[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Rules and Regulations]
[Pages 18899-18906]
[FR Doc No: 2011-7774]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0636; FRL-8864-3]

Indaziflam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
indaziflam in or on multiple commodities which are identified and
discussed later in this document. Bayer CropScience LP requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 6, 2011. Objections and
requests for hearings must be received on or before June 6, 2011, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0636. 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: Bethany Benbow, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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://www.gpoaccess.gov/ecfr.

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-2009-0636 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
June 6, 2011. 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-2009-0636, 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<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of January 6, 2010 (75 FR 864) (FRL-8801-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of two pesticide petitions (PP
9F7589 and PP 9E7588) by Bayer CropScience LP, 2 T.W. Alexander Dr.,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
part 180 be amended by adding a section for the herbicide indaziflam
and establishing tolerances therein for residues of indaziflam, N-
[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-(1-fluoroethyl)-
1,3,5-triazine-2,4-diamine, in or on fruit, citrus, group 10; fruit,
pome, group 11; fruit, stone, group 12; nut, tree, group 14; pistachio;
grape; and olive; each at 0.01 parts per million (ppm) and almond,
hulls at 0.20 ppm (PP 9F7589). Additionally, Bayer CropScience LP
requested an import tolerance for sugarcane, sugar, refined at 0.01 ppm
(PP 9E7588). That notice referenced a summary of the petitions prepared
by Bayer CropScience LP, 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 petitions, EPA has
modified the petitioner's request by lowering the proposed tolerance
level for almond, hulls from 0.20 ppm to 0.15 ppm. EPA is also revising
the proposed commodity term, ``Sugarcane, sugar, refined'' to read
``Sugarcane, refined sugar.'' Additionally, EPA is revising the citrus
and pome fruit crop group names and the requested tolerance expression.
The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for indaziflam including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with indaziflam
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 toxicology database for indaziflam is complete and adequate for
selecting toxicity endpoints for risk assessment. The scientific
quality of the data is relatively high, and the toxicity is well-
characterized for all types of effects, including potential
developmental, reproductive, immunologic and neurologic toxicity.
    Indaziflam has low acute toxicity via the oral, dermal, and
inhalation routes of exposure. It is not irritating to the eye or skin
and is not a dermal sensitizer.
    The nervous system is a target for indaziflam in rats and dogs. In
the dog degenerative neuropathology of the brain, spinal cord and
sciatic nerve was reported in the dog following both subchronic and
chronic oral exposure. Neuropathology in the dog was the most sensitive
effect and was selected as the risk assessment endpoint for all

repeated exposure scenarios. In the rat, histopathology of the brain
and pituitary pars nervosa was observed following chronic exposure.
Clinical signs of neurotoxicity were observed in both species in
several studies, including rat adult and developmental neurotoxicity
studies. Decreased motor activity observed in the rat acute
neurotoxicity study was selected as the appropriate endpoint for
assessing acute oral exposures.
    In addition to the neurological system, chronic exposure was
associated with degenerative renal effects in the rat and mouse,
hypertrophy (considered adaptive), increased macrovacuolation and
multinucleated hepatocytes in the rat liver, increased follicular cell
hypertrophy and colloid alteration in the rat thyroid, degeneration in
rat reproductive tissues including atrophied seminal vesicles (males),
and in female mice, blood-filled ovarian cysts/follicles (females) and
gastric lesions. Thyroid and gastric effects were also observed
following subchronic exposure of the rat. Decreased body weight gains
were generally observed in the available subchronic and chronic
studies. No systemic toxicity was observed in a 28-day dermal toxicity
study in the rat.
    Developmental effects in offspring were absent or limited to doses
that also caused systemic toxicity in the adult. In the rat
developmental toxicity study, decreased fetal weight was observed in
the presence of maternal effects that included decreased body weight
and clinical signs of toxicity. No developmental effects were observed
in rabbits up to maternally toxic dose levels. Decreased pup weight and
delays in sexual maturation (preputial separation in males and vaginal
patency in females) were observed in the rat 2-generation reproductive
toxicity study, along with clinical signs of toxicity, at a dose
causing parental toxicity that included clinical signs and decreased
weight gain. In the developmental neurotoxicity study, transiently
decreased motor activity (PND 21 only) in male offspring was observed
and was considered a potential neurotoxic effect. It was observed at a
dose that also caused clinical signs of neurotoxicity along with
decreased body weight in maternal animals.
    There was no evidence of carcinogenicity observed in the 2-year
dietary rat or mouse carcinogenicity bioassays and no evidence of
genotoxicity in mutagenicity studies (reverse gene mutation in
bacteria, forward gene mutation in mammalian cells) or in vitro and in
vivo chromosomal aberration assays. Based on the lack of evidence of
carcinogenicity or genotoxicity, the Agency classified indaziflam as
``not likely to be carcinogenic to humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by indaziflam, 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 document ``Indaziflam: Human health risk
assessment for use in citrus, stone, and pome fruits; grapes; tree
nuts; pistachios; olives; and sugar cane (imported refined sugar),'' p.
41 in docket ID number EPA-HQ-OPP-2009-0636.

