Flupyradifurone; Pesticide Tolerances for Emergency Exemptions, 13251-13256 [2017-04794]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 82, Number 46 (Friday, March 10, 2017)]
[Rules and Regulations]
[Pages 13251-13256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04794]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0557; FRL-9958-75]


Flupyradifurone; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of flupyradifurone [4-[[(6-chloro-3-pyridinyl)methyl](2,2-
difluoroethyl)amino]-2(5H)-furanone] in or on sweet sorghum, forage and 
sorghum, syrup resulting from use of flupyradifurone in accordance with 
the terms of crisis exemptions issued under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA). This action is in 
response to the issuance of crisis emergency exemptions under FIFRA 
section 18 authorizing use of the pesticide on sweet sorghum. This 
regulation establishes maximum permissible levels for residues of 
flupyradifurone in or on sweet sorghum forage and sorghum syrup. These 
time-limited tolerances expire on December 31, 2019.

DATES: This regulation is effective March 10, 2017. Objections and 
requests for hearings must be received on or before May 9, 2017, 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-2016-0557, 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

[[Page 13252]]

the visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. 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 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 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 
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2016-0557 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 9, 2017. 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-2016-0557, 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/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. 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 time-limited tolerances for residues of flupyradifurone in 
or on sweet sorghum, forage at 30.0 parts per million (ppm) and 
sorghum, syrup at 90.0 ppm. There are no Canadian or Codex MRLs for 
residues of flupyradifurone in or on sweet sorghum, forage or sorghum, 
syrup at this time, so international harmonization is not an issue for 
these time-limited tolerances. These time-limited tolerances expire on 
December 31, 2019.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement of a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under crisis exemptions issued 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 Exemptions for Flupyradifurone on Sweet Sorghum and 
FFDCA Tolerances

    Crisis exemptions for use of flupyradifurone on sweet sorghum to 
control sugarcane aphids were issued to the Arkansas, Kentucky, 
Mississippi, North Carolina, and Tennessee Departments of Agriculture. 
Sweet sorghum growers in these states experienced severe and damaging 
infestations of sugarcane aphids.
    The state agencies asserted that emergency conditions existed in 
accordance with the criteria for approval of an emergency exemption, 
and declared crisis exemptions under 40 CFR part 166, subpart C, to 
allow the use of flupyradifurone on sweet sorghum for control of 
sugarcane aphids. After having reviewed the emergency actions, EPA 
concurred on the crisis exemptions on July 21, 2016 in order to meet 
the needs of sweet sorghum growers in Arkansas, Kentucky, Mississippi, 
North Carolina, and Tennessee who faced significant economic loss 
resulting from sugarcane aphid damage. These crisis exemption programs 
expired on November 15, 2016.

[[Page 13253]]

    As part of its evaluation of the proposed crisis exemptions, EPA 
assessed the potential risks presented by residues of flupyradifurone 
in or on sweet sorghum. In doing so, EPA considered the safety standard 
in FFDCA section 408(b)(2), and EPA decided that the necessary time-
limited 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 these emergency exemptions in order to address 
an urgent non-routine situation and to ensure that the resulting food 
is safe and lawful, EPA is issuing these time-limited tolerances 
without notice and opportunity for public comment as provided in FFDCA 
section 408(l)(6). Although these time-limited tolerances expire on 
December 31, 2019 under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerances 
remaining in or on sweet sorghum, forage and sorghum, syrup 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 these time-limited tolerances at the time 
of that application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with scientific data or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
flupyradifurone meets FIFRA's registration requirements for use on 
sweet sorghum or whether permanent tolerances for this use would be 
appropriate. Under these circumstances, EPA does not believe that these 
time-limited tolerance decisions serve as a basis for registration of 
flupyradifurone by a State for special local needs under FIFRA section 
24(c), nor do these time-limited tolerances by themselves serve as the 
authority for persons in any State other than Arkansas, Kentucky, 
Mississippi, North Carolina, and Tennessee to use this pesticide on 
sweet sorghum under FIFRA section 18 absent the issuance of an 
emergency exemption applicable within that State. For additional 
information regarding the emergency exemptions for flupyradifurone, 
contact the Agency's Registration Division at the address provided 
under FOR FURTHER INFORMATION CONTACT.

