82_FR_13297 82 FR 13251 - Flupyradifurone; Pesticide Tolerances for Emergency Exemptions

82 FR 13251 - Flupyradifurone; Pesticide Tolerances for Emergency Exemptions

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 46 (March 10, 2017)

Page Range13251-13256
FR Document2017-04794

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.

Federal Register, Volume 82 Issue 46 (Friday, March 10, 2017)
[Federal Register Volume 82, Number 46 (Friday, March 10, 2017)]
[Rules and Regulations]
[Pages 13251-13256]
From the Federal Register Online  [www.thefederalregister.org]
[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 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

[[Page 13252]]

the visitor instructions and additional information about the docket 
available at http://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 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 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: 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. 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 http://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

[[Page 13254]]

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 http://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: 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 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 http://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



                                                                        Federal Register / Vol. 82, No. 46 / Friday, March 10, 2017 / Rules and Regulations                                                                         13251

                                             U.S.C. 3501 et seq., nor does it require                                67249, November 9, 2000) do not apply                                    PART 180—[AMENDED]
                                             any special considerations under                                        to this action. In addition, this action
                                             Executive Order 12898, entitled                                         does not impose any enforceable duty or                                  ■ 1. The authority citation for part 180
                                             ‘‘Federal Actions to Address                                            contain any unfunded mandate as                                          continues to read as follows:
                                             Environmental Justice in Minority                                       described under Title II of the Unfunded
                                             Populations and Low-Income                                              Mandates Reform Act (UMRA) (2 U.S.C.                                         Authority: 21 U.S.C. 321(q), 346a and 371.
                                             Populations’’ (59 FR 7629, February 16,                                 1501 et seq.).                                                           ■ 2. In § 180.337 revise paragraph (b) to
                                             1994).                                                                    This action does not involve any
                                                                                                                     technical standards that would require                                   read as follows:
                                                Since tolerances and exemptions that
                                             are established in accordance with                                      Agency consideration of voluntary                                        § 180.337 Oxytetracycline; tolerances for
                                             FFDCA sections 408(e) and 408(l)(6),                                    consensus standards pursuant to section                                  residues.
                                             such as the tolerance in this final rule,                               12(d) of the National Technology
                                                                                                                                                                                              *      *    *    *     *
                                             do not require the issuance of a                                        Transfer and Advancement Act
                                             proposed rule, the requirements of the                                  (NTTAA) (15 U.S.C. 272 note).                                              (b) Section 18 emergency exemptions.
                                             Regulatory Flexibility Act (RFA) (5                                                                                                              Time-limited tolerances specified in the
                                                                                                                     VIII. Congressional Review Act                                           following table are established for
                                             U.S.C. 601 et seq.) do not apply.
                                                                                                                       Pursuant to the Congressional Review                                   residues of the fungicide/bactericide
                                                This action directly regulates growers,
                                                                                                                     Act (5 U.S.C. 801 et seq.), EPA                                          oxytetracycline, including its
                                             food processors, food handlers, and food
                                                                                                                     submitted a report containing this rule                                  metabolites and degradates, in or on the
                                             retailers, not States or tribes, nor does
                                                                                                                     and other required information to the                                    commodities in the table in this
                                             this action alter the relationships or
                                                                                                                     U.S. Senate, the U.S. House of                                           paragraph. Compliance with the
                                             distribution of power and                                               Representatives, and the Comptroller
                                             responsibilities established by Congress                                                                                                         tolerance levels specified in this
                                                                                                                     General of the United States prior to                                    paragraph is to be determined by
                                             in the preemption provisions of FFDCA                                   publication of the rule in the Federal
                                             section 408(n)(4). As such, the Agency                                                                                                           measuring only oxytetracycline,
                                                                                                                     Register. This action is not a ‘‘major
                                             has determined that this action will not                                                                                                         (4S,4aR,5S,5aR,6S,12aS)-4-
                                                                                                                     rule’’ as defined by 5 U.S.C. 804(2).
                                             have a substantial direct effect on States                                                                                                       (dimethylamino)-1,4,4a,5,5a,6,11,12a-
                                             or tribal governments, on the                                           List of Subjects in 40 CFR Part 180                                      octahydro-3,5,6,10,12,12a-hexahydroxy-
                                             relationship between the national                                         Environmental protection,                                              6-methyl-1,11-dioxo-2-
                                             government and the States or tribal                                     Administrative practice and procedure,                                   naphthacenecarboxamide, in or on the
                                             governments, or on the distribution of                                  Agricultural commodities, Pesticides                                     specified agricultural commodities,
                                             power and responsibilities among the                                    and pests, Reporting and recordkeeping                                   resulting from use of the pesticide
                                             various levels of government or between                                 requirements.                                                            pursuant to FIFRA section 18
                                             the Federal Government and Indian                                                                                                                emergency exemptions. The tolerances
                                                                                                                       Dated: February 23, 2017,
                                             tribes. Thus, the Agency has determined                                                                                                          expire on the dates specified in the
                                             that Executive Order 13132, entitled                                    Michael Goodis,
                                                                                                                     Director, Registration Division, Office of                               table.
                                             ‘‘Federalism’’ (64 FR 43255, August 10,
                                                                                                                     Pesticide Programs.
                                             1999) and Executive Order 13175,
                                             entitled ‘‘Consultation and Coordination                                  Therefore, 40 CFR chapter I is
                                             with Indian Tribal Governments’’ (65 FR                                 amended as follows:

                                                                                                                                                                                                                                Expiration/
                                                                                                                                                                                                                   Parts per
                                                                                                                      Commodity                                                                                                 revocation
                                                                                                                                                                                                                    million        date

                                             Fruit, citrus, group 10–10 ........................................................................................................................................     0.40       12/31/2019



