[Federal Register Volume 84, Number 216 (Thursday, November 7, 2019)]
[Rules and Regulations]
[Pages 59932-59936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24268]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0357; FRL-10000-96]


Dinotefuran; Pesticide Tolerance for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of dinotefuran in or on fuzzy kiwifruit. This action is in 
response to EPA's granting of an emergency exemption under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of 
the pesticide on fuzzy kiwifruit. This regulation establishes a maximum 
permissible level for residues of dinotefuran in or on this commodity. 
The time-limited tolerance expires on December 31, 2022.

DATES: This regulation is effective November 7, 2019. Objections and 
requests for hearings must be received on or before January 6, 2020 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-2019-0357, 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: [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 40 CFR 
part 180 through the Government Publishing Office's e-CFR site at 
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp.

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

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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

[[Page 59933]]

proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2019-0357 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 January 6, 2020. 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-2019-0357, 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.
     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/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing a time-limited tolerance for residues of dinotefuran, and 
its metabolites DN,1-methyl-3-(tetrahydro-3-furylmethyl)guanidine, and 
UF, 1-methyl-3-(tetrahydro-3-furylmethyl)urea, calculated as the 
stoichiometric equivalent of dinotefuran, in or on kiwifruit, fuzzy at 
0.9 part per million (ppm). This time-limited tolerance expires on 
December 31, 2022.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    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. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Dinotefuran on Fuzzy Kiwifruit and FFDCA 
Tolerance

    According to the Alabama Department of Agriculture and Industries 
(ADAI), in 2017 brown marmorated stink bug (BMSB) damage was observed 
in a small block of nursery stock plants. This observation alerted the 
staff at the kiwi nursery to the potential of BMSB for the 2018 crop 
season. ADAI claimed that in 2018, BMSB severely damaged the kiwifruit 
crop, making it unmarketable. ADAI estimated losses as high as 50% for 
2018 and projected 2019 losses to be over $1.6 million without the use 
of this section 18 emergency exemption.
    After having reviewed the submission, EPA determined that an 
emergency condition exists for this State, and that the criteria for 
approval of an emergency exemption are met. EPA has authorized a 
specific exemption under FIFRA section 18 for the use of dinotefuran on 
fuzzy kiwifruit for control of brown marmorated stink bug in Alabama.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of dinotefuran 
in or on fuzzy kiwifruit. In doing so, EPA considered the safety 
standard in FFDCA section 408(b)(2), and EPA decided that the necessary 
tolerances under FFDCA section 408(l)(6) would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent, 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in FFDCA section 408(l)(6). Although 
this time-limited tolerance expires on December 31, 2022, under FFDCA 
section 408(l)(5), residues of the pesticide not in excess of the 
amount specified in the tolerance remaining in or on fuzzy kiwifruit 
after that date will not be unlawful, provided the pesticide was 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by this time-limited tolerance 
at the time of that application. EPA will take action to revoke this 
time-limited tolerance earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions about whether 
dinotefuran meets FIFRA's registration requirements for use on fuzzy 
kiwifruit or whether a permanent tolerance for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
time-limited tolerance decision serves as a basis for registration of 
dinotefuran by a State for special local needs under FIFRA section 
24(c), nor does this tolerance by itself serve as the authority for 
persons in any State other than Alabama to use this pesticide on the 
applicable crop under FIFRA section 18, absent the issuance of an 
emergency exemption applicable within that State. For additional 
information regarding the emergency exemption for dinotefuran, contact 
the Agency's Registration Division at the address provided under FOR 
FURTHER INFORMATION CONTACT.

[[Page 59934]]

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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 expected as a result of this emergency exemption request and 
the time-limited tolerance for residues of dinotefuran on kiwifruit, 
fuzzy at 0.9 ppm. EPA's assessment of exposures and risks associated 
with establishing the time-limited tolerance follows.

A. 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/pesticide-science-and-assessing-pesticide-risks.
    A summary of the toxicological endpoints for dinotefuran used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of April 10, 2013 (78 FR 21269) (FRL-
9381-5).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to dinotefuran, EPA considered exposure under the time-limited 
tolerance established by this action as well as all existing 
dinotefuran tolerances in 40 CFR 180.603. EPA assessed dietary 
exposures from dinotefuran in food as follows:
    i. Acute exposure. Acute effects were identified for dinotefuran. 
In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
2003-2008 National Health and Nutrition Examination Survey, What We Eat 
in America (NHANES/WWEIA). As to residue levels in food, EPA assumed 
tolerance-level residues, corrected for additional residues which are 
of concern for risk assessment, default processing factors when 
appropriate, and 100% crop treated assumptions.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level 
residues, corrected for additional residues which are of concern for 
the risk assessment, default processing factors when appropriate, and 
100% crop treated assumptions.
    iii. Cancer. Based on the data referenced in Unit IV.A., EPA has 
concluded that dinotefuran 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 dinotefuran. Tolerance level residues and 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 dinotefuran in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of dinotefuran. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Tier 1 Rice Model, the estimated drinking water 
concentrations (EDWCs) for surface water are 269 parts per billion 
(ppb) for acute exposure and 257 ppb for chronic exposure. Based on the 
use on turf, ornamentals, and Christmas trees, the EDWCs for ground 
water are 154 ppb for acute exposure and 132 ppb for chronic exposure.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 269 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 257 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).
    Dinotefuran is currently registered for uses that could result in 
short-term residential exposures: (Turf, ornamentals, indoor foggers, 
indoor broadcast, spot-ons, crack and crevice). Dinotefuran is also 
used on dogs, cats, and horses (spot-on and/or spray). The only 
potential post-application exposure pathway that was quantitatively 
assessed is the incidental oral exposure pathway for children 1 to less 
than 2 years old due to currently registered uses. The resulting 
margins of exposure (MOEs) range from 1,200 to 5,500,000 and are 
significantly greater than EPA's level of concern (LOC = 100). 
Residential exposure is not anticipated from the proposed use on 
kiwifruit; therefore, an updated residential exposure assessment was 
not conducted.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at: https://www.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 made a common 
mechanism of toxicity finding as to dinotefuran and any other 
substances and dinotefuran does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that dinotefuran 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://www.epa.gov/pesticide-
science-and-

