[Federal Register Volume 77, Number 42 (Friday, March 2, 2012)]
[Rules and Regulations]
[Pages 12731-12740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4983]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-1079; FRL-9331-8]
Thiamethoxam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
thiamethoxam in or on multiple commodities which are identified and
discussed later in this document. Syngenta Crop Protection, Inc.
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective March 2, 2012. Objections and
requests for hearings must be received on or before May 1, 2012, 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-2010-1079. 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.
[[Page 12732]]
FOR FURTHER INFORMATION CONTACT: Gene Benbow, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 347-0235; 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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-1079 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 1, 2012. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-1079, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 26, 2011 (76 FR 53372) (FRL-8884-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F7805) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR 180.565 be amended by
establishing tolerances for residues of the insecticide thiamethoxam,
3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine and its metabolite, N-[(2-chloro-thiazol-5-
yl)methyl]-N'-methyl-N''-nitro-guanidine], in or on: buckwheat, grain
at 0.02 per million (ppm); buckwheat, forage at 0.50 ppm; buckwheat,
hay at 0.02 ppm; buckwheat, straw at 0.02 ppm; oat, grain at 0.02 ppm;
oat, forage at 0.50 ppm, oat, hay at 0.02 ppm; oat, straw at 0.02 ppm;
millet, pearl, grain at 0.02 ppm; millet, pearl, forage at 0.02 ppm;
millet, pearl, stover at 0.02 ppm; millet, proso, grain at 0.02 ppm;
millet, proso, forage at 0.02 ppm; millet, proso, stover at 0.02 ppm;
millet, proso, straw at 0.02 ppm; rye, grain at 0.02 ppm; rye, forage
at 0.50 ppm; rye, straw at 0.02 ppm; teosinte, grain at 0.02 ppm;
teosinte, forage at 0.10 ppm; teosinte, stover at 0.05 ppm; triticale,
grain at 0.02 ppm; triticale, forage at 0.05 ppm; triticale, hay at
0.02 ppm; triticale, straw at 0.02 ppm; wild rice, grain at 0.02 ppm.
That notice referenced a summary of the petition prepared by Syngenta
Crop Protection, Inc., the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
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 thiamethoxam including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with thiamethoxam
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.
[[Page 12733]]
Thiamethoxam shows toxicological effects primarily in the liver,
kidney, testes, and hematopoietic system. In addition, developmental
neurological effects were observed in rats. This developmental effect
is being used to assess risks associated with acute exposures to
thiamethoxam, and the liver and testicular effects are the basis for
assessing longer term exposures. Although thiamethoxam causes liver
tumors in mice, the Agency has classified thiamethoxam as ``not likely
to be carcinogenic to humans'' based on convincing evidence that a non-
genotoxic mode of action for liver tumors was established in the mouse
and that the carcinogenic effects are a result of a mode of action
dependent on sufficient amounts of a hepatotoxic metabolite produced
persistently. The non-cancer (chronic) assessment is sufficiently
protective of the key events (perturbation of liver metabolism,
hepatotoxicity/regenerative proliferation) in the animal mode of action
for cancer.
Specific information on the studies received and the nature of the
adverse effects caused by thiamethoxam 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 section 4.5.1 in the document ``Thiamethoxam--
Human Health Risk Assessement for Crop Group 15 (including buckwheat,
pearl millet, proso millet, oats, rye, teosinte, triticale) and Crop
Group 16 Commodities (forage, fodder and straw of cereal grains
group)'' in docket ID number EPA-HQ-OPP-2010-1079 at http://www.regulations.gov.
Thiamethoxam produces a metabolite known as CGA-322704 (referred to
in the remainder of this rule as clothianidin). Clothianidin is also
registered as a pesticide. While some of the toxic effects observed
following testing with thiamethoxam and clothianidin are similar, the
available information indicates that thiamethoxam and clothianidin have
different toxicological effects in mammals and should be assessed
separately. A separate risk assessment of clothianidin has been
completed in conjunction with the registration of clothianidin. The
most recent assessment, which provides details regarding the toxicology
of clothianidin, is available in the docket EPA-HQ-OPP-2008-0945, at
http://www.regulations.gov. Refer to the document ``Clothianidin: Human
Health Risk Assessment for the Requested New Use on Mustard Seen as
well as New Uses of Thiamethoxam on Peanuts, Alfalfa, in Food-Handling
Establishments, and as a Seed Treatment for Cereal Grains.''
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 (U/S F) 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 thiamethoxam used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Thiamethoxam for Use in Human Health Risk Assessment
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Point of departure and uncertainty/ RfD, PAD, LOC for risk
Exposure/scenario safety factors assessment Study and toxicological effects
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Acute dietary (All populations NOAEL = 34.5 mg/kg/day Acute RfD = 0.35 mg/kg/ Rat Developmental Neurotoxicity study.
including infants and children). UFA = 10x day. LOAEL = 298.7 mg/kg/day based on delayed sexual
UFH = 10x aPAD = 0.35 mg/kg/day... maturation in male pups, and reduced brain
FQPA SF = 1 morphometric measurements.
