[Federal Register Volume 79, Number 19 (Wednesday, January 29, 2014)]
[Rules and Regulations]
[Pages 4624-4630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01363]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0014; FRL-9903-88]
Indaziflam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
indaziflam in or on coffee, banana, and palm oil. Bayer Crop Science
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective January 29, 2014. Objections and
requests for hearings must be received on or before March 31, 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-2013-0014, 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:
[[Page 4625]]
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-2013-0014 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
March 31, 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-2013-0014, 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.htm.
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 February 15, 2013 (78 FR 32) (FRL-9378-
4), 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
2E8125) by Bayer Crop Science, 2 T.W. Alexander Drive; P.O. Box 12014;
Research Triangle Park, NC 27709. The petition requested that 40 CFR
180.653 be amended by establishing tolerances for residues of the
herbicide indaziflam, N-[(1R, 2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-
yl-1,3,5-triazine-2,4-diamine]-6-(1-fluoroethyl) and its fluoroethyl-
indaziflam metabolite, each expressed as the parent compound, in or on
coffee at 0.01 part per million (ppm), banana at 0.01 ppm, and palm oil
at 0.03 ppm. That document referenced a summary of the petition
prepared by Bayer CropScience, the registrant, which is available in
the docket, http://www.regulations.gov. A comment was received on the
notice of filing. EPA's response to this comment is discussed 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 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 nervous system is the major target for indaziflam toxicity in
rats and dogs, with the dog being the more sensitive species based on
neuropathology (degenerative nerve fibers in the brain, spinal cord and
sciatic nerve). Clinical signs of neurotoxicity were observed in the
acute, subchronic, and developmental neurotoxicity studies and
consisted primarily of tremors, changes in activity and reactivity,
repetitive chewing, dilated pupils, and oral, perianal, and nasal
staining. Similar clinical signs of neurotoxicity were observed in the
2-generation reproduction study, the rat chronic toxicity study, and
the combined rat carcinogenicity/chronic toxicity study. Neuropathology
findings were also observed in the rat manifested as focal/multifocal
vacuolation of the median eminence of the brain and the pituitary pars
nervosa and degenerative nerve fibers in the gasserian ganglion,
sciatic nerve, and tibial nerve. Evidence of neurotoxicity was not seen
in the mouse.
Other organs affected by indaziflam in mice and rats include the
kidney, liver, thyroid, stomach, seminal vesicles, and ovaries. Effects
on the kidney were observed following chronic exposure in rats and mice
while effects on the liver were observed following chronic exposure in
the rat. Effects on the thyroid were only observed in multiple
[[Page 4626]]
dose rat studies. Chronic exposures also lead to atrophied or small
seminal vesicles in male and female mice. However, these effects
occurred at higher doses than those at which neurotoxicity was observed
in the dog.
Decreased body weight gain was observed in most studies following
exposure to indaziflam. There was no evidence of immunotoxicity in the
available studies, which included a guideline immunotoxocity study in
the rat. No systemic effects were observed in the rat following a 28-
day dermal exposure period.
No evidence of increased quantitative or qualitative susceptibility
was seen in developmental toxicity studies in rats and rabbits or in a
reproduction study in rats. In the rat developmental toxicity study,
decreased fetal weight was observed in the presence of maternal effects
that included decreased body weight gain and food consumption. 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 coarse tremors, renal toxicity 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.
Indaziflam showed no evidence of carcinogenicity in the 2-year
dietary rat and mouse bioassays. All genotoxicity studies that were
conducted on indaziflam were negative.
Testing in acute lethality studies with indaziflam resulted in low
toxicity via the oral, dermal, and inhalation routes of exposure.
Indaziflam was not an irritant to eyes Category IV) or skin and was not
a skin sensitizer.
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 to Support Proposed New Import Tolerances (Without a U.S.
Registration) on Banana, Coffee, and Palm Oil at page 33 in docket ID
number EPA-HQ-OPP-2013-0014.
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 indaziflam used for
human risk assessment is shown in Table 1 of this unit.
Table 1--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 = 7.5 mg/kg/day.. Acute RfD = 0.075 mg/kg/ Subchronic Gavage
including infants and children). UFA = 10x.............. day. Toxicity Study in
UFH =10x............... aPAD = 0.075 mg/kg/day. Dogs.
