[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Rules and Regulations]
[Pages 27144-27149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12348]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0255; FRL-9961-95]
Spirotetramat; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
spirotetramat in or on multiple commodities which are identified and
discussed later in this document. In addition, this regulation removes
several previously established tolerances that are superseded by this
final rule. Interregional Research Project Number 4 (IR-4) and Bayer
CropScience, requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective June 14, 2017. Objections and
requests for hearings must be received on or before August 14, 2017,
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-2016-0255, 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), West William Jefferson Clinton 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: Michael Goodis, 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: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0255 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
August 14, 2017. 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-2016-0255, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of Wednesday, June 22, 2016 (81 FR 40594)
(FRL-9947-32) and Monday, August 29, 2016 (81 FR 59165) (FRL-9950-22),
EPA issued documents pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3),
[[Page 27145]]
announcing the filing of pesticide petitions (PPs) by IR-4 (PP 6E8467);
and Bayer CropScience (PP 6F8461). These petitions request that 40 CFR
180.641 be amended by establishing tolerances for residues of the
insecticide spirotetramat, (cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-
1-azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate) and its metabolites cis-
3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-
one, cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-
azaspiro[4.5]decane-2,4-dione, cis-3-(2,5-dimethylphenyl)-8-methoxy-2-
oxo-1-azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside, and cis-3-
(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-one,
calculated as the stoichiometric equivalent of spirotetramat, in or on
several commodities as follows:
Pesticide petition 6E8467 submitted by IR-4 Project Headquarters,
500 College Road East, Suite 201 W., Princeton, NJ 08540 requests
tolerances for carrot, roots at 0.15 parts per million (ppm); fruit,
stone, group 12-12 at 4.5 ppm; and nut, tree, group 14-12 at 0.25 ppm.
Pesticide petition 6F8461 submitted by Bayer CropScience, P.O. Box
12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709
requests tolerances on sugar beet, molasses at 0.20 ppm and sugar beet,
root at 0.15 ppm.
Summaries of the petitions prepared by the registrant, Bayer
CropScience, are available in the docket, http://www.regulations.gov
under document ID EPA-HQ-OPP-2016-0255. One comment was received in
response to the notices of filings. EPA's response to the comment is
discussed in Unit IV.C.
Based upon review of the data supporting the petitions, EPA has
revised the tolerance levels for several proposed commodities and
corrected several commodity listings. The reason for these changes are
explained in Unit IV.D.
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 spirotetramat including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with spirotetramat
follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
The target organs of toxicity following subchronic and chronic oral
exposures to spirotetramat were different in rats and dogs. The thyroid
and thymus glands were the target organs identified in subchronic and
chronic toxicity studies in dogs while the testes were the target
organs identified in rats. The dog was the most sensitive species, and
in both rats and dogs, males were more sensitive than females. The
thyroid effects in the dog consisted of lower circulating levels of
thyroid hormones (T3 and/or T4) along with a reduction in follicle
size, a possible indication of reduced amount of colloid. In all dog
studies, thymus effects were observed (reduced size, atrophy). In the
one-year study, this was described microscopically as involution.
In rats, reported testicular effects consisted of abnormal
spermatozoa and hypospermia in the epididymis, decreased testicular
weights, and testicular degenerative vacuolation. An investigative
subchronic study where rats were dosed with a primary enol metabolite
of spirotetramat reproduced the same testicular effects as the parent
chemical, suggesting that this metabolite is, at minimum, a primary
contributor to the observed male reproductive toxicity. Consistent with
this notion, orally administered spirotetramat was demonstrated in rats
to be extensively metabolized, and males were noted to achieve much
higher systemic exposures than their female counterparts, which helps
explain the higher sensitivity of males. Other effects reported in a
rat chronic toxicity study were associated with kidney effects
consisting of decreased organ weight and tubular dilatation.
In one- and two-generation rat reproductive toxicity studies, male
reproductive toxicity (abnormal sperm cells and reproductive
performance) similar to that reported in subchronic toxicity studies
with adult rats was reported in the first generation (F1)
males at relatively high dose levels. In all cases, a well-defined no-
observed adverse-effect level (NOAEL) was established.
There was evidence of increased qualitative susceptibility in the
rat developmental study with reduced fetal weight and increased
incidences of malformations and skeletal deviations observed at the
limit dose, while maternal effects at this dose consisted of only body-
weight decrements. There was no evidence of increased quantitative or
qualitative susceptibility to offspring following pre- or post-natal
exposure to spirotetramat in the rabbit developmental or two-generation
reproduction studies.
