82 FR 46929 - Tolfenpyrad; Pesticide Tolerances for Emergency Exemptions

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 194 (October 10, 2017)

This regulation establishes time-limited tolerances for residues of tolfenpyrad in or on dry bulb onion and watermelon. This action is in response to EPA's granting of emergency exemptions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on dry bulb onion and watermelon. This regulation establishes maximum permissible levels for residues of tolfenpyrad in or on these commodities. The time-limited tolerances expire on December 31, 2020.

[Federal Register Volume 82, Number 194 (Tuesday, October 10, 2017)]
[Rules and Regulations]
[Pages 46929-46934]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21797]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0309; FRL-9967-72]


Tolfenpyrad; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes time-limited tolerances for 
residues of tolfenpyrad in or on dry bulb onion and watermelon. This 
action is in response to EPA's granting of emergency exemptions under 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on dry bulb onion and watermelon. This 
regulation establishes maximum permissible levels for residues of 
tolfenpyrad in or on these commodities. The time-limited tolerances 
expire on December 31, 2020.

DATES: This regulation is effective October 10, 2017. Objections and 
requests for hearings must be received on or before December 11, 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-2017-0309, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION: 

[[Page 46930]]

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select 
``Test Guidelines for Pesticides and Toxic Substances.''

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-
2017-0309 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 December 11, 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-2017-0309, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing time-limited tolerances for residues of tolfenpyrad (4-
chloro-3-ethyl-1-methyl-N-[4-(p-tolyloxy)benzyl]pyrazole-5-
carboxamide), including its metabolites and degradates, in or on dry 
bulb onion at 0.09 parts per million (ppm), and watermelon at 0.7 ppm. 
These time-limited tolerances expire on December 31, 2020.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemptions for Tolfenpyrad on Dry Bulb Onion and 
Watermelon, and FFDCA Tolerances

    The Texas Department of Agriculture (TDA) stated that an emergency 
situation required the use of tolfenpyrad on dry bulb onions (Allium 
cepa) to control onion thrips (Thrips tabaci Lindeman) in the Texas 
counties of Cameron, Dimmitt, Frio, Hidalgo, Maverick, Starr, Uvalde, 
Willacy and Zavala. According to TDA, this year's exceptionally mild 
winter and record high heat caused the development of large populations 
of onion thrips, a principle pest of onions, early in the onion crop 
cycle. The threshold level for applying pesticides to control thrips in 
onions is 5 to 25 thrips per plant, and TDA stated that over 100 thrips 
per plant were observed in Texas' dry bulb onion fields in early March, 
2017. TDA stated that multiple applications of registered pesticides 
were not controlling these extreme population levels which can reduce 
yields and bulb size by as much as 50%. In addition, the transmission 
of iris yellow spot virus in onions, exclusively vectored by onion 
thrips, is a concern, and several onion fields have been observed with 
positive symptoms. TDA stated that this virus severely affects the 
shipping quality of onions, and can be more devastating than damage 
from the thrips themselves. Upon EPA concurrence, TDA allowed the use 
of tolfenpyrad under the provisions of a crisis exemption beginning on 
March 17, 2017, and

[[Page 46931]]