FQPA SF = 1x........... LOAEL = 15 mg/kg/day
based on axonal
degenerative
microscopic findings
in the brain, spinal
cord and sciatic
nerve.
Chronic dietary (All populations).... NOAEL= 2 mg/kg/day..... Chronic RfD = 0.02 mg/ Chronic Dietary
UFA = 10x.............. kg/day. Toxicity Study in
UFH = 10x.............. cPAD = 0.02 mg/kg/day.. Dogs.
FQPA SF = 1x........... LOAEL = 6/7 mg/kg/day M/
F 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 Gavage
days). UFA = 10x.............. Toxicity Study in
UFH = 10x.............. Dogs.
FQPA SF = 1x........... LOAEL = 15 mg/kg/day
based on axonal
degenerative
microscopic findings
in the brain, spinal
cord and sciatic
nerve.
Incidental oral intermediate-term (1 NOAEL= 7.5 mg/kg/day... LOC for MOE = 100...... Subchronic Gavage
to 6 months). UFA = 10x.............. Toxicity Study in
UFH = 10x.............. Dogs.
FQPA SF = 1x........... LOAEL = 15 mg/kg/day
based on axonal
degenerative
microscopic findings
in the brain, spinal
cord and sciatic
nerve.
[[Page 4627]]
Dermal short-term (1 to 30 days)..... Dermal (or oral) study LOC for MOE = 100...... Subchronic Gavage
NOAEL = 7.5 mg/kg/day Toxicity Study in
(dermal absorption Dogs.
factor) = 7.3%. LOAEL = 15 mg/kg/day
UFA = 10x.............. based on axonal
UFH = 10x.............. degenerative
FQPA SF = 1x........... microscopic findings
in the brain, spinal
cord and sciatic
nerve.
Dermal intermediate-term (1 to 6 Dermal (or oral) study LOC for MOE = 100...... Subchronic Gavage
months). NOAEL = 7.5 mg/kg/day Toxicity Study in
(dermal absorption Dogs.
factor) = 7.3%. LOAEL = 15 mg/kg/day
UFA = 10x.............. based on axonal
UFH = 10x.............. degenerative
FQPA SF = 1x........... microscopic findings
in the brain, spinal
cord and sciatic
nerve.
Inhalation short-term (1 to 30 days). Inhalation (or oral) LOC for MOE = 100...... Subchronic Gavage
study NOAEL = 7.5 mg/ Toxicity Study in
kg/day (Inhalation Dogs.
toxicity considered LOAEL = 15 mg/kg/day
equivalent to oral based on axonal
toxicity). degenerative
UFA = 10x.............. microscopic findings
UFH = 10x.............. in the brain, spinal
FQPA SF = 1x........... cord and sciatic
nerve.
Inhalation (1 to 6 months)........... Inhalation (or oral) LOC for MOE = 100...... Subchronic Gavage
study NOAEL = 7.5 mg/ Toxicity Study in
kg/day (Inhalation Dogs.
toxicity considered LOAEL = 15 mg/kg/day
equivalent to oral based on axonal
toxicity). degenerative
UFA = 10x.............. microscopic findings
UFH = 10x.............. in the brain, spinal
FQPA SF = 1x........... cord and sciatic
nerve.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).... No evidence of carcinogenicity. Classified as ``Not Likely to be
Carcinogenic to Humans.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligrams/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL.