Chronic dietary (All populations NOAEL = 1.2 mg/kg/day Chronic RfD = 0.012 mg/ 2-Generation reproduction study.
including infants and children). UFA = 10x kg/day. 1. LOAEL = 1.8 mg/kg/day based on increased
UFH = 10x cPAD = 0.012 mg/kg/day.. incidence and severity of tubular atrophy in
FQPA SF = 1 testes of F1 generation males.
2-Generation reproduction study.
2. LOAEL = 3 (males), not determined (females) mg/
kg/day based on sperm abnormalities in F1 males.
Incidental oral (all durations)....... NOAEL = 8.23 mg/kg/day MOE = 100 (residential). 90-day Dog study.
UFA = 10x LOAEL = 32 (males) 33.9 (females) mg/kg/day based
UFH = 10x on slightly prolonged prothrombin times and
FQPA SF = 1 decreased plasma albumin and A/G ratio (both
sexes); decreased calcium levels and ovary
weights and delayed maturation in the ovaries
(females); decreased cholesterol and
phospholipid levels, testis weights,
spermatogenesis, and spermatic giant cells in
testes (males).
[[Page 12734]]
Dermal (all durations) (Adults)....... Oral study NOAEL = 1.2 mg/kg/day MOE = 100 (residential). 2-Generation reproduction study.
(dermal absorption rate = 5%) LOAEL = 1.8 mg/kg/day based on increased
UFA = 10x incidence and severity of tubular atrophy in
UFH = 10x testes of F1 generation males.
FQPA SF = 1 2-Generation reproduction study.
LOAEL = 3 (males), not determined (females) mg/kg/
day based on sperm abnormalities in F1 males.
Dermal (all durations) (infants/ Dermal study NOAEL = 60 mg/kg/day MOE = 100 (residential). Rat 28-Day Dermal Toxicity Study.
children 1-6 yrs). UFA = 10x LOAEL = 250 (females) mg/kg/day based on
UFH = 10x increased plasma glucose, triglyceride levels,
FQPA SF = 1 and alkaline phosphatase activity and
inflammatory cell infiltration in the liver and
necrosis of single hepatocytes in females.
Inhalation (all durations)............ Oral study NOAEL = 1.2 mg/kg/day MOE = 100 (residential). 2-Generation reproduction study.
(inhalation absorption rate = 100% LOAEL = 1.8 mg/kg/day based on increased
of oral absorption) incidence and severity of tubular atrophy in
UFA = 10x testes of F1 generation males.
UFH = 10x 2-Generation reproduction study.
FQPA SF = 1 LOAEL = 3 (males), not determined (females) mg/kg/
day based on sperm abnormalities in F1 males.
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UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of
exposure. LOC = level of concern. mg/kg/day = milligrams/kilogram/day.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to thiamethoxam, EPA considered exposure under the petitioned-
for tolerances as well as all existing thiamethoxam tolerances in 40
CFR 180.565. EPA assessed dietary exposures from thiamethoxam in food
as follows:
For both acute and chronic exposure assessments for thiamethoxam,
EPA combined residues of clothianidin coming from thiamethoxam with
residues of thiamethoxam per se. As discussed in this unit,
thiamethoxam's major metabolite is CGA-322704, which is also the
registered active ingredient in clothianidin. Available information
indicates that thiamethoxam and clothianidin have different
toxicological effects in mammals and should be assessed separately;
however, these exposure assessments for this action incorporated the
total residue of thiamethoxam and clothianidin from use of thiamethoxam
because the total residue for each commodity for which thiamethoxam has
a tolerance has not been separated between thiamethoxam and its
clothianidin metabolite. The combining of these residues, as was done
in this assessment, results in highly conservative estimates of dietary
exposure and risk. A separate assessment was done for clothianidin. The
clothianidin assessment included clothianidin residues from use of
clothianidin as a pesticide and clothianidin residues from use of
thiamethoxam on those commodities for which the pesticide clothianidin
does not have a tolerance. As to these commodities, EPA has separated
total residues between thiamethoxam and clothianidin.
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 thiamethoxam. 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). For residue levels in food, EPA
assumed tolerance level residues of thiamethoxam and clothianidin. It
was further assumed that 100% of crops with registered or requested
uses of thiamethoxam and 100% of crops with registered or requested
uses of clothianidin were treated.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. For residue levels in food, EPA assumed tolerance level
and/or anticipated residues (averages) from field trial data. It was
again assumed that 100% of crops with registered or requested uses of
thiamethoxam and 100% of crops with registered or requested uses of
clothianidin were treated.
