Methoxyfenozide; Pesticide Tolerances, 8820-8825 [2019-04458]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 84, Number 48 (Tuesday, March 12, 2019)]
[Rules and Regulations]
[Pages 8820-8825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04458]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0494; FRL-9985-06]


Methoxyfenozide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective March 12, 2019. Objections and 
requests for hearings must be received on or before May 13, 2019, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0494, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0494 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 
May 13, 2019. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2017-0494, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.

[[Page 8821]]

     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of November 27, 2017 (82 FR 56017) (FRL-
9968-55), 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 
7E8601) by Dow Agrosciences, LLC, 9330 Zionsville Road, Indianapolis, 
IN 46268. The petition requested that 40 CFR 180.544 be amended by 
establishing tolerances for residues of the insecticide 
methoxyfenozide, in or on tea, dried at 20 parts per million (ppm) and 
tea, instant at 20 ppm. That document referenced a summary of the 
petition prepared by Dow Agrosciences, LLC, the registrant, which is 
available in the docket, https://www.regulations.gov. Comments were 
received on the notice of filing. EPA's response to these comments is 
discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for methoxyfenozide including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with methoxyfenozide 
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.
    Many of the available short-term or subchronic toxicity studies on 
methoxyfenozide showed little or no toxicity. The main target organs 
identified from the toxicity studies in the rat and dog were the liver, 
thyroid, and red blood cells (RBCs). The most consistent findings 
across species and studies were transiently decreased RBC parameters 
and increased liver, thyroid, adrenal, and spleen weights. Increases in 
thyroid and adrenal weights were observed in the rat chronic oral 
study. Thyroid weights were also increased in the dog following chronic 
exposure. However, no accompanying histopathology was observed.
    Acute and subchronic oral neurotoxicity studies in the rat did not 
show evidence of potential neurotoxicity. In the acute study, decreased 
hindlimb grip strength on Day 0 was reported in males. This finding was 
only observed at the limit dose in males and was not observed in the 
subchronic neurotoxicity study and was therefore not considered 
evidence of neurotoxicity. No clinical signs of neurotoxicity or 
neurohistopathology were observed in other guideline studies.
    No maternal or developmental effects were observed in either the 
rat or rabbit oral developmental toxicity studies. In the rat 2-
generation reproductive toxicity study, parental effects were limited 
to increased liver weight and microscopic periportal hypertrophy. No 
offspring or reproductive toxicity was observed. In a 28-day dietary 
immunotoxicity study in the rat, no immunotoxicity was observed, and 
the only observed effect was increased liver weight.
    There was no evidence of carcinogenicity in the rat dietary 24-
month chronic toxicity/carcinogenicity study or the mouse dietary 18-
month carcinogenicity study. No mutagenic or clastogenic potential was 
observed in the battery of genotoxicity studies on methoxyfenozide. 
Based on these findings, methoxyfenozide is classified as ``not likely 
to be carcinogenic to humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by methoxyfenozide 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 https://www.regulations.gov in document, ``Methoxyfenozide. Human Health Draft 
Risk Assessment for Registration Review and New Use Risk Assessment to 
Support the Registration of Proposed Use on Chives, and Crop Group 
Expansions for Stone Fruit and Tree Nuts'' at pp. 42-47 in docket ID 
number EPA-HQ-OPP-2014-0591.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for methoxyfenozide used 
for human risk assessment is shown in Table 1 of this unit.