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 as well as all existing indaziflam tolerances in 40 CFR
180.653. 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)'s 2003-2008 National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA). As to
residue levels in food, the acute dietary assessment assumes 100% crop
treated (PCT) along with tolerance or maximum residue level estimates
for indaziflam. It used DEEM-WWEIA analyses to estimate the dietary
exposure of the U.S. population and various population subgroups.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's 2003-2008
NHANES/WWEIA. As to residue levels in food, the chronic dietary
assessment used the same residue levels, analysis and PCT assumptions
used in the acute dietary assessment.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that indaziflam 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
anticipated residue and/or PCT information in the dietary assessment
for indaziflam. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for indaziflam in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of indaziflam. 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 equivalents for acute exposures are estimated to be 84 parts
per billion (ppb) for surface water and 3.7 ppb for ground water. For
chronic exposures for non-cancer assessments
[[Page 4628]]
the estimates are 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: Home lawn/turf and gardens/tree uses. There are
no new indaziflam residential uses associated with this regulatory
action. A re-evaluation of existing indaziflam residential uses was
conducted to incorporate updated policies and guidance in place since
previous risk assessments. Short-term dermal and inhalation handler
exposures for residential are expected for those making applications at
their homes and short-term dermal and incidental oral exposures are
expected via contact with residues following applications in outdoor
home environments. For adults, the highest exposure was from dermal
post-application high-contact (playing) activities on treated turf
during spray applications. The highest exposure scenarios for children
1<2 years old were from dermal post-application high-contact (playing)
and incidental oral exposure from treated turf. These exposure
scenarios were then combined to determine a total residential exposure
and risk estimate for children to be used for the aggregate assessment.
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, 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 toxicology database for
indaziflam consists of developmental toxicity studies in rats and
rabbits and a reproduction study in rats. No developmental effects were
observed in rabbits up to maternally toxic dose levels. Offspring
effects in the developmental toxicity study in rats, developmental
neurotoxicity study in rats, and the multigeneration toxicity study in
rats only occurred in the presence of maternal toxicity and were not
considered more severe than the parental effects. EPA concluded that
there is no evidence of increased quantitative or qualitative
susceptibility to rat or rabbit fetuses exposed in utero and/or post-
natally to indaziflam.
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 complete.
ii. The endpoints selected for risk assessment are based on and are
protective of the neurotoxic effects seen in the guideline studies.
iii. There is no evidence that indaziflam results in increased
susceptibility in utero in 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 tolerance or maximum residue levels for residues of concern and
assumed 100 PCT. EPA made conservative (protective) assumptions in the
ground water and surface water modeling used to assess exposure to
indaziflam in drinking water. EPA used similarly conservative
assumptions to assess dermal post-application exposure as well as
incidental oral exposure of children. 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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to indaziflam will occupy 19% of the aPAD for infants <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 8% of the cPAD for infants
<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-and intermediate-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.
[[Page 4629]]
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 1,400 for adults
(post-application) and 560 for children (post-application). Because
EPA's level of concern for indaziflam is a MOE of 100 or below, these
MOEs are not of concern.
4. 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.
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 indaziflam residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography with tandem
mass spectrometry detection [LC/MS/MS] method (DH-003-P07-02) for fruit
and nut tree matrices for indaziflam and FDAT) 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 indaziflam.
C. Response to Comments
EPA received a comment to the notice of filing which said that
pesticide residues should not be increased. The Agency understands the
commenter's concerns and recognizes that some individuals believe that
pesticides should be banned on agricultural crops. However, the
existing legal framework provided by section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA) states that tolerances may be set when
persons seeking such tolerances or exemptions have demonstrated that
the pesticide meets the safety standard imposed by that statute. This
citizen's comment appears to be directed at the underlying statute and
not EPA's implementation of it; the citizen has made no contention that
EPA has acted in violation of the statutory framework.
V. Conclusion
Therefore, tolerances are established for residues of indaziflam,
N-[(1R, 2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl-1,3,5-triazine-2,4-
diamine]-6-(1-fluoroethyl) and its fluoroethyl-indaziflam metabolite,
each expressed as the parent compound, in or on coffee, green bean at
0.01 ppm, banana at 0.01 ppm, and palm oil at 0.03 ppm.
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, 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: January 10, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
[[Page 4630]]
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. 180.653, alphabetically add the following commodities,
redesignate footnote 1 as footnote 2, and add a new footnote 1 to the
table in paragraph (a) to read as follows:
Sec. 180.653 Indaziflam; tolerances for residues.
(a) General. * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Banana \1\................................................. 0.01
Coffee, green bean \1\..................................... 0.01
* * * * *
Palm, oil \1\.............................................. 0.03
* * * * *
------------------------------------------------------------------------
\1\ No U.S. Registrations as of 12/02/2013.
* * * * *
[FR Doc. 2014-01363 Filed 1-28-14; 8:45 am]
BILLING CODE 6560-50-P