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 NOAEL are observed and the LOAEL which
adverse effects 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 indaziflam used for human
risk assessment is shown in the table below of this unit.

   Table--Summary of Toxicological Doses and Endpoints for Indaziflam 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 (General population    NOAEL = 50 mg/kg/day..  Acute RfD = 0.5 mg/kg/  Acute oral neurotoxicity in
 including females 13-49 years of    UFA = 10x.............   day.                    the rat. LOAEL = 100 mg/kg/
 age and infants and children).      UFH = 10x.............  aPAD = 0.5 mg/kg/day..   day based on decreased
                                     FQPA SF = 1x..........                           motor and locomotor
                                                                                activity in females.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)..  NOAEL = 2 mg/kg/day...  Chronic RfD = 0.02 mg/  Chronic oral (dietary)
                                     UFA = 10x.............   kg/day.                 toxicity in the dog. LOAEL
                                     UFH = 10x.............  cPAD = 0.02 mg/kg/day.   = \6/7\ mg/kg/day M/F,
                                     FQPA SF = 1x..........                           based on nerve fiber
                                                                                degenerative lesions in
                                                                                the brain, spinal cord and
                                                                                sciatic nerve.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to 30  NOAEL= 7.5 mg/kg/day..  LOC for MOE = 100.....  Subchronic oral (gavage) in
 days) and intermediate-term (1 to   UFA = 10x.............                           the dog. LOAEL = 15 mg/kg/
 6 months).                          UFH = 10x.............                           day based on axonal
                                     FQPA SF = 1x..........                           degenerative microscopic
                                                                                findings in the brain,
                                                                                spinal cord and sciatic
                                                                                nerve.
----------------------------------------------------------------------------------------------------------------

