83_FR_39129 83 FR 38976 - Spinetoram; Pesticide Tolerances

83 FR 38976 - Spinetoram; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 153 (August 8, 2018)

Page Range38976-38981
FR Document2018-16989

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).

Federal Register, Volume 83 Issue 153 (Wednesday, August 8, 2018)
[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Rules and Regulations]
[Pages 38976-38981]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16989]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

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


Spinetoram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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: [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 
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 
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 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 
size,

[[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
                                                   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).
 (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
  (intraspecies).

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 
exception

[[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 
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), 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 
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 spinetoram is adequate for FQPA SF 
consideration.
    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 
identical.
    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: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    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-
[alpha]-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(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-
[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- 
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); ND-J: 
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13 
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-

[[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-
([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-O-
methyl-[alpha]-L-mannopyranosyl) oxy]-9-ethyl-14-methyl-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-
indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-
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:

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.  180.635 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]
 BILLING CODE 6560-50-P



                                           38976            Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Rules and Regulations

                                                                                 SUBSTITUTES THAT ARE ACCEPTABLE SUBJECT TO USE CONDITIONS
                                              End-use         Substitute         Decision                                 Use conditions                                                      Further information

                                           Household re-    Isobutane (R-      Acceptable      As of September 7, 2018: ................................................   Applicable OSHA requirements at 29 CFR part 1910
                                             frigerators,     600a).             subject to    These refrigerants may be used only in new equipment                          must be followed, including those at 29 CFR 1910.106
                                             freezers,      Propane (R-          use condi-      designed specifically and clearly identified for the re-                    (flammable and combustible liquids), 1910.110 (stor-
                                             and com-         290).              tions.          frigerant (i.e., none of these substitutes may be used                      age and handling of liquefied petroleum gases),
                                             bination re-   R-441A .........                     as a conversion or ‘‘retrofit’’ refrigerant for existing                    1910.157 (portable fire extinguishers), and 1910.1000
                                             frigerators                                         equipment designed for a different refrigerant).                            (toxic and hazardous substances).
                                             and freezers                                      These refrigerants may be used only in a refrigerator or                    Proper ventilation should be maintained at all times dur-
                                             (New equip-                                         freezer, or combination refrigerator and freezer, that                      ing the manufacture and storage of equipment con-
                                             ment only).                                         meets all requirements listed in the 2nd edition of the                     taining hydrocarbon refrigerants through adherence to
                                                                                                 Underwriters Laboratories (UL) Standard for Safety:                         good manufacturing practices as per 29 CFR
                                                                                                 Household and Similar Electrical Appliances—Safe-                           1910.106. If refrigerant levels in the air surrounding
                                                                                                 ty—Part 2–24: Particular Requirements for Refrig-                           the equipment rise above one-fourth of the lower flam-
                                                                                                 erating Appliances, Ice-Cream Appliances and Ice-                           mability limit, the space should be evacuated and re-
                                                                                                 Makers, UL 60335–2–24, dated April 28, 2017.                                entry should occur only after the space has been
                                                                                                                                                                             properly ventilated.
                                                                                                                                                                           Technicians and equipment manufacturers should wear
                                                                                                                                                                             appropriate personal protective equipment, including
                                                                                                                                                                             chemical goggles and protective gloves, when han-
                                                                                                                                                                             dling these refrigerants. Special care should be taken
                                                                                                                                                                             to avoid contact with the skin since these refrigerants,
                                                                                                                                                                             like many refrigerants, can cause freeze burns on the
                                                                                                                                                                             skin.
                                                                                                                                                                           A Class B dry powder type fire extinguisher should be
                                                                                                                                                                             kept nearby.
                                                                                                                                                                           Technicians should only use spark-proof tools when
                                                                                                                                                                             working on refrigerators and freezers with these refrig-
                                                                                                                                                                             erants.
                                                                                                                                                                           Any recovery equipment used should be designed for
                                                                                                                                                                             flammable refrigerants.
                                                                                                                                                                           Any refrigerant releases should be in a well-ventilated
                                                                                                                                                                             area, such as outside of a building.
                                                                                                                                                                           Only technicians specifically trained in handling flam-
                                                                                                                                                                             mable refrigerants should service refrigerators and
                                                                                                                                                                             freezers containing these refrigerants. Technicians
                                                                                                                                                                             should gain an understanding of minimizing the risk of
                                                                                                                                                                             fire and the steps to use flammable refrigerants safe-
                                                                                                                                                                             ly.

                                                              *                      *                       *                          *                          *                      *                    *
                                              Note: The use conditions in this appendix contain references to certain standards from Underwriters Laboratories Inc. (UL). The standards are incorporated by ref-
                                           erence, and the referenced sections are made part of the regulations in part 82:
                                              1. UL 471. Commercial Refrigerators and Freezers. 10th edition. Supplement SB: Requirements for Refrigerators and Freezers Employing a Flammable Refrigerant
                                           in the Refrigerating System. Underwriters Laboratories, Inc. November 24, 2010.
                                              2. UL 484. Room Air Conditioners. 8th edition. Supplement SA: Requirements for Room Air Conditioners Employing a Flammable Refrigerant in the Refrigerating
                                           System and Appendices B through F. December 21, 2007, with changes through August 3, 2012.
                                              3. UL 541. Refrigerated Vending Machines. 7th edition. Supplement SA: Requirements for Refrigerated Venders Employing a Flammable Refrigerant in the Refrig-
                                           erating System. December 30, 2011.
                                              4. UL Standard 60335–2–24. Standard for Safety: Requirements for Household and Similar Electrical Appliances,—Safety—Part 2–24: Particular Requirements for
                                           Refrigerating Appliances, Ice-Cream Appliances and Ice-Makers, Second edition, dated April 28, 2017.


