[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
[Rules and Regulations]
[Pages 68938-68944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24093]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0193; FRL-9951-57]
Tolfenpyrad; 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 tolfenpyrad in or on vegetable, fruiting, group 8-10. This
action is in response to EPA's granting of an emergency exemption under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on agricultural commodities in the
group ``vegetable, fruiting, group 8-
[[Page 68939]]
10.'' This regulation establishes a maximum permissible level for
residues of tolfenpyrad in or on these commodities.
The time-limited tolerances expire on December 31, 2019.
DATES: This regulation is effective October 5, 2016. Objections and
requests for hearings must be received on or before December 5, 2016,
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-2016-0193, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://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 http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''
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-
2016-0193 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 5, 2016. 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-2016-0193, 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 tolfenpyrad, 4-
chloro-3-ethyl-1-methyl-N-[4-(p-tolyloxy)benzyl]pyrazole-5-carboxamide,
in or on agricultural commodities in the group ``vegetable, fruiting,
group 8-10'' at 0.70 parts per million (ppm). 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 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.''
[[Page 68940]]
EPA has established regulations governing such emergency exemptions in
40 CFR part 166.
III. Emergency Exemption for Tolfenpyrad on Vegetable, Fruiting, Group
8-10 Commodities and FFDCA Tolerances
The Florida Department of Agriculture and Consumer Services (FDACS)
requested an emergency exemption for the use of tolfenpyrad on fruiting
vegetables to reduce damage incurred by thrips. Thrips have become a
severe problem in Florida on account of their developing resistance to
the insecticides currently registered for use on fruiting vegetable
crops, combined with the appearance of Tomato Chlorotic Spot Virus, a
newly established invasive virus disease vectored by thrips attacking
fruiting vegetables. According to FDACS, substantial economic damage is
occurring and 30% to 90% yield loss has been documented due to the
insufficient efficacy of registered alternatives.
After having reviewed the submission, EPA determined that an
emergency condition exists for this State, and that the criteria for
approval of an emergency exemption are met. EPA has authorized a
specific exemption under FIFRA section 18 for the use of tolfenpyrad on
vegetable, fruiting, group 8-10 for control of thrips in Florida.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of tolfenpyrad
in or on vegetable, fruiting, group 8-10. In doing so, EPA considered
the safety standard in FFDCA section 408(b)(2), and EPA decided that
the necessary tolerances under FFDCA section 408(l)(6) would be
consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent, non-routine situation and to ensure that
the resulting food is safe and lawful, EPA is issuing 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, 2019, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on vegetable, fruiting, group 8-10 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
vegetable, fruiting, group 8-10 or whether permanent tolerances for
this use would be appropriate. Under these circumstances, EPA does not
believe that this time-limited tolerance decision serves as a basis for
registration of tolfenpyrad by a State for special local needs under
FIFRA section 24(c), nor does this tolerance by itself serve as the
authority for persons in any State other than Florida 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 exemption 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
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 this emergency exemption request and
the time-limited tolerances for residues of tolfenpyrad on vegetable,
fruiting, group 8-10 at 0.70 ppm. EPA's assessment of exposures and
risks associated with establishing 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 NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological 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 exposure 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. Quantitative acute dietary exposure and risk
assessment 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
[[Page 68941]]
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA).
For purposes of this acute exposure assessment, EPA assumed 100 percent
crop treated (PCT) and tolerance-level residues.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption information from the USDA
2003-2008 NHANES/WWEIA. For purposes of this chronic exposure
assessment, EPA relied upon average residue levels from crop field
trials. EPA also used PCT estimates (discussed further in Unit
IV.B.1.iv., below) for certain commodities that were shown to have a
high contribution to the overall dietary exposure, while assuming 100
PCT for the rest of the commodities.
iii. Cancer. Based on the data summarized in Unit IV.A., EPA has
concluded that tolfenpyrad 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.
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.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
In this case, EPA used data from the USDA NASS Agricultural
Chemical Usage--Fruit Summary (2003, 2005, 2007, 2009), Vegetable
Summary (2004, 2006, 2010), along with proprietary data to estimate PCT
for four commodities (all others being assumed to be 100 PCT). Based on
that data, EPA estimated average PCTs of 40% for oranges, 60% for
apples, 65% for table grapes, and 50% for spinach.
The Agency believes that the three conditions discussed in Unit
IV.B1.iv. have been met. With respect to Condition a, PCT estimates are
derived from Federal and private market survey data, which are reliable
and have a valid basis. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which tolfenpyrad may be applied in a particular area.
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 http://www.epa.gov/oppefed1/models/water/index.htm.
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 for acute exposures are estimated to be 26.9 parts per
billion (ppb) for surface water and 11 ppb for ground water. For
chronic exposures for non-cancer assessments, the EDWCs are estimated
to be 12.2 ppb for surface water and 11 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
For acute dietary risk assessment, the water concentration value of
26.9 ppb was used to assess the contribution to drinking water.
For chronic dietary risk assessment, the water concentration value
of 12.2 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). 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: 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 tolfenpyrad to share a common mechanism of
toxicity
[[Page 68942]]
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 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 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 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, a 10X 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. EPA used similarly conservative assumptions to assess
post-application exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by 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 and
drinking water and relevant residential exposure scenarios. Since acute
residential exposure is not anticipated, acute aggregate risk from
exposure to tolfenpyrad results from 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 U.S. general population. Children 3-5 years old are
the highest-exposed population subgroup with an estimated exposure of
81% 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
chronic residential exposure is not anticipated for tolfenpyrad,
chronic aggregate risk from exposure to tolfenpyrad results from
exposure to residues in food and drinking water alone. Therefore,
chronic aggregate risk estimates 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 69% of the cPAD for
(children 1-2 years old) the population group receiving the greatest
exposure. There are no residential uses for tolfenpyrad.
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 (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. Short-term risk is assessed based on short-term
residential exposure plus chronic dietary exposure. Because there is no
short-term residential exposure and chronic dietary
[[Page 68943]]
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 non-dietary, non-occupational
exposure plus chronic exposure to 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. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
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
An 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 a MRL for tolfenpyrad residues in/on
fruiting vegetables.
VI. Conclusion
Therefore, a time-limited tolerance is established for residues of
tolfenpyrad, (4-chloro-3-ethyl-1-methyl-N-[4-(p-
tolyloxy)benzyl]pyrazole-5-carboxamide, in or on the agricultural
commodity ``vegetable, fruiting, group 8-10'' at 0.70 ppm. This
tolerance expires on December 31, 2019.
VII. Statutory and Executive Order Reviews
This action establishes a tolerance 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 tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 26, 2016.
Michael L. Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
[[Page 68944]]
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. [emsp14]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 FFIFRA 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 date specified in the table.
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Vegetable, fruiting, group 8-10............... 0.70 12/31/2019
------------------------------------------------------------------------
* * * * *
[FR Doc. 2016-24093 Filed 10-4-16; 8:45 am]
BILLING CODE 6560-50-P