[Federal Register Volume 84, Number 142 (Wednesday, July 24, 2019)]
[Rules and Regulations]
[Pages 35546-35555]
[FR Doc No: 2019-15648]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0179; FRL-9995-63]

Sulfoxaflor; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
sulfoxaflor in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project No. 4
(IR-4) and Dow AgroSciences LLC requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 24, 2019. Objections and
requests for hearings must be received on or before September 23, 2019,
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-2018-0179, 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<PHONE_NUMBER>, and the telephone number for the
OPP Docket is<PHONE_NUMBER>. Please review the visitor instructions
and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
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
Publishing 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-2018-0179 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
September 23, 2019. 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-2018-0179, 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 Tolerances

    In the Federal Register of April 23, 2014 (79 FR 22602) (FRL-9907-
39), 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
4F8237) by Dow AgroSciences, LLC, 9330 Zionsville Rd., Indianapolis, IN
46268. The petition requested to establish tolerances in 40 CFR part
180 for residues of the insecticide, sulfoxaflor (N-[methyloxido[1-[6-
(trifluoromethyl)-3-pyridinyl]ethyl]-[lambda]\4\-
sulfanylidene]cyanamide), in or on alfalfa, forage at 7 parts per
million (ppm); alfalfa, hay at 20 ppm; alfalfa, seed at 30 ppm;
alfalfa, silage at 9 ppm; animal feed, non-grass, group 18, forage at
15 ppm; animal feed, non-grass, group 18, hay at 20 ppm; animal feed,
non-grass, group 18, silage at 9 ppm; buckwheat, forage at 1 ppm;
buckwheat, grain at 0.08 ppm; buckwheat, hay at 1.5 ppm; buckwheat,
straw at 2 ppm; cacao bean, dried bean at 0.15 ppm; clover forage at 15
ppm; clover hay at 20 ppm; clover silage at 8 ppm; corn, field, forage
at 0.5 ppm; corn, field, grain at 0.015 ppm; corn, field, stover at 0.8
ppm; corn, pop at 0.015 ppm; corn, pop, stover at 0.8 ppm; corn, sweet,
at 0.01 ppm; corn, sweet, forage at 0.6 ppm; corn, sweet, stover at 0.7
ppm; millet, forage at 0.4 ppm; millet, grain at 0.3 ppm; oat, grain at
0.4 ppm; oat, hay at 1 ppm; oat, straw at 2 ppm; pineapple at 0.09 ppm;
rye, forage at 1 ppm; rye, grain at 0.08 ppm; rye, hay at 1.5 ppm; rye,
straw at 2 ppm; sorghum, forage at 0.4 ppm; sorghum, grain at 0.3 ppm;
sorghum, stover at 0.9 ppm; teff, forage at 1 ppm; teff, grain at 0.08
ppm; teff, hay at 1.5 ppm; teff, straw at 2 ppm; teosinte, grain at
0.015 ppm; triticale, forage at 1 ppm; triticale, grain at 0.08 ppm;
triticale, hay at 1.5 ppm; and triticale, straw at 2 ppm. That document
referenced a summary of the petition prepared by Dow AgroSciences, the
registrant, which is available in docket number EPA-HQ-OPP-2014-0156,
http://www.regulations.gov. The petition also requested revisions to
the certain existing animal commodity tolerances, as follows: Milk at 1
ppm; fat of cattle, goat, horse and sheep at 0.6 ppm; meat of cattle,
goat, horse and sheep at 1 ppm; meat byproducts of cattle, goat, horse
and sheep at 2.5 ppm; hog, fat at 0.04 ppm; hog, meat at 0.07 ppm; hog,
meat byproducts at 0.2 ppm; egg at 0.08 ppm; poultry, meat at 0.09 ppm;
poultry, fat at 0.03 ppm; poultry, meat byproducts at 0.2 ppm. These
requested revisions were inadvertently omitted from the April 23, 2014
Federal Register notice (79 FR 22602) (FRL-9907-39) but were included
in the summary of the petition that was available in the docket.
Comments were received on the notice of filing. EPA's response to these
comments is discussed in Unit IV.C.
    In the Federal Register of July 24, 2018 (83 FR 34968) (FRL-9980-
31), 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
8E8666) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201W, Princeton,
NJ 08540. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of sulfoxaflor (N-[methyloxido[1-
[6-(trifluoromethyl)-3-pyridinyl]ethyl]-[lambda]\4\-
sulfanylidene]cyanamide) in or on the following raw agricultural
commodities: Artichoke, globe at 0.70 ppm; asparagus at 0.015 ppm;
brassica, leafy greens, subgroup 4-16B, except watercress at 2.0 ppm;
bushberry subgroup 13-07B at 2.0 ppm; caneberry subgroup 13-07A at 1.5
ppm; celtuce at 2.0 ppm; florence fennel at 2.0 ppm; fruit, stone,
group 12-12 at 3.0 ppm; kohlrabi at 2.0 ppm; leafy greens subgroup 4-
16A at 6.0

ppm; leaf petiole vegetable subgroup 22B at 2.0 ppm; nut, tree, group
14-12 at 0.015 ppm; sunflower subgroup 20B at 0.30 ppm; and vegetable,
brassica, head and stem, group 5-16, except cauliflower at 2.0 ppm.
Additionally, the petition requested to amend 40 CFR 180.668 by
removing the established tolerances for residues of sulfoxaflor in or
on the following raw agricultural commodities: Fruit, stone, group 12
at 3.0 ppm; leafy greens, subgroup 4A at 6.0 ppm; leafy petiole,
subgroup 4B at 2.0 ppm; nuts, tree, group 14 at 0.015 ppm; pistachio at
0.015 ppm; and vegetable, brassica, leafy, group 5, except cauliflower
at 2.0 ppm. That document referenced a summary of the petition prepared
by Dow AgroSciences, the registrant, which is available in docket
number EPA-HQ-OPP-2018-0179, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA is
establishing tolerances that vary from what the petitioner requested
(PP 8E8666), as authorized under FFDCA section 408(d)(4)(A)(i). Also,
the petitioner withdrew the tolerances proposed for buckwheat and
clover (PP 4F8237). Since clover is a representative commodity for non-
grass animal feeds (group 18), a crop group tolerance cannot be
established for that crop group. Additionally, existing tolerances for
livestock commodities (e.g., cattle, goats, sheep, and horse) are being
revised based upon a recalculation of the livestock dietary burden. The
reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for sulfoxaflor including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with sulfoxaflor 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.
    Specific information on the studies received and the nature of the
adverse effects caused by sulfoxaflor as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of May 17, 2013 (78 FR 29041) (FRL-
9371-4). Further discussion of the toxicological profile for
sulfoxaflor can be found at http://www.regulations.gov in section 4.0
titled ``Hazard Characterization and Dose-Response Assessment'' (pages
14-28) of the document titled ``Sulfoxaflor. Human Health Risk
Assessment for New Food Uses on Avocado and Rice'' and pages 13-26 of
the document titled ``Sulfoxaflor. Human Health Risk Assessment for New
Food Uses on Artichoke, Asparagus, Bushberry, Caneberry and Sunflower,
and Multiple Crop Group Conversions'' in docket ID number EPA-HQ-OPP-
2018-0179.

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-pesticide.
    A summary of the toxicological endpoints for sulfoxaflor used for
human risk assessment is shown in the table of this unit.

   Table--Summary of Toxicological Doses and Endpoints for Sulfoxaflor 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 (Females 13-49       NOAEL = 1.8 mg/kg/    Acute RfD = 0.06 mg/ Developmental Neurotoxicity Study
 years of age).                     day.                  kg/day.              (DNT).
                                   UFA = 3x............  aPAD = 0.06 mg/kg/   LOAEL = 7.1 mg/kg/day based on
                                   UFH = 10x...........   day.                 decreased neonatal survival (PND
                                   FQPA SF = 1x........                        0-4).