A complete listing of the inputs used in these assessments can be
found in the following documents: ``Thiamethoxam. Acute and Chronic
Aggregate Dietary (Food and Drinking Water) Exposure and Risk
Assessments for the Section 3 Registration on Crop Group 15/16
Commodities'' available in the docket EPA-HQ-OPP-2010-1079, at http://www.regulations.gov; and ``Clothianidin--Acute and Chronic Aggregate
Dietary (Food and Drinking Water) Exposure and Risk Assessments to
Evaluate Requested Uses on Mustard Seed and Requested uses of
Thiamethoxam on Peanuts, in Food-Handling Establishments, and as a Seed
Treatment for Cereal Grains,'' available in the docket EPA-HQ-OPP-2008-
0945, at http://www.regulations.gov.
iii. Cancer. EPA concluded that thiamethoxam is ``not likely to be
carcinogenic to humans'' based on convincing evidence that a non-
genotoxic mode of action for liver tumors was established in the mouse,
and that the carcinogenic effects are a result of a mode of action
dependent on sufficient amounts of a hepatotoxic metabolite produced
persistently. The non-cancer (chronic) assessment is sufficiently
protective of the key events (perturbation of liver metabolism,
hepatotoxicity/regenerative proliferation) in the animal mode of
[[Page 12735]]
action for cancer and thus a separate exposure assessment pertaining to
cancer risk is not necessary. Because clothianidin is not expected to
pose a cancer risk, a quantitative dietary exposure assessment for the
purposes of assessing cancer risk was not conducted.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for thiamethoxam in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of thiamethoxam. 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 Tier 1 Rice Model for surface water and the Screening
Concentration in Ground Water (SCI-GROW) model for ground water, the
estimated drinking water concentrations (EDWCs) of thiamethoxam for
acute exposures are estimated to be 0.13177 ppm for surface water and
0.00466 ppm for ground water. The chronic exposure for surface water
and ground water is estimated to be 0.01131 ppm and 0.00466 ppm
respectively. Modeled estimates of drinking water concentrations were
directly entered into the dietary exposure model.
Since clothianidin is not a significant degradate of thiamethoxam
in surface water or ground water sources of drinking water, it was not
included in the EDWCs for the thiamethoxam dietary assessment. For the
clothianidin assessments, the EDWC value of 0.0724 ppm for clothianidin
was incorporated into the acute and chronic dietary assessments.
A complete listing of the inputs used in these assessments can be
found in the following documents: ``Thiamethoxam. Acute and Chronic
Aggregate Dietary (Food and Drinking Water) Exposure and Risk
Assessments for the Section 3 Registration on Crop Group 15/16
Commodities'' available in the docket EPA-HQ-OPP-2010-1079, at http://www.regulations.gov; and ``Tier I Drinking Water Exposure Assessment
for the Section 3 New Uses of Clothianidin on Rice and Leafy
Vegetables,'' available in the docket EPA-HQ-OPP-2008-0945, at http://www.regulations.gov.
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). Thiamethoxam is
currently registered for the following uses that could result in
residential exposures: Turfgrass on golf courses, residential lawns,
commercial grounds, parks, playgrounds, athletic fields, landscapes,
interiorscapes, sod farms, and indoor crack and crevice or spot
treatments to control insects in residential settings. EPA assessed
residential exposure using the assumption that thiamethoxam is applied
by commercial applicators only. However, entering areas previously
treated with thiamethoxam could lead to exposures for adults and
children. As a result, risk assessments have been completed for
postapplication scenarios.
Short-term postapplication exposures (1 to 30 days of continuous
exposure) may occur as a result of activities on treated turf or
entering indoor areas previously treated with a thiamethoxam indoor
crack and crevice product. EPA combined all non-dietary sources of
children's post application exposure to obtain an estimate of potential
combined exposure. These scenarios consisted of dermal postapplication
exposure and oral (hand-to-mouth) exposures for children 3 to 6 years
of age.
A complete listing of the inputs used in these assessments can be
found in the document ``Thiamethoxam--Human Health Risk Assessment for
Crop Group 15 (including buckwheat, pearl millet, proso millet, oats,
rye, teosinte, triticale) and Crop Group 16 Commodities (forage, fodder
and straw of cereal grains group)'' in docket ID number EPA-HQ-OPP-
2010-1079 at http://www.regulations.gov. 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.''
Thiamethoxam is a member of the neonicotinoid class of pesticides
and produces, as a metabolite, another neonicotinoid, clothianidin.