IV. 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 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 these emergency exemption requests and 
the time-limited tolerances for residues of flupyradifurone on sweet 
sorghum, forage and sorghum, syrup at 30.0 and 90.0 parts per million 
(ppm) respectively. EPA's assessment of exposures and risks associated 
with establishing these time-limited tolerances 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 no 
observed adverse effect level or NOAEL) and the lowest dose at which 
adverse effects of concern are identified (the lowest observed adverse 
effect level or 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 flupyradifurone used 
for human risk assessment is discussed in Table 1 of Unit III B. of the 
final rule published in the Federal Register of January 23, 2015 (80 FR 
3483) (FRL-9914-77).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to flupyradifurone, EPA considered exposure under the time-
limited tolerances established by this action as well as all existing 
flupyradifurone tolerances in 40 CFR 180.679. EPA assessed dietary 
exposures from flupyradifurone 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. Such effects were identified 
for flupyradifurone. In estimating acute dietary exposure, EPA used 
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; 2003-2008), which it 
should be noted did not identify any individuals as consuming sweet 
sorghum. The flupyradifurone acute dietary exposure assessment was 
conducted using the Dietary Exposure Evaluation Model (DEEM, ver. 
3.16). An unrefined acute dietary exposure analysis was performed for 
the established and requested uses of flupyradifurone that incorporated 
recommended tolerance-level residues, default and empirical processing 
factors, and assumed that 100% of the crops were treated.
    ii. Chronic exposure. In conducting the chronic dietary (food and 
drinking water) exposure and risk assessment EPA used the food 
consumption data from the USDA's NHANES/WWEIA; 2003-2008, which did not 
identify any

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individuals as consuming sweet sorghum. The flupyradifurone chronic 
dietary exposure assessment was conducted using the Dietary Exposure 
Evaluation Model (DEEM, ver. 3.16). An unrefined chronic dietary 
exposure analysis was performed for the established and requested uses 
of flupyradifurone that incorporated recommended tolerance-level 
residues, default and empirical processing factors, and assumed that 
100% of the crops were treated.
    iii. Cancer. Based on the data summarized in Table 1 of Unit III B. 
of the final rule published in the Federal Register of January 23, 2015 
(80 FR 3483) (FRL-9914-77), EPA has concluded that flupyradifurone 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 flupyradifurone. 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 flupyradifurone in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of flupyradifurone. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS), Tier 1 Rice Model and Pesticide Root Zone Model 
Ground Water (PRZM GW) model, the estimated drinking water 
concentrations (EDWCs) of flupyradifurone for acute exposures are 
estimated to be 112 parts per billion (ppb) for surface water and 352 
ppb for ground water, and for chronic exposures are estimated to be 112 
ppb for surface water and 307 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 352 ppb was used to assess 
the contribution to drinking water. For the chronic dietary risk 
assessment, the water concentration value of 307 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).
    Flupyradifurone is not registered for any specific use patterns 
that would result in residential exposure. Residential exposure is not 
anticipated from the proposed section 18 use on sweet sorghum.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at: https://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 flupyradifurone to share a common mechanism of 
toxicity with any other substances, and flupyradifurone does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this time-limited tolerance action, therefore, EPA has 
assumed that flupyradifurone 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 Web site 
at https://www.epa.gov/pesticides/cumulative.