Acute dietary (General population  NOAEL = 25 mg/kg/day  Acute RfD = 0.25 mg/ Acute Neurotoxicity Study.
 including infants and children).  UFA = 10x...........   kg/day.             LOAEL = 75 mg/kg/day based on
                                   UFH = 10x...........  aPAD = 0.25 mg/kg/    decreased motor activity.
                                   FQPA SF = 1x........   day.
Chronic dietary (All populations)  NOAEL= 5.13 mg/kg/    Chronic RfD = 0.05   Chronic/Carcinogenicity Study--
                                    day.                  mg/kg/day.           Rat.
                                   UFA = 10x...........  cPAD = 0.05 mg/kg/   LOAEL = 21.3 mg/kg/day based on
                                   UFH = 10x...........   day.                 liver effects including increased
                                   FQPA SF = 1x........                        blood cholesterol, liver weight,
                                                                               hypertrophy, fatty change, single
                                                                               cell necrosis and macrophages.
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Cancer (Oral, dermal, inhalation)  Classification: ``Suggestive Evidence of Carcinogenic Potential.''
                                    Quantification of risk using a non-linear approach (i.e., reference dose
                                    (RfD)) will adequately account for all chronic toxicity, including
                                    carcinogenicity, that could result from exposure to sulfoxaflor.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. 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 sulfoxaflor, EPA considered exposure under the petitioned-
for tolerances as well as all existing sulfoxaflor tolerances in 40 CFR
180.668. EPA assessed dietary exposures from sulfoxaflor 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 sulfoxaflor. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption information from
the U.S. Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
As to residue levels in food, the acute assessment was based on the
maximum observed residue levels from crop field trials and 100 percent
crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the 2003-2008 food consumption data from the USDA's
NHANES/WWEIA. As to residue levels in food, the chronic assessment
assumed average field trial residues and 100 PCT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that quantification of risk using a non-linear approach
(i.e., RfD/cPAD) will adequately account for all chronic toxicity,
including carcinogenicity. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    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 sulfoxaflor in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of sulfoxaflor. 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.
    Environmental fate data indicate that the use of sulfoxaflor is
likely to result in different residue profiles in surface water and
ground water. The residues in surface water are likely to include
parent sulfoxaflor and X11719474/X11519540 degradates while X11719474/
X11519540 will predominate in ground water. When the residue profiles
are coupled with the toxicological database, it becomes apparent that
the EDWCs for assessing acute dietary exposure for the general
population, acute dietary exposure for women of child-bearing age, and
chronic dietary exposure for all populations need to be addressed
differently. An explanation of the three scenarios and the rationale
for the approaches taken by EPA is provided below.
    Acute Exposure: Separate acute endpoints were selected for the
general population and females 13 to 49 years of age. For the general
population, the point of departure is based on decreased motor activity
observed in the acute neurotoxicity study. As there are no data
available to examine the potency of X11719474 and X11519540 with
respect to this endpoint, EPA has assumed that the two metabolites
possess similar toxicity relative to sulfoxaflor in order to assess
acute dietary risk for the general population. The EDWC for ground
water is significantly greater than the acute estimate for surface
water and, per Agency policy, is being used in the acute dietary
assessment for the general population. As it is a ground water EDWC, it
represents residues of the metabolites.
    For females 13 to 49 years of age, the developmental endpoint of
increased neonatal deaths was chosen because a single exposure during
late gestation can adversely affect the developing fetus via agonism of
the muscle nicotinic

acetylcholine receptor (nAChR), and the age group represents women of
child-bearing age. Studies with the metabolite X11719474 demonstrated
that it does not cause agonism of the fetal rat muscle nAChR. Based on
structural similarity between X11719474 and X11519540, the Agency
further determined that X1159540 is not likely to result in agonism of
the muscle nAChR. Therefore, both metabolites have been excluded from
assessment scenarios using the developmental endpoint. Since the ground
water EDWC represents residues of only these metabolites, the acute
surface water EDWC, which consists of only parent sulfoxaflor, is the
appropriate estimate for assessing dietary exposure for women of child-
bearing age.
    Chronic Exposure: The endpoint for assessing chronic dietary
exposure is hepatotoxicity. The Agency has determined that it is
appropriate to combine residues of sulfoxaflor, X11719474, and
X11519540 when assessing chronic exposure and, furthermore, there is
sufficient evidence to adjust the assessment to account for the
different potencies of the metabolites. Based on NOAELs in the 28-day
oral toxicity studies in rats, the potencies of the metabolites,
relative to sulfoxaflor, are 0.3X for X11719474 and 3.4X for X11519540.
To account for the relative toxicity, the EDWCs for each metabolite are
multiplied by their respective potency factors.
    EDWCs Used in the Assessment: For the acute dietary risk assessment
of the general population, the groundwater EDWC is greater than the
surface water EDWC and was used in the assessment. The residue profile
in groundwater is 12 ppb X11719474 and 1.6 ppb X11519540 (totaling 13.6
ppb). Parent sulfoxaflor is not expected in groundwater. For this
assessment, the regulatory toxicological endpoint is based on
neurotoxicity. There is no information to relate the neurotoxicity of
the metabolites to that of sulfoxaflor; therefore, no toxicity
adjustment was made to the EDWC.
    For the acute dietary risk assessment of females 13 to 49, the
regulatory endpoint is attributable only to the parent compound (as
previously discussed); therefore, the surface water EDWC is the most
appropriate EDWC for this assessment even though it is of a lower value
than the groundwater EDWC, which reflects metabolites only. The EDWC of
9.2 ppb was used and no toxicological adjustment was made.
    For the chronic dietary risk assessment, the toxicological endpoint
is liver effects, for which it is possible to account for the relative
toxicities of X11719474 and X11519540 as compared to sulfoxaflor. The
groundwater EDWC is greater than the surface water EDWC. The residue
profile in groundwater consists of 8 ppb X11719474 and 1.1 ppb
X11519540. Adjusting for the relative toxicity results in 2.4 ppb
equivalents of X11719474 and 3.7 ppb X11519540 (totaling 6.1 ppb). The
adjusted groundwater EDCW is greater than the surface water EDWC and
was, therefore, used to assess the chronic dietary exposure scenario.
    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). Sulfoxaflor is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found sulfoxaflor to share a common mechanism of
toxicity with any other substances, and sulfoxaflor does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
sulfoxaflor does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. Developmental/offspring
toxicity, manifested as skeletal abnormalities and neonatal deaths, was
observed in rats only. The skeletal abnormalities, forelimb flexure,
bent clavicles, and hindlimb rotation likely result from skeletal
muscle contraction due to agonism of the muscle nAChR in utero.
Similarly, contraction of the diaphragm muscle prevents normal
breathing in neonates resulting in increased mortality. The skeletal
abnormalities were observed at high doses in the developmental and
reproduction studies and decreased neonatal survival was consistently
observed in the reproduction and developmental neurotoxicity studies.
These developmental effects were not observed in the rabbit.
    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 sulfoxaflor is complete.
    ii. In the acute neurotoxicity study, decreased motor activity and
clinical signs associated with neurotoxicity (increased muscle tremors
and twitches, convulsions, hindlimb splaying, increased lacrimation and
salivation, decreased pupil size and response to touch, gait
abnormalities and decreased rectal temperature) were observed. However,
the level of concern for neurotoxicity is low because (1) the effects
are well characterized; (2) the dose-response curve for these effects
is well characterized; (3) clear NOAELs have been identified; and (4)
the endpoints chosen for risk assessment are protective for the
observed neurotoxicity.
    iii. Although there was quantitative susceptibility observed in the
DNT and developmental rat studies, there is no residual uncertainty
because (1) the effects are well characterized; (2) clear NOAELs were
identified; and (3) the endpoints chosen for risk assessment are
protective of potential in utero and developmental effects.
Quantitative susceptibility in the DNT was based on an increased rate
of neonatal deaths at a dose where no maternal toxicity was observed.
Quantitative susceptibility was also observed in the developmental rat
study as decreased fetal weight, forelimb flexure, hindlimb rotation,
and bent clavicles at a dose that did not cause maternal toxicity.
However, the apparent enhanced sensitivity in this

study may be due to the limited number of evaluations conducted in dams
in the study rather than a true sensitivity of the young. In that
regard, adverse liver effects were observed in the 90-day rat study at
a LOAEL lower than the highest dose tested in the developmental rat
study. The dams in the developmental rat study had increased liver
weights but clinical chemistry and liver histopathological analysis
were not investigated to determine if the effects on the liver were
adverse. Qualitative susceptibility was observed in the two-generation
reproduction study since neonatal deaths were observed at the same dose
that resulted in hepatotoxicity in parental animals. However, these
effects occurred at a higher dose compared to the offspring effects
observed in the DNT. Finally, there was no evidence of quantitative or
qualitative susceptibility in the developmental studies in the rabbit.
    iv. There are no residual uncertainties with regard to dietary
exposure. The dietary exposure assessments are based on high-end
residue estimates, processing factors, and 100 PCT, as well as upper-
bound modeled estimates of residues in drinking water. These
assessments will not underestimate the exposure and risks posed by
sulfoxaflor.