                                              The Director of the Federal Register                    www.archives.gov/federal-register/cfr/ibr-                              DATES:  This regulation is effective
                                           approves the incorporation by reference of                 locations.html.                                                         August 8, 2018. Objections and requests
                                           the material under ‘‘Use Conditions’’ in the               *          *       *        *         *                                 for hearings must be received on or
                                           table ‘‘SUBSTITUTES THAT ARE                               [FR Doc. 2018–16773 Filed 8–7–18; 8:45 am]                              before October 9, 2018, and must be
                                           ACCEPTABLE SUBJECT TO USE                                  BILLING CODE 6560–50–P                                                  filed in accordance with the instructions
                                           CONDITIONS’’ (5 U.S.C. 552(a) and 1 CFR                                                                                            provided in 40 CFR part 178 (see also
                                           part 51). Copies of UL Standards 471, 484,                                                                                         Unit I.C. of the SUPPLEMENTARY
                                           541, and 60335–2–24, may be purchased by                   ENVIRONMENTAL PROTECTION                                                INFORMATION).
                                           mail at: COMM 2000, 151 Eastern Avenue,                    AGENCY                                                                  ADDRESSES: The docket for this action,
                                           Bensenville, IL 60106; Email: orders@
                                           shopulstandards.com; Telephone: 1–888–                     40 CFR Part 180                                                         identified by docket identification (ID)
                                           853–3503 in the U.S. or Canada (other                                                                                              number EPA–HQ–OPP–2017–0352, is
                                                                                                      [EPA–HQ–OPP–2017–0352; FRL–9978–83]                                     available at http://www.regulations.gov
                                           countries dial 1–415–352–2178); internet
                                           address: http://www.shopulstandards.com/                                                                                           or at the Office of Pesticide Programs
                                                                                                      Spinetoram; Pesticide Tolerances                                        Regulatory Public Docket (OPP Docket)
                                           Catalog.aspx.
                                              You may inspect a copy at U.S. EPA’s Air                AGENCY:  Environmental Protection                                       in the Environmental Protection Agency
                                           Docket; EPA West Building, Room 3334;                      Agency (EPA).                                                           Docket Center (EPA/DC), West William
                                           1301 Constitution Ave. NW, Washington, DC                  ACTION: Final rule.                                                     Jefferson Clinton Bldg., Rm. 3334, 1301
                                                                                                                                                                              Constitution Ave. NW, Washington, DC
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                                           or at the National Archives and Records
                                           Administration (NARA). For questions                       SUMMARY:   This regulation establishes                                  20460–0001. The Public Reading Room
                                           regarding access to these standards, the                   tolerances for residues of spinetoram in                                is open from 8:30 a.m. to 4:30 p.m.,
                                           telephone number of EPA’S Air Docket is                    or on tea, dried and tea, instant. Dow                                  Monday through Friday, excluding legal
                                           202–566–1742. For information on the                       AgroSciences, LLC., requested these                                     holidays. The telephone number for the
                                           availability of this material at NARA, call                tolerances under the Federal Food,                                      Public Reading Room is (202) 566–1744,
                                           202–741–6030, or go to: https://                           Drug, and Cosmetic Act (FFDCA).                                         and the telephone number for the OPP


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                                                            Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Rules and Regulations                                         38977