Structural similarities or common effects do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same sequence of
major biochemical events. Although clothianidin and thiamethoxam bind
selectively to insect nicotinic acetylcholine receptors (nAChR), the
specific binding site(s)/receptor(s) for clothianidin, thiamethoxam,
and the other neonicotinoids are unknown at this time. Additionally,
the commonality of the binding activity itself is uncertain, as
preliminary evidence suggests that clothianidin operates by direct
competitive inhibition, while thiamethoxam is a non-competitive
inhibitor. Furthermore, even if future research shows that
neonicotinoids share a common binding activity to a specific site on
insect nicotinic acetylcholine receptors, there is not necessarily a
relationship between this pesticidal action and a mechanism of toxicity
in mammals. Structural variations between the insect and mammalian
nAChRs produce quantitative differences in the binding affinity of the
neonicotinoids towards these receptors, which, in turn, confers the
notably greater selective toxicity of this class towards insects,
including aphids and leafhoppers, compared to mammals. While the
insecticidal action of the neonicotinoids is neurotoxic, the most
sensitive regulatory endpoint for thiamethoxam is based on unrelated
effects in mammals, including effects on the liver, kidney, testes, and
hematopoietic system. Additionally, the most sensitive toxicological
effect in mammals differs across the neonicotinoids (e.g., testicular
tubular atrophy with thiamethoxam; mineralized particles in thyroid
colloid with imidacloprid).
Thus, EPA has not found thiamethoxam or clothianidin to share a
common mechanism of toxicity with any other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
thiamethoxam and clothianidin do 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
[[Page 12736]]
safety is commonly referred to as the FQPA SF. In applying this
provision, EPA either retains the default value of 10X, or uses a
different additional safety factor when reliable data available to EPA
support the choice of a different factor.
2. Prenatal and postnatal sensitivity. In the developmental
studies, there is no evidence of increased quantitative or qualitative
susceptibility of rat or rabbit fetuses to in utero exposure to
thiamethoxam. The developmental NOAELs are either higher than or equal
to the maternal NOAELs. The toxicological effects in fetuses do not
appear to be any more severe than those in the dams or does. In the rat
developmental neurotoxicity study, there was no quantitative evidence
of increased susceptibility; however, there was increased qualitative
susceptibility because the effects in the pups (reduced brain weight
and significant changes in brain morphometric measurements) were
considered to be more severe than findings in the dams (decreased body
weight gain and food consumption).
There is evidence of increased quantitative susceptibility for male
pups in both 2-generation reproductive studies. In one study, there are
no toxicological effects in the dams; whereas, for the pups, reduced
bodyweights are observed at the highest dose level, starting on day 14
of lactation. This contributes to an overall decrease in bodyweight
gain during the entire lactation period. The reproductive effects in
males appear in the F1 generation in the form of increased
incidence and severity of testicular tubular atrophy (see
developmental/reproductive section). These data are considered to be
evidence of increased quantitative susceptibility for male pups
(increased incidence of testicular tubular atrophy at 1.8 mg/kg/day)
when compared to the parents (hyaline changes in renal tubules at 61
mg/kg/day; NOAEL is 1.8 mg/kg/day).
In a more recent 2-generation reproduction study, the most
sensitive effect was sperm abnormalities at 3 mg/kg/day (the NOAEL is
1.2 mg/kg/day) in the F1 males. This study also indicates
increased susceptibility for the offspring for this effect.
Although there is evidence of increased quantitative susceptibility
for male pups in both reproductive studies, NOAELs and LOAELs were
established in these studies and the Agency selected the NOAEL for
testicular effects in F1 pups as the basis for risk
assessment. The Agency has confidence that the NOAEL selected for risk
assessment is protective of the most sensitive effect (testicular) for
the most sensitive subgroup (pups) observed in the toxicological
database.
