[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Rules and Regulations]
[Pages 49195-49201]
[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

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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2018-0525 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

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.
----------------------------------------------------------------------------------------------------------------

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-

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:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with

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

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