                                           Docket is (703) 305–5805. Please review                 as described in 40 CFR part 178, please               all anticipated dietary exposures and all
                                           the visitor instructions and additional                 submit a copy of the filing (excluding                other exposures for which there is
                                           information about the docket available                  any Confidential Business Information                 reliable information.’’ This includes
                                           at http://www.epa.gov/dockets.                          (CBI)) for inclusion in the public docket.            exposure through drinking water and in
                                           FOR FURTHER INFORMATION CONTACT:                        Information not marked confidential                   residential settings, but does not include
                                           Michael Goodis, Registration Division                   pursuant to 40 CFR part 2 may be                      occupational exposure. Section
                                           (7505P), Office of Pesticide Programs,                  disclosed publicly by EPA without prior               408(b)(2)(C) of FFDCA requires EPA to
                                           Environmental Protection Agency, 1200                   notice. Submit the non-CBI copy of your               give special consideration to exposure
                                           Pennsylvania Ave., NW, Washington,                      objection or hearing request, identified              of infants and children to the pesticide
                                           DC 20460–0001; main telephone                           by docket ID number EPA–HQ–OPP–                       chemical residue in establishing a
                                           number: (703) 305–7090; email address:                  2017–0352, by one of the following                    tolerance and to ‘‘ensure that there is a
                                           RDFRNotices@epa.gov.                                    methods:                                              reasonable certainty that no harm will
                                                                                                     • Federal eRulemaking Portal: http://               result to infants and children from
                                           SUPPLEMENTARY INFORMATION:
                                                                                                   www.regulations.gov. Follow the online                aggregate exposure to the pesticide
                                           I. General Information                                  instructions for submitting comments.                 chemical residue. . . .’’
                                                                                                   Do not submit electronically any                         Consistent with FFDCA section
                                           A. Does this action apply to me?                                                                              408(b)(2)(D), and the factors specified in
                                                                                                   information you consider to be CBI or
                                              You may be potentially affected by                   other information whose disclosure is                 FFDCA section 408(b)(2)(D), EPA has
                                           this action if you are an agricultural                  restricted by statute.                                reviewed the available scientific data
                                           producer, food manufacturer, or                           • Mail: OPP Docket, Environmental                   and other relevant information in
                                           pesticide manufacturer. The following                   Protection Agency Docket Center (EPA/                 support of this action. EPA has
                                           list of North American Industrial                       DC), (28221T), 1200 Pennsylvania Ave.                 sufficient data to assess the hazards of
                                           Classification System (NAICS) codes is                  NW, Washington, DC 20460–0001.                        and to make a determination on
                                           not intended to be exhaustive, but rather                 • Hand Delivery: To make special                    aggregate exposure for spinetoram
                                           provides a guide to help readers                        arrangements for hand delivery or                     including exposure resulting from the
                                           determine whether this document                         delivery of boxed information, please                 tolerances established by this action.
                                           applies to them. Potentially affected                   follow the instructions at http://                    EPA’s assessment of exposures and risks
                                           entities may include:                                   www.epa.gov/dockets/contacts.html.                    associated with spinetoram follows.
                                              • Crop production (NAICS code 111).                    Additional instructions on
                                                                                                                                                         A. Toxicological Profile
                                              • Animal production (NAICS code                      commenting or visiting the docket,
                                           112).                                                   along with more information about                        EPA has evaluated the available
                                              • Food manufacturing (NAICS code                     dockets generally, is available at http://            toxicity data and considered its validity,
                                           311).                                                   www.epa.gov/dockets.                                  completeness, and reliability as well as
                                              • Pesticide manufacturing (NAICS                                                                           the relationship of the results of the
                                           code 32532).                                            II. Summary of Petitioned-For                         studies to human risk. EPA has also
                                                                                                   Tolerance                                             considered available information
                                           B. How can I get electronic access to                      In the Federal Register of October 23,             concerning the variability of the
                                           other related information?                              2017 (82 FR 49020) (FRL–9967–37),                     sensitivities of major identifiable
                                              You may access a frequently updated                  EPA issued a document pursuant to                     subgroups of consumers, including
                                           electronic version of EPA’s tolerance                   FFDCA section 408(d)(3), 21 U.S.C.                    infants and children. Spinetoram and
                                           regulations at 40 CFR part 180 through                  346a(d)(3), announcing the filing of a                spinosad are considered by EPA to be
                                           the Government Printing Office’s e-CFR                  pesticide petition (PP 7E8554) by Dow                 toxicologically identical for human
                                           site at http://www.ecfr.gov/cgi-bin/text-               AgroSciences LLC, 9330 Zionsville                     health risk assessment based on their
                                           idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    Road, Indianapolis, Indiana 46268–                    very similar chemical structures and
                                           40tab_02.tpl.                                           1054. The petition requested that 40                  similarity of the toxicological databases
                                                                                                   CFR 180.635 be amended by                             for currently available studies, therefore,
                                           C. How can I file an objection or hearing                                                                     the Agency has assessed and
                                                                                                   establishing tolerances for residues of
                                           request?                                                                                                      summarized the toxicological profile for
                                                                                                   the insecticide spinetoram, in or on tea,
                                             Under FFDCA section 408(g), 21                        dried at 70 parts per million (ppm) and               both together. The primary toxic effect
                                           U.S.C. 346a, any person may file an                     tea, instant at 70 ppm. That document                 observed from exposure to spinetoram
                                           objection to any aspect of this regulation              referenced a summary of the petition                  and spinosad was histopathological
                                           and may also request a hearing on those                 prepared by Dow AgroSciences, the                     changes in multiple organs (specific
                                           objections. You must file your objection                registrant, which is available in the                 target organs were not identified).
                                           or request a hearing on this regulation                 docket, http://www.regulations.gov.                   Vacuolization of cells and/or
                                           in accordance with the instructions                     There were no comments received in                    macrophages was the most common
                                           provided in 40 CFR part 178. To ensure                  response to the notice of filing.                     histopathological finding noted across
                                           proper receipt by EPA, you must                                                                               the toxicological database with the dog
                                           identify docket ID number EPA–HQ–                       III. Aggregate Risk Assessment and                    being the most sensitive species. In
                                           OPP–2017–0352 in the subject line on                    Determination of Safety                               addition to the numerous organs
                                           the first page of your submission. All                     Section 408(b)(2)(A)(i) of FFDCA                   observed with histopathological
                                           objections and requests for a hearing                   allows EPA to establish a tolerance (the              changes, anemia was noted in several
                                           must be in writing, and must be                         legal limit for a pesticide chemical                  studies. There was no evidence of
                                           received by the Hearing Clerk on or                     residue in or on a food) only if EPA                  increased quantitative or qualitative
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                                           before October 9, 2018. Addresses for                   determines that the tolerance is ‘‘safe.’’            susceptibility from spinetoram or
                                           mail and hand delivery of objections                    Section 408(b)(2)(A)(ii) of FFDCA                     spinosad exposure. In developmental
                                           and hearing requests are provided in 40                 defines ‘‘safe’’ to mean that ‘‘there is a            studies, no maternal or developmental
                                           CFR 178.25(b).                                          reasonable certainty that no harm will                effects were seen in rats or rabbits. In
                                             In addition to filing an objection or                 result from aggregate exposure to the                 the rat reproduction toxicity studies,
                                           hearing request with the Hearing Clerk                  pesticide chemical residue, including                 offspring toxicity (decreased litter size,