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 sulfoxaflor will occupy 28% of the aPAD for both children 1 to 2
years old and females 13 to 49 years old, the population groups
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
sulfoxaflor from food and water will utilize 47% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. There are no residential uses for sulfoxaflor.
    3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Short- and intermediate-term adverse effects were identified;
however, sulfoxaflor is not registered for any use patterns that would
result in short- or intermediate-term residential exposure. Short- and
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. Because there
is no short- or intermediate-term residential exposure and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess short- or intermediate-term risk), no further assessment of
short- or intermediate-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short- and intermediate-
term risk for sulfoxaflor.
    4. Aggregate cancer risk for U.S. population. EPA assessed cancer
risk using a non-linear approach (i.e., RfD) since it adequately
accounts for all chronic toxicity, including carcinogenicity, that
could result from exposure to sulfoxaflor. As the chronic dietary
endpoint and dose are protective of potential cancer effects,
sulfoxaflor is not expected to pose an aggregate cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to sulfoxaflor residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    High performance liquid chromatographic methods with positive-ion
electro spray interface (ESI) and tandem mass spectrometric detection
(LC/MS/MS) were previously reviewed and found to be acceptable for
tolerance enforcement of sulfoxaflor residues (the two metabolites,
X11719474 and X11721061, are also quantitated). The limit of
quantitation (LOQ), determined as the lowest level of method validation
(LLMV), is 0.010 ppm in all matrices.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint 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 MRLs for residues of sulfoxaflor on broccoli
(3 ppm) and head cabbage (0.4 ppm). These commodities are covered in
the U.S. crop group 5-16 (vegetable, brassica, head and stem), for
which EPA is establishing a tolerance at 2 ppm in this rulemaking. This
2 ppm tolerance is part of a conversion from the existing group 5A,
including broccoli and cabbage, to the new crop group 5-16. The old
group was not harmonized with the Codex MRL. EPA is not harmonizing the
new crop group 5-16 either because the representative commodity data
for the new group 5-16 support establishing one tolerance level for all
commodities in the group rather than a higher broccoli and lower
cabbage tolerance.
    In addition, Codex has established MRLs for leafy vegetables at 6
ppm. EPA's leafy vegetable crop group 4-16 is split into two subgroups:
4-16A for leafy greens and 4-16B for Brassica, leafy greens. Although
EPA is establishing a subgroup 4-16A tolerance at 6 ppm, which
harmonizes with the Codex MRL, EPA is also establishing a subgroup 4-
16B tolerance at 2 ppm, which is not harmonized with the Codex MRL.
This is because the representative commodity data for mustard greens
indicates that lower residues of the pesticide are present on the
brassica, leafy greens commodities.
    The tolerances in meat and meat byproducts of hogs and poultry are
being harmonized with the corresponding Codex MRLs instead of the
levels proposed by the petitioner. Therefore, tolerances in hog meat
and hog meat byproducts are being established at 0.3 and 0.6 ppm,

respectively (rather than 0.07 and 0.2 ppm), in order to harmonize with
MRLs of 0.3 mg/kg in meat from mammals other than marine mammals, and
0.6 mg/kg in mammalian edible offal. Similarly, tolerances in poultry
meat and poultry meat byproducts are being established at 0.1 and 0.3
ppm, respectively (rather than 0.09 and 0.2 ppm), in order to harmonize
with Codex MRLs of 0.1 mg/kg in poultry meat, and 0.3 ppm in poultry
edible offal.

C. Response to Comments

    Thirteen comments were received in response to the NOF for petition
4F8237. Nine of these comments were primarily related to bee toxicity,
which is not an issue that is relevant to the Agency's evaluation of
safety of the sulfoxaflor tolerances under section 408 of the FFDCA,
which requires the Agency to evaluate the potential harms to human
health, not effects on the environment.
    Another four comments were primarily related to a general
disapproval of pesticides in general. Although the Agency recognizes
that some individuals believe that pesticides should be banned on
agricultural crops, the existing legal framework provided by section
408 of the Federal Food, Drug and Cosmetic Act (FFDCA) authorizes EPA
to establish tolerances when it determines that the tolerance is safe.
Upon consideration of the validity, completeness, and reliability of
the available data as well as other factors the FFDCA requires EPA to
consider, EPA has determined that these sulfoxaflor tolerances are
safe. The commenters have provided no information supporting a contrary
conclusion.

D. Revisions to Petitioned-For Tolerances

    The Agency is establishing a tolerance of 0.01 ppm in asparagus as
opposed to the 0.015 ppm proposed by the petitioner. In the field
trials that serve as the basis for the tolerance level, the application
rates were exaggerated by 4.2-6.5X the proposed application rate, and
the resulting residues in all but one trial were <0.01 ppm and in the
other trial the residues measured 0.011 ppm. When sulfoxaflor is used
in accordance with the proposed label, all residues are expected to be
<0.01 ppm. Therefore, the Agency is establishing the tolerance at the
limit of quantification (0.01 ppm).
    Tolerances are not being established in clover or buckwheat
commodities (as these proposed new uses were subsequently withdrawn by
the registrant after submission of the original petition), nor in non-
grass feeds (group 18), for which clover is a representative commodity.
    In order to maximize global regulatory harmonization, it became EPA
policy in April 2011 to use the OECD calculation procedures to derive
tolerance levels. As such, the proposed tolerance of 0.9 ppm in
sorghum, grain, stover will be listed as 1 ppm; the proposed tolerance
of 30 ppm in alfalfa seed will be changed to 40 ppm; the proposed
tolerance of 0.09 ppm in pineapple will be changed to 0.1 ppm; and the
proposed tolerance of 0.15 ppm in cacao, dried bean will be changed to
0.05 ppm.
    For millet, there is no established ``parent'' millet term that
covers more than one millet. As such, the tolerances are being
established specifying both proso and pearl millet individually.
    Tolerances of 0.6 and 2.5 ppm in the fat and meat byproducts,
respectively, of cattle, goats, horses and sheep were proposed by the
petitioner. However, revised tolerances of 0.2 and 0.8 ppm in these fat
and meat byproducts are appropriate since the clover use was withdrawn,
resulting in a lower dietary burden to livestock and lower anticipated
residues in livestock commodities than originally considered by the
petitioner.
    Existing tolerances in cattle, meat; goat, meat; sheep, meat; and
horse, meat is being revised in this action to 0.4 ppm, consistent with
anticipated residues based upon a recalculated dietary burden of
sulfoxaflor, and the results of a lactating dairy cattle feeding study.
    For several commodities in the IR-4 petition (PP 8E8666), the
requested tolerances include an additional significant figure (such as
1.0 ppm rather than 1 ppm). EPA is establishing the tolerances without
the trailing zero to be consistent with current rounding practice.

E. International Trade Considerations

    In this final rule, EPA is reducing the existing tolerances for
arugula; cress, garden; and cress, upland from 6 ppm to 2 ppm.
Currently, these commodities are included in leafy greens subgroup 4A,
which has a tolerance of 6 ppm. In 2016, EPA moved these commodities to
the Brassica leafy greens subgroup 4-16B. (81 FR 26471; FRL-9944-87
(May 3, 2016)). In today's rule, EPA is establishing a tolerance for
residues of sulfoxaflor in or on commodities in Brassica leafy greens
subgroup 4-16B, which now includes arugula, garden cress, and upland
cress, at 2 ppm, based on available residue data. This results in a
reduction of tolerance levels for these three commodities.
    In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the
WTO of this revision. In addition, the SPS Agreement requires that
members provide a ``reasonable interval'' between the publication of a
regulation subject to the agreement and its entry into force to allow
time for producers in exporting member countries to adapt to the new
requirement. At this time, EPA is establishing an expiration date for
the existing tolerances to allow those tolerances to remain in effect
for a period of six months after the effective date of this final rule,
in order to address the requirement to provide a reasonable interval.
After the six-month period expires, residues of sulfoxaflor on arugula;
cress, garden; and cress, upland cannot exceed the newly established
tolerances of 2 ppm.
    This reduction in tolerance levels is not discriminatory; the same
food safety standard contained in the FFDCA applies equally to
domestically produced and imported foods. The new tolerance levels are
supported by available residue data.