The only evidence of neurotoxicity in the rat acute neurotoxicity
study was based on decreased motor and locomotor activity, which
occurred only at relatively high dose levels. The rat subchronic
neurotoxicity (SCN) study does not indicate a concern for
neurotoxicity, even at relatively high dose levels. The results of an
immunotoxicity study in rats do not indicate any functional deficits in
immune function.
There is no evidence of carcinogenicity in chronic toxicity/
carcinogenicity studies performed in rats and mice. Spirotetramat has
been classified as ``not likely to be carcinogenic to humans'' based on
lack of evidence for carcinogenicity in rodent studies. Spirotetramat
was also negative for mutagenicity and clastogenicity in in vivo and in
vitro assays.
Specific information on the studies received and the nature of the
adverse effects caused by spirotetramat 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: ``Spirotetramat. Human Health Risk
Assessment for the Tolerance Petition for Residues in/on Sugar Beet and
Carrot and Crop Group Conversions for
[[Page 27146]]
Tree Nut Group 14-12 and Fruit, Stone, Group 12-12.'' at pages 25-30 in
docket ID number EPA-HQ-OPP-2016-0255.
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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for spirotetramat used for
human risk assessment is discussed in Unit III. B. Toxicological Points
of Departure/Levels of Concern of the final rule published in the
Federal Register of Tuesday, October 25, 2016 (81 FR 73342) (FRL-89951-
80).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spirotetramat, EPA considered exposure under the
petitioned-for tolerances as well as all existing spirotetramat
tolerances in 40 CFR 180.641. EPA assessed dietary exposures from
spirotetramat 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 spirotetramat.
In estimating acute dietary exposure, EPA used food consumption
data from the U.S. Department of Agriculture's (USDA's) National Health
and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA)
from 2003 through 2008. As to residue levels in food, EPA assumed
tolerance-level residues, 100 percent crop treated (PCT) information
for all commodities and Dietary Exposure Evaluation Model (DEEM) 7.81
default processing factors where available.
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, EPA used 100 PCT, average
field trial residues for some commodities, and tolerance-level residues
for the remaining commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that spirotetramat 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 percent crop treated (PCT) 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.
The Agency did not use percent crop treated estimates.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spirotetramat in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of spirotetramat. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Tier 1 Rice Model and Pesticide Root Zone Model Ground
Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of
spirotetramat and its metabolites and degradates of concern for acute
exposures are estimated to be 395 parts per billion (ppb) for surface
water and 7.99 ppb for ground water.
Chronic exposures for non-cancer assessments are estimated to be
395 ppb for surface water and 5.36 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 assessment, the water concentration value of 395 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).
Spirotetramat is currently registered for the following uses that
could result in residential exposures: Citrus trees grown in
residential areas and turf grass including sod farm and golf course
turf only. There is the potential for post-application dermal exposure
from both residential citrus tree and golf course uses. The golf course
use could result in potential post-application dermal exposure;
however, there is no dermal hazard and therefore, quantification of
dermal risk is not necessary. For the residential citrus tree use,
because the product is sold in bulk packaging for agricultural uses and
the label requires that handlers wear specific clothing (e.g., long-
sleeve shirt/long pants) and the use of personal-protective equipment
(e.g., gloves), based on current Agency policy, EPA has made the
assumption that this product is not meant for homeowner use, and
therefore, there is no need to conduct a quantitative residential
handler assessment.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
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.''
[[Page 27147]]
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to spirotetramat and any
other substances and spirotetramat does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that spirotetramat has
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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
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. There is no evidence of
quantitative susceptibility of offspring following pre- or postnatal
exposure to spirotetramat. There is evidence of qualitative
susceptibility in the rat developmental study, where developmental
effects, including reduced fetal weight and increased incidences of
malformations and skeletal deviations, were observed in the presence of
body weight decrements in maternal animals. However, concern is low
since effects were only seen at the limit dose and selected endpoints
are protective of the observed effects.
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 spirotetramat is complete.
ii. Although spirotetramat was shown to elicit neurotoxic response
in the acute neurotoxicity study; however, concern is low since the
effects are well-characterized with clearly established NOAEL/LOAEL
values, the selected endpoints are protective of the observed
neurotoxic effect, there are no neurotoxic effects seen in the
subchronic neurotoxicity study, and the existing toxicological database
indicates that spirotetramat is not a neurotoxic chemical.
iii. There is no evidence of quantitative susceptibility of
offspring following pre- or postnatal exposure. There is evidence of
qualitative susceptibility in the rat developmental study; however,
there is no residual uncertainty concerning these effects due to the
clear NOAEL/LOAELs in the study for these effects. Moreover, concern
for these effects is low since effects were only seen at the limit
dose, effects were seen in the presence of maternal toxicity, and
selected endpoints are protective of the observed effects.
iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary food and drinking water exposure
assessment utilizes tolerance-level residues and 100 PCT information
for all commodities. The chronic dietary food and drinking water
exposure assessment utilizes average field trial residues for some
commodities, tolerance-level residues for the remaining commodities,
and 100 PCT. The chronic assessment is somewhat refined; however, since
it is based on reliable data, it will not underestimate exposure and
risk. There are no quantifiable potential exposure/risks from
residential citrus tree and golf course uses. The drinking water
assessments provide conservative, health-protective, high-end estimates
of water concentrations that will not likely be exceeded. These
assessments will not underestimate the exposure and risks posed by
spirotetramat.