subsequently requested a specific exemption to allow the use of 
tolfenpyrad in dry bulb onions to continue beyond the 15 days provided 
by a crisis exemption alone.
    Separately, the Hawaii Department of Agriculture (HDA) stated that 
an emergency developed due to outbreaks of melon thrips in watermelon 
fields at unusually high levels, (up to 200 thrips per leaf), which 
registered pesticides were not controlling. HDA stated that above-
average rainfall caused rapid growth of host plants, leading to 
development of very high levels of melon thrips in areas near 
watermelon fields. Subsequently, a 6-week drought caused early dry-down 
of this rainy-season vegetation, prompting massive migrations of melon 
thrips into neighboring watermelon fields. HDA stated that the melon 
thrips infestations have caused stunted vines, foliage discoloration, 
and in some instances have caused such severe damage that the plants no 
longer produce fruit. The melon aphid also transmits the tomato spotted 
wilt virus, which causes silver mottle disease in watermelon, further 
damaging the plants and causing additional yield losses. HDA stated 
that some watermelon acreage was abandoned due to the high level of 
damage from melon thrips infestations, and that significant yield and 
economic losses would occur in the remaining watermelon acreage without 
the requested use of tolfenpyrad. Upon EPA concurrence, HDA allowed the 
use of tolfenpyrad under the provisions of a crisis exemption, 
beginning on May 31, 2017, subsequently requesting a specific exemption 
to allow the use of tolfenpyrad in watermelon to continue beyond the 15 
days provided under a crisis exemption alone.
    After having reviewed the submissions, EPA determined that 
emergency conditions exist for these States, and that the criteria for 
approval of the emergency exemptions had been met. Therefore, EPA 
authorized specific exemptions under FIFRA section 18 for the use of 
tolfenpyrad on dry bulb onion for control of onion thrips in Texas, and 
on watermelon for control of melon thrips in Hawaii.
    As part of its evaluation of the emergency exemption applications, 
EPA assessed the potential risks presented by residues of tolfenpyrad 
in or on dry bulb onion and watermelon. In doing so, EPA considered the 
safety standard in FFDCA section 408(b)(2), and decided that the 
necessary tolerances under FFDCA section 408(l)(6) would be consistent 
with the safety standard and with FIFRA section 18. Consistent with the 
need to move quickly on the emergency exemptions in order to address 
urgent, non-routine situations and to ensure that the resulting food is 
safe and lawful, EPA is issuing these 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, 2020, 
under FFDCA section 408(l)(5), residues of the pesticide not in excess 
of the amounts specified in the tolerances remaining in or on dry bulb 
onion or watermelon 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 on, 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 
tolfenpyrad meets FIFRA's registration requirements for use on dry bulb 
onion and watermelon or whether permanent tolerances for these uses 
would be appropriate. Under these circumstances, EPA does not believe 
that these time-limited tolerance decisions serve as bases for 
registration of tolfenpyrad by a State for special local needs under 
FIFRA section 24(c), nor do these tolerances by themselves serve as the 
authority for persons in any States other than Texas and Hawaii to use 
this pesticide on the applicable crops under FIFRA section 18, absent 
the issuance of an emergency exemption applicable within that State. 
For additional information regarding the emergency exemptions for 
tolfenpyrad, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with the factors specified in FFDCA section 
408(b)(2)(D), EPA has reviewed the available scientific data and other 
relevant information in support of this action. EPA has sufficient data 
to assess the hazards of, and to make a determination on, aggregate 
exposure expected as a result of these emergency exemptions and the 
time-limited tolerances for residues of tolfenpyrad on dry bulb onion 
at 0.09 ppm, and watermelon at 0.7 ppm. EPA's assessment of exposures 
and risks associated with establishing the 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 to humans by exposure to 
the pesticide. For hazards that have a threshold below which there is 
no appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    A summary of the toxicological profile and endpoints for 
tolfenpyrad used for human health risk assessment is discussed in Table 
1 of the final rule published in the Federal Register of January 9, 
2014, (79 FR 1599) (FRL-9904-70).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tolfenpyrad, EPA considered exposures under the time-
limited tolerances established by this action as well as all existing 
tolfenpyrad tolerances in 40 CFR 180.675. EPA assessed dietary 
exposures from tolfenpyrad in food as follows:
    i. Acute exposure. Acute dietary exposure is quantified 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 tolfenpyrad. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination 
Survey/What We

[[Page 46932]]