3. Conclusion. i. In the final rule published in the Federal
Register of January 5, 2005 (70 FR 708) (FRL-7689-7), EPA had
previously determined that the FQPA SF should be retained at 10X for
thiamethoxam, based on the following factors: Effects on endocrine
organs observed across species; significant decrease in alanine amino
transferase levels in companion animal studies and in dog studies; the
mode of action of this chemical in insects (interferes with the
nicotinic acetylcholine receptors of the insect's nervous system); the
transient clinical signs of neurotoxicity in several studies across
species; and the suggestive evidence of increased quantitative
susceptibility in the rat reproduction study. Since that determination,
EPA has received and reviewed a developmental neurotoxicity (DNT) study
in rats, and an additional reproduction study in rats. Taking the
results of these studies into account, as well as the rest of the data
on thiamethoxam, 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 (June 23, 2010, 75 FR 35653; FRL-8830-4); (June 22,
2007, 72 FR 34401). That decision is based on the following findings:
a. The toxicity database for thiamethoxam is largely complete,
including acceptable/guideline developmental toxicity, 2-generation
reproduction, and DNT studies designed to detect adverse effects on the
developing organism, which could result from the mechanism that may
have produced the decreased alanine amino transferase levels. The
available data for thiamethoxam show the potential for immunotoxic
effects. In the subchronic dog study, leukopenia (decreased white blood
cells) was observed in females only, at the highest dose tested (HDT)
of 50 mg/kg/day; the NOAEL for this effect was 34 mg/kg/day. The
overall study NOAEL was 9.3 mg/kg/day in females (8.2 mg/kg/day in
males) based on hematology and other clinical chemistry findings at the
LOAEL of 34 mg/kg/day (32 mg/kg/day in males). In the subchronic mouse
study, decreased spleen weights were observed in females at 626 mg/kg/
day; the NOAEL for this effect was the next lowest dose of 231 mg/kg/
day. The overall study NOAEL was 1.4 mg/kg/day (males) based on
increased hepatocyte hypertrophy observed at the LOAEL of 14.3 mg/kg/
day. The decreased absolute spleen weights were considered to be
treatment related, but were not statistically significant at 626 mg/kg/
day or at the HDT of 1,163 mg/kg/day. Since spleen weights were not
decreased relative to body weights, the absolute decreases may have
been related to the decreases in body weight gain observed at higher
doses. Overall, the Agency has a low concern for the potential for
immunotoxicity related to these effects for the following reasons: In
general, the Agency does not consider alterations in hematology
parameters alone to be a significant indication of potential
immunotoxicity. In the case of thiamethoxam, high-dose females in the
subchronic dog study had slight microcytic anemia as well as leukopenia
characterized by reductions in neutrophils, lymphocytes and monocytes;
the leukopenia was considered to be related to the anemic response to
exposure. Further, endpoints and doses selected for risk assessment are
protective of the observed effects on hematology. Spleen weight
decreases, while considered treatment-related, were associated with
decreases in body weight gain, and were not statistically significant.
In addition, spleen weight changes occurred only at very high doses,
more than 70 times higher than the doses selected for risk assessment.
In addition to the previous considerations, a 28-day immunotoxicity
study in female mice was recently received and has undergone a
preliminary review. There were no immunotoxic effects observed at doses
exceeding the limit dose of 1,000 mg/kg/day.
b. For the reasons discussed in Unit III.D.2., there is low concern
for an increased susceptibility in the young.
c. Although there is evidence of neurotoxicity after acute exposure
to thiamethoxam at doses of 500 mg/kg/day including drooped palpebral
closure, decrease in rectal temperature and locomotor activity and
increase in forelimb grip strength, no evidence of neuropathology was
observed. These effects occurred at doses at least 14-fold and 416-fold
higher than the doses used for the acute, and chronic risk assessments,
respectively; thus, there is low concern for these effects since it is
expected that the doses used for regulatory purposes would be
protective of the effects noted at much higher doses.
In the developmental neurotoxicity study (DNT), there was no
evidence of neurotoxicity in the dams exposed up to 298.7 mg/kg/day; a
dose that was associated with decreases in body weight gain and food
consumption. In pups exposed to 298.7 mg/kg/day, there
[[Page 12737]]
were significant reductions in absolute brain weight and size (i.e.,
length and width of the cerebellum was less in males on day 12, and
there were significant decreases in Level 3-5 measurements in males and
in Level 4-5 measurements in females on day 63). However, there is low
concern for this increased qualitative susceptibility observed in the
DNT study because the doses and endpoints selected for risk assessment
are protective of the effects in the offspring. As noted previously,
for risk assessment the Agency selected the NOAEL for testicular
effects in F1 pups based on two reproductive toxicity
studies to be protective of all sensitive subpopulations.
d. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed using
tolerance-level and/or anticipated residues that are based on reliable
field trial data observed in the thiamethoxam field trials. Although
there is available information indicating that thiamethoxam and
clothianidin have different toxicological effects in mammals and should
be assessed separately, the residues of each have been combined in
these assessments to ensure that the estimated exposures of
thiamethoxam do not underestimate actual potential thiamethoxam
exposures. An assumption of 100 percent crop treated (PCT) was made for
all foods evaluated in the assessments. For the acute and chronic
assessments, the EDWCs of 131.77 parts per billion (ppb) and 11.3 ppb,
respectively, were used to estimate exposure via drinking water.
Compared to the results from small scale prospective ground water
studies where the maximum observed residue levels from any monitoring
well were 1.0 ppb for thiamethoxam and 0.73 ppb for clothianidin, the
modeled estimates are protective of what actual exposures are likely to
be. EPA used similarly conservative (protective) assumptions to assess
postapplication exposure to children and adults including incidental
oral exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by thiamethoxam.
ii. In the final rule published in the Federal Register of February
6, 2008 (73 FR 6851) (FRL-8346-9), EPA had previously determined that
the FQPA SF for clothianidin should be retained at 10X because EPA had
required the submission of a developmental immunotoxicity study to
address the combination of evidence of decreased absolute and adjusted
organ weights of the thymus and spleen in multiple studies in the
clothianidin database, and evidence showing that juvenile rats in the
2-generation reproduction study appear to be more susceptible to these
potential immunotoxic effects. In the absence of a developmental
immunotoxicity study, EPA concluded that there was sufficient
uncertainty regarding immunotoxic effects in the young that the 10X
FQPA factor should be retained as a database uncertainty factor.