V. Conclusion

    Therefore, tolerances are established for residues of sulfoxaflor
in or on Alfalfa, forage at 7 ppm; Alfalfa, hay at 20 ppm; Alfalfa,
seed at 40 ppm; Alfalfa, silage at 9 ppm; Artichoke, globe at 0.7 ppm;
Asparagus at 0.01 ppm; Brassica, leafy greens, subgroup 4-16B, except
watercress at 2 ppm; Bushberry subgroup 13-07B at 2 ppm; Cacao, dried
bean at 0.05 ppm; Caneberry subgroup 13-07A at 1.5 ppm; Celtuce at 2
ppm; Corn, field, forage at 0.5 ppm; Corn, field, grain at 0.015 ppm;
Corn, field, stover at 0.8 ppm; Corn, pop, grain at 0.015 ppm; Corn,
pop, stover at 0.8 ppm; Corn, sweet, forage at 0.6 ppm; Corn, sweet,
kernel plus cob with husks removed at 0.01 ppm; Corn, sweet, stover at
0.7 ppm; Fennel, Florence, fresh leaves and stalk at 2 ppm; Fruit,
stone, group 12-12 at 3 ppm; Kohlrabi at 2 ppm; Leaf petiole vegetable
subgroup 22B at 2 ppm; Leafy greens subgroup 4-16A at 6 ppm; Millet,
proso, forage at 0.4 ppm; Millet, pearl, forage at 0.4 ppm; Millet,
proso, grain at 0.3 ppm; Nut, tree, group 14-12 at 0.015 ppm; Oat,
grain at 0.4 ppm; Oat, hay at 1 ppm; Oat, straw at 2 ppm; Pineapple at
0.1 ppm; Rye, forage at 1 ppm; Rye, grain at 0.08 ppm; Rye, hay at 1.5
ppm; Rye, straw at 2 ppm; Sorghum, grain, forage at 0.4 ppm; Sorghum,
grain, grain at 0.3 ppm; Sorghum, grain, stover at 1 ppm; Sunflower
subgroup 20B at 0.3 ppm; Teff, forage at 1 ppm; Teff, grain at 0.08
ppm; Teff, hay at 1.5 ppm; Teff,

straw at 2 ppm; Teosinte, grain at 0.015 ppm; Triticale, forage at 1
ppm; Triticale, grain at 0.08 ppm; Triticale, hay at 1.5 ppm;
Triticale, straw at 2 ppm; and Vegetable, brassica, head and stem,
group 5-16, except cauliflower at 2 ppm.
    Additionally, the following existing tolerances are revised as
follows: Cattle, fat at 0.2 ppm; Cattle, meat at 0.4 ppm; Cattle, meat
byproducts at 0.8 ppm; Egg at 0.06 ppm; Goat, fat at 0.2 ppm; Goat,
meat at 0.4 ppm; Goat, meat byproducts at 0.8 ppm; Hog, fat at 0.03
ppm; Hog, meat at 0.3 ppm; Hog, meat byproducts at 0.6 ppm; Horse, fat
at 0.2 ppm; Horse, meat at 0.4 ppm; Horse, meat byproducts at 0.8 ppm;
Milk at 0.3 ppm; Poultry, fat at 0.02 ppm; Poultry, meat at 0.1 ppm;
Poultry, meat byproducts at 0.3 ppm; Sheep, fat at 0.2 ppm; Sheep, meat
at 0.4 ppm; and Sheep, meat byproducts at 0.8 ppm.
    The established tolerances for Fruit, stone, group 12; Leafy
greens, subgroup 4A; Leafy petiole, subgroup 4B; Nuts, tree, group 14;
Pistachio; and Vegetable, Brassica, leafy, group 5, except cauliflower
are removed as unnecessary due to the establishment of the above
tolerances.
    Lastly, in order to provide a reasonable interval for
implementation of certain tolerances being reduced through this rule,
EPA is leaving in place the following individual tolerances for a
period of six months: Arugula; cress, garden; and cress, upland.

VI. Statutory and Executive Order Reviews

    This action establishes and modifies tolerances under FFDCA section
408(d) in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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 tolerances 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: July 12, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.668, amend the table in paragraph (a) as follows:
0
a. Add alphabetically the entries Alfalfa, forage; Alfalfa, hay;
Alfalfa, seed; Alfalfa, silage; Artichoke, globe; Arugula; Asparagus;
Brassica, leafy greens, subgroup 4-16B, except watercress; Bushberry
subgroup 13-07B; Cacao, dried bean; Caneberry subgroup 13-07A; Celtuce;
Corn, field, forage; Corn, field, grain; Corn, field, stover; Corn,
pop, grain; Corn, pop, stover; Corn, sweet, forage; Corn, sweet, kernel
plus cob with husks removed; Corn, sweet, stover; Cress, garden; Cress,
upland; Fennel, Florence, fresh leaves and stalk; Fruit, stone, group
12-12; Kohlrabi; Leaf petiole vegetable subgroup 22B; Leafy greens
subgroup 4-16A; Millet, proso, forage; Millet, pearl, forage; Millet,
proso, grain; Millet, pearl, grain; Nut, tree, group 14-12; Oat, grain;
Oat, hay; Oat, straw; Pineapple; Rye, forage; Rye, grain; Rye, hay;
Rye, straw; Sorghum, grain, forage; Sorghum, grain, grain; Sorghum,
grain, stover; Sunflower subgroup 20B; Teff, forage; Teff, grain; Teff,
hay; Teff, straw; Teosinte, grain; Triticale, forage; Triticale, grain;
Triticale, hay; Triticale, straw; and Vegetable, brassica, head and
stem, group 5-16, except cauliflower;
0
b. Revise the entries for Cattle, fat; Cattle, meat; Cattle, meat
byproducts; Goat, fat; Goat, meat; Goat, meat byproducts; Hog, fat;
Hog, meat; Hog, meat byproducts; Horse, fat; Horse, meat; Horse, meat
byproducts; Milk; Poultry, eggs; Poultry, fat; Poultry, meat; Poultry,
meat byproducts; Sheep, fat; Sheep, meat; and Sheep, meat byproducts;
and
0
c. Remove the entries for Fruit, stone, group 12; Leafy greens,
subgroup 4A; Leafy petiole, subgroup 4B; Nuts, tree, group 14;
Pistachio; and Vegetable, Brassica, leafy, group 5, except cauliflower.
    The revisions and additions read as follows:

Sec.  180.668   Sulfoxaflor; tolerances for residues

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.........................................               7
Alfalfa, hay............................................              20
Alfalfa, seed...........................................              40
Alfalfa, silage.........................................               9

                              * * * * * * *
Artichoke, globe........................................             0.7
Arugula \1\.............................................               6
Asparagus...............................................            0.01

                              * * * * * * *
Brassica, leafy greens, subgroup 4-16B, except                         2
 watercress.............................................
Bushberry subgroup 13-07B...............................               2
Cacao, dried bean.......................................            0.05
Caneberry subgroup 13-07A...............................             1.5
Cattle, fat.............................................             0.2
Cattle, meat............................................             0.4
Cattle, meat byproducts.................................             0.8

                              * * * * * * *
Celtuce.................................................               2

                              * * * * * * *
Corn, field, forage.....................................             0.5
Corn, field, grain......................................           0.015
Corn, field, stover.....................................             0.8
Corn, pop, grain........................................           0.015
Corn, pop, stover.......................................             0.8
Corn, sweet, forage.....................................             0.6
Corn, sweet, kernel plus cob with husks removed.........            0.01
Corn, sweet, stover.....................................             0.7

                              * * * * * * *
Cress, garden \1\.......................................               6
Cress, upland \1\.......................................               6

                              * * * * * * *
Egg.....................................................            0.06
Fennel, Florence, fresh leaves and stalk................               2

                              * * * * * * *
Fruit, stone, group 12-12...............................               3
Goat, fat...............................................             0.2
Goat, meat..............................................             0.4
Goat, meat byproducts...................................             0.8

                              * * * * * * *
Hog, fat................................................            0.03
Hog, meat...............................................             0.3
Hog, meat byproducts....................................             0.6
Horse, fat..............................................             0.2
Horse, meat.............................................             0.4
Horse, meat byproducts..................................             0.8
Kohlrabi................................................               2
Leaf petiole vegetable subgroup 22B.....................               2
Leafy greens subgroup 4-16A.............................               6
Milk....................................................             0.3

                              * * * * * * *
Millet, proso, forage...................................             0.4
Millet, pearl, forage...................................             0.4
Millet, proso, grain....................................             0.3
Millet, pearl, grain....................................             0.3
Nut, tree, group 14-12..................................           0.015
Oat, grain..............................................             0.4
Oat, hay................................................               1
Oat, straw..............................................               2

                              * * * * * * *
Pineapple...............................................             0.1

Poultry, fat............................................            0.02
Poultry, meat...........................................             0.1
Poultry, meat byproducts................................             0.3

                              * * * * * * *
Rye, forage.............................................               1
Rye, grain..............................................            0.08
Rye, hay................................................             1.5
Rye, straw..............................................               2
Sheep, fat..............................................             0.2
Sheep, meat.............................................             0.4
Sheep, meat byproducts..................................             0.8
Sorghum, grain, forage..................................             0.4
Sorghum, grain, grain...................................             0.3
Sorghum, grain, stover..................................               1

                              * * * * * * *
Sunflower subgroup 20B..................................             0.3
Teff, forage............................................               1
Teff, grain.............................................            0.08
Teff, hay...............................................             1.5
Teff, straw.............................................               2
Teosinte, grain.........................................           0.015

                              * * * * * * *
Triticale, forage.......................................               1
Triticale, grain........................................            0.08
Triticale, hay..........................................             1.5
Triticale, straw........................................               2
Vegetable, brassica, head and stem, group 5-16, except                 2
 cauliflower............................................