                                             *        *        *        *         *                                  difluoroethyl)amino]-2(5H)-furanone] in                                  in accordance with the instructions
                                             [FR Doc. 2017–04795 Filed 3–9–17; 8:45 am]                              or on sweet sorghum, forage and                                          provided in 40 CFR part 178 (see also
                                             BILLING CODE 6560–50–P                                                  sorghum, syrup resulting from use of                                     Unit I.C. of the SUPPLEMENTARY
                                                                                                                     flupyradifurone in accordance with the                                   INFORMATION).
                                                                                                                     terms of crisis exemptions issued under
                                             ENVIRONMENTAL PROTECTION                                                                                                                         ADDRESSES:   The docket for this action,
                                                                                                                     section 18 of the Federal Insecticide,
                                             AGENCY                                                                                                                                           identified by docket identification (ID)
                                                                                                                     Fungicide, and Rodenticide Act
                                                                                                                                                                                              number EPA–HQ–OPP–2016–0557, is
                                                                                                                     (FIFRA). This action is in response to
                                             40 CFR Part 180                                                                                                                                  available at http://www.regulations.gov
                                                                                                                     the issuance of crisis emergency
                                                                                                                                                                                              or at the Office of Pesticide Programs
                                             [EPA–HQ–OPP–2016–0557; FRL–9958–75]                                     exemptions under FIFRA section 18
                                                                                                                                                                                              Regulatory Public Docket (OPP Docket)
                                                                                                                     authorizing use of the pesticide on
                                                                                                                                                                                              in the Environmental Protection Agency
                                             Flupyradifurone; Pesticide Tolerances                                   sweet sorghum. This regulation
                                                                                                                                                                                              Docket Center (EPA/DC),West William
                                             for Emergency Exemptions                                                establishes maximum permissible levels
                                                                                                                                                                                              Jefferson Clinton Bldg., Rm. 3334, 1301
                                                                                                                     for residues of flupyradifurone in or on
                                             AGENCY:  Environmental Protection                                                                                                                Constitution Ave. NW., Washington, DC
pmangrum on DSK3GDR082PROD with RULES




                                                                                                                     sweet sorghum forage and sorghum
                                             Agency (EPA).                                                                                                                                    20460–0001. The Public Reading Room
                                                                                                                     syrup. These time-limited tolerances
                                             ACTION: Final rule.                                                                                                                              is open from 8:30 a.m. to 4:30 p.m.,
                                                                                                                     expire on December 31, 2019.
                                                                                                                                                                                              Monday through Friday, excluding legal
                                             SUMMARY:  This regulation establishes                                   DATES: This regulation is effective                                      holidays. The telephone number for the
                                             time-limited tolerances for residues of                                 March 10, 2017. Objections and requests                                  Public Reading Room is (202) 566–1744,
                                             flupyradifurone [4-[[(6-chloro-3-                                       for hearings must be received on or                                      and the telephone number for the OPP
                                             pyridinyl)methyl](2,2-                                                  before May 9, 2017, and must be filed                                    Docket is (703) 305–5805. Please review


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                                             13252               Federal Register / Vol. 82, No. 46 / Friday, March 10, 2017 / Rules and Regulations

