[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Rules and Regulations]
[Pages 38976-38981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16989]



40 CFR Part 180

[EPA-HQ-OPP-2017-0352; FRL-9978-83]

Spinetoram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
spinetoram in or on tea, dried and tea, instant. Dow AgroSciences, 
LLC., requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 8, 2018. Objections and 
requests for hearings must be received on or before October 9, 2018, 
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-2017-0352, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP

[[Page 38977]]

Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

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


I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0352 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 
October 9, 2018. 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-2017-0352, 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 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 23, 2017 (82 FR 49020) (FRL-
9967-37), 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 
7E8554) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, 
Indiana 46268-1054. The petition requested that 40 CFR 180.635 be 
amended by establishing tolerances for residues of the insecticide 
spinetoram, in or on tea, dried at 70 parts per million (ppm) and tea, 
instant at 70 ppm. That document referenced a summary of the petition 
prepared by Dow AgroSciences, the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
    Consistent with 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 spinetoram including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with spinetoram 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. Spinetoram and spinosad are considered by EPA to be 
toxicologically identical for human health risk assessment based on 
their very similar chemical structures and similarity of the 
toxicological databases for currently available studies, therefore, the 
Agency has assessed and summarized the toxicological profile for both 
together. The primary toxic effect observed from exposure to spinetoram 
and spinosad was histopathological changes in multiple organs (specific 
target organs were not identified). Vacuolization of cells and/or 
macrophages was the most common histopathological finding noted across 
the toxicological database with the dog being the most sensitive 
species. In addition to the numerous organs observed with 
histopathological changes, anemia was noted in several studies. There 
was no evidence of increased quantitative or qualitative susceptibility 
from spinetoram or spinosad exposure. In developmental studies, no 
maternal or developmental effects were seen in rats or rabbits. In the 
rat reproduction toxicity studies, offspring toxicity (decreased litter 

[[Page 38978]]

survival, and body weights with spinosad; increased incidence of late 
resorptions and post-implantation loss with spinetoram) was seen in the 
presence of parental toxicity (increased organ weights, mortality, and 
histopathological findings) at approximately the same dose for both 
chemicals. Dystocia and/or other parturition abnormalities were 
observed with both spinetoram and spinosad in the reproduction toxicity 
studies. There was no evidence of neurotoxicity, immunotoxicity, or 
carcinogenicity from spinetoram exposure.
    Specific information on the studies received and the nature of the 
adverse effects caused by spinetoram as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Spinosad/Spinetoram. Human Health 
Risk Assessment in Support of Proposed Spinetoram Tolerance for 
Residues in/on Imported Tea'' at page 8 in docket ID number EPA-HQ-OPP-
2017-0352 and in document ``Spinosad/Spinetoram. Draft Human Health 
Risk Assessment for Registration Review,'' at pages 12-17 in docket ID 
number EPA-HQ-OPP-2011-0666.