[[Page 8822]]



     Table 1--Summary of Toxicological Doses and Endpoints for Methoxyfenozide for Use in Human Health Risk
                                                   Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations                  No hazard was identified for a single oral exposure.
 including infants and children
 and females 13-49 years of age).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 10.2 mg/kg/   Chronic RfD = 0.10   Co-critical studies:
                                    day.                  mg/kg/day.          Combined oral chronic toxicity/
                                   UFA = 10x...........  cPAD = 0.10 mg/kg/    carcinogenicity-rat
                                   UFH = 10x...........   day.                LOAEL = 411/491 mg/kg/day [M/F],
                                   FQPA SF = 1x........                        based on hematological changes
                                                                               (decreased RBC parameters),
                                                                               periportal liver hypertrophy,
                                                                               thyroid hypertrophy and altered
                                                                               colloid; possibly increased
                                                                               adrenal weight.
                                                                              Chronic oral toxicity-dog
                                                                              NOAEL = 9.8/12.6 mg/kg/day [M/F]
                                                                              LOAEL = 106.1/110.6 mg/kg/day,
                                                                               based on hematological changes
                                                                               (decreased RBC parameters, slight
                                                                               methemoglobinemia) and increased
                                                                               serum bilirubin.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL= 16.8 mg/kg/    Residential LOC for  Two-week oral range-finding study-
 30 days).                          day.                  MOE <=100.           dog
                                   UFA = 10x...........                       LOAEL = 90.8 mg/kg/day based on
                                   UFH = 10x...........                        hematological changes (decreased
                                   FQPA SF = 1x........                        RBC parameters, increased Heinz
                                                                               body count, reticulocyte counts,
                                                                               erythrocyte morphology and
                                                                               methemoglobinemia) and increased
                                                                               spleen weights.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)         No toxicity, i.e., no hazard, was identified for dermal exposure.
 or Intermediate-term (1 to 6
 months).
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     NOAEL= 16.8 mg/kg/    Residential LOC for  Two-week oral range-finding study-
 days) and Intermediate-term (1     day (Inhalation       MOE <=100.           dog
 to 6 months).                      toxicity considered                       LOAEL = 90.8 mg/kg/day based on
                                    equivalent to oral                         hematological changes (decreased
                                    toxicity.).                                RBC parameters, increased Heinz
                                   UFA = 10x...........                        body count, reticulocyte counts,
                                   UFH = 10x...........                        erythrocyte morphology and
                                   FQPA SF = 1x........                        methemoglobinemia) and increased
                                                                               spleen weights.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)                     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). 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 methoxyfenozide, EPA considered exposure under the 
petitioned-for tolerances as well as all existing methoxyfenozide 
tolerances in 40 CFR 180.544. EPA assessed dietary exposures from 
methoxyfenozide 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 methoxyfenozide; 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 United States 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, EPA used tolerance-level residues, 100 percent 
crop treated (100%CT), and default processing factors for most 
processed commodities that do not have individual tolerances; the only 
exception being a processing factor for orange juice based on a 
processing study.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that methoxyfenozide 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 anticipated residue and/or PCT information in the 
dietary assessment for methoxyfenozide. Tolerance level residues and/or 
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for methoxyfenozide in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of methoxyfenozide. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at https://www2.epa.gov/pesticide-science-and-
assessing-

[[Page 8823]]

pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the FQPA Index Reservoir Screening Tool (FIRST) for 
surface water, along with the Screening Concentration In GROund Water 
(SCI-GROW) model and Pesticide Root Zone Model Ground Water (PRZM GW) 
models for groundwater, the estimated drinking water concentrations 
(EDWCs) of methoxyfenozide for chronic exposures for non-cancer 
assessments are estimated to be 7.57 ppb for surface water and 214 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 214 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). Methoxyfenozide is 
currently registered for use on ornamentals in and around home gardens, 
which could result in residential exposures. EPA assessed residential 
exposure using the following assumptions: Residential handlers were 
assessed for potential short-term inhalation exposures from mixing, 
loading, and applying methoxyfenozide. A quantitative dermal assessment 
for residential handlers was not conducted since there is no systemic 
toxicity associated with dermal exposures to methoxyfenozide. Adult 
post-application exposures were not quantitatively assessed since no 
dermal hazard was identified for methoxyfenozide and inhalation 
exposures are typically negligible in outdoor settings. Furthermore, 
the inhalation exposure assessment performed for residential handlers 
is representative of worse case inhalation exposures and is considered 
protective for post-application inhalation exposure scenarios.
    Post-application oral exposure to children is not expected since 
the extent to which young children engage in activities associated with 
areas where treated ornamentals are grown (or utilize these areas for 
prolonged periods of play) is low. Therefore, an incidental oral post-
application exposure assessment was not conducted. Further information 
regarding EPA standard assumptions and generic inputs for residential 
exposures may be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/framework-assessing-non-occupational-non-dietary.
    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 methoxyfenozide to share a common mechanism of 
toxicity with any other substances, and methoxyfenozide does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
methoxyfenozide does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
qualitative or quantitative susceptibility of the developing fetus or 
offspring, based on the developmental and reproductive toxicity study 
results for methoxyfenozide. No developmental toxicity was observed in 
either the rat or rabbit developmental toxicity studies, and there was 
no evidence of offspring or reproductive toxicity in the rat 2-
generation reproductive toxicity study.
    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 methoxyfenozide is complete.
    ii. There is no indication that methoxyfenozide is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that methoxyfenozide results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study
    iv. There are no residual uncertainties identified in the exposure 
databases. The chronic dietary food exposure assessment was performed 
based on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to methoxyfenozide in drinking water. Based on the 
discussion in Unit III.C.3, regarding residential use patterns, EPA 
does not expect residential uses of methoxyfenozide to result in post-
application exposure of children or incidental oral exposures of 
toddlers. These assessments will not underestimate the exposure and 
risks posed by methoxyfenozide.

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, 
methoxyfenozide 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 
methoxyfenozide from food and water will utilize 84% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit

[[Page 8824]]

III.C.3., regarding residential use patterns, chronic residential 
exposure to residues of methoxyfenozide result in risk estimates (MOEs 
> 100) which are not of concern.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). 
Methoxyfenozide is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to methoxyfenozide.
    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 an aggregate MOE of 530. Because 
EPA's level of concern for methoxyfenozide is a MOE of 100 or below, 
this MOE is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
methoxyfenozide is not registered for any use patterns that would 
result in intermediate-term residential exposure. Intermediate-term 
risk is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure. Because there is no intermediate-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess intermediate-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for methoxyfenozide.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, methoxyfenozide is not expected to pose a cancer risk to 
humans.
    6. 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 methoxyfenozide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies, using high performance liquid 
chromatography (HPLC), with either tandem mass spectrometric detection 
(LC-MS/MS), or ultraviolet detection (HPLC-UV) or the multiresidue 
QuEChERS method, combined with an HPLC-MS/MS, 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: 
residuemethods@epa.gov.

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 methoxyfenozide in or on 
tea.

C. Response to Comments

    EPA received three comments, only one of which was specific to the 
petition for methoxyfenozide tolerances. The specific comment opposed 
``allowing such high residues'' but did not provide any information 
relevant to the safety of the pesticide. The Agency recognizes that 
some individuals believe that pesticides should be banned on 
agricultural crops; however, the existing legal framework provided by 
section 408 of the FFDCA states that tolerances may be set when persons 
seeking such tolerances or exemptions have demonstrated that the 
pesticide meets the safety standard imposed by that statute. The 
comment appears to be directed at the underlying statute and not EPA's 
implementation of it; the citizen has made no contention that EPA has 
acted in violation of the statutory framework.

V. Conclusion

    Therefore, tolerances are established for residues of 
methoxyfenozide, in or on imported tea, dried at 20 ppm and tea, 
instant at 20 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); 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

[[Page 8825]]

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: March 4, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. In Sec.  180.544, add alphabetically the commodities ``Tea, dried'' 
and ``Tea, instant'' to the table in paragraph (a) to read as follows:


Sec.  180.544   Methoxyfenozide; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Tea, dried \1\.............................................           20
Tea, instant \1\...........................................           20
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of March 12, 2019 for use on tea.

* * * * *
[FR Doc. 2019-04458 Filed 3-11-19; 8:45 am]
 BILLING CODE 6560-50-P