Dermal short-term..................  Dermal (or oral) study  LOC for MOE = 100.....  Subchronic oral (gavage) in
(1 to 30 days) and intermediate-      NOAEL = 7.5 mg/kg/day                           the dog. LOAEL = 15 mg/kg/
 term (1 to 6 months).                (dermal absorption                              day based on axonal
                                      rate = 7.3%).                                   degenerative microscopic
                                     UFA = 10x.............                           findings in the brain,
                                     UFH = 10x.............                           spinal cord and sciatic
                                     FQPA SF = 1x..........                           nerve.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30       Inhalation (or oral)    LOC for MOE = 100.....  Subchronic oral (gavage) in
 days) and intermediate-term (1 to    study NOAEL= 7.5 mg/                            the dog. LOAEL = 15 mg/kg/
 6 months).\1\                        kg/day (inhalation                              day based on axonal
                                      absorption rate =                               degenerative microscopic
                                      100%).                                          findings in the brain,
                                     UFA = 10x.............                           spinal cord and sciatic
                                     UFH = 10x.............                           nerve.
                                     FQPA SF = 1x..........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..    Classification: ``Not Likely to be Carcinogenic to Humans'' based on the
                                        absence of significant tumor increases in the two-year dietary rat and
                                                                   mouse bioassays.
----------------------------------------------------------------------------------------------------------------
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. MOE = margin of exposure. LOC = level of
  concern.
\1\ EPA selected a point of departure from an oral study to assess short-term residential handler inhalation
  risks for indaziflam. While it is possible that extrapolation of an inhalation endpoint from an oral study may
  sometimes underestimate inhalation risk, in this case the Agency believes the risk assessment is protective of
  adult handlers. MOEs calculated for residential handlers ranged from 3,000 to 510,000, thus providing an ample
  margin of safety to account for any uncertainties in route-to-route extrapolation. Further, the contribution
  of residential inhalation exposure to aggregate risk is small.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to indaziflam, EPA considered exposure under the petitioned-
for tolerances. There are no tolerances currently established for
indaziflam. EPA assessed dietary exposures from indaziflam 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 indaziflam. 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 assumed that residues are present in all
commodities at the tolerance level and that 100% of commodities are
treated with indaziflam. DEEM-FCID, Version 2.03 default concentration
factors were used to estimate residues of indaziflam in processed
commodities with the exception of the empirically derived raisin
processing factor of 2.8x.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed that residues
are present in all commodities at the tolerance level and that 100% of
commodities are treated with indaziflam. DEEM-FCID, Version 2.03
default concentration factors were used to estimate residues of
indaziflam in processed commodities with the exception of the
empirically derived raisin processing factor of 2.8x.
    iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, EPA classified indaziflam as ``Not Likely to be
Carcinogenic to Humans'' therefore, a dietary exposure assessment for
the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for indaziflam. Tolerance level residues and 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The residues of concern in
drinking water include indaziflam and its degradates: Triazine
indanone, indaziflam-carboxylic acid, indaziflam-olefin, indaziflam-
hydroxyethyl, fluoroethyl-diaminotriazine (FDAT), and
dihydroaminotriazine (a degradate of FDAT). The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for indaziflam and its degradates in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of indaziflam and its degradates.
Further information regarding EPA drinking water models used in
pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
indaziflam and its degradates for acute exposures are estimated to be
84 parts per billion (ppb) for surface water and 3.7 ppb for ground
water. The chronic exposures for non-cancer assessments are estimated
to be 26 ppb for surface water and 3.7 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 84 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 26 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). Indaziflam