Since that determination, EPA has received and reviewed an
acceptable/guideline developmental immunotoxicity study, which
demonstrated no treatment-related effects. Taking the results of this
study into account, as well as the rest of the data on clothianidin,
EPA has determined that reliable data show the safety of infants and
children would be adequately protected if the FQPA SF for clothianidin
were reduced to 1X (February 11, 2011, 76 FR 7712) (FRL-8858-3). That
decision is based on the following findings:
a. The toxicity database for clothianidin is complete. As noted,
the prior data gap concerning developmental immunotoxicity has been
addressed by the submission of an acceptable developmental
immunotoxicity study.
b. A rat developmental neurotoxicity study is available and shows
evidence of increased quantitative susceptibility of offspring.
However, EPA considers the degree of concern for the developmental
neurotoxicity study to be low for prenatal and postnatal toxicity
because the NOAEL and LOAEL were well characterized, and the doses and
endpoints selected for risk assessment are protective of the observed
susceptibility; therefore, there are no residual concerns regarding
effects in the young.
c. While the rat multi-generation reproduction study showed
evidence of increased quantitative susceptibility of offspring compared
to adults, the degree of concern is low because the study NOAEL and
LOAEL have been selected for risk assessment purposes for relevant
exposure routes and durations. In addition, the potential immunotoxic
effects observed in the study have been further characterized with the
submission of a developmental immunotoxicity study that showed no
evidence of susceptibility. As a result, there are no concerns or
residual uncertainties for prenatal and postnatal toxicity after
establishing toxicity endpoints and traditional UFs to be used in the
risk assessment for clothianidin.
d. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on assumptions that were judged to be highly conservative and health-
protective for all durations and population subgroups, including
tolerance-level residues, adjustment factors from metabolite data,
empirical processing factors, and 100 PCT for all commodities.
Additionally, EPA made conservative (protective) assumptions in the
ground water and surface water modeling used to assess exposure to
clothianidin in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children and adults
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by clothianidin.
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 thiamethoxam will occupy 9.5% of the aPAD for All infants (<1 year),
the population group receiving the greatest exposure. Acute dietary
exposure from food and water to clothianidin is estimated to occupy 23%
of the aPAD for children 1 to 2 years old, the population group
receiving the greatest exposure.
2. Chronic risk. In examining chronic aggregate risk, EPA has
assumed that the only pathway of exposure relevant to that time frame
is dietary exposure. Using this assumption for chronic exposure, EPA
has concluded that chronic exposure to thiamethoxam from food and water
will utilize 43% of the cPAD for Children 1 to 2 years old, the
population group receiving the greatest exposure. Chronic exposure to
clothianidin from food and water will utilize 19% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water
[[Page 12738]]
(considered to be a background exposure level). Thiamethoxam 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 thiamethoxam.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures for thiamethoxam result in aggregate MOEs of:
370 for the general U.S. population; 490 for all infants; 440 for
children 1 to 2 years; 450 for children 3 to 5 years; 370 for children
6 to 12 years; 380 for youth 13 to 19 years, adults 20 to 49 years,
adults 50+ years, and females 13 to 49 years. Because EPA's level of
concern for thiamethoxam is a MOE of 100 or below, these MOEs are not
of concern.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures for clothianidin result in aggregate MOEs of:
1,200 for the general U.S. population; 480 for all infants (<1 year);
370 for children 1 to 2 years; 490 for children 3 to 5 years; 1,000 for
children 6 to 12 years; 1,400 for youth 13 to 19 years, adults 20-49
years, and females 13 to 49 years; and 1,300 for adults 50+ years.
Because EPA's level of concern for clothianidin is a MOE of 100 or
below, 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).
Thiamethoxam is currently registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to thiamethoxam.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures for
thiamethoxam result in aggregate MOEs of: 370 for the general U.S.
population; 540 for all infants (<1 year); 470 for children 1 to 2
years; 490 for children 3 to 5 years; 370 for children 6 to 12 years;
380 for youth 13 to 19 years, adults 20 to 49 years, adults 50+ years,
and females 13 to 49 years. Because EPA's level of concern for
thiamethoxam is a MOE of 100 or below, these MOEs are not of concern.
