Document ID: EPA-HQ-OPP-2015-0705-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Thiamethoxam
Posted Date: 2017-02-15T05:00Z

[Federal Register Volume 82, Number 30 (Wednesday, February 15, 2017)]
[Rules and Regulations]
[Pages 10712-10718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03075]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0705; FRL-9957-00]

Thiamethoxam; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
thiamethoxam in or on bananas. Syngenta Crop Protection, LLC requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 15, 2017. Objections and 
requests for hearings must be received on or before April 17, 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-2015-0705, 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.

[[Page 10713]]

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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-2015-0705 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 
April 17, 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-2015-0705, 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 November 23, 2015 (80 FR 72941) (FRL-
9936-73), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
5E8401) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27409-8300. The petition requested that 40 CFR part 180 be amended 
by establishing a tolerance for residues of the insecticide, 
thiamethoxam, in or on banana at 0.04 parts per million (ppm). That 
document referenced a summary of the petition prepared by Syngenta, the 
registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the level at which the tolerance is being established. The 
reason for this change is 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. . . 
.''
    Tolerances for residues of thiamethoxam are listed in 40 CFR 
180.565 and are expressed in terms of the combined residues of the 
insecticide thiamethoxam and its metabolite CGA-322704. Metabolite CGA-
322704 is also the registered active ingredient clothianidin (tolerance 
listings in 40 CFR 180.586). Clothianidin (hereinafter referred to as 
CGA-322704) has a complete toxicological database and appears to have 
effects in mammals that are different from those of thiamethoxam. A 
separate risk assessment that addresses risks from CGA-322704 residues 
resulting from the direct application of CGA-322704 (clothianidin), as 
well as risks from residues of CGA-322704 coming from thiamethoxam uses 
has been conducted, and there are no risk estimates of concern as a 
result of the proposed tolerance for thiamethoxam residues in imported 
bananas. This risk assessment can be found at http:www.regulations.gov 
in docket ID number EPA-HQ-OPP-2015-0705.
    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 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 10714]]

    In mammals, toxicological effects are seen primarily in the liver, 
kidney, testes, and blood cellular system. In addition, developmental 
neurological effects were observed in rats. These developmental effects 
are 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.
    There is no indication of quantitative or qualitative 
susceptibility in the developmental toxicity studies. There is evidence 
of quantitative susceptibility in the developmental neurotoxicity study 
and both two-generation reproductive studies. However, clear no 
observed adverse effects levels (NOAELs) were identified for the 
susceptibility in the 2-generation reproduction and developmental 
neurotoxicity (DNT) studies and the endpoints and doses chosen for risk 
assessment are protective of the susceptibility observed in these 
studies.
    Thiamethoxam is classified as ``not likely to be carcinogenic to 
humans'' at levels below which certain amounts of metabolites are 
produced. The liver tumors that were observed in the mouse have been 
demonstrated to be a result of a non-genotoxic mode of action dependent 
on sufficient amounts of a hepatotoxic metabolite being produced. 
Although humans are qualitatively capable of producing the active 
metabolite, thiamethoxam is unlikely to pose a cancer risk to humans 
unless sufficient amounts of metabolites are persistently formed to 
drive a carcinogenic response. The chronic endpoint selected for 
regulating exposure to thiamethoxam is sufficiently protective of the 
key events (perturbation of liver metabolism, hepatotoxicity/
regenerative proliferation) in the animal mode of action. At those 
levels, the Agency does not expect sufficient generation of the 
necessary metabolites to elicit a carcinogenic response; therefore, 
separate quantification of carcinogenic potential is not required.
    Specific information on the studies received and the nature of the 
adverse effects caused by thiamethoxam as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http:www.regulations.gov in the document titled 
``Thiamethoxam. Human Health Risk Assessment for Tolerances on Imported 
Bananas'' on page 33 in docket ID number EPA-HQ-OPP-2015-0705.

