organ in chronic studies in the rat, mouse and dog. The thyroid is also
a target organ in the rat. 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
rat.
No treatment-related effects were observed on motor activity or in
the functional observation battery (FOB) parameters measured in the
subchronic neurotoxicity study in rats. In this subchronic
neurotoxicity study, marginal decreases in brain weights were observed
only in high dose males. In the acute neurotoxicity study in rats, the
most commonly observed clinical sign was staining/soiling of the
anogenital region. Other day-1 FOB findings included mucous in the
feces, 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
Residues.''
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
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Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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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.
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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.
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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
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 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
commodities.
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
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 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
factor.
2. Prenatal and postnatal sensitivity. The pre- and postnatal
toxicity database for fenamidone includes rat and rabbit developmental
toxicity studies, a rat developmental neurotoxicity study (DNT), and a
2-generation reproduction toxicity study in rats. No evidence of
increased quantitative or qualitative susceptibility of rat or rabbit
fetuses to in utero exposure was observed in the developmental toxicity
studies. There was no developmental toxicity in rabbit fetuses up to
100 milligrams/kilogram/day (mg/kg/day), the highest dose tested (HDT);
whereas an increase in absolute liver weight was observed in the 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
identified;
iii. The endpoints used for the various risk assessment scenarios
are much more sensitive than that of the decreased bodyweight of the
offspring occurring at almost half the limit-dose (429 mg/kg/day); and
iv. The 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
findings:
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: 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 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
States
[[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
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 27, 2011.
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, revise paragraphs (a)(1) introductory text, (a)(2)
introductory text, (c) introductory text, and paragraph (d) to read as
follows:
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
rice.....................................................
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]
BILLING CODE 6560-50-P