Eat in America (NHANES/WWEIA). For the purposes of this acute exposure 
assessment, EPA assumed tolerance-level residues and 100 percent crop 
treated (PCT) for those crops on which tolfenpyrad use is registered 
and proposed.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. For the purposes of this chronic exposure assessment, EPA 
assumed 100 PCT and incorporated average residue levels from crop field 
trials for registered and proposed uses of tolfenpyrad.
    iii. Cancer. No evidence of carcinogenicity was observed in cancer 
studies with mice and rats. For further detail on the results of these 
studies see ``Tolfenpyrad. Human Health Risk Assessment'' at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2012-0909. 
Therefore, in accordance with EPA's Final Guidelines for Carcinogen 
Risk Assessment (March 2005), tolfenpyrad is classified as ``not likely 
to be carcinogenic to humans'' and a cancer risk assessment is 
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for tolfenpyrad in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of tolfenpyrad. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
tolfenpyrad are 26.9 ppb for acute exposure and 12.2 ppb for chronic 
exposure. These modeled estimates of drinking water concentrations were 
directly entered into the dietary exposure model.
    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).
    Tolfenpyrad is not registered for any specific use patterns that 
would result in residential exposure. Further information regarding EPA 
standard assumptions and generic inputs for residential exposures may 
be found at: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found tolfenpyrad to share a common mechanism of 
toxicity with any other substances, and tolfenpyrad does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
tolfenpyrad does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. No evidence of increased 
quantitative or qualitative susceptibility was observed in 
developmental toxicity studies in rats or rabbits or a reproduction 
toxicity study in rats. However, the developmental immunotoxicity study 
(DIT) in rats suggests increased qualitative susceptibility in the 
young since toxicity observed in offspring animals was more pronounced 
than toxicity seen in maternal animals at the same dose. No evidence of 
quantitative susceptibility was seen in the study. There is low concern 
and there are no residual uncertainties regarding the increased 
qualitative prenatal and/or postnatal susceptibility observed for 
tolfenpyrad. When the DIT and the reproduction study are considered 
together, the offspring toxicity in the DIT is comparable in severity 
to maternal toxicity observed at the same dose in the reproduction 
study. Since the adverse effects in young occurred at exposure levels 
that have shown comparable effects in adults, EPA does not consider the 
DIT persuasive evidence of an increased susceptibility of infants or 
children to tolfenpyrad. Additionally, the effects observed in the DIT 
study are well-characterized, a clear NOAEL was identified, and the 
endpoints chosen for risk assessment are protective of potential 
offspring effects since a dermal hazard was not identified for 
tolfenpyrad, inhalation risk assessments are based on a route specific 
inhalation study, and the POD used for chronic dietary risk assessment 
is lower than where offspring effects were seen in the DIT study.
    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 tolfenpyrad is complete.
    ii. There is no indication that tolfenpyrad is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. Although there is possibly increased qualitative 
susceptibility in the young in the DIT study in rats, there are no 
residual uncertainties regarding increased susceptibility for 
tolfenpyrad since, (1) comparable maternal toxicity was observed at the 
same dose in the

[[Page 46933]]