                              * * * * * * *
------------------------------------------------------------------------
\1\ This tolerance expires on January 24, 2020.

* * * * *
[FR Doc. 2019-15648 Filed 7-23-19; 8:45 am]
 BILLING CODE 6560-50-P


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

CHEMICAL SAFETY

AND POLLUTION PREVENTION

MEMORANDUM

Date:		May 3, 2010

Subject:	Thiamethoxam: Occupational and Residential Exposure/Risk
Assessment for Proposed Section 3 Registration for Seed Treatment Use on
Bulb Onions.

		PC Code: 060109			DP Barcode: D372848

                        MRID No.:  NA			Registration No.:  100-1294
Cruiser 70 WS

		Petition No.:  NA			Regulatory Action: Section 3 Registration

                        Assessment Type: ORE		Reregistration Case No.:
NA

                        TXR No.:   NA			CAS No.:  152719-23-4

                        Decision No.:  415289		40 CFR:  180.565

TO:		Venus Eagle, RM 01

		Insecticide-Rodenticide Branch

		Registration Division (7505P)

FROM:	Shih-Chi Wang, Biologist

		Risk Assessment Branch 2

		Health Effects Division (7509P)

THRU:	Richard Loranger, Ph.D., Branch Senior Scientist

		Risk Assessment Branch 2

		Health Effects Division (7509P)

CONCLUSIONS

HED has evaluated the proposed seed treatment use of thiamethoxam on
bulb onions.  With the exception of the multiple activities scenario,
using HED’s standard assumptions for the amount of seed treated per
day (5,500 & 300 lbs treated/day for film-coated and pelletized seed
treatments, respectively), the potential occupational exposures/risks
resulting from the proposed use do not exceed HED’s level of concern.

The margin of exposure (MOE) of 59 estimated for the multiple activities
scenario with film-coated seed is below HED’s level of concern of an
MOE of 100; however, this is a conservative estimate for the following
reasons.  First, it was based on the use of a single layer plus gloves
as personal protection.  If dust mask and coveralls (currently required
on the label) are added, the exposure for multiple activities workers
may be not of concern.  In addition, the MOE of 59 for the multiple
activities scenario is based on the unit exposure value for liquid
products, but the product being evaluated for the proposed use of
thiamethoxam is a wettable powder packaged in water soluble packets (an
engineering control measure which can provide more than 50% reduction in
exposures).  Therefore, HED does not consider the MOE of 59 to be of
concern.

If the Registration Division considers it appropriate, additional label
language can be added to minimize the chance that the LOC of 100 is
exceeded for multiple activities workers.  In this case, the label
should indicate that the maximum amount of CRUISER® 70WS Insecticide
that can be used to treat bulb onion seed in a seed treatment facility
is 260 lbs per production line per 8-hour work shift (based on the MOE
calculated for treating 3,000 lbs seed per day;   MOE for multiple
activities worker = 110).  This requires that a worker perform tasks
associated with seed treatment only on one production line per 8-hour
shift and the worker works no more than one 8-hour shift per 24 hour
period.

	Table of Contents

 TOC \f

1.0  Executive Summary	3

2.0  Hazard Characterization	5

Acute Toxicity of Thiamethoxam 	6

Toxicological PODs Selected by the HED for Thiamethoxam 	6

3.0  Proposed Use Pattern	7

4.0  Residential (Non-Occupational) Exposure 	7

5.0  Occupational Exposure	8

            5.1  Handlers 	8

5.2  Secondary Seed Handlers 	11

6.0  Review of Human Research 	12

I.	EXECUTIVE SUMMARY

Thiamethoxam is a systemic insecticide belonging to the neonicotinoid
class of chemistry.  It is used to treat various agricultural crops,
turf grass, sod farms, golf course, residential lawns, indoor cracks and
crevices, ornamental plants grown in greenhouses, and Christmas trees.
The registrant, Syngenta, has requested a registration to the CRUISER®
70WS Insecticide (packaged in water soluble bags) for both pelletized &
film-coated seed treatment uses on bulb onions.  Thiamethoxam is to be
applied only in commercial seed treatment facilities.  Based on proposed
label information, occupational exposure is expected to occur for short-
and intermediate-term durations.

Although there are existing residential (indoor crack and crevice and
outdoor turf) scenarios, the proposed seed treatment use on bulb onions
does not result in additional residential exposure and risk.
Residential exposures and risks were previously summarized for the
purpose of conducting an aggregate exposure and risk assessment.

Hazard Characterization

Thiamethoxam is classified as Toxicity Category III for acute oral
toxicity and Category IV for acute dermal, inhalation toxicity and eye
irritation.  Thiamethoxam is not a dermal sensitizer.

Although points of departure and endpoints for risk assessment were
selected for children’s dermal and incidental oral exposures, these
are not discussed herein, since only adult occupational workers are
expected to be exposed based on the proposed label for seed treatment
use.

The adult dermal NOAEL of 1.2 mg/kg/day (point of departure for all
durations) is based on sperm abnormalities and testicular effects
observed after in utero and post-natal exposure at LOAELs of 1.8 and 3
mg/kg/day in 2 rat reproduction toxicity studies.  Although a 21-day
dermal toxicity study in rats is available, HED selected the endpoint
and dose (NOAEL) from the reproduction toxicity study because the
reproductive parameters were not evaluated in the dermal toxicity study,
and therefore use of the dermal toxicity study for endpoint selection
would not be protective of potential reproductive effects.

A route-specific inhalation toxicity study has not been submitted for
thiamethoxam.  Therefore, HED selected the same NOAEL of 1.2 mg/kg/day
(point of departure for all durations) and reproductive effects
(endpoints) for inhalation risk assessment that were used in the dermal
assessment.   Since an oral study was selected for both dermal and
inhalation risk assessments, corresponding dermal and inhalation
absorption factors were used for route-to-route extrapolation. For both
dermal and inhalation risk assessments, a 60 kg body weight (for
females) was used to calculate exposure since reproductive endpoints
were selected for risk assessment.

For all exposure scenarios, uncertainty factors (UFs) of 10x for
interspecies extrapolation and 10x for intraspecies variability (total
UF of 100x) were used.  Therefore, for all occupational and residential
exposure scenarios, the level of concern (LOC) is a margin of exposure
(MOE) of 100. That is, MOEs less than 100 represent risks of concern.

Cancer Assessments:

Thiamethoxam is classified 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.
Quantification of cancer risk is not required.

Residential Exposure:

A residential (non-occupational) exposure/risk assessment was not
performed in conjunction with the proposed use, which is limited to
occupational workers (handlers and postapplication).  For the purpose of
conducting an aggregate assessment, refer to the most recent residential
exposure and risk assessment (M. Collantes, November 24, 2009, D371303)
for a summary of scenarios, exposures and risks.  All handlers and
post-application scenarios resulted in MOEs greater than 100 and are not
of concern.  All combined residential post-application scenarios
resulted in MOEs greater than 100 and are not of concern.

Occupational Exposure:

The handler assessments for the proposed use on bulb onions for seed
treatment were based on the unit exposure data from the Science Advisory
Council for Exposure (Exposure SAC) Policy #14: Standard Operating
Procedures (SOP) for Seed Treatment (May 1, 2003) and on the
treating/planting data from the Exposure SAC Policy #15 & Policy # 14:
Amount of Seed Treated or Planted Per Day (March 2, 2004).  The one
exception is the substitution of the loader/operator exposure estimates
with the unit exposures given for the water soluble packets formulation
in the Pesticide Handlers Exposure Database (PHED).  This substitution
was made because the product being evaluated is a water soluble bag, and
not a liquid.