                                             the visitor instructions and additional                 as described in 40 CFR part 178, please               from the requirement of a tolerance on
                                             information about the docket available                  submit a copy of the filing (excluding                its own initiative, i.e., without having
                                             at http://www.epa.gov/dockets.                          any Confidential Business Information                 received any petition from an outside
                                             FOR FURTHER INFORMATION CONTACT:                        (CBI)) for inclusion in the public docket.            party.
                                             Michael L. Goodis, Registration Division                Information not marked confidential                      Section 408(b)(2)(A)(i) of FFDCA
                                             (7505P), Office of Pesticide Programs,                  pursuant to 40 CFR part 2 may be                      allows EPA to establish a tolerance (the
                                             Environmental Protection Agency, 1200                   disclosed publicly by EPA without prior               legal limit for a pesticide chemical
                                             Pennsylvania Ave. NW., Washington,                      notice. Submit the non-CBI copy of your               residue in or on a food) only if EPA
                                             DC 20460–0001; main telephone                           objection or hearing request, identified              determines that the tolerance is ‘‘safe.’’
                                             number: (703) 305–7090; email address:                  by docket ID number EPA–HQ–OPP–                       Section 408(b)(2)(A)(ii) of FFDCA
                                             RDFRNotices@epa.gov.                                    2016–0557, by one of the following                    defines ‘‘safe’’ to mean that ‘‘there is a
                                                                                                     methods:                                              reasonable certainty that no harm will
                                             SUPPLEMENTARY INFORMATION:
                                                                                                       • Federal eRulemaking Portal: http://               result from aggregate exposure to the
                                             I. General Information                                  www.regulations.gov. Follow the online                pesticide chemical residue, including
                                                                                                     instructions for submitting comments.                 all anticipated dietary exposures and all
                                             A. Does this action apply to me?
                                                                                                     Do not submit electronically any                      other exposures for which there is
                                                You may be potentially affected by                   information you consider to be CBI or                 reliable information.’’ This includes
                                             this action if you are an agricultural                  other information whose disclosure is                 exposure through drinking water and in
                                             producer, food manufacturer, or                         restricted by statute.                                residential settings, but does not include
                                             pesticide manufacturer. The following                     • Mail: OPP Docket, Environmental                   occupational exposure. Section
                                             list of North American Industrial                       Protection Agency Docket Center (EPA/                 408(b)(2)(C) of FFDCA requires EPA to
                                             Classification System (NAICS) codes is                  DC), (28221T), 1200 Pennsylvania Ave.                 give special consideration to exposure
                                             not intended to be exhaustive, but rather               NW., Washington, DC 20460–0001.                       of infants and children to the pesticide
                                             provides a guide to help readers                          • Hand Delivery: To make special                    chemical residue in establishing a
                                             determine whether this document                         arrangements for hand delivery or                     tolerance and to ‘‘ensure that there is a
                                             applies to them. Potentially affected                   delivery of boxed information, please                 reasonable certainty that no harm will
                                             entities may include:                                   follow the instructions at http://                    result to infants and children from
                                                • Crop production (NAICS code 111).                  www.epa.gov/dockets/contacts.html.                    aggregate exposure to the pesticide
                                                • Animal production (NAICS code                        Additional instructions on                          chemical residue. . . .’’
                                             112).                                                   commenting or visiting the docket,                       Section 18 of FIFRA authorizes EPA
                                                • Food manufacturing (NAICS code                     along with more information about                     to exempt any Federal or State agency
                                             311).                                                   dockets generally, is available at http://            from any provision of FIFRA, if EPA
                                                • Pesticide manufacturing (NAICS                     www.epa.gov/dockets.                                  determines that ‘‘emergency conditions
                                             code 32532).                                            II. Background and Statutory Findings                 exist which require such exemption.’’
                                                                                                                                                           EPA has established regulations
                                             B. How can I get electronic access to                      EPA, on its own initiative, in                     governing such emergency exemptions
                                             other related information?                              accordance with FFDCA sections 408(e)                 in 40 CFR part 166.
                                               You may access a frequently updated                   and 408(l)(6) of, 21 U.S.C. 346a(e) and
                                             electronic version of 40 CFR part 180                   346a(1)(6), is establishing time-limited              III. Emergency Exemptions for
                                             through the Government Printing                         tolerances for residues of                            Flupyradifurone on Sweet Sorghum
                                             Office’s e-CFR site at http://                          flupyradifurone in or on sweet sorghum,               and FFDCA Tolerances
                                             www.ecfr.gov/cgi-bin/text-                              forage at 30.0 parts per million (ppm)                   Crisis exemptions for use of
                                             idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    and sorghum, syrup at 90.0 ppm. There                 flupyradifurone on sweet sorghum to
                                             40tab_02.tpl.                                           are no Canadian or Codex MRLs for                     control sugarcane aphids were issued to
                                                                                                     residues of flupyradifurone in or on                  the Arkansas, Kentucky, Mississippi,
                                             C. How can I file an objection or hearing               sweet sorghum, forage or sorghum,                     North Carolina, and Tennessee
                                             request?                                                syrup at this time, so international                  Departments of Agriculture. Sweet
                                               Under section 408(g) of the Federal                   harmonization is not an issue for these               sorghum growers in these states
                                             Food, Drug, and Cosmetic Act (FFDCA),                   time-limited tolerances. These time-                  experienced severe and damaging
                                             21 U.S.C. 346a, any person may file an                  limited tolerances expire on December                 infestations of sugarcane aphids.
                                             objection to any aspect of this regulation              31, 2019.                                                The state agencies asserted that
                                             and may also request a hearing on those                    Section 408(l)(6) of FFDCA requires                emergency conditions existed in
                                             objections. You must file your objection                EPA to establish a time-limited                       accordance with the criteria for
                                             or request a hearing on this regulation                 tolerance or exemption from the                       approval of an emergency exemption,
                                             in accordance with the instructions                     requirement of a tolerance for pesticide              and declared crisis exemptions under 40
                                             provided in 40 CFR part 178. To ensure                  chemical residues in food that will                   CFR part 166, subpart C, to allow the
                                             proper receipt by EPA, you must                         result from the use of a pesticide under              use of flupyradifurone on sweet
                                             identify docket ID number EPA–HQ–                       crisis exemptions issued under FIFRA                  sorghum for control of sugarcane
                                             OPP–2016–0557 in the subject line on                    section 18. Such tolerances can be                    aphids. After having reviewed the
                                             the first page of your submission. All                  established without providing notice or               emergency actions, EPA concurred on
                                             objections and requests for a hearing                   period for public comment. EPA does                   the crisis exemptions on July 21, 2016
                                             must be in writing, and must be                         not intend for its actions on FIFRA                   in order to meet the needs of sweet
pmangrum on DSK3GDR082PROD with RULES




                                             received by the Hearing Clerk on or                     section 18 related time-limited                       sorghum growers in Arkansas,
                                             before May 9, 2017. Addresses for mail                  tolerances to set binding precedents for              Kentucky, Mississippi, North Carolina,
                                             and hand delivery of objections and                     the application of FFDCA section 408                  and Tennessee who faced significant
                                             hearing requests are provided in 40 CFR                 and the safety standard to other                      economic loss resulting from sugarcane
                                             178.25(b).                                              tolerances and exemptions. Section                    aphid damage. These crisis exemption
                                               In addition to filing an objection or                 408(e) of FFDCA allows EPA to                         programs expired on November 15,
                                             hearing request with the Hearing Clerk                  establish a tolerance or an exemption                 2016.


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                                                                 Federal Register / Vol. 82, No. 46 / Friday, March 10, 2017 / Rules and Regulations                                         13253