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                                           38978            Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Rules and Regulations

                                           survival, and body weights with                            and in document ‘‘Spinosad/                           a population-adjusted dose (PAD) or a
                                           spinosad; increased incidence of late                      Spinetoram. Draft Human Health Risk                   reference dose (RfD)—and a safe margin
                                           resorptions and post-implantation loss                     Assessment for Registration Review,’’ at              of exposure (MOE). For non-threshold
                                           with spinetoram) was seen in the                           pages 12–17 in docket ID number EPA–                  risks, the Agency assumes that any
                                           presence of parental toxicity (increased                   HQ–OPP–2011–0666.                                     amount of exposure will lead to some
                                           organ weights, mortality, and                                                                                    degree of risk. Thus, the Agency
                                                                                                      B. Toxicological Points of Departure/
                                           histopathological findings) at                                                                                   estimates risk in terms of the probability
                                                                                                      Levels of Concern
                                           approximately the same dose for both                                                                             of an occurrence of the adverse effect
                                           chemicals. Dystocia and/or other                              Once a pesticide’s toxicological                   expected in a lifetime. For more
                                           parturition abnormalities were observed                    profile is determined, EPA identifies                 information on the general principles
                                           with both spinetoram and spinosad in                       toxicological points of departure (POD)               EPA uses in risk characterization and a
                                           the reproduction toxicity studies. There                   and levels of concern to use in                       complete description of the risk
                                           was no evidence of neurotoxicity,                          evaluating the risk posed by human                    assessment process, see http://
                                           immunotoxicity, or carcinogenicity from                    exposure to the pesticide. For hazards                www.epa.gov/pesticides/factsheets/
                                           spinetoram exposure.                                       that have a threshold below which there               riskassess.htm.
                                              Specific information on the studies                     is no appreciable risk, the toxicological
                                           received and the nature of the adverse                     POD is used as the basis for derivation                  Spinetoram and spinosad should be
                                           effects caused by spinetoram as well as                    of reference values for risk assessment.              considered toxicologically identical in
                                           the no-observed-adverse-effect-level                       PODs are developed based on a careful                 the same manner that metabolites are
                                           (NOAEL) and the lowest-observed-                           analysis of the doses in each                         generally considered toxicologically
                                           adverse-effect-level (LOAEL) from the                      toxicological study to determine the                  identical to the parent. As a result,
                                           toxicity studies can be found at http://                   dose at which no adverse effects are                  studies from both toxicological
                                           www.regulations.gov in document                            observed (the NOAEL) and the lowest                   databases were considered for endpoint
                                           ‘‘Spinosad/Spinetoram. Human Health                        dose at which adverse effects of concern              selection.
                                           Risk Assessment in Support of Proposed                     are identified (the LOAEL). Uncertainty/                 A summary of the toxicological
                                           Spinetoram Tolerance for Residues in/                      safety factors are used in conjunction                endpoints for spinetoram used for
                                           on Imported Tea’’ at page 8 in docket                      with the POD to calculate a safe                      human risk assessment is shown in
                                           ID number EPA–HQ–OPP–2017–0352                             exposure level—generally referred to as               Table 1 of this unit.

                                                TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPINETORAM/SPINOSAD FOR USE IN HUMAN
                                                                                  HEALTH RISK ASSESSMENT
                                                                                       Point of departure        RfD, PAD, LOC for
                                                   Exposure/scenario                    and uncertainty/                                                    Study and toxicological effects
                                                                                                                  risk assessment
                                                                                         safety factors

                                           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/           Chronic RfD =              Chronic Toxicity—Dog (Spinetoram).
                                                                                      kg/day.                     0.0249 mg/kg/day.        LOAEL = 5.36/5.83 mg/kg/day (males/females) based on arte-
                                                                                     UFA = 10x                  cPAD = 0.0249 mg/            ritis and necrosis of the arterial walls of the epididymides in
                                                                                     UFH = 10x                    kg/day.                    males and of the thymus, thyroid, larynx, and urinary bladder
                                                                                     FQPA SF = 1x                                            in females.

                                           Incidental oral short-term (1 to          NOAEL = 4.9 mg/kg/         Residential LOC for        Subchronic Oral Toxicity—Dog Study (with spinosad).
                                             30 days) and intermediate-               day.                        MOE <100.                LOAEL = 9.73 mg/kg/day based on microscopic changes in
                                             term (1 to 6 months).                   UFA = 10x                                               multiple organs, clinical signs of toxicity, decreases in body
                                                                                     UFH = 10x                                               weights and food consumption, and biochemical evidence of
                                                                                     FQPA SF = 1x                                            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 Study (with spinosad).
                                             days) and Intermediate-Term               study NOAEL =              MOE <100.                LOAEL = 9.73 mg/kg/day based on microscopic changes in
                                             (1–6 months).                             4.9 mg/kg/day (in-                                    multiple organs, clinical signs of toxicity, decreases in body
                                                                                       halation assumed                                      weights and food consumption, and biochemical evidence of
                                                                                       equivalent to oral).                                  anemia and liver damage.
                                                                                     UFA = 10x
                                                                                     UFH = 10x
                                                                                     FQPA SF = 1x

                                           Cancer (Oral, dermal, inhala-                                            Classified as ‘‘not likely to be carcinogenic to humans.’’
                                             tion).
                                             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 ab-
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                                           sence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies).