With the exception of the multiple activities scenario using HED’s
standard assumption regarding the amount of seed treated per day (5,500
lbs treated/day, MOE=59), the potential occupational exposures/risks
resulting from the proposed use do not exceed the HED level of concern
(MOEs range from 300 to 7,400).  The MOE of 59 for the multiple
activities scenario is a very conservative estimate because it was based
on single layer plus gloves protection.  If dust mask and coveralls are
added, as currently required on the label, the exposure for multiple
task workers may be not of concern.  In addition, the MOE of 59 for the
multiple activities scenario is based on the unit exposure for liquid
product, and the product being evaluated here is a wettable powder
packaged in water soluble packets (an engineering control measure which
can provide more than 50% reduction in exposures); therefore this MOE is
not of concern.

All MOEs for secondary seed handlers (i.e., those who plant treated
seed) are greater than 100 assuming a single layer of clothing plus
gloves, with MOEs ranging from 190 to 310.

Review of Human Research

This risk assessment relies in part on data from studies in which adult
human subjects were intentionally exposed to a pesticide or other
chemical.  These studies, which comprise the Pesticide Handlers Exposure
Database (PHED) have been determined to require a review of their
ethical conduct, and have received that review; and were considered
appropriate for use in risk assessments.

2.0.	HAZARD CHARACTERIZATION

	2.1	Hazard Profile

The database for acute toxicity for thiamethoxam is complete and is
summarized below in Table 1.  Thiamethoxam is classified as Toxicity
Category III for acute oral toxicity and Category IV for acute dermal,
inhalation toxicity and eye irritation.  Thiamethoxam is not a dermal
sensitizer.

Although points of departure and endpoints for risk assessment were
selected for children’s dermal and incidental oral exposures, these
are not discussed herein, since only adult occupational workers are
expected to be exposed based on the proposed label for seed treatment
use.

The adult dermal NOAEL of 1.2 mg/kg/day (point of departure for all
durations) is based on sperm abnormalities and testicular effects
observed after in utero and post-natal exposure at LOAELs of 1.8 and 3
mg/kg/day in 2 rat reproduction toxicity studies.  Although a 21-day
dermal toxicity study in rats is available, HED selected the endpoint
and dose (NOAEL) from the reproduction toxicity study because the
reproductive parameters were not evaluated in the dermal toxicity study,
and therefore use of the dermal toxicity study for endpoint selection
would not be protective of potential reproductive effects.

A route-specific inhalation toxicity study has not been submitted for
thiamethoxam.  Therefore, HED selected the same NOAEL of 1.2 mg/kg/day
(point of departure for all durations) and reproductive effects
(endpoints) for inhalation risk assessment that were used in the dermal
assessment.   Since an oral study was selected for both dermal and
inhalation risk assessments, corresponding dermal and inhalation
absorption factors were used for route-to-route extrapolation. For both
dermal and inhalation risk assessments, a 60 kg body weight (for
females) was used to calculate exposure since reproductive endpoints
were selected for risk assessment.

For all exposure scenarios, uncertainty factors (UF) of 10x for
interspecies extrapolation and 10x for intraspecies variability (total
UF of 100x) were used.    Therefore, for all occupational and
residential exposure scenarios, the level of concern (LOC) is a margin
of exposure (MOE) of 100. That is, MOEs less than 100 represent risks of
concern.

HED’s CARC 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.  Quantification of cancer risk is not required.

A summary of the toxicological doses and points of departure is provided
in Table 2.

FQPA and Uncertainty Factor Considerations

Based upon the hazard data and the methods used to estimate exposure,
HED previously recommended the 10X FQPA SF for the protection of infants
and children be reduced to 1X.  The complete discussion of the rationale
for reducing the FQPA SF to 1X is provided in the 11/24/2009 risk
assessment (D371303).  No additional uncertainty factors were considered
necessary to account for missing data, for severity of toxic effects, or
for the lack of a NOAEL.  Therefore, the standard 10X uncertainty
factors to account for intraspecies variability and interspecies
extrapolation (for a total of 100X) serve as the basis for the level of
concern (LOC) of 100 for both residential and occupational exposure
assessments.

Table 1.	Acute Toxicity Profile of Thiamethoxam.

Guideline No.	Study Type	MRID(s)	Results	Toxicity Category

870.1100	Acute oral [rat]	44703314	LD50: 1563 mg/kg	III

870.1200	Acute dermal [rabbit]	44703316	LD50 = 13.3 g/kg	IV

870.1300	Acute inhalation [rat]	44703317	LC50 > 3.72 mg/L 	IV

870.2400	Acute eye irritation [rabbit]	44703318	PIS = 10 at 1 hr

PIS = 0 at 24 hr

Minimally irritating	IV

870.2500	Acute dermal irritation 	44703319	PIS = 0	IV

870.2600	Skin sensitization 	44710401	Is not a sensitizer using method
of Magnusson and Kligman	N/A

Table 2.        Toxicological Doses and Endpoints for Thiomethoxam
Occupational Handler Risk Assessments.

Exposure/

Scenario	Point of Departure	Uncertainty Factors	Level of Concern for
Risk Assessment	Study and Toxicological Effects

Dermal (all durations) (Adults)

	Oral study NOAEL= 1.2

 mg/kg/day

(dermal absorption rate = 5%)	UFA= 10x

UFH= 10x

	LOC = an MOE of 100 (occupational)	2-Generation reproduction study
(MRID 44718707)

LOAEL = 1.8 mg/kg/day based on increased incidence and severity of
tubular atrophy in testes of F1 generation males.

2-Generation reproduction study (46402904)

LOAEL = 3 (males), not determined (females) mg/kg/day based on sperm
abnormalities in F1 males.

Inhalation (all durations)

	Oral study NOAEL= 1.2 mg/kg/day

(inhalation absorption rate = 100% of oral absorption)	UFA= 10x

UFH= 10x

	LOC = an MOE of 100 (occupational)	2-Generation reproduction study(MRID
44718707)

LOAEL = 1.8 mg/kg/day based on increased incidence and severity of
tubular atrophy in testes of F1 generation males.

2-Generation reproduction study (46402904)

LOAEL = 3 (males), not determined (females) mg/kg/day based on sperm
abnormalities in F1 males.

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 and that the
carcinogenic effects are a result of a mode of action dependent on
sufficient amounts of a hepatotoxic metabolite produced persistently.
Quantification of cancer risk is not required.

UF = Uncertainty Factor

LOC = Level of Concern

3.0	PROPOSED USE PATTERN

The proposed use pattern for thiamethoxam (packaged in water soluble
bags, thiamethoxam 70.0%) as a seed treatment for bulb onions is
summarized in Table 3.

Table 3.  Proposed Use Pattern for Thiamethoxam.

Crop

Seed

Product, Formulation

Treatment Type

Applications Per Season 1

Maximum Application Rate2

(lb ai/lb seed)

PHI3

(days)

Per Application

Per Season

	Bulb Onions	Cruiser 70WS

-water soluble bags	Seed Treatment: commercial-

pelleted & film-coated

seed treatment	NA	0.06	NA	NA

1 Maximum number of applications allowed on label.

2 Rate = Maximum application rates specified on proposed labels (0.20 mg
per seed, 136,000 seeds per pound).  This number of       seeds per
pound represents the middle of the range specified in Exp SAC SOP 15
(120,000 to 154,640 seeds per pound).

3 PHI = Pre-harvest Interval

4 NA= Not Applicable

RESIDENTIAL (NON-OCCUPATIONAL) EXPOSURE/RISK PATHWAY

Residential exposure assessments were previously performed for the use
thiamethoxam on turf    (M. Collantes; March 2007; D332064) and indoor
crack and crevice applications (M. Collantes, July 2009, D359207). The
product labels indicate that thiamethoxam is applied by commercial
applicators only.  Therefore, a quantitative assessment for handler
exposure was performed for commercial applicators only.   However,
residential post-application exposure assessments for adults and
toddlers were conducted.

HED assumes that inhalation exposures are minimal following outdoor
applications of an active ingredient, due to the large volume of air
exchange.  A separate inhalation post-application risk assessment was
not conducted since post-application inhalation exposure is expected to
be much lower than the inhalation exposure associated with pesticide
applications.  Therefore, a handlers’ inhalation exposure and risk
assessment is protective of post-application exposure and risk.  All
post-application dermal and oral scenarios associated with turf and
indoor crack and crevice uses resulted in MOEs greater than 100 and are
not of concern.

A revised combined residential assessment based on indoor crack and
crevice use was performed in the July 2009 thiamethoxam residential
assessment (M. Collantes, July 2009, D359462).   HED combined all
non-dietary sources of post-application exposure to obtain an estimate
of potential combined residential exposure.  All combined
post-application scenarios resulted in MOEs greater than 100 and were
not of concern.  These exposures and risks were greater than
exposure/risk from the use on lawns.  Therefore, the indoor exposures
should be used in an aggregate assessment in order to be protective.  A
summary of the combined residential exposures is provided in Table 4.