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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    Spinetoram and spinosad should be considered toxicologically 
identical in the same manner that metabolites are generally considered 
toxicologically identical to the parent. As a result, studies from both 
toxicological databases were considered for endpoint selection.
    A summary of the toxicological endpoints for spinetoram used for 
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Spinetoram/Spinosad for Use in Human Health Risk
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
Acute dietary (All populations)..       A dose and endpoint of concern attributable to a single dose was not
Chronic dietary (All populations)  NOAEL = 2.49 mg/kg/   Chronic RfD =        Chronic Toxicity--Dog
                                    day.                  0.0249 mg/kg/day.    (Spinetoram).
                                   UFA = 10x...........  cPAD = 0.0249 mg/kg/ LOAEL = 5.36/5.83 mg/kg/day (males/
                                   UFH = 10x...........   day.                 females) based on arteritis and
                                   FQPA SF = 1x........                        necrosis of the arterial walls of
                                                                               the epididymides in males and of
                                                                               the thymus, thyroid, larynx, and
                                                                               urinary bladder in females.
Incidental oral short-term (1 to   NOAEL = 4.9 mg/kg/    Residential LOC for  Subchronic Oral Toxicity--Dog
 30 days) and intermediate-term     day.                  MOE <100.            Study (with spinosad).
 (1 to 6 months).                  UFA = 10x...........                       LOAEL = 9.73 mg/kg/day based on
                                   UFH = 10x...........                        microscopic changes in multiple
                                   FQPA SF = 1x........                        organs, clinical signs of
                                                                               toxicity, decreases in body
                                                                               weights and food consumption, and
                                                                               biochemical evidence of anemia
                                                                               and liver damage.
Dermal (All durations)...........     No hazard was identified for dermal exposure; therefore, a quantitative
                                                          dermal assessment is not needed.
Inhalation short-term (1 to 30     Inhalation (or oral)  Residential LOC for  Subchronic Oral Toxicity--Dog
 days) and Intermediate-Term (1-6   study NOAEL = 4.9     MOE <100.            Study (with spinosad).
 months).                           mg/kg/day                                 LOAEL = 9.73 mg/kg/day based on
                                    (inhalation assumed                        microscopic changes in multiple
                                    equivalent to oral).                       organs, clinical signs of
                                   UFA = 10x...........                        toxicity, decreases in body
                                   UFH = 10x...........                        weights and food consumption, and
                                   FQPA SF = 1x........                        biochemical evidence of anemia
                                                                               and liver damage.
Cancer (Oral, dermal, inhalation)            Classified as ``not likely to be carcinogenic to humans.''
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spinetoram and spinosad, EPA considered exposure under the 
petitioned-for tolerances as well as all existing spinetoram tolerances 
in 40 CFR 180.635 as well as existing spinosad tolerances. With the 

[[Page 38979]]

of tea, spinosad is registered for application to all of the same crops 
as spinetoram, with similar pre-harvest and retreatment intervals, and 
application rates greater than or equal to spinetoram. Further, both 
active ingredients control the same pest species. For this reason, EPA 
has concluded it would overstate exposure to assume that residues of 
both spinosad and spinetoram would appear on the same food. The risk 
assessment included commodities that have tolerances for both spinosad 
and spinetoram as well as commodities where only spinosad tolerances 
are established. EPA aggregated exposure by assuming that all 
commodities, with the exception of tea, contain spinosad (because side-
by-side spinetoram and spinosad residue data indicated that spinetoram 
residues were less than or equal to spinosad residues); for tea, EPA 
assumed spinetoram residues were present. EPA assessed dietary 
exposures from spinetoram 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. No such effects were 
identified in the toxicological studies for spinetoram or spinosad; 
therefore, a quantitative acute dietary exposure assessment is 
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA (2003-2008). As to residue levels in food, EPA assumed 100 
percent crop treated (PCT), average field-trial residues or tolerance-
level residues for crop commodities, average residues from the 
livestock feeding studies, spinosad residue estimates for fish/
shellfish (residues of spinetoram in fish/shellfish are expected to be 
insignificant), and experimental or default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that spinetoram does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use PCT information in the dietary assessment for 
spinetoram. 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 spinetoram and spinosad in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of spinetoram and spinosad. Further 
information regarding EPA drinking water models used in pesticide 
exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the surface water concentration calculator (SWCC) and 
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of spinetoram for acute exposures 
are estimated to be 25.9 parts per billion (ppb) for surface water and 
below the levels of detection for ground water. For chronic exposures 
for non-cancer assessments, the spinetoram EDWCs are estimated to be 
19.3 ppb for surface water and well below the levels of detection for 
ground water. EDWCs of spinosad for acute exposures are estimated to be 
30.6 ppb for surface water and below the levels of detection for ground 
water. For chronic exposures for noncancer assessments, the spinetoram 
EDWCs are estimated to be 22.8 ppb for surface water and below the 
levels of detection for ground water.
    Modeled estimates of drinking water concentration were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 22.8 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    EPA assessed residential exposure using the following assumptions: 
The use on tea will not result in residential exposure; however, 
spinetoram and spinosad are currently registered for uses that could 
result in residential exposures including home lawns and pet (cats/
kittens) spot-on applications; therefore, there is potential for 
residential handler and post-application exposures to both spinetoram 
and spinosad. Since spinosad and spinetoram control the same pests, EPA 
concludes that these products will not be used for the same uses in 
combination with each other and thus combining spinosad and spinetoram 
residential exposures would overstate exposure. EPA assessed 
residential exposure for both spinosad and spinetoram using the most 
conservative residential exposure scenarios for either chemical.
    EPA assessed the following ``worst-case'' residential exposure 
scenarios as: (1) Adult residential handler (inhalation exposure from 
applications to lawns and turf) and (2) child (1-<2 years) (hand-to-
mouth exposures from post-application exposure to turf). Because EPA's 
level of concern for spinetoram is a MOE below 100, the MOEs for both 
of these residential exposure scenarios are not of concern. In 
addition, the short-term assessment is protective of intermediate-term 
exposure as the short- and intermediate-term PODs are identical. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found spinetoram to share a common mechanism of 
toxicity with any other substances, and spinetoram does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
spinetoram 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.