is currently registered for the following uses that could result in
residential exposures: Residential turfgrass and recreational areas.
EPA assessed residential exposure using the following assumptions:
There is a potential for short-term exposure of homeowners applying
products containing indaziflam on home lawns. There is also a potential
for short- and intermediate-term post-application exposure of adults
and children entering lawn and recreation areas, including golf
courses, which have been treated with indaziflam. Indaziflam post-
application inhalation exposures are expected to be negligible due to
its low vapor pressure, low application rates, and the types of
application equipment used (i.e., hand-held equipment that is not
likely to generate a vapor). Therefore, a quantitative post-application
inhalation exposure assessment was not considered necessary. EPA
assessed the following residential exposure scenarios:
    i. Short-term dermal and inhalation exposures of residential
handlers using various types of application equipment and formulation
types on the proposed residential use sites;
    ii. Short-term post-application dermal exposures of adults and
children entering treated turf areas; and
    iii. Short-term postapplication incidental oral exposures of
children from contact with treated turfgrass.
    Since the doses and endpoints selected to assess short- and
intermediate-term exposures are the same, a separate quantitative
intermediate-term assessment was not completed; the short-term risk
assessments are protective of intermediate-term risks.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 indaziflam to share a common mechanism of
toxicity with any other substances. Indaziflam and its metabolite
fluoroethyldiaminotriazine (FDAT) contain a triazine moiety within
their chemical structures. Several triazine herbicides were determined
by EPA to have a common mechanism of toxicity based on their ability to
disrupt the hypothalamic-pituitary-gonadal axis (U.S. EPA, 2002). The
triazine common mechanism group (TCMG) includes atrazine, simazine,
propazine, and the metabolites desethyl-s-atrazine (DEA), deisopropyl-
s-atrazine (DIA), and diaminochlorotriazine (DACT). Indaziflam and its
metabolite FDAT were considered for incorporation into the TCMG by EPA
based on structure; indaziflam, FDAT, and the TCMG members contain a
common triazine moiety. However, EPA determined that it would not be
appropriate to include indaziflam and FDAT in the TCMG for the
following reasons:
    i. The structure of indaziflam and FDAT are unique in that they
contain a fluoroethyl group at the 2-position of the triazine ring,
whereas the TCMG members contain a chlorine substituent at the 2-
position of the triazine ring and;
    ii. Indaziflam and FDAT do not elicit the same toxicological
responses shared by the TCMG members. The TCMG members cause an
increase in mammary gland tumors in rats and multiple developmental
effects such as attenuation of the luteinizing hormone surge, altered
pregnancy outcome, and delayed preputial separation. Although delayed
sexual maturation was observed in the rat reproductive toxicity study,
the effects occurred only at the highest dose. None of the other
effects associated with the TCMG members were observed in the
carcinogenicity, developmental, or reproductive guideline studies for
indaziflam. In a non-guideline study, FDAT delayed vaginal patency in a
dose-dependent manner. However, none of the other characteristic
developmental effects of the TCMG members were observed, and this
effect only occurred at higher doses compared to DACT. Therefore,
unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA found that
neither indaziflam nor its metabolite FDAT have a common mechanism of
toxicity with any other substances, and indaziflam does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
indaziflam 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 post-natal
toxicity database for indaziflam includes guideline rat and rabbit
developmental toxicity studies, a 2-generation reproduction toxicity
study in rats and a developmental neurotoxicity study in rats. As
discussed in Unit III.A., there was no evidence of increased pre- or
post-natal susceptibility of fetuses or offspring in any of these
studies.
    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 indaziflam is considered complete and
includes acceptable developmental toxicity studies in rats and rabbits,
a 2-generation reproductive toxicity study in rats, a developmental
neurotoxicity in rats, acute and subchronic neurotoxicity screening
studies in rats, and an immunotoxicity study.
    ii. There is no evidence that indaziflam results in increased pre-
or post-natal susceptibility of rats or rabbits in the prenatal
developmental studies of rats in the 2-generation reproduction study,
or of rats in the developmental neurotoxicity study.
    iii. There are no significant residual uncertainties in the
exposure databases. The final report on the stability of indaziflam in
frozen storage and processing data for citrus oil were only recently
submitted by the petitioner and are currently undergoing full review at
the Agency; however, based on a preliminary screening of the data, EPA
does not expect these studies to have a measurable impact on exposure
estimates for indaziflam.
    a. Storage stability. Preliminary information from the study
indicates that indaziflam is stable in frozen

storage over a 25-26 month period, well beyond the 17-month period that
samples from the residue field trials were stored frozen prior to
analysis.
    b. Citrus oil processing data. Although all citrus commodities from
submitted field trials and a processing study have total residues below
the method limit of quantitation (LOQ) at a 5x exaggerated application
rate, data were required for the processed commodity citrus oil due to
the extremely high theoretical concentration factor (1000x). Citrus oil
was not analyzed during the originally submitted processing study. Data
from the recently submitted study indicate that indaziflam residues
concentrate in citrus oil at approximately 11.7x compared to those in
citrus raw agricultural commodities (RACs). Based on this preliminary
concentration factor, the total residues in citrus oil are still
estimated to be less than the LOQ. Therefore, EPA believes that the
tolerance of 0.01 ppm (the LOQ) for citrus fruit is adequate to cover
residues in citrus oil, as no finite residues would be expected in
citrus oil even at exaggerated rates.
    The dietary food exposure assessments were performed assuming
tolerance-level residues and 100 PCT for all commodities. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to indaziflam in drinking water. EPA
used similarly conservative assumptions to assess post-application
exposure of children including incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by indaziflam.