                                                As part of its evaluation of the                     IV. Aggregate Risk Assessment and                     exposure level—generally referred to as
                                             proposed crisis exemptions, EPA                         Determination of Safety                               a population-adjusted dose (PAD) or a
                                             assessed the potential risks presented by                  Section 408(b)(2)(A)(i) of FFDCA                   reference dose (RfD)—and a safe margin
                                             residues of flupyradifurone in or on                    allows EPA to establish a tolerance (the              of exposure (MOE). For non-threshold
                                             sweet sorghum. In doing so, EPA                         legal limit for a pesticide chemical                  risks, the Agency assumes that any
                                             considered the safety standard in                       residue in or on a food) only if EPA                  amount of exposure will lead to some
                                             FFDCA section 408(b)(2), and EPA                        determines that the tolerance is ‘‘safe.’’            degree of risk. Thus, the Agency
                                             decided that the necessary time-limited                 Section 408(b)(2)(A)(ii) of FFDCA                     estimates risk in terms of the probability
                                             tolerances under FFDCA section                          defines ‘‘safe’’ to mean that ‘‘there is a            of an occurrence of the adverse effect
                                             408(l)(6) would be consistent with the                                                                        expected in a lifetime. For more
                                                                                                     reasonable certainty that no harm will
                                             safety standard and with FIFRA section                                                                        information on the general principles
                                                                                                     result from aggregate exposure to the
                                             18. Consistent with the need to move                                                                          EPA uses in risk characterization and a
                                                                                                     pesticide chemical residue, including
                                                                                                                                                           complete description of the risk
                                             quickly on these emergency exemptions                   all anticipated dietary exposures and all
                                                                                                                                                           assessment process, see http://
                                             in order to address an urgent non-                      other exposures for which there is
                                                                                                                                                           www.epa.gov/pesticides/factsheets/
                                             routine situation and to ensure that the                reliable information.’’ This includes
                                                                                                                                                           riskassess.htm.
                                             resulting food is safe and lawful, EPA is               exposure through drinking water and in                   A summary of the toxicological
                                             issuing these time-limited tolerances                   residential settings, but does not include            endpoints for flupyradifurone used for
                                             without notice and opportunity for                      occupational exposure. Section                        human risk assessment is discussed in
                                             public comment as provided in FFDCA                     408(b)(2)(C) of FFDCA requires EPA to                 Table 1 of Unit III B. of the final rule
                                             section 408(l)(6). Although these time-                 give special consideration to exposure                published in the Federal Register of
                                             limited tolerances expire on December                   of infants and children to the pesticide              January 23, 2015 (80 FR 3483) (FRL–
                                             31, 2019 under FFDCA section 408(l)(5),                 chemical residue in establishing a                    9914–77).
                                             residues of the pesticide not in excess                 tolerance and to ‘‘ensure that there is a
                                                                                                     reasonable certainty that no harm will                B. Exposure Assessment
                                             of the amounts specified in the
                                             tolerances remaining in or on sweet                     result to infants and children from                      1. Dietary exposure from food and
                                             sorghum, forage and sorghum, syrup                      aggregate exposure to the pesticide                   feed uses. In evaluating dietary
                                             after that date will not be unlawful,                   chemical residue. . . .’’                             exposure to flupyradifurone, EPA
                                                                                                        Consistent with the factors specified              considered exposure under the time-
                                             provided the pesticide was applied in a
                                                                                                     in FFDCA section 408(b)(2)(D), EPA has                limited tolerances established by this
                                             manner that was lawful under FIFRA,
                                                                                                     reviewed the available scientific data                action as well as all existing
                                             and the residues do not exceed a level
                                                                                                     and other relevant information in                     flupyradifurone tolerances in 40 CFR
                                             that was authorized by these time-                      support of this action. EPA has                       180.679. EPA assessed dietary
                                             limited tolerances at the time of that                  sufficient data to assess the hazards of              exposures from flupyradifurone in food
                                             application. EPA will take action to                    and to make a determination on                        as follows:
                                             revoke these time-limited tolerances                    aggregate exposure expected as a result                  i. Acute exposure. Quantitative acute
                                             earlier if any experience with scientific               of these emergency exemption requests                 dietary exposure and risk assessments
                                             data or other relevant information on                   and the time-limited tolerances for                   are performed for a food-use pesticide,
                                             this pesticide indicate that the residues               residues of flupyradifurone on sweet                  if a toxicological study has indicated the
                                             are not safe.                                           sorghum, forage and sorghum, syrup at                 possibility of an effect of concern
                                                Because these time-limited tolerances                30.0 and 90.0 parts per million (ppm)                 occurring as a result of a 1-day or single
                                             are being approved under emergency                      respectively. EPA’s assessment of                     exposure. Such effects were identified
                                             conditions, EPA has not made any                        exposures and risks associated with                   for flupyradifurone. In estimating acute
                                             decisions about whether                                 establishing these time-limited                       dietary exposure, EPA used food
                                             flupyradifurone meets FIFRA’s                           tolerances follows.                                   consumption data from the United
                                             registration requirements for use on                                                                          States Department of Agriculture’s
                                                                                                     A. Toxicological Points of Departure/                 (USDA’s) National Health and Nutrition
                                             sweet sorghum or whether permanent                      Levels of Concern
                                             tolerances for this use would be                                                                              Examination Survey, What We Eat in
                                                                                                        Once a pesticide’s toxicological                   America (NHANES/WWEIA; 2003–
                                             appropriate. Under these circumstances,
                                                                                                     profile is determined, EPA identifies                 2008), which it should be noted did not
                                             EPA does not believe that these time-
                                                                                                     toxicological points of departure (POD)               identify any individuals as consuming
                                             limited tolerance decisions serve as a
                                                                                                     and levels of concern to use in                       sweet sorghum. The flupyradifurone
                                             basis for registration of flupyradifurone
                                                                                                     evaluating the risk posed by human                    acute dietary exposure assessment was
                                             by a State for special local needs under                exposure to the pesticide. For hazards                conducted using the Dietary Exposure
                                             FIFRA section 24(c), nor do these time-                 that have a threshold below which there               Evaluation Model (DEEM, ver. 3.16). An
                                             limited tolerances by themselves serve                  is no appreciable risk, the toxicological             unrefined acute dietary exposure
                                             as the authority for persons in any State               POD is used as the basis for derivation               analysis was performed for the
                                             other than Arkansas, Kentucky,                          of reference values for risk assessment.              established and requested uses of
                                             Mississippi, North Carolina, and                        PODs are developed based on a careful                 flupyradifurone that incorporated
                                             Tennessee to use this pesticide on sweet                analysis of the doses in each                         recommended tolerance-level residues,
                                             sorghum under FIFRA section 18 absent                   toxicological study to determine the                  default and empirical processing factors,
                                             the issuance of an emergency exemption                  dose at which no adverse effects are                  and assumed that 100% of the crops
pmangrum on DSK3GDR082PROD with RULES