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 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
        Exposure/scenario            and uncertainty/      RfD, PAD, LOC for    Study and toxicological effects
                                      safety  factors       risk assessment
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Acute dietary (All populations     NOAEL = 34.5 mg/kg/   Acute RfD = 0.35 mg/  Rat Developmental Neurotoxicity
 including infants and children).   day UFA = 10x.        kg/day.               study.
                                   UFH = 10x...........  aPAD = 0.35 mg/kg/    LOAEL = 298.7 mg/kg/day based on
                                   FQPA SF = 1x........   day.                  decreased body weight and
                                                                                reduced brain morphometric
                                                                                measurements.
Chronic dietary (All populations)  NOAEL= 1.2 mg/kg/day  Chronic RfD = 0.012   2-Generation reproduction study.
                                    UFA = 10x.            mg/kg/day.           LOAEL = 1.8 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.012 mg/kg/    increased incidence and severity
                                   FQPA SF = 1x........   day.                  of tubular atrophy in testes of
                                                                                F1 generation males.
                                                                               2-Generation reproduction study,
                                                                               LOAEL = 156 mg/kg/day (males),
                                                                                not determined (females) based
                                                                                on sperm abnormalities and germ
                                                                                cell loss in F1 males.
Incidental oral short-term         NOAEL= 31.6 mg/kg/    LOC for MOE = 100...  28-day Dog study.
 infants/children <6 years old (1   day UFA = 10x.                             LOAEL = 47.7/43.0 (M/F) mg/kg/day
 to 30 days).                      UFH = 10x...........                         based on body weight loss;
                                   FQPA SF = 1x........                         leukopenia and increased
                                                                                hematocrit, hemoglobin and
                                                                                erythrocyte count; increased
                                                                                plasma urea and creatinine;
                                                                                reduced thymus weight in males
                                                                                and females, increased thyroid
                                                                                weight in males and reduced
                                                                                brain weight in females; and,
                                                                                histopathological changes in
                                                                                liver, thymus and spleen.

[[Page 10715]]

 
Dermal short-term adults (1 to 30  Oral study NOAEL =    LOC for MOE = 100...  2-Generation reproduction study;
 days).                             1.2 mg/kg/day                               1998.
                                    (dermal absorption                         LOAEL = 1.8 mg/kg/day based on
                                    rate = 5%.                                  increased incidence and severity
                                   UFA = 10x...........                         of tubular atrophy in testes of
                                   UFH = 10x...........                         F1 generation males.
                                   FQPA SF = 1x........                        2-Generation reproduction study;
                                                                                2004.
                                                                               LOAEL = 156 mg/kg/day (males),
                                                                                not determined (females) based
                                                                                on sperm abnormalities and germ
                                                                                cell loss in F1 males.
Dermal short-term infants/         Dermal study NOAEL=   LOC for MOE = 100...  Rat 28-Day Dermal Toxicity Study.
 children <6 years old (1 to 30     60 mg/kg/day.                              LOAEL = 250 (females) mg/kg/day
 days).                            UFA = 10x...........                         based on increased plasma
                                   UFH = 10x...........                         glucose, triglyceride levels,
                                   FQPA SF = 1x........                         and alkaline phosphatase
                                                                                activity and inflammatory cell
                                                                                infiltration in the liver and
                                                                                necrosis of single hepatocytes
                                                                                in females.
Inhalation short-term adults (1    Oral study NOAEL=     LOC for MOE = 100...  2-Generation reproduction study.
 to 30 days).                       1.2 mg/kg/day.                             LOAEL = 1.8 mg/kg/day based on
                                   UFA = 10x...........                         increased incidence and severity
                                   UFH = 10x...........                         of tubular atrophy in testes of
                                   FQPA SF = 1x........                         F1 generation males.
                                                                               2-Generation reproduction study.
                                                                               LOAEL = 156 mg/kg/day (males),
                                                                                not determined (females) based
                                                                                on sperm abnormalities and germ
                                                                                cell loss in F1 males.
Inhalation short-term infants/     Inhalation (or oral   LOC for MOE = 100...  28-day Dog study.
 children <6 years old (1 to 30     study NOAEL = 31.6                         LOAEL = 47.7/43.0 (M/F) mg/kg/day
 days).                             mg/kg/day                                   based on body weight loss;
                                    (inhalation                                 leukopenia and increased
                                    toxicity = oral                             hematocrit, hemoglobin and
                                    toxicity).                                  erythrocyte count; increased
                                   UFA = 10x...........                         plasma urea and creatinine;
                                   UFH = 10x...........                         reduced thymus weight in males
                                   FQPA SF = 1x........                         and females, increased thyroid
                                                                                weight in males and reduced
                                                                                brain weight in females; and,
                                                                                histopathological changes in
                                                                                liver, thymus and spleen.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  ``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. Quantification of cancer risk is not required.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