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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
indaziflam will occupy 3% of the aPAD for infants, less than 1 year
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
indaziflam from food and water will utilize 10% of the cPAD for
infants, less than 1 year old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
indaziflam is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Indaziflam is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to indaziflam.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 2,400 for adults
and 1,300 for children. For adults, EPA aggregated short-term
residential handler inhalation and dermal exposure with chronic dietary
exposure from food and water. For children, EPA aggregated short-term
dermal and incidental oral residential exposures plus chronic dietary
exposure from food and water. Because EPA's level of concern for
indaziflam is for MOEs below 100, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Since the doses and endpoints selected to assess short- and
intermediate-term exposures to indaziflam are the same, a separate
quantitative intermediate-term assessment was not completed; the short-
term risk assessments are protective of both short- and intermediate-
term risks.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, indaziflam is not expected to pose a cancer risk to humans.
    6. 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 indaziflam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry (LC/MS/MS) Method DH-003-P07-02) is
available to enforce the tolerance expression. The method is able to
determine, separately, residues of indaziflam and FDAT. The method may
be requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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 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 an MRL for indaziflam.

C. Revisions to Petitioned-For Tolerances

    EPA is lowering the almond, hulls tolerance proposed at 0.20 ppm to
0.15 ppm based on analysis of the field trial data using the Agency's
NAFTA-harmonized tolerance/MRL calculator in accordance with the
Guidance for Setting Pesticide Tolerances Based on Field Trial Data.
EPA is also revising the proposed commodity term, ``Sugarcane, sugar,
refined'' to read ``Sugarcane, refined sugar'' to agree with the
Agency's Food and Feed Vocabulary. Additionally, EPA is revising the
requested tolerance expression to clarify the chemical moieties that
are covered by the tolerances and specify how compliance with the
tolerances is to be measured. The revised tolerance expression makes
clear that the

tolerances cover residues of the herbicide indaziflam, including its
metabolites and degradates, but that compliance with the tolerance
levels is to be determined by measuring only indaziflam, N-[(1R,2S)-
2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-(1-fluoroethyl)-1,3,5-
triazine-2,4-diamine, in or on the commodities.
    EPA was petitioned for tolerances on citrus fruit group 10 and pome
fruit group 11. In the Federal Register of December 8, 2010 (75 FR
76284) (FRL-8853-8), EPA issued a final rule that revised the crop
grouping regulations. As part of this action, EPA expanded and revised
the existing citrus fruit group 10 and pome fruit group 11. Changes to
crop group 10 included adding the specialty commodities Australian
desert lime, Australian finger lime, Australian round lime, Brown River
finger lime, Japanese summer grapefruit, Mediterranean mandarin, Mount
White lime, New Guinea wild lime, Russell River lime, sweet lime,
Tachibana orange, Tahiti lime, tangelo, tangor, trifoliate orange, and
uniq fruit; creating subgroups; revising the representative
commodities; and naming the new crop group citrus fruit group 10-10.
Changes to crop group 11 included adding the specialty commodities
azarole, medlar, Asian pear, Chinese quince, Japanese quince, and
tejocote; creating subgroups; revising the representative commodities;
and naming the new crop group pome fruit group 11-10. EPA indicated in
the December 8, 2010 final rule as well as the earlier January 6, 2010
proposed rule (75 FR 807) (FRL-8801-2) that, for existing petitions for
which a Notice of Filing had been published, the Agency would attempt
to conform these petitions to the rule. Therefore, consistent with this
rule, EPA has assessed exposure to the herbicide, indaziflam, assuming
use under the revised crop groups. Because revising the requested crop
groups to the updated crop groups did not result in a risk of concern,
EPA is proposing to establish tolerances for indaziflam residues on
citrus fruit group 10-10 and pome fruit group 11-10.