Spray drift is always a potential source of exposure to residents nearby
to spraying operations.  This is particularly the case with aerial
application, but, to a lesser extent, could also be a potential source
of exposure from the ground application method employed for
thiamethoxam.  The Agency has been working with the Spray Drift Task
Force, EPA Regional Offices and State Lead Agencies for pesticide
regulation and other parties to develop the best spray drift management
practices.  The Agency is now requiring interim mitigation measures for
aerial applications that must be placed on product labels/labeling.  The
Agency has completed its evaluation of the new database submitted by the
Spray Drift Task Force, a membership of U.S. pesticide registrants, and
is developing a policy on how to appropriately apply the data and the
AgDRIFT computer model to its risk assessments for pesticides applied by
air, orchard airblast and ground hydraulic methods.  After the policy is
in place, the Agency may impose further refinements in spray drift
management practices to reduce off-target drift and risks associated
with aerial as well as other application types where appropriate.

 Table 4.  Combined Residential Exposure and Risk Estimates from the
Indoor Crack and Crevice Use.

Post-application

Scenarios	Daily Dose

(mg/kg/day) 1	MOE 2	Combined

MOE 3

Short-term

Adult Dermal – indoor surface	0.0027	430	430

Toddler Dermal - indoor surface	0.08	750

610

Hand-to-Mouth	0.00267	3100

	Intermediate-term

Adult Dermal - indoor surface	0.027	430	430

Toddler Dermal - indoor surface	0.08	750

680

Hand-to-Mouth	0.001267	6500

		1.  Daily Dose = see Tables <IP_ADDRESS> and <IP_ADDRESS>

	2.  Adult Dermal MOE = NOAEL (1.2 mg/kg/day)	Child Dermal MOE = NOAEL
(60 mg/kg/day)

       		 Dermal Dose					Dermal Dose

	      Hand-to-Mouth MOE = NOAEL (8.23 mg/kg/day)

			Oral Dose

	3.  Toddler Combined MOE = 1/ [(1/MOEDermal) + (1/MOEHand-to-Mouth)]

  SEQ CHAPTER \h \r 1 5.0.	OCCUPATIONAL EXPOSURE

This assessment only covers commercial handlers (loader/applicator,
sewer, bagger, and multiple activities worker).  HED generally relied on
the seed treatment policies and standard assumptions to evaluate
occupational exposure.

5.1   Handlers

Based on the proposed use pattern, pesticide handlers will be exposed
to thiamethoxam when they perform seed treatment activities.

Equations/Calculations

HED uses standard equations when estimating handler exposure during seed
treatments.  Exposure is based on the application rate and the amount of
seed treated per day.  The following equations were used to calculate
handler exposure and risk:

Dermal Dose (mg/kg/day) 	=	Rate (lb ai/lb seed) x UE (mg/lb ai) x DA x
lb. Treated (lb/day)

BW (kg)

Inhalation Dose (mg/kg/day)	=	 Rate (lb ai/lb seed) x UE (mg/lb ai) x
lb. Treated (lb/day)

        BW (kg)

Where:

Rate (Application Rate)		=	Maximum application rate on product label (lb
ai/lb seed)

UE (Unit Exposure)		=	Exposure value derived from Exposure SAC Policy
#14; May 1, 2003

DA (dermal absorption factor)	=	Factor to account for dermal absorption
(5%) when POD is selected from an oral study.

lb. Treated			=	Maximum number of pounds (of seeds) treated per day

                             (lb/day)

BW				=	Body weight (60 kg)

Combined Daily Dose (mg/kg/day) 	=	Dermal Dose (mg/kg/day) + Inhalation
Dose (mg/kg/day)

MOE	                                                         =
 NOAEL (1.2 mg/kg/day)

             Combined Daily Dose (mg/kg/day)

Exposure Scenarios

There are four handler scenarios that are typically assessed by HED and
are expected to result in the highest exposure for the proposed use:

Loading (Open)/Applying Water Soluble Bags for Seed Treatment (Scenario
1)

Sewing Bags after Seed Treatment (Scenario 2)

Bagging Seeds after Seed Treatment (Scenario 3)

Multiple Activities Worker for Seed Treatment (Scenario 4)

Application Rate

The maximum application rate listed on the proposed label provided by
the Registration Division was used for all exposure assessments.  The
maximum rate for treating bulb onion seeds is 0.06 lb ai/lb seed.

Treating Capacity

The treating capacity, which is the amount of seed treated per day in a
commercial seed treatment facility, was based on the data shown in the
Science Advisory Council for Exposure (Exposure SAC) Policy #15 or in
HED’s previous documents.  The following treating capacities were used
to assess seed treatment handlers:

5,500  lbs/day for film-coated treatment of vegetable seeds (HED
standard assumption);

300 lbs/day for pelletized seed treatment (as used in previous
assessment; M. Collantes, 11/12/08, D 354886)

Body Weight

The average adult female weight of 60 kg was used for estimating dermal
and inhalation exposure

Because the endpoint selected for risk assessment was based on
testicular effects in male pups (F1generation) seen in two different
2-generation reproductive studies in the rat.   Because these effects
could have been due to in utero exposure, the female body weight is used
in order to be protective of these effects.

Exposure Frequency/Duration

No data on the number of exposure days per year was provided.  Due to
the seasonal nature of seed treatment operation, it was assumed that
handlers would be exposed for less than 6 months per year (i.e.
short-/intermediate-term durations).

Unit Exposures

The unit exposures used for assessing seed treatment risks were based on
the exposure data (Table 5) obtained from the Exposure SAC Policy #14:
Standard Operating Procedures (SOP) for Seed Treatment (May 1, 2003).
The one exception is the substitution of the loader/operator exposure
estimates recommended in Policy #14 with the unit exposures given for
loader/applicator for the water soluble packets formulation in the PHED
(because the product being evaluated is water soluble bags, not liquid).

                Table 5.  Unit Exposure Values from Exposure SAC Policy
#14.

Scenario

Dermal (mg/lb ai)

Inhalation (mg/lb ai)

PPE Level

Loader/Operator

0.0098

0.00024

single layer, glove

Sewer

0.0062

0.00023

single layer, no glove

Bagger

0.0091

0.00016

single layer, no glove

Multiple Activities

0.042

0.0016

single layer, glove

                 The unit exposures for loader/operator are substituted
with those for water soluble packets in the PHED.

Handlers’ Exposure and Risk

With the exception of the multiple activities scenario using HED’s
standard assumption regarding the amount of seed treated per day (5,500
lbs treated/day, MOE=59), the potential occupational exposures/risks
resulting from the proposed use do not exceed the HED level of concern
(MOEs range from 300 to 7,400).

According to the label, loader/applicator must wear personal protective
equipment (PPE) consisting of a single layer of clothing plus
chemical-resistant gloves and dust mask; workers conducting sewer and
bagger activities must wear a single layer of clothing plus
chemical-resistant gloves.  The multiple task workers must wear (1) a
single layer of clothing, (2) chemical-resistant gloves, (3) dust mask,
and (4) chemical-resistant coveralls.  Thus, the MOE of 59 for the
multiple activities scenario is a very conservative estimate because it
was based on single layer plus gloves protection.  If dust mask and
coveralls are added to the single layer plus gloves protection, the
exposure for multiple task workers may not be of concern.

In addition, the MOE of 59 for the multiple activities scenario is based
on the unit of exposure for liquid product, and the product being
evaluated here is a wettable powder packaged in water soluble packets;
the use of water soluble packaging is considered to be an engineering
control measure which can provide more than 50% reduction in exposure,
because the unit exposure is approximately 2X lower than the unit
exposure for a liquid (see below).  Since a significant portion of the
exposure in the multiple activities scenario is likely a result of
mixer/loader exposure, the MOE of 59 is not of concern in light of the
use of water soluble packaging

Note:  The significance of using water soluble packets in exposure
reduction:

●   PHED unit exposure for mixing/loading liquid product

      = 0.023 + 0.0012 = 0.0242 mg/lb ai handled

●   PHED unit exposure for mixing/loading water soluble packet product

      = 0.0098 + 0.00024 = 0.01004 mg/lb ai handled

A summary of the exposures and risks for handlers is presented in Table
6.

