[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Rules and Regulations]
[Pages 20037-20042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09377]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0532; FRL-9990-60]


Cyflumetofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
insecticide cyflumetofen in or on tea, dried. OAT Agrio. Ltd., Tokyo, 
Japan c/o Landis International, Inc. requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 8, 2019. Objections and 
requests for hearings must be received on or before July 8, 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-2017-0532, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, P.E., Director, 
Registration Division (750P), 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-2017-0532 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 
July 8, 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-2017-0532, 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 December 15, 2017 (82 FR 59604) (FRL-
9970-50), 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 
7E8609) by OAT Agrio. Ltd., Tokyo, Japan, c/o Landis International, 
Inc., 3185 Madison Highway, P.O. Box 5126, Valdosta,

[[Page 20038]]

Georgia 31603-5126. The petition requested that 40 CFR 180.677 be 
amended by establishing tolerances for residues of the insecticide 
cyflumetofen, (2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-
dimethylethyl)phenyl]-[beta]-oxo-2-(trifluoromethyl)benzenepropanoate), 
in or on tea at 40 parts per million (ppm). That document referenced a 
summary of the petition prepared by OAT Agrio. Ltd. c/o Landis 
International, Inc., the registrant, which is available in the docket, 
http://www.regulations.gov. These tolerances were requested to cover 
residues of cyflumetofen in or on tea resulting from use of this 
pesticide on tea outside the United States. There is no current U.S. 
registration for use of cyflumetofen on tea. Four comments were 
submitted to the docket concerning issues outside the scope of this 
rulemaking.
    Based upon review of the data supporting the referenced petition, 
EPA is establishing a tolerance for residues of cyflumetofen on tea, 
dried.

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 cyflumetofen including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with cyflumetofen 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.
    Cyflumetofen has a low acute toxicity via the acute oral, dermal, 
and inhalation routes of exposure. It is minimally irritating to the 
eyes but not to the skin. Cyflumetofen is a skin sensitizer. The major 
target organ in rats, mice, and dogs following short- and long-term 
oral administration of cyflumetofen is the adrenal glands characterized 
by increased organ weight and histopathology (vacuolation and 
hypertrophy of the adrenal cortical cells).
    There is no evidence of increased qualitative or quantitative 
susceptibility in the rat 2-generation reproduction study; however, the 
rat and rabbit developmental studies indicate susceptibility in the 
pups. There is evidence of increased quantitative susceptibility in the 
rabbit developmental toxicity study, since developmental effects at the 
limit dose were observed where no maternal toxicity was present. There 
is evidence of increased qualitative susceptibility in the rat 
developmental toxicity study as developmental effects were seen at the 
same dose that caused an increase in adrenal weights and organ-to-body 
weight ratio in the maternal animals.
    There is no evidence of neurotoxicity in any of the submitted 
studies for cyflumetofen.
    Cyflumetofen has been classified as having ``Suggestive Evidence of 
Carcinogenic Potential'' in accordance with the EPA's Final Guidelines 
for Carcinogen Risk Assessment (March 2005). This classification is 
based on the presence of a single tumor type (thyroid c-cell) in one 
sex (male) and one species (rat), and the lack of concern for 
mutagenicity. When there is suggestive evidence of carcinogenicity, the 
Agency does not attempt a dose-response assessment as the nature of the 
data generally would not support one. Therefore, the Agency has 
determined that quantification of risk using a non-linear approach 
(i.e., the chronic reference dose) will adequately protect for all 
chronic toxicity, including carcinogenicity, likely to result from 
exposure to cyflumetofen.
    More detailed information on the studies received and the nature of 
the adverse effects caused by cyflumetofen as well as the NOAEL and the 
LOAEL from the toxicological studies can be found in the document 
entitled, ``Cyflumetofen. Human Health Risk Assessment to Support New 
Uses on Imported Tea,'' dated March 4, 2019, by going to http://www.regulations.gov. The referenced document is available in the docket 
established by this action, which is described under ADDRESSES. Locate 
and click on the hyperlink for docket ID number EPA-HQ-OPP-2017-0532. 
Double-click on the document to view the referenced information.