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


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                                                            Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Rules and Regulations                                       38979

                                           of tea, spinosad is registered for                      such information, EPA must require                    spinosad are currently registered for
                                           application to all of the same crops as                 pursuant to FFDCA section 408(f)(1)                   uses that could result in residential
                                           spinetoram, with similar pre-harvest                    that data be provided 5 years after the               exposures including home lawns and
                                           and retreatment intervals, and                          tolerance is established, modified, or                pet (cats/kittens) spot-on applications;
                                           application rates greater than or equal to              left in effect, demonstrating that the                therefore, there is potential for
                                           spinetoram. Further, both active                        levels in food are not above the levels               residential handler and post-application
                                           ingredients control the same pest                       anticipated. For the present action, EPA              exposures to both spinetoram and
                                           species. For this reason, EPA has                       will issue such Data Call-Ins as are                  spinosad. Since spinosad and
                                           concluded it would overstate exposure                   required by FFDCA section 408(b)(2)(E)                spinetoram control the same pests, EPA
                                           to assume that residues of both spinosad                and authorized under FFDCA section                    concludes that these products will not
                                           and spinetoram would appear on the                      408(f)(1). Data will be required to be                be used for the same uses in
                                           same food. The risk assessment                          submitted no later than 5 years from the              combination with each other and thus
                                           included commodities that have                          date of issuance of these tolerances.                 combining spinosad and spinetoram
                                           tolerances for both spinosad and                           2. Dietary exposure from drinking                  residential exposures would overstate
                                           spinetoram as well as commodities                       water. The Agency used screening-level                exposure. EPA assessed residential
                                           where only spinosad tolerances are                      water exposure models in the dietary                  exposure for both spinosad and
                                           established. EPA aggregated exposure by                 exposure analysis and risk assessment                 spinetoram using the most conservative
                                           assuming that all commodities, with the                 for spinetoram and spinosad in drinking               residential exposure scenarios for either
                                           exception of tea, contain spinosad                      water. These simulation models take                   chemical.
                                           (because side-by-side spinetoram and                    into account data on the physical,                       EPA assessed the following ‘‘worst-
                                           spinosad residue data indicated that                    chemical, and fate/transport                          case’’ residential exposure scenarios as:
                                           spinetoram residues were less than or                   characteristics of spinetoram and                     (1) Adult residential handler (inhalation
                                           equal to spinosad residues); for tea, EPA               spinosad. Further information regarding               exposure from applications to lawns
                                           assumed spinetoram residues were                        EPA drinking water models used in                     and turf) and (2) child (1–<2 years)
                                           present. EPA assessed dietary exposures                 pesticide exposure assessment can be                  (hand-to-mouth exposures from post-
                                           from spinetoram in food as follows:                     found at http://www2.epa.gov/pesticide-               application exposure to turf). Because
                                              i. Acute exposure. Quantitative acute                science-and-assessing-pesticide-risks/                EPA’s level of concern for spinetoram is
                                           dietary exposure and risk assessments                   about-water-exposure-models-used-                     a MOE below 100, the MOEs for both of
                                           are performed for a food-use pesticide,                 pesticide.                                            these residential exposure scenarios are
                                           if a toxicological study has indicated the                 Based on the surface water                         not of concern. In addition, the short-
                                           possibility of an effect of concern                     concentration calculator (SWCC) and                   term assessment is protective of
                                           occurring as a result of a 1-day or single              Pesticide Root Zone Model Ground                      intermediate-term exposure as the short-
                                           exposure. No such effects were                          Water (PRZM GW), the estimated                        and intermediate-term PODs are
                                           identified in the toxicological studies                 drinking water concentrations (EDWCs)                 identical. Further information regarding
                                           for spinetoram or spinosad; therefore, a                of spinetoram for acute exposures are                 EPA standard assumptions and generic
                                           quantitative acute dietary exposure                     estimated to be 25.9 parts per billion                inputs for residential exposures may be
                                           assessment is unnecessary.                              (ppb) for surface water and below the                 found at http://www2.epa.gov/pesticide-
                                              ii. Chronic exposure. In conducting                  levels of detection for ground water. For             science-and-assessing-pesticide-risks/
                                           the chronic dietary exposure assessment                 chronic exposures for non-cancer                      standard-operating-procedures-
                                           EPA used the food consumption data                      assessments, the spinetoram EDWCs are                 residential-pesticide.
                                           from the USDA NHANES/WWEIA                              estimated to be 19.3 ppb for surface                     4. Cumulative effects from substances
                                           (2003–2008). As to residue levels in                    water and well below the levels of                    with a common mechanism of toxicity.
                                           food, EPA assumed 100 percent crop                      detection for ground water. EDWCs of                  Section 408(b)(2)(D)(v) of FFDCA
                                           treated (PCT), average field-trial                      spinosad for acute exposures are                      requires that, when considering whether
                                           residues or tolerance-level residues for                estimated to be 30.6 ppb for surface                  to establish, modify, or revoke a
                                           crop commodities, average residues                      water and below the levels of detection               tolerance, the Agency consider
                                           from the livestock feeding studies,                     for ground water. For chronic exposures               ‘‘available information’’ concerning the
                                           spinosad residue estimates for fish/                    for noncancer assessments, the                        cumulative effects of a particular
                                           shellfish (residues of spinetoram in fish/              spinetoram EDWCs are estimated to be                  pesticide’s residues and ‘‘other
                                           shellfish are expected to be                            22.8 ppb for surface water and below                  substances that have a common
                                           insignificant), and experimental or                     the levels of detection for ground water.             mechanism of toxicity.’’
                                           default processing factors.                                Modeled estimates of drinking water                   EPA has not found spinetoram to
                                              iii. Cancer. Based on the data                       concentration were directly entered into              share a common mechanism of toxicity
                                           summarized in Unit III.A., EPA has                      the dietary exposure model. For chronic               with any other substances, and
                                           concluded that spinetoram does not                      dietary risk assessment, the water                    spinetoram does not appear to produce
                                           pose a cancer risk to humans. Therefore,                concentration of value 22.8 ppb was                   a toxic metabolite produced by other
                                           a dietary exposure assessment for the                   used to assess the contribution to                    substances. For the purposes of this
                                           purpose of assessing cancer risk is                     drinking water.                                       tolerance action, therefore, EPA has
                                           unnecessary.                                               3. From non-dietary exposure. The                  assumed that spinetoram does not have
                                              iv. Anticipated residue and percent                  term ‘‘residential exposure’’ is used in              a common mechanism of toxicity with
                                           crop treated (PCT) information. EPA did                 this document to refer to non-                        other substances. For information
                                           not use PCT information in the dietary                  occupational, non-dietary exposure                    regarding EPA’s efforts to determine
                                           assessment for spinetoram. Section                      (e.g., for lawn and garden pest control,              which chemicals have a common
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                                           408(b)(2)(E) of FFDCA authorizes EPA                    indoor pest control, termiticides, and                mechanism of toxicity and to evaluate
                                           to use available data and information on                flea and tick control on pets).                       the cumulative effects of such
                                           the anticipated residue levels of                          EPA assessed residential exposure                  chemicals, see EPA’s website at http://
                                           pesticide residues in food and the actual               using the following assumptions: The                  www2.epa.gov/pesticide-science-and-
                                           levels of pesticide residues that have                  use on tea will not result in residential             assessing-pesticide-risks/cumulative-
                                           been measured in food. If EPA relies on                 exposure; however, spinetoram and                     assessment-risk-pesticides.