                                             applicable within that State. For                       observed (the no observed adverse effect              were treated.
                                             additional information regarding the                    level or NOAEL) and the lowest dose at                   ii. Chronic exposure. In conducting
                                             emergency exemptions for                                which adverse effects of concern are                  the chronic dietary (food and drinking
                                             flupyradifurone, contact the Agency’s                   identified (the lowest observed adverse               water) exposure and risk assessment
                                             Registration Division at the address                    effect level or LOAEL). Uncertainty/                  EPA used the food consumption data
                                             provided under FOR FURTHER                              safety factors are used in conjunction                from the USDA’s NHANES/WWEIA;
                                             INFORMATION CONTACT.                                    with the POD to calculate a safe                      2003–2008, which did not identify any


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                                             13254               Federal Register / Vol. 82, No. 46 / Friday, March 10, 2017 / Rules and Regulations

                                             individuals as consuming sweet                          occupational, non-dietary exposure                    increase in susceptibility in the rabbit
                                             sorghum. The flupyradifurone chronic                    (e.g., for lawn and garden pest control,              developmental and rat reproduction
                                             dietary exposure assessment was                         indoor pest control, termiticides, and                studies. In the rabbit developmental
                                             conducted using the Dietary Exposure                    flea and tick control on pets).                       study, no maternal effect was seen at the
                                             Evaluation Model (DEEM, ver. 3.16). An                     Flupyradifurone is not registered for              highest tested dose (80 milligram/
                                             unrefined chronic dietary exposure                      any specific use patterns that would                  kilogram/day (mg/kg/day)), while there
                                             analysis was performed for the                          result in residential exposure.                       was an increase in fetal death and
                                             established and requested uses of                       Residential exposure is not anticipated               decrease fetal body weight at the same
                                             flupyradifurone that incorporated                       from the proposed section 18 use on                   dose level. In the rat reproduction
                                             recommended tolerance-level residues,                   sweet sorghum.                                        study, decreases in maternal body
                                             default and empirical processing factors,                  Further information regarding EPA                  weight were seen at 137 mg/kg/day,
                                             and assumed that 100% of the crops                      standard assumptions and generic                      whereas decreases in pup body weight
                                             were treated.                                           inputs for residential exposures may be               were seen at the next lower dose, 38.7
                                                iii. Cancer. Based on the data                       found at: http://www.epa.gov/                         mg/kg/day. However, the PODs selected
                                             summarized in Table 1 of Unit III B. of                 pesticides/trac/science/trac6a05.pdf.                 for risk assessment are protective of the
                                             the final rule published in the Federal                    4. Cumulative effects from substances              quantitative susceptibility seen in the
                                             Register of January 23, 2015 (80 FR                     with a common mechanism of toxicity.                  rabbit fetuses and rat pups.
                                             3483) (FRL–9914–77), EPA has                            Section 408(b)(2)(D)(v) of FFDCA                         3. Conclusion. EPA has determined
                                             concluded that flupyradifurone does not                 requires that, when considering whether               that reliable data show that the safety of
                                             pose a cancer risk to humans. Therefore,                to establish, modify, or revoke a                     infants and children would be
                                             a dietary exposure assessment for the                   tolerance, the Agency consider                        adequately protected if the FQPA SF
                                             purpose of assessing cancer risk is                     ‘‘available information’’ concerning the
                                                                                                                                                           were reduced to 1x. That decision is
                                             unnecessary.                                            cumulative effects of a particular
                                                                                                                                                           based on the following findings:
                                                iv. Anticipated residue and percent                  pesticide’s residues and ‘‘other
                                                                                                                                                              i. The toxicity database for
                                             crop treated (PCT) information. EPA did                 substances that have a common
                                                                                                                                                           flupyradifurone is complete.
                                             not use anticipated residue and/or PCT                  mechanism of toxicity.’’
                                                                                                        EPA has not found flupyradifurone to                  ii. Although there is evidence that
                                             information in the dietary assessment
                                                                                                     share a common mechanism of toxicity                  flupyradifurone has neurotoxic effects,
                                             for flupyradifurone. Tolerance level
                                                                                                     with any other substances, and                        EPA has a complete set of neurotoxicity
                                             residues and 100% CT were assumed
                                                                                                     flupyradifurone does not appear to                    studies (acute, subchronic, and
                                             for all food commodities.
                                                2. Dietary exposure from drinking                    produce a toxic metabolite produced by                developmental). The effects of those
                                             water. The Agency used screening level                  other substances. For the purposes of                 studies are well-characterized and
                                             water exposure models in the dietary                    this time-limited tolerance action,                   indicate neurotoxic effects that occur at
                                             exposure analysis and risk assessment                   therefore, EPA has assumed that                       levels above the chronic POD that was
                                             for flupyradifurone in drinking water.                  flupyradifurone does not have a                       selected for risk assessment. The
                                             These simulation models take into                       common mechanism of toxicity with                     NOAEL for the acute neurotoxicity
                                             account data on the physical, chemical,                 other substances. For information                     study is being used for the acute POD.
                                             and fate/transport characteristics of                   regarding EPA’s efforts to determine                  Therefore, there is no need to retain the
                                             flupyradifurone. Further information                    which chemicals have a common                         10X FQPA SF to account for any
                                             regarding EPA drinking water models                     mechanism of toxicity and to evaluate                 uncertainty concerning these effects.
                                             used in pesticide exposure assessment                   the cumulative effects of such                           iii. There is no evidence that
                                             can be found at http://www.epa.gov/                     chemicals, see EPA’s Web site at http://              flupyradifurone produces increased
                                             oppefed1/models/water/index.htm.                        www.epa.gov/pesticides/cumulative.                    susceptibility in the prenatal
                                                Based on the Pesticide Root Zone                                                                           developmental study in rats, but there is
                                             Model/Exposure Analysis Modeling                        C. Safety Factor for Infants and Children             increased quantitative susceptibility in
                                             System (PRZM/EXAMS), Tier 1 Rice                           1. In general. Section 408(b)(2)(C) of             rabbit fetuses and in the rat pups.
                                             Model and Pesticide Root Zone Model                     FFDCA provides that EPA shall apply                   However, the PODs selected for risk
                                             Ground Water (PRZM GW) model, the                       an additional tenfold (10X) margin of                 assessment are protective of the
                                             estimated drinking water concentrations                 safety for infants and children in the                quantitative susceptibility seen in the
                                             (EDWCs) of flupyradifurone for acute                    case of threshold effects to account for              fetuses and rat pups.
                                             exposures are estimated to be 112 parts                 prenatal and postnatal toxicity and the                  iv. There are no residual uncertainties
                                             per billion (ppb) for surface water and                 completeness of the database on toxicity              identified in the exposure databases.
                                             352 ppb for ground water, and for                       and exposure unless EPA determines                    The dietary food exposure assessments
                                             chronic exposures are estimated to be                   based on reliable data that a different               were performed based on 100 PCT and
                                             112 ppb for surface water and 307 ppb                   margin of safety will be safe for infants             tolerance-level residues. EPA made
                                             for ground water.                                       and children. This additional margin of               conservative (protective) assumptions in
                                                Modeled estimates of drinking water                  safety is commonly referred to as the                 the ground and surface water modeling
                                             concentrations were directly entered                    Food Quality Protection Act (FQPA)                    used to assess exposure to
                                             into the dietary exposure model. For the                Safety Factor (SF). In applying this                  flupyradifurone in drinking water. EPA
                                             acute dietary risk assessment, the water                provision, EPA either retains the default             used similarly conservative assumptions
                                             concentration value of 352 ppb was                      value of 10X, or uses a different                     to assess post-application exposure of
                                             used to assess the contribution to                      additional SF when reliable data                      children. These assessments will not
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                                             drinking water. For the chronic dietary                 available to EPA support the choice of                underestimate the exposure and risks
                                             risk assessment, the water concentration                a different factor.                                   posed by flupyradifurone.
                                             value of 307 ppb was used to assess the                    2. Prenatal and postnatal sensitivity.                EPA made conservative (protective)
                                             contribution to drinking water.                         There is no evidence in the rat                       assumptions in the ground and surface
                                                3. From non-dietary exposure. The                    developmental study that developing                   water modeling used to assess exposure
                                             term ‘‘residential exposure’’ is used in                animals have increased susceptibility to              to flupyradifurone in drinking water.
                                             this document to refer to non-                          flupyradifurone. There is quantitative                These assessments will not