[[Page 38980]]

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 
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased prenatal or postnatal susceptibility.
    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 
    i. The toxicity database for spinetoram is adequate for FQPA SF 
    ii. There is no evidence of neurotoxicity from spinetoram exposure.
    iii. There is no evidence that spinetoram results in increased pre- 
or post-natal susceptibility in rats or rabbits.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (protective) assumptions in assessing 
exposures and these assessments will not underestimate the exposure and 
risks posed by spinetoram.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
spinetoram is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
spinetoram from food and water will utilize 72% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
spinetoram is not expected; therefore, the chronic dietary estimate 
represents the chronic aggregate estimate.
    3. Short- and Intermediate-term risk. Short- and Intermediate-term 
aggregate exposures takes into account short-term and intermediated-
term residential exposures plus chronic exposure to food and water 
(considered to be a background exposure level). Spinetoram is currently 
registered for uses that could result in short- and intermediate-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short- and intermediate-term residential exposures to spinetoram.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 780 for adults 
(handler) and 200 for children (post-application). Because EPA's level 
of concern for spinetoram is a MOE below 100, these MOEs are not of 
concern. In addition, the short-term assessment is protective of 
intermediate-term exposure as the short- and intermediate-term PODs are 
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, spinetoram is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to spinetoram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available for both plant and 
livestock commodities. Method GRM 05.03 (HPLC/MS/MS) is an acceptable 
method for the determination of spinetoram residues in a variety of 
crops. Methods GRM 05.15 and GRM 06.08 (HPLC/MS) are acceptable methods 
for determination of spinetoram residues in bovine and poultry tissues, 
milk, cream, and eggs. Both methods are available to enforce the 
tolerance expression.
    The methods 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: 

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for spinetoram.

V. Conclusion

    Therefore, tolerances are established for residues of spinetoram, 
expressed as the combined residues of XDE-175-J: 1-H-as-indaceno[3,2-
d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-
(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl] oxy]-9-ethyl-
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro 14-methyl-, 
(2R,3aR,5aR,5bS,9S,13S, 14R,16aS,16bR); XDE-175-L: 1H-as-indaceno[3,2-
d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); ND-J: 

[[Page 38981]]

d]oxacyclododecin-2-yl 6-deoxy-3-O-ethyl-2,4-di-O-methyl-[alpha]-L-
mannopyranoside; and NF-J: (2R,3S,6S)-6-
methyl-[alpha]-L-mannopyranosyl) oxy]-9-ethyl-14-methyl-7,15-dioxo-
3-yl(methyl)formamide, in or on tea, dried at 70 parts per million 
(ppm) and tea, instant at 70 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or 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 tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: July 24, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.635 add alphabetically the entries for ``Tea, dried''; 
and ``Tea, instant''; and footnote 1 to the table in paragraph (a) to 
read as follows:

Sec.  180.635   Spinetoram; tolerances for residues.

    (a) * * *

                                                             Parts per
                        Commodity                             million
                                * * * * *
Tea, dried \1\..........................................              70
Tea, instant \1\........................................              70
                                * * * * *
\1\ There are no U.S. registrations as of August 8, 2018 for use on tea.

* * * * *
[FR Doc. 2018-16989 Filed 8-7-18; 8:45 am]