reproduction study, (2) the offspring effects observed in the DIT study 
are well characterized and there is a clear NOAEL for the effects seen, 
(3) no evidence of quantitative susceptibility was seen in the DIT 
study and susceptibility was not observed (quantitative or qualitative) 
in rat or rabbit developmental toxicity or reproduction studies tested 
at similar doses, (4) the endpoints and PODs selected for risk 
assessment are protective, and (5) direct non-dietary exposure to 
children is not anticipated since there are no residential uses for 
tolfenpyrad. Thus, an additional FQPA safety factor is not necessary to 
protect infants and children.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to tolfenpyrad in 
drinking water. Accordingly, these assessments will not underestimate 
the exposure and risks posed by tolfenpyrad.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food, 
drinking water and relevant residential exposure scenarios. Since there 
are no residential uses for tolfenpyrad, acute residential exposure is 
not anticipated and acute aggregate exposure results from dietary 
exposure to residues in food and drinking water alone. Therefore, acute 
aggregate risk estimates are equivalent to the acute dietary risk 
estimates. Using the exposure assumptions discussed in this unit for 
acute exposure, the acute dietary exposure from food and water to 
tolfenpyrad will occupy 56% of the aPAD for the general U.S. 
population. Children 3-5 years old are the highest-exposed population 
subgroup with an estimated acute dietary exposure of 80% of the aPAD. 
Typically, EPA has concerns when estimated exposures exceed 100% of the 
acute or chronic population-adjusted dose (aPAD or cPAD). Acute dietary 
risk estimates are below EPA's level of concern for all populations.
    2. Chronic risk. A chronic aggregate risk assessment takes into 
account chronic exposure estimates from dietary consumption of food and 
drinking water and relevant residential exposure scenarios. Since there 
are no residential uses for tolfenpyrad, chronic residential exposure 
is not anticipated and chronic aggregate exposure to tolfenpyrad 
results from dietary exposure to residues in food and drinking water 
alone. Therefore, chronic aggregate risk estimates for tolfenpyrad are 
equivalent to the chronic dietary risk estimates. Using the exposure 
assumptions described in this unit for chronic exposure, EPA has 
concluded that chronic exposure to tolfenpyrad from food and water will 
utilize 32% of the cPAD for the general U.S. population, and 81% of the 
cPAD for children 1-2 years old (the population group receiving the 
greatest exposure).
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic dietary exposure 
from food and water (considered to be a background (average) exposure 
level). A short-term adverse effect was identified; however, 
tolfenpyrad is not registered for any use patterns that would result in 
short-term residential exposure. Because there is no short-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess short-term risk), no further 
assessment of short-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short-term risk for 
tolfenpyrad.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
dietary exposure from food and water (considered to be a background 
exposure level). An intermediate-term adverse effect was identified; 
however, tolfenpyrad is not registered for any use patterns that would 
result in intermediate-term residential exposure. Because there is no 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess intermediate-term 
risk), no further assessment of intermediate-term risk is necessary, 
and EPA relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for tolfenpyrad.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, tolfenpyrad 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 tolfenpyrad residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/tandem mass 
spectrometry (LC/MS/MS)) is available to enforce the tolerance 
expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established MRLs for tolfenpyrad residues in dry bulb onion or 
watermelon.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
tolfenpyrad (4-chloro-3-ethyl-1-methyl-N-[4-(p-
tolyloxy)benzyl]pyrazole-5-carboxamide), including its metabolites and 
degradates, in or on onion, dry bulb at 0.09 ppm, and watermelon at 0.7 
ppm. These tolerances expire on December 31, 2020.

[[Page 46934]]

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 contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 25, 2017.
Michael L. 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.  180.675, revise paragraph (b) to read as follows:


Sec.  180.675  Tolfenpyrad; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of 
tolfenpyrad, (4-chloro-3-ethyl-1-methyl-N-[4-(p-
tolyloxy)benzyl]pyrazole-5-carboxamide, including its metabolites and 
degradates, in or on the specified agricultural commodities, resulting 
from use of the pesticide pursuant to FIFRA section 18 emergency 
exemptions. Compliance with the tolerance levels specified below is to 
be determined by measuring only tolfenpyrad, 4-chloro-3-ethyl-1-methyl-
N-[4-(p-tolyloxy)benzyl]pyrazole-5-carboxamide. The tolerances expire 
on the dates specified in the table.

------------------------------------------------------------------------
                                             Parts per      Expiration
                Commodity                     million          date
------------------------------------------------------------------------
Onion, dry bulb.........................            0.09      12/31/2020
Vegetable, fruiting, group 8-10.........            0.70        12/31/19
Watermelon..............................            0.70      12/31/2020
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-21797 Filed 10-6-17; 8:45 am]
BILLING CODE 6560-50-P