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:
    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's (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, EPA assumed tolerance level residues and 100 
percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from USDA's NHANES/WWEIA. 
As to residue levels in food, the chronic analysis is based on 
tolerance levels and anticipated residues calculated from field trial 
data for selected commodities and 100 PCT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that thiamethoxam does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

[[Page 10716]]

    Based on the Tier 1 Rice Model and Screening Concentration in 
Ground Water (SCI-GROW) models, the estimated drinking water 
concentrations (EDWCs) of thiamethoxam for acute exposures are 
estimated to be 131.77 parts per billion (ppb) for surface water and 
4.66 ppb for ground water and for chronic exposures are estimated to be 
11.31 ppb for surface water and 4.66 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 131.77 ppb was used to 
assess the contribution to drinking water. For the chronic dietary risk 
assessment, the water concentration of value 11.31 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).
    Thiamethoxam is currently registered for the following uses that 
could result in residential exposures: Turf and indoor environments 
(crack-and-crevice uses). EPA assessed residential exposure using the 
following assumptions: For residential handlers, short-term dermal and 
inhalation exposure is anticipated from both the lawn/turf and indoor 
crack-and-crevice uses. In terms of post application exposure, short-
term dermal and incidental oral exposures are anticipated from both the 
lawn/turf and the crack-and-crevice uses. These exposures are expected 
from activities on turf such as playing, mowing, golfing, hand-to-
mouth, object-to-mouth, incidental soil ingestion, and from contacting 
treated carpets. Post application inhalation exposure is also 
anticipated from indoor crack-and-crevice applications. The Agency 
selected only the most conservative, or worst case, residential adult 
and child scenarios to be included in the aggregate estimates, based on 
the lowest overall MOE (i.e., highest risk estimates). The worst case 
residential exposures for adults and children 1 to 2 years old were 
associated with post-application exposure to treated turf. 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.''
    Thiamethoxam is a member of the neonicotinoid class of pesticides 
and produces, as a metabolite, another neonicotinoid, CGA-322704. 
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 (EPA, 2002). Although CGA-322704 and 
thiamethoxam bind selectively to insect nicotinic acetylcholine 
receptors (nAChR), the specific binding site(s)/receptor(s) for CGA-
322704, 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 CGA-322704 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 nAChRs, 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 CGA-322704 is based on unrelated effects in mammals, including 
changes in body and thymus weights, delays in sexual maturation, and 
still births. Additionally, the most sensitive toxicological effect in 
mammals differs across the neonicotinoids (such as testicular tubular 
atrophy with thiamethoxam, and mineralized particles in thyroid colloid 
with imidacloprid). Therefore, 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 
thiamethoxam and any other substances and thiamethoxam 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 
thiamethoxam 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 the policy statements concerning common 
mechanism determinations, and procedures for cumulating effects from 
substances found to have a common mechanism, released by OPP on 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 Food Quality 
Protection Act (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. In the developmental 
studies, there was no evidence of increased quantitative or qualitative 
susceptibility of rat or rabbit fetuses to in utero exposure to 
thiamethoxam. Effects in the young were seen in the presence of 
maternal toxicity. There was evidence of quantitative susceptibility in 
the developmental neurotoxicity study and both two-generation 
reproductive studies. Although there was evidence of increased 
quantitative susceptibility, there are no residual uncertainties with 
regard to pre- and/or postnatal toxicity following in utero exposure to 
rats or rabbits and pre and/or post-natal exposures to rats. 
Considering the overall toxicity profile and the doses and endpoints 
selected for risk assessment, the degree of concern for the effects 
observed in the studies is low because the developmental/offspring 
effects observed in the studies are well characterized and clear 
NOAELs/LOAELs have been identified in the studies for the effects of 
concern. Additionally, the Agency is confident that the endpoints and 
PODs selected