Using the exposure assumptions described in this unit for
intermediate exposures, EPA has concluded the combined intermediate
food, water, and residential exposures for clothianidin result in
aggregate MOEs of: 1,200 for the general U.S. population; 480 for all
infants (<1 year); 370 for children 1 to 2 years; 490 for children 3 to
5 years; 1,000 for children 6 to 12 years; 1,400 for youth 13 to 19
years, adults 20 to 49 years, and females 13 to 49 years; and 1,300 for
adults 50+ years. Because EPA's level of concern for clothianidin is a
MOE of 100 or below, these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. The Agency has
classified thiamethoxam as not likely to be a human carcinogen based on
convincing evidence that a non-genotoxic mode of action for liver
tumors was established in the mouse and that the carcinogenic effects
are a result of a mode of action dependent on sufficient amounts of a
hepatotoxic metabolite produced persistently. Therefore, thiamethoxam
is not expected to pose a cancer risk. Clothianidin has been classified
as ``not likely to be a human carcinogen'' and is not expected to pose
a cancer risk.
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 thiamethoxam or clothianidin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The High Production Liquid Chromatography (HPLC) Method AG-675 with
ultraviolet (UV) or Mass Spectrometry (MS) detection was previously
submitted in conjunction with thiamethoxam petitions. Method AG-675 has
been determined to be adequate for enforcing the tolerance expression
for residues of thiamethoxam and CGA-322704 in crop and livestock
commodities. Syngenta Crop Protection, Inc., has submitted a revised
Method AG-675, i.e., Method GRM.009.04A. The full extraction steps for
plant and livestock commodities, including the microwave extraction
step for liver, have been incorporated. The limits of quantitation
(LOQs) of Method GRM.009.04A have been established at 0.01 ppm each for
residues of thiamethoxam, CGA-322704 and CGA-265307. Method validation
data are available for Method GRM.009.04A.
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 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.
EPA is increasing the barley grain tolerance to 0.4 ppm in order to
harmonize with the Codex MRL of 0.4 ppm. The MRL expressions continue
to remain different, as the Codex MRL is for the parent compound only.
C. Revisions to Petitioned-For Tolerances
Although the petitioner sought tolerances for many of the
commodities in Crop Groups 15 and 16, the petitioner did not request
crop group tolerances. EPA has determined that a tolerance for either
Crop Group 15 or Crop Group 16 commodities is not appropriate except
for Crop Group 15 grains (except barley), because the use pattern is
not the same for all Crop Group 15 commodities. Specifically, there is
a foliar use on barley and there are much higher tolerances for barley
hay and straw associated with this foliar use. It is for similar
reasons that a Crop Group 16 tolerance would not be appropriate.
In addition, there are also significant differences in the
tolerances for the different cereal forages, i.e., wheat forage at 0.5
ppm, corn forage at 0.10 ppm, and sorghum forage at 0.02 ppm.
Therefore, tolerances for each individual commodity have been
established by translating residue data from the most appropriate
representative commodity, except for grains which all have the same
tolerance (excluding barley). Tolerances are not required for triticale
and wild rice because these commodities are covered by the wheat and
rice tolerances, as
[[Page 12739]]
specified in 40 CFR 180.1. Tolerances are also not needed for teosinte
forage and stover as these are not considered significant livestock
feed items and are not consumed by humans.
V. Conclusion
Therefore, tolerances are established for residues of thiamethoxam,
3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine and its metabolite, N-[(2-chloro-thiazol-5-
yl)methyl]-N '-methyl-N ''-nitro-guanidine, in or on barley, grain at
0.4 ppm; buckwheat, forage at 0.50 ppm; buckwheat, hay at 0.02 ppm;
buckwheat, straw at 0.02 ppm; grain, cereal, group 15, except barley at
0.02 ppm; oat, forage at 0.50 ppm, oat, hay at 0.02 ppm; oat, straw at
0.02 ppm; millet, pearl, forage at 0.02 ppm; millet, pearl, stover at
0.02 ppm; millet, proso, forage at 0.02 ppm; millet, proso, stover at
0.02 ppm; millet, proso, straw at 0.02 ppm; rye, forage at 0.50 ppm;
rye, straw at 0.02 ppm. Tolerances are revoked for corn, field, grain;
corn, pop, grain; rice, grain; sorghum, grain; wheat, grain. These
tolerances are no longer needed, since residues on these commodities
will be covered by the crop group 15 tolerances being established in
this rule.
In addition, administrative corrections are being made to the
existing tolerances for grain, aspirated fractions and soybean, hulls,
as follows: The tolerance for grain, aspirated fractions at 0.08 ppm is
being corrected to grain, aspirated fractions at 2.0 ppm; the tolerance
for soybean, hulls at 2.0 ppm is being corrected to soybean, hulls at
0.08 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 17, 2012.