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                                                                 Federal Register / Vol. 82, No. 46 / Friday, March 10, 2017 / Rules and Regulations                                         13255

                                             underestimate the exposure and risks                       5. Aggregate cancer risk for U.S.                  sorghum, syrup at 90.0 parts per million
                                             posed by flupyradifurone.                               population. Based on the lack of                      (ppm).
                                                                                                     evidence of carcinogenicity in two
                                             D. Aggregate Risks and Determination of                                                                       VII. Statutory and Executive Order
                                                                                                     adequate rodent carcinogenicity studies,
                                             Safety                                                                                                        Reviews
                                                                                                     flupyradifurone is not expected to pose
                                                EPA determines whether acute and                     a cancer risk to humans.                                 This action establishes tolerances
                                             chronic dietary pesticide exposures are                    6. Determination of safety. Based on               under FFDCA sections 408(e) and
                                             safe by comparing aggregate exposure                    these risk assessments, EPA concludes                 408(l)(6). The Office of Management and
                                             estimates to the acute PAD (aPAD) and                   that there is a reasonable certainty that             Budget (OMB) has exempted these types
                                             chronic PAD (cPAD). For linear cancer                   no harm will result to the general                    of actions from review under Executive
                                             risks, EPA calculates the lifetime                      population, or to infants and children,               Order 12866, entitled ‘‘Regulatory
                                             probability of acquiring cancer given the               from aggregate exposure to                            Planning and Review’’ (58 FR 51735,
                                             estimated aggregate exposure. Short-,                   flupyradifurone residues.                             October 4, 1993). Because this action
                                             intermediate-, and chronic-term risks                                                                         has been exempted from review under
                                                                                                     V. Other Considerations                               Executive Order 12866, this action is
                                             are evaluated by comparing the
                                             estimated aggregate food, water, and                    A. Analytical Enforcement Methodology                 not subject to Executive Order 13211,
                                             residential exposure to the appropriate                                                                       entitled ‘‘Actions Concerning
                                                                                                        An adequate analytical method                      Regulations That Significantly Affect
                                             PODs to ensure that an adequate MOE                     (Method RV–001–P10–03), which uses
                                             exists.                                                                                                       Energy Supply, Distribution, or Use’’ (66
                                                                                                     high-performance liquid                               FR 28355, May 22, 2001) or Executive
                                                1. Acute risk. Using the exposure                    chromatography with tandem mass
                                             assumptions discussed in this unit for                                                                        Order 13045, entitled ‘‘Protection of
                                                                                                     spectrometry (HPLC/MS/MS) to                          Children from Environmental Health
                                             acute exposure, the acute dietary                       quantitate residues of flupyradifurone
                                             exposure from food and water to                                                                               Risks and Safety Risks’’ (62 FR 19885,
                                                                                                     and difluoroacetic acid (DFA) in various              April 23, 1997). This action does not
                                             flupyradifurone will occupy 37% of the                  crops, is available for enforcement.
                                             aPAD for children 1–2 years old, the                                                                          contain any information collections
                                                                                                        The method may be requested from:                  subject to OMB approval under the
                                             population group receiving the greatest                 Chief, Analytical Chemistry Branch,
                                             exposure.                                                                                                     Paperwork Reduction Act (PRA), 44
                                                                                                     Environmental Science Center, 701                     U.S.C. 3501 et seq., nor does it require
                                                2. Chronic risk. Using the exposure                  Mapes Rd., Ft. Meade, MD 20755–5350;                  any special considerations under
                                             assumptions described in this unit for                  telephone number: (410) 305–2905;                     Executive Order 12898, entitled
                                             chronic exposure, EPA has concluded                     email address: residuemethods@                        ‘‘Federal Actions to Address
                                             that chronic exposure to                                epa.gov.                                              Environmental Justice in Minority
                                             flupyradifurone from food and water
                                                                                                     B. International Residue Limits                       Populations and Low-Income
                                             will utilize 86% of the cPAD for
                                                                                                                                                           Populations’’ (59 FR 7629, February 16,
                                             (children 1–2 years old) the population                    In making its tolerance decisions, EPA             1994).
                                             group receiving the greatest exposure.                  seeks to harmonize U.S. tolerances with                  Since tolerances and exemptions that
                                             There are no residential uses for                       international standards whenever                      are established in accordance with
                                             flupyradifurone and residential uses are                possible, consistent with U.S. food                   FFDCA sections 408(e) and 408(l)(6),
                                             not anticipated from the proposed                       safety standards and agricultural                     such as the tolerances in this final rule,
                                             section 18 on sweet sorghum.                            practices. EPA considers the                          do not require the issuance of a
                                                3. Short-term risk. Short-term                       international maximum residue limits                  proposed rule, the requirements of the
                                             aggregate exposure takes into account                   (MRLs) established by the Codex                       Regulatory Flexibility Act (RFA) (5
                                             short-term residential exposure plus                    Alimentarius Commission (Codex), as                   U.S.C. 601 et seq.) do not apply.
                                             chronic exposure to food and water                      required by FFDCA section 408(b)(4).                     This action directly regulates growers,
                                             (considered to be a background                          The Codex Alimentarius is a joint                     food processors, food handlers, and food
                                             exposure level).                                        United Nations Food and Agriculture                   retailers, not States or tribes, nor does
                                                As there are no residential uses of                  Organization/World Health                             this action alter the relationships or