[[Page 10717]]

for risk assessment are protective of potential developmental/
reproductive 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 thiamethoxam is complete.
    ii. Evidence of neurotoxicity was seen in the acute and 
developmental neurotoxicity studies. However, there is a low degree of 
concern for the potential neurotoxic effects of thiamethoxam since 
clear NOAELs were identified for the neurotoxic effects, the neurotoxic 
effects were not the most sensitive endpoint in the toxicity database 
and the endpoints chosen for risk assessment are protective of any 
potential neurotoxicity.
    iii. There is no evidence that thiamethoxam results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies. There was evidence of quantitative 
susceptibility in the developmental neurotoxicity study and both two-
generation reproductive studies, however, for the reasons cited above 
in section III.D.2., the Agency is confident that the endpoints and 
PODs selected for risk assessment are protective of potential 
developmental/reproductive effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary exposure assessments are based on high-end 
residue levels and processing factors, both of which account for parent 
and metabolites of concern, and the assumption of 100 PCT for all 
registered crops. EPA made conservative (protective) assumptions in the 
ground and surface water modeling used to assess exposure to 
thiamethoxam in drinking water. EPA used similarly conservative 
assumptions to assess post-application exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by thiamethoxam.

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 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 
thiamethoxam from food and water will utilize 45% of the cPAD for 
children 1-2 years old the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
thiamethoxam is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    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 result in aggregate MOEs of 500 for adults 
and 580 for children 1<2 years old. Because EPA's level of concern for 
thiamethoxam 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).
    An intermediate-term adverse effect was identified; however, 
thiamethoxam is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no 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 intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
thiamethoxam.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A. and based on the lack of chronic risk discussed in Unit 
III.E.2., thiamethoxam is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to thiamethoxam residues.

IV. Other Considerations

 A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography (HPLC)) is available to enforce the tolerance 
expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    Codex has established an MRL for thiamethoxam in bananas at 0.02 
mg/kg which is different than the U.S. tolerance of 0.3 ppm. At this 
time, the Codex and EPA residue definitions are different (Codex's MRL 
is for the parent compound, thiamethoxam only, while EPA's is 
thiamethoxam plus metabolite CGA-322704); therefore, it is not possible 
to harmonize with the Codex MRL.

C. Response to Comments

    Three comments were received in response to the Notice of Filing. 
One

[[Page 10718]]

simply said ``Good.'' The other two comments noted general concerns 
about approving ``more herbicides and pesticides from Dow, Bayer, and 
Monsanto'' and the toxicity of this chemical, stating, in part, that 
``food should not be contaminated with these chemicals.'' The Agency 
recognizes that some individuals believe that pesticides should be 
banned on agricultural crops; however, the existing legal framework 
provided by section 408 of the Federal Food, Drug and Cosmetic Act 
(FFDCA) states that tolerances may be set when persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute. EPA has assessed the effects 
of this chemical on human health and determined that aggregate exposure 
to it will be safe. These comments provide no information to support a 
different conclusion.

D. Revisions to Petitioned-For Tolerances

    The submitted banana field trial data support a tolerance of 0.03 
ppm, instead of the petitioned-for tolerance of 0.04 ppm, in whole 
bananas. The petitioner used a combined limit of quantitation (LOQ) 
different from that used by the Agency for the input dataset of the 
Organization for Economic Cooperation and Development (OECD) tolerance 
calculation procedure. The combined LOQ used by EPA resulted in a 
recommended tolerance of 0.03 ppm.

V. Conclusion

    Therefore, a tolerance is established for residues of thiamethoxam, 
including its metabolites and degradates, in or on banana at 0.03 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance 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).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: January 13, 2017.
Michael Goodis,
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. In Sec.  180.565, add alphabetically the commodity ``Banana'' to the 
table in paragraph (a) and revise footnote 1 to read as follows:

Sec.  180.565  Thiamethoxam; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Banana \1\..............................................            0.03
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for these commodities as of February
  15, 2017.

* * * * *
[FR Doc. 2017-03075 Filed 2-14-17; 8:45 am]
BILLING CODE 6560-50-P