Daniel J. Rosenblatt,
Acting 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. Section 180.565 paragraph (a) is revised to read as follows:
Sec. 180.565 Thiamethoxam; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide thiamethoxam, including its metabolites and degradates, in
or on the following commodities. Compliance with the tolerance levels
specified below is to be determined by measuring only thiamethoxam 3-
[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine and its metabolite CGA-322704 N-[(2-chloro-thiazol-5-
yl)methyl]-N'-methyl-N''-nitro-guanidine, calculated as the
stoichiometric equivalent of thiamethoxam, in or on the following
commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage........................................... 0.05
Alfalfa, hay.............................................. 0.12
Almond, hulls............................................. 1.2
Artichoke, globe.......................................... 0.45
Avocado................................................... 0.40
Barley, grain............................................. 0.4
Barley, hay............................................... 0.40
Barley, straw............................................. 0.40
Bean, succulent........................................... 0.02
Berry, low growing, subgroup 13-07G, except cranberry..... 0.30
Borage, seed.............................................. 0.02
Brassica, head and stem, subgroup 5-A..................... 4.5
Brassica, leafy greens, subgroup 5-B...................... 3.0
Buckwheat, forage......................................... 0.50
Buckwheat, hay............................................ 0.02
Buckwheat, straw.......................................... 0.02
Bushberry subgroup 13-07B, except lingonberry and 0.20
blueberry, lowbush.......................................
Canistel.................................................. 0.40
Canola, seed.............................................. 0.02
Cattle, meat.............................................. 0.02
[[Page 12740]]
Cattle, meat byproducts................................... 0.04
Citrus, dried pulp........................................ 0.60
Coffee, bean, green \1\................................... 0.05
Corn, field, forage....................................... 0.10
Corn, field, stover....................................... 0.05
Corn, pop, forage......................................... 0.10
Corn, pop, stover......................................... 0.05
Corn, sweet, forage....................................... 0.10
Corn, sweet, kernel plus cob with husks removed........... 0.02
Corn, sweet, stover....................................... 0.05
Cotton, gin byproducts.................................... 1.5
Cotton, undelinted seed................................... 0.10
Crambe, seed.............................................. 0.02
Cranberry................................................. 0.02
Flax, seed................................................ 0.02
Food commodities and feed commodities (other than those 0.02
covered by a higher tolerance as a result of use on
growing crops) in food/feed handling establishments......
Fruit, citrus, group 10................................... 0.40
Fruit, pome, group 11..................................... 0.2
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy 0.20
kiwifruit................................................
Fruit, stone, group 12.................................... 0.5
Goat, meat................................................ 0.02
Goat, meat byproducts..................................... 0.04
Grain, aspirated fractions................................ 2.0
Grain, cereal, group 15, except barley.................... 0.02
Grape, raisin............................................. 0.30
Hog, meat................................................. 0.02
Hog, meat byproducts...................................... 0.02
Hop, dried cones.......................................... 0.10
Horse, meat............................................... 0.02
Horse, meat byproducts.................................... 0.04
Mango..................................................... 0.40
Milk...................................................... 0.02
Millet, pearl, forage..................................... 0.02
Millet, pearl, stover..................................... 0.02
Millet, proso, forage..................................... 0.02
Millet, proso, stover..................................... 0.02
Millet, proso, straw...................................... 0.02
Oat, forage............................................... 0.50
Oat, hay.................................................. 0.02
Oat, straw................................................ 0.02
Peanut.................................................... 0.05
Peanut, hay............................................... 0.25
Peanut, meal.............................................. 0.15
Peppermint, tops.......................................... 1.5
Pistachio................................................. 0.02
Potato.................................................... 0.25
Radish, tops.............................................. 0.80
Rapeseed, seed............................................ 0.02
Rye, forage............................................... 0.50
Rye, straw................................................ 0.02
Sapodilla................................................. 0.40
Sapote, black............................................. 0.40
Sapote, mamey............................................. 0.40
Sheep, meat............................................... 0.02
Sheep, meat byproducts.................................... 0.04
Sorghum, forage........................................... 0.02
Sorghum, grain, stover.................................... 0.02
Soybean, hulls............................................ 0.08
Spearmint, tops........................................... 1.5
Star apple................................................ 0.40
Sunflower................................................. 0.02
Tomato, paste............................................. 0.80
Vegetable, cucurbit, group 9.............................. 0.2
Vegetable, fruiting, group 8.............................. 0.25
Vegetable, leafy, except brassica, group 4................ 4.0
Vegetable, legume, group 6................................ 0.02
Vegetable, root, subgroup 1A.............................. 0.05
Vegetable, tuberous and corm, except potato, subgroup 1D.. 0.02
Wheat, forage............................................. 0.50
Wheat, hay................................................ 0.02
Wheat, straw.............................................. 0.02
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of September 17, 2003.
* * * * *
[FR Doc. 2012-4983 Filed 3-1-12; 8:45 am]
BILLING CODE 6560-50-P