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 Food Quality 
Protection Act (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 is no evidence in the 
rat developmental study that developing animals have increased 
susceptibility to flupyradifurone. There is quantitative increase in 
susceptibility in the rabbit developmental and rat reproduction 
studies. In the rabbit developmental study, no maternal effect was seen 
at the highest tested dose (80 milligram/kilogram/day (mg/kg/day)), 
while there was an increase in fetal death and decrease fetal body 
weight at the same dose level. In the rat reproduction study, decreases 
in maternal body weight were seen at 137 mg/kg/day, whereas decreases 
in pup body weight were seen at the next lower dose, 38.7 mg/kg/day. 
However, the PODs selected for risk assessment are protective of the 
quantitative susceptibility seen in the rabbit fetuses and rat pups.
    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 flupyradifurone is complete.
    ii. Although there is evidence that flupyradifurone has neurotoxic 
effects, EPA has a complete set of neurotoxicity studies (acute, 
subchronic, and developmental). The effects of those studies are well-
characterized and indicate neurotoxic effects that occur at levels 
above the chronic POD that was selected for risk assessment. The NOAEL 
for the acute neurotoxicity study is being used for the acute POD. 
Therefore, there is no need to retain the 10X FQPA SF to account for 
any uncertainty concerning these effects.
    iii. There is no evidence that flupyradifurone produces increased 
susceptibility in the prenatal developmental study in rats, but there 
is increased quantitative susceptibility in rabbit fetuses and in the 
rat pups. However, the PODs selected for risk assessment are protective 
of the quantitative susceptibility seen in the fetuses and rat pups.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were 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 flupyradifurone in drinking water. EPA used 
similarly conservative assumptions to assess post-application exposure 
of children. These assessments will not underestimate the exposure and 
risks posed by flupyradifurone.
    EPA made conservative (protective) assumptions in the ground and 
surface water modeling used to assess exposure to flupyradifurone in 
drinking water. These assessments will not

[[Page 13255]]

underestimate the exposure and risks posed by flupyradifurone.

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 flupyradifurone will occupy 37% of the aPAD for children 1-2 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 
flupyradifurone from food and water will utilize 86% of the cPAD for 
(children 1-2 years old) the population group receiving the greatest 
exposure. There are no residential uses for flupyradifurone and 
residential uses are not anticipated from the proposed section 18 on 
sweet sorghum.
    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).
    As there are no residential uses of flupyradifurone, 
flupyradifurone does not pose a short-term aggregate risk that differs 
from the chronic dietary risk addressed in Unit IV.D.2. Chronic dietary 
risks do not exceed the Agency's level for the U.S. population or any 
other population subgroups.
    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).
    As there are no residential uses of flupyradifurone, 
flupyradifurone does not pose an intermediate-term aggregate risk that 
differs from the chronic dietary risk addressed in Unit IV.D.2. Chronic 
dietary risks do not exceed the Agency's level for the U.S. population 
or any other population subgroups.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, flupyradifurone 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 flupyradifurone residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method (Method RV-001-P10-03), which uses 
high-performance liquid chromatography with tandem mass spectrometry 
(HPLC/MS/MS) to quantitate residues of flupyradifurone and 
difluoroacetic acid (DFA) in various crops, is available for 
enforcement.
    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: 
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.
    There are currently no established Codex or Canadian MRLs for 
flupyradifurone residues in sweet sorghum commodities.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
flupyradifurone, [4-[[(6-chloro-3-pyridinyl)methyl](2,2-
difluoroethyl)amino]-2(5H)-furanone] in or on sweet sorghum, forage at 
30.0 and sorghum, syrup at 90.0 parts per million (ppm).

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). 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 tolerances 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

[[Page 13256]]

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 submitted a report containing a draft of 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: February 13, 2017.
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.  180.679, revise paragraph (b) to read as follows:


Sec.  180.679  Flupyradifurone; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of flupyradifurone, including its metabolites 
and degradates in or on the specified commodities listed in the table 
below, resulting from use of the pesticide under section 18 emergency 
exemptions granted by EPA. The time-limited tolerances expire and are 
revoked on the date specified in the table. Compliance with the 
tolerance levels specified in the following table is to be determined 
by measuring only flupyradifurone, 4-[[(6-chloro-3-
pyridinyl)methyl](2,2-difluoroethyl)amino]-2(5H)-furanone in or on the 
commodity.

------------------------------------------------------------------------
                                 Parts per
          Commodity            million (ppm)        Expiration date
------------------------------------------------------------------------
sorghum, syrup..............            90.0  December 31, 2019.
sweet sorghum, forage.......            30.0  December 31, 2019.
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-04794 Filed 3-9-17; 8:45 am]
 BILLING CODE 6560-50-P