[[Page 59935]]

assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

C. 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 SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There was no evidence 
(qualitative or quantitative) of increased susceptibility of the young 
following in utero exposures to rats and rabbits and following pre- and 
post-natal exposure to rats for 2-generations.
    3. Conclusion. EPA has determined that reliable data show that 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 dinotefuran is complete.
    ii. The neurotoxic potential of dinotefuran has been adequately 
considered. Dinotefuran is a neonicotinoid and has a neurotoxic mode of 
pesticidal action. Consistent with the mode of action, changes in motor 
activity were seen in repeat-dose studies, including the subchronic 
neurotoxicity study. Additionally, decreased grip strength and brain 
weight were observed in the offspring of a multi-generation 
reproduction study albeit at doses close to the limit dose. For these 
reasons, a developmental neurotoxicity (DNT) study was required. The 
DNT study did not show evidence of a unique sensitivity of the 
developing nervous system; no effects on neurobehavioral parameters 
were seen in the offspring at any dose, including the limit dose.
    iii. There is no evidence that dinotefuran 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 dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues corrected for additional 
residues of concern for risk assessment. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to dinotefuran in drinking water. EPA used similarly 
conservative assumptions to assess post application exposure of 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
dinotefuran.

D. 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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to dinotefuran will occupy 11% of the aPAD for children 1 to 2 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
dinotefuran from food and water will utilize 5.2% of the cPAD for 
(children 1 to 2 years old) the population group receiving the greatest 
exposure. Based on the explanation in the unit regarding residential 
use patterns, chronic residential exposure to residues of dinotefuran 
is not expected.
    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). Dinotefuran 
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 dinotefuran.
    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 720 for children 
1 to less than 2 years old from post-application hand-to-mouth 
exposures from fogger applications in indoor rooms or areas to control 
fleas. Although adults are expected to have short-term handler and 
post-application exposures to dinotefuran due to registered residential 
use patterns, quantitative dermal and inhalation assessments are not 
required since there was no dermal and inhalation hazard identified in 
the toxicity database. Therefore, the short-term aggregate assessment 
for adults is equivalent to the chronic dietary exposure and risk 
estimate for the most highly exposed adult population subgroup, adults 
20 to 49 years old, and is not of concern (1.4% cPAD). Because EPA's 
level of concern for dinotefuran is an MOE of 100 or below, these MOEs 
are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Dinotefuran is currently registered for uses that could result in 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to dinotefuran.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 1,400 for children 1 to less than 2 years old. The 
recommended residential exposure estimates for use in the children 1 to 
less than 2 years old intermediate- and chronic/long-term aggregate 
assessment reflects post-application hand-to-mouth exposures from pet 
spot-on applications to small dogs. Although adults are expected to 
also have long-term post-application exposures to dinotefuran due to 
the pet spot-on treatments, quantitative dermal and inhalation 
assessments are not required since there was no dermal and inhalation 
hazard identified in the toxicity database and oral exposure is not 
anticipated for adults. Therefore, the intermediate- and chronic/long-
term aggregate assessment for adults is equivalent to the chronic 
dietary exposure and risk estimate for the most highly exposed adult 
population subgroup, adults 20 to 49 years old, and is not of concern 
(1.4% cPAD). Because EPA's level of concern for dinotefuran is an MOE 
of 100 or below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of

[[Page 59936]]

evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, dinotefuran 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 dinotefuran residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (high performance liquid 
chromatography/tandem mass spectrometry (HPLC/MS/MS method for the 
determination of residues of dinotefuran, and the metabolites DN, and 
UF; an HPLC/ultraviolet (UV) detection method for the determination of 
residues of dinotefuran; and HPLC/MS and HPLC/MS/MS methods for the 
determination of DN and UF) 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 an MRL for residues of dinotefuran on 
kiwifruit, fuzzy.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
dinotefuran and its metabolites DN,1-methyl-3-(tetrahydro-3-
furylmethyl)guanidine, and UF, 1-methyl-3-(tetrahydro-3-
furylmethyl)urea, calculated as the stoichiometric equivalent of 
dinotefuran, in or on kiwifruit, fuzzy at 0.9 ppm. This tolerance 
expires on December 31, 2022.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and 
408(l)(6). 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 
it 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 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance 
with FFDCA sections 408(e) and 408(l)(6), 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).

VIII. 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: October 25, 2019.
Daniel Rosenblatt,
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.  180.603, add alphabetically an entry for ``Kiwifruit, 
fuzzy'' to the table in paragraph (b) to read as follows:


Sec.  180.603  Dinotefuran; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                 Parts per    Expiration
                   Commodity                      million        date
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                                * * * * *
Kiwifruit, fuzzy..............................          0.9   12/31/2022
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* * * * *
[FR Doc. 2019-24268 Filed 11-6-19; 8:45 am]
 BILLING CODE 6560-50-P