B. Toxicological Points of Departure/Levels of Concern

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

[[Page 20039]]



  Table --Summary of Toxicological Doses and Endpoints for Cyflumetofen 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)..  An acute RfD has not been established for either the general U.S. population
                                    or for females 13-49 years of age since there were no appropriate studies
                                    that demonstrated evidence of toxicity attributable to a single dose for
                                    these populations.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All Populations)  NOAEL = 16.5 mg/kg/   Chronic RfD = 0.17   Three co-critical studies:
                                    day.                  mg/kg/day.          90-Day Feeding Study in Rats.
                                   UFA = 10x...........  cPAD = 0.17 mg/kg/    LOAEL = 1,000 ppm (54.5/62.8 mg/
                                   UFH = 10x...........   day.                 kg/day in males/females) based on
                                   FQPA SF = 1x........                        hematology and organ weight
                                                                               changes in the liver, adrenal,
                                                                               kidney and ovaries; and
                                                                               histopathology effects in the
                                                                               adrenals and the ovaries. NOAEL =
                                                                               300 ppm (16.5/19 mg/kg/day in
                                                                               males/females).
                                                                              Chronic Toxicity/Carcinogenicity
                                                                               Study in Rats. LOAEL = 1,500 ppm
                                                                               (49.5/61.9 mg/kg/day in males/
                                                                               females) based on increased
                                                                               adrenal weights and
                                                                               histopathology. NOAEL = 500 ppm
                                                                               (16.5/20.3 mg/kg/day in males/
                                                                               females).
                                                                              Two-Generation Reproduction Study
                                                                               in Rats. Parental: LOAEL = 500
                                                                               ppm (30.6/46.6 mg/kg/day in males/
                                                                               females) based on increased organ
                                                                               weight and histopathology in
                                                                               adrenals. NOAEL = 150 ppm (9.2/
                                                                               13.8 mg/kg/day in males/females).
----------------------------------------------------------------------------------------------------------------
Adult and Incidental Oral (Short-  NOAEL = 16.5 mg/kg/   LOC for MOE = <100.  Same as chronic dietary endpoint.
 and Intermediate-Term).            day.
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Dermal (Short- and Intermediate-   No dermal hazard was identified. No appropriate endpoint was selected for
 Term).                             risk assessment.
----------------------------------------------------------------------------------------------------------------
Inhalation (Short- and             NOAEL = 16.5 mg/kg/   Occupational and     Same as chronic dietary endpoint.
 Intermediate-Term).                day.                  Residential LOC
                                   UFA = 10x...........   for MOE = <100.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, Dermal, and          Classification: ``Suggestive Evidence of Carcinogenic Potential.''
 Inhalation).
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = Food Quality
  Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose.
  MOE = margin of exposure. LOC = level of concern. N/A = not applicable.

    More detailed information on the toxicological endpoints for 
cyflumetofen can be found in the document entitled, ``Cyflumetofen. 
Human Health Risk Assessment to Support New Uses on Imported Tea,'' 
dated March 4, 2019, by going to http://www.regulations.gov. The 
referenced document is available in the docket established by this 
action, which is described under ADDRESSES. Locate and click on the 
hyperlink for docket ID number EPA-HQ-OPP-2017-0532. Double-click on 
the document to view the referenced information.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyflumetofen, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyflumetofen tolerances in 40 
CFR 180.677. EPA assessed dietary exposures from cyflumetofen in food 
as follows:
    i. Acute exposure. No acute dietary exposure and risk analysis was 
performed since there were no appropriate studies identified in the 
toxicology database that demonstrated evidence of toxicity attributable 
to a single dose.
    ii. Chronic exposure. An unrefined chronic dietary analysis was 
conducted that was based on tolerance-level residues, 100% crop treated 
(%CT) assumptions, and empirical processing estimates when available or 
DEEM\TM\ processing factors. Using assumptions considered to be highly 
protective, the estimated dietary risks ranged from <1% of the cPAD for 
the general U.S. population to 2.4% of the cPAD for the highest exposed 
population subgroup of children 1-2 years old. The Agency's LOC is 
<100% cPAD.
    iii. Cancer. As explained in unit III.A., quantification of risk 
using a non-linear approach (i.e., a cPAD) will adequately account for 
all chronic toxicity, including carcinogenicity, that could result from 
exposure to cyflumetofen.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue information in the dietary 
assessment for cyflumetofen. Tolerance-level residues and/or 100% CT 
were assumed for all food commodities.
    More detailed information on the acute and chronic dietary (food 
only) exposure and risk assessment for cyflumetofen can be found in the 
document entitled, ``Cyflumetofen. Human Health Risk Assessment to 
Support New Uses on Imported Tea,'' dated March 4, 2019, by going to 
http://www.regulations.gov. The referenced document is available in the 
docket established by this action, which is described under ADDRESSES. 
Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2017-
0532. Double-click on the document to view the referenced information.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for cyflumetofen in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of cyflumetofen. Further information regarding EPA 
drinking water models used in pesticide exposure assessment