 V. Conclusion

    Therefore, tolerances are established for residues of the herbicide
indaziflam, including its metabolites and degradates, in or on fruit,
citrus, group 10-10 at 0.01 ppm; fruit, pome, group 11-10 at 0.01 ppm;
fruit, stone, group 12 at 0.01 ppm; nut, tree, group 14 at 0.01 ppm;
pistachio at 0.01 ppm; almond, hulls at 0.15 ppm; grape at 0.01 ppm;
olive at 0.01 ppm; and sugarcane, refined sugar at 0.01 ppm. Compliance
with the tolerance levels is to be determined by measuring only
indaziflam, N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-(1-
fluoroethyl)-1,3,5-triazine-2,4-diamine, in or on the commodities.

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: March 23, 2011.
Steven Bradbury,
Director, 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. Section 180.653 is added to read as follows:

Sec.  180.653  Indaziflam; tolerances for residues:

    (a) General. Tolerances are established for residues of the
herbicide indaziflam, N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-
yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine, including its
metabolites and degradates, in or on the commodities in the following
table. Compliance with the tolerance levels specified in the table
below is to be determined by

measuring only indaziflam, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................         0.15
Fruit, citrus, group 10-10.................................         0.01
Fruit, pome, group 11-10...................................         0.01
Fruit, stone, group 12.....................................         0.01
Grape......................................................         0.01
Nut, tree, group 14........................................         0.01
Olive......................................................         0.01
Pistachio..................................................         0.01
Sugarcane, refined sugar \1\...............................         0.01
------------------------------------------------------------------------
\1\ Tolerance without a corresponding U.S. registration.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2011-7774 Filed 4-5-11; 8:45 am]
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[Federal Register Volume 76, Number 249 (Wednesday, December 28, 2011)]
[Notices]
[Page 81513]
[FR Doc No: 2011-33292]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0313]

Guidance for Industry: Prevention of Salmonella Enteritidis in
Shell Eggs During Production, Storage, and Transportation; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Prevention of
Salmonella Enteritidis in Shell Eggs During Production, Storage, and
Transportation.'' The document provides guidance to egg producers on
how to comply with certain provisions contained in FDA's final rule
``Prevention of Salmonella Enteritidis in Shell Eggs During Production,
Storage, and Transportation'' (the final rule), including how to
implement Salmonella Enteritidis (SE) prevention measures, how to
sample for SE., and how to maintain records documenting compliance with
the final rule.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Plant and Dairy Food Safety/Office of Food Safety,
Center for Food Safety and Applied Nutrition (HFS-315), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nancy Bufano, Center for Food Safety
and Applied Nutrition (HFS-316), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued a
final rule requiring shell egg producers to implement measures to
prevent SE from contaminating eggs on the farm and from further growth
during storage and transportation, to maintain records concerning their
compliance with the final rule, and to register with FDA. This final
rule became effective September 8, 2009. In the Federal Register of
August 12, 2010 (75 FR 48973), FDA made available a draft guidance
entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage, and Transportation'' and gave interested parties
an opportunity to submit comments by October 12, 2010. The Agency
reviewed and evaluated these comments and has modified the guidance
where appropriate.
    The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on how to comply with certain SE prevention
measures, how to sample for SE., and how to maintain records
documenting compliance with the final rule. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternate approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 118.5, 118.6, 118.10, and 118.11
have been approved under OMB control number 0910-0660.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding the
guidance. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Always
access an FDA document using the FDA Web site listed previously to find
the most current version of the guidance.

    Dated: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33292 Filed 12-27-11; 8:45 am]
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