                                             flupyradifurone, flupyradifurone does                   Organization food standards program,                  distribution of power and
                                             not pose a short-term aggregate risk that               and it is recognized as an international              responsibilities established by Congress
                                             differs from the chronic dietary risk                   food safety standards-setting                         in the preemption provisions of FFDCA
                                             addressed in Unit IV.D.2. Chronic                       organization in trade agreements to                   section 408(n)(4). As such, the Agency
                                             dietary risks do not exceed the Agency’s                which the United States is a party. EPA               has determined that this action will not
                                             level for the U.S. population or any                    may establish a tolerance that is                     have a substantial direct effect on States
                                             other population subgroups.                             different from a Codex MRL; however,                  or tribal governments, on the
                                                4. Intermediate-term risk.                           FFDCA section 408(b)(4) requires that                 relationship between the national
                                             Intermediate-term aggregate exposure                    EPA explain the reasons for departing                 government and the States or tribal
                                             takes into account intermediate-term                    from the Codex level.                                 governments, or on the distribution of
                                             non-dietary, non-occupational exposure                     There are currently no established                 power and responsibilities among the
                                             plus chronic exposure to food and water                 Codex or Canadian MRLs for                            various levels of government or between
                                             (considered to be a background                          flupyradifurone residues in sweet                     the Federal Government and Indian
                                             exposure level).                                        sorghum commodities.                                  tribes. Thus, the Agency has determined
                                                As there are no residential uses of                                                                        that Executive Order 13132, entitled
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                                             flupyradifurone, flupyradifurone does                   VI. Conclusion                                        ‘‘Federalism’’ (64 FR 43255, August 10,
                                             not pose an intermediate-term aggregate                    Therefore, time-limited tolerances are             1999) and Executive Order 13175,
                                             risk that differs from the chronic dietary              established for residues of                           entitled ‘‘Consultation and Coordination
                                             risk addressed in Unit IV.D.2. Chronic                  flupyradifurone, [4-[[(6-chloro-3-                    with Indian Tribal Governments’’ (65 FR
                                             dietary risks do not exceed the Agency’s                pyridinyl)methyl](2,2-                                67249, November 9, 2000) do not apply
                                             level for the U.S. population or any                    difluoroethyl)amino]-2(5H)-furanone] in               to this action. In addition, this action
                                             other population subgroups.                             or on sweet sorghum, forage at 30.0 and               does not impose any enforceable duty or


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                                             13256                      Federal Register / Vol. 82, No. 46 / Friday, March 10, 2017 / Rules and Regulations

                                             contain any unfunded mandate as                                          List of Subjects in 40 CFR Part 180                                       § 180.679 Flupyradifurone; tolerances for
                                             described under Title II of the Unfunded                                                                                                           residues.
                                             Mandates Reform Act (UMRA) (2 U.S.C.                                       Environmental protection,                                               *      *     *    *     *
                                             1501 et seq.).                                                           Administrative practice and procedure,
                                               This action does not involve any                                       Agricultural commodities, Pesticides                                         (b) Section 18 emergency exemptions.
                                             technical standards that would require                                   and pests, Reporting and recordkeeping                                    Time-limited tolerances are established
                                             Agency consideration of voluntary                                        requirements.                                                             for residues of flupyradifurone,
                                             consensus standards pursuant to section                                                                                                            including its metabolites and degradates
                                                                                                                        Dated: February 13, 2017.
                                             12(d) of the National Technology                                                                                                                   in or on the specified commodities
                                                                                                                      Michael Goodis,
                                             Transfer and Advancement Act                                                                                                                       listed in the table below, resulting from
                                                                                                                      Director, Registration Division, Office of                                use of the pesticide under section 18
                                             (NTTAA) (15 U.S.C. 272 note).
                                                                                                                      Pesticide Programs.
                                                                                                                                                                                                emergency exemptions granted by EPA.
                                             VIII. Congressional Review Act                                             Therefore, 40 CFR chapter I is                                          The time-limited tolerances expire and
                                               Pursuant to the Congressional Review                                   amended as follows:                                                       are revoked on the date specified in the
                                             Act (5 U.S.C. 801 et seq.), EPA                                                                                                                    table. Compliance with the tolerance
                                             submitted a report containing a draft of                                 PART 180—[AMENDED]                                                        levels specified in the following table is
                                             this rule and other required information                                                                                                           to be determined by measuring only
                                             to the U.S. Senate, the U.S. House of                                    ■ 1. The authority citation for part 180                                  flupyradifurone, 4-[[(6-chloro-3-
                                             Representatives, and the Comptroller                                     continues to read as follows:                                             pyridinyl)methyl](2,2-
                                             General of the United States prior to
                                                                                                                          Authority: 21 U.S.C. 321(q), 346a and 371.                            difluoroethyl)amino]-2(5H)-furanone in
                                             publication of the rule in the Federal
                                                                                                                                                                                                or on the commodity.
                                             Register. This action is not a ‘‘major                                   ■ 2. In § 180.679, revise paragraph (b) to
                                             rule’’ as defined by 5 U.S.C. 804(2).                                    read as follows:

                                                                                                                                                                                                            Parts per
                                                                                                                 Commodity                                                                                   million          Expiration date
                                                                                                                                                                                                             (ppm)

                                             sorghum, syrup ............................................................................................................................................            90.0   December 31, 2019.
                                             sweet sorghum, forage ................................................................................................................................                 30.0   December 31, 2019.



                                             *        *        *         *         *                                  are listed in the www.regulations.gov                                     consistent with, and no less stringent
                                             [FR Doc. 2017–04794 Filed 3–9–17; 8:45 am]                               index. Although listed in the index,                                      than the federal program. As the federal
                                             BILLING CODE 6560–50–P                                                   some of the information is not publicly                                   program changes, states must change
                                                                                                                      available, e.g., Confidential Business                                    their programs and request EPA to
                                                                                                                      Information or other information whose                                    authorize the changes. Changes to state
                                             ENVIRONMENTAL PROTECTION                                                 disclosure is restricted by statute.                                      programs may be necessary when
                                             AGENCY                                                                   Certain other material, such as                                           federal or state statutory or regulatory
                                                                                                                      copyrighted material, will be publicly                                    authority is modified or when certain
                                             40 CFR Part 271                                                          available only in hard copy. Publicly                                     other changes occur. Most commonly,
                                             [EPA–R05–RCRA–2015–0555; FRL–9958–                                       available docket materials are available                                  states must change their programs
                                             05–Region 5]                                                             either electronically at                                                  because of changes to EPA’s regulations
                                                                                                                      www.regulations.gov or in hard copy.                                      in 40 Code of Federal Regulations (CFR)
                                             Illinois: Final Authorization of State                                   You may view and copy Illinois’                                           parts 124, 260 through 266, 268, 270,
                                             Hazardous Waste Management                                               application from 9:00 a.m. to 4:00 p.m.                                   273 and 279.
                                             Program Revision                                                         at the following addresses: U.S. EPA
                                                                                                                                                                                                B. What decisions have we made in this
                                             AGENCY:  Environmental Protection                                        Region 5, LR–8J, 77 West Jackson
                                                                                                                                                                                                rule?
                                             Agency (EPA).                                                            Boulevard, Chicago, Illinois 60604,
                                             ACTION: Final rule.                                                      contact: Gary Westefer (312) 886–7450;                                       We conclude that Illinois’ application
                                                                                                                      or Illinois Environmental Protection                                      to revise its authorized program meets
                                             SUMMARY:   EPA is granting the State of                                  Agency, 1021 North Grand Avenue,                                          all of the statutory and regulatory
                                             Illinois Final Authorization of the                                      East, Springfield, Illinois, contact: Todd                                requirements established by RCRA.
                                             changes to its hazardous waste program                                   Marvel (217) 524–5024.                                                    Therefore, we are granting Illinois final
                                             under the Resource Conservation and                                      FOR FURTHER INFORMATION CONTACT: Gary                                     authorization to operate its hazardous
                                             Recovery Act (RCRA). The Agency                                          Westefer, Illinois Regulatory Specialist,                                 waste program with the changes
                                             published a proposed rule on March 18,                                   U.S. EPA Region 5, LR–8J, 77 West                                         described in the authorization
                                             2016, and provided for public comment.                                   Jackson Boulevard, Chicago, Illinois                                      application. Illinois will have
                                             EPA received no comments. No further                                     60604, (312) 886–7450, email                                              responsibility for permitting treatment,
                                             opportunity for comment will be                                          westefer.gary@epa.gov.                                                    storage, and disposal facilities (TSDFs)
                                             provided. EPA has determined that                                        SUPPLEMENTARY INFORMATION:                                                within its borders (except in Indian
                                             these changes satisfy all requirements                                                                                                             Country) and for carrying out the
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                                             needed to qualify for final authorization.                               A. Why are revisions to state programs                                    aspects of the RCRA program described
                                             DATES: The final authorization will be                                   necessary?                                                                in its revised program application,
                                             effective on March 10, 2017.                                               States which have received final                                        subject to the limitations of the
                                             ADDRESSES: EPA has established a                                         authorization from EPA under RCRA                                         Hazardous and Solid Waste
                                             docket for this action under Docket                                      Section 3006(b) of RCRA, 42 U.S.C.                                        Amendments of 1984 (HSWA). New
                                             Identification No. EPA–R05–RCRA–                                         6926(b), must maintain a hazardous                                        federal requirements and prohibitions
                                             2015–0555. All documents in the docket                                   waste program that is equivalent to,                                      imposed by federal regulations that EPA


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Document Created: 2018-02-01 14:52:36
Document Modified: 2018-02-01 14:52:36
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective 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).
ContactMichael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
FR Citation82 FR 13251 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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