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                                           38980            Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Rules and Regulations

                                           D. Safety Factor for Infants and                        and no acute dietary endpoint was                     GRM 05.15 and GRM 06.08 (HPLC/MS)
                                           Children                                                selected. Therefore, spinetoram is not                are acceptable methods for
                                              1. In general. Section 408(b)(2)(C) of               expected to pose an acute risk.                       determination of spinetoram residues in
                                           FFDCA provides that EPA shall apply                        2. Chronic risk. Using the exposure                bovine and poultry tissues, milk, cream,
                                           an additional tenfold (10X) margin of                   assumptions described in this unit for                and eggs. Both methods are available to
                                           safety for infants and children in the                  chronic exposure, EPA has concluded                   enforce the tolerance expression.
                                                                                                   that chronic exposure to spinetoram                      The methods may be requested from:
                                           case of threshold effects to account for
                                                                                                   from food and water will utilize 72% of               Chief, Analytical Chemistry Branch,
                                           prenatal and postnatal toxicity and the
                                                                                                   the cPAD for children 1–2 years old, the              Environmental Science Center, 701
                                           completeness of the database on toxicity                                                                      Mapes Rd., Ft. Meade, MD 20755–5350;
                                           and exposure unless EPA determines                      population group receiving the greatest
                                                                                                   exposure. Based on the explanation in                 telephone number: (410) 305–2905;
                                           based on reliable data that a different                                                                       email address: residuemethods@
                                           margin of safety will be safe for infants               Unit III.C.3., regarding residential use
                                                                                                   patterns, chronic residential exposure to             epa.gov.
                                           and children. This additional margin of
                                           safety is commonly referred to as the                   residues of spinetoram is not expected;               B. International Residue Limits
                                           FQPA Safety Factor (SF). In applying                    therefore, the chronic dietary estimate
                                                                                                   represents the chronic aggregate                         In making its tolerance decisions, EPA
                                           this provision, EPA either retains the                                                                        seeks to harmonize U.S. tolerances with
                                           default value of 10X, or uses a different               estimate.
                                                                                                      3. Short- and Intermediate-term risk.              international standards whenever
                                           additional safety factor when reliable                                                                        possible, consistent with U.S. food
                                                                                                   Short- and Intermediate-term aggregate
                                           data available to EPA support the choice                                                                      safety standards and agricultural
                                                                                                   exposures takes into account short-term
                                           of a different factor.                                                                                        practices. EPA considers the
                                                                                                   and intermediated-term residential
                                              2. Prenatal and postnatal sensitivity.                                                                     international maximum residue limits
                                                                                                   exposures plus chronic exposure to food
                                           There is no evidence of increased                                                                             (MRLs) established by the Codex
                                                                                                   and water (considered to be a
                                           prenatal or postnatal susceptibility.                                                                         Alimentarius Commission (Codex), as
                                              3. Conclusion. EPA has determined                    background exposure level). Spinetoram
                                                                                                   is currently registered for uses that                 required by FFDCA section 408(b)(4).
                                           that reliable data show the safety of                                                                         The Codex Alimentarius is a joint
                                           infants and children would be                           could result in short- and intermediate-
                                                                                                   term residential exposure, and the                    United Nations Food and Agriculture
                                           adequately protected if the FQPA SF                                                                           Organization/World Health
                                           were reduced to 1X. That decision is                    Agency has determined that it is
                                                                                                   appropriate to aggregate chronic                      Organization food standards program,
                                           based on the following findings:                                                                              and it is recognized as an international
                                              i. The toxicity database for spinetoram              exposure through food and water with
                                                                                                   short- and intermediate-term residential              food safety standards-setting
                                           is adequate for FQPA SF consideration.                                                                        organization in trade agreements to