[[Page 20040]]

can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    The estimated drinking water concentrations (EDWCs) previously used 
in the dietary risk assessment were incorporated directly into this 
dietary assessment. The Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM/EXAMS) simulations of a NY grapes scenario 
produced the highest surface-water EDWCs (0.33 ppb for chronic dietary 
exposure) and an updated EDWC was not required for this assessment 
since the proposed use on imported tea will not impact the previously 
provided estimates.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.33 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). The registered uses 
of cyflumetofen on ornamentals may result in adult residential handler 
and post-application exposure. This exposure is expected to be only 
short-term in duration (i.e., 1 to 30 days) as intermediate- or long-
term exposures are not likely based on the intermittent nature of 
applications by homeowners. Since no dermal hazard was identified for 
cyflumetofen in the toxicological database, only inhalation exposure 
assessments were conducted. The resulting inhalation margins of 
exposure (MOEs) for all scenarios are not of concern since they are 
above the level of concern (LOC) of 100 (MOEs >=100). Based on the 
registered use pattern, exposure to children in residential settings is 
not anticipated. Further information regarding EPA standard assumptions 
and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 cyflumetofen to share a common mechanism of 
toxicity with any other substances, and cyflumetofen does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
cyflumetofen 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://www.epa.gov/pesticides/cumulative.

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 Food Quality 
Protection Act Safety Factor (FQPA 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 qualitative or quantitative susceptibility in the rat 2-
generation reproduction study; however, the rat and rabbit 
developmental studies indicate susceptibility in the pups. There is 
evidence of increased quantitative susceptibility in the rabbit 
developmental toxicity study, since developmental effects (changes in 
ossicification, paw flexion, and decreased fetal body weights) at the 
limit dose were observed where no maternal toxicity was present. There 
is evidence of increased qualitative susceptibility in the rat 
developmental toxicity study as developmental effects (increased 
incidence of incompletely ossified sternal centra) were seen at the 
same dose that caused an increase in adrenal weights and organ-to-body 
weight ratio in the maternal animals. Notwithstanding, the degree of 
concern for these effects in infants and children is low because the 
rat and rabbit developmental effects have clearly defined NOAEL/LOAELs 
and the dose selected for chronic risk assessment is protective of 
these effects. Therefore, the PODs based on adrenal effects in rat are 
health protective of all life stages.
    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 cyflumetofen is complete and adequate 
to characterize potential pre- and/or post-natal risk for infants and 
children.
    ii. There are acute and subchronic neurotoxicity studies available. 
There is no indication that cyflumetofen is a neurotoxic chemical in 
any of the submitted studies for cyflumetofen, and there is no need for 
a developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iii. While there is evidence of increased susceptibility in the 
rabbit and rat developmental studies, these studies have clearly 
defined NOAEL/LOAELs based on the explanation in Unit III.D.2. above.
    iv. There are no residual uncertainties identified in the exposure 
database. Since the dietary and residential exposure estimates were 
based on conservative assumptions, EPA is confident that this 
assessment does not underestimate dietary (food and water) or 
residential exposure.