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 spirotetramat will occupy 16% 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
spirotetramat from food and water will utilize 77% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure.
3. Short- and Intermediate-term risks. Short- and intermediate-term
aggregate exposures take into account short- and intermediate-term
residential exposures plus chronic exposure to food and water
(considered to be a background exposure level). A short- and
intermediate-term inhalation adverse effect was identified; however,
spirotetramat is not registered for any use patterns that would result
in either short- or intermediate-term inhalation residential exposure.
In a dermal toxicity study, no evidence of dermal hazard was found;
therefore, dermal risk was not included in the aggregate assessment.
Short- and intermediate-term aggregate risks are assessed based on
short- and intermediate-term residential exposures 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 risks for spirotetramat.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, spirotetramat 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 spirotetramat residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high-performance liquid
chromatography with tandem mass spectrometry (HPLC-MS/MS)) is available
to enforce the tolerance expression.
[[Page 27148]]
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint 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 spirotetramat.
C. Response to Comments
One comment was received from an anonymous source requesting that
the Agency deny IR-4's petition for use of spirotetramat on all food
items claiming it is a toxic chemical and its use would result in harm
to humans.
The Agency's Response: The Agency recognizes that some individuals
believe that certain pesticides are ``toxic chemicals'' that should not
be permitted in our food; however, the commenter provided no
information demonstrating toxicity of spirotetramat or that EPA could
use to evaluate the safety of the pesticide. 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. When new
or amended tolerances are requested for residues of a pesticide in food
or feed, the Agency, as is required by Section 408 of the Federal Food,
Drug and Cosmetic Act (FFDCA), estimates the risk of the potential
exposure to these residues. The Agency has concluded after this risk
assessment, which includes the consideration of long-term animal
studies with spirotetramat, that there is a reasonable certainty that
no harm will result from aggregate human exposure to spirotetramat and
that, accordingly, the use of spirotetramat on petitioned-for food
commodities is ``safe.''
D. Revisions to Petitioned-For Tolerances
Based on available residue data, EPA is establishing tolerance
level on sugar beet molasses at 0.30 ppm instead of 0.20 ppm, to cover
anticipated residues. In addition, EPA corrected the commodity
terminology for ``sugar beet root'' and ``sugar beet molasses'' to
``beet, sugar, roots'' and ``beet, sugar, molasses,'' respectively, in
order to conform to terms used in the Agency's Food and Feed Commodity
Vocabulary.
V. Conclusion
Therefore, tolerances are established for residues of
spirotetramat, (cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate) and its metabolites cis-3-
(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one,
cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-
2,4-dione, cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside, and cis-3-(2,5-
dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-one,
calculated as the stoichiometric equivalent of spirotetramat, in or on
beet, sugar, molasses at 0.30 ppm; beet, sugar, roots at 0.15 ppm;
carrot, roots at 0.15 ppm; fruit, stone, group 12-12 at 4.5 ppm; and
nut, tree, group 14-12 at 0.25 ppm. In addition, EPA is revoking the
existing tolerances for fruit, stone, group 12 and nut, tree, group 14
as they are superseded by the new tolerances for groups 12-12 and 14-12
established under this final rule.
VI. Statutory and Executive Order Reviews
This action 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 action has been
exempted from review under Executive Order 12866, this action 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 action 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (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).
[[Page 27149]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 8, 2017.
Michael Goodis,
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. 180.641, in the table in paragraph (a)(1):
0
i. Add alphabetically the entries: ``Beet, sugar, molasses''; ``Beet,
sugar, roots''; ``Carrot, roots''; ``Fruit, stone, group 12-12''; and
``Nut, tree, group 14-12''; and
0
ii. Remove entries for ``Fruit, stone, group 12'' and ``Nut, tree,
group 14''.
The additions read as follows:
Sec. 180.641 Spirotetramat; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Beet, sugar, molasses....................................... 0.30
Beet, sugar, roots.......................................... 0.15
* * * * *
Carrot, roots............................................... 0.15
* * * * *
Fruit, stone, group 12-12................................... 4.5
* * * * *
Nut, tree, group 14-12...................................... 0.25
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-12348 Filed 6-13-17; 8:45 am]
BILLING CODE 6560-50-P