                                              ii. There is no evidence of                          exposures to spinetoram.
                                                                                                      Using the exposure assumptions                     which the United States is a party. EPA
                                           neurotoxicity from spinetoram                                                                                 may establish a tolerance that is
                                                                                                   described in this unit for short-term
                                           exposure.                                                                                                     different from a Codex MRL; however,
                                              iii. There is no evidence that                       exposures, EPA has concluded the
                                                                                                   combined short-term food, water, and                  FFDCA section 408(b)(4) requires that
                                           spinetoram results in increased pre- or                                                                       EPA explain the reasons for departing
                                           post-natal susceptibility in rats or                    residential exposures result in aggregate
                                                                                                   MOEs of 780 for adults (handler) and                  from the Codex level.
                                           rabbits.                                                                                                         The Codex has not established a MRL
                                              iv. There are no residual uncertainties              200 for children (post-application).
                                                                                                                                                         for spinetoram.
                                           identified in the exposure databases.                   Because EPA’s level of concern for
                                           EPA made conservative (protective)                      spinetoram is a MOE below 100, these                  V. Conclusion
                                           assumptions in assessing exposures and                  MOEs are not of concern. In addition,                    Therefore, tolerances are established
                                           these assessments will not                              the short-term assessment is protective               for residues of spinetoram, expressed as
                                           underestimate the exposure and risks                    of intermediate-term exposure as the                  the combined residues of XDE–175–J: 1-
                                           posed by spinetoram.                                    short- and intermediate-term PODs are                 H-as-indaceno[3,2-d]oxacyclododecin-
                                                                                                   identical.                                            7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-
                                           E. Aggregate Risks and Determination of                    4. Aggregate cancer risk for U.S.                  O-methyl-a-L-mannopyranosyl)oxy]-13-
                                           Safety                                                  population. Based on the lack of                      [[(2R,5S,6R)-5-(dimethylamino)
                                              EPA determines whether acute and                     evidence of carcinogenicity in two                    tetrahydro-6-methyl-2H-pyran-2-yl]
                                           chronic dietary pesticide exposures are                 adequate rodent carcinogenicity studies,              oxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,
                                           safe by comparing aggregate exposure                    spinetoram is not expected to pose a                  11,12,13,14,16a,16b-hexadecahydro 14-
                                           estimates to the acute PAD (aPAD) and                   cancer risk to humans.                                methyl-, (2R,3aR,5aR,5bS,9S,13S,
                                           chronic PAD (cPAD). For linear cancer                      5. Determination of safety. Based on               14R,16aS,16bR); XDE–175–L: 1H-as-
                                           risks, EPA calculates the lifetime                      these risk assessments, EPA concludes                 indaceno[3,2-d]oxacyclododecin-7,15-
                                           probability of acquiring cancer given the               that there is a reasonable certainty that             dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-
                                           estimated aggregate exposure. Short-,                   no harm will result to the general                    methyl-a-L-mannopyranosyl)oxy]-13-
                                           intermediate-, and chronic-term risks                   population, or to infants and children                [[(2R,5S,6R)-5-(dimethylamino)
                                           are evaluated by comparing the                          from aggregate exposure to spinetoram                 tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-
                                           estimated aggregate food, water, and                    residues.                                             9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,
                                           residential exposure to the appropriate                 IV. Other Considerations                              16a,16b-tetradecahydro-4,14-dimethyl-
                                           PODs to ensure that an adequate MOE                                                                           (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS);
                                           exists.                                                 A. Analytical Enforcement Methodology                 ND–J: (2R,3aR,5aR,5bS,9S,
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                                              1. Acute risk. An acute aggregate risk                  Adequate enforcement methodology                   13S,14R,16aS,16bR)-9-ethyl-14-methyl-
                                           assessment takes into account acute                     is available for both plant and livestock             13 [[(2S,5S,6R)-6-methyl-5-
                                           exposure estimates from dietary                         commodities. Method GRM 05.03                         (methylamino)tetrahydro-2H-pyran-2-
                                           consumption of food and drinking                        (HPLC/MS/MS) is an acceptable method                  yl]oxy]-7,15-dioxo-2,3,3a,4,5,5a,5b,6,
                                           water. No adverse effect resulting from                 for the determination of spinetoram                   7,9,10,11,12,13,14,15,16a,16b-
                                           a single oral exposure was identified                   residues in a variety of crops. Methods               octadecahydro-1H-as-indaceno[3,2-


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                                                            Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Rules and Regulations                                                        38981