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 dietary risk assessment takes 
into account acute exposure estimates from dietary consumption of food 
and drinking water. No acute dietary exposure and risk analysis was 
performed since there were no appropriate studies identified in the 
toxicology database that demonstrated evidence of toxicity attributable 
to a single dose.
    2. Chronic risk. Using the exposure assumptions described in the 
unit for chronic exposure, EPA has concluded that chronic exposure to 
cyflumetofen from food and water will utilize 2.4% 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 
cyflumetofen is not expected.

[[Page 20041]]

    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). Cyflumetofen 
is currently registered for use on ornamentals that result in 
residential handler exposure. Residential handler exposure is expected 
to be short-term in duration as intermediate- or long-term exposures 
are not likely because of the intermittent nature of applications by 
homeowners, and the Agency has determined that it is appropriate to 
aggregate chronic exposure through food and water with short-term 
residential exposures to cyflumetofen.
    Since no dermal hazard was identified for cyflumetofen in the 
toxicological database, only inhalation exposure assessments were 
conducted for residential handlers. The most conservative residential 
exposure scenario was chosen for the adult population which reflects 
inhalation exposure from mixing/loading/applying the liquid 
cyflumetofen formulation with a backpack sprayer. For background 
dietary exposure, the adult sub-population with the highest exposure 
(adults 50-99) was chosen since this is protective for all other adult 
sub-populations. There are no residential exposures expected for 
children; therefore, a short-term aggregate risk assessment for 
children is equal to the chronic food and drinking water exposure and 
risk estimates and is not of concern. 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 above the LOC of 100 for all scenarios assessed and are 
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, 
cyflumetofen 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 
cyflumetofen.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA concluded that the nonlinear approach for assessing 
potential cancer risk from exposure to cyflumetofen is appropriate. As 
noted in this Unit, the chronic risk aggregate exposure to cyflumetofen 
is below the Agency's level of concern; therefore, the Agency concludes 
that there is not a cancer risk of concern from exposure to 
cyflumetofen.
    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 cyflumetofen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology is available to enforce the 
HED-recommended tolerances for cyflumetofen in plant commodities. The 
high-performance liquid chromatography with tandem mass spectrometry 
(HPLC-MS/MS) method has been adequately validated, has undergone a 
successful ILV (independent laboratory validation), is considered 
adequately radio-validated and has been reviewed by the Agency for 
appropriateness as an enforcement method. The method limit of detection 
(LOD) for residues of cyflumetofen in tea is 0.01 ppm. Cyflumetofen has 
also been subjected to analysis by the Food and Drug Administration 
(FDA) multi-residue method (MRM) protocols. Cyflumetofen is not 
adequately recovered through any of the FDA multi-residue protocols.
    The method 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.
    Codex has not established maximum residue limits (MRLs) for 
residues of cyflumetofen in tea commodities; therefore, there are no 
harmonization issues.

C. Revisions to Petitioned-For Tolerances

    To conform with to the Agency's preferred commodity vocabulary, EPA 
is establishing the tolerance for tea on ``tea, dried'', which will 
cover residues on all tea commodities.

V. Conclusion

    Therefore, a tolerance is established for residues of the 
insecticide cyflumetofen, (2-methoxyethyl [alpha]-cyano-[alpha]-[4-
(1,1-dimethylethyl)phenyl]-[beta]-oxo-2-
(trifluoromethyl)benzenepropanoate), in or on tea at 40 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance 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), nor is considered a regulatory 
action under 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

[[Page 20042]]

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: April 26, 2019.
Donna Davis,
Acting 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.  180.677, add alphabetically the commodity ``tea, dried'' to 
the table in paragraph (a) to read as follows:


Sec.  180.677   Cyflumetofen; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Tea, dried \1\..............................................          40
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for this commodity as of May 8,
  2019.

* * * * *
[FR Doc. 2019-09377 Filed 5-7-19; 8:45 am]
BILLING CODE 6560-50-P