If the Registration Division considers it appropriate, additional label
language can be added to minimize the chance that the LOC of 100 is
exceeded for multiple activities workers.  In this case, the label
should indicate that the maximum amount of CRUISER® 70WS Insecticide
that can be used to treat bulb onion seed in a seed treatment facility
is 260 lbs per production line per 8-hour work shift (based on the MOE
calculated for treating 3,000 lbs seed per day; MOE for multiple
activities worker = 110).  This requires that a worker perform tasks
associated with seed treatment only on one production line per 8-hour
shift and the worker works no more than one 8-hour shift per 24 hour
period.

The handler exposure estimates in this assessment are based on a central
tendency estimate of unit exposure and an upper-percentile assumption
for the application rate, and are assumed to be representative of
high-end exposures.  The uncertainties associated with this assessment
stem from the assumptions regarding that amount of chemical handled and
the amount of seed treated per day.  The estimated exposures are
believed to be reasonable high-end estimates based on observations from
field studies and professional judgment.

5.2  Secondary Seed Handlers  tc \l2 "5.2.2  Post-application

Scenario and Unit Exposure

The exposure scenario for secondary seed handlers from treated seeds
consists of the farmer purchasing bags of treated seeds, placing the
seeds in the hopper, and planting seeds in fields.  The exposure
associated with handling treated seeds was calculated using unit
exposures given in the HED Exposure Science Advisory Council (ExpoSAC)
Policy #14 (May 1, 2003).

Assumptions and Factors

Unit exposure is based on HED Exposure SAC Policy #14 (dermal unit
exposure = 0.25 mg/lb ai; inhalation unit exposure  = 0.0034 mg/lb ai)

Amount of seed planted per day (lb seed/day) is based on the data shown
in HED Exposure SAC Policy # 15 (400 lb/day) or based on the amount
provided by Syngenta (240 lb/day) (provided thru an e-mail from Patrick
McCain of Syngenta to Julie Chao, 1/19/2010)..

Exposure frequency = 60 days/year and 8 hour/day exposure

Body weight  = 60 kg

Dermal absorption (DA) = 5%, inhalation absorption = 100%

Equations and Calculations

Daily Dermal Dose 	= Dermal UE x Amount of Seed Planted/day x
Application Rate x DA

Body Weight (kg)

Daily Inhalation Dose      = Inhalation UE x Amount of Seed Planted/day
x Application Rate

Body Weight (kg)

              Combined Daily Dose Dose (mg/kg/day) = Daily Dermal Dose +
Daily Inhalation Dose

MOE		 =	 NOAEL (1.2 mg/kg/day)

                                                          Combined Daily
Dose (mg/kg/day)

Secondary Seed Handler’s Exposure and Risk

All MOEs for secondary seed handlers are greater than 100 and do not
exceed HED’s level of concern at the single layer plus gloves level of
mitigation (190 or 310).  A summary of the exposure/risk values is
presented in Table 7.

The secondary seed handler’s exposure estimates in this assessment are
based on a central tendency estimate of unit exposure, upper-percentile
assumptions for the application rate, and a conservative estimate of
exposure frequency; and are assumed to be representative of high-end
exposures.  The uncertainties associated with this assessment stem from
the use of surrogate exposure data (e.g., differences in use scenario
and data confidence) and assumptions regarding that amount of chemical
handled.  The estimated exposures are believed to be reasonable high-end
estimates based on observations from field studies and professional
judgment.

Restricted Entry Interval

The restricted entry interval (REI) is based on the acute dermal
toxicity, eye irritation and skin irritation effects of the active
ingredient.  The thiamethoxam technical material is classified as
Category III for acute oral and Category IV for acute dermal and eye
irritation.  Thiamethoxam is not a dermal sensitizer.  Acute toxicity
categories III and IV chemicals require a 12-hour REI.

The Worker Protection Standard (WPS) allows workers to enter treated
areas without restriction if there will be no contact with anything that
has been treated with the pesticide.  For purposes of seed treatment,
once the seeds are planted, workers can enter during the REI, provided
they do not contact the soil/media subsurface that contains the treated
seeds.  Certain tasks may involve contact with the soil subsurface (e.g.
repair of certain irrigation equipment) and they are covered by the REI.
 Therefore, a 12-hour REI on the proposed label is required.

6.0         SEQ CHAPTER \h \r 1 REVIEW OF HUMAN RESEARCH

This risk assessment relies in part on data from studies in which adult
human subjects were         intentionally exposed to a pesticide or
other chemical.  These studies, which comprise the Pesticide Handlers
Exposure Database (PHED) have been determined to require a review of
their ethical conduct, and have received that review. The studies in
PHED were considered appropriate (or ethically conducted) for use in
risk assessments.

Table 6.  Thiamethoxam Non-Cancer Risk for Seed-Treatment Handlers.

Exposure Scenario (Scenario #)

Mitigation Level

Dermal Unit Exposure (mg/lb ai)

Inhalation Unit Exposure   (mg/lb ai)

Seed Species

Application Rate

(lb ai  per lb seed)

Amount Treateda

(lb seed trt per day)

Daily

Dermal

Dose b (mg/kg/day)

Daily

Inhalation

Dosec (mg/kg/day)

Combined Daily Dosed  (mg/kg/day)

MOEe

Loader/Applicator

Loading/Applying

Water soluble bags  for Seed Treatment (1)	Single Layer, Gloves	0.0098
0.00024	Onion (bulb)	0.06	5,500	0.002695	0.00132	0.004015	300

300	0.00015	0.000072	0.000222	5,400

Sewer

Sewing Bags after Seed treatment (2)	Single Layer,

No Gloves	0.0062	0.00023	Onion (bulb)	0.06	5,500	0.001705	0.001265
0.00297	400

300	0.000093	0.000069	0.000162	7,400

Bagger

Bagging Seeds after Seed treatment (3)	Single Layer,

No Gloves	0.0091	0.00016	Onion (bulb)	0.06	5,500	0.002503	0.00088
0.003383	360

300	0.000136	0.000048	0.000184	6,500

Multiple Activities Worker

Multiple Activities for Seed treatment (4)	Single Layer, Gloves	0.042
0.0016	Onion (bulb)	0.06	5,500	0.01155	0.0088	0.02035	59

300	0.000631	0.00048	0.001111	1,100

a	Daily amounts treated values are based on exposure SAC Policy #15 or
the information provided by the Registrant through Registration
Division.  5,500 for film-coated treatment,

                  300 for pelletizing treatment.

b	Daily dermal dose (mg/kg/d) =  [unit dermal exposure (mg/lb ai) *
dermal absorption (0.05) * application rate (lb ai/lb seed) * daily
amounts treated] /  body weight (60 kg).

c	Daily inhalation dose (mg/kg/d) = [unit exposure (mg/lb ai) *
application. rate (lb ai/lb seed) * daily amounts treated] / body weight
(60 kg).

d	Combined daily dose (mg/kg/d) =  Daily dermal dose (mg/kg/d) + Daily
inhalation dose (mg/kg/d).

e	MOE = NOAEL (1.2  mg/kg/d) / combined daily dose.  UF = 100.

Table 7.  Thiamethoxam Non-Cancer Risk for Secondary Seed Handlers.

Exposure Scenario (Scenario #)

Mitigation Level

Dermal Unit Exposure (mg/lb ai)

Inhalation Unit Exposure   (mg/lb ai)

Seed Species

Application Rate

(lb ai  per lb seed)

Amount Planteda

(lb seed pnted/day)

Daily

Dermal

Dose b (mg/kg/day)

Daily

Inhalation

Dosec (mg/kg/day)

Combined Daily Dosed (mg/kg/day)

MOEe

Secondary Seed Handlers

Secondary Seed Handlers: planting seeds in the field	Single Layer,
Gloves	0.25	0.00342	Onion (bulb)	0.06	400	0.005	0.00136	0.00636	190

240	0.003	0.000816	0.003816	310

a	Daily amounts planted values are based on exposure SAC Policy #15 or
the information provided by the Registrant through Registration
Division.

b	Daily dermal dose (mg/kg/d) =  [unit dermal exposure (mg/lb ai) *
dermal absorption (0.05) * application rate (lb ai/lb seed) * daily
amounts treated] /  body weight (60 kg).

c	Daily inhalation dose (mg/kg/d) = [unit exposure (mg/lb ai) *
application. rate (lb ai/lb seed) * daily amounts treated] / body weight
(60 kg).

d	Combined daily dose (mg/kg/d) =  Daily dermal dose (mg/kg/d) + Daily
inhalation dose (mg/kg/d).

e	MOE = NOAEL (1.2 mg/kg/d) / combined daily dose.  UF = 100.

CC:   RAB2 RF, D. McNeilly, S. Wang

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