                                           d]oxacyclododecin-2-yl 6-deoxy-3-O-                     the requirements of the Regulatory                    and pests, Reporting and recordkeeping
                                           ethyl-2,4-di-O-methyl-a-L-                              Flexibility Act (RFA) (5 U.S.C. 601 et                requirements.
                                           mannopyranoside; and NF–J:                              seq.), do not apply.                                    Dated: July 24, 2018.
                                           (2R,3S,6S)-6-([                                            This action directly regulates growers,
                                           (2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)                   food processors, food handlers, and food              Michael Goodis,
                                           -2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-                 retailers, not States or tribes, nor does             Director, Registration Division, Office of
                                           a-L-mannopyranosyl) oxy]-9-ethyl-14-                    this action alter the relationships or                Pesticide Programs.
                                           methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,                 distribution of power and
                                                                                                                                                           Therefore, 40 CFR chapter I is
                                           9,10,11,12,13,14,15,16a,16b-octade                      responsibilities established by Congress
                                           cahydro-1H-as-indaceno[3,2-d]                           in the preemption provisions of FFDCA                 amended as follows:
                                           oxacyclododecin-13-yl]oxy)-2-                           section 408(n)(4). As such, the Agency                PART 180—[AMENDED]
                                           methyltetrahydro-2H-pyran-3-                            has determined that this action will not
                                           yl(methyl)formamide, in or on tea, dried                have a substantial direct effect on States
                                           at 70 parts per million (ppm) and tea,                  or tribal governments, on the                         ■ 1. The authority citation for part 180
                                           instant at 70 ppm.                                      relationship between the national                     continues to read as follows:

                                           VI. Statutory and Executive Order                       government and the States or tribal                       Authority: 21 U.S.C. 321(q), 346a and 371.
                                           Reviews                                                 governments, or on the distribution of
                                                                                                                                                         ■ 2. In § 180.635 add alphabetically the
                                                                                                   power and responsibilities among the
                                              This action establishes tolerances                                                                         entries for ‘‘Tea, dried’’; and ‘‘Tea,
                                                                                                   various levels of government or between
                                           under FFDCA section 408(d) in                           the Federal Government and Indian                     instant’’; and footnote 1 to the table in
                                           response to a petition submitted to the                 tribes. Thus, the Agency has determined               paragraph (a) to read as follows:
                                           Agency. The Office of Management and                    that Executive Order 13132, entitled
                                           Budget (OMB) has exempted these types                                                                         § 180.635 Spinetoram; tolerances for
                                                                                                   ‘‘Federalism’’ (64 FR 43255, August 10,               residues.
                                           of actions from review under Executive                  1999) and Executive Order 13175,
                                           Order 12866, entitled ‘‘Regulatory                      entitled ‘‘Consultation and Coordination                  (a) * * *
                                           Planning and Review’’ (58 FR 51735,                     with Indian Tribal Governments’’ (65 FR
                                           October 4, 1993). Because this action                   67249, November 9, 2000) do not apply                                                                Parts per
                                                                                                                                                                      Commodity
                                           has been exempted from review under                                                                                                                           million
                                                                                                   to this action. In addition, this action
                                           Executive Order 12866, this action is                   does not impose any enforceable duty or
                                           not subject to Executive Order 13211,                   contain any unfunded mandate as
                                           entitled ‘‘Actions Concerning                                                                                    *          *              *             *          *
                                                                                                   described under Title II of the Unfunded              Tea, dried 1 ...........................                   70
                                           Regulations That Significantly Affect                   Mandates Reform Act (UMRA) (2 U.S.C.
                                           Energy Supply, Distribution, or Use’’ (66                                                                     Tea, instant 1 .........................                   70
                                                                                                   1501 et seq.).
                                           FR 28355, May 22, 2001) or Executive                       This action does not involve any                        *           *             *           *          *
                                           Order 13045, entitled ‘‘Protection of                   technical standards that would require
                                           Children from Environmental Health                      Agency consideration of voluntary                       1 There are no U.S. registrations as of Au-

                                           Risks and Safety Risks’’ (62 FR 19885,                  consensus standards pursuant to section               gust 8, 2018 for use on tea.
                                           April 23, 1997); or Executive Order                     12(d) of the National Technology                      *        *       *       *         *
                                           13771, entitled ‘‘Reducing Regulations                  Transfer and Advancement Act                          [FR Doc. 2018–16989 Filed 8–7–18; 8:45 am]
                                           and Controlling Regulatory Costs’’ (82                  (NTTAA) (15 U.S.C. 272 note).                         BILLING CODE 6560–50–P
                                           FR 9339, February 3, 2017). This action
                                           does not contain any information                        VII. Congressional Review Act
                                           collections subject to OMB approval                       Pursuant to the Congressional Review
                                           under the Paperwork Reduction Act                       Act (5 U.S.C. 801 et seq.), EPA will
                                           (PRA) (44 U.S.C. 3501 et seq.), nor does                submit a report containing this rule and
                                           it require any special considerations                   other required information to the U.S.
                                           under Executive Order 12898, entitled                   Senate, the U.S. House of
                                           ‘‘Federal Actions to Address                            Representatives, and the Comptroller
                                           Environmental Justice in Minority                       General of the United States prior to
                                           Populations and Low-Income                              publication of the rule in the Federal
                                           Populations’’ (59 FR 7629, February 16,                 Register. This action is not a ‘‘major
                                           1994).                                                  rule’’ as defined by 5 U.S.C. 804(2).
                                              Since tolerances and exemptions that
                                           are established on the basis of a petition              List of Subjects in 40 CFR Part 180
                                           under FFDCA section 408(d), such as                       Environmental protection,
                                           the tolerance in this final rule, do not                Administrative practice and procedure,
                                           require the issuance of a proposed rule,                Agricultural commodities, Pesticides
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Document Created: 2018-08-08 02:05:26
Document Modified: 2018-08-08 02:05:26
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactMichael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460-0001; main telephone
FR Citation83 FR 38976 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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