[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Rules and Regulations]
[Pages 49195-49201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19664]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0525; FRL-9995-90]


Spinosad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
spinosad 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 September 19, 2019. Objections and 
requests for hearings must be received on or before November 18, 2019, 
and must be filed in accordance with the instructions provided in 40 
CFR part

[[Page 49196]]

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-2018-0525, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2018-0525 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 
November 18, 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-2018-0525, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 24, 2018 (83 FR 42818) (FRL-9982-
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 
8E8674) by Dow Agro Sciences LLC, 9330 Zionsville Road, Indianapolis, 
Indiana 46268-1054. The petition requested that 40 CFR 180.495 be 
amended by establishing import tolerances for residues of the 
insecticide spinosad, determined by measuring two related active 
ingredients: Spinosyn A (Factor A: CAS #131929-60-7) or 2-[(6-deoxy-
2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-
(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; 
CAS #131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-manno-
pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-
yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-
4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione], 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 Agro 
Sciences LLC, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received in response to the notice 
of filing, and the Agency's response can be found in Unit IV.D.
    Based upon review of the data supporting the petition, EPA has 
established import tolerances for tea, dried and tea, instant each at 2 
ppm rather than the requested 70 ppm. The reason for this change is 
explained in Unit IV.C.

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 spinosad

[[Page 49197]]

including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with 
spinosad 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.
    Spinosad and spinetoram 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 spinosad and spinetoram 
together. The primary toxic effect observed from exposure to spinosad 
and spinetoram 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 spinosad or spinetoram 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 
size, 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 spinosad and spinetoram in the 
reproduction toxicity studies. There was no evidence of neurotoxicity, 
immunotoxicity, or carcinogenicity from spinosad exposure.
    Specific information on the studies received and the nature of the 
adverse effects caused by spinosad 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.
    A summary of the toxicological endpoints for spinosad used for 
human risk assessment is shown in the Table of this unit.

    Table--Summary of Toxicological Doses and Endpoints for Spinosad/Spinetoram for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                    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
                                                                      observed.
----------------------------------------------------------------------------------------------------------------
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). LOAEL =
 (1 to 6 months).                  UFA = 10x...........                        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     study NOAEL = 4.9     MOE <100.            Study (with spinosad).
 to 6 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.
----------------------------------------------------------------------------------------------------------------

[[Page 49198]]

 
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). UUFH = 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 spinosad, EPA considered exposure under the petitioned-for 
tolerances as well as all existing spinosad tolerances in 40 CFR 
180.495 and existing spinetoram tolerances in 40 CFR 180.635. 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. Because both active 
ingredients control the same pest species, 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 includes 
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 contain spinosad 
residues as either average field-trial residues; tolerance-level 
residues for crop commodities; spinosad residue estimates for fish/
shellfish (spinetoram residues in fish/shellfish are expected to be 
insignificant); experimental or default processing factors; and refined 
milk, egg, and ruminant/hog/poultry tissue spinosad residue estimates. 
EPA assessed dietary exposures from spinosad 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 spinosad or spinetoram; 
therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    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) for all commodities; average spinosad field-
trial residues or tolerance-level residues for crop commodities 
(spinosad or spinetoram residues whichever was higher, assumed that 
crop will not be treated with both spinosad and spinetoram as they 
control the same pests); spinosad residue estimates for fish/shellfish 
(spinetoram residues in fish/shellfish are expected to be 
insignificant); spinetoram tea tolerance (established 70 ppm tea 
tolerance is higher than the petitioned-for spinosad tea tolerance); 
experimental or default processing factors; and refined milk, egg, and 
ruminant/hog/poultry tissue spinosad residue estimates.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that spinosad 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. 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 spinosad and spinetoram in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of spinosad and spinetoram. 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 spinosad for chronic exposures 
for non-cancer assessments, the spinosad EDWCs are estimated to be 22.8 
ppb for surface water and below the levels of detection for ground 
water. EDWCs of spinetoram for chronic exposures for non-cancer 
assessments are estimated to be 19.3 ppb for surface water and below 
the levels of detection for ground water. Modeled estimates of drinking 
water concentrations 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).
    The use on tea will not result in residential exposure; however, 
spinosad and spinetoram are currently registered for the following 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 spinosad 
and spinetoram 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 to <2 years) (hand-to-
mouth exposures from post-

[[Page 49199]]

