Sulfoxaflor; Pesticide Tolerances, 35546-35555 [2019-15648]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 84, Number 142 (Wednesday, July 24, 2019)]
[Rules and Regulations]
[Pages 35546-35555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://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

[[Page 35547]]

Public Reading Room is (202) 566-1744, and the telephone number for the 
OPP Docket is (703) 305-5805. Please review the visitor instructions 
and additional information about the docket available at https://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: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing Office's e-CFR site at https://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: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://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, 
https://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

[[Page 35548]]

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, https://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 https://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 https://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).

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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.
                                  ------------------------------------------------------------------------------
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 https://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

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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 https://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

[[Page 35551]]

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: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    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,

[[Page 35552]]

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,

[[Page 35553]]

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:

[[Page 35554]]

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

[[Page 35555]]

 
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