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 spinosad to share a common mechanism of toxicity 
with any other substances, and spinosad does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that spinosad does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. 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 
findings:
    i. The toxicity database for spinosad is complete for FQPA SF 
consideration.
    ii. There is no evidence of neurotoxicity from spinosad exposure.
    iii. There is no evidence that spinosad results in increased pre- 
or post-natal susceptibility in rats or rabbits.
    iv. There are no residual uncertainties identified in the spinosad 
and spinetoram exposure databases. The dietary exposure assessment is 
conservative as it assumes 100 PCT and residue estimates are based on 
field trial data and fish nature of the residue studies. Moreover, EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to spinosad and spinetoram in 
drinking water. EPA used similarly conservative assumptions to assess 
post-application exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by spinosad and 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, 
spinosad 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 
spinosad from food and water will utilize 72% of the cPAD for children 
1 to 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 spinosad is not 
expected; therefore, the chronic dietary estimate represents the 
chronic aggregate estimate.
    3. Short- and Intermediate-term risk. Short-term aggregate exposure 
takes into account short-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Spinosad is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to spinosad.
    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 spinosad are MOEs below 100, these MOEs are not of 
concern. The short-term assessment is protective of intermediate-term 
exposure as the short- and intermediate-term PODs are identical.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, spinosad 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 spinosad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate plant, ruminant, poultry, fish, and shellfish methods 
(high-performance liquid chromatography (HPLC)/ultraviolet (UV)) are 
available for enforcement of the established spinosad tolerances. These 
methods were forwarded to the Food and Drug Administration (FDA) for 
inclusion in Pesticide Analytical Methods Volume II. Additional details 
on the analytical methods can be found in the supporting documentation 
in docket ID (EPA-HQ-OPP-2011-0667-0027).
    Methods not found in PAM Vol II 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

[[Page 49200]]

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.
    An MRL for spinosad in/on tea has not been established by Codex.

C. Revisions to Petitioned-For Tolerances and Tolerance Definition

    The registrant indicated that the proposed 70 ppm tolerances for 
tea, dried and tea, instant were based on translation of the recently 
established spinetoram tolerances on import tea to spinosad. However, 
based on the available residue data and the different application 
scenarios for spinosad and spinetoram, this translation is not 
appropriate. Based on the available data, EPA determined that import 
tolerances for residues of spinosad in or on tea, dried and tea, 
instant at 2 ppm are appropriate.
    Additionally, the tolerance definition has been updated as shown in 
the part 180 Amendment to be consistent with Chemical Abstracts Service 
(CAS) Nomenclature.

D. Response to Comments

    One comment was submitted opposing sale or use of Dow's product in 
the United States. This tolerance action does not permit sale or use of 
spinosad pesticide products in the United States; sale and use of 
pesticide products are regulated under the Federal Insecticide, 
Fungicide, and Rodenticide Act. Moreover, the commenter provided no 
information to support a conclusion that this tolerance is not safe.

V. Conclusion

    Therefore, tolerances are established for residues of spinosad, 
determined by measuring two related active ingredients: Spinosyn A 
(Factor A: CAS #131929-60-7; (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-
[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-mannopyranosyl)oxy]-13-
[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-
ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-
1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione); and Spinosyn D 
(Factor D; CAS #131929-63-0; (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-
[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-mannopyranosyl)oxy]-13-
[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-
ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-
dimethyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione), in or on 
tea, dried at 2 ppm and tea, instant at 2 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: August 28, 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.


[[Page 49201]]



0
 2. In Sec.  180.495, amend paragraph (a) by revising the introductory 
text and adding alphabetically the entries for ``Tea, dried''; and 
``Tea, instant'' to the table to read as follows:


Sec.  180.495  Spinosad; tolerances for residue.

    (a) General. Tolerances are established for residues of the 
insecticide spinosad, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
spinosyn A (Factor A: CAS #131929-60-7; 
(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-
[alpha]-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
indaceno[3,2-d]oxacyclododecin-7,15-dione); and Spinosyn D (Factor D; 
CAS #131929-63-0) or (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-[(6-deoxy-
2,3,4-tri-O-methyl-[alpha]-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-
1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione), calculated as the 
stoichiometric equivalent of spinosad.

------------------------------------------------------------------------
                                                              Parts  per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Tea, dried \1\..............................................           2
Tea, instant \1\............................................           2
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for use on tea.

* * * * *
[FR Doc. 2019-19664 Filed 9-18-19; 8:45 am